A Study to Evaluate the Safety and Effectiveness of the Biotrue ONEday for Astigmatism Soft Contact Lens When Worn on a Daily Basis
Phase: NA
Conditions: Astigmatism
Sponsor: Bausch & Lomb Incorporated

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h  a n d De vel o p me nt 
1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Cli nic al St u d y Pr ot oc ol 
Bi otr ue O N E d a y f or Asti g m atis m S oft C o nt act Le ns 
Pr ot oc ol 8 8 5  
A St u d y  t o E v al u ate t he S afet y a n d Effecti ve ness of t he Bi otr ue O N E d a y f or 
Asti g m atis m S oft C o nt act Le ns W he n W or n o n a D ail y B asis  
De vel o p me ntal p hase of st u d y:  
Pi v otal Trial  
St u d y desi g n  
I n vesti gat or/ S p o ns or mas ke d , ra n d o mize d, o pe n -la bel, 
parallel -gr o u p, m ultice nter st u d y  
Date:  
2 3 -A u g -2 0 1 8  
S p o ns or re prese ntati ve  
Cli nical Trial Ma na ger  
S p o ns or 
Ba usc h & L o m b  I nc., a Di visi o n of Valea nt  Researc h  
a n d De vel o p me nt , a s u bsi diar y of Valea nt 
P har mace ut icals N ort h A merica, L L C  
4 0 0 S o merset C or p orate Bl v d.  
Bri d ge water, NJ 0 8 8 0 7  
T he i nf or mati o n i n t h e f oll o wi n g d oc u me nt is c o nfi d e ntial. T he i nf or mati o n c o ntai ne d herei n will n ot be discl ose d t o ot h ers wit h o ut 
writte n a ut h orizati o n fr o m V alea nt P har mace uticals N ort h A meric a, L L C ( V P N A ) a n d its affiliates. T his cli nical i n vesti gati o n will be 
c o n d ucte d i n acc or da nce wit h t he Declarati o n of Helsi n ki o n Et hical Pri n ci ples f or Me dical Researc h I n v ol vi n g H u ma n S u bjects, a n d 
wit h G o o d Cli nical Practice ( G C P), as re q uire d b y t h e U S C o de of Fe deral Re g ulati o ns a p plica ble t o cli nical st u dies ( 2 1 C F R P arts 
1 1, 5 0, 5 4, 5 6 a n d 3 1 2, 4 2 U S C 2 8 2(j),: G C P a n d E 2 A: Safet y D at a Ma na ge me nt, a n d a p plica ble l ocal re g ulati o ns. 
A n y bra n d na mes/ pr o d uct na mes are tra de mar ks of t h eir res pecti ve o w ners. 
N C T: N C T 0 3 6 8 1 8 0 8

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Pers o n nel Res p o nsi ble f or C o n d ucti n g t he St u d y 
 
A St u d y t o E v al u ate t he S af et y a n d Effecti ve ness of t he Bi otr ue O N E d a y f or Asti g m atis m S oft 
C o nt act Le ns W he n W or n o n a D ail y B asis 
 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Pri nci p al I n vesti g at or Pr ot oc ol A gree me nt P a ge 
I a gree: 
 T o ass u me res p o nsi bilit y f or t he pr o per c o n d u ct of t his cli nical st u d y at t his site a n d t o 
c o n d uct t he st u d y i n c o m plia nce wit h t his pr ot oc ol, a n y f ut ure a me n d me nts, a n d wit h a n y 
ot her st u d y c o n d uct pr oce d ures pr o vi d e d b y t he S p o ns or. 
 T hat I a m a ware of, a n d will c o m pl y wit h, t he i nter nati o nall y rec o g nize d c o de of G o o d 
Cli nica l Practices ( G C P) a n d all ot her a p plica ble re g ul at or y re q uir e me nts t o o btai n writte n a n d 
date d a p pr o val fr o m t he I nstit uti o nal or Ce ntral Re vie w B oar d (I R B) or I n d e pe n de nt Et hics 
C o m mittee (I E C) f or t he st u d y pr ot oc ol, writte n i nf or me d c o nse nt, c o nse nt f or m u p dates, 
s u bject-recr uit me nt pr oce d ures (e g, a d vertise me nts), a n d a n y ot her writte n i nf or mati o n t o be 
pr o vi de d t o t he s u bjects, bef ore i nitiati n g t his cli nical st u d y. 
 N ot t o i m ple me nt a n y c h a n ges t o, or de viati o ns fr o m t he pr ot oc ol wit h o ut pri or a gree me nt 
fr o m t he Sp o ns or a n d re vie w a n d d oc u me nt e d a p pr o val fr o m t he I R B/I E C, e x ce pt t o eli mi nate 
a n i m me diate hazar d t o t he st u d y s u bjects, or w he n c ha n ge(s) i n v ol ves o nl y l o gistical or 
a d mi nistrati ve as pects of t he cli nical st u d y. 
 T o per mit direct m o nit ori n g a n d a u diti n g b y t he S p o ns or or S p o ns or’s re prese ntati ves a n d 
i ns pecti o n by t he a p pr o priate re g ulat or y a ut h orit y(ies). 
 T hat I a m t h or o u g hl y fa miliar wit h t he a p pr o priate use of t he i n vesti gati o nal pr o d ucts(s), as 
descri be d i n t his pr ot oc ol, a n d a n y ot her i nf or mati o n pr o vi de d b y t he S p o ns or or desi g nee, 
i ncl u di n g, b ut n ot li mite d t o, t he c urre nt I n v esti gat or Br oc h ure or e q ui vale nt d oc u me nt a n d 
a p pr o ve d pr o d u ct la bel (if a p plica ble). 
 T o pr o vi de s ufficie nt ti m e, a n d a d e q uate n u m bers of q ualifie d staff a n d faciliti es f or t he 
f oresee n d urati o n of t he cli nical st u d y t o c o n d uct t he st u d y pr o perl y, et hicall y, a n d safel y. 
 T o e ns ure all pers o ns assisti n g i n t his st u d y are a d e q uatel y i nf or me d a b o ut t he pr ot oc ol, 
i n vesti gati o nal pr o d u ct(s), a n d t heir cli nical st u d y-relate d d uties a n d f u ncti o ns. 
 
 
 
 
Pri nci pal I n v esti gat or ( pri nt na me)  
 
 
 
 
 
Pri nci pal I n v esti gat or (si g nat ur e)  
 
Date  
 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
2  S y n o psis 
N a me of S p o ns or/ C o m p a n y: Ba usc h & L o m b I nc., a Di visi o n of Valea nt Researc h a n d D e vel o p me nt, a 
s u bsi diar y of Valea nt P har ma ce uticals N ort h A merica, L L C  
N a me of I n vesti g ati o n al Pr o d uct:  Bi otr ue O N E da y F or Asti g matis m S oft C o ntact L e ns  
N a me of Acti ve I n gre die nt: nes ofilc o n A  
Title of St u d y :.A St u d y t o E val uate t he Safet y  a n d  Effecti ve ness of t he Bi otr ue O N E da y  f or 
Asti g matis m S oft C o ntact Le ns W he n W or n o n a Dail y Basis  
N u m ber of C li nic al C e nters:  1 3  
O bjecti ves:  
T he o bj ecti ve of t his st u d y is t o e val uate t he safet y  a n d  effecti ve ness of t he Bi otr ue O N E da y for 
Asti g matis m S oft C o ntact L e ns w he n w or n o n a dail y basis b y c urre ntl y a da pte d s oft c o nt act le ns 
wearers i n a p o p ulati o n i ncl u di n g C hi nese a ncestr y.  
M et h o d ol o g y:  
T his is a m ultice nter, ra n d o mi ze d 1: 1, parallel -gr o u p , bilateral, In vesti gat or -mas ke d st u d y at 
1 3  i n vesti gati ve sites i n t he U nite d States ( U S) in a p o p ulati o n i ncl u di n g C hi nese s u bj ects ( mater nal a n d 
pater nal gra n d pare nts b or n i n C hi na), c o m pari n g Bi otr ue O N E da y for Asti g matis m S oft C o ntact L e ns 
( T est) t o 1 -Da y Ac u v ue M oist  f or Asti g matis m c o ntact le nses ( C o ntr ol). 
A p pr o xi matel y 2 4 4  s u bj ects will be ra n d o mize d i n t his 3-m o nt h, parallel -gr o u p , bilateral, In vesti gat or -
mas ke d  st u d y at 1 3  i n vesti gati ve sites i n t he U S e nr olli n g a p pr o xi matel y 5 0 % C hi nese s u bj ects. I n or der 
f or s u b missi o n of t his st u d y t o t he C hi nese Re g ulat or y A ut h orities, a p pr o xi matel y 2 4 4  s u bj ects will be 
e nr olle d  a n d ra n d o mize d , i ncl u di n g t h ose of C hi nese desce nt ( b ot h mater nal a n d pater nal gra n d pare nts 
b or n i n C hi na, wit h a d oc u me nte d fa mil y tre e w o r ks heet ke pt wit h t he s u bj ects so urce d oc u me nts).  
At t he Scree ni n g V isit, a p pr o xi matel y half of t he eli gi ble s u bj ects will be ra n d o mize d t o recei ve Bi otr ue 
O N E da y f or Asti g matis m S oft C o ntact L e nses ( T est) a n d t he ot her eli gi ble half will be ra n d o mize d  t o 
recei ve 1 -Da y Ac u v ue M oist f or Asti g matis m c o ntact le nses ( C o ntr ol). B ot h gr o u ps will wear t heir 
assi g ne d le nses o n a dail y wear basis t hr o u g h o ut t he st u d y wit h visits pla n ne d f or Scree ni n g ( Visit 1), 
Dis pe nse ( Visit 2), 1  wee k ( Visit 3), 1 M o nt h ( Visit 4), 3 M o nt hs ( Visit 5), a n d /or a fi nal E xit V isit. 
S u bj ects will be ra n d o mize d s e q ue ntiall y. S u bj ects will be dis pe nse d pr o d uct acc or di n g t o t he treat me nt 
ar m c orres p o n di n g t o t heir ra n d o mizati o n  a n d will be u n mas ke d . 
S u bj ects will be i nstr ucte d t o use t heir ha bit ual re wetti n g dr o ps as nee de d d uri n g t he st u d y. S u bj ects will 
be pr o vi de d wit h T est le nses or C o ntr ol le nses as part of t he dis pe nsi n g pac ka ge a n d i nstr ucti o ns f or t he 
use a n d care f or t he test articles.  
S u bj ects will als o be re q uire d t o c o m plete a pa per diar y  o n a wee kl y basis . S u bj ects will be pr o vi de d 
wit h a re mi n der at e ver y visit t o c o m plete t he diar y  t o ca pt ure wear e x perie nce o n a wee kl y basis u ntil 
t he y e xit t he st u d y.  
N u m ber of S u bjects  P l a n ne d: 2 4 4  
Di a g n osis a n d M ai n C riteri a f or Incl usi o n:  
T he B a usc h + L o m b Bi otr ue O N E da y f or Asti g matis m ( nes ofilc o n A) S oft ( H y dr o p hilic) C o ntact Le ns 
is i n dicate d f or t he dail y wear c orrecti o n of refracti ve a metr o pia ( m y o pia, h y per o pia, asti g matis m) i n 
a p ha kic or n o na p ha kic pers o ns wit h  n o n -disease d e yes, e x hi biti n g asti g matis m of 5. 0 0 di o pters or less, 
t hat d oes n ot i nterfere wit h vis ual ac uit y ( V A). T he le ns ma y be prescri be d i n s p herical p o wers ra n gi n g 
fr o m +4 . 0 0 D t o -9 . 0 0 D. T he le ns has bee n prescri be d f or si n gle-use dis p osa ble wear . N o le nses s h o ul d 
be dis p ose d of.  All le nses, w or n or u n w or n, will be ret ur ne d t o t he S p o ns or.  
T o be eli gi ble f or e ntr y i nt o t he st u d y, t he s u bj ect m ust meet t he f oll o wi n g i ncl usi o n criteri a:  
 
S u bj ect m ust b e of le gal a ge ( at least 1 8 or as defi ne d b y state la w) o n t he date t he i nf or me d c o nse nt 
f or m (I C F) is si g ne d a n d ha ve t he ca pacit y t o pr o vi de v ol u nt ar y i nf or me d c o nse nt. 
 
S u bj ect m ust b e a ble t o rea d, u n dersta n d a n d pr o vi de writte n i nf or me d c o nse nt o n t he I R B a p pr o ve d 
I C F a n d pr o vi de a ut h orizati o n as a p pr o priate f or l ocal pri vac y re g ulati o ns. 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 
S u bj ect m ust ha ve p h ysi ol o gic all y n or mal a nteri or se g me nts n ot e x hi biti n g cli nicall y si g nifica nt 
bi o micr osc o p y fi n di n gs ( greater t ha n G ra de 1 a n d/ or prese nce of i nfiltrates) a n d ha ve clear ce ntral 
6  m m c or neas.  
 
S u bj ect m ust b e a n a d a pte d wearer of s oft c o ntact le nses, wear a le ns i n eac h e ye, a n d eac h le ns 
m ust b e of t he sa me ma n ufact ure a n d bra n d.   
 
S u bj ect m ust ha ve visi o n c orrecta ble t hr o u g h s p her oc yli n d rical refracti o n t o 45  letters 
(0. 0 4  l o g M A R) or better ( dista nce, hi g h c o ntrast) i n eac h e ye. Vis ual ac uit y of 0. 0 4 l o g M A R is t he 
ac uit y w here a n i n di vi d ual s u bj ect w o ul d be gi ve n cre dit f or rea di n g l o g M A R 0. 0 a n d l o g M A R 0. 0 
is e q ui vale nt t o C hi nese l o garit h mic vis ual ac uit y c hart val ue of 5. 0. 
 
S u bj ect  m ust b e m y o pic or h y per o pic a n d re q uire le ns c orrect i o n fr o m + 4. 0 0 di o pter (D) t o -9 .0 0  D  
i n b ot h e yes. 
 
S u bj ect m ust b e a ha bit ual we arer  of t oric s oft c o ntact le nses . 
 
S u bj ect m ust b e a ble t o be fit i n b ot h t he T est a n d C o ntr ol le nses i n t he liste d para meters. 
 
S u bj ect ha ve n o acti ve oc ular disease or aller gic c o nj u ncti vitis.  
 
S u bj ect m ust n ot b e usi n g a n y t o pical oc ular me dicati o ns.  
 
S u bj ect m ust a gree t o wear t heir st u d y le nses o n a dail y wear basis f or t he d urati o n of t he st u d y.  
 
S u bj ect m ust b e willi n g a n d a ble t o f oll o w t he visit sc he d ul e a n d f oll o w i nstr ucti o ns f or use of t he 
st u d y pr o d ucts. 
 
Ke y e xcl usi o n criteri a:  
T he s u bj ect is n ot eli gi ble t o partici pate i n t he st u d y if t he s u bj ect meets a n y of t he f oll o wi n g e xcl usi o n 
criteria:  
 
S u bj ect has w or n gas per mea ble ( G P) c o ntact le nses wit hi n l ast 3 0 da ys or p ol y met h yl met hacr ylate 
( P M M A) le nses wit hi n last 3 m o nt hs. 
 
S u bj ect has s yste mic disease affecti n g oc ular healt h.  
 
S u bj ect is usi n g a n y s yste mic or t o pica l me dicati o ns t hat will affect o c ular p h ysi ol o g y or le ns 
perf or ma nce.  
 
S u bj ect has a n acti ve oc ular disease (f or e xa m ple b ut n ot li mite d t o pa pillar y c o nj u ncti vitis, a n y 
c o nj u ncti vitis: viral, bacterial, aller gic), a n y c or neal i nfiltrati ve res p o nse or are u si n g a n y o c ular 
me dicati o ns.  
 
S u bj ect has a n y “ Prese nt” fi n di n g d uri n g t he slit la m p e xa mi nati o n t hat, i n t he I n vesti gat or’s 
j u d g me nt, i nterferes wit h c o nt act le ns wear. 
 
S u bj ect has a n y scar or ne o vas c ularizati o n wit hi n t he ce ntral 6  m m of t he c or nea. Mi n or  peri p heral 
c or neal scarri n g (t hat d oes n ot e xte n d i nt o t he ce ntral 6 m m of t he c or nea ), t hat i n t he I n vesti gat or's 
j u d g me nt, d oes n ot i nterfere wit h c o ntact le ns wear, are eli gi ble f or t his st u d y. 
 
S u bj ect has a nis o metr o pia (s p herical e q ui vale nt) of greate r t ha n 2. 0 0 D base d o n s p her oc yli n drical 
refracti o n. 
 
S u bj ect is a p ha kic . 
 
S u bj ect is a m bl y o pic . 
 
S u bj ect has h a d a n y c or neal s ur ger y (e g, refracti ve s ur ger y).  
 
S u bj ect is p artici pati n g i n a c o nflicti n g st u d y ( or acti vel y partici pati n g wit hi n a n ot her acti ve c o h ort 
of t his st u d y).  
 
S u bj ect has p artici pate d i n a n y dr u g or de vice cli nical i n vesti gati o n ( wit hi n 1 4 da ys) pri or t o e ntr y 
i nt o t his st u d y a n d/ or d uri n g t he peri o d of st u d y partici pati o n. 
 
S u bj ect is a w o m an of c hil d be ari n g p ote ntial if o ne of t he f oll o wi n g: pre g na nt, pla ns t o bec o me 
pre g na nt d uri n g st u d y or is breast  fee di n g. 
 
S u bj ect m eets a n y of t he f oll o wi n g criteria:  
 
O p ht hal m ol o gist, O D, O pticia n, O p ht hal m ol o gist’s Assista nt/ T ec h nicia n  

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 
e m pl o yee of a mar ket researc h fir m 
 
e m pl o yee of ma n ufact urer of c o ntact le ns or c o ntact le ns care pr o d ucts  
 
e m pl o yee of t he i n vesti gati o nal site  
 
S u bj ect w ears m o n o visi o n or m ultif ocal c o ntact le nses.  
 
S u bj ect is c o nsi dere d b y t he I n vesti gat or t o n ot be a s uita ble ca n di date f or partici pati o n.  
 
I n vesti g ati o n al P r o d uct, D os a ge a n d M o de of A d mi nistr ati o n  ( Test A rticle) : 
T he T est P r o d uct i n t his case is t he Bi otr ue O N E da y f or Asti g matis m S oft C o ntact L e ns. T he descri pti o n 
is as f oll o ws: 
Dia meter: 1 4. 5  m m  
B ase C ur ve:  8. 4  m m  
Material: nes ofilc o n A  
S p heric al P o w er: Pl a n o t o – 6. 0 0 D (i n 0. 2 5 D ste ps);  
C yli n der P o wers; -. 7 5, -1. 2 5, -1. 7 5  
A xis: 1 0°, 2 0°, 6 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 2 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 2  a xes) 
 
C yli n der P o wers; -2. 2 5  
A xis 2 0°,   9 0°, 1 6 0°, 1 8 0° ( 4  a xes) 
 
S p heric al P o w er: -6. 5 0 t o -9. 0 0 (i n 0. 5 0 D Ste ps);  
C yli n der P o wers; -. 7 5, -1. 2 5, -1. 7 5  
A xis: 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 0  a xes) 
 
S p heric al P o w er:   + 0. 2 5 D t o + 4. 0 0 D (i n 0. 2 5 D ste ps);  
C yli n der P o wers: -0. 7 5 D, -1. 2 5 D, -1. 7 5 D  
A xis: 2 0°, 7 0°,   9 0°, 1 1 0°, 1 6 0°, 1 8 0°   ( 6 a xes) 
 
Orie nta ti o n Mar k at 6 o’cl oc k 
 
D ur ati o n of T re at me nt:  
D urati o n of cli nical trial per s u bj ect : 3 m o nt hs 
Visits sc he d ule d at Scree ni n g ( Visit 1), Dis pe nse ( Visit 2), 1 wee k ( Visit 3), 1 m o nt h ( Visit 4), 3 m o nt hs  
( Visit 5), a n d/ or a fi nal E xit V isit. 
 
Refere nce T her a p y, D os a ge a n d M o de of A d mi nistr ati o n:  
T he C o ntr ol Pr o d uct i n t his case is t he 1 -Da y Ac u v ue M oist f or Asti g matis m  c o ntact le nses wit h t he 
f oll o wi n g descri pti o n: 
Dia meter: 1 4. 5 m m  
B ase C ur ve:  8. 5 m m  
Material: etafilc o n A  
S p heric al P o w er: Pl a n o t o – 6. 0 0 D  (i n 0. 2 5 D ste ps); 
C yli n der P o wers; -. 7 5, -1. 2 5, -1. 7 5  
A xis: 1 0°, 2 0°, 6 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 2 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 2  a xes) 
 
C yli n der P o wers; -2. 2 5  
A xis 2 0°,   9 0°, 1 6 0°, 1 8 0° ( 4  a xes) 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
P o w er: -6. 5 0 t o -9. 0 0 (i n 0. 5 0 D Ste ps);  
C yli n der P o wers; -. 7 5, -1. 2 5, -1. 7 5  
A xis: 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 0  a xes) 
 
S p heric al P o w er:   + 0. 2 5 D t o + 4. 0 0 D (i n 0. 2 5 D ste ps);  
C yli n der P o wers: -0. 7 5 D, -1. 2 5 D, -1. 7 5 D  
A xis: 2 0°, 7 0°,   9 0°, 1 1 0°, 1 6 0°, 1 8 0°   ( 6 a xes) 
Orie ntati o n Mar k s at 3 a n d 9 o ’cl oc k 
 
Criteri a f or E v al u ati o n:  
T he pri mar y effecti ve ness e n d p oi nt is t he pr o p orti o n of s u bj ects ac hie vi n g a c o ntact le ns c orrecte d 
dista nce l o g M A R V A of 0. 0 4  or better i n b ot h e yes, e val uate d at t he 1 -Wee k F oll o w -u p Visit.   Vis ual 
ac uit y of 0. 0 4 l o g M A R  is t he ac uit y w here a n i n di vi d ual s u bj ect w o ul d be gi ve n cre dit f or rea di n g 
l o g M A R 0. 0 a n d l o g M A R 0. 0 is e q ui vale nt t o C hi nese l o garit h mic vis ual ac uit y c hart val ue of 5. 0. 
Ot her perf or ma nce criteria f or e val uati o n  will be s u m marize d descri pti vel y.  
Effect i ve ness: 
1  
Vis ual ac uit y  
 
o pti mal c orrecte d dista nce B S C V A  meas ure d wit h t he p h or o pter 
 
c o ntact le ns c orrecte d dista nce V A  
Safet y:  
1  
E ye c o n diti o n  
E ye c o n diti o n criteria i ncl u de t he f oll o wi n g, w hic h will be s u m marize d descri pti vel y.  
 
Slit la m p fi n di n gs  
 
Dilate d f u n d us e xa m fi n di n gs 
 
I ntra o c ular press ure 
2  
Le ns S uita bilit y  
 
Ce ntrati o n  
 
W etta bilit y  
 
M o ve me nt  
3  
Le ns Stat us  
 
De p osits  
4  
Vis ual ac uit y  
 
u nc orrecte d dista nce V A  
5  
C ha n ge i n ma nifest refracti o n bet wee n t he S cree ni n g a n d E xit V isits 
6  
C ha n ge i n c or neal c ur vat ure bet wee n t he S cree ni n g a n d E xit V isits 
St atistic al M et h o ds:  
Ge neral Statistical Met h o ds  
I n ge neral, data will be s u m marize d b y treat me nt gr o u p a n d visit as a p pr o priate. Data will be 
s u m marize d se p aratel y at t he s u bj ect a n d e ye le vels. S u bj ect le vel s u m maries will s u m mari ze t he 
a vera ge of t he s u bj ect’s 2  e yes f or c o nti n u o us varia bles a n d t he w orst case o ver b ot h e yes f or 
cate g orical varia bles.  
S u m maries f or c o nti n u o us varia bles will i ncl u de t he sa m ple size, mea n, sta n dar d de viati o n, me di a n, 
mi ni m u m, a n d ma xi m u m. Me a ns a n d me dia ns will be prese nte d wit h o ne m ore deci mal pl ace t ha n t he 
rec or de d ra w data. Sta n dar d de viati o ns will be prese nte d wit h 2  m ore deci mal places t ha n t he rec or de d 
ra w data. Mi ni ma a n d ma xi ma will be prese nte d wit h t he sa me n u m ber of deci mal places as t he 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
rec or de d ra w data. Val ues wit h ma g nit u de less t ha n 1 will b e prese nte d wit h a lea di n g zer o t o t he left 
of t he deci mal (e g , 0. 1 2 3 or -0. 1 2 3).  
Cate g orical data will be s u m marize d usi n g fre q ue ncies a n d p erce nta ges. P erce nt a ges will be prese nte d 
wit h o ne deci mal place. P erce nta ges ma y n ot be prese nte d w he n t he c o u nt is zer o. U nless ot her wise 
s pecifie d t he de n o mi nat or f or perce nta ges will be t he n u m ber of n o n -missi n g val ues wit hi n t he gr o u p 
bei n g prese nte d.  
Pri mar y E ffecti ve ness A nal ysis  
At t he 1-W ee k F oll o w -u p Visit , s u bj ects wit h n o n-missi n g l o g M A R ac uities  0. 0 4  or better i n b ot h e yes 
will b e classifie d as “ 0. 0 4  or B etter.” S u bj ects wit h at least o ne l o g M A R ac uit y >  0. 0 4  at t he visit will 
be classifie d as “ W orse t ha n 0. 0 4 .” S u bj ects wit h at least  o ne missi n g val ue at t he visit will n ot be 
classifie d a n d t heir classificati o n val ue will be assi g ne d as missi n g.  
T he s u m maries a n d a nal yses of t he pri mar y effecti ve ness e n d p oi nt will be at t he s u bj ect le vel.  
Use of t he I nte nti o n-t o-Treat (I T T) P o p ulati o n  a n d i m p utati o n of missi n g val ues are n ot c o nser vati ve 
practices i n n o n -i nferi orit y a nal yses. C o nse q ue ntl y, t he P er Pr ot oc ol P o p ulati o n  will be us e d f or t he 
pri mar y a nal ysis wit h o ut i m p utati o n of missi n g data.  
V A Effecti ve ness will b e  s u m marize d cate g oricall y (0. 0 4  or Better, W orse t ha n 0. 0 4 ) b y treat me nt 
gr o u p at t he 1 -W ee k F oll o w -u p Visit  f or t he P er Pr ot oc ol ( P P) P o p ulati o n  i n a ta ble. Missi n g data will 
n ot b e i m p ute d f or t his pri mar y a nal ysis of t he P P P o p ulati o n . T he de n o mi nat or for perce nta ges will be 
t he n u m ber of n o n-missi n g val ues.  
T he differe nce bet wee n treat me nt gr o u ps ( T est mi n us C o ntr ol) i n t he pr o p orti o n of s u bj ects classifie d 
as “0. 0 4  or B etter” will be esti mate d.  A n as y m pt otic Wal d n o n -i nferi orit y test ( wit h o ut c o nti n uity 
c orrecti o n; usi n g t he sa m ple varia nce; al p ha ris k = 0. 0 2 5) a n d t he ass ociate d t w o – si de d 9 5 % 
c o nfi de nce i nter val will be use d t o test t he statistical h y p ot hesis . T he differe nce bet wee n tr eat me nt 
gr o u ps (i n perce nta ge u nits), t he as y m pt otic sta n dar d err or f or t he differe nce (i n perce nta ge u nits), t he 
ass ociate d Z val ue, t he p -val ue f or t he n o n -i nferi orit y test, a n d a t w o– si de d 9 5 % c o nfi de nce i nter val (i n 
perce nta ge u nits) ar o u n d t he differe nce will be prese nte d . 
 
 
 
 
S a m ple S ize C alc ul ati o ns:  
Pri m ar y Effecti ve ness E n d p oi nt  
T he n ull h y p ot hesis is t hat t he differe nce i n t he pr o p orti o n of s u bj ects wit h b ot h e yes “ 0. 0 4  or Better” 
bet wee n t he test gr o u p ( π T ) a n d t he c o ntr ol gr o u p ( πC ) is less t ha n or e q ual t o t he ne gati ve val ue of t he 
n o n -i nferi orit y mar gi n (-δ). T he alter nati ve h y p ot hesis is t hat t he differe nce i n pr o p orti o ns is greater t ha n 
t he ne gati ve val ue of t he n o n-i nferi orit y mar gi n. 
H 0: πT -π C ≤ -δ  
H 1: πT -π C > -δ  
I n a pre vi o us e val uati o n of Bi otr ue O N E da y  f or Asti g matis m Soft C o ntact L e nses, 9 2 .5 % of s u bj ects 
wit h baseli ne l o g M A R B S C V A of 0. 0 4  or better ac hie ve d t he pri mar y effecti ve ness e n d p oi nt of t his 
st u d y at t he f oll o w-u p visit. C o nse q ue ntl y 9 2 .5 % is t he e x pe cte d perce nta ge of s u bj ects “ 0. 0 4  or Better ” 
i n t he T est a n d C o ntr ol gr o u ps. 
 
 
A o ne -si de d al p ha ris k of 0. 0 2 5 (e g, a t w o-si de d 9 5 % c o nfi de nce i nter val) will be use d t o test t he 
h y p ot hesis.  
W he n t he sa m ple size i n eac h gr o u p is 1 0 9  s u bj ects, a t w o-gr o u p lar ge -sa m ple n or mal a p pr o xi mati o n 
test of pr o p orti o ns wit h a o ne-si de d 0. 0 2 5 si g nifica nce le vel will ha ve 8 0 % p o wer t o rej ect t he n ull 
h y p ot hesis t hat t he test is i nferi or t o t he c o ntr ol 
 
 
 i n 
fa v or of t he alter nati ve h y p ot hesis t hat t he test le ns is n o n-i nferi or, ass u mi n g t hat t he e x pecte d differe nce 
i n pr o p orti o ns is 0. 0 0 0 a n d t he pr o p orti o n i n t he sta n dar d gr o u p is 0. 92 3.  
 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
O ver all P o w er a n d S a m ple Size  
I n or der t o all o w f or dr o p o uts of u p t o 1 0 %, at least a p pr o xi matel y 1 0 9 /( 1-0. 1) ≈ 1 2 2  s u bjects will be 
e nr olle d i n eac h treat me nt gr o u p f or a t otal e nr oll me nt of a p pr o xi matel y 2 4 4  s u bj ects. 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
3  T a ble of C o nte nts 
1  
TI T L E P A G E .......................................................................................................... 1 
2  
S Y N O P SI S .............................................................................................................. 6  
3  
T A B L E O F C O N T E N T S ...................................................................................... 1 2  
4  
LI S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N S O F T E R M S ....................... 1 6  
5  
I NT R O D U C TI O N A N D R A TI O N A L E ............................................................... 1 7  
5. 1  
I ntr o d ucti o n ............................................................................................... 1 7  
5. 2  
Ra ti o nale.................................................................................................... 1 7 
5. 2. 1  St u d y R ati o nale ............................................................................. 1 7  
5. 2. 2  Desi g n Rati o nal e a n d Ris k Assess me nt ........................................ 1 7  
6  
S T U D Y O BJ E C TI V E S A N D P U R P O S E ............................................................. 1 7  
6. 1  
O bjec ti ve ................................................................................................... 1 7 
7  
I NV E S TI G A TI O N A L P L A N ............................................................................... 1 7  
7. 1  
Descri pti o n of t he Pr ot oc ol ....................................................................... 1 7  
7. 2  
D ura ti o n of St u d y Partici pati o n................................................................. 1 8 
7. 2. 1  D ura ti o n of St u d y Partici pati o n f or Eac h S u bject ......................... 1 8 
7. 2. 2  Deter mi nati o n of E n d of Cli nical Trial ( All S u bjects) .................. 1 9  
7. 3  
St u d y Desi g n a n d Ass ess me nts ................................................................. 1 9  
8  
S E L E C TI O N A N D WI T H D R A W A L O F S U BJ E C T S ........................................ 2 2  
8. 1  
N u m ber of S u bjects Pla n ne d ..................................................................... 2 2  
8. 2  
S u bjec t I n cl usi o n Criteria .......................................................................... 2 2 
8. 3  
S u bjec t E x cl usi o n Criteria ......................................................................... 2 3 
8. 4  
S u bjec t Wit h dra wal Criteria ...................................................................... 2 4 
8. 4. 1  List  of Treat me nt Wit h dra wal Criteria .......................................... 2 4 
8. 4. 2  Re as o ns f or Treat me nt Wit h dra wal............................................... 2 5  
8. 4. 3  L ost t o F oll o w- u p .......................................................................... 2 5  
8. 4. 4  Tre at me nt Wit h dra wal F oll o w- u p Pr oce d ure ................................ 2 6  
9  
T R E A T M E N T P L A N ........................................................................................... 2 6  
9. 1  
Ra n d o miz ati o n a n d Met h o ds of Assi g ni n g S u bjects t o Treat me nt Gr o u ps 2 6  
9. 2  
C o nc o mita nt Me dicati o ns ......................................................................... 2 7  
9. 3  
Treat me nt A d mi nistrati o n a n d C o m plia nce .............................................. 2 7  
9. 4  
Pr ot oc ol De viati o ns ................................................................................... 2 7  
1 0  
S T U D Y M A T E RI A L S A N D M A N A G E M E N T .................................................. 2 7  
1 0. 1  
I n vesti gati o nal Pr o d uct, Bi otr ue O N E da y f or Asti g matis m ...................... 2 8  

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 0. 2  
I n v esti gati o nal C o ntr ol Pr o d uct, 1- Da y Ac u v ue M oist f or Asti g matis m 
C o ntact Le ns .............................................................................................. 2 8  
1 0. 2. 1  Pac ka gi n g a n d La b eli n g ................................................................ 2 9  
1 0. 2. 2  St ora ge, Ha n dli n g, a n d Dis p osal of St u d y Le nses ........................ 3 0  
1 0. 2. 3  St u d y Le ns Pre p arati o n ................................................................. 3 0  
1 0. 2. 4  A d mi nistra ti o n ............................................................................... 3 0 
1 0. 2. 4. 1  S u bject I nstr u cti o ns ...................................................... 3 0  
1 0. 2. 4. 2  S u bject Diar y  ................................................................ 3 1 
1 0. 3  
St u d y Le ns Acc o u nta bilit y ........................................................................ 3 1  
1 0. 4  
N o ni n vesti gati o nal Pr o d ucts ..................................................................... 3 2  
1 0. 5  
Re s p o nsi bilit y ............................................................................................ 3 2 
1 1  
S T U D Y P R O C E D U R E S A N D E V A L U A TI O N S ................................................ 3 2  
1 1. 1  
Visit Sc he d ule ........................................................................................... 3 3  
1 1. 1. 1  Sc ree ni n g Visit .............................................................................. 3 3 
1 1. 1. 2  Dis pe nsi n g  Visit ............................................................................ 3 5 
1 1. 1. 3  1- Wee k, 1- M o nt h, a n d 3- M o nt h F oll o w- u p Visits ....................... 3 6  
1 1. 1. 4  E xit Visit  ...................................................................................... 3 8  
1 1. 1. 5  U nsc he d ule d Visits ........................................................................ 3 9  
1 1. 1. 6  Misse d V isits ................................................................................. 4 0 
1 1. 1. 7  St u d y R estricti o ns ......................................................................... 4 1  
1 1. 2  
Defi niti o n of S o urce D ata ......................................................................... 4 1  
1 1. 3  
Ha n dli n g of S u bject Wit h dra wal ............................................................... 4 1  
1 1. 4  
E val uati o n of Ef fecti ve n ess ....................................................................... 4 1 
1 1. 4. 1  Effe cti ve n ess Para m eters............................................................... 4 1  
1 1. 5  
E val uati o n of Saf et y .................................................................................. 4 1  
1 1. 5. 1  E y e C o n diti o n ................................................................................ 4 1  
1 1. 5. 2  Le ns S uita bilit y ............................................................................. 4 1  
1 1. 5. 3  Le ns Stat us .................................................................................... 4 1  
1 1. 5. 4  Vis ual Ac uit y................................................................................. 4 2  
1 1. 5. 5  C ha n ge i n M a nifest Refracti o n Bet w ee n t he Scree ni n g a n d E xit Visits
  
 ...................................................................................... 4 2 
1 1. 5. 6  C ha n ge i n C or n eal C ur vat ure Bet wee n t h e Scree ni n g a n d E xit Visits
  
 ...................................................................................... 4 2 
1 1. 5. 7  A d verse E v e nt Defi niti o ns ............................................................ 4 2  
1 1. 5. 8  A d verse  E v e nt ............................................................................... 4 3 
1 1. 5. 8. 1  Seri o us A d verse  E v e nts ................................................ 4 3 
1 1. 5. 8. 2  Si g nifica nt N o n- Seri o us A d verse E v e nts ..................... 4 4  
1 1. 5. 8. 3  A d verse E v e nt Treat me nt a n d C ult uri n g ...................... 4 4  

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 5. 8. 4  Me dical Treat me nt I ncl u di n g n o n- A d verse E v e nts ...... 4 5  
1 1. 5. 8. 5  E val uati o ns ................................ ................................... 4 5 
1 1. 5. 8. 6  Pr oce d ure s f or Re p orti n g A d verse E v e nts a n d Seri o us 
A d verse E v e nts ............................................................. 4 5  
1 1. 5. 9  O bli gati o ns of t he S p o ns or ............................................................ 4 7  
1 1. 5. 1 0  
Re p orti n g De vice Defici e ncies ..................................... 4 8  
1 2  
S T A T I S TI C S ......................................................................................................... 4 8 
1 2. 1  
Deter mi nati o n of Sa m ple Size................................................................... 4 8  
1 2. 1. 1  Pri mar y Effecti ve ness E n d p oi nts .................................................. 4 8  
1 2. 1. 2  O vera ll P o wer a n d Sa m ple Size .................................................... 4 9 
1 2. 2  
A nal ysis P o p ulati o ns ................................................................................. 4 9  
1 2. 2. 1  I nte nti o n-t o- Treat (I T T) P o p ulati o n .............................................. 4 9  
1 2. 2. 2  Per Pr ot oc ol P o p ulati o n ................................................................. 4 9  
1 2. 2. 3  Sa fet y P o p ulati o n .......................................................................... 4 9 
1 2. 3  
Assess m e nt of Effecti ve n ess ..................................................................... 4 9  
1 2. 3. 1  Statist ical A nal ysis ........................................................................ 4 9 
1 2. 3. 1. 1  Descri pti ve  Statistics .................................................... 4 9 
1 2. 3. 2  Pri mar y Effecti ve ness A nal ysis .................................................... 5 0  
1 2. 3. 3  A d verse  E v e nts .............................................................................. 5 3 
1 2. 3. 3. 1  Defi niti o ns .................................................................... 5 3  
1 2. 3. 3. 2  Treat m e nt-e mer ge nt or P ost-treat me nt A d verse E v e nts 5 3  
1 2. 3. 3. 3  Deat hs, Se ri o us a n d Ot h er Si g nifica nt A d v erse E v e nts 5 4 
1 2. 3. 3. 4  A d verse E v e nts Lea di n g t o Treat me nt Disc o nti n uati o n 5 4  
1 2. 4  
S u bject Dis p ositi o n ................................................................................... 5 4  
1 2. 5  
De m o gra p hics a n d Baseli ne C haract eristics ............................................. 5 4  
1 2. 5. 1  S u bjec t De m o gra p hic C h aract eristics, Me dical Hist or y a n d Dia g n oses
  
 ...................................................................................... 5 4 
1 2. 6  
Pr ot oc ol De viati o ns ................................................................................... 5 4  
1 2. 7  
C o m pl ia nce................................................................................................ 5 5 
1 2. 8  
I nteri m A nal yses ....................................................................................... 5 5 
1 2. 9  
A d diti o na l Statistical C o nsi derati o ns ........................................................ 5 5 
1 2. 9. 1  Pri or / C o nc o mita nt Me dicati o n/ T hera p y ....................................... 5 5 
1 3  
Q U A LI T Y C O N T R O L A N D Q U A LI T Y A S S U R A N C E .................................... 5 5  
1 3. 1  
St u d y M o nit ori n g ...................................................................................... 5 5  
1 3. 2  
A u dits a n d I ns p ecti o ns .............................................................................. 5 6  
1 3. 3  
Data Q ualit y Ass ura nce ............................................................................. 5 6  
1 3. 3. 1  Use a n d C o m pleti o n of Case Re p ort F or ms ( C R Fs) a n d A d diti o nal 
Re q ue st  ...................................................................................... 5 6 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 4  
E T HI C S A N D A D MI NI S T R A TI V E I S S U E S ...................................................... 5 6  
1 4. 1  
Et hic al C o n d uct of t he St u d y .................................................................... 5 6  
1 4. 2  
Et hic s Re vie w ............................................................................................ 5 7 
1 4. 3  
Writt e n I nf or m e d C o nse nt ......................................................................... 5 7  
1 4. 4  
S u bjec t Data Pr otecti o n ............................................................................. 5 8 
1 4. 5  
I ns ura nce C o m pe nsati o n ........................................................................... 5 8 
1 4. 6  
Fi na nc ial Discl os ur e .................................................................................. 5 8 
1 4. 7  
I n vesti gat or O bli gati o ns ............................................................................ 5 8  
1 4. 7. 1  C ur ric ul u m Vitae ........................................................................... 5 9 
1 4. 8  
C ha n ges t o t he Pr ot oc ol............................................................................. 5 9  
1 4. 9  
C o nfi de ntialit y/ P u blicati o n of t he St u d y ................................................... 5 9  
1 4. 9. 1  C o nfi de ntialit y ............................................................................... 5 9  
1 4. 1 0  St u d y Ter mi nati o n ..................................................................................... 6 0  
1 4. 1 1  Pr o pe rt y Ri g hts .......................................................................................... 6 0 
1 5  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G ................................................. 6 1  
1 5. 1  
Rete nti o n of Rec or ds ................................................................................. 6 1  
1 5. 2  
Cli nical Trial Res ults ................................................................................. 6 1  
1 5. 3  
P u bli cati o ns ............................................................................................... 6 1  
1 6  
R E F E R E N C E S ...................................................................................................... 6 2  
1 7  
A P P E N DI C E S ....................................................................................................... 6 3  
1 7. 1  
A p pe n di x A: Met h o ds of Cli nical E val uati o n ........................................... 6 3  
1 7. 2  
A p pe n di x  B: S u bject I nstr ucti o ns ............................................................. 7 8 
1 7. 3  
A p pe n di x  C: Fitti n g G ui de ........................................................................ 8 8 
1 7. 4  
A p pe n di x  D: 
 1 2 1 
1 7. 5  
A p pe n di x E: C or neal I nfiltrates E val uati o n F or m .................................. 1 2 3  
 
LI S T O F T A B L E S 
Ta ble 1.  
St u d y Desi g n a n d Sc h e d ule of Assess me nts .................................................. 2 0  
 
 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
4  List of A b bre vi ati o ns a n d Defi niti o ns of Ter ms 
 
A b bre vi ati o n or s peci alist ter m  
Defi niti o n or E x pl a n ati o n  
A D E  
A d verse d e vice effect  
A E  
A d verse e ve nt  
B S C V A  
Best s pectacle -c orrecte d vis ual ac uit y  
C F R  
C o de of Fe deral Re g ulati o ns  
C R A  
Cli nical researc h ass ociate  
C R F  
Case re p ort f or m  
C T M  
Cli nical trial materials  
D  
D i o pter 
F D A  
U S F o o d a n d Dr u g A d mi nistr ati o n  
G C P  
G o o d cli nical practice  
G P  
Gas per mea ble  
HI P A A  
Healt h I ns ura nce P orta bilit y Acc o u nta bilit y Act  
I C F 
I nf or me d c o nse nt f or m 
I C H 
I nter nati o nal C o nfere nce o n H ar m o nisati o n 
I D 
I de ntificati o n  
I E C 
I n de pe n de nt Et hics C o m mitte e 
I O P 
I ntra oc ular press ure 
I R B 
I nstit uti o nal re vie w b oar d 
I T T 
I nte nt-t o-treat 
l o g M A R 
L o garit h m of t he mi ni m u m a n gle of res ol uti o n  
M C M C  
Mar k o v c hai n M o nte Carl o  
Me d D R A  
Me dical Dicti o nar y f or Re g ul at or y Acti vities  
M P S  
M ulti -p ur p ose s ol uti o n  
O D  
D oct or of o pt o metr y  
P M M A  
P ol y met h yl met hacr ylate  
P P  
P er pr ot oc ol  
P T  
Preferre d ter m  
S A E  
Seri o us a d verse  e ve nt  
S O C  
S yste m or ga n class  
S O P  
Sta n dar d o perati n g pr oce d ure  
S U S A R  
S us pecte d  u ne x pecte d seri o us a d verse  reacti o n 
T E A E  
Treat me nt -e mer ge nt a d verse e ve nt  
U A D E  
U na ntici pate d a d verse de vice effect  
U S  
U nite d States  
V A  
Vis ual ac uit y  
  
N O T E: T he first occ urre nce of s o m e a b brevi ati o ns is n ot s pelle d o ut i n t he d oc u m e nt (e g, u nits of m e as ure). 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
5  I ntr o d ucti o n a n d R ati o n ale 
5. 1  
I ntr o d ucti o n 
T he Ba usc h + L o m b Bi otr ue ® O N E d a y f or Asti g matis m ( nes ofilc o n A) S oft ( H y dr o p hilic) C o ntact 
Le ns is i n dicat e d f or d ail y w ear f or t he c orrecti o n of asti g matis m. T he le ns is prescri be d f or si n gle-
use dis p osa ble wear, a n d is t o be discar de d after eac h re m o val. 
5. 2  
R ati o n ale 
5. 2. 1  St u d y R ati o n ale 
T he ra ti o nale f or t he st u d y is t o e val uat e t his le ns i n a p o p ulati o n i ncl u di n g c urre ntl y a d a pte d s oft 
c o ntact lens wearers of C hi nese a ncestr y. 
5. 2. 2  Desi g n R ati o n ale a n d Ris k Assess me nt 
T he assess me nts r e q uire d f or t he st u d y are r o uti nel y perf or me d a n d are sta n dar d of care f or c o nt act 
le ns wearers. T he s u bj ects will be i nf or me d of a n y p ote ntial st u d y s pecifi c ris ks i n t he i nf or me d 
c o nse nt f or m (I C F) or if ne w ris ks bec o m e a p pare nt d uri n g t he st u d y. 
6  St u d y O bjecti ves a n d P ur p ose 
6. 1  
O bjecti v e 
T he o bjecti ve of t his st u d y is t o e val uat e t he safet y a n d effecti ve n ess of t he Bi otr ue O N E da y f or 
Asti g matis m S oft C o ntact Le ns w h e n w or n o n a d ail y basis b y c urre ntl y a d a pte d s oft c o ntact le ns 
wearers i n a p o p ulati o n i ncl u di n g C hi nese a ncestr y. 
7  I n vesti g ati o n al Pl a n 
7. 1  
Descri pti o n of t he Pr ot oc ol 
T his is a m ultice nter, ra n d o mize d 1: 1, parallel- gr o u p, bilateral, I n vesti gat or- mas ke d st u d y at 
1 3 i n vesti gati ve sites i n t he U nite d States ( U S) o n a p o p ulati o n i ncl u di n g a p pr o xi matel y 5 0 % 
C hi nese s u bj ects ( mater n al a n d pater n al gra n d p are nts b or n i n C hi na), c o m pari n g Bi otr ue O N E da y 
f or Asti g matis m S oft C o ntact Le ns ( Test) t o 1- Da y Ac u v ue M oist f or Asti g matis m c o ntact le ns 
( C o ntr ol). 
A p pr o xi ma tel y 2 4 4 s u bj ects will be ra n d o mize d i n t his 3 m o nt h, parallel- gr o u p, bilateral, 
I n v estigat or- mas ke d  st u d y at 1 3 i n vesti gati ve sites i n t he U S e nr olli n g C hi nese s u bjects. I n or der f or 
s u b missi o n of t his st u d y t o t he C hi nese Re g ul at or y A ut h orities, a p pr o xi matel y 2 4 4 ra n d o mize d 
s u bjects will be e nr olle d, i ncl u di n g t h ose of C hi nese ori gi n wit h 2n d ge nerati o n C hi nese a ncestr y 
wit h b ot h sets of gra n d pare nts bei n g of C hi nese ori gi n, wit h a d oc u me nt e d fa mil y tr ee w or ks h eet 
ke pt wit h t he s u bj ect’s s o urce d oc u m e nts. 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
A pers o n wit h C hi nese a ncestr y w o ul d be d efi ne d as a s u bject wit h b ot h sets of gra n d pare nts b or n i n 
C hi na. A pers o n wit h 3 C hi nese gra n d p are nts a n d o ne gra n d pare nt of f ull C hi nese a ncestr y w h o was 
n ot b or n i n C hi na will be de fi ne d as “ N o n- C hi nes e”. 
At t he Scree ni n g Visit, a p pr o xi matel y h alf of t he s u bjects will be ra n d o mize d t o recei ve Bi otr ue 
O N E da y f or Asti g matis m S oft C o ntact Le nses ( Test) a n d t he ot her half will be ra n d o mize d t o 
recei v e 1- D a y Ac u v u e M oist f or Asti g matis m c o ntact le nses ( C o ntr ol). B ot h gr o u ps will wear t heir 
assi g ne d l e nses o n a d ail y w ear basis t hr o u g h o ut t he st u d y wit h visits pla n ne d f or Scree ni n g 
( Visit 1), Dis pe nse ( Visit 2), 1 wee k ( Visit 3), 1 M o nt h ( Visit 4), 3 M o nt hs ( Visit 5), a n d/ or a fi nal 
E xit V isit. 
S u bjects will be ra n d o mize d se q ue ntiall y. S u bjects will be dis pe nse d pr o d u ct acc or di n g t o t he 
treat me nt ar m c orres p o n di n g t o t heir ra n d o mizati o n a n d will be u n mas ke d. 
S u bjects will  be i nstr ucte d t o use t heir ha bit ual re wetti n g dr o ps as nee d e d d uri n g t he st u d y. S u bjects 
will be pr o vi de d wit h st u d y le nses as part of t he dis pe nsi n g pac ka ge a n d i nstr ucti o ns f or t he use a n d 
care f or t he test articles. 
S u bjects will als o be re q uire d t o c o m plete a p a per diar y. S u bjects will be pr o vi de d wit h a re mi n der 
t o c o m plete t he diar y t o c a pt ure wear e x perie nce o n a wee kl y  b asis u ntil t he y e xit t he st u d y. 
7. 2  
D ur ati o n of St u d y P arti ci p ati o n 
7. 2. 1  D ur ati o n  of St u d y P arti ci p ati o n f or E ac h S u bject 
I n v esti gat ors will ha ve u p t o 3 wee ks bet w ee n t he Scree ni n g a n d Dis pe nsi n g Visit. 
S u bjects will  be f oll o we d f or 3 m o nt hs ( u nless disc o nti n ue d or l ost t o f oll o w- u p) a n d m ust a d here t o 
t he f oll o wi n g sc he d ule: 
Visit  
T ar get  
Acce pt a ble Visit R a n ge  
V 1 : Scree ni n g Visit 
N o ne  
Da y -2 1 t o Da y -1 4  
V 2 : Dis pe nsi n g Visit 
Da y 1  
N A  
V 3 : 1-W ee k F oll o w -u p Visit  
Da y 8  
Da y 6  –  1 0  
V 4 : 1 -M o nt h F oll o w -u p Visit  
Da y 3 1   
Da y 2 8  –  3 6  
V 5 : 3 -M o nt h F oll o w -u p Visit  
Da y 9 2   
Da y  9 2  –  1 0 2  
N A = n ot a p plica ble  
N ote s: T he 3 -m o nt h f oll o w -u p visit  m ust occ ur n o e arlier t h a n D a y 9 2.  T here is n o D a y 0 i n t his n u m beri n g 
sc he me.  T he d a y pri or t o dis pe nsi n g is D a y-1.  
 
T he visit ra n ge is base d o n t he date test articles are i nitiall y dis pe ns e d ( Dis p e nsi n g Visit). A visit 
sc he d uli n g ta bl e will be pr o vi de d i n t he i nitial st u d y s hi p me nt t o ai d t he I n vesti gat or i n sc he d uli n g 
F oll o w- u p Visits. 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
1 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
7. 2. 2  Deter mi n ati o n of E n d of Cli nic al T ri al ( A ll S u b jects) 
T he s u bject has c o m plet e d t he st u d y w he n t he 3- M o nt h F oll o w- u p visit ( Visit 5) is c o ncl u de d. 
S u bjects w h o re q uire  f urt her f oll o w- u p will be f oll o we d acc or di n g t o t he a d verse e v e nt ( A E) s ecti o n 
( Secti o n 1 1. 5. 8 ). 
Ba usc h +  L o m b Cli nical O perati o ns will n otif y t h e I n vesti gat or w h e n t o c o ntact t he I R B t o i nf or m 
t he m t hat t he st u d y is c o m plete. 
If d uri n g t he st u d y it bec o mes e vi de nt t o t he S p o ns or t hat t he st u d y s h o ul d be st o p pe d pre mat urel y 
or place d o n h ol d, a p pr o priate n otificati o n will be gi ve n t o t he U S F D A, I n vesti gat or(s), a n d I R Bs, 
as a p plica ble. Ba us c h + L o m b Cli nical O perati o ns will i nstr uct t he I n vesti gat ors t o st o p/restart 
dis pe nsi n g st u d y materials a n d will arra n ge f or st u d y cl ose o ut, if a p plica ble, at eac h site. 
7. 3  
St u d y Desi g n a n d Assess me nts 
St u d y  assess me nts are s u m marize d i n Ta ble 1 . Met h o ds of cli nical e val uati o n are prese nte d i n 
A p pe n di x A . 

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
2 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
T a ble 1.  
St u d y Desi g n a n d Sc he d ule of Assess me nts 
P R O C E D U R E/ A S S E S S M E N T S  
Visit 1 - 
Scree ni n g  
Visit 2  
Dis pe nse  
( D a y 1) 
Visit 3  
1 -Wee k  
F oll o w -u p  
( D a y 6 -1 0 ) 
Visit 4  
1 -M o nt h  
F oll o w -u p  
( D a y 28 -3 6 ) 
Visit 5  
3 -M o nt h  
F oll o w -u p  
( D a y 92 -1 0 2 1) 
U nsc he d ule d 
Visit  
E xit 
Visit  
I nf or me d C o nse nt/ HI P A A A ut h orizati o n  
X  
 
 
 
 
 
 
De m o gra p hics/ B aseli ne E ye/ Le ns C haracteristics  
X  
 
 
 
 
 
 
Me dical Hist or y  
X  
 
 
 
 
 
 
Eli gi bilit y  
X  
 
 
 
 
 
 
Ra n d o mizati o n  
X  
 
 
 
 
 
 
Dis pe nse a n d / or ret ur n st u d y materials 
 
X 4 
X 4 
X 4 
X 4 
X 4 
X 4 
Diar y i nstr ucti o n/re mi n ders a n d ret ur n  
 
X  
X  
X  
X  
X  
X  
S y m pt o ms/ C o m plai nts ( wit h ha bit ual le nses i ncl u di n g 
re wetti n g dr o ps usa ge ) 
X  
 
 
 
 
 
 
A d verse E ve nts  
X  
X  
X  
X  
X  
X  
X  
Wit h o ut Le nses  
 
 
 
 
 
 
 
U nc orrecte d dista nce V A  
X  
 
 
 
 
 
X  
A ut orefracti o n  
X  
 
 
 
X  
 
X  
S p her oc yli n drical Refracti o n  
X  
X  
X  
X  
X  
X  
X  
Dista nce B S C V A  
X  
X  
X  
X  
X  
X  
X  
Kerat o metr y  
X  
 
 
 
 
 
X  
Slit La m p E xa m  
X  
X  
X  
X  
X  
X  
 
I ntra o c ular Press ure (I O P)  
X  
X  
X  
X  
X  
X  
X  
Direct O p ht hal m osc o pe ( n o n -dilate d) o n t he cr ystalli ne 
le ns, oc ular me dia, mac ular re gi o n a n d o ptic ner ve hea d) 
X  
X  
X  
X  
X  
X  
X  
Dilate d F u n d us E xa m  
X  
 
 
 
 
 
X  
Wit h St u d y Le nses  
 
 
 
 
 
 
 
S y m pt o ms/ C o m plai nts 
(i ncl u di n g 
re wetti n g 
dr o ps 
usa ge)  
X 6 
X  
X  
X  
X  
X 5 
X  
Dista nce  hi g h c o ntrast  l o g M A R le ns V A  
 
X 2 
X 2, 3 
X 2, 3 
X 3 
X 2, 3 
 
O ver -refracti o n a n d Dista nce V A 
 
X 2 
X 2, 3 
X 2, 3 
X 3 
X 2, 3 
 
V A li ne c ha n ge c o m paris o n –  Dis pe nse  V isit t o B S C V A 
 
X 2 
 
 
 
 
 
V A li ne c ha n ge c o m paris o n –  E xit B S C V A t o Scree ni n g  
B S C V A  
 
 
 
 
 
 
X  
Kerat o metr y c o m paris o n  
 
 
 
 
 
 
X  

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt R esearc h a n d De vel o p me nt 
 
2 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
P R O C E D U R E/ A S S E S S M E N T S  
Visit 1 - 
Scree ni n g  
Visit 2  
Dis pe nse  
( D a y 1) 
Visit 3  
1 -Wee k  
F oll o w -u p  
( D a y 6 -1 0 ) 
Visit 4  
1 -M o nt h  
F oll o w -u p  
( D a y 28 -3 6 ) 
Visit 5  
3 -M o nt h  
F oll o w -u p  
( D a y 92 -1 0 2 1) 
U nsc he d ule d 
Visit  
E xit 
Visit  
V A li ne c ha n ge c o m paris o n –  Hi g h c o ntrast dista nce 
le ns V A at U nsc he d ule d Visit t o hi g h c o ntrast B S C V A 
at Dis pe nsi n g Visit  
 
 
 
 
 
X  
 
V A li ne c ha n ge c o m paris o n 
–  F oll o w -u p visit  t o 
Dis pe nse Visit c o ntact le ns V A  
 
 
X  
X  
X  
 
 
Le ns W etta bilit y/ Ce ntrati o n/ M o ve me nt / a n d R otati o n  
X  
X 2 
X 2, 3 
X 2, 3 
X 3 
X 2, 3 
 
Le ns De p osits  
X  
X 2 
X 2, 3 
X 2, 3 
X 2, 3 
X 2, 3 
 
B S C V A =  best s pectacle-c orre cte d vis ual ac uit y, HI P P A = H ealt h I ns ura nce P orta bilit y Ac c o u nta bilit y Act, V A = vis ual ac uit y 
1 T he 3- M o nt h F oll o w- u p Visit m ust o cc ur n o earlier t ha n D a y 9 2. 
2 T o be assesse d f or le nses dis pe nse d at t his visit if t he s u bj ect di d n ot wear le nses t o t he visit. 
3 T o be assesse d f or le nses w or n t o t he visit. 
4 Le ns es will be dis pe nse d as a 3 m o nt h s u p pl y at Visit 2 ( or a n U nsc he d ule d Visit i n t he e ve nt of l ost le nses w he n a fres h s u p pl y is re or dere d a n d dis pe nse d). Use d 
le nses will be c ollecte d at Visit 3, 4, 5, E xit Visit, a n d/ or U nsc he d ule d Visit (i n t he e ve nt of l ost le nses w he n a fres h s u p pl y has t o re or dere d a n d dis pe nse d w hic h w o ul d 
occ ur at a n U nsc he d ule d Visit). 
5.I n t he e ve nt t he s u bj ect c o mes i n f or a n U nsc he d ule d Visit beca use he is e x perie nci n g a pr o ble m, S y m pt o ms a n d C o m pl ai nts ha ve t o be assesse d at t his ti me. 
6 C ollecti o n of wetti n g dr o p usa ge n ot re q uire d at Visit 1 ( Scree ni n g). 
N ote: T he E xit Visit will be dela ye d i n t he e ve nt t hat t here is a c o m plicati o n a n d t he s u bj ect nee ds t o be f oll o we d u p t hr o u g h a n U nsc he d ule d Visit.  
 
.

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h a n d De vel o p me nt 
2 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
8  Selecti o n a n d Wit h dr a w al of S u bjects 
8. 1  
N u m ber of S u bjects Pl a n ne d 
A p pr o xi matel y 2 4 4 s u bj ects will be ra n d o mize d i n t his 3- m o nt h, parallel- gr o u p, bilateral, 
I n v estigat or- mas ke d st u d y at 1 3 i n vesti gati ve sites i n t he U S e nr olli n g C hi nese s u bjects. 
8. 2  
S u bject I ncl usi o n Criteri a 
T o be eli gi ble f or e ntr y i nt o t he st u d y, t he s u bject m ust meet t he f oll o wi n g i ncl usi o n criteria: 
1.  S u bject m ust be of le gal a ge (at least 1 8 or as d efi ne d b y st ate la w) o n t h e date t he I C F is 
si g ne d a n d ha ve t he ca p acit y t o pr o vi de v ol u ntar y i nf or me d c o nse nt. 
2.  S u bject m ust be a ble t o rea d, u n derst a n d a n d pr o vi de writte n i nf or me d c o nse nt o n t he 
I R B a p pr o ve d I C F a n d pr o vi de a ut h orizati o n as a p pr o priate f or l ocal pri vac y re g ulati o ns. 
3.  S u bject m ust ha ve p h ysi ol o gicall y n or mal a nteri or se g me nts n ot e x hi biti n g cli nicall y 
si g nifica nt bi o micr os c o p y fi n di n gs ( greater t ha n Gra de 1 a n d/ or prese nce of i nfiltrates) 
a n d ha ve clear ce ntr al 6 m m c or neas. 
4.  S u bject m ust be a n a da pt e d wearer of s oft c o ntact le nses, wear a le ns i n eac h e ye, a n d 
eac h le ns m ust be of t h e sa me ma n ufact ure a n d bra n d. 
5.  S u bject m ust ha ve visi o n c orrecta ble t hr o u g h s p h er oc yli n drical r efracti o n t o 4 5 letters 
( 0. 0 4 l o g M A R) or better ( dista nce, hi g h c o ntr ast) i n eac h e ye.  Vis ual ac uit y of 0. 0 4 
l o g M A R is t he ac uit y w h ere a n i n di vi d ual s u bject w o ul d be gi v e n cre dit f or rea di n g 
l o g M A R 0. 0 a n d l o g M AR 0. 0 is e q ui vale nt t o C hi nese l o garit h mic vis ual ac uit y c h art 
val ue of 5. 0. 
6.  S u bject m ust be m y o pic or h y p er o pic a n d re q uir e le ns c orrecti o n fr o m + 4. 0 0 di o pter ( D) 
t o - 9. 0 0 D i n b ot h e yes. 
7.  S u bject m ust be a ha bit ual wearer of t oric s oft c o ntact le nses. 
8.  S u bject m ust be a ble t o be fit i n b ot h t he Test a n d C o ntr ol le nses i n t he liste d para meters. 
9.  S u bject ha ve n o acti ve oc ular disease or aller gic c o nj u ncti vitis. 
1 0.  S u bject m ust n ot be usi n g a n y t o pical oc ular m e dicati o ns. 
1 1.  S u bject m ust a gree t o wear t heir st u d y le nses o n a dail y wear basis f or t he d urati o n of t he 
st u d y. 
1 2.  S u bject m ust be willi n g a n d a ble t o f oll o w t he visit sc he d ule a n d f oll o w i nstr ucti o ns f or 
use of t he st u d y pr o d ucts. 
Writte n i nf or me d c o nse n t, e nr oll me nt i n t he st u d y, or dis pe nsi n g of st u d y pr o d ucts ca n n ot 
be gi n u ntil t he I n vesti gat or has recei ve d I R B a p pr o val t o c o n d uct t he st u d y. T he S p o ns or a n d 
I R B m ust a p pr o ve a n y a d vertisi n g use d t o r ecr uit s u bjects pri or t o use of t hat a d vertisi n g. 
All c o nse nte d s u bjects m ust be acc o u nte d f or, w het her t he y partici pate i n t he st u d y or n ot. 
Ba usc h + L o m b will pr o vi de a Scree ni n g L o g o n w hic h t o e nter i nf or m ati o n f or eac h s u bject 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
w h o si g ns a n I C F. All scree ne d s u bjects m ust be e ntere d o nt o t he Scree ni n g L o g, i n t he or der 
i n w hic h t he y were c o nse nte d, w here t h e y will be assi g ne d a se q ue ntial s u bject i de ntificati o n 
(I D) n u m ber. O nce a p ot e ntial s u bject is c o nse nte d a n d t heir i nitials are e nt ere d o nt o t he 
Scree ni n g L o g, t he I n v esti gat or s h o ul d pr ocee d wit h Scree ni n g pr oce d ures. 
P ote ntial s u bjects are dee me d eit her “ Scree n Pass ” or “ Scree n Fail.” “ Scree n Fail” s u bjects 
ha ve n ot met t he st u d y i n cl usi o n criteria or h a ve m et t he e x cl usi o n criteria. “ Scree n Fail” 
s u bjects ca n n ot be ra n d o mize d. S u bjects are c o nsi dere d e nr olle d w he n t h e y ha ve si g ne d t he 
I C F. T he c o p y of t heir si g ne d I C F a n d a n y i nf or m ati o n c ollecte d as p art of scree ni n g (e g, 
s o urce d oc u m e nts, etc.) m ust be ke pt i n t heir me dical rec or ds. 
“ Scree n Pass ” s u bjects h a ve m et all of t he st u d y i ncl usi o n criteria a n d h a v e n ot met a n y of 
t he e x cl usi o n criteria. O nl y “ Scree n Pass ” s u bjects ca n be ra n d o mize d t o recei ve t he st u d y 
le nses. 
O nce a s u bject has si g ne d t he I C F, a s u bject is c o nsi dere d e nr olle d a n d m ust be acc o u nte d f or 
at e ver y visit u ntil e xite d (c o m plete d, disc o nti n ue d, or n o n- dis pe nse d) fr o m t he st u d y, e v e n if 
t he y are n ot dis pe nse d st u d y materials. 
8. 3  
S u bject E xcl usi o n Criteri a 
T he s u bject is n ot  eli gi bl e t o partici pate i n t he st u d y if t he s u bject meets a n y of t he f oll o wi n g 
e x cl usi o n criteria: 
1.  S u bject has w or n gas p er mea ble ( G P) c o ntact le ns es wit hi n last 3 0 da ys or 
p ol y met h yl met hacr yl ate ( P M M A) le nses wit hi n last 3 m o nt hs. 
2.  S u bject has s yste mic dise ase affecti n g oc ul ar healt h. 
3.  S u bject is usi n g a n y s yste mic or t o pical me dicati o ns t hat will affect oc ul ar p h ysi ol o g y or 
le ns perf or m a nce. 
4.  S u bject has a n acti ve o c ular disease (f or e x a m ple b ut n ot li mite d t o pa pillar y 
c o nj u ncti vitis, a n y c o nj u ncti vitis: viral, bacterial, aller gic), a n y c or n eal i nfiltrati ve 
res p o nse or are usi n g a n y oc ular me dicati o ns. 
5.  S u bject has a n y “ Pres e nt” fi n di n g d uri n g t h e slit la m p e xa mi nati o n t hat, i n t he 
I n v esti gat or’s j u d g me nt, i nterferes wit h c o ntact le ns wear. 
6.  S u bject has a n y scar or n e o vasc ularizati o n wit hi n t he ce ntral 6 m m of t he c or nea. Mi n or 
peri p her al c or neal scarri n g (t hat d o es n ot e xte n d i nt o t he ce ntral 6 m m of t h e c or nea), 
t hat i n t he I n v esti gat or's j u d g me nt, d oes n ot i nterfere wit h c o ntact le ns wear, are eli gi ble 
f or t his st u d y. 
7.  S u bject has a nis o metr o pia (s p herical e q ui vale nt) of great er t ha n 2. 0 0 D bas e d o n 
s p her oc yli n drical refracti o n. 
8.  S u bject is a p ha kic. 
9.  S u bject is a m bl y o pic. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 0.  S u bject has ha d a n y c or neal s ur ger y (e g, refracti v e s ur ger y). 
1 1.  S u bject is partici pati n g i n a c o nflicti n g st u d y ( or acti vel y partici pati n g wit hi n a n ot her 
acti ve c o h ort of t his st u d y). 
1 2.  S u bject has pa rtici pate d i n a n y dr u g or de vi ce cli nical i n vesti gati o n ( wit hi n 1 4 da ys) 
pri or t o e ntr y i nt o t his st u d y a n d/ or d uri n g t he peri o d of st u d y partici pati o n. 
1 3.  S u bject is a w o ma n of c hil d beari n g p ot e ntial if o ne of t he f oll o wi n g: pre g n a nt, pla ns t o 
bec o me pre g na nt d uri n g st u d y or is breast fee di n g. 
1 4.  S u bject m eets a n y of t he f oll o wi n g criteria: 
 O p ht hal m ol o gist, O D, O pticia n, O p ht hal m ol o gist’s Assista nt/ Tec h nicia n 
 e m pl o yee of a m ar ket r es earc h fir m 
 e m pl o yee of ma n ufact ur er of c o ntact le ns or c o ntact le ns care pr o d ucts 
 e m pl o yee of t he i n vesti gati o nal site 
1 5.  S u bject wears m o n o visi o n or m ultif ocal c o ntact le nses. 
1 6.  S u bject is c o nsi dere d b y t he I n v esti gat or t o n ot be a s uita ble ca n di dat e f or partici pati o n. 
 
If a s u bject meets all t he i ncl usi o n criteria a n d d o es n ot e x hi bit a n y of t he e x cl usi o n criteria, 
t he s u bject is eli gi ble t o be e nr olle d i nt o t he st u d y. I n eli gi ble s u bjects M U S T N O T be 
e nr olle d i n t his st u d y a n d are c o nsi d ere d a “ Scree n Fail”. A n y s u bject e nr oll e d i n t he st u d y 
w h o later is f o u n d t o ha v e n ot met t he eli gi bilit y criteria at e ntr y will be disc o nti n ue d. 
N ote:  A ny exce pti o ns t o t he I ncl usi o n a n d Excl usi o n criteri a m ust be cle ar e d by t he S p o ns or.  
8. 4  
S u b ject Wit h dr a w al Criteri a 
8. 4. 1  List of Tre at me nt Wit h dr a w al Criteri a 
A s u bject M U S T be disc o nti n ue d pri or t o t he fi nal st u d y visit f or a n y of t h e f oll o wi n g 
reas o ns: 
 v ol u ntar y wit h dra wal 
 dea t h 
 I n vesti gat or decisi o n t hat it is n ot i n t he best me dical i nterest of t he s u bj ect t o c o nti n ue 
partici pati o n i n t he i n vesti gati o n 
 i neli gi ble at t he Scree ni n g Visit - d oes n ot meet t h e eli gi bilit y criteria i n t he pr ot oc ol 
 i na bilit y t o mai ntai n r ec o m me n de d weari n g s c he d ule 
 c o ntin ue d fail ure t o f oll o w s u bject i nstr ucti o ns 
 mi sses m ore t ha n 1 F oll o w- u p Visit, n ot i ncl u di n g t he 3- M o nt h Visit 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 lac k of m oti vati o n 
 l ost t o f ollo w- u p (see S ecti o n 8. 4. 3 ) 
 i nstillati o n of n o n- me dicall y i n dicate d s ol uti o n n ot s pecifie d i n t he pr ot oc ol 
 ot her e ye is disc o nti n ue d 
 bec o mes pre g na nt d uri n g t he st u d y 
 3- m o nt h f oll o w- u p visit is c o n d ucte d pri or t o D a y 9 2 
P ri or t o disco nti n ui n g a s u bject, e ver y eff ort s h o ul d be ma de t o c o ntact t he s u bject, sc he d ule 
a fi nal st u d y visit, o btai n as m uc h f oll o w- u p data as p ossi ble, a n d t o retrie ve all st u d y 
materials. A d vers e e v e nts will be f oll o we d as descri be d i n Secti o n 1 1. 5. 8 . S u bject 
disc o nti n uati o ns will be d oc u me nte d clearl y o n t h e s o urce d o c u me nt a n d a p plica ble e C R F. 
T he I n vesti gat or s h o ul d i n dicate t he P RI M A R Y ( o ne) reas o n t hat t he s u bject was 
disc o nti n ue d f or eac h e ye. S u bjects t hat are disc o nti n ue d fr o m t he st u d y f oll o wi n g 
ra n d o mizati o n will n ot be re pla ce d. 
8. 4. 2  Re as o ns f or Tre at me nt Wit h dr a w al 
A s u bject M A Y be disc o nti n ue d (at t he discreti o n of t he I n vesti gat or, t he S p o ns or, a n d/ or t he 
I R B) pri or t o t he fi nal st u d y visit f or a v ariet y of reas o ns, i ncl u di n g, b ut n ot li mite d t o: 
 a n A E occ urri n g d uri n g t he c o urse of t he st u d y, w hic h precl u des c o nti n ue d treat me nt or 
f oll o w- u p 
 persiste nt slit la m p fi n di n gs ( m ust be re p orte d t o t he S p o ns or wit hi n 2 4 h o urs) of t he 
f ollo wi n g gra des: 
 M o derate 
 Se vere 
 persist e nt st u d y-relate d s y m pt o ms/c o m plai nts 
 u nac ce pta ble dista nce le ns V A, le ns ce ntr ati o n, le ns m o ve me nt, or u nacce pt a ble le ns 
r otati o n 
8. 4. 3  L ost t o F oll o w- u p  
S u bjects w h o d o n ot ret ur n f or sc he d ule d F oll o w- u p Visits, as defi ne d b y t he visit wi n d o w, 
a n d ca n n ot be c o ntacte d, are t o be c o nsi dere d l ost t o f oll o w- u p. All atte m pts t o c o ntact t he 
s u bject s h o ul d be d oc u m e nte d a n d ke pt wit h t he s u bject’s s o urce d oc u me nt ati o n, a n d t he 
a p plica ble e C R Fs will be c o m plete d. T he dat e of e xit re p orte d s hall be t he date of last 
i n-cli nic st u dy visit. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
8. 4. 4  Tre at me nt Wit h dr a w al F oll o w- u p Pr oce d ure 
E xit Visit assess me nts s h o ul d be c o m plete d f or dis c o nti n ue d s u bjects. 
9  Tre at me nt Pl a n 
T he st u d y will be c o n d ucte d at a p pr o xi matel y 1 3 i n vesti gati ve sites l oc ate d i n t he U S b y 
I n v estigat ors w h o are det er mi ne d b y Ba usc h + L o m b t o be s uita bl y q ualifie d b y trai ni n g a n d 
e x perie nce t o c o n d u ct t his st u d y. Pri nci pal I n vesti gat ors will be i de ntifie d o n t he De vice 
I n v esti gat or A gree me nt F or m. 
I n t he e ve nt t hat sel ecte d sites d o n ot meet f ull e nr oll me nt, t he S p o ns or ma y deci de t o 
i ncreas e e nr oll me nt as n ee de d at ot her c urre ntl y acti ve sites a n d/ or a d diti o nal site(s) ma y be 
a d de d t o satisf y t he e nr oll me nt re q uire me nts of t h e st u d y. 
9. 1  
R a n d o miz ati o n a n d Met h o ds of Assi g ni n g S u bjects t o Tr e at me nt Gr o u ps 
S u bjects will  be ra n d o mize d t o o ne of 2 treat me nt ar ms at a 1: 1 rati o, weari n g eit her Test or 
C o ntr ol le nses i n b ot h e yes f or t he d urati o n of t he st u d y. Ra n d o mizati o n will be stratifie d b y 
site, a ncestr y ( C hi nes e, N o n- C hi nese), a n d s p h ere p o wer si g n ( p ositi ve, ne gati ve). 
S u bjects will be ra n d o mize d se q ue ntiall y. 
T he ra n d o mizati o n sc he me will be pr o d uce d pri or t o st u d y e nr oll me nt b y a n u n mas ke d 
statisticia n n ot ot her wise i n v ol ve d i n t he trial. A n u n mas ke d d esi g nee at eac h site will be 
res p o nsi ble f or dis pe nsi n g t he st u d y le nses acc or di n g t o t he ra n d o mize d treat me nt 
assi g n me nts. Le ns es will be dis pe nse d directl y t o t he s u bject b y t he u n mas k e d desi g n ee, 
t here b y mai ntai ni n g I n vesti gat or mas ki n g. I n a n eff ort t o e ns ure t hat t he I n v esti gat or re mai ns 
mas ke d, t he u n mas ke d d esi g nee M U S T dis pe nse t he st u d y le nses a n d M U S T re m o ve f oils 
fr o m t heir blister pac ks o ut of t he I n vesti gat or’s si g ht i m me diatel y pri or t o dis pe nsi n g. 
U n w or n ( u n o pe n e d) le ns es t hat are ret ur n e d b y t he s u bject t o t he site m ust be ret ur n e d i n a 
ma n ner s o as n ot t o u n m as k t he I n vesti gat or a n d ot her staff me m b ers at t h e site (ie, ret ur ne d 
i n a n o pa q ue ba g or c o nt ai ner la bel e d wit h s u bject i de ntifiers). T he u n mas ke d desi g nee will 
be res p o nsi ble f or p h ysi call y e x a mi ni n g t he u n o pe ne d le ns blister pac k a ge l a beli n g t o e ns ure 
t he a p pr o priat e le nses w ere ret ur n e d, a n d will d oc u me nt t he ret ur n of t hes e le nses i n t he 
C T M Pr o d uct Acc o u nta bilit y L o g. T h e I n vesti gat or s h o ul d c o ntact t he Me di cal M o nit or pri or 
t o e mer ge nc y u n m as ki n g of st u d y ar m assi g n me nt. I n a n ur ge nt sit uati o n, h o we ver, w here 
k n o wle d ge of t he st u d y ar m assi g n me nt is critic al t o s u bject safet y, t he c o d e ma y be br o ke n 
b y re q uesti n g t he all ocate d treat me nt f or t hat s u bject fr o m t he u n mas k e d d esi g nee. 
T he I n vesti gat or m ust n otif y t he S p o ns or/ Me dical M o nit or a n d/ or St u d y M a na ger as s o o n as 
p ossi ble after e m er ge n c y u n mas ki n g. I n a d diti o n, t he I n v esti gat or m ust rec or d t he date, ti me, 
a n d reas o n f or u n mas ki n g t he st u d y ar m assi g n m e nt i n t he s o urce d oc u me ntati o n. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
St u d y M o nit ors will bec o me u n mas ke d d uri n g site visits as t he y perf or m rec o nciliati o n 
acti vities a n d/ or re vie w ra n d o mizati o n assi g n me nts, pr o d uct acc o u nta bilit y rec or ds, pr o d uct 
i n ve nt or y, a n d s u bject r ec or ds. St u d y M o nit ors m ust ta ke care n ot t o u n m as k t he St u d y 
Ma na ger, ot h er Ba usc h + L o m b staff, C o ntract Researc h Or ga nizati o n ( C R O ) staff, or site 
staff d uri n g t he st u d y. 
9. 2  
C o nc o mit a nt Me dic ati o ns 
S u bjects will be i nstr ucte d t o use t heir ha bit ual re wetti n g dr o ps as nee d e d d uri n g t he st u d y. 
Ot her c o nta ct le nses/s ol uti o ns are n ot all o we d t o b e use d b y s u bjects d uri n g t he st u d y. All 
c o nc o mita nt me dicati o ns ( oc ular, s yste mic or t o pi cal) t hat ha ve bee n t a ke n i n t he past 
3 0 da ys b ef ore si g ni n g t h e I C F a n d d uri n g t he c o urse of t he st u d y will be c ollecte d. 
I n t he e ve nt t hat a s u bj ect re q uires me dical treat m e nt ( prescri pti o n me dicati o n) f or a n oc ular 
c o n diti o n, treat t he s u bject as a p pr o pri ate t o pre v e nt f urt her c o m plicati o ns a n d t o p ote ntiall y 
res ol ve t he e v e nt. 
9. 3  
Tre at me nt A d mi nistr ati o n a n d C o m pli a nce 
T he I n vesti gat or or ot h er desi g nee will re vie w i nstr ucti o ns a n d war ni n gs f or le ns wear, le ns 
care, h a n dli n g, clea ni n g, a n d disi nfecti n g wit h t he s u bject. A n y s u bject w h o d oes n ot f oll o w 
i nstr ucti o ns t o a de gree t hat, i n t he S p o ns or or I n v esti gat or’s o pi ni o n, je o par dizes t he 
s u bject’s well- bei n g or t h e vali dit y of t he st u d y, m ust be disc o nti n ue d (see Secti o n 8. 4 ). 
9. 4  
Pr o t oc ol D e vi ati o ns 
T he date of a n d reas o n f or de viati o ns will be d oc u me nte d i n all cases. Si g nifica nt or maj or 
pr ot oc ol de viati o ns i m pacti n g t he safet y of t he s u bject or t he i nte grit y of t he st u d y m ust be 
re p orte d b y t he I n vesti gat or t o t he I R B i m me diatel y. Re p orti n g of all ot her pr ot oc ol 
de viati o ns m ust a d here t o t he re q uire m e nts of t he g o ver ni n g I R B. 
S u bjects ma y c o nti n ue t o partici pate u ntil t he e n d of t he st u d y, u nless t he pr ot oc ol de viati o ns 
p ut t he s u bject at ris k or t he s u bject’s c o n diti o n re q uires t hat t he y be disc o nti n ue d fr o m t he 
st u d y. 
1 0  St u d y M ateri als a n d M a n a ge me nt 
Ba usc h + L o m b will pr o vi de all st u d y materials at n o c har ge t o t he I n vesti gat or. Sites will be 
pr o vi de d wit h dis pe nsi n g sets f or b ot h t he Test a n d C o ntr ol le nses. All ot her materi als will be 
pr o vi de d t o t he site pri or t o t he start of t he st u d y. 
S u bjects will  be gi ve n a n a de q uate s u p pl y of st u d y le nses t o wear o n a dail y dis p osa ble basis 
f or t he d urati o n of t h e st u d y. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
S u bjects will be pr o vi de d wit h le ns cases i n w hic h t o dr y sta c k t heir use d le nses. All use d 
le nses a n d blister f oils will be ret ur ne d at 1 wee k ( Visit 3), 1 M o nt h ( Visit 4), 3 M o nt hs 
( Visit 5), a n d E xit Visits a n d all u n use d le nses will be ret ur ne d t o t he S p o ns or at e n d of t he 
st u d y. 
S u bjects will be i nstr ucte d t o use t heir ha bit ual re wetti n g dr o ps as nee d e d  d uri n g t he st u d y. 
Use of ot her c o ntact le ns es or care pr o d u cts is n ot all o we d . 
 
 
 
1 0. 1  I n vesti g ati o n al Pr o d uct, Bi otr ue O N E d a y f or Asti g m atis m 
T he Test Pr o d uct i n t his case is t he Bi otr ue O N E d a y f or Asti g matis m S oft C o ntact Le ns. T he 
descri pti o n is as f oll o ws: 
Dia meter: 1 4. 5 m m 
Base C ur v e: 8. 4 m m 
Material: nes ofilc o n A 
 
S p heric al P o w er: Pl a n o t o – 6. 0 0 D (i n 0. 2 5 D ste ps); 
C yli n d er P o wers; -. 7 5, - 1. 2 5, - 1. 7 5 
A xis: 1 0°, 2 0°, 6 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 2 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 2 a x es) 
 
C yli n d er P o wers; - 2. 2 5 
A xis 2 0°,  9 0°, 1 6 0°, 1 8 0° ( 4 a x es) 
 
P o w er : - 6. 5 0 t o - 9. 0 0 (i n 0. 5 0 D Ste ps); 
C yli n d er P o wers; -. 7 5, - 1. 2 5, - 1. 7 5 
A xis: 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 0 a x es) 
 
S p he ric al P o w er:  + 0. 2 5 D t o + 4. 0 0 D (i n 0. 2 5 D ste ps); 
C yli n d er P o wers: - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D 
A xis: 2 0°, 7 0°,   9 0°, 1 1 0°, 1 6 0°, 1 8 0° ( 6 a x es) 
 
Orie ntati o n Mar k at 6 o’cl oc k. 
1 0. 2  I n vesti g ati o n al C o ntr ol Pr o d uct, 1- D a y Ac u v ue M oist f or Asti g m atis m C o nt act 
Le ns 
T he C o ntr ol Pr o d uct i n t his case is t he 1- Da y Ac u v ue M oist f or Asti g matis m c o ntact le nses 
wit h t he f oll o wi n g des cri pti o n: 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
2 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Dia meter: 1 4. 5 m m 
Base C ur v e: 8. 5 m m 
Material: etafilc o n A 
 
S p heric al P o w er: Pl a n o t o – 6. 0 0 D (i n 0. 2 5 D ste ps); 
C yli n d er P o wers; -. 7 5, - 1. 2 5, - 1. 7 5  
A x is: 1 0°, 2 0°, 6 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 2 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 2 a x es) 
 
C yli n d er P o wers; - 2. 2 5 
A xis 2 0°,  9 0°, 1 6 0°, 1 8 0° ( 4 a x es) 
 
S p he ric al P o w er: - 6. 5 0 t o - 9. 0 0 (i n 0. 5 0 D Ste ps); 
C yli n d e r P o wers; -. 7 5, - 1. 2 5, - 1. 7 5 
A xis: 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 6 0°, 1 7 0°, 1 8 0° ( 1 0 a x es) 
 
S p he ric al P o w er:  + 0. 2 5 D t o + 4. 0 0 D (i n 0. 2 5 D ste ps); 
C yli n d er P o wers: - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D 
A xis: 2 0°, 7 0°,  9 0°, 1 1 0°, 1 6 0°, 1 8 0°  ( 6 a x es) 
 
Orie ntati o n Mar ks at 3 a n d 9 o’cl oc k. 
 
T he I n v esti gat or s h o ul d r efer t o A p pe n di x C  f or t he fitti n g g ui de f or t he st u d y le nses. 
1 0. 2. 1  P ac k a gi n g a n d L a beli n g 
T he Test le nses ( Bi otr ue O N E da y f or Asti g matis m) use d i n t his st u d y will be pr o vi de d i n t he 
c urre ntl y mar k ete d pac ka gi n g. T he blister la bel will c o ntai n t he f oll o wi n g i nf or mati o n: 
 le ns p o wer 
 base  c ur v e 
 le ns dia meter 
 l ot n u m ber 
 e x pirati o n date 
 ma n ufact ur ers na m e 
T he C o ntr ol l e nses ( 1- D a y A c u v ue M oist f or Asti g matis m ) use d i n t his st u d y  will be 
pr o vi de d i n t he c urre ntl y mar kete d pac ka gi n g. T h e blister la bels will c o ntai n t he f oll o wi n g 
i nf or mati o n: 
 le ns p o wer 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 base c ur v e 
 le ns dia meter 
 l ot n u m ber 
 e x pirati o n date 
 ma n ufact ur er’s n a me 
T he c o m m ercial cart o ns f or b ot h Test a n d C o ntr ol le nses will c o ntai n a n a d diti o nal la bel: 
“ St u d y 8 8 5 F or Cli nical Trial Use O nl y”. 
1 0. 2. 2  St or a ge, H a n dli n g, a n d Dis p os al of St u d y Le nses 
All Test a n d C o ntr ol le nses pr o vi de d b y t he S p o ns or m ust be st ore d i n a sec ure l ocati o n 
accessi ble o nl y t o st u d y pers o n nel a n d mai ntai n e d at r o o m te m perat ur e. N o le nses s h o ul d be 
dis p ose d of. All le nses, w or n or u n w or n, will be ret ur ne d t o t he S p o ns or. 
1 0. 2. 3  St u d y Le ns Pre p ar ati o n 
T he I n vesti gat or s h o ul d refer t o t he Fitti n g G ui de (see A p pe n di x C ) f or fitti n g t he Test a n d 
C o ntr ol le nses.  
1 0. 2. 4  A d mi nistr ati o n 
Test or C o ntr ol le nses will be w or n o n a dail y dis p osa ble wear basis. O ne h u n dre d t we nt y 
( 1 2 0) ne w st u d y le nses will be s hi p pe d t o t he site per e ye. U p t o 1 1 0 ne w st u d y le nses will be 
dis pe nse d per e ye at t he Dis pe nsi n g Visit t o pr o vi de s ufficie nt q ua ntities t o mai ntai n a dail y 
dis p osa ble wear m o dalit y f or at least 1 0 2 da ys. T e n ( 1 0) st u d y l e nses will r e mai n at t he site 
f or all Foll o w- u p Visits. 
After c o nt act le ns assess me nts are c o m plet e at F oll o w- u p Visits, t he I n vesti gat or will c ollect 
a n d st ore w or n l e nses f or s u bse q ue nt ret ur n t o t he S p o ns or. 
1 0. 2. 4. 1  S u bject I nstr ucti o ns 
All s u bjects m ust be gi ve n S u bject I nstr u cti o ns f or t he use of st u d y le nses (refer t o A p pe n di x 
B  f or S u bje ct I nstr ucti o ns). S u bjects m ust c o m pl y wit h t he i nstr ucti o ns pr o vi de d t o t he m. 
S u bject I nstr u cti o ns will be s u p plie d t o t he I n vesti gat or b y Ba usc h + L o m b f or distri b uti o n t o 
t he s u bjects. 
All s u bjects m ust refer t o le ns s u bject i nstr ucti o ns f or preca uti o ns a n d war ni n gs rel ate d t o 
c o ntact le ns wear. S u bjects s h o ul d refer t o t he pac ka ge i nsert f or preca uti o ns a n d war ni n gs 
relate d t o t he use of t his le ns care pr o d uct. 
T he I n vesti gat or or ot h er desi g nee m ust re vie w, wit h t he s u bject, t he S u bject I nstr ucti o ns a n d 
t he preca uti o ns a n d war ni n gs, as a p pr o priate f or t he st u d y. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
A n y s u bject w h o d oes n ot f oll o w i nstr ucti o ns t o a de gree t h at, i n t he S p o ns or or 
I n v esti gat or's o pi ni o n, je o par dizes t he s u bject's w ell- bei n g or t he vali dit y of t he st u d y, s h o ul d 
be disc o nti n ue d. 
1 0. 2. 4. 2  S u bject Di ar y 
S u bjects will be re q uire d t o c o m plete a pa p er diar y. S u bjects will be pr o vi de d wit h a 
re mi n der t o c o m plete t he diar y t o ca pt ur e wear e x perie nce o n a wee kl y basis u ntil t he y e xit 
t he st u d y. Eac h e nr olle d s u bject will be pr o vi de d wit h i nstr ucti o ns f or c o m pleti n g t he diar y 
after 7 da ys of le ns w ear. T here will be a s pecifi e d ti mefra me i n w hic h t he diar y m ust be 
c o m plete d. 
1 0. 3  St u d y Le ns Acc o u nt a bilit y 
T he u n mas ke d desi g nee at eac h site will be res p o nsi ble f or kee pi n g c urre nt a n d acc urate 
rec or ds of t he a m o u nt of st u d y le nses recei ve d a n d dis pe nse d, a n d t heir dis p ositi o n. T he 
st u d y le nses m ust be st or e d u n der t he a p pr o priat e c o n diti o ns i n a sec ure area a n d are t o be 
dis pe nse d o nl y t o s u bjects e nr olle d i n t he st u d y, i n acc or d a nce wit h t he c o n diti o ns s pecifie d 
i n t his pr ot oc ol. D uri n g t he c o urse of t he st u d y, t he u n mas ke d desi g nee m ust mai ntai n a n 
i n ve nt or y of all st u d y le nses dis pe nse d t o or ret ur ne d b y t h e s u bject, i ncl u di n g s u bject 
i de ntifiers. A Cli nical Trial Materials ( C T M) Pr o d uct Acc o u nta bilit y L o g will be pr o vi de d t o 
t he sites t o mai ntai n rec or ds of t he st u d y l e nses assi g ne d t o eac h e nr olle d s u bject. 
At ti me p oi nts t hr o u g h o ut t he st u d y a n d/ or u p o n c o m pleti o n of t he st u d y, t he 
S p o ns or/ S p o ns or's re pres e ntati ve ma y re vi e w t he Pr o d uct Acc o u nta bilit y L o g t o verif y t he 
I n v esti gat or's acc o u nta bilit y rec or ds. 
T he s u bject will be dis pe nse d u p t o 1 1 0 le nses f or t he e ntire st u d y at t he Dis pe nse Visit. T he 
s u bject will dr ysta c k u p t o 1 0 w or n le nses per left e ye a n d 1 0 w or n le nses per ri g ht e ye i n 
o ne le ns cas e. T he s u bject will ret ur n all blister f oils f or t he w or n le ns es a n d t he dr yst ac k le ns 
cases at eac h visit. T he u n mas ke d desi g nee will c ollect t he le ns cas es a n d blister f oils, a n d 
c o m plete t he Pr o d uct Acc o u nta bilit y L o g. T he dr ystac k e d le ns cases will be place d i n a 
reseal a ble plastic ba g wit h a ‘ W or n Le ns La b el’ la bel a d here d t o t he ba g. T he reseala ble b a gs 
fr o m eac h visit will be c ollecte d i n o ne w hite o pa q ue ba g per s u bj ect. T he o pa q ue ba g will be 
la bele d wit h s u bject I D, I n vesti gat or I D, a n d I n vesti gat or na m e. D o n ot per ma ne ntl y seal t he 
o pa q ue ba g  u ntil s u bject acc o u nta bilit y at e n d of t he st u d y. At t he e n d of t h e st u d y, all 
u n w or n/ u n o pe ne d le ns es ret ur ne d b y t he s u bject s h o ul d be i n t he s u bject’s w hite o pa q ue ba g. 
O nl y t he u n mas k e d desi g nee will ha n dle t he w or n a n d u n w or n/ u n o pe ne d le ns ret ur ns a n d 
w hite o pa q ue ba gs. T h e u n mas ke d desi g nee m ust e nter all le nses dis pe ns e d a n d ret ur n e d 
i m me diatel y i nt o t he C T M Pr o d uct Acc o u nta bilit y L o g. O nce t he Pr o d uct Acc o u nta bilit y 
L o g has b ee n v erifie d b y t he st u d y cli nical researc h ass ociate ( C R A ) ( with si g nat ur e), cl ose 
a n d seal e ac h s u bject’s w hite o pa q ue ba g. F oll o wi n g verificati o n, a n d as directe d b y t he 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
S p o ns or, all s u bject’s seale d o pa q ue ba gs t hat i ncl u de t heir w or n a n d u n w or n st u d y le ns es 
m ust be ret ur ne d at t he e n d of t he st u d y t o t he S p o ns or’s C T M S u p pl y C hai n at t he a d dress 
liste d bel o w. Fe d E x ta gs will be pr o vi de d t o t h e sites f or ret ur n of s u bject o pa q ue ba gs. 
 
 
 
 
 
1 0. 4  N o ni n vesti g ati o n al Pr o d ucts 
S u bjects will be i nstr ucte d t o use t heir ha bit ual re wetti n g dr o ps as nee d e d d uri n g t he st u d y. 
T he use of ot her c o nta ct le ns care pr o d ucts is n ot all o we d. 
1 0. 5  Res p o nsi bil it y 
S u bject data re q uir e d b y t his pr ot oc ol are t o be tra nsferre d fr o m t he s o urce t o t he e C R Fs. T he 
I n v esti gat or a n d his/ her st u d y sit e pers o n nel will be res p o nsi ble f or c o m pleti n g t he e C R Fs. 
T he I n vesti gat or is r e q uir e d t o verif y t hat all of t he re q ueste d i nf or mati o n is acc uratel y 
rec or d e d o n t he e C R Fs b y pr o vi di n g a n electr o ni c si g nat ur e. All i nf or mati o n re q ueste d o n t he 
e C R Fs nee ds t o be s u p pli e d, i ncl u di n g s u bject i de ntificati o n a n d i nitials, date(s), assess me nt 
val ues, etc, a n d a n y o missi o n or discre pa n c y will re q uire e x pla nati o n. All i nf or mati o n o n 
e C R Fs m ust be tracea ble t o s o urce d oc u me nts. 
T he st u d y m o nit or will be res p o nsi ble f or re vie wi n g a n d v erif yi n g t he data rec or d e d o n t he 
e C R Fs per t he st u d y M o nit ori n g Pla n, utilizi n g t he ori gi n al s o urce d o c u me ntati o n a n d will 
q uer y discre p a nt fi n di n gs. T he I n vesti gat or a n d st u d y site pers o n nel will be res p o nsi ble f or 
a ns weri n g all q ueries. 
T he e C R Fs will be s u b mitte d t o Ba usc h + L o m b Gl o bal Cli nical O perati o ns f or q ualit y 
ass ura nce re vi e w, data e ntr y, a n d st atistical a nal ysis. 
A c o p y of t he e C R Fs will be pr o vi de d t o t he I n vesti gat or at t he c o ncl usi o n of t he st u d y, w h o 
m ust e ns ure t hat it is st ore d i n a sec ure place. 
1 1  St u d y Pr o ce d ures a n d E v al u ati o ns 
N O T E: 
All V A me as ure me nts M U S T be m a de usi n g a p h or o pter. 
N O T E: 
Use t he s a me ker at o meter at t he Scree ni n g a n d E xit Visits. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 1  Visit Sc he d ule 
1 1. 1. 1  Scree ni n g Visit 
A Scree ni n g L o g will be pr o vi de d b y t he S p o ns or t o trac k all c o nse nt e d s u bjects t hat t he 
I n v esti gat or i nter vie ws re gar di n g t h e st u d y. O nce all a vaila ble li nes o n t he Scree ni n g L o g 
ha ve bee n c o m plete d, or t he I n v esti gat or has f ulfille d his/ her q u ota of s u bjects, t he 
I n v esti gat or will si g n a n d dat e t he f or m t o verif y t hat all t he s u bjects w h o i nter vie we d f or t he 
st u d y ha v e pr o vi de d i nf or me d c o nse nt a n d Healt h I ns ura nce P orta bilit y Acc o u nta bilit y Act 
( HI P A A) a ut h orizati o n. T he I n vesti gat or will se n d t he b ott o m c o p y of eac h Scree ni n g L o g t o 
t he S p o ns or as s o o n as t he q u ota of s u bjects f or his/ her site has bee n e nr oll e d i nt o t he st u d y. 
T he I n vesti gat or will ret ai n t he ori gi nal d oc u m e nt f or t heir rec or ds. 
After o btai ni n g writte n i nf or me d c o ns e nt, pr os pecti ve s u bjects will be scree ne d t o det er mi ne 
w het her t he y me et t he e ntr y criteria f or t he st u d y. 
Scree ni n g will pr ocee d as f oll o ws: 
a. E nter t he s u bje ct i nf or m ati o n o n t he ne xt a vaila ble li ne of t he Scree ni n g L o g. 
b.  C ollect t he f oll o wi n g le ns hist or y i nf or mati o n fr o m t he s u bject: a vera ge dail y weari n g 
ti me h o urs le nses w or n o n t he da y of t his visit c urre nt le ns bra n d a n d le ns wear m o dalit y, 
c urre nt le ns care pr o d ucts. C ollect t he rele va nt me dical hist or y f or t he past 2 years. 
c. C ollec t de m o gra p hic a n d baseli ne i nf or mati o n a n d perf or m t he f oll o wi n g 
baseli ne/ Scree ni n g assess me nts ( wit h o ut le nses) a n d rec or d i n t he s u bject’s s o urce 
d oc u me nt: u nc orrecte d dista nce V A , a ut orefracti o n, s p her oc yli n drical refracti o n, dista nce 
best s pec tacl e-c orrecte d vis ual ac uit y ( B S C V A), kerat o metr y, i ntra o c ular press ure (I O P) 
usi n g t he T o n o Pe n or t he G ol d ma n n A p pla nati o n T o n o meter, dilate d f u n d us e xa m, direct 
o p ht hal m osc o pe e x a m ( n o n- dilate d). 
d.  P erf or m a slit la m p e x a mi nati o n (re m o ve t he le ns es if t he s u bject w ore l e nses t o t he 
visit). Rec or d a n d dia gra m t he res ults a n d fi n di n gs i n t he s u bject’s s o urce d oc u me nt a n d 
a p pr o priate eC R F : 
 a n y u n gra de d fi n di n g m ar ke d as “ P R E S E N T” 
 a n y n e w c or neal s cars 
 a n y n e o vasc ul arizati o n wit hi n t he ce ntral 6 m m of t he c or nea 
 a n y c or neal stai ni n g 
 a n y c or neal i nfiltrate (rec or d details o n t he C or neal I nfiltrat es E val uati o n F or m 
[A p pe n di x E ]) 
 a n y ot h er gra de d slit la m p fi n di n gs Gra de 2 or greater 
e. If t he s u bject is eli gi ble, c ollect A E a n d S y m pt o ms/ C o m plai nts i nf or mati o n fr o m t he 
s u bject regar di n g t h eir ha bit ual le nses. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
f. Assi g n s u bject n u m bers t o eac h eli gi ble s u bject i n asce n di n g or der. A l o g will be 
pr o vi de d t o eac h site t o mai ntai n a rec or d of t he s u bject n u m bers assi g ne d t o eac h 
e nr olle d s u bject. Rec or d t he assi g n e d s u bject I D o n t he Scree ni n g L o g. 
g.  T he u n mas ke d desi g nee will deter mi ne t he eli gi ble s u bject’s ra n d o mize d le ns t y pe 
(treat me nt gr o u p). 
h.  T he Scree ni n g Visit e C R F s h o ul d be c o m plete d o nl y if t he s u bject is a “ Scree n Pass.” 
i. C o n d uct a dia g n ostic fitti n g e v al uati o n f or t he Test or C o ntr ol le nses t o t he le ns t he 
s u bject is ra n d o mize d t o, usi n g t he Fitti n g Sets pr o vi de d. T he pres cri pti o n deter mi ne d 
fr o m t his fitti n g assess m e nt will be use d t o dis pe nse/ or der Test or C o ntr ol le nses 
acc ordi n g t o t he le ns t h e s u bject is ra n d o mize d t o. T he I n vesti gat or s h o ul d e ns ure t hat t he 
le ns was i nserte d wit h t h e t oric etc h mar ks r o u g hl y at t he 6 o’cl oc k p ositi o ns a n d / or 
all o w t he trial le nses t o pr o perl y settle o n t he e ye f or a mi ni m u m of 5 mi n utes. C ollect t he 
f oll o wi n g i nf or mati o n f or b ot h st u d y le nses usi n g t he st u d y site’s sta n dar d dia g n ostic 
fitti n g tec h ni q ues: 
 C ollect S y m pt o ms/ C o m plai nts i nf or mati o n usi n g t he S y m pt o ms/ C o m plai nts Rati n g 
Scales i n A p pe n di x A  
 le ns wetta bilit y 
 le ns ce ntrati o n 
 le ns m o ve me nt 
 le ns r otati o n 
 lens de p osi ts 
Rec or d t he le ns para met ers t o be dis pe nse d/ or dere d base d o n t he dia g n ostic fitti n g. 
j. “ Scree n Fail” s u bj ects are i neli gi ble a n d n o n- dis p e nse d a n d ca n n ot be e nr olle d i n t he 
st u d y if para meters are u na vaila ble or fit is dee me d u nacce pta ble. T he reas o n f or scree n 
fail ure m ust be d oc u me nt e d a n d mai ntai ne d wit h a c o p y of t heir I C F. 
k.  I n dic ate o n t he Scree ni n g L o g w het her t he s u bject is a “ Scree n Pass” or “ Scree n Fail.” 
“ Scree n Fail” s u bj ects are i neli gi ble a n d ca n n ot b e ra n d o mize d i n t he st u d y. T he reas o n 
f or scree n fail ure m ust be d oc u me nte d o n t he Scree ni n g L o g a n d i n t he s u bject rec or d, 
a n d mai ntai ne d wit h a c o p y of t heir I C F. 
O nl y “ Scree n P ass” s u bjects s h o ul d be ra n d o mize d i n t he st u d y. 
l. Re -e m p hasize t he e x cl usi o n criteri o n stati n g t h at if t he s u bject is a fe mal e of c hil d 
beari n g  p ote ntial a n d is pre g na nt a n d or breast fee di n g, s he is i neli gi ble t o be a part of t he 
st u d y. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
F or eac h s u bject, use t he Material Or der F or m f or St u d y 8 8 5 t o or der t he a p pr o priate st u d y 
c o ntact le nses (t est or c o ntr ol). Sc he d ule t he s u bject f or t heir Dis pe nsi n g Visit wit hi n 
3  wee ks as i nstr uct e d b y t he S p o ns or. 
1 1. 1. 2  Dis pe nsi n g Visit 
a. C ollec t/assess all A Es, i ncl u di n g seri o us or si g nifi ca nt n o n-seri o us A Es 
b.  Perf or m a slit la m p e x a mi nati o n (re m o ve t he le ns es if t he s u bject w ore l e nses t o t he 
visit). Rec or d a ll slit la m p fi n di n gs a n d, at a mi ni m u m, s ketc h t he f oll o wi n g i n t he 
s u bject’s s o urce d oc u me nt: 
 a n y u n gra de d fi n di n g m ar ke d as “ P R E S E N T” 
 a n y n e w c or neal s cars 
 a n y n e o vasc ul arizati o n wit hi n t he ce ntral 6 m m of t he c or nea 
 a n y c or neal stai ni n g 
 a n y c or neal i nfiltrate (rec or d details o n t he C or neal I nfiltrat es E val uati o n F or m 
[A p pe n di x E ]) 
 a n y ot h er gra de d slit la m p fi n di n gs Gra de 2 or greater 
c. Perf or m t he f oll o wi n g assess me nts wit h o ut le nses a n d rec or d i n t he s u bject’s s o urce 
d oc u me nt: s p her oc yli n drical refracti o n, dista nce B S C V A, a n d direct o p ht hal m osc o pe 
e x a m ( n o n-dilate d). I O P will be meas ure d usi n g t he T o n o Pe n or G ol d ma n n met h o d. 
d.  In a n eff ort t o e ns ur e t he I n v esti gat or re m ai ns mas ke d, t he u n mas ke d desi g nee M U S T 
dis pe nse t he le ns blister pac ks. T he u n mas k e d desi g nee will dis pe nse 1 1 0 le nses per e ye 
t o s ufficie ntl y mai ntai n a dail y dis p osa ble m o dalit y u ntil t he 3- M o nt h F oll o w- u p Visit 
a n d rec or d i n t he Pr o d uct Acc o u nta bilit y L o g. A 1 0 da y l e ns s u p pl y p er e ye ca n be 
mai ntai ne d at t he offic e f or eac h s u bj ect’s visits s h o ul d t he s u bject f or get t o wear t heir 
le nses t o t heir f oll o w- u p office visits. 
e. Ha ve t he s u bject i nsert o ne pair of t he st u d y le ns es i n t heir e yes. I n a n eff ort t o e ns ure t he 
I n v esti gat or re m ai ns mas ke d, t he s u bject M U S T i nsert t he le nses o ut of t he si g ht of t he 
I n v esti gat or. 
N O T E: St u d y le nses s h o ul d be all o we d t o e q uili brate a mi ni m u m of 3 mi n utes o n t he e ye. 
After a mi ni m u m of 3 mi n utes, perf or m t he f oll o wi n g assess me nts a n d rec or d i n t he 
s o urce d oc u me ntati o n a n d a p plica ble e C R F: 
 C ollec t S y m pt o ms/ C o m plai nts i nf or mati o n usi n g t he S y m pt o ms/ C o m plai nts Rati n g 
Scales i n A p pe n di x A  
 dista nce hi g h c o ntrast le ns V A 
 o ver-refracti o n a n d dista nce V A 
 le ns wetta bilit y 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 le ns ce ntrati o n 
 le ns m o ve me nt 
 le ns r otati o n 
 le ns de p osits 
F or eac h e ye, c o m pare t h e hi g h c o ntrast dista nce l e ns V A t o t he hi g h c o ntr ast B S C V A 
o btai ne d at t his visit. If t he V A has d ecrease d b y 5 letters ( 0. 1 l o g M A R) or m ore, e x plai n. 
f. Dis pe nse le ns ca ses. I nstr uct t he s u bject t o place all w or n le nses i n a le ns case ( u p t o 
1 0 pairs of le nses p er e ye per cas e) wit h n o s ol uti o n ( dr y). T he s u bj ect will ret ur n t he le ns 
cases a n d blister l a bels t o t he site at t he 1- Wee k F oll o w- U p Visit. 
g.  Disc uss t he diar y wit h i nstr ucti o ns t o c o m plete o n a wee kl y b asis. S u bjects will be 
pr o vi de d wit h a  re mi n der at e ver y visit t o c o m plete t he diar y t o ca pt ure wear e x perie nce 
o n a wee kl y b asis u ntil t he y e xit t he st u d y. 
h.  If t he s u bject is disc o nti n ue d or e xite d at t his visit, c o m plete t he E xit Visit e C R F. 
i. Re -e m p hasize t he e x cl usi o n criteri o n stati n g t h at if t he s u bject is a fe mal e of c hil d 
beari n g p ote ntial a n d is pre g na nt a n d or breast fee di n g, s he is i neli gi ble t o be a part of t he 
st u d y. 
1 1. 1. 3  1- Wee k, 1- M o nt h, a n d 3- M o nt h F oll o w- u p Visits 
a. If t his is a n E xit Visit, i n dicate t hat o n t he e C R F a n d, i n a d diti o n t o c o m pleti n g t he 
a p pr o priate F oll o w - U p Visit F or m, c o m plete t he E xit Visit F or m. If a s u bject misses t he 
sc he d ule d f oll o w- u p visit a n d ca n n ot be s ee n pri or t o t he start of t he visit wi n d o w f or t he 
ne xt sc he d ule d f oll o w- u p visit, t he n t he visit is c o nsi dere d misse d a n d it s h o ul d be 
rec or d e d as a misse d visit i n t he a p plica ble e C R F. 
b.  C ollect/assess all A Es, i ncl u di n g seri o us or si g nifi ca nt n o n-seri o us A Es. 
c. If t he s u bject di d n ot wear le nses t o t he visit, t he s u bject ca n use a pair fr o m t he 1 0 le nses 
per e ye st or e d i n t he offi ce t o c o m plete t he assess me nt. 
d.  C ollect S y m pt o ms/ C o m plai nts i nf or mati o n usi n g t he S y m pt o ms/ C o m plai nts Rati n g 
Scales i n A p pe n di x A  a n d rec or d t h e m i n t he s o urce d oc u me nt ati o n a n d e C R F. 
e. E val uate t he le nses ( w hil e o n e ye) a n d rec or d t he f oll o wi n g assess me nts i n t he s o urce 
d oc u me ntati o n a n d e C R F: 
 dista nce hi g h c o ntract le ns V A 
 o ver-refracti o n a n d dista nce V A 
 le ns wetta bilit y 
 le ns ce ntrati o n 
 le ns m o ve me nt 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 le ns r otati o n 
 le ns de p osits 
F or eac h e ye, c o m pare t h e hi g h c o ntrast dista nce c o ntact le ns V A fr o m eac h res pecti ve / 
c urre nt vi sit ( 1- Wee k, 1- M o nt h, 3- M o nt h F oll o w- u p Visits) t o t he hi g h c o ntrast dista nce 
co ntact le ns V A o btai n e d at t he Dis pe nsi n g Visit. If t he V A has d ecrease d b y 1 0 letters 
( 0. 2 l o g M A R) or m ore, rec or d i n t he s u bject’s s o urce d oc u m e nt a n d e x plai n. 
f. Perf or m a slit la m p e x a mi nati o n (re m o ve t he le ns es if t he s u bject w ore l e nses t o t he visit) 
a n d rec or d t he f oll o wi n g assess me nts i n t he s o urce d oc u me ntati o n a n d t he e C R F. Rec or d 
all slit la m p fi n di n gs a n d, at a mi ni m u m, s ketc h t he f oll o wi n g i n t he s u bject’s s o urce 
d oc u me nt: 
 a n y u n gra de d fi n di n g m ar ke d as “ P R E S E N T” 
 a n y n e w c or neal s cars 
 a n y n e o vasc ul arizati o n wit hi n t he ce ntral 6 m m of t he c or nea 
 a n y c or neal stai ni n g 
 a n y c or neal i nfiltrate (rec or d details o n t he C or neal I nfiltrat es E val uati o n F or m 
[A p pe n di x E ]) 
 a n y ot h er gra de d slit la m p fi n di n gs Gra de 2 or greater 
g.  Perf or m t he f oll o wi n g assess me nts wit h o ut le nses a n d rec or d i n t he s u bject’s s o urce 
d oc u me nt: s p her oc yli n drical refracti o n, dista nce B S C V A, a n d direct o p ht hal m osc o pe 
e x a m ( n o n-dilate d). I O P will be meas ure d usi n g t he T o n o Pe n or G ol d ma n n met h o d at all 
visits. A ut ore fracti o n will be meas ure d usi n g t he sta n dar d a ut or efract or met h o d at t he 
3- M o nt h Visit o nl y. 
h.  T he  s u bject will ret ur n t h e w or n dr y sta c ke d le ns es i n le ns cases a n d blister f oils t o t he 
site at eac h F oll o w- U p Visit. T he u n mas ke d desi g nee will c ollect t he le ns cases a n d p ut 
t he m i nt o t he zi pl oc ba g la bele d f or t hat visit. T he zi pl oc ba g will t he n be k e pt i n t he 
s u bject’s o pa q ue b a g f or ret ur n t o t he S p o ns or at t he e n d of st u d y. F or all visits, e x ce pt 
t heir E xit Visit, dis pe nse le ns cases. I nstr u ct t he s u bject t o place all w or n le nses i n a le ns 
case ( 1 0 p airs of le ns es p er e ye p er case) wit h n o s ol uti o n ( dr y) a n d kee p t h e blister f oils 
t o ret ur n at t heir ne xt f oll o w- u p visit. 
i. R e vie w diar y wit h i nstr u cti o ns t o c o m plete o n a wee kl y basis.  At t he 1- W ee k visit, 
pr o vi de s u bj ect wit h se parate diari es f or M o nt h 1, M o nt h 2, a n d M o nth 3. C ollect t he 
pre vi o us m o nt h’s diar y at eac h f oll o w- u p visit. 
j. Re -e m p hasize t he e x cl usi o n criteri o n stati n g t h at if t he s u bject is a fe mal e of c hil d 
beari n g p ote ntial a n d is pre g na nt a n d or breast fee di n g, s he is i neli gi ble t o be a part of t he 
st u d y. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
If all sc he d ule d visits are perf or me d o n ti me a n d t he s u bject c o m pletes t he 3- M o nt h Visit, t he 
E xit Visit will be d o ne at t he sa me ti me. 
1 1. 1. 4  E xit Visit 
A n E xit Visit s h o ul d be c o m plete d f or all s u bjects w h o c o m plete t he st u d y ( 3- M o nt h Visit) or 
disc o nti n ue d t he st u d y earl y ( 1- Wee k, 1- M o nt h Visit, or at a n U nsc he d ule d Visit). 
T he  E xit Visit will be dela ye d i n t he e v e nt t hat t here is a c o m plicati o n a n d t he s u bject nee ds 
t o be f oll o we d u p t hr o u g h a n U nsc he d ul e d Visit. 
a. I n dic ate stat us of t he s u bj ect o n t he E xit Visit F or m. If t h e stat us is “ Disc o nti n ue d” or 
“ N o n- dis pe nse d, ” i n dicat e t he P RI M A R Y e xit reas o n f or eac h e ye o n t he E xit Visit 
F or m. 
b.  C ollect/assess all A Es, i ncl u di n g seri o us or si g nifi ca nt n o n-seri o us A Es. 
c. F or a ll dis pe nse d s u bjects, c o m plete a n e xit oc ular e x a mi nati o n wit h o ut le nses o n t he 
e yes. Perf or m t he f oll o wi n g ass ess me nts: u nc orrecte d dista nce V A, a ut orefracti o n, 
s p her oc ylin drical refracti o n, hi g h c o ntr ast dista nce B S C V A, kerat o metr y, dilate d f u n d us 
e x a m, a n d direct o p ht hal m osc o pe e x a m ( n o n- dilate d). I O P will be meas ure d usi n g t he 
T o n o Pe n or G ol d m a n n met h o d. 
d.  F or eac h e ye, c o m pare t h e E xit Visit hi g h c o ntrast dista nce B S C V A t o t he hi g h c o ntr ast 
dista nce  B S C V A o btai ne d at t he Scree ni n g Visit. If t he V A has d ecrease d b y 1 0 letters 
( 0. 2 l o g M A R) or m ore, rec or d i n t he s u bject’s s o urce d oc u m e nt a n d e x plai n. 
e. F or eac h e ye, c o m pare t h e E xit Visit kerat o metr y rea di n gs t o t he Scree ni n g Visit 
kerat o me tr y rea di n gs. If t here is a c ha n ge of 1. 0 0 D or m ore, rec or d i n t he s u bject’s 
s o urce d oc u m e nt a n d e x plai n. 
f. T he u n mas ke d C R A  m ust c ollect all w or n a n d u n w or n le nses, blister f oils, a n d 
dr ysta c ke d le ns cases fr o m t he s u bject a n d rec or d a n d rec o n cile i n t he C T M Pr o d uct 
Acc o u nta bilit y L o g. All s u bject materials will be ke pt i n t he s u bject’s o pa q u e ba g t o be 
verifie d/rec o ncile d b y t h e st u d y m o nit or bef ore st u d y cl ose o ut. O nce rec o ncile d, t he 
o pa q ue ba g ca n be s eale d a n d ret ur n e d t o Cli nical Trial Materials a d dress i n Secti o n 1 0. 3 . 
g.  T he E xit Visit e C R F s h o ul d be c o m plete d, i n a d diti o n t o t he a p pr o priate F oll o w- U p Visit 
F or m. 
N O T E:  All u n w or n, dis pe nse d, n o n- dis pe nse d st u dy le nses are t o be ret ur ne d t o t he S p o ns or aft er t he st u dy 
is c o m plete a n d t he le ns rec o ncili ati o n h as bee n fi n alize d. W or n le nses will be dry st ac ke d i n le ns c ases a n d 
ret ur ne d t o B a usc h a n d L o m b. All c o nt act le nses m ust be acc o m p a nie d by a C T M Pr o d uct Acc o u nt a bility 
L o g. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
3 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 1. 5  U nsc he d ule d Visits 
A d diti o nal visits ma y b e sc he d ule d, as n ecess ar y, t o e ns ure t he safet y a n d well- bei n g of 
s u bjects. All a d diti o nal e x a ms s h o ul d be f ull y d oc u me nte d i n t he s o urce d o c u me nts a n d o n 
U nsc he d ule d Visit e C R Fs, as a p pr o priat e. Visits i nte n de d t o f ulfill sc he d ul e d visit 
re q uire me nts t hat f all o utsi de t he desi g n ate d sc h e d ule d visit ra n ge, are n ot U nsc he d ule d 
Visits. I n t hese cases, t he visit data will be c ollecte d a n d tra ns cri be d t o t he a p pr o priate 
sc he d ule d visit e C R F. 
If a s u bject is se e n f or m ulti ple visits d uri n g a gi v e n visit ti mefra me, t he data fr o m t he visit 
t hat is i nte n de d t o meet t he pr ot oc ol re q uir e me nts f or t he sc he d ule d visit s h o ul d be ca pt ure d 
o n t he visit e C R F. W here s uc h a deter mi nati o n ca n n ot be ma de, t he first visit wit hi n t he 
sc he d ule d visit i nter val will be use d f or c o m pleti o n of t he pr ot oc ol re q uire d sc he d ule d visit 
e C R F. Data fr o m a n y a d diti o nal visits wit hi n a sc he d ule d visit i nter val will be ca pt ure d o n a n 
U nsc he d ule d Visit e C R F. 
Pr o d uct Dis pe nsi n g O nl y ( P a rt of t he U nsc he d ule d Visit - use d o nl y if le ns s u p pl y is 
l ost) 
If a s u bject is o nl y see n f or a n u nsc he d ul e d le ns re place me nt, a c o m plete e x a m is n ot 
re q uire d as l o n g as t he s u bject is n ot e x perie nci n g a n y pr o ble ms. I n a n eff ort t o e ns ure t he 
I n v esti gat or re m ai ns mas ke d, a n u n mas ke d d esi g n ee M U S T dis pe nse t he le ns(es) t o t he 
s u bject. Rec or d le ns es dis pe nse d i n t he C T M Pr o d uct Acc o u nta bilit y L o g. If st u d y le ns es are 
dis pe nse d, c ollect t he f oll o wi n g i nf or m ati o n i n t he s o urce d oc u m e nt a n d tra nscri be t o t he 
Pr o d uct Dis pe nsi n g O nl y e C R F F or m: 
 
visit date 
 
s u bject I D n u m ber 
 
s u bject initials 
 
pri mar y reas o n f or le ns re place m e nt 
 
dis pe nse d le ns p o wer 
If a n y ass ess me nt is perf or me d, t he n a n U ns c he d ule d Visit F or m m ust be c o m plete d i nstea d 
of a Pr o d uct Dis pe nsi n g O nl y F or m. 
N O T E:   All w or n st u dy le nses are t o be ret ur ne d t o t he S p o ns or at t he e n d of t he st u dy as directe d wit h t he 
m ateri als pr ovi de d. W or n le nses will be dry st ac ke d i n le ns c ases a n d ret ur ne d t o B a usc h a n d L o m b. All 
c o nt act le nses m ust b e acc o m p a nie d by a C T M Pr o d uct Acc o u nt a bility L o g. 
If a s u bject is e x perie n ci n g pr o ble ms, c o m plete t h e f oll o wi n g: 
a. I n dic ate t he reas o n f or t h e U nsc he d ule d Visit. 
b.  C ollect/assess all A Es, i ncl u di n g seri o us or si g nifi ca nt n o n-seri o us A Es. 
c. C ollect S y m pt o ms/ C o m plai nts i nf or mati o n usi n g t he S y m pt o ms/ C o m plai nts Rati n g 
Scales i n A p pe n di x  A 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
d.  E val uate t he le nses ( w hil e o n e ye) a n d rec or d t he f oll o wi n g assess me nts i n t he s o urce 
d oc u me ntati o n a n d e C R F: 
 dista nce hi g h c o ntrast le ns V A 
 o ver-refracti o n a n d dista nce V A 
 le ns wetta bilit y 
 le ns ce ntrati o n 
 le ns m o ve me nt 
 le ns r otati o n 
 le ns de p osits 
F or eac h e ye, c o m pare t h e hi g h c o ntrast dista nce l e ns V A t o t he hi g h c o ntr ast B S C V A 
o btai ne d at t he Dis pe nsi n g Visit. If t he V A has decreas e d b y 1 0 letters ( 0. 2 l o g M A R) or 
m ore, rec or d i n t he s u bject’s s o urce d o c u me nt a n d e x plai n. 
e. Pe rf or m t he f oll o wi n g assess me nts wit h o ut le nses a n d rec or d i n t he s u bject’s s o urce 
d oc u me nt: s p her oc yli n drical refracti o n, dista nce B S C V A, a n d direct o p ht hal m osc o pe 
e x a m ( n o n-dilate d). I O P will be meas ure d usi n g t he T o n o Pe n or G ol d ma n n met h o d. 
f. Perf or m a slit la m p e x a mi nati o n ( wit h o ut le nses). Rec or d all slit la m p fi n di n gs a n d, at a 
mi ni m u m, s ketc h t he f oll o wi n g i n t he s u bject’s s o urce d oc u m e nt: 
 a n y u n gra de d fi n di n g m ar ke d as “ P R E S E N T” 
 a n y n e w c or neal s cars 
 a n y n e o vasc ul arizati o n wit hi n t he ce ntral 6 m m of t he c or nea 
 a n y c or neal stai ni n g 
 a n y c or neal i nfiltrate (rec or d details o n t he C or neal I nfiltrat es E val uati o n F or m 
[A p pe n di x E ]) 
 a n y ot h er gra de d slit la m p fi n di n gs Gra de 2 or greater 
g.  Re mi n d s u bj ect t o c o m plete t he diar y o n a wee kl y basis as i nstr ucte d. 
h.  Re -e m p hasize t he e x cl usi o n criteri o n stati n g t h at if t he s u bject is a fe mal e of c hil d 
beari n g p ote ntial a n d is pre g na nt a n d or breast fee di n g, s he is i neli gi ble t o be a part of t he 
st u d y. 
i. T he U nsc he d ul e d F oll o w- u p Visit e C R F s h o ul d be c o m plete d. If t he s u bject is 
disc o nti n ue d or e x ite d at t his visit, t he E xit Visit F or m s h o ul d als o be c o m plete d. 
1 1. 1. 6  Misse d Visits 
If a s u bject misses a n y s c he d ule d f oll o w- u p visit a n d ca n n ot be see n pri or t o t he start of t he 
visit ra n ge f or t he n e xt sc he d ule d f oll o w- u p visit, t he visit is c o nsi dere d misse d. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 1. 7  St u d y Restricti o ns 
Weari n g restricti o ns are prese nte d i n A p pe n di x B . 
1 1. 2  Defi niti o n of S o urce D at a 
All e val uati o ns re p orte d i n t he e C R F  m ust be s u p p orte d b y a p pr o priatel y i de ntifie d s o urce 
d oc u me ntati o n.  
1 1. 3  H a n dli n g of S u bject Wit h dr a w al 
N o s u bjects will be re pla ce d o n st u d y if a s u bject wit h dra ws or is re m o v e d. 
1 1. 4  E v al u ati o n of Effecti ve ness 
1 1. 4. 1  Effecti ve ness P ar a meters 
T he pri mar y effecti ve ness e n d p oi nt is t he pr o p orti o n of s u bjects ac hie vi n g a c o ntact lens 
c orrecte d dista nce l o g M A R V A of 0. 0 4 or better i n b ot h e yes, e val uate d at t he 1- Wee k 
F oll o w- u p Visit. 
Ot her perf or ma n ce criteri a f or e v al uati o n will be s u m marize d descri pti vel y. 
1  Vis ual ac uit y 
 o pti mal c orrecte d dista nce V A  meas ure d wit h t he p h or o pter 
 c o ntact le ns c orrecte d dista nce V A  
1 1. 5  E v al u ati o n of S afet y 
1 1. 5. 1  E ye C o n diti o n 
E ye c o n diti o n criteria i n cl u de t he f oll o wi n g, w hi c h will be s u m marize d descri pti vel y. 
 Slit la m p fi n di n gs 
 Dilate d f u n d us e x a m fi n di n gs 
 I ntra oc ular press ure 
1 1. 5. 2  Le ns S uit a bilit y 
 Ce ntrati o n 
 We tta bilit y 
 M o ve me nt  
1 1. 5. 3  Le ns St at us 
 De p osits 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 5. 4  Vis u al Ac uit y 
 U nc orrecte d dista nce V A 
1 1. 5. 5  C h a n ge  i n M a nifest Refr acti o n Bet wee n t he Scree ni n g a n d E xit Visits 
1 1. 5. 6  C h a n ge i n C or ne al C ur v at ure Bet wee n t he Scree ni n g a n d E xit Visits 
1 1. 5. 7  A d verse E ve nt D efi niti o ns 
 A d verse E v e nt ( A E): a n y u nt o war d me dical o cc urre nce, u ni nte n d e d diseas e or i nj ur y, or 
u nt o war d cli nical si g ns (i ncl u di n g a b n or mal la b orat or y fi n di n gs) i n a s u bject, user or 
ot her pers o ns, w h et her or n ot relate d t o t he i n vesti gati o nal me di cal de vice. T his defi niti o n 
i ncl u des e ve nts rel ate d t o t he i n vesti gati o nal me di cal de vice, c o m parat or or t he 
pr oce d ures i n v ol ve d. F or users or ot her pers o ns, t his defi niti o n is restricte d t o e ve nts 
relate d t o i n vesti gati o nal me dical de vices. 
 A d verse D e vice Effect ( A D E): a n A E  related t o t he use of a n i n v esti gati o n al me dical 
de vice. T his defi niti o n i ncl u des A Es res ulti n g fr o m i ns ufficie nt or i na de q u ate i nstr ucti o ns 
f or use; de pl o y me nt, i m pla ntati o n, i nstallati o n, or o perati o n; or a n y malf u n cti o n of t he 
i n vesti gati o nal me dic al de vice. T his defi niti o n als o i ncl u des a n y e ve nt res ulti n g fr o m use 
err or or fr o m i nte nti o nal mis use of t he i n vesti gati o nal me dical de vice. 
 Seri o us A d verse E v e nt ( S A E) is a n A E t hat: 
 le d t o deat h; 
 le d t o seri o us deteri or ati o n i n t he healt h of t he s u bj ect, t hat res ulte d i n: 
 a life-t hreate ni n g ill ness or i nj ur y; or 
 a per ma n e nt i m pair me nt of a b o d y str uct ur e or a b o d y f u n cti o n (e g, bli n d ness); or 
 i n- patie nt or pr ol o n ge d h os pitalizati o n; or 
 me dical or s ur gic al i nter ve nti o n t o pre ve nt life-t hreate ni n g ill ness or i nj ur y or 
per ma ne nt i m pair me nt t o a b o d y str u ct ure or a b o d y f u ncti o n; 
 le d t o fetal distress, fet al deat h, or a c o n ge nital a b n or malit y or birt h defect. 
N O T E: Pla n ne d h os pitaliz ati o n f or a pre-e xisti n g c o n diti o n, or a pr oce d ure re q uire d 
b y t he pr ot oc ol, wit h o ut seri o us deteri or ati o n i n healt h, is n ot c o nsi dere d a n S A E. 
 U na ntici pate d A d v erse D e vice Effect ( U A D E): a n y seri o us a d verse effect o n healt h or 
safety or a n y life-t hr eate ni n g pr o ble m or d eat h ca use d b y, or ass ociat e d wit h a de vice, if 
t hat effect, pr o ble m or d eat h was n ot pre vi o usl y i de ntifie d i n nat ure, se verit y or d e gree of 
i nci de nce i n t he i n vesti gati o nal pla n or a p plicati o n (i ncl u di n g a s u p pl e me nt ar y pla n or 
a p plicati o n), or a n y ot h er u na ntici pate d seri o us pr o ble m ass ociate d wit h a de vice t hat 
relates t o t he ri g hts, safet y, or welfare of s u bj ects. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 5. 8  A d verse E ve nt 
T hr o u g h o ut t he c o urse of t his st u d y, all eff orts will be ma de t o re mai n alert t o p ossi ble A Es. 
T he ter m “ A Es ” i ncl u des b ot h S A Es a n d Si g nifica nt N o n- Seri o us A d verse E ve nts. Eac h are 
defi ne d bel o w. 
If a n A E o cc urs, t h e first c o ncer n will be t he safet y of t he s u bj ect a n d a p pr o priate me dical 
i nter ve nti o n will be ma de. All A Es (seri o us A Es a n d si g nifica nt n o n-seri o us A Es) t hat occ ur 
will be re p orte d i n t his st u d y. 
A Es s h o ul d be differe ntiate d i nt o de vice relate d a n d n o n- de vice relate d. A n y c or neal 
i nfiltrate, ulcer, ne o vasc ulariz ati o n, etc. s hall be pres u me d t o be de vice rel ate d, i n t he 
a bse nce of a n alter nati ve e x pla nati o n. 
All A Es occ urri n g after si g ni n g of i nf or me d c o nse nt a n d t hr o u g h t he s u bj ect’s e n d of 
partici pati o n i n t he st u d y m ust be re p orte d. All A Es m ust be f oll o we d u ntil t he e ve nt r es ol ves 
or sta biliz e s. 
All A Es s h o ul d be p h ot o d oc u me nte d a n d c o m m u nicate d t o t he C R O a n d S p o ns or i n 
electr o nic f or m. 
1 1. 5. 8. 1  Seri o us A d verse E ve nts 
Seri o us a d verse e ve nts are t h ose e ve nts t hat r es ult i n, or ha ve p ote ntial t o ca use, eit her 
per ma ne nt i m pair me nt of a n oc ular f u ncti o n or da ma ge t o a n oc ular str uct ure, a n d ma y 
necessi tate me dical or s ur gic al i nter ve nti o n. 
Seri o us a d verse e ve nts m a y i n cl u de a n y h azar d o us, si g ht-t hre ate ni n g c o n diti o ns occ urri n g 
after ex p os ure t o t he test article, i ncl u di n g t he f oll o wi n g: 
 A pres u me d i nf ecti o us ulcer ( defi ne d as a pr o gressi ve er osi o n of t he c or neal tiss ue). F or 
t he p ur p oses of re p orti n g: 
 ce ntral or p arace ntr al l ocati o n; 
 pe netrati o n of B o w ma n’s me m bra ne; 
 i nfiltrate ≥2 m m dia meter; 
 ass ociate d wit h iritis Gra de 2 or greater; 
 ass ociate d wit h a n y i ncrease i n i ntra oc ular press ur e; 
 c ult ure p ositi ve f or micr o or ga nis ms; 
 i ncreasi n g siz e or se verit y at s u bse q u e nt visits. 
 N ote: Si g ns of a pres u me d i nfecti o us c or neal ulcer ma y i ncl u d e irre g ul ar f o cal i nfiltrates; 
acti ve lesi o ns wit h raise d e d ges; si g nifica nt diff us e i nfiltrati o n; a nteri or c or neal t o 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
mi d -str o mal i n v ol ve me nt; er osi o n wit h o verl yi n g stai ni n g; c o nj u ncti val a n d li d e de ma; 
a nteri or c h a m ber reacti o n (iritis); se vere b ul bar a n d li m bal re d ness. S y m pt o ms ass ociate d 
wit h a pres u me d i nfecti o us ulcer ( micr o bi al keratitis) ma y i ncl u de p ai n of ra pi d o ns et; 
se vere re d ness; p ur ul e nt or m uc o p ur ule nt disc har ge; teari n g; p h ot o p h o bia. 
 A n y ce ntral or parace ntral ( wit hi n 6 m m of c or nea) c or neal e ve nt t hat res ults i n 
pe r ma ne nt o pa cificati o n (s uc h as vasc ularizati o n); 
 A n y s eri o us a d verse o p ht hal mic e ve nts i ncl u di n g h y p o p y o n a n d h y p h e ma; 
 A n y  n e o vasc ul arizati o n wit hi n t he ce ntral 6 m m of t he c or n ea; 
 Pe r ma ne nt l oss of 2 or m ore li nes of B S C V A; 
 All cases of iritis. 
1 1. 5. 8. 2  Si g n ific a nt N o n- Seri o us A d verse E ve nts 
Si g nifica nt N o n- Seri o us A d verse E v e nts s h o ul d i ncl u de: 
 Peri p heral n o n- pr o gressi ve n o n-i nfecti o us c or neal ulcers; 
 All s y m pt o matic c or n eal i nfiltrati ve e ve nts; 
 All case s of c or neal stai ni n g greater t h a n or e q u al t o Gra de 3; 
 A te m p ora r y l oss of 2 or m ore li nes of B S C V A (f or great er t ha n or e q ual t o 2 wee ks); 
 Ne o va sc ularizati o n cases e q ual t o Gra d e 2 or great er; 
 A n y  o c ular e v e nt t hat ne cessitates te m p orar y le ns disc o nti n uati o n of greater t ha n or e q u al 
t o 2 wee ks. 
1 1. 5. 8. 3  A d verse E ve nt Tre at me nt 
 
Wit h a n y A E, treat t he s u bject as a p pr o priate t o pre ve nt f urt her c o m plicati o ns a n d t o 
p ote ntiall y res ol v e t he e v e nt c o nsiste nt wit h t he sta n dar d of care. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 5. 8. 4  Me dic al Tre at me nt I ncl u di n g n o n- A d verse E ve nts 
I n t he e vent t hat a s u bj ect re q uires me dical treat m e nt ( prescri pti o n me dicati o n) f or a n oc ular 
c o n diti o n, treat t he s u bject as a p pr o pri ate t o pre v e nt f urt her c o m plicati o ns a n d t o p ote ntiall y 
res ol ve t he ev e nt. 
1 1. 5. 8. 5  E v al u ati o ns 
W he n e val uati n g A Es, t he I n vesti gat or m ust deter mi ne if t he e ve nt is seri o us (refer t o Secti o n 
1 1. 5. 8. 1  f or criteria), ass ess t he se verit y of s y m pt o ms a n d t he relati o ns hi p of t he e ve nt t o t he 
st u d y de vic e usin g t h e f oll o wi n g g ui deli nes: 
a. Se verit y 
- 
Mil d : S u bject a ware ness of a si g n or s y m pt o m t hat is easil y t olerat e d, re q uires n o 
treat me nt, a n d d oes n ot i nterfere wit h s u bject’s d ail y acti vities. 
- 
M o der ate : S u bject a ware ness of a si g n or s y m pt o m w hic h ma y b e a l o w le vel of 
c o ncer n t o t he s u bj ect a n d ma y i nterfere wit h dail y acti vities, b ut ca n be relie ve d b y 
si m ple t hera pe utic care. 
- 
Se vere : A si g n or s y m pt o m t hat i nterr u pts t he s u bj ect’s dail y acti vit y a n d re q uires 
s yste mic t hera p y or ot her treat me nt. 
b. Rel ati o ns hi p t o St u d y De vice a n d/ or Re wetti n g Dr o ps 
- 
Rel ate d:  T here is at least a reas o n a ble p ossi bilit y t hat t he A E/ S A E is relate d t o t he 
st u d y de vice a n d/ or Re wetti n g Dr o ps Reas o na ble p ossi bilit y mea ns t hat t here is 
e vi de nce t o s u g gest a ca usal relati o ns hi p or ass oci ati o n bet wee n t he st u d y d e vice 
a n d/ or Re wetti n g Dr o ps a n d t he A E. Als o r eferre d t o as a n A D E. 
- 
U nrel ate d:  T h ere is little or n o reas o n a ble p ossi bilit y t hat t he A E/ S A E is r elate d t o 
t he st u d y de vice a n d/ or R e wetti n g Dr o ps. T his ass ess me nt i m plies t hat t he A E/ S A E 
has n o e vi de nce  t o s u g gest eit her a ca usal relati o ns hi p or ass ociati o n t o t he st u d y 
de vice a n d/ or R e wetti n g Dr o ps a n d m ore li kel y or certai n a n alter nati ve eti ol o g y 
e xists. 
1 1. 5. 8. 6  Pr o ce d ures f or R e p orti n g A d verse E ve nts a n d Seri o us A d verse E ve nts 
I n t he cas e of a n A E ( Seri o us a n d Si g nifica nt N o n- Seri o us) or Me dical Treat me nt ( n o n- A E), 
t he I n v esti gat or m ust: 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 Re p ort t he A E or Me dic al Treat me nt t o t he Me dical M o nit or wit hi n 2 4 h o urs of 
k n o wle d ge of t he e ve nt usi n g t he S p o ns or- pr o vi d e d f or m ( S A E/ U D E re p orti n g 
f or m) b y e maili n g t he c o m plete d f or m t o t he Me dical M o nit or 
 
 
 
 
 
 I n dic ate o n t he I nitial SA E / U A D E re p orti n g f or m w het her t he S A E / U A D E is pres u me d 
t o be n ot st u d y-relate d, le ns-relate d, s ol uti o n-relate d, or b ot h le ns/s ol uti o n relate d. 
 E ns ure t hat t he s u bject's i de ntit y is pr otect e d a n d t he s u bject's i de ntifiers i n t he cli nical 
trial are pr o perl y me nti o ne d o n t he f or m. 
 B E GI N T R E A T M E N T O F T H E A E I M M E DI A T E L Y B Y A S UI T A B L Y LI C E N S E D 
E Y E C A R E P R O F E S SI O N A L. 
 E nter t he S A E /U A D E i nt o t he e C R F wit hi n 3 b usi ness da ys of s u b mitti n g t he I nitial 
A E / Me dical Tr eat me nt N otificati o n F or m. 
 C o nti n ue t o u p date t he e C R F, if a p plica ble, eac h ti me t he s u bject is see n d uri n g t he 
ma na ge me nt of t he i n ci de nt a n d at res ol uti o n of t he i nci de nt. W he ne ver p ossi ble, it is 
s u g geste d t h at t he I n vesti gat or t a ke p h ot o gra p hs of all A Es a n d f or war d t h e m t o t he 
S p o ns or. 
 Cases re q uiri n g me dical treat me nt will be e v al uate d b y t he S p o ns or. U p o n re vie w of t he 
me dical t reat me nt, Ba us c h + L o m b Cli nical O perati o ns re prese ntati ves ma y c o ntact t he 
I n v esti gat or t o re q u est f urt her i nf or mati o n c o ncer ni n g t he treat me nt. 
 S u b mit all bills, prescri pti o n recei pts, a n d c ult ure re p orts/fees relate d t o t he A E t o Ba us c h 
+ L o m b Cli nical O p erati o ns. E x pe nses i nc urre d f or st u d y-relate d m e dical treat me nt will 
be pai d b y Ba usc h + L o m b Cli nical O perati o ns. 
G ui deli nes f or Re p orti n g Pre g n a ncies 
All fe male s u bjects of c hil d beari n g p ot e ntial m ust use a n effecti ve m et h o d of birt h c o ntr ol 
d uri n g t he st u d y, t o i ncl u de 2 wee ks after l ast visit, i n a ma n ner s uc h t h at ris k of 
c o ntracepti ve fail ure is mi ni mize d. A bsti ne nce is all o we d as a birt h c o ntr ol met h o d. Bef ore 
e nr olli n g a fe male s u bject of c hil d beari n g p ote ntial, t he I n v esti gat or m ust re vie w t he 
f oll o wi n g i nf or mati o n a b o ut st u d y partici pati o n: 
 I nf or me d c o ns e nt re q uir e me nt 
 C o ntrace pti ves i n use 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
F oll o wi n g re vie w of t his i nf or mati o n a n d a p pr o priate c o u nseli n g, t he I n v esti gat or or desi g nee 
a n d t he s u bject m ust si g n t he i nf or me d c o nse nt b ef ore st u d y e nr oll me nt. D uri n g t he st u d y, all 
fe male s u bjects of c hil d b eari n g p ote ntial s h o ul d b e i nstr ucte d t o c o ntact t he I n vesti gat or 
i m me diatel y if t he y s us p ect t he y mi g ht b e pre g n a nt (e g, misse d or late me nstr ual peri o d). 
If a s u bject or I n vesti gat or s us pects t hat t he s u bject ma y b e pre g n a nt pri or t o st u d y 
e nr oll me nt, t he st u d y le ns m ust be wit h hel d u ntil t he res ults of la b orat or y pre g na nc y t esti n g 
are a v aila ble. If pre g n a nc y is c o nfir me d, t he s u bject m ust n ot recei ve st u d y le ns a n d m ust n ot 
be e nr oll e d i n t he st u d y. If pre g na n c y is s us pecte d w hile t he s u bject is recei vi n g st u d y 
treat me nt, t he st u d y le ns m ust i m me diatel y b e wit h hel d u ntil t he res ult of pre g na nc y t esti n g 
is k n o w n. If pre g n a nc y is c o nfir me d, t he st u d y le ns will be per ma ne ntl y disc o nti n ue d a n d t he 
s u bject will be f oll o we d u ntil t he pre g n a nc y c o m es t o ter m. A Pre g na nc y R e p ort f or m will be 
s u b mitte d t o t he S p o ns or, i nitiall y a n d at t he e n d of t he pre g n a nc y, w hic h i n cl u des t he 
o utc o me of t he pre g na nc y a n d a n y c o m plicati o ns occ urri n g d uri n g t he pre g na nc y or t he 
deli ver y. 
All c o nfir me d pre g n a nci es m ust be i m me diatel y re p orte d t o t he Me dical M o nit or wit hi n 2 4 
h o urs of t he I n vesti gat or’s a ware ness of t he pre g n a nc y. All c o nfir m e d pre g na ncies m ust be 
re p orte d via c o nfir me d facsi mile/e mail tra ns missi o n a n d m ust be s u b mitte d o n a Pre g na nc y 
Re p ort f or m wit hi n 2 4 h o urs of t he I n vesti gat or’s a ware n ess of t he pre g na n c y usi n g t he sa me 
re p orti n g as pr o ce d ure f or a n S A E. Alt h o u g h pre g na nc y occ urri n g i n a cli nical st u d y is n ot 
c o nsi dered t o be a n A E or S A E, a n y pre g n a nc y c o m plicati o n or electi ve ter mi nati o n of a 
pre g na nc y, f or me dical r eas o ns, will be rec or de d as a n A E or S A E. A n y s eri o us 
c o m plicati o ns or e ve nt r es ulti n g fr o m t he pre g n a n c y s h o ul d b e re p orte d t o t he S p o ns or wit hi n 
2 4 h o urs o n a S A E/ U A D E f or m al o n g wit h t he Pre g n a nc y Re p ort f or m. 
1 1. 5. 9  O bli g ati o n s of t he S p o ns or 
D uri n g t h e st u d y, t he S p o ns or will re p ort i n a n e x pe dite d ma n ner: 
 All u ne x pecte d S A Es p ossi bl y relate d t o I M P ( S U S A R), t o t he Healt h 
A ut h orities, as a p pr o priat e a n d t o t he I n vesti gat ors. 
 All S A Es p ossi bl y relate d t o t he Test Pr o d uct, t o t he I R B/I E C as a p pr o priat e a n d 
t o t he In v esti gat ors. 
 All U A D Es relat e d t o t he Test Pr o d uct, t o Healt h A ut h orities, t o t he I R B/I E C as 
a p pr o priate a n d t o I n vesti gat ors. 
A n y A E n ot liste d as a n e x pecte d e ve nt i n t he pac k a ge i nsert or i n t his pr ot o c ol will be 
c o nsi dere d as u ne x pecte d. 
T he S p o ns or will re p ort all safet y o bs er vati o ns ma de d uri n g t he c o n d uct of t he trial i n t he 
cli nical st u d y re p ort. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 1. 5. 1 0 
Re p orti n g De vic e Deficie ncies 
A de vice d eficie n c y is defi ne d as a n i na d e q uac y of a me dical de vice wit h res pect t o its 
i de ntit y, q ualit y, d ura bilit y, relia bilit y, safet y or perf or ma nce. De vi ce defici e ncies i ncl u de 
malf u ncti o ns, use err ors, a n d i na de q uat e la beli n g. All de vice defi cie ncies will be re p orte d t o 
t he S p o ns or a n d its re prese ntati ves o n a De vi ce Deficie nc y R e p ort f or m. 
I n v esti gat ors m ust e val uate, rec or d, a n d re p ort via a p plica ble f or ms a n y 
c o m plai nts/ deficie ncies, or malf u ncti o ns t hat c o ul d p ote ntiall y lea d t o a S A E d uri n g t his trial 
t o t he S p o ns or a n d its re prese ntati ve wit h o ut u nj ustifie d dela y. As re q uire d, s uc h re p orts ma y 
be pr o vi de d t o t he re vie wi n g I R B per t heir esta blis he d re p orti n g pr oce d ures a n d t he F D A b y 
t he I n v esti gat or. U p o n t h e S p o ns or’s re q u est, I n vesti gat ors m ust s u p pl y a n y a d diti o nal 
i nf or mati o n relate d t o t he safet y re p orti n g of a partic ular e ve nt. 
T he c o ntact f or re p orti n g de vice deficie nci es is: 
 
 
 
 
T he S p o ns or s hall re vie w all de vice deficie nci es a n d deter mi ne a n d d o c u me nt i n writi n g 
w het her t he y c o ul d ha ve le d t o a S A E. I n t he e v e nt of a disa gree me nt bet w ee n t he S p o ns or 
a n d t he I n vesti gat or(s), t he S p o ns or s hall c o m m u nicate b ot h o pi ni o ns t o t he re vi e wi n g I R B 
per t heir esta blis he d re p orti n g pr oce d ures a n d t he healt h a ut h orit y. 
1 2  St atistics 
1 2. 1  Deter mi n ati o n of S a m ple Size 
1 2. 1. 1  Pri m ar y Effecti ve ness E n d p oi nts 
T he n ull h y p ot hesis is t hat t he differe nce i n t he pr o p orti o n of s u bjects wit h b ot h e yes “ 0. 0 4 or 
Bette r” bet w ee n t he test gr o u p ( πT ) a n d t he c o ntr ol gr o u p ( πC ) is less t ha n or e q ual t o t he 
ne gati ve val ue of t he n o n-i nferi orit y mar gi n (- δ) . T he alter nati ve h y p ot hesis is t hat t he 
differe n ce i n pr o p orti o ns is greater t ha n t h e ne gati ve val ue of t he n o n-i nferi orit y mar gi n. 
H 0: πT - πC ≤ - δ 
H 1: πT - πC > - δ 
I n a previ o us e val uati o n of Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns es, 9 2. 5 % of 
s u bjects wit h baseli ne l o g M A R B S C V A of 0. 0 4 or better ac hie ve d t he pri mar y effecti ve n ess 
e n d p oi nt of t his st u d y at t he f oll o w- u p visit. C o nse q ue ntl y 9 2. 5 % is t he e x pecte d perce nt a ge 
of s u bjec ts “ 0. 0 4 or Better” i n t he Test a n d C o ntr ol gr o u ps. T h e n o n-i nferi orit y mar gi n will 
be set at 1 0 %  a n d t h e l o wer c o nfi de nce li mit will be c o m pare d t o - 1 0%.  

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
4 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
A o ne-si de d al p h a ris k of 0. 0 2 5 (e g, a t w o –si de d 9 5 % c o nfi de n ce i nter val) will be use d t o 
test t he h yp ot hesis. 
W he n t he sa m ple siz e i n eac h gr o u p is 1 0 9 s u bjects, a t w o- gr o u p lar ge-sa m ple n or mal 
a p pr o xi mati o n test of pr o p orti o ns wit h a o ne-si de d 0. 0 2 5 si g nifica n ce le vel will ha ve 8 0% 
p o wer t o rej ect t he n ull h y p ot hesis t hat t he test is i nferi or t o t he c o ntr ol (t he differe n ce i n 
pr o p orti o ns, π T  - πC , is -0. 1 0 or less) i n fa v or of t h e alter nati ve h y p ot h esis t hat t he test le ns is 
n o n- i nferi or, ass u mi n g t h at t he e x pecte d differe n ce i n pr o p orti o ns is 0. 0 0 0 a n d t he pr o p orti o n 
i n t he sta n dar d gr o u p is 0. 9 2 5. 
1 2. 1. 2  O ver all P o w er a n d S a m ple Size 
I n or der t o all o w f or dr o p o uts of u p t o 1 0 %, at least a p pr o xi matel y 1 0 9/( 1- 0. 1) ≈ 1 2 2 s u bjects 
will be e nr olle d i n eac h treat me nt gr o u p f or a t otal e nr oll me nt of a p pr o xi matel y 2 4 4 s u bjects. 
1 2. 2  A n al ysis P o p ul ati o ns 
1 2. 2. 1   
I nte nti o n-t o- Tre at (I T T) P o p ul ati o n 
T he I T T  P o p ulati o n will i ncl u de all ra n d o mize d s u bjects (a n d b ot h of t heir e yes) w h o are 
dee me d eli gi ble bas e d o n pre-ra n d o mizati o n eli gi bilit y assess me nts. S u bjects i n t he I T T 
P o p ulati o n will be i ncl u de d i n s u m maries u n der t h e le ns t y p e t o w hic h t he y were 
ra n d o miz e d. 
1 2. 2. 2   
Per Pr ot oc ol P o p ul ati o n 
T he P P P o p ulati o n will i ncl u de all ra n d o mize d s u bjects wit h o ut maj or pr ot oc ol de viati o ns 
w h o c o m plete t he st u d y t hr o u g h Visit 3 ( Da ys 6 - 1 0). Maj or pr ot oc ol de vi ati o ns affecti n g 
o nl y o ne e ye will res ult i n t he e x cl usi o n of b ot h e yes fr o m e ye l e vel s u m maries. 
1 2. 2. 3   
 S afet y P o p ul ati o n 
T he Safe t y P o p ulati o n will i ncl u de all dis pe nse d s u bjects (all s u bjects fitte d wit h c o ntact 
le nses). I n t he Safet y P o p ulati o n, s u bjects will be i ncl u de d i n s u m maries u n der t he le ns t y pe 
act uall y dis pe nse d a n d us e d. If m ulti ple le ns t y p es are dis pe nse d a n d use d i n cl u di n g t he test 
le ns, t he n t he s u bject will be i ncl u de d i n s u m maries u n der t he test le ns treat me nt gr o u p. 
1 2. 3  Assess me nt of Eff ecti ve ness 
1 2. 3. 1  St atistic al A n al ysis 
1 2. 3. 1. 1  Descri pti ve St atisti cs 
I n ge neral, data will be s u m marize d b y treat me nt gr o u p a n d visit as a p pr o priate. Data will be 
s u m marize d se paratel y at t he s u bject a n d e ye le vels. S u bject le vel s u m maries will s u m marize 
t he a vera ge of t h e s u bject’s 2 e yes f or c o nti n u o us varia bles a n d t h e w orst c ase o ver b ot h e yes 
f or cate g orical v aria bles. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
S u m maries f or c o nti n u o us varia bles will i ncl u de t he sa m ple size, mea n, sta n dar d de viati o n, 
me dia n, mi ni m u m, a n d ma xi m u m. Mea ns a n d me dia ns will be prese nt e d wit h o ne m ore 
deci mal place t h a n t he rec or de d ra w dat a. Sta n d ar d de viati o ns will be prese nte d wit h 2 m ore 
de ci mal places t h a n t he rec or de d ra w data. Mi ni ma a n d ma xi ma will be prese nte d wit h t he 
sa me n u m ber of d eci mal places as t he rec or de d ra w data. Val u es wit h ma g nit u de less t ha n 1 
will be prese nte d wit h a l ea di n g zer o t o t he left of t he deci mal (e g, 0. 1 2 3 or - 0. 1 2 3). 
Cate g o rical data will be s u m mariz e d usi n g fre q ue n cies a n d perce nt a ges. Perce nta ges will be 
prese nte d wit h o ne d eci mal place. Perce nta ges ma y n ot b e pres e nte d w he n t he c o u nt is zer o. 
U nless ot her wise s pecifie d t he de n o mi nat or f or p erce nta ges will be t he n u m ber of n o n-
missi n g val ues wit hi n t he gr o u p b ei n g pres e nte d. 
1 2. 3. 2  Pri m ar y Effecti ve ness A n al ysis 
At t he 1- Wee k F oll o w- u p Visit, s u bjects wit h n o n- missi n g l o g M A R ac uities 0. 0 4 or better i n 
b ot h e ye s will be classifi e d as “ 0. 0 4 or Better.” S u bjects wit h at least o ne l o g M A R ac uit y 
> 0. 0 4 at t he visit will be classifie d as “ W orse t h a n 0. 0 4.” S u bjects wit h at least o ne mi ssi n g 
val ue at t he visit will n ot be classifie d a n d t h eir classificati o n val ue will be assi g ne d as 
missi n g.  Vis ual ac uit y of 0. 0 4 l o g M A R is t he ac uit y w here a n i n di vi d ual s u bject w o ul d be 
gi ve n cre dit f or rea di n g l o g M A R 0. 0 a n d l o g M A R 0. 0 is e q ui vale nt t o C hi nese l o garit h mic 
vis ual ac uit y c hart v al ue of 5. 0. 
T he s u m maries a n d a nal ys es of t he pri mar y effecti ve ness e n d p oi nt will be at t he s u bject 
le vel. 
Use of t he I T T P o p ulati o n a n d i m p utati o n of missi n g val u es are n ot c o nser vati ve practices i n 
n o n-i nferi orit y a n al ys es. C o nse q ue ntl y, t he P P P o p ulati o n will be use d f or t he pri mar y 
a nal ysis  wit h o ut i m p utati o n of missi n g data. 
Pri m ary N o n-I nferi ority A n alysis wit h t he Per Pr ot oc ol P o p ul ati o n 
V A Effecti ve ness will be s u m mariz e d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment gr o u p at t he 1- Wee k F oll o w- u p Visit f or t he Per Pr ot oc ol ( P P) P o p ulati o n i n a 
ta ble. Missi n g data will n ot be i m p ute d f or t his pri mar y a nal ysis of t he P P P o p ulati o n. T he 
de n o mi nat or f or perce nta ges will be t he n u m ber of n o n- missi n g val ues. 
T he differe nce bet w ee n treat me nt gr o u ps ( T est mi n us C o ntr ol) i n t he pr o p orti o n of s u bjects 
classifie d as “ 0. 0 4 or Better” will be esti mate d. A n as y m pt otic Wal d n o n-i nferi orit y test 
( wit h o ut c o nti n uity c orrecti o n; usi n g t he sa m ple v aria nce; al p ha ris k = 0. 0 2 5) a n d t he 
ass ociate d t w o – si de d 9 5 % c o nfi de n ce i nter val will be use d t o test t he statistical h y p ot hesis. 
T he differe nce bet w ee n treat me nt gr o u ps (i n p erce nta ge u nits), t he as y m pt otic sta n dar d err or 
f or t he differe n ce (i n p erce nta ge u nits), t he ass oci ate d Z val ue, t he p- val ue f or t he n o n-
i nferi orit y t est, a n d a t w o –si de d 9 5 % c o nfi de n ce i nter val (i n perce nta ge u nits) ar o u n d t he 
differe n ce will be prese nt e d.  
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 
 
 
Se nsitivity A n alysis Usi n g t he I T T P o p ul ati o n 
V A Effecti ve ness will be s u m marize d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment gr o u p at t he 1- Wee k f oll o w- u p visit f or t he I T T P o p ulati o n i n a ta ble. T he 
de n o mi nat or f or perce nta ges will be t he n u m ber of n o n- missi n g val ues. Missi n g data will n ot 
be i m p ute d f or t his cate g orical s u m mar y. 
If t here are n o missi n g l e ns V A data at t he 1- Wee k f oll o w- u p visit f or I T T s u bjects, t he n t he 
f oll o wi n g will be c o m plete d. 
 T he differe nce bet w ee n treat me nt gr o u ps ( T est mi n us C o ntr ol) i n t he pr o p orti o n of 
s u bjects classifie d as “ 0. 0 4 or Better” will be esti mate d. 
If t here are missi n g le ns V A data f or I T T s u bjects at t he 1- Wee k f oll o w- u p visit t he n missi n g 
data will be i m p ute d as f oll o ws pri or t o h y p ot hesis testi n g. 
 T he differe nce bet w ee n treat me nt gr o u ps ( T est mi n us C o ntr ol) i n t he pr o p orti o n of 
s u bjects classifie d as “ 0. 0 4 or Better” a n d t h e as y m pt otic sta n dar d err or will be esti mate d 
b y i m p utati o n.  
 A n esti mate d differe nce bet wee n tr eat me nt gr o u ps a n d t w o-si de d as y m pt otic Wal d 9 5 % 
c o nfi de nc e i nter val ar o u n d t he differe nce will be c o nstr ucte d via c o m bi nati o n of t he 
pr o p orti o n differe nces a n d sta n dar d err ors fr o m t he i m p utati o ns.  
 If all of t he i m p utati o ns res ult i n t he sa me esti mate d differe nce a n d c o nfi de nce i nter val, 
t he n t he res ults of a si n gl e i m p utati o n ma y be us e d. 
T he esti mate d differe n ce bet wee n tr eat me nt gr o u ps ( Test mi n us C o ntr ol) i n t he perce nta ge of 
s u bjects classifie d as “ 0. 0 4 or Better” will be pres e nte d al o n g wit h t he t w o-si de d as y m pt otic 
Wal d 9 5 % c o nfi de nce i nter val ar o u n d t he differe n ce. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Ev al u ati o n of Se nsitivity t o Missi n g D at a 
As a n e val uati o n of s e nsiti vit y t o missi n g V A Effecti ve ness data, a best-cas e a nal ysis, 
w orst-cas e a nal ysis, a n d ti p pi n g p oi nt a nal ysis will be c o m plete d f or t he I T T P o p ulati o n ( X u 
et al, 2 0 0 9). If t he re are n o missi n g I T T P o p ulati o n data t he n t hese a nal yses will n ot be 
c o m plete d.  
Ev al u ati o n of t he I nfl ue nce of Site o n t he Tre at me nt Effect 
V A Effecti ve ness will be s u m mariz e d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment gr o u p a n d site f or t he I T T P o p ulati o n i n a ta ble. T his will be a s u bject le vel 
s u m mar y. T h e de n o mi nat or f or perce nta ges will be t he n u m ber of n o n- missi n g val ues. 
Missi n g data will n ot be i m p ute d. 
A Bresl o w- Da y t est f or h o m o ge n eit y of o d ds rati os will be use d t o e val uate t he c o nsiste nc y 
of t he treat m e nt effect a m o n g t he sites. If t h e p- v al ue fr o m t his test is less t ha n 0. 0 5 t he n t he 
differe n ce b et wee n sites will be c o nsi dere d t o be statisticall y si g nifi ca nt. 
Ev al u ati o n of t he I nfl ue nces of A ge, Sex, a n d Des ce nt o n t he Tre at me nt Eff ect 
V A Effe cti ve ness will be s u m marize d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment a n d a ge gr o u p (less t ha n 3 0, 3 0 t o 3 9, 4 0 t o 4 9, 5 0 or greater) f or t he I T T 
P o p ulati o n i n a ta ble. T he de n o mi nat or f or p erce nta ges will be t he n u m ber of n o n- missi n g 
val ues. Missi n g da ta will n ot be i m p ute d. 
A Bresl o w- Da y t est f or h o m o ge n eit y of o d ds rati os will be use d t o e val uate t he c o nsiste nc y 
of t he treat me nt effect a m o n g t he a ge gr o u ps. If t he p- val ue fr o m t his test is less t ha n 0. 0 5 
t he n t he differe nce a m o n g a ge gr o u ps will be c o nsi dere d t o be statisticall y si g nifica nt. 
V A Effecti ve ness will be s u m mariz e d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment a n d se x ( Male, Fe male) f or t he I T T P o p ulati o n i n a ta ble. T his will be a s u bject 
le vel s u m mar y. T he de n o mi nat or f or perce nta ges will be t he n u m ber of n o n- missi n g val ues. 
Missi n g data will n ot be i m p ute d. 
A Bresl o w- Da y t est f or h o m o ge n eit y of o d ds rati os will be use d t o e val uate t he c o nsiste nc y 
of t he treat me nt effect bet wee n t he se x es. If t he p- val ue fr o m t his test is less t ha n 0. 0 5 t he n 
t he difference b et wee n t he se x es will be c o nsi dere d t o be statisticall y si g nifica nt. 
V A Effecti ve ness will be s u m mariz e d cate g oricall y ( 0. 0 4 or Better, W orse t ha n 0. 0 4) b y 
treat ment a n d des ce nt ( C hi nese, N o n- C hi nese) f or t he I T T P o p ulati o n i n a ta ble. T his will be 
a s u bject le vel s u m mar y. T he de n o mi nat or f or perce nta ges will be t he n u m ber of n o n- missi n g 
val ues. Missi n g data will n ot be i m p ute d. 
A Bresl o w- Da y t est f or h o m o ge n eit y of o d ds rati os will be use d t o e val uate t he c o nsiste nc y 
of t he treat me nt effect bet wee n t he des ce nt cate g ories. If t he p- v al ue fr o m t his test is less 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
t ha n 0. 0 5 t he n t he differe nce bet w ee n t he d esce nt cate g ories will be c o nsi dere d t o be 
statisticall y si g nifica nt. 
V A  effecti ve n ess will als o be s u m marize d descri pti vel y f or eac h sc he d ule d f oll o w u p visit. 
1 2. 3. 3  A d verse E ve nts 
1 2. 3. 3. 1  Defi niti o ns 
A d verse e ve nts will be c o de d per t he M e dical Dicti o nar y f or Re g ulat or y Acti vities 
( Me d D R A). T h e y will be classifie d i nt o pre defi ne d sta n dar d cate g ories p er c hr o n ol o gical 
criteria: 
• 
Pretreat me nt A Es: A Es t hat de vel o pe d or w orse n e d d uri n g t he pretr eat me nt p hase; 
• 
Treat me nt- e mer ge nt a d v erse e v e nts ( T E A Es): A Es t hat occ urre d or w orse n e d at a n y 
time d uri n g t he o n-tr eat me nt p hase; 
• 
P ost-treat me nt A Es: A Es t hat occ urre d d uri n g t he p ost-treat me nt p hase after 
disc o nti n uati o n of  le ns wear. 
 
If t he start dat e ( or ti me) of a n A E is i nc o m plete or missi n g, t he n t he A E will be c o nsi dere d 
as a T E A E u nless a parti al date ( or ti me) s h o w it as a pre- or p ost-tr eat me nt e ve nt. 
All A Es re p orte d i n t he st u d y will be liste d b y s u bject a n d o nset date. Ne vert heless, t he 
a nal ys es of t he A Es will f oc us o n t he treat me nt-e mer ge nt or p ost-treat me nt a d verse e ve nts. 
1 2. 3. 3. 2  Tre at me nt-e mer g e nt or P ost-tre at me nt A d vers e E ve nts 
A n i n-te xt ta ble of o ver vie w of treat me nt-e mer ge nt or p ost-treat me nt a d verse e ve nts s u bjects 
wit h a n y tr eat me nt- e mer ge nt or p ost-treat me nt A E, s u bjects wit h a n y s e vere treat me nt-
e mer ge nt or p ost-tr eat me nt A E, s u bjects wit h a n y treat me nt-e mer ge nt or p ost-treat me nt 
seri o us A E, s u bjects wit h a n y tr eat me nt-e mer ge nt or p ost-treat me nt A E lea di n g t o per ma ne nt 
treat ment disc o nti n uati o n, or a n y treat me nt-e mer ge nt or p ost-treat me nt A E lea di n g t o d eat h 
( o nl y if d eat h oc c urre d), will be pr o d uce d b y tr eat me nt gr o u p. 
S u bjects prese nti n g wit h treat me nt-e mer ge nt or p ost-treat me nt A Es will be liste d s orte d b y 
treat me nt gr o u p, pri mar y s yste m or ga n class ( S O C), a n d preferre d ter m ( P T). 
Treat me nt- e mer ge nt or p ost-treat me nt A Es wi ll be s u m marize d b y tr eat me nt gr o u p, 
ta b ulati n g: 
• 
T he n u m ber a n d p erce nt of s u bjects wit h at least 1 treat me nt-e mer ge nt or p ost-
treat ment A E wit hi n eac h a n d o ver all S O C(es); 
• 
T he n u m ber a n d p erce nt of s u bjects e x perie nci n g eac h P T i n eac h S O C; 
• 
T he n u m ber of o cc urre nces of all P T(s) wit hi n eac h a n d o ver all S O C(es); 
• 
T he n u m ber of occ urre nces of eac h P T i n eac h S O C. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 2. 3. 3. 3  De at hs, Seri o us a n d Ot her Si g nific a nt A d verse E ve nts 
A n y d eat hs a n d S A Es will be liste d. 
1 2. 3. 3. 4  A d verse E ve nts Le a di n g t o Tre at me nt Disc o nti n u ati o n 
A n y T E A E or p ost-tr eat me nt A E  lea di n g t o per m a ne nt treat me nt disc o nti n uati o n will be 
liste d. 
1 2. 4  S u bject Dis p ositi o n 
A detaile d descri pti o n of s u bject acc o u nt a bilit y, i n cl u di n g n u m ber of s u bjects ra n d o mize d 
a n d recei vi n g Test or C o ntr ol pr o d uct, n u m ber of s u bjects w h o di d n ot c o m plete t he st u d y 
treat me nt peri o d al o n g wit h t he mai n reas o n f or p er ma ne nt treat me nt disc o nti n uati o n, a n d 
n u m ber of s u bjects w h o re q ueste d treat me nt disc o nti n uati o n, will be ge nerate d f or all 
s u bjects. 
1 2. 5  De m o gr a p hics a n d B aseli ne C h ar acteristics 
1 2. 5. 1  S u bject De m o g r a p hic C h ar acteristi cs, Me dic al Hist or y a n d Di a g n oses 
C o nti n u o us varia bles (a ge) a n d t he q ualitati ve vari a bles ( ge n d er, race) will be s u m marize d b y 
descri pti ve statistics f or all s u bjects f or t he Safet y P o p ulati o n. I n t he e v e nt t hat m ore t ha n 
1 0 % of s u bjects disc o nti n ue pri or t o c o m pleti n g t he st u d y, se parate s u m maries of 
de m o gra p hic c h aracteristics will be pr o vi de d f or t he P P P o p ulati o n. 
Me dical hist or y t h at is c urre nt a n d rele va nt f or t he past 2 years will be c ollecte d. 
De m o gra p hic d ata will be liste d b y s u bject. 
1 2. 6  Pr ot oc ol D e vi ati o ns 
T he f oll o wi n g pr ot oc ol d e viati o ns will be classifie d as maj or de viati o ns w he n re p ort e d i n t he 
case r e p ort f or ms. 
 I n eli gi bilit y 
 N o n- dis pe nse d s u bjects 
 Misra n d o mizati o n 
 Dis pe nsi n g  or us e of t he i nc orrect le ns t y p e 
 Dis pe nsi n g  of t h e i nc orrect le ns p o wer, defi ne d as a discre p a nc y greater t ha n 0. 2 5 D i n 
s p here, cyli n der, or s p herical e q ui vale nt 
 N o n-c o m plia nce wit h t he rec o m me n de d weari n g sc he d ule, s uc h as 
 weari n g le ns es less t ha n 8 0 % of t he rec o m me n de d ti me, or 
 weari n g a l e ns f or m ulti ple da ys 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 Use of me dic ati o ns t hat c o ul d p ote ntiall y affect oc ular p h ysi ol o g y or le ns p erf or ma nce 
 Fa il ure t o c o m pl y wit h t h e pr oce d ures use d t o assess pri mar y effecti ve n ess e n d p oi nts, 
s uc h as missi n g t he ass ess me nt or faili n g t o c o m pl ete t he pr oce d ure i n acc or da nce wit h 
t he i nstr ucti o ns pr o vi de d b y site pers o n nel. 
A d diti o nal maj or cate g ories ma y b e a d de d pri or t o u n mas ki n g. Maj or d e viati o ns will be 
pr o vi de d i n a listi n g. 
1 2. 7  C o m pli a nce 
S u bject c o m plia nce will be meas ur e d b y re vie wi n g diar y e ntries a n d q u esti o ni n g t he s u bject 
at eac h visit. 
1 2. 8  I nteri m A n al yses 
N ot a p plica ble 
1 2. 9  A d diti o n al St atistic al C o nsi der ati o ns 
1 2. 9. 1  Pri o r/ C o nc o mit a nt Me dic ati o n/ T her a p y 
Me dicati o ns will be classifie d b y t he l atest versi o n of t he W H O- D D E dicti o nar y. 
1 3  Q u alit y C o ntr ol a n d Q u alit y Ass ur a nce 
1 3. 1  St u d y M o nit ori n g 
Ba usc h + L o m b re prese ntati ves m ust be all o we d t o visit all st u d y site l ocati o ns t o assess t he 
data, q ualit y, a n d st u d y i nte grit y i n a ma n n er c o nsiste nt wit h a p plica ble healt h a ut h orit y 
re g ulati o ns a n d t he pr o ce d ures a d o pte d b y Ba us c h + L o m b. 
Pri or t o t he start of t he st u d y, me m ber(s) of Ba usc h + L o m b ( or desi g nees) will re vie w t he 
pr ot oc ol, e C R F, re g ul at or y o bli gati o ns, a n d ot her material or e q ui p me nt r el e va nt t o t he 
c o n d uct of t he st u d y wit h t he I n v esti gat or/ S u b-I n v esti gat or a n d rel e va nt st u d y site pers o n nel. 
M o nit ori n g visits a n d tele p h o ne c o ns ultati o ns will occ ur as n ecessar y, or per t he M o nit ori n g 
Pla n, d uri n g t he c o urse of t he i n vesti gati o n
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
D uri n g t h e c o urs e of t he st u d y, if t he S p o ns or deter mi nes t hat a n I n vesti gat or is n ot 
c o m plia nt wit h t he pr ot oc ol a n d/ or a p plica bl e re g ulat or y re q uire m e nts, t he S p o ns or will ta ke 
acti o n t o sec ure c o m plia nce. I n a d diti o n, t he S p o ns or ma y t er mi nate t he I n vesti gat or’s 
partici pati o n i n t he st u d y if a p pr o priate, or if t he I n vesti gat or re mai ns n o n-c o m plia nt des pite 
t he S p o nsor’s ac ti o ns. 
1 3. 2  A u dits a n d I ns pecti o ns 
A u dits of cli nical researc h acti vities i n acc or d a nce wit h t he S p o ns or’s i nter nal Sta n dar d 
O perati n g Pr oce d ures t o e val uate c o m plia nce wit h t he pri nci ples of G C P ma y t a ke place. A 
re g ulat or y a ut h orit y ma y als o wis h t o c o n d uct a n i ns pecti o n ( d uri n g t he st u d y or after its 
c o m pleti o n). If a n i ns pecti o n is re q ueste d b y a re g ulat or y a ut h orit y a n d/ or I R B, t he 
I n v esti gat or m ust i nf or m t he S p o ns or i m me diatel y t hat t his re q uest has bee n ma de. 
1 3. 3  D at a Q u alit y Ass ur a nce 
1 3. 3. 1  Use a n d C o m pleti o n of C ase Re p ort F or ms ( C R Fs) a n d A d diti o n al Re q uest 
S u bject data re q uir e d b y t his pr ot oc ol are t o be tra nsferre d fr o m t he s o urce t o t he e C R Fs. T he 
I n v esti gat or a n d his/ her st u d y site pers o n nel will be res p o nsi ble f or c o m pleti n g t he e C R Fs. 
T he I n vesti gat or is r e q uir e d t o verif y t hat all of t he re q ueste d i nf or mati o n is acc uratel y 
rec or d e d o n t he e C R Fs b y pr o vi di n g a n electr o ni c si g nat ur e. All i nf or mati o n re q ueste d o n t he 
e C R Fs nee ds t o be s u p pli e d, i ncl u di n g s u bject i de ntificati o n a n d i nitials, date(s), assess me nt 
val ues, etc., a n d a n y o missi o n or discre pa n c y will re q uire e x pla nati o n. All i nf or mati o n o n 
e C R Fs m ust be tracea ble t o s o urce d oc u me nts. 
T he st u d y m o nit or will be res p o nsi ble f or re vie wi n g a n d v erif yi n g t he data rec or d e d o n t he 
e C R Fs per t he st u d y M o nit ori n g Pla n, utilizi n g t he ori gi n al s o urce d o c u me ntati o n a n d will 
q uer y discre p a nt fi n di n gs. T he I n vesti gat or a n d st u d y site pers o n nel will be res p o nsi ble f or 
a ns weri n g all q ueries. 
A c o p y of t he e C R Fs will be retai ne d b y t he I n vesti gat or at t he c o ncl usi o n of t he st u d y, w h o 
m ust e ns ure t hat t he y are st ore d i n a sec ure place. 
1 4  Et hics a n d A d mi nistr ati ve Iss ues 
1 4. 1  Et hic al C o n d uct of t he St u d y 
T his cli nical trial will be c o n d ucte d i n acc or d a nce wit h t he pri nci ples lai d d o w n b y t he W orl d 
Me dical Ass oc iati o n – G e neral Ass e m bl y ( Helsi n ki, a n d all a p plica ble a m e n d me nts) lai d 
d o w n b y t he W or l d Me di cal Ass ociati o n ge n eral asse m blies, a n d t he I nter n ati o nal 
C o nfere nce o n Har m o nisati o n (I C H) g ui deli nes f or G C P. T his cli nical trial will be c o n d ucte d 
wit h all i nter nati o nal g ui deli nes, nati o nal la ws a n d re g ulati o ns of t he c o u ntr y(i es) i n w hic h 
t he cli nical trial is perf or me d, as well as a n y a p plica ble g ui deli nes. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 4. 2  Et hics Re vie w 
As re q uire d b y l o cal re g ulati o n, t he I n v esti gat or a n d/ or t he S p o ns or m ust s u b mit t his cli nical 
trial pr ot oc ol t o t he a p pr o priate I R B/I E C, a n d is re q uire d t o f or war d t o t he res pecti ve ot her 
part y a c o p y of t he writte n a n d date d a p pr o val/fa v ora ble o pi ni o n of t he I R B/I E C (si g ne d b y 
t he c hair ma n wit h I R B/I E C c o m p ositi o n). 
T he cli nical trial (st u d y n u m ber, cli nical trial pr ot o c ol title a n d versi o n n u m ber), t he 
d oc u me nts re vie we d (cli nical trial pr ot oc ol, I C F, I n v esti gat or’s Br oc h ure, I n v esti gat or’s 
c urric ula vita e, etc.) a n d t he date of t he re vie w s h o ul d be clearl y stat e d o n t he writte n 
I R B/I E C a p pr o v al/fa v ora ble o pi ni o n. 
I n v esti gati o nal me dici nal pr o d uct will n ot be release d at t he st u d y site a n d t he I n vesti gat or 
will n ot start t he st u d y b ef ore t he writte n a n d date d a p pr o val is recei ve d b y t he I n v esti gat or 
a n d t he S p o ns or. 
D uri n g t h e cli nical trial, a n y a me n d me nt or m o dificati o n t o t he cli nical trial pr ot oc ol s h o ul d 
be s u b mitte d t o t he I R B/I E C bef ore i m ple me ntati o n, u nless t he c ha n ge is ne cessar y t o 
eli mi nate a n i m me diate h azar d t o t he s u bjects, i n w hic h case t h e I R B/I E C s h o ul d be 
i nf or me d as s o o n as p ossi ble. It s h o ul d als o be i nf or me d of a n y e ve nt li kel y t o affect t he 
safet y of s u bjects or t he c o nti n ue d c o n d uct of t he cli nical trial, i n partic ular a n y c ha n ge i n 
safet y. All u p dates t o t he I n v esti gat or’s Br oc h ure will be se nt t o t he I R B/I E C. 
A pr o gress r e p ort is se nt t o t he I R B/I E C at least a n n uall y a n d a s u m mar y of t he trial’s 
o utc o me at t he  e n d of t h e cli nical trial. 
1 4. 3  Writte n I nf or me d C o nse nt 
T he I n vesti gat or (acc or di n g t o a p plica ble re g ul at or y re q uire m e nts), or a p ers o n desi g nat e d b y 
t he I n v esti gat or a n d u n d er t he I n vesti gat or’s res p o nsi bilit y, s h o ul d f ull y i nf or m t he s u bject of 
all perti ne nt as pects of t he cli nical trial i ncl u di n g t he writte n i nf or mati o n gi vi n g 
a p pr o val/fa v ora ble o pi ni o n b y t he et hics c o m mittee (I R B/I E C). All partici pa nts s h o ul d be 
i nf or me d t o t he f ullest e xte nt p ossi ble a b o ut t he st u d y, i n la n g ua g e a n d ter ms t he y are a bl e t o 
u n dersta n d. 
Pri or t o a s u bject’s partici pati o n i n t he cli nical trial, t he writte n I C F s h o ul d be si g ne d, na me 
fille d i n, a n d pers o nally date d b y t he s u bject or b y t he s u bject’s le gall y acce pta ble 
re pres e ntati ve, a n d b y t h e pers o n w h o c o n d ucte d t he i nf or me d c o ns e nt disc ussi o n. A c o p y of 
t he si g ne d a n d date d writte n I C F will be pr o vi de d t o t he s u bject. 
T he I C F use d b y t h e I n vesti gat or f or o btai ni n g t h e s u bject’s i nf or me d c o ns e nt m ust be 
re vie we d a n d a p pr o ve d b y t he S p o ns or pri or t o s u b missi o n t o t he a p pr o priate I R B/I E C f or 
a p pr o val/fa v ora ble o pi ni o n. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 4. 4  S u bject D at a Pr otecti o n 
T he s u bject's pers o n al data, w hic h are i ncl u de d i n t he S p o ns or data base, s h all be treate d i n 
c o m plia nce wit h all a p pli ca ble la ws a n d re g ul ati o ns. 
W he n arc hi vi n g or pr ocessi n g pers o nal data pertai ni n g t o t he I n vesti gat or a n d/ or t o t he 
s u bjects, t he S p o ns or s hall ta ke all a p pr o priate m eas ures t o safe g uar d a n d pre ve nt access t o 
t his data b y a n y u n a ut h oriz e d t hir d part y. 
T he S p o ns or als o c ollects s pecific data re gar di n g I n v esti gat or as w ell as pers o nal data fr o m 
a n y p ers o n i n v ol ve d i n t h e st u d y. T his data w hic h ma y b e i ncl u de d i n t he S p o ns or’s 
data bases, s hall be treat e d b y b ot h t he S p o ns or a n d t he I n v esti gat or i n c o m plia nce wit h all 
a p plica ble la ws a n d re g ul ati o ns. 
1 4. 7  I n vesti g at or O bli g ati o ns 
T he I n vesti gat or(s) a n d d ele gate d I n v esti gat or staff u n derta k e(s) t o perf or m t he cli nical trial 
i n acc or d a nce wit h t his cli nical trial pr ot oc ol, I C H g ui deli nes f or G C P a n d t he a p plica ble 
re g ulat or y re q uire me nts. 
T he I n vesti gat or is r e q uir e d t o e ns ure c o m plia nce wit h all pr oce d ures re q uire d b y t he cli nical 
trial pr ot oc ol a n d wit h all st u d y pr oce d ures pr o vi d e d b y t h e S p o ns or (i ncl u di n g sec urit y 
r ules). T he I n vesti gat or a grees t o pr o vi de relia ble data a n d all i nf or m ati o n re q ueste d b y t he 
cli nical trial pr ot oc ol (fr o m t he e C R F , discre p a nc y res ol uti o n f or m, or ot her a p pr o priate 
i nstr u me nt) i n a n acc urat e a n d le gi ble ma n ner acc or di n g t o t he i nstr ucti o ns pr o vi de d a n d t o 
e ns ure direct access t o s o urce d oc u m e nts t o S p o ns or re prese ntati ves. 
If a n y cir c uits i ncl u de tra nsfer of d ata, partic ul ar atte nti o n s h o ul d be pai d t o t he 
c o nfi de ntialit y of t he s u bject’s data t o be tr a nsferre d. 
T he I n vesti gat or ma y a p p oi nt s uc h ot her i n di vi d uals as he/s he ma y dee m a p pr o priate as 
s u bi n vesti gat ors t o assist i n t he c o n d uct of t he cli nical trial i n acc or da nce wit h t he cli nical 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
5 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
trial pr ot oc ol. All s u bi n vesti gat ors s h all be a p p oi nte d a n d liste d i n a ti mel y ma n ner. T he 
s u bi n vesti gat ors will be s u per vise d b y a n d w or k u n der t he res p o nsi bilit y of t he I n v esti gat or. 
T he I n vesti gat or will pr o vi de t he m wit h a c o p y of t he cli nical trial pr ot oc ol a n d all necessar y 
i nf or mati o n. 
1 4. 7. 1  C urric ul u m Vit ae 
A c urre nt c o p y of t he c urric ul u m vitae descri bi n g t he e x perie nce, q u alificati o n a n d trai ni n g 
of eac h I n vesti gat or a n d s u b-i n vesti gat or will be si g ne d, d ate d a n d pr o vi d e d t o t he S p o ns or 
pri or t o t he be gi n ni n g of t he cli nical trial. 
1 4. 8  C h a n ges t o t he Pr ot o c ol 
All a p pe n dices attac he d heret o a n d referre d t o herei n are ma de part of t his cli nical trial 
pr ot oc ol. 
T he I n vesti gat or s h o ul d n ot i m ple m e nt a n y de viati o n fr o m, or c ha n ges of t he cli nical trial 
pr ot oc ol. C ha n ges will be i m ple me nt b y t he S p o ns or a n d s u b mitte d t o t he I R B/I E C f or 
re vie w a n d d o c u me nte d a p pr o val/fa v ora ble o pi ni o n fr o m t he I R B/I E C of a n a me n d me nt, 
e x ce pt w here n ecess ar y t o eli mi n ate a n i m me diate hazar d(s) t o cli nical trial s u bjects, or w he n 
t he c ha n ge(s) i n v ol ves o nl y l o gistical or a d mi nistrati ve as pects of t he trial. A n y c ha n ge 
a gree d u p o n will be rec or de d i n writi n g, t he writte n a me n d me nt will be si g ne d b y t h e 
I n v esti gat or a n d b y t he S p o ns or a n d t he si g ne d a m e n d me nt will be file d wit h t his cli nical 
trial pr ot oc ol. 
A n y a me n d me nt t o t he cli nical trial pr ot oc ol re q uires writte n a p pr o val/fa v ora ble o pi ni o n b y 
t he I R B/I E C pri or t o its i m ple me ntati o n, u nless t here are o v erri di n g safet y reas o ns. 
I n s o me i nsta n ces, a n a m e n d me nt ma y re q uir e a c ha n ge t o t he I C F. T h e I n vesti gat or m ust 
recei v e a n I R B/I E C writt e n a p pr o val/fa v ora bl e o pi ni o n c o ncer ni n g t he re vise d I C F pri or t o 
i m ple me ntati o n of t he ch a n ge a n d s u bject si g n at ur e s h o ul d be re-c ollecte d if necess ar y. 
1 4. 9  C o nfi de nti alit y/ P u blic ati o n of t he St u d y 
1 4. 9. 1  C o nfi de nti alit y 
All i nf or mati o n discl ose d or pr o vi de d b y t he S p o ns or ( or a n y c o m pa n y/i nstit uti o n acti n g o n 
t heir be half), or pr o d uce d d uri n g t he cli nical trial, i ncl u di n g, b ut n ot li mite d t o, t he cli nical 
trial pr ot oc ol, t he eC R F s, t he I n v esti gat or’s Br oc h ure, a n d t he res ults o btai ne d d uri n g t he 
cli nical t rial, is c o nfi de ntial, pri or t o t he p u blicati o n of res ults. T he I n v esti gat or a n d a n y 
pers o n u n der his/ her a ut h orit y a gree t o u n d erta ke t o kee p c o nfi d e ntial a n d n ot t o discl ose t he 
i nf or mati o n t o a n y t hir d part y wit h o ut t he pri or writte n a p pr o val of t he S p o ns or. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
H o we ver, t he s u b missi o n of t his cli nical trial pr ot oc ol a n d ot her necessar y d oc u me ntati o n t o 
t he I R B/I E C is e x pressl y per mitte d, t he I R B/I E C me m bers ha vi n g t he sa m e o bli gati o n of 
c o nfi de ntialit y. 
T he s u bi n vesti gat ors s hall be b o u n d b y t he s a me o bli gati o n as t he I n v esti gat or. T he 
I n v esti gat or s hall i nf or m t he s u bi n vesti gat ors of t h e c o nfi de ntial nat ure of t he cli nical trial. 
T he I n vesti gat or a n d t he s u bi n vesti gat ors s hall use t he i nf or mati o n s olel y f or t he p ur p oses of 
t he cli nical trial, t o t he e x cl usi o n of a n y use f or t heir o w n or f or a t hir d part y’s acc o u nt. 
F urt her m ore, t he I n v esti gat or a n d t he S p o ns or a gree t o a d here t o t he pri nci ples of pers o nal 
data c o nfi de ntialit y i n rel ati o n t o t he s u bjects, I n v esti gat or a n d its c olla b orat ors i n v ol ve d i n 
t he st u d y. 
1 4. 1 0   St u d y Ter mi n ati o n 
T he S p o ns or or it s re prese ntati ve ma y ter mi nate t h e st u d y at a n y ti me f or scie ntific or 
c or p orat e reas o ns. 
If d uri n g t he st u d y it bec o mes e vi de nt t o t he S p o ns or t hat t he st u d y s h o ul d be st o p pe d 
pre mat urel y or pl ace d o n h ol d, a p pr o priate n otificati o n will be gi ve n t o t he U S F D A, 
I n v esti gat or(s), a n d I R Bs, as a p plica ble. Ba us c h + L o m b Cli nical O perati o ns will i nstr uct t he 
I n v esti gat ors t o st o p/restart dis pe nsi n g st u d y materials a n d will arra n ge f or st u d y cl ose o ut, if 
a p plica ble, at e ac h site. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 5  D at a H a n dli n g a n d Rec or d Kee pi n g 
1 5. 1  Rete nti o n of Rec or ds 
T he I n vesti gat or m ust mai ntai n c o nfi de ntial all st u d y d oc u m e ntati o n, a n d t a ke meas ures t o 
pre ve nt a cci de ntal or pre mat ure destr ucti o n of t h ese d oc u me nts. 
T he I n vesti gat or s h o ul d r etai n t he st u d y d o c u me nts at least 1 5 years after t he c o m pleti o n or 
disc o nti n uati o n of t he cli nical trial. 
H o we ver, a p plica ble re g ulat or y re q uire m e nts s h o ul d be ta ke n i nt o acc o u nt i n t he e ve nt t hat a 
l o n ger peri o d is re q uir e d. 
T he I n vesti gat or m ust n otif y t he S p o ns or pri or t o destr o yi n g a n y st u d y ess e ntial d oc u me nts 
f oll o wi n g t he cli nic al trial c o m pleti o n or disc o nti n uati o n. 
If t he I n vesti gat or’s pers o nal sit uati o n is s uc h t hat arc hi vi n g ca n n o l o n ger be e ns ure d b y 
hi m/ her, t he I n vesti gat or s hall i nf or m t he S p o ns or a n d t he rele va nt rec or ds s hall be 
tra nsferre d t o a m ut uall y a gree d u p o n d esi g nee. 
If t he I n vesti gat or retires, rel ocates, or f or ot her reas o ns wit h dra ws fr o m t h e res p o nsi bilit y of 
kee pi n g t he st u d y rec or ds, c ust o d y m ust be tra nsferre d b y t h e I n vesti gat or t o a pers o n w h o 
will acce pt t he res p o nsi bilit y. T h e S p o ns or m ust be n otifie d i n writi n g b y t he I n vesti gat or of 
t he na me a n d a d dress of t he ne w c ust o dia n a n d recei ve d oc u me nte d acce pta nce fr o m t he ne w 
c ust o dia n. 
1 5. 2  Cli nic al Tr i al Res ults 
T he S p o ns or will be res p o nsi ble f or pre p ari n g a cli nical st u d y re p ort a n d t o pr o vi de a 
s u m mar y of st u d y res ults t o t he I n v esti gat or. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 6  Refere nces 
X u Y, S hi o wje n L & Ni n g L. Missi n g Data Ha n dli n g Met h o ds i n Me dical De vice Cli nical 
Trials, J o ur nal of Bi o p har mace utical Statistics. 2 0 0 9; 1 9: 6, 1 0 8 5- 1 0 9 8. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 7  A p pe n dices 
1 7. 1  A p pe n di x A: 
Me t h o ds of Cli nic al E v al u ati o n 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
6 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 7. 2  A p pe n di x B: 
S u bject I nstr ucti o ns 
F O R SI N G L E- U S E DI S P O S A B L E W E A R 
C a uti o n: F or cli nic al tri al use o nl y 
I N T R O D U C TI O N 
Y o u will partici pate i n t his st u d y d esi g ne d t o e val uate t he pr o d uct p erf or ma nce of Bi otr ue 
O N E da y f or Asti g matis m S oft C o ntact Le nses ( Test) w he n c o m p are d t o t he c urre ntl y 
mar kete d J o h ns o n & J o h ns o n 1- Da y Ac u v u e M oist f or Asti g matis m c o ntact le ns ( C o ntr ol). 
As a partici pa nt i n t his st u d y, y o u will be ra n d o ml y assi g ne d t o w ear eit her t he Test or 
C o ntr ol le nses o n a dail y dis p osa ble basis. St u d y le nses will be dis pe nse d at t he Dis pe nsi n g 
Visit. It is ver y i m p orta nt t hat y o u d o n ot use a n y ot her c o ntact le ns es d uri n g t he st u d y. 
Y o u will wea r t he le ns es o n a dail y dis p osa bl e basis. Y o u will re place t he l e nses dail y, a n d 
a n y ti me y o u re m o ve y o ur le nses, or w he n re m o v e d fr o m y o ur e yes as i n dicate d b y y o ur 
dis pe nsi n g e ye care pr ofessi o nal. All le nses, use d a n d u n us e d, a n d blister f oils m ust be 
ret ur ne d t o yo ur e ye care pr ofessi o nal. It is esse nti al t o y o ur safet y t hat y o u rea d a n d 
u n dersta n d t he i nf or m ati o n a n d i nstr ucti o ns i n t hese S u bject I nstr ucti o ns a n d ha ve y o ur e ye 
care pr ofessi o nal a ns wer a n y q u esti o ns, b ot h bef ore a n d aft er y o u recei v e c o ntact le nses. 
D o n ot disc uss or descri b e y o ur c o ntact le nses wit h a n y o n e e x ce pt t he pers o n w h o ga ve y o u 
t he st u d y le nses at t he Dis pe nsi n g Visit. Y o u s h o ul d n ot s h o w t he st u d y blister pac ks a n d 
f oils t o t he I n vesti gat or or site staff u nless i nstr uct e d t o d o s o. 
Please kee p all a p p oi nt me nts a n d f oll o w t hese i nstr ucti o ns t h or o u g hl y. If y o u ha ve a n y 
q uesti o ns or pr o ble ms, call y o ur e ye care pr ofessi o nal at _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _. 
N ote: 
Ple ase sc he d ule y o ur 1- Wee k F oll o w- u p, 1- M o nt h F oll o w- u p, a n d 3- M o nt h F oll o w- u p 
Visits at t h e Dis pe nsi n g Visit. 
Visit  
Da y/ M o nt h/ Year  
Ti me  
1 Wee k  
/ 
 
/ 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
1 M o nt h  
/ 
 
/ 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
3 M o nt h  
/ 
 
/ 
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
N ote: We ar y o ur st u dy le nses t o e ac h of y o ur F oll o w- u p Visits. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
7 9 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
F or t his st u d y, y o u will b e usi n g t he f oll o wi n g pr o d ucts: 
 Ha bit ual e ye dr o ps (t o be use d if nee d e d). 
 Le ns cases f or st ora ge of w or n st u d y le ns es ( u p t o 1 0 pairs of le nses p er e ye, 
stac ke d dr y). 
 
G E N E R A L I N F O R M A TI O N  
D o N O T use a ny pr o d ucts ot her t h a n t h ose liste d a b ove or dis pe nse d t o y o u by y o ur eye 
c are pr ofessi o n al f or use i n t his st u dy.  
If pr o ble ms or s y m pt o ms s h o ul d occ ur, i m me diatel y re m o v e y o ur le nses a n d f oll o w t he ste ps 
descri be d i n t he secti o ns of t hese i nstr ucti o ns e ntitle d W ar ni n gs a n d A dverse Effects . Pr o m pt 
attenti o n t o pr o ble ms is esse ntial a n d ma y re q uir e i m me diate pr ofessi o nal care. 
Re me m ber, w he n weari n g c o nt act le nses y o ur e yes s h o ul d l o o k a n d feel g o o d a n d y o ur 
visi o n s h o ul d be clear. 
Beca use t he y are w or n directl y o n y o ur e yes, c o nt act le nses affect t he wa y i n w hic h y o ur 
e yes f u ncti o n. T hes e effects te n d t o i ncreas e wit h t he le n gt h of ti me t he le ns es re mai n o n 
y o ur e yes bet wee n re m o vals. Alt h o u g h t he great maj orit y of pe o ple s uccessf ull y wear c o nt act 
le nses wit h o ut pr o ble ms, bef ore y o u d eci de w het h er t o c o nti n ue weari n g c o ntact le nses f or 
dail y dis p osa ble wear, y o u s h o ul d disc uss wit h y o ur e ye care pr ofessi o nal t he effects of 
c o ntact le nses o n y o ur e yes a n d t he ris ks ass oci ate d wit h weari n g c o ntact le nses. Y o u als o 
s h o ul d rea d t he secti o ns of t hese i nstr ucti o ns e ntitle d “ War ni n gs ”, “ A d verse Reacti o ns”, 
“ Preca uti o ns”, a n d “ Weari n g Restricti o ns a n d I n dicati o ns”. As k y o ur e ye care pr ofessi o nal t o 
e x plai n a n yt hi n g t h at y o u d o n ot u n dersta n d, i ncl u di n g a n y a d diti o nal restri cti o ns w hic h ma y 
be gi v e n t o y o u b y y o ur e ye care pr ofessi o nal. T hese c o ntact le ns es ha ve b ee n prescri be d f or 
si n gle- us e dis p osa ble wear, a n d s h o ul d be re place d eac h ti me le nses are re m o ve d fr o m y o ur 
e yes. 
Y o u als o nee d t o r e me m ber t hat s oft c o ntact le nses, i ncl u di n g t h ose c o v er e d b y t hes e 
i nstr ucti o ns, are ma de of a t y p e of plastic t hat a bs or bs li q ui ds, va p ors a n d s mall particles, a n d 
f or s o me pe o ple, ma y c ollect de p osits fr o m y o ur nat ural e ye fl ui ds. T heref ore, y o u s h o ul d 
strictl y f oll o w t hese i nstr ucti o ns a n d a n y ot her i nstr ucti o ns gi ve n t o y o u b y y o ur e ye care 
pr ofessi o nal. A n y fail ure t o f oll o w t hese i nstr ucti o ns a n d t he weari n g restri cti o ns will 
i ncreas e t he c h a nces of c o nta mi nati o n, da ma ge t o t he le nses, or a b uil d u p of de p osits o n t he 
le nses, w hic h ca n lea d t o seri o us, si g ht-t hr eate ni n g e ye i nfecti o ns a n d i nj uries. 
A d here n ce t o y o ur prescri be d weari n g s c he d ule a n d re g ular c hec k- u p visits t o y o ur e ye care 
pr ofessi o nal are als o ne cessar y f or t he pr o per a n d safe use of c o ntact le nses. S oft c o ntact 
le nses ge nerall y are c o mf orta ble fr o m t he be gi n ni n g. T heref ore, b e s ure t o f oll o w t he 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 0 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
weari n g sc he d ule prescri be d f or y o u, a n d d o n ot o ver- wear y o ur le nses si m pl y beca use t he y 
re mai n c o mf ort a ble a n d y o u are n ot e x perie n ci n g a pr o ble m. O nl y y o ur e ye care 
pr ofessi o nal, t hr o u g h a pr ofessi o nal e x a mi nati o n, ca n deter mi ne h o w y o ur e yes are reacti n g 
t o t he c o ntact le nses a n d w het her t here are a n y earl y si g ns of p ossi ble pr o bl e ms. 
Fi nall y, if pr o ble ms or s y m pt o ms s h o ul d occ ur, i m me diatel y re m o ve y o ur le nses a n d f oll o w 
t he ste ps descri be d i n t he secti o n of t hese i nstr ucti o ns e ntitle d “ War ni n gs a n d A d verse 
Reacti o ns.” Pr o m pt atte nti o n t o pr o ble ms is esse ntial a n d ma y re q uir e i m me diatel y 
pr ofessi o nal c are. 
Re me m ber, w he n weari n g s oft c o nt act le nses y o ur e yes s h o ul d l o o k a n d feel g o o d, a n d y o ur 
visi o n s h o ul d be clear. 
1. W E A RI N G R E S T RI C TI O N S a n d I N DI C A TI O N S  
T he le nses ha ve bee n prescri be d f or si n gle- use dis p osal wear, a n d will be re place d after eac h 
re m o val. 
 Kee p a s p are p air of le ns es a vaila ble i n case y o u h a ve t o re m o ve y o ur le nses 
i m me diatel y u p o n t he a p peara n ce of a pr o ble m or s y m pt o m. 
 A v oi d r u b bi n g y o ur e yes wit h t he le nses i n, w hic h ca n irritate t he e ye or disl o d ge t h e 
le ns. 
 If y o u get s o met hi n g i n y o ur e ye, re m o ve t he le ns i m me diatel y. D o n ot re place wit h 
ne w le ns u ntil y o ur e ye feels n or mal. 
 Tell y o ur re g ular p h ysi cia n a n d e v er y ot her d o ct or t hat y o u visit, t hat y o u wear 
c o ntact le nses a n d t he t y pe of le nses t hat y o u wear. If y o u are a d mitte d t o a h os pital, 
als o tell y o ur n urs es t hat y o u wear c o ntact le ns es. 
 D o n ot use a n y e ye dr o ps, oi nt me nts, or me dici nes i n y o ur e ye u nless t he y are 
s pecificall y a p pr o ve d b y y o ur e ye care pr ofessi o nal or p h ysi cia n. S o me dr o ps, 
oi nt me nts, or me dici nes will ca use i nj ur y t o t he e ye if us e d b y a c o ntact le ns wearer. 
 As k y o ur e ye care pr ofessi o nal w het her t here are a n y ot h er weari n g restricti o ns t hat 
a p pl y t o y o u, write t h ose restricti o ns i n t he s paces pr o vi de d bel o w a n d f oll o w t he m 
caref ull y. 
 
 
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
2. W A R NI N G S  
Y o u s h o ul d be a ware of a n d f ull y disc uss wit h y o ur e ye care pr ofessi o nal t he f oll o wi n g 
war ni n gs pert ai ni n g t o c o ntact le ns wear: 
 Pr o ble ms wit h c o nta ct le nses c o ul d res ult i n seri o us i nj ur y t o y o ur e ye. It is esse ntial 
t hat y o u f oll o w y o ur e ye care pr ofessi o nal’s directi o n a n d all la beli n g i nstr ucti o ns f or 
pr o per use of le nses. E ye pr o ble ms, i ncl u di n g c or neal ulcers, ca n d e vel o p r a pi dl y a n d 
lea d t o l oss of visi o n. 
 Dail y dis p osa ble l e nses are n ot i n dicate d f or o ver ni g ht wear, a n d y o u s h o ul d n ot wear 
le nses w hile slee pi n g. Cli nical st u dies ha ve s h o w n t hat t he ris k of seri o us a d verse 
reacti o ns is i ncrease d w h e n dail y dis p osa bl e le nses are w or n o ver ni g ht. 
 Strict c o m plia nce wit h y o ur weari n g restricti o ns, weari n g sc he d ule, a n d f oll o w- u p 
visit sc he d ule s h o ul d be f oll o we d. 
 St u dies ha ve s h o w n t hat c o ntact le ns wearers w h o are s m o kers ha ve a hi g h er 
i nci de nce of a d verse reacti o ns t ha n n o ns m o kers. 
 If yo u e x perie nce e ye dis c o mf ort, e xcessi ve teari n g, visi o n c ha n ges, or re d ness of t he 
e ye, y o u s h o ul d i m me diatel y re m o ve le nses a n d pr o m ptl y c o ntact y o ur e ye care 
pr ofessi o nal. 
 D o n ot e x p ose y o ur c o nt act le nses t o wat er w hile weari n g t he m. 
3. P R E C A U TI O N S  
Y o u s h o ul d be a ware of a n d f ull y disc uss wit h y o ur e ye care pr ofessi o nal t he f oll o wi n g 
safet y preca uti o ns: 
 D o n ot use sali va or a n yt hi n g ot her t ha n t h e rec o m me n de d s ol uti o ns f or l u bricati n g or 
wetti n g y o ur le ns es. 
 If t he le ns stic ks (st o ps m o vi n g) o n y o ur e ye, f oll o w t he rec o m me n d e d directi o ns o n 
Care f or a Stic ki n g Le ns. T he le ns s h o ul d m o ve freel y o n y o ur e ye f or t he c o nti n ue d 
healt h of y o ur e ye. If n o n- m o ve me nt of t he le ns c o nti n ues, y o u s h o ul d i m me diatel y 
c o ns ult y o ur e ye c are pr ofessi o nal. D o n ot atte m pt t o re m o ve t he le ns, e x ce pt o n t he 
i nstr ucti o ns of y o ur e ye care pr ofessi o nal. 
 Al wa ys was h a n d ri nse y o ur ha n ds bef ore ha n dli n g le nses. D o n ot get c os metics, 
l oti o ns, s oa ps, crea ms, de o d ora nts, or s pra ys i n y o ur e yes or o n t h e le nses. It is best t o 
p ut o n le nses bef ore p utti n g o n ma ke u p. Water- b ase c os metics are less li kel y t o 
da ma ge le nses t h a n oil- base pr o d ucts. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 Be certai n t hat t he fi n gers or ha n ds are free of f orei g n mat erials bef ore t o u c hi n g y o ur 
le nses, as micr osc o pic s cratc hes of t h e le nses ma y occ ur, ca usi n g dist orte d visi o n 
a n d/ or i nj ur y t o t he e ye. 
 Caref ull y f oll o w t hese h a n dli n g, i nserti o n, re m o val a n d weari n g i nstr ucti o ns f or t he 
dail y dis p osa ble c o ntact l e nses a n d t h ose i nstr ucti o ns prescri be d b y y o ur e ye care 
pr ofessi o nal. 
 Ne ver wear le nses be y o n d t he peri o d rec o m me n de d b y y o ur e ye care pr ofessi o nal. 
 Al wa ys ha n dle le ns es ge ntl y a n d a v oi d dr o p pi n g t he m. 
 A v oi d, if p ossi ble, all har mf ul or irritati n g v a p ors a n d f u mes w he n weari n g le nses. 
 If aer os ol pr o d ucts are us e d w hile weari n g le nses, e x ercise ca uti o n a n d k ee p e yes 
cl ose d u ntil t he s pra y has settle d. 
 As k y o ur e ye care pr ofessi o nal a b o ut weari n g le ns es d uri n g water acti vities a n d ot her 
s p orts. E x p os ure t o water w hile weari n g c o ntact le nses i n acti vities s uc h as 
s wi m mi n g, water s kii n g a n d h ot t u bs ma y i ncreas e t he ris k of oc ular i nfecti o n 
i ncl u di n g b ut n ot li mite d t o Ac a nt h a m oe b a keratitis. 
 I nf or m y o ur d oct or ( healt h care pr ofessi o nal) a b o ut bei n g a c o ntact le ns w earer. 
 Ne ver us e t weezers or ot her t o ols t o re m o ve le nses fr o m t he le ns c o ntai ner u nless 
s pecificall y i n dicate d f or t hat use. P o ur t he le ns i nt o y o ur ha n d. 
 D o n ot t o uc h t he le ns wit h y o ur fi n ger nails. 
 Al wa ys c o nta ct y o ur e ye care pr ofessi o nal b ef ore usi n g a n y me dici n e i n y o ur e yes. 
 Bef ore le a vi n g y o ur e ye care pr ofessi o nal’s office be cert ai n t hat y o u are a ble t o 
re m o ve y o ur le ns es pr o m ptl y or ha v e s o me o ne else a vaila ble t o re m o ve t he m f or y o u. 
 Al wa ys i nf or m y o ur e m pl o yer of bei n g a c o ntact l e ns wearer. S o me j o bs m a y re q uir e 
use of e ye pr otecti o n e q ui p me nt or ma y re q uire t h at y o u n ot w ear c o ntact l e nses. 
 As wit h a n y c o ntact le ns, F oll o w- u p Visits are n ecessar y t o ass ure t he c o nti n ui n g 
healt h of y o ur e yes. Y o ur e ye care pr ofessi o nal s h o ul d pr o vi de y o u wit h a 
rec o m me n de d f oll o w- u p sc he d ule. 
4. A D V E R S E R E A C TI O N S ( Pr o ble ms A n d W h at T o D o) 
Y o u s h o ul d be a ware t hat t he f oll o wi n g pr o bl e ms ma y o cc ur: 
 E yes sti n gi n g, b ur ni n g, itc hi n g (irritati o n), or ot her e ye pai n, 
 C o mf ort is less t ha n w he n le ns was first place d o n e ye, 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 A b n or mal feeli n g of s o m et hi n g i n t he e ye (f orei g n b o d y, scratc he d area), 
 E x cessi ve wateri n g (te ari n g) of t he e yes, 
 U n us ual e ye secreti o ns, 
 Re d ness of t he e yes, 
 Re d uce d s har p ness of visi o n ( p o or V A ), 
 Bl urre d visi o n, rai n b o ws, or hal os ar o u n d o bjects, 
 Se nsiti vit y t o li g ht ( p h ot o p h o bia), 
 Dr y e yes. 
If y o u n otice a n y of t he a b o ve, y o u s h o ul d: 
 I m me diat el y re m o ve y o ur le nses. 
 If t he disc o mf ort or pr o ble m st o ps, t he n l o o k cl osel y at t he le ns. If t he le ns is i n a n y 
wa y da ma ge d, d o n ot p ut t he le ns bac k i n y o ur e ye. Y o u s h o ul d re m o ve t he le ns a n d 
i nsert a ne w le ns o n t he e ye. If t he pr o bl e m c o nti n ues, y o u s h o ul d i m me diatel y 
re m o ve t he le ns es a n d c o ns ult y o ur e ye care pr ofessi o nal. 
W he n a n y of t h e a b o ve pr o ble ms occ ur, a seri o us c o n diti o n s uc h as i nfecti o n, c or neal ulcer, 
ne o vasc ularizati o n, or iritis ma y be prese nt. Y o u s h o ul d kee p t he le ns off y o ur e ye a n d s ee k 
i m me diatel y pr ofessi o nal i de ntificati o n of t he pr o ble m a n d pr o m pt treat me nt t o a v oi d seri o us 
e ye da ma ge. 
5. P E R S O N A L C L E A N LI N E S S a n d L E N S H A N D LI N G  
Pre p ari n g t he Le ns f or We ari n g:  
It is esse ntial t hat y o u le ar n a n d use g o o d h y gie nic met h o ds i n t he care a n d ha n dli n g of t he 
le nses. Clea nli ness is t he first a n d m ost i m p orta nt as pect of pr o p er c o ntact l e ns care. I n 
partic ular, y o ur ha n ds s h o ul d be clea n a n d free of a n y f orei g n s u bsta n ces w he n y o u h a n dle 
y o ur le ns es. T he pr oce d ures are: 
 Al wa ys was h y o ur ha n ds t h or o u g hl y wit h mil d s oa p, ri nse c o m pletel y, a n d dr y wit h a 
li nt-free t o wel b ef ore t o uc hi n g y o ur le nses. 
 A v oi d t he use of s oa ps c o ntai ni n g c ol d crea m, l oti o n, or oil y c os metics bef ore 
ha n dli n g y o ur le ns es, si nce t hese s u bsta n ces ma y c o me i nt o c o ntact wit h t he le nses 
a n d i nterfere wit h s uccessf ul weari n g. 
 Ha n dle y o ur le ns es wit h y o ur fi n gerti ps, a n d be caref ul t o a v oi d c o ntact wit h 
fi n ger nails. It is hel pf ul t o kee p y o ur fi n ger nails s h ort a n d s m o ot h. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 Start off c orrectl y b y getti n g i nt o t he ha bit of al w a ys usi n g pr o per h y gi e nic 
pr oce d ures s o t hat t he y b ec o me a ut o matic. 
 De vel o p t he ha bit of al w a ys w or ki n g wit h t he sa me le ns first t o a v oi d mi x- u ps. 
 P osit i o n t he le ns o n y o ur i n de x fi n ger a n d e x a mi ne it t o be s ure t hat it is m oist, clea n, 
a n d fre e of a n y ni c ks or t ears. 
 S h o ul d y o u acci de ntall y place a n i nsi de- o ut le ns o n y o ur e ye, o n e of t he f oll o wi n g 
si g ns s h o ul d sig nal y o u t o re m o ve a n d re place it c orrectl y: 
▪ Less t ha n us ual c o mf ort, 
▪ T he le ns ma y f ol d o n t he e ye, 
▪ E x cessi ve le ns m o ve me nt o n bli n k, 
▪ Bl urre d visi o n. 
If t he le ns f ol ds a n d stic ks t o get her: Place t he le ns i n t he pal m of y o ur ha n d a n d wet 
t h or o u g hl y wit h re wetti n g s ol uti o n. T he n G E N T L Y r u b t he le ns bet w ee n y o ur i n de x fi n ger 
a n d pal m i n a ge ntle bac k a n d f ort h m oti o n. Re place t he l e ns if it d oes n ot u nf ol d. 
If t he le ns flatte ns or dra pes acr oss y o ur fi n ger, t h e le ns or y o ur fi n ger ma y be t o o wet. T o 
c orrect t his, dr y y o ur fi n ger b y tra nsferri n g t he l e ns se veral ti mes fr o m o n e i n de x fi n ger t o 
t he ot her, dr yi n g t he o p p osite fi n ger eac h ti me. 
Pl aci n g t he Le ns o n t he E ye:  
T here are ot her met h o ds of le ns place m e nt. If t he f oll o wi n g met h o ds are diffic ult f or y o u, 
y o ur e ye care pr ofessi o nal will pr o vi de y o u wit h a n alter nat e met h o d. 
N ote : If after pl ace m e nt of t he le ns, y o ur visi o n is bl urre d, c h ec k f or t he f oll o wi n g: 
 T he le ns is n ot ce ntere d o n t he e ye (s ee “ Ce nt eri n g t he Le ns,” ne xt i n t hese 
i nstr uctio ns).  
 If t he le ns is ce nt ere d, re m o ve t he le ns (see “ Re m o vi n g t he Le ns ” secti o n) a n d c hec k 
f or t he f ollo wi n g: 
▪ C os metics or oils o n t he le ns (re pl ace t h e le ns), 
▪ T he le ns is o n t he wr o n g e ye, 
▪ T he le ns is i nsi de- o ut (it w o ul d als o n ot be as c o mf orta ble as n or m al). 
If y o u fi n d t hat y o ur visi o n is still bl urre d after c h ec ki n g t he a b o v e p ossi bilities, re m o ve b ot h 
lenses a n d c o ns ult y o ur e ye pr ofessi o nal. 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
T he O ne- H a n d Pl ace me nt Tec h ni q ue  
Place t he le ns o n y o ur i n de x fi n ger. Wit h y o ur h ea d u p, l o o ki n g strai g ht a hea d, p ull d o w n 
y o ur l o w er e yeli d wit h t he mi d dle fi n ger of y o ur place me nt ha n d. L o o k u p stea dil y at a p oi nt 
a b o ve y o u. T he n pla ce t h e le ns o n t he l o wer w hite part of y o ur e ye. Re m o v e y o ur i n de x 
fi n ger a n d sl o wl y release t he l o wer li d. L o o k d o w n t o p ositi o n t he le ns pr o perl y. Cl ose y o ur 
e yes f or a m o me nt; t he le ns will ce nter itself o n y o ur e ye. 
 
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 6 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
T he T w o- H a n d Pl ace me nt Tec h ni q ue  
Wit h t he le ns o n y o ur i n de x fi n ger, use t h e mi d dle fi n ger 
of t he ot her ha n d t o p ull t he u p per li d a gai nst t he br o w. 
Use t he mi d dle fi n ger of y o ur pla ce me nt h a n d t o p ull 
d o w n t he l o wer li d a n d t he n place t h e le ns ce ntrall y o n 
y o ur e ye. W hile h ol di n g t his p ositi o n, l o o k d o w n war d t o 
p ositi o n t he le ns pr o perl y. Sl o wl y release y o ur e yeli ds.  
 
If t he le ns f eels u nc o mf orta ble, t he n l o o k i n t he mirr or 
a n d ge ntl y pl ace a fi n ger o n t he e d ge of t he c o ntact le ns 
a n d sl o wl y sli de t he le ns a wa y fr o m y o ur n ose w hile 
l o o ki n g i n t he o p p osite directi o n. T he n b y bli n ki n g, t he 
le ns will re-ce nt er itself. If t he le ns still feels 
u nc o mf orta ble, f oll o w t h e ste ps descri b e d i n t he secti o n 
of t hese i nstr ucti o ns e ntitle d “ A d verse Reacti o ns.”  
Ce nteri n g t he Le ns : 
Ver y rarel y, a l e ns t hat is o n t he c or nea will be dis place d o nt o t he w hite part of t he e ye 
d uri n g le ns w ear. T his ca n als o occ ur d uri n g place me nt a n d re m o val of t h e le nses if t he 
c orrect tec h ni q ues are n ot perf or me d pr o perl y. T o ce nter a le ns, f oll o w o ne of t he pr oce d ures 
bel o w. 
H ol d t he u p per a n d l o w er e yeli ds o pe n wit h y o ur fi n gers. T he n w hile l o o ki n g i n a mirr or, 
ge ntl y pla ce a fi n ger o n t he c o ntact le ns a n d ge ntl y sli de t he le ns t o w ar d t h e ce nter of t he e ye. 
Or  
H ol d t he u p per a n d l o w e r e yeli ds o pe n wit h y o ur fi n gers. T he n, w hile l o o ki n g i n a mirr or, 
m o ve y o ur e ye t o w ar d t h e le ns t o place it o n t he ce nter of t he e ye. 
Re m o vi n g t he  Le ns: 
Al wa ys re m o ve t h e sa me le ns first. 
1) Was h, ri nse, a n d dr y y o ur ha n ds t h or o u g hl y. 
2) Al wa ys be s ure t hat t h e le ns is i n t he c orrect p ositi o n o n y o ur e ye b ef ore y o u tr y t o r e m o ve 
it (a si m ple c hec k of y o ur visi o n, cl osi n g o ne e ye at a ti me, will tell y o u if t he le ns is i n t he 
c orrect p ositi o n). L o o k u p a n d sl o wl y p ull d o w n y o ur l o wer e yeli d wit h t he mi d dle fi n ger of 
y o ur re m o val ha n d a n d place y o ur i n de x fi n ger o n t he l o wer e d ge of le ns. S q ueeze t he le ns 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 7 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
li g htl y b et wee n t h e t h u m b a n d t he i n de x fi n ger a n d re m o ve it. A v oi d stic ki n g t he e d ges of t he 
le ns t o get her. 
3) Re m o ve t he ot her le ns b y f oll o wi n g t he sa m e pr oce d ure. 
N ote: If t his m et h o d of re m ovi n g y o ur le ns is diffic ult f or y o u, y o ur eye c are pr ofessi o n al 
will pr ovi de y o u wit h a n alter n ate m et h o d.  
C are f or a Stic ki n g ( N o n m o vi n g) Le ns:  
It is i m p orta nt t o t he healt h of y o ur e yes t hat y o ur c o ntact le nses m o ve freel y. If a le ns stic ks 
(st o ps m o vi n g), p ut a fe w dr o ps of y o ur ha bit ual l u bricati n g or rewetti n g s ol uti o n i nt o y o ur 
e ye. I n t his cas e, d o n ot use plai n water or a n yt hi n g ot her t h a n t he rec o m me n de d s ol uti o ns. 
D o n ot atte m pt  t o re m o ve a le ns t hat is stic ki n g, w hic h c o ul d da ma ge y o ur e ye. If t he le ns 
d oes n ot be gi n t o m o ve w he n y o u bli n k after se v eral a p plicati o ns of t he s ol uti o n or, c o ntact 
y o ur e ye care pr ofessi o nal i m me diatel y. D o n ot atte m pt t o re m o ve t he le ns e x ce pt o n t he 
a d vice of y o ur e ye care pr ofessi o nal. 
6. E M E R G E N CI E S  
If c he micals of a n y ki n d ( h o use h ol d pr o d ucts, gar de ni n g s ol uti o ns, la b orat or y c he micals, 
etc.) are s plas he d i nt o y o ur e yes, y o u s h o ul d: F L U S H E Y E S I M M E DI A T E L Y WI T H 
T A P W A T E R A N D T H E N R E M O V E L E N S E S P R O M P T L Y. C O N T A C T Y O U R E Y E 
C A R E P R O F E S SI O N A L O R VI SI T A H O S PI T A L E M E R G E N C Y R O O M 
WI T H O U T D E L A Y.  

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
8 8 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 7. 3  A p pe n di x C: 
Fitti n g G ui de 
Fit G ui de f or Bi otr ue O N E d a y f or Asti g m atis m 
 

I M P O R T A N T
This packa ge insert an d fittin g gui de has been devel o pe d t o pr ovi de practiti oners 
with inf or mati on c overin g characteristics of the Bausch + L o m b Bi otrue ®  
O N E day (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens, Bausch + L o m b 
Bi otrue ®  O N E day f or Pres by o pia (nes ofilc on A) S oft ( Hy dr o philic) C ontact 
Lens an d Bausch + L o m b Bi otrue ®  O N E day f or Asti g matis m (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens an d t o illustrate fittin g pr oce dures. It is effective as of 
May 2 01 6 ( 2 01 6- 0 5- 01)an d su perse des all pri or fittin g gui des f or the pr o duct 
descri be d. Please rea d carefully an d kee p this inf or mati on f or future use.
This packa ge insert an d fittin g gui de is inten de d f or the eye care pr ofessi onal, but 
sh oul d be ma de availa ble t o patients u p on re quest. The eye care pr ofessi onal 
sh oul d pr ovi de the patient with the patient instructi ons that pertain t o the patient’s 
prescri be d lens an d the rec o m men de d wearin g sche dule
D E S C RI P TI O N
The Bausch + L o m b Bi otrue ®  O N E day lens material, Hy per gel ™ (nes ofilc on A), 
is a hy dr o philic c o p oly mer of 2-hy dr oxyethyl methacrylate an d N-vinyl 
pyrr oli d one an d is 7 8 % water by wei ght when i m merse d in a sterile saline s oluti on. 
A benz otriaz ole U V-a bs or bin g m on o mer is inc or p orate d int o the manufacturin g 
pr ocess t o bl ock U V ra diati on. The trans mittance characteristics are less than 5 % 
in the U V B ran ge of 2 8 0n m t o 31 5n m an d less than 5 0 % in the U V A ran ge of 
31 6n m t o 3 8 0n m. This lens is tinte d blue with Reactive Blue Dye 2 4 6. 
The physical / o ptical pr o perties of the lens are:
S pecific Gravity:  
1. 0 3 9
Refractive In de x: 
1. 3 74
Li ght Trans mittance:  
C.I. E. Y value - a p pr oxi mately 9 9 %
Water C ontent:  
7 8 %
Oxy gen Per mea bility ( Dk):    4 2 x 1 0 –11[c m3O
2( ST P) x c m]/(sec x c m2 x m m H g) 
@ 3 5° C ( Polar o gra phic Meth o d) 
The lens is t o be prescri be d f or sin gle-use dis p osa ble wear, an d is t o be discar de d 
after each re m oval.
© Ba usch & L o m b I nc or p orat e d.  
All ri ghts res erve d w orl d wi d e.  
®/ T M are tra d e marks of  
Ba usch & L o m b I nc or p orat e d  
or its affiliat es. A ny oth er pr o d uct/  
bra n d na m es are tra d e marks of  
th eir res p ective o w n ers.
Na m e a n d A d dress of Man ufact urer:  
Ba usch & L o m b I nc or p orat e d  
1 4 0 0 N orth G o o d ma n Stre et 
R och est er, N e w York, U S A 1 4 6 0 9
T A b l E  O f C O N T E N T S
I m p ortant 
2
Descri pti on  
2
Lens Para meters Availa ble 
5
H o w the Lens Works ( Acti ons)  
6
In dicati ons 
6
C ontrain dicati ons ( Reas ons N ot t o Use)  
7
Warnin gs  
7
Precauti ons  
8
A dverse Reacti ons  
1 0 
 
I m p ortant Treat ment Inf or mati on f or A dverse Reacti ons  
11
Selecti on of Patients  
1 2
Fittin g Pr oce dure  
1 3 
 
Pre-Fittin g Exa minati on  
1 3 
 
Initial Lens Po wer Selecti on 
1 3 
 
Initial Lens Evaluati on 
1 3 
 
Criteria of a Well-Fitte d Lens  
1 3 
 
Characteristics of a Ti ght ( Stee p) Lens  
1 4 
 
Characteristics of a L o ose (Flat) Lens  
1 4 
 
Foll o w-u p Care  
1 4
Practiti oner Fittin g Sets  
1 5
Wearin g Sche dule  
1 5
M on ovisi on Fittin g Gui delines  
1 6 
 
Patient Selecti on  
1 6 
 
Eye Selecti on  
1 7 
 
S pecial Fittin g C onsi derati ons  
1 7 
 
Near A d d Deter minati on  
1 8 
 
Trial Lens Fittin g  
1 8 
 
A da ptati on  
1 9 
 
Other Su g gesti ons  
1 9
Multi-Focal Fittin g Gui delines  
2 0  
 
Patient Selecti on  
2 0  
 
Lens Selecti on  
2 0  
 
Lens Fittin g  
2 0  
 
Sy m pt o m Res oluti on  
21  
 
Patient E ducati on  
21  
Han dlin g of Lenses  
21
Care f or a Stickin g ( N on m ovin g) Lens  
2 2
E mer gencies  
2 2
Re p ortin g of A dver se Reacti ons 
2 2
H o w Su p plie d  
2 2
The ty pical trans mittance pr ofile of nes ofilc on A lenses vs a Hu man C ornea an d 
Hu man Lens:
Nes ofilc on A Lens — N o minal Center Thickness 0.1 m m (-1. 2 5 D).
C ornea — Hu man C ornea fr o m a 2 4-year- ol d pers on as descri be d in Ler man, S., 
Ra diant Ener gy an d the Eye, Mac Millan, Ne w York, 1 9 8 0, p. 5 8, fi g. 2- 21.
Lens — Hu man crystalline lens fr o m a 2 5-year- ol d pers on as descri be d in Waxler 
M., Hitchins V. M., O ptical Ra diati on an d Visual Health, C R C Press, B oca Rat on, 
Fl ori da, 1 9 8 6, p. 1 9, fi g. 5.
War ni n g 
U V a bs or bin g c ontact lenses are N OT su bstitutes f or pr otective U V a bs or bin g 
eye wear such as U V a bs or bin g g o g gles or sun glasses because they d o n ot 
c o m pletely c over the eye an d surr oun din g area. You sh oul d c ontinue t o use U V 
a bs or bin g eye wear as directe d.
N ot e
L on g ter m ex p osure t o U V ra diati on is one of the risk fact ors ass ociate d with cataracts. 
Ex p osure is base d on a nu m ber of fact ors such as envir on mental c on diti ons (altitu de, 
ge o gra phy, cl ou d c over) an d pers onal fact ors (extent an d nature of out d o or activities). 
U V bl ockin g c ontact lenses hel p pr ovi de pr otecti on a gainst har mful U V ra diati on.
N ot e
The effectiveness of wearin g U V a bs or bin g c ontact lenses in preventin g or re ducin g 
the inci dence of ocular dis or ders ass ociate d with ex p osure t o U V li ght has n ot been 
esta blishe d at this ti me. H o wever, clinical stu dies have n ot been d one t o de m onstrate 
that wearin g U V bl ockin g c ontact lenses re duce the risk of devel o pin g cataracts or 
other eye dis or ders. C onsult y our Eye Care Pr ofessi onal f or m ore inf or mati on.
l E N S P A R A M E T E R S A V AI l A b l E
The Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on A) S oft ( Hy dr o philic) C ontact 
Lens is a he mis pherical shell of the f oll o win g di mensi ons:
Dia meter:  
1 4. 2 m m 
  
 
1 4. 5 m m ( Asti g matis m)
Center Thickness:  
0. 0 5 m m t o 0. 7 5 m m (v aries with p o wer)
Base Curve:  
8. 6 m m  
  
 
8. 4 m m ( Asti g matis m)
Po wers ( S pherical):  
+ 6. 0 0 D t o - 6. 0 0 D in 0. 2 5 D ste ps  
  
 
- 6. 5 0 D t o - 9. 0 0 D in 0. 5 0 D ste ps
Po wers ( Pres by o pia):  
+ 6. 0 0 D t o - 9. 0 0 D in 0. 2 5 D ste ps  
A d d Po wers:  
L o w ( + 0. 7 5 D t o +1. 5 0 D) an d  
  
 
Hi gh ( +1. 7 5 D t o + 2. 5 0 D)
Po wers ( Asti g matis m):  
+ 4. 0 0 D t o - 6. 0 0 D in 0. 2 5 D ste ps  
Cylin der Po wers:  
- 0. 7 5 D, -1. 2 5 D, -1. 7 5 D an d - 2. 2 5 D 
Axis:  
0° t o 1 8 0°
A d diti onal para meters may be intr o duce d ov er ti me, check f or pr o duct availa bility.
H O W T H E l E N S W O R K S ( A C TI O N S)
In its hy drate d state, the Bausch + L o m b Bi otrue®  O N E day (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens, Bausch + L o m b Bi otrue®  O N E day f or Pres by o pia 
(nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens an d Bausch + L o m b Bi otrue®  
O N E day f or Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens, when 
place d on the c ornea, act as a refractin g me diu m t o f ocus li ght rays on the retina.
The trans mittance characteristics are less than 5 % in the U V B ran ge of 2 8 0n m t o 
31 5n m an d less than 5 0 % in the U V A ran ge of 31 6n m t o 3 8 0n m.
I N DI C ATI O N S
S V S
The Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on A) S oft ( Hy dr o philic)
C ontact Lens is in dicate d f or the daily wear c orrecti on of refractive a metr o pia 
( my o pia, hy per o pia an d asti g matis m) in a phakic an d/or n on-a phakic pers ons 
with n on- disease d eyes, exhi bitin g asti g matis m of 2. 0 0 di o pters or less, that d oes 
n ot interfere with visual acuity. The lens may be prescri be d in s pherical p o wers 
ran gin g fr o m + 2 0. 0 0 D t o - 2 0. 0 0 D.
Pr es by o pi a
The Bausch + L o m b Bi otrue ®  O N E day f or Pres by o pia (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens is in dicate d f or daily wear f or the c orrecti on of 
refractive a metr o pia ( my o pia, hy per o pia, an d asti g matis m) an d pres by o pia 
in a phakic an d/or n on-a phakic pers ons with n on- disease d eyes, exhi bitin g 
asti g matis m of 2. 0 0 di o pters or less, that d oes n ot interfere with visual acuity. The 
lens may be prescri be d in p o wers ran gin g fr o m + 2 0. 0 0 D t o - 2 0. 0 0 D with a d d 
p o wer ran gin g fr o m + 0. 7 5 D t o + 5. 0 0 D.
Asti g m atis m
The Bausch + L o m b Bi otrue ®  O N E day f or Asti g matis m (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens is in dicate d f or daily wear f or the c orrecti on of 
refractive a metr o pia ( my o pia, hy per o pia, an d asti g matis m) in a phakic an d/or n on-
a phakic pers ons with n on- disease d eyes, exhi bitin g asti g matis m of u p t o 5. 0 0 
di o pters, that d oes n ot interfere with visual acuity. The lens may be prescri be d in 
p o wers ran gin g fr o m + 2 0. 0 0 D t o - 2 0. 0 0 D f or daily wear.
The lens is t o be prescri be d f or sin gle-use dis p osa ble wear, an d is t o be discar de d 
after each re m oval.
P A C K A G E I N S E R T / FI T TI N G G UI D E
81 01 9 0 3
2
6
5
4
3
C A U TI O N:  Fe d eral la w 
restricts t his d evic e t o sal e 
b y or o n t h e or d er of a 
lic e ns e d practiti o n er.
S y M b O l R E f E R E N C E  GUI D E
For la bel an d cart ons:
 
  
 D o N ot Reuse
  
 Te m perature 
Li mitati on
   Sterile  Usin g 
Stea m or Dry Heat
  
 See  Instructi on 
Leaflet
   In dicates  the 
C E C onf or mity 
Markin g an d the 
N otifie d B o dy 
Nu m ber
  
 Auth orize d 
Re presentative  
in Eur o pean 
C o m munity 
  
 Cauti on:  Fe deral 
la w restricts this 
device t o sale by  
or on the or der 
of a license d 
practiti oner
  
 Fee Pai d f or Waste 
Mana ge ment
  
 Use by Date 
( Ex pirati on Date)
 
Batch C o de
 
Dia meter
 
 Di o pter  
( Lens Po wer)
 
Base Curve
  
 L o w or Hi gh  
A d d Po wer
 
 S phere  Po wer 
( Di o pters)
 
 Cylin der  Axis 
( De grees)
 
 Cylin der  Po wer 
( Di o pters)
Y Y Y Y- M M- D D  
Effective Date
Print e d in th e U. S. A.
O N E d ay  
f or Asti g m atis m 
(n es oﬁl c o n A)  
S oft ( Hy dr o p hili c)  
C o nt a ct L e ns es
O N E d ay  
f or Pr es by o pi a 
(n es oﬁl c o n A)  
S oft ( Hy dr o p hili c)  
C o nt a ct L e ns es
O N E d ay  
(n es oﬁl c o n A)  
S oft ( Hy dr o p hili c)  
C o nt a ct L e ns es 

C O N T R AI N DI C ATI O N S  
( R E A S O N S N O T T O U S E)
D O N OT U S E the Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens, Bausch + L o m b Bi otrue®  O N E day f or Pres by o pia 
(nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens or Bausch + L o m b Bi otrue®  
O N E day f or Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens when 
any of the f oll o win g c on diti ons exist:
•  
Acute an d su bacute infla m mati on or  infecti on of  the anteri or cha m ber of   
the eye
•  
Any eye disease,  injury, or  a bn or mality that affects the c ornea, c onjunctiva, or  
eyeli ds
•  
Severe insufficiency of  lacri mal secreti on ( dry eyes)
•  
C orneal hy p oesthesia (re duce d c orneal sensitivity) 
•  
Any syste mic disease  that may  affect the eye or  be  exa g gerate d  by  wearin g  
c ontact lenses
•  
Aller gic reacti ons of  ocular  surfaces or  a dnexa (surr oun din g tissue) that  
may be in duce d or exa g gerate d by wearin g c ont act lenses or use of c ontact 
lens s oluti ons
•  
Any active c orneal infecti on ( bacterial, fun gal, or  viral)
•  If eyes bec o me  re d or  irritate d
W A R NI N G S
After a th or ou gh eye exa minati on, inclu din g a p pr o priate me dical backgr oun d, 
patients sh oul d be fully a p prise d by the prescri bin g pr ofessi onal of all the risks 
with c ontact lens wear. Pati e nts s h o ul d b e a dvis e d of t h e f oll o wi n g w ar ni n gs 
p ert ai ni n g t o c o nt act l e ns w e ar:
•  
Pr o ble ms with  c ontact lenses an d lens care pr o ducts  c oul d result in s eri o us 
i nj ur y t o the eye. It is essential that patients f oll o w their eye care pr ofessi onal’s  
directi on an d all la belin g instructi ons f or pr o per use of lenses an d lens care 
pr o ducts, inclu din g the lens case. Eye pr o ble ms, inclu din g c orneal ulcers, can 
devel o p ra pi dly an d lea d t o l oss of visi o n.
•  
Daily wear  lenses are n ot in dicate d f or overni ght  wear,  an d p ati e nts s h o ul d 
b e i nstr uct e d n ot t o w e ar l e ns es w hil e sl e e pi n g.  Clinical stu dies have 
sh o wn that the risk of seri ous a dverse reacti ons is increase d when daily wear 
lenses are w orn overni ght.
•  
Stu dies have sh o wn that c ontact lens wearers  wh o  are s m okers have a hi gher  
inci dence of a dverse reacti ons than n ons m okers.
• 
If a patient  ex periences  eye disc o mf ort,  excessive  tearin g, visi on chan ges, or  
re dness of the eye, the patient sh oul d be instructe d t o i m m e di at ely re m ov e 
l e ns es an d pr o m ptly c ontact his or her eye care pr ofessi onal.
•  
Patients sh oul d be  instructe d n ot t o ex p ose their c ontact lenses t o water  while  
wearin g the m.
 
Water can har b or micr o or ganis ms that can lea d t o sever e infecti on, visi on l oss or 
blin dness. If their c ontact lenses have been su b merse d in water when s wi m min g in 
p o ols, lakes or oceans, the c ontact lenses sh oul d be discar de d an d re place d with 
a ne w pair. Rec o m men dati ons f or wearin g lenses durin g any water activity sh oul d 
be discusse d with the patient.
P R E C A U TI O N S
S p eci al Pr ec a uti o ns f or Ey e C ar e Pr of essi o n als:
•  
Due t o the s mall nu m ber of  patients  enr olle d in clinical investi gati on of  lenses, all 
refractive p o wers, desi gn c onfi gurati ons, or lens para meters availa ble in the lens 
material are n ot evaluate d in si gnificant nu m bers. C onse quently, when selectin g 
an a p pr o priate lens desi gn an d para meters, the eye care pr ofessi onal sh oul d 
c onsi der all characteristics of the lens that can affect lens perf or mance an d ocular 
health, inclu din g oxy gen per mea bility, wetta bility, central an d peri pheral thickness, 
an d o ptic z one dia meter.
• 
 The  p otential  i m pact of  these fact ors on  the patient’s  ocular  health sh oul d be  
carefully wei ghe d a gainst the patient’s nee d f or refractive c orrecti on; theref ore, 
the c ontinuin g ocular health of the patient an d lens perf or mance on eye sh oul d be 
carefully m onit ore d by the prescri bin g eye care pr ofessi onal. 
• 
Patients wh o wear c ontact lenses t o c orrect pres by o pia may n ot achieve the best 
c orrecte d visual acuity f or either far or near visi on. Visual re quire ments vary with 
the in divi dual an d sh oul d be c onsi dere d when selectin g the m ost a p pr o priate ty pe 
of lens f or each patient.
•  
Eye care pr ofessi onals  sh oul d instruct the patient  t o R E M O V E  A  L E N S  
I M M E DI AT E L Y if an eye bec o mes re d or irritate d.
• 
Flu orescein,  a yell o w dye,  sh oul d n ot be  use d while  the lenses are on  the eyes. The  
lenses a bs or b this dye an d bec o me disc ol ore d. Whenever flu orescein is use d in 
eyes, the eyes sh oul d be flushe d with sterile saline s oluti on that is rec o m men de d 
f or in-eye use. 
•  
The patient  sh oul d be  instructe d t o al ways discar d  dis p osa ble  lenses an d lenses 
w orn on a fre quent/planne d re place ment sche dule after the r ec o m men de d 
wearin g sche dule prescri be d by the eye care pr ofessi onal. 
•  
As with  any c ontact lens, f oll o w-u p visits are necessary t o assure the c ontinuin g 
health of the patient’s eyes. The patient sh oul d be instructe d as t o a rec o m men de d 
f oll o w-u p sche dule.
•  
A phakic patients  sh oul d n ot be  fitte d with  Bausch  +  L o m b  Bi otrue ®  O N E day 
(nes ofilc on A) S oft ( Hy dr o philic) C ontact Lenses, Bausch + L o m b 
Bi otrue ®  O N E day f or Pres by o pia (nes ofilc on A) S oft ( Hy dr o philic) C ontact 
Lenses or Bausch + L o m b Bi otrue ®  O N E day f or Asti g matis m (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lenses until the deter minati on is ma de that the eye has 
heale d c o m pletely.
• 
 The  lenses are prescri be d  f or dis p osa ble  wear,  an d are t o be  dis p ose d  of  once  
they are re m ove d fr o m the patient’s eye. It is i m p ortant that patients be instructe d 
t o al ways have availa ble a pair of re place ment lenses. In the event that a lens must 
be re m ove d fr o m the eye because of dust, a f orei gn b o dy or other c onta minant 
gets on the lens or the lens bec o mes dehy drate d, the lens sh oul d be re m ove d an d 
re place d with a re place ment lens.
• 
Eyecare pr ofessi onals sh oul d carefully instruct patients a b out the f oll o win g 
safety precauti ons. It is str on gly rec o m men de d that patients be pr ovi de d with a 
c o py of the Patient Inf or mati on B o oklet f or Bausch + L o m b Bi otrue ®  O N E day 
(nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens / Bausch + L o m b Bi otrue®  
O N E day f or Pres by o pia (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens 
/ Bausch + L o m b Bi otrue®  O N E day f or Asti g matis m (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lens, availa ble fr o m Bausch + L o m b, an d un derstan d its 
c ontents pri or t o dis pensin g the lenses.
H a n dli n g Pr ec a uti o ns:
•  
Al ways wash  an d rinse han ds bef ore  han dlin g lenses. D o  n ot get  c os metics, 
l oti ons, s oa ps, crea ms, de o d orants, or s prays in the eyes or on the lenses.  
It is best t o put on lenses bef ore puttin g on makeu p. Water- base c os metics are 
less likely t o da ma ge lenses than oil- base pr o ducts.
•  
Be sure that bef ore  leavin g the eye care pr ofessi onal’s  office,  the patient   
is a ble t o re m ove lenses pr o m ptly or have s o me one else availa ble t o re m ove the m.
•  
Be certain that the fin gers or  han ds are free of  f orei gn materials  bef ore  t ouchin g 
lenses, as micr osc o pic scratches of the lenses may occur, causin g dist orte d visi on 
an d/or  injury t o the eye.
•  
Al ways han dle lenses carefully an d av oi d dr o p pin g  the m.
•  
D o n ot t ouch the lens with  fin gernails.
•  
Carefully f oll o w the han dlin g, inserti on, re m oval, cleanin g disinfectin g,  
st orin g an d wearin g instructi ons in the Patient Inf or mati on B o oklet f or the 
Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on A) S oft ( Hy dr o philic) C ontact 
Lenses / Bausch + L o m b Bi otrue ®  O N E day f or Pres by o pia (nes ofilc on A) 
S oft ( Hy dr o philic) C ontact Lenses / Bausch + L o m b Bi otrue ®  O N E day f or 
Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lenses an d th ose 
prescri be d by the eye care pr ofessi onal.
•  
Never use t weezers or  other  t o ols t o re m ove lenses fr o m the lens c ontainer 
unless s pecifically in dicate d f or that use. Pour the lens int o the han d.
To pics t o Disc uss wit h t h e Pati e nt:
•  
As with  any c ontact lens, f oll o w-u p visits are necessary t o assure the 
c ontinuin g health of the eyes. The patient sh oul d be instructe d as t o a 
rec o m men de d f oll o w-u p sche dule. 
•  
Patients sh oul d be  a dvise d a b out wearin g  lenses durin g  s p ortin g an d water  
relate d activities. Ex p osure t o water while wearin g c ontact lenses in activities 
such as s wi m min g, water skiin g an d h ot tu bs may increase the risk of ocular 
infecti on inclu din g but n ot li mite d t o Acantha m oe ba  keratitis.
•  
Al ways c ontact the eye care pr ofessi onal  bef ore  usin g any me dicine  in the 
eyes.
W h o S h o ul d K n o w T h at t h e Pati e nt is W e ari n g C o nt act L e ns es:
•  
Patients sh oul d inf or m their d oct or  (health care pr ofessi onal)  a b out bein g  a 
c ontact lens wearer.
•  
Patients sh oul d al ways inf or m their e m pl oyer  of  bein g  a c ontact lens wearer.  
S o me  j o bs may  re quire the use of  eye pr otecti on  e qui p ment  or  may  re quire 
that y ou d o n ot wear lenses.
A D V E R S E R E A C TI O N S
The patient sh oul d be inf or me d that the f oll o win g pr o ble ms may occur:
•  
Eyes stin gin g, burnin g,  itchin g (irritati on), or  other  eye pain
•  
C o mf ort is less than when  lens was  first place d  on  eye
•  
A bn or mal feelin g of  s o methin g in the eye (f orei gn b o dy,  scratche d area)
•  
Excessive waterin g  (tearin g) of  the eyes
•  
Unusual eye secreti ons
•  
Re dness of  the eyes
•  
Re duce d shar pness of  visi on ( p o or visual acuity)
•  
Blurre d visi on, rain b o ws, or  hal os ar oun d o bjects
•  
Sensitivity t o li ght ( ph ot o ph o bia)
•  
Dry eyes
If t h e p ati e nt n otic es a ny of t h e a b ove, h e or s h e s h o ul d b e i nstr uct e d t o:
• 
 I m m e di at ely r e m ov e t h e l e ns es.
•  If the disc o mf ort  or  pr o ble m  st o ps, then l o ok cl osely at the lens. If the lens is 
in any way da ma ge d, d o n ot  put the lens back on the eye. Place the lens in 
the st ora ge case an d c ontact the eye care pr ofessi onal. If the lens has dirt, 
an eyelash, or other f orei gn b o dy on it, or the pr o ble m st o ps an d the lens 
a p pears un da ma ge d, the patient sh oul d th or ou ghly clean, rinse, an d disinfect 
the lenses; then reinsert the m. After reinserti on, if the pr o ble m c ontinues, the 
patient sh oul d i m m e di at el y r e m o v e t h e l e ns es a n d c o ns ult his or h er 
ey e c ar e pr of essi o n al .
•  If the a b ove sy m pt o ms c ontinue after re m oval of  the lens, or  u p on reinserti on 
of a lens, or u p on inserti on of a ne w lens, the patient sh oul d i m m e di at el y 
r e m ov e t h e l e ns es a n d c o nt act his or h er ey e c ar e pr of essi o n al 
or physician, wh o must deter mine the nee d f or exa minati on, treat ment 
or referral with out delay. ( See I m p ortant Treat ment Inf or mati on f or 
A dverse Reacti ons.) A seri ous c on diti on such as infecti on, c orneal ulcer, 
c orneal vascularizati on, or iritis may be present, an d may pr o gress ra pi dly. 
Less seri ous reacti ons such as a brasi ons, e pithelial stainin g or bacterial 
c onjunctivitis must  be  mana ge d  an d treate d carefully t o av oi d m ore  seri ous 
c o m plicati ons. 
I m p ort a nt Tre at m e nt I nf or m ati o n f or A dv ers e R e acti o ns
Si ght-threatenin g ocular c o m plicati ons ass ociate d with c ontact lens wear can 
devel o p ra pi dly, an d theref ore early rec o gniti on an d treat ment of pr o ble ms 
are critical. Infecti ous c orneal ulcerati on is one of the m ost seri ous p otential 
c o m plicati ons, an d may be a m bi gu ous in its early sta ge. Si gns an d sy m pt o ms of 
infecti ous c orneal ulcerati on inclu de disc o mf ort, pain, infla m mati on, purulent 
dischar ge, sensitivity t o li ght, cells an d flare, an d c orneal infiltrates. 
Initial sy m pt o ms of a min or a brasi on an d an early infecte d ulcer are s o meti mes 
si milar. Acc or din gly, such e pithelial defect, if n ot treate d pr o perly, may devel o p 
int o an infecte d ulcer. In or der t o prevent seri ous pr o gressi on of these c on diti ons, 
a patient presentin g sy m pt o ms of a brasi ons or early ulcers sh oul d be evaluate d as 
a p otential me dical e mer gency, treate d acc or din gly, an d be referre d t o a c orneal 
s pecialist when a p pr o priate. Stan dar d thera py f or c orneal a brasi ons such as eye 
patchin g or the use of ster oi ds or ster oi d/anti bi otic c o m binati ons may exacer bate 
the c on diti on. If the patient is wearin g a c ontact lens on the affecte d eye when 
exa mine d, the lens sh oul d be re m ove d i m me diately an d the lens an d lens care 
pr o ducts retaine d f or analysis an d culturin g. 
S E l E C TI O N O f  P ATI E N T S
The eye care pr ofessi onal sh oul d n ot fit patients wh o cann ot or will n ot a dhere t o a 
rec o m men de d care or re place ment re gi men, or are una ble t o place an d re m ove the 
lenses. Failure t o f oll o w han dlin g an d cleanin g instructi ons c oul d lea d t o seri ous eye 
infecti ons which mi ght result in c orneal ulcers.
Patient c o m municati on is vital because it relates n ot only t o patient selecti on but als o 
t o ensure c o m pliance. It is als o necessary t o discuss the inf or mati on c ontaine d in the 
Patient Inf or mati on B o oklet with the patient at the ti me of the initial exa minati on.
Patients selecte d t o wear Bausch + L o m b Bi otrue ® O N E day (nes ofilc on A) S oft 
( Hy dr o philic) C ontact Lenses, Bausch + L o m b Bi otrue®  O N E day f or Pres by o pia 
(nes ofilc on A) S oft ( Hy dr o philic) C ontact Lenses or Bausch + L o m b Bi otrue®  
O N E day f or Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lenses sh oul d 
be ch osen f or their m otivati on t o wear c ontact lenses, general health an d c o o perati on. 
The eye care pr ofessi onal must take care in selectin g, exa minin g an d instructin g 
c ontact lens patients. Patient hy giene an d willin gness t o f oll o w practiti oner instructi ons 
are essential t o their success.
A detaile d hist ory is crucial t o deter minin g patient nee ds an d ex pectati ons.  
Your patient sh oul d be questi one d re gar din g v ocati on, desire d lens wearin g ti me (full 
or part ti me), an d desire d lens usa ge (rea din g, recreati on or h o b bies).
Initial evaluati on of the trial lens sh oul d be prece de d by a c o m plete eye exa minati on, 
inclu din g visual acuity with an d with out c orrecti on at b oth distance an d near, 
kerat o metry an d slit la m p exa minati on.
It is n or mal f or the patient t o ex perience mil d sy m pt o ms such as lens a wareness, 
varia ble visi on, occasi onal tearin g ( watery eyes) an d sli ght re dness durin g the 
a da ptati on peri o d. Alth ou gh the a da ptati on peri o d varies f or each in divi dual, generally 
within one week these sy m pt o ms will disa p pear. 
If these sy m pt o ms persist, the patient sh oul d be instructe d t o c ontact his or her eye 
care pr ofessi onal.
f I T TI N G P R O C E D U R E
1. 
Pr e- Fitti n g Ex a mi n ati o n
A pre-fittin g patient hist ory an d exa minati on ar e necessary t o:
•  
Deter mine whether  a patient  is a suita ble can di date f or c ontact lenses (c onsi der 
patient hy giene an d mental an d physical state),
•  
Make ocular  measure ments  f or initial c ontact lens para meter  selecti on, an d
•  
C ollect an d rec or d baseline  clinical inf or mati on t o which  p ost-fittin g  exa minati on  
results can be c o m pare d. 
A pre-fittin g ex a minati on sh oul d inclu de s pher ocylin der refracti on an d V A, 
kerat o metry, an d bi o micr osc o pic exa minati on.
2.  I niti al L e ns Po w er S el ecti o n
a. Lens p o wer is deter mine d fr o m the patient’s s pherical e quiv alent prescri pti on 
c orrecte d t o the c orneal plane. 
b.  Select the a p pr o priate lens an d place on the eye. All o w the lens t o re main on 
the eye l on g en ou gh (1 0 t o 2 0 minutes) t o achieve a state of e quili briu m. S mall 
variati ons in the t onicity, p H of the lens s oluti ons, an d in divi dual tear c o m p ositi on 
may cause sli ght chan ges in fittin g characteristics.
c. All o w any increase in tear fl o w t o su bsi de bef ore ev aluatin g the lens. The ti me 
re quire d will vary with the in divi dual.
3.  I niti al L e ns Ev al u ati o n
a. To deter mine pr o per lens para meters o bserv e the lens relati onshi p t o the eye 
usin g a slit la m p.
•  
M ove ment: The  lens sh oul d pr ovi de  discerni ble  m ove ment  with:
—  Pri mary gaze blink
—  U p gaze blink
—  U p gaze la g
•  
Centrati on: The  lens sh oul d pr ovi de  full c orneal c overa ge.
b.  Lens evaluati on all o ws the c ont act lens fitter t o evaluate the lens/c ornea 
relati onshi p in the sa me manner as w oul d be d one with any s oft lens. 
4.  Crit eri a of a Well- Fitt e d L e ns
If the initial lens selecti on fully c overs the c ornea, pr ovi des discerni ble m ove ment after 
a blink, is c o mf orta ble f or the patient an d pr ovi des satisfact ory visual perf or mance, it is 
a well fitte d lens an d can be dis pense d.
5.  C h ar act eristics of a Ti g ht ( St e e p) L e ns
A  lens which  is much  t o o stee p may  su bjectively an d o bjectively  cause dist orti on  
which will vary after a blink. H o we ver, if a lens is only mar ginally stee p, the initial 
su bjective an d o bjective  visi on an d c o mf ort fin din gs may  be  quite  g o o d.  A  
mar ginally stee p lens may be differentiate d fr o m a pr o perly fitte d lens b y havin g 
the patient gaze u p war d. A pr o perly fitte d lens will ten d t o sli de d o wn war d 
a p pr oxi mately 0. 5 m m while a stee p lens will re main relatively sta ble in relati onshi p 
t o the c ornea, particularly with the blink.
6.  C h ar act eristics of a L o os e ( Fl at) L e ns
If the lens is t o o flat, it will:
• 
Decenter , es pecially on p ost- blink.
• 
Hav e a ten dency t o e d ge lif t inferi orly an d sit on the l o wer li d, rather than 
p ositi onin g  bet ween  the sclera an d pal pe bral  c onjunctiva.
• 
Have a ten dency t o be unc o mf ort a ble an d irritatin g with fluctuatin g visi on.
• 
Have a ten dency t o dr o p or la g greater than 2. 0 m m on u p gaze p ost- blink.
7.  Foll o w- u p C ar e
a. Foll o w-u p exa minati ons are necessary t o ensure c ontinue d successful c ontact 
lens wear. Fr o m the day of dis pensin g, the f oll o win g sche dule is a su g geste d 
gui deline f or f oll o w u p.
•  3– 4 days  p ost- dis pensin g
•  1 0 days
•  1 m onth
•  3 m onths  
•  Every six m onths  thereafter
  
 At the initial f oll o w-u p evaluati ons the ey e care pr ofessi onal sh oul d a gain 
reassure the patient that any of the previ ously descri be d a da ptive sy m pt o ms 
are n or mal, an d that the a da ptati on peri o d sh oul d be relatively brief. 
b.  Pri or t o a f oll o w-u p exa minati on, the c ont act lenses sh oul d be w orn f or at least 
4 c ontinu ous h ours an d the patient sh oul d be aske d t o i dentify any pr o ble ms 
which mi ght be occurrin g relate d t o c ontact lens wear. 
c. With lenses in place on the eyes, evaluate fittin g perf or mance t o as sure that 
C RI T E RI A OF A W E L L FI T T E D L E N S c ontinue t o be satisfie d. Exa mine the 
lenses cl osely f or surface de p ositi on an d/or da ma ge.
1 0
1 4
9
1 3
8
1 2
7
11

d.  After the lens re m oval, instill s o diu m flu orescein [unless c ontrain dicate d] int o 
the eyes an d c on duct a th or ou gh bi o micr osc o py exa minati on.
1. The presence of vertical c orneal striae in the p osteri or central c ornea 
an d/or c orneal ne ovascularizati on may be in dicative of excessive  
c orneal e de ma.
2.  The  presence  of  c orneal stainin g an d/or li m bal-c onjunctival hy pere mia  
can be in dicative of an unclean lens, a reacti on t o s oluti on preserv atives, 
excessive lens wear, an d/or a p o orly fittin g lens.
3.  Pa pillary  c onjunctival chan ges may  be  in dicative of  an unclean an d/or 
da ma ge d lens.
 
 If any of  the a b ove o bservati ons  are ju d ge d a bn or mal, vari ous pr ofessi onal  
ju d g ments are necessary t o alleviate the pr o ble m  an d rest ore the eye t o 
o pti mal c on diti ons. If the C RI T E RI A OF A W E L L FI T T E D L E N S are n ot 
satisfie d durin g any f oll o w-u p exa minati on, the patient sh oul d be re-fitte d with 
a m ore a p pr o priate lens.
P R A C TI TI O N E R f I T TI N G S E T S
Lenses must be discar de d after sin gle use an d must n ot be use d fr o m patient t o 
patient.
W E A RI N G S C H E D U l E
The wearin g an d re place ment sche dules sh oul d be deter mine d by the eye care 
pr ofessi onal. Re gular checku ps, as deter mine d by the eye care pr ofessi onal, are 
extre mely i m p ortant.
D aily We ar
There may be a ten dency f or the daily wear patient t o over- wear the lenses initially. 
Theref ore, the i m p ortance of a dherin g t o a pr o per, initial daily wearin g sche dule 
sh oul d be stresse d t o these patients. The wearin g sche dule sh oul d be deter mine d 
by the eye care pr ofessi onal. The wearin g sche dule ch osen by the eye care 
pr ofessi onal sh oul d be pr ovi de d t o the patient. The lens is t o be prescri be d f or 
sin gle-use dis p osa ble wear, an d is t o be discar de d after each re m oval.
M O N O VI SI O N f I T TI N G G UI D El I N E S
1. Pati e nt S el ecti o n
a. M on ovisi on Nee ds Assess ment  
For a g o o d pr o gn osis the patient sh oul d ha ve a de quately c orrecte d distance 
an d near visual acuity in each eye. The a m bly o pic patient or the patient with 
si gnificant asti g matis m ( greater than one [1] di o pter) in one eye may n ot be a g o o d 
can di date f or m on ovisi on with the Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on 
A) S oft ( Hy dr o philic) C ontact Lenses or Bausch + L o m b Bi otrue ®  O N E day f or 
Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lenses.
  
 Occu pati onal an d envir on mental visual de man ds sh oul d be c onsi dere d. If 
the patient re quires critical visi on (visual acuity an d stere o psis) it sh oul d be 
deter mine d by trial whether this patient can functi on a de quately with m on ovisi on. 
M on ovisi on c ontact lens wear may n ot be o pti mal f or such activities as:
1. Visually de man din g situati ons such as o peratin g p otentially dan ger ous 
machiner y or perf or min g other p otentially hazar d ous activities; an d
2.  Drivin g aut o m o biles (e. g., drivin g at ni ght). Patients wh o cann ot pass their 
state drivers license re quire ments with m on ovisi on c orrecti on sh oul d be 
a dvise d t o n ot drive with this c orrecti on, O R may re quire that a d diti onal over-
c orrecti on be prescri be d.
b.  Patient E ducati on  
All patients d o n ot functi on e qually well with m on ovisi on c orrecti on. P atients may 
n ot perf or m as well f or certain tasks with this c orrecti on as they have with bif ocal 
rea din g glasses. Each patient sh oul d un derstan d that m on ovisi on can create 
a visi on c o m pr o mise that may re duce visual acuity an d de pth perce pti on f or 
distance an d near tasks. Durin g the fittin g pr ocess it is necessary f or the patient t o 
realize the disa dvanta ges as well as the a dvanta ges of clear near visi on in strai ght 
ahea d an d u p war d gaze that m on ovisi on c ontact lenses pr ovi de.
1 6
1 5
2. Ey e S el ecti o n
Generally, the n on- d o minant eye is c orrecte d f or near visi on. The f oll o win g test f or eye 
d o minance can be use d.
a. Ocular Preference Deter minati on Meth o ds
•  
Meth o d 1 — Deter mine which  eye is the “si ghtin g d o minant  eye.” Have  the 
patient  p oint  t o an o bject  at the far en d of  the r o o m. C over  one  eye. If the 
patient  is still p ointin g  directly  at the o bject,  the eye bein g  use d is the d o minant  
(si ghtin g) eye.
•  
Meth o d 2 — Deter mine  which  eye will  acce pt the a d de d p o wer  with  the least 
re ducti on in visi on. Place a trial s pectacle near a d d lens in fr ont of one eye 
an d then the other while the distance refractive err or c orrecti on is in place f or 
b oth eyes. Deter mine whether the patient functi ons best with the near a d d 
lens over the ri ght or left eye.
b.  Refractive Err or Meth o d  
For anis o metro pic c orrecti ons, it is generally best t o fit the m ore hy per o pic (less 
my o pic) eye f or distance an d the m ore my o pic (less hy per o pic) eye f or near.
c. Visual De man ds Meth o d  
C onsi der the patient’s occu pati on durin g the eye selecti on pr ocess t o deter mine 
the critical visi on re quire ments. If a patient’s gaze f or near tasks is usually in one 
directi on c orrect the eye on that si de f or near.
 
 Exa m ple:  
 A secretary wh o places c o py t o the left si de of the desk will usually functi on best  
with the near lens on the left eye.
3. S p eci al Fitti n g C o nsi d er ati o ns
U nil at er al L e ns C orr ecti o n  
There are circu mstances where only one c ontact lens is re quire d. As an exa m ple, 
an e m metr o pic patient w oul d only re quire a near lens while a bilateral my o pe may 
re quire only a distance lens.
Exa m ple:  
A pres by o pic e m metr o pic patient wh o re quires a +1. 7 5 di o pter a d d w oul d have a 
+1. 7 5 di o pter lens on the near eye an d the other eye left with out a lens.
A pres by o pic patient re quirin g a +1. 5 0 di o pter a d d wh o is – 2. 5 0 di o pters my o pic 
in the ri ght eye an d –1. 5 0 di o pters my o pic in the left eye may have the ri ght eye 
c orrecte d f or distance an d the left unc orrecte d f or near.
4. N e ar A d d D et er mi n ati o n
Al ways prescri be the lens p o wer f or the near eye that pr ovi des o pti mal near acuity 
at the mi d p oint of the patient’s ha bitual rea din g distance. H o wever, when m ore 
than one p o wer pr ovi des o pti mal rea din g perf or mance, prescri be the least plus 
( m ost minus) of the p o wers.
5. Tri al L e ns Fitti n g
A trial fittin g is perf or me d in the office t o all o w the patient t o ex perience 
m on ovisi on c orrecti on. Lenses are fit acc or din g t o the directi ons in the general 
fittin g gui delines.
Case hist ory an d stan dar d clinical evaluati on pr oce dure sh oul d be use d t o 
deter mine the pr o gn osis. Deter mine which eye is t o be c orrecte d f or distance an d 
which eye is t o be c orrecte d f or near. Next deter mine the near a d d.  
With trial lenses of the pr o per p o wer in place o bserve the reacti on t o this m o de 
of c orrecti on.
 I m me diately after the c orrect p o wer lenses are in place, walk acr oss the r o o m an d 
have the patient l o ok at y ou. Assess the patient’s reacti on t o distance visi on un der 
these circu mstances. Then  have the patient  l o ok at fa miliar near o bjects  such as 
a watch face or fin gernails. A gain assess the reacti on. As the patient c ontinues  
t o l o ok ar oun d the r o o m at b oth  near an d distant  o bjects,  o bserve  the reacti ons. 
Only after these visi on tasks are c o m plete d sh oul d the patient be aske d t o rea d  
print. Evaluate the patient’s reacti on t o lar ge print (e. g. ty pe written c o py) at first 
an d then gra duate t o ne ws print an d finally s maller ty pe sizes.
After the patient’s perf or mance un der the a b ove c on diti ons are c o m plete d, tests 
of visual acuity an d rea din g a bility un der c on diti ons of m o derately di m illu minati on 
sh oul d be atte m pte d.
An initial unfav ora ble res p onse in the office, while in dicative of a guar de d 
pr o gn osis, sh oul d n ot i m me diately rule out a m ore extensive trial un der the usual 
c on diti ons in which a patient functi ons.
6. A d a pt ati o n
Visually de man din g situati ons sh oul d be av oi de d durin g the initial wearin g peri o d. 
A patient may at first ex perience s o me mil d blurre d visi on, dizziness, hea daches, 
an d a feelin g of sli ght i m balance. You sh oul d ex plain the a da ptati onal sy m pt o ms 
t o the patient. These sy m pt o ms may last f or a brief minute or f or several weeks. 
The l on ger these sy m pt o ms persist, the p o orer the pr o gn osis f or successful 
a da ptati on.
To hel p in the a da ptati on pr ocess the patient can be a dvise d t o first use the lenses 
in a c o mf orta ble fa miliar envir on ment such as in the h o me.
S o me patients feel that aut o m o bile drivin g perf or mance may n ot be o pti mal 
durin g the a da ptati on pr ocess. This is particularly true when drivin g at ni ght. 
Bef ore drivin g a m ot or vehicle, it may be rec o m men de d that the patient be 
a passen ger first t o make sure that their visi on is satisfact ory f or o peratin g an 
aut o m o bile. Durin g the first several weeks of wear ( when a da ptati on is occurrin g), 
it may be a dvisa ble f or the patient t o only drive durin g o pti mal drivin g c on diti ons. 
After a da ptati on an d success with these activities, the patient sh oul d be a ble t o 
drive un der other c on diti ons with cauti on.
7. Ot h er S u g g esti o ns
The success of the m on ovisi on techni que may be further i m pr ove d by havin g y our 
patient f oll o w the su g gesti ons bel o w.
•  
Havin g a thir d c ontact lens ( distance p o wer)  t o use when  critical distance  
vie win g is nee de d.
•  
Havin g a thir d c ontact lens (near p o wer)  t o use when  critical near vie win g  
is nee de d.
 •  
Havin g su p ple mental s pectacles t o wear  over  the m on ovisi on  c ontact lenses 
f or s pecific visual tasks may i m pr ove the success of m on ovisi on c orrecti on. 
This is particularly a p plica ble f or th ose patients wh o cann ot meet state 
licensin g re quire ments with a m on ovisi on c orrecti on.
•  
Make use of  pr o per  illu minati on when  carryin g out  visual tasks. 
Success in fittin g m on ovisi on can be i m pr ove d b y the f oll o win g su g gesti ons:
•  
Reverse the distance  an d near eyes if a patient  is havin g tr ou ble a da ptin g.
•  
Refine the lens p o wers  if there is tr ou ble with  a da ptati on. Accurate  lens p o wer  
is critical f or pres by o pic patients.
• 
 E m phasize  the benefits  of  the clear near visi on in strai ght ahea d an d u p war d  
gaze with m on ovisi on.
•  
T h e d ecisi o n  t o fit a  p ati e nt  wit h  a  m o n o visi o n  c orr ecti o n is m ost  
a p pr o pri at el y  l eft t o t h e ey e  c ar e pr of essi o n al  i n c o nj u ncti o n  wit h  t h e 
p ati e nt aft er c ar ef ull y c o nsi d eri n g t h e p ati e nt’s n e e ds.
•  
All p ati e nts  s h o ul d b e  s u p pli e d wit h  a  c o py of  t h e B a usc h + L o m b Bi otr u e®  
O N E d ay ( n es ofilc o n A) S oft ( Hy dr o p hilic) C o nt act L e ns / B a usc h + L o m b 
Bi otr u e ®  O N E d ay f or Pr es by o pi a ( n es ofilc o n A) S oft ( Hy dr o p hilic) C o nt act 
L e ns / B a usc h + L o m b Bi otr u e ®  O N E d ay f or Asti g m atis m ( n es ofilc o n A) S oft 
( Hy dr o p hilic) C o nt act L e ns Pati e nt I nf or m ati o n B o o kl et.
M U lTI- f O C A l  f I T TI N G G UI D El I N E S
1. Pati e nt S el ecti o n
a. G o o d m otivati on
b.  Realistic ex pectati ons
2. L e ns S el ecti o n
a. U p date s pectacle refracti on an d A d d p o w er.
b.  Deter mine ocular d o minance f or distance visi on.
c. Select lens distance prescri pti on base d u p on s pherical e quivalent fr o m s pectacle  
prescri pti on,  a djuste d f or vertex distance  if necessary.
d.  Ch o ose trial lenses base d u p on the a b ove calculati on an d select A d d p o wer . 
•  L o w A d d:  + 0. 7 5 D  t o +1. 5 0 D
•  Hi gh A d d:  +1. 7 5 D  t o + 2. 5 0 D
3. L e ns Fitti n g
a. E quili brate f or 1 0 minutes.
b.  Evaluate distance an d near visi on bin ocularly in n or mal r o o m illu minati on.
c. If visi on at distance an d near are satisfact ory, dis pense lenses an d sche dule f oll o w-
u p exa m within 1- 2 weeks.
4. To r efi n e N e ar Visi o n
If patient is wearin g t w o L o w A d d lenses: 
•  Refine ment 1: 
 
Place Hi gh A d d lens in n on- d o minant eye while kee pin g L o w A d d lens in 
d o minant-eye.
•  Refine ment 2:  
If visi on is still unsatisfact ory, c ontinue a d din g + 0. 2 5 D at a ti me t o the n on-
d o minant  eye usin g han dhel d lenses. A djust  c ontact lens p o wer  when  visi on 
in satisfact ory.
If patient is wearin g t w o Hi gh A d d lenses:
• 
Refine ment  1: 
A d d + 0. 2 5 D t o the n on- d o minant eye.
•  Refine ment 2:   
If visi on is still unsatisfact ory, c ontinue a d din g + 0. 2 5 D at a ti me t o the n on-
d o minant eye usin g han dhel d lenses.
5. To r efi n e Dist a nc e Visi o n:
If patient is wearin g t w o L o w A d d lenses:
•  Refine ment 1:  
Place S V S lens in d o minant eye while kee pin g L o w A d d lens in n on- d o minant 
eye.
•  Refine ment 2:   
If visi on is still unsatisfact ory, a d d - 0. 2 5 D at a ti me t o d o minant eye usin g han d 
hel d lenses. A djust  c ontact lens p o wer  when  visi on in satisfact ory.
If patient is wearin g t w o Hi gh Ad d lenses:
•  Refine ment 1:  
Place L o w A d d lens in d o minant eye while kee pin g Hi gh A d d lens in n on-
d o minant eye. 
•  Refine ment 2:   
If visi on is still unsatisfact ory, a d d - 0. 2 5 D at a ti me t o d o minant eye usin g han d 
hel d lenses. A djust  c ontact lens p o wer  when  visi on in satisfact ory.
6. Pati e nt E d uc ati o n
All patients d o n ot functi on e qually w ell with multif ocal c orrecti on. Patients may n ot 
perf or m as well f or certain tasks with this c orrecti on as they have with multif ocal 
rea din g glasses. Each patient sh oul d un derstan d that multif ocal c orrecti on can create 
a visi on c o m pr o mise that may re duce visual acuity an d de pth perce pti on f or distance 
an d near tasks. Durin g the fittin g pr ocess it is necessary f or the patient t o realize the 
disa dvanta ges as well as the a dvanta ges of clear near visi on in strai ght ahea d an d 
u p war d gaze that multif ocal c ontact lenses pr ovi de.
H A N D l I N G Of  l E N S E S
Pati e nt L e ns C ar e Dir ecti o n 
When lenses are dis pense d, the patient sh oul d be pr ovi de d with a p pr o priate an d 
a de quate instructi ons an d warnin gs f or lens care han dlin g. The eye care pr ofessi onal 
sh oul d rec o m men d a p pr o priate an d a de quate pr oce dures f or each in divi dual patient 
in acc or dance with the particular lens wearin g sche dule. 
1 7
1 8
2 0
1 9
21
2 2
C A R E f O R A S TI C KI N G 
( N O N M O VI N G) l E N S
If the lens sticks (st o ps m ovin g), the patient sh oul d be instructe d t o use a 
lu bricatin g or re wettin g s oluti on in their eye. The patient sh oul d be instructe d 
t o n ot  use plain water, or anythin g other than the rec o m men de d s oluti ons. The 
patient sh oul d be instructe d t o c ontact the eye care pr ofessi onal if the lens d oes 
n ot be gin t o m ove u p on blinkin g after several a p plicati ons of the s oluti on, an d t o 
n ot atte m pt t o re m ove the lens exce pt on the a dvice of the eye care pr ofessi onal. 
E M E R G E N CI E S
If che micals of any kin d (h ouseh ol d pr o ducts, gar denin g s oluti ons, la b orat ory 
che micals, etc.) are s plashe d int o y our eyes, y ou sh oul d: F L U S H E Y E S 
I M M E DI AT E L Y WI T H T A P W AT E R A N D T H E N R E M O V E D L E N S E S 
P R O M PT L Y. C O N T A CT Y O U R E Y E C A R E P R OF E S SI O N A L O R VI SI T A 
H O S PI T A L E M E R G E N C Y R O O M WI T H O U T D E L A Y.
R E P O R TI N G O f  A D V E R S E R E A C TI O N S
All seri ous a dverse ex periences an d a dverse reacti ons o bserve d in patients 
wearin g Bausch + L o m b Bi otrue ®  O N E day (nes ofilc on A) S oft ( Hy dr o philic) 
C ontact Lenses, Bausch + L o m b Bi otrue ®  O N E day f or Pres by o pia (nes ofilc on A) 
S oft ( Hy dr o philic) C ontact Lenses or Bausch + L o m b Bi otrue ®  O N E day f or 
Asti g matis m (nes ofilc on A) S oft ( Hy dr o philic) C ontact Lens, or ex perience d with 
the lenses, sh oul d be re p orte d t o:
Bausch & L o m b Inc or p orate d  
1 4 0 0 N orth G o o d man Street 
Rochester, Ne w York 1 4 6 0 9  
Toll  Fr e e  Tel e p h o n e  N u m b er  
In the C ontinental U. S., Alaska, Hawaii  
1- 8 0 0- 5 5 3- 5 3 4 0 
In Cana da  
1- 8 8 8- 4 5 9- 5 0 0 0 ( O pti on 1 - En glish, O pti on 2 - French)
H O W S U P P l I E D
Each sterile lens is su p plie d in a plastic packa ge c ontainin g b orate buffere d saline 
s oluti on with p ol oxa mine. Each c ontainer is marke d with the manufacturin g l ot 
nu m ber of the lens, di o pter p o wer, an d ex pirati on date.

Pr ot oc ol 8 8 5  Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h a n d De vel o p me nt 
9 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
Fit G ui de f or 1- D a y Ac u v ue M oist f or Asti g m atis m 
 

I M P O R T A N T:  Pl e as e r e a d c ar ef ully a n d k e e p t his 
i nf or m ati o n f or f ut ur e us e.
T his P a c k a g e I ns ert a n d Fitti n g I nstr u cti o n G ui d e is 
i nt e n d e d f or t h e Ey e C ar e Pr of essi o n al, b ut s h o ul d b e 
m a d e av ail a bl e t o p ati e nts u p o n r e q u est. 
T h e Ey e C ar e Pr of essi o n al s h o ul d pr o vi d e t h e p ati e nt 
wit h t h e a p pr o pri at e i nstr u cti o ns t h at p ert ai n t o t h e 
p ati e nt’s pr es cri b e d l e ns es. C o pi es ar e av ail a bl e f or 
d o w nl o a d at w w w. a c uv u e. c o m.
et a ﬁ l c o n A S oft ( hy dr o p hili c) C o nt a ct L e ns es
Visi bility Ti nt e d wit h U V Bl o c k er
f or D aily Dis p os a bl e We ar
C A U TI O N: U. S. Fe deral la w restricts t his device t o 
sale by or o n t he or der of a lice nse d practiti o ner.
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e ns es
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e ns es f or A S TI G M ATI S M
1- D A Y A C U V U E ®  M OI S T Br a n d M U LTI F O C A L C o nt a ct L e ns es

S Y M B O L S  K E Y
T h e f oll o wi n g  s y m b ol s  m a y  a p p e ar  o n t h e l a b el  or  p a c k a gi n g:
Vi sit  w w w. a c u v u e. c o m/ g ui d e s f or  a d diti o n al i nf or m ati o n  a b o ut  s y m b ol s.
D E S C RI P TI O N
1- D A Y  A C U V U E ® M OI S T  Br a n d  C o nt a ct  L e n s e s,  1- D A Y  A C U V U E
® M OI S T 
Br a n d  C o nt a ct  L e n s e s f or  A S TI G M A TI S M,  a n d  1- D A Y  A C U V U E ®   M OI S T  Br a n d 
M U L TI F O C A L  C o nt a ct  L e n s e s  ar e  s oft ( h y dr o p hili c)  c o nt a ct l e n s e s  a v ail a bl e  a s 
s p h eri c al, t ori c,  or  m ultif o c al l e n s e s,  a n d i n cl u d e  L A C R E O N ®   Te c h n ol o g y.
T h e l e n s  m at eri al ( et a ﬁ l c o n  A) i s  a  c o p ol y m er  of  2- h y dr o x y et h yl  m et h a cr yl at e  a n d 
m et h a cr yli c  a ci d  cr o s s-li n k e d  wit h  1,  1,  1-tri m et h yl ol  pr o p a n e tri m et h a cr yl at e  a n d 
et h yl e n e  gl y c ol  di m et h a cr yl at e. 
D at e  of  M a n uf a ct ur e
M a n uf a ct ur er
C o n s ult I n str u cti o n s f or  U s e
U s e  B y  D at e ( e x pir ati o n  d at e)
B at c h  C o d e
L O T
St erili z e d  U si n g  St e a m  H e at
S T E RI L E
1 2 3
L e n s  Ori e nt ati o n  C orr e ct
1 2 3
L e n s  Ori e nt ati o n I n c orr e ct ( L e n s I n si d e  O ut)
 
Q u alit y  S y st e m  C erti ﬁ c ati o n  S y m b ol
F e e  P ai d f or  W a st e  M a n a g e m e nt
D o  N ot  R e- U s e ( Si n gl e  U s e)
A ut h ori z e d  R e pr e s e nt ati v e i n t h e  E ur o p e a n  C o m m u nit y
R E P
E C
2

T h e l e n s e s  ar e ti nt e d  bl u e  u si n g  R e a cti v e  Bl u e  D y e  # 4 t o  m a k e t h e l e n s e s  m or e 
vi si bl e f or  h a n dli n g.  A  b e n z otri a z ol e  U V  a b s or bi n g  m o n o m er i s  u s e d t o  bl o c k  U V 
r a di ati o n. 
L e n s  Pr o p erti e s:
T h e  p h y si c al/ o pti c al  pr o p erti e s  of t h e l e n s  ar e:
•  S p e ci ﬁ  c  Gr a vit y ( c al c ul at e d):   
0. 9 8  –  1. 1 2
•  R efr a cti v e I n d e x:  
1. 4 0
•  Li g ht  Tr a n s mitt a n c e: 
8 5 %  mi ni m u m
•  S urf a c e  C h ar a ct er:  
H y dr o p hili c
•  W at er  C o nt e nt: 
5 8 %
•  O x y g e n  P er m e a bilit y ( D/ k):
V A L U E  
M E T H O D
2 1. 4 x  1 0 - 1 1 (c m2/s ec)
( ml  O2/ ml x  m m  H g)  @  3 5° C  
F att ( b o u n d ary c orr ect e d,  e d g e c orr ect e d)
2 8. 0 x  1 0 - 1 1 (c m2/s ec)
( ml  O2/ ml x  m m  H g)  @  3 5° C
F att ( b o u n d ary c orr ect e d,  n o n- e d g e c orr ect e d)
L e n s  P ar a m et er s  R a n g e s:
•  Di a m et er ( DI A): 
1 2. 0  m m t o  1 5. 0  m m
•  C e nt er  T hi c k n e s s: 
V ari e s  wit h  p o w er
•  B a s e  C ur v e ( B C): 
7. 8 5  m m t o  1 0. 0 0  m m
•  S p h eri c al  P o w er ( D):  
- 2 0. 0 0 D t o  + 2 0. 0 0 D
•  C yli n d er  P o w er ( C Y L):  
- 0. 2 5 D t o - 1 0. 0 0 D
•  A xi s ( A XI S): 
2. 5° t o  1 8 0°
•  A D D  P o w er s :
+ 0. 2 5 D t o  + 4. 0 0 D
A V AI L A B L E  L E N S  P A R A M E T E R S
1- D A Y  A C U V U E ®   M OI S T  Br a n d  C o nt a ct  L e n s e s  ar e  h e mi s p h eri c al  s h ell s  of t h e 
f oll o wi n g  di m e n si o n s:
Di a m et er ( DI A): 
1 4. 2  m m
C e nt er  T hi c k n e s s: 
0. 0 8 4  m m t o  0. 2 3 0  m m ( v ari e s  wit h  p o w er)
3

B a s e  C ur v e ( B C): 
8. 5  m m,  9. 0  m m
P o w er s ( D): 
- 0. 5 0 D t o - 6. 0 0 D (i n  0. 2 5 D i n cr e m e nt s)
- 6. 5 0 D t o - 1 2. 0 0 D (i n  0. 5 0 D i n cr e m e nt s)
+ 0. 5 0 D t o  + 6. 0 0 D (i n  0. 2 5 D i n cr e m e nt s)
1- D A Y  A C U V U E ®   M OI S T  Br a n d  C o nt a ct  L e n s e s f or  A S TI G M A TI S M  ar e  h e mit ori c 
s h ell s  of t h e f oll o wi n g  di m e n si o n s:
Di a m et er ( DI A): 
1 4. 5  m m
C e nt er  T hi c k n e s s: 
0. 0 9 0  m m t o  0. 1 8 9  m m ( v ari e s  wit h  p o w er)
B a s e  C ur v e ( B C): 
8. 5  m m
P o w er s ( D): 
+ 0. 0 0 t o - 6. 0 0 D (i n  0. 2 5 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D, - 2. 2 5 D*
A xi s ( A XI S):  1 0° t o  1 8 0° i n  1 0° i n cr e m e nt s
*- 2. 2 5 D  c yli n d er i s  a v ail a bl e i n  1 0°,  2 0°,  7 0°,  8 0°,  9 0°, 
1 0 0°,  1 1 0°,  1 6 0°,  1 7 0°,  1 8 0°  a x e s  o nl y
- 6. 5 0 D t o - 9. 0 0 D (i n  0. 5 0 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D, - 2. 2 5 D*
A xi s ( A XI S):  1 0°,  2 0°,  6 0°,  7 0°,  8 0°,  9 0°,  1 0 0°,  1 1 0°, 
1 2 0°,  1 6 0°,  1 7 0°,  1 8 0°
*- 2. 2 5 D  c yli n d er i s  a v ail a bl e i n  2 0°,  9 0°,  1 6 0°,  1 8 0° 
a x e s  o nl y
+ 0. 2 5 D t o  + 4. 0 0 D (i n  0. 2 5 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D
A xi s ( A XI S):  1 0°,  2 0°,  7 0°,  8 0°,  9 0°,  1 0 0°,  1 1 0°,  1 6 0°, 
1 7 0°,  1 8 0°
1- D A Y  A C U V U E ®   M OI S T  Br a n d  M U L TI F O C A L  C o nt a ct  L e n s e s  ar e  h e mi s p h eri c al 
s h ell s  of t h e f oll o wi n g  di m e n si o n s:
Di a m et er ( DI A): 
1 4. 3  m m
C e nt er  T hi c k n e s s: 
0. 0 8 4  m m t o  0. 2 0 7  m m ( v ari e s  wit h  p o w er)
B a s e  C ur v e ( B C): 
8. 4  m m
P o w er s ( D):
+ 6. 0 0 D t o - 9. 0 0 D (i n  0. 2 5 D i n cr e m e nt s)
N e ar  A D D  P o w er s 
( M A X  A D D):
L o w  N e ar  A D D ( L O W):  + 1. 2 5 D
M e di u m  N e ar  A D D ( MI D):  + 1. 7 5 D
Hi g h  N e ar  A D D ( H G H):  + 2. 5 0 D
4

1- D A Y  A C U V U E ®   M OI S T  Br a n d  C o nt a ct  L e n s e s ( et a ﬁ l c o n  A)  Vi si bilit y  Ti nt e d  wit h 
U V  Bl o c k er  v s.  2 4  yr.  ol d  h u m a n  c or n e a  a n d  2 5  yr.  ol d  h u m a n  cr y st alli n e l e n s. 
* T h e  d at a  ar e r e pr es e nt ativ e  m e as ur e m e nts t a k e n t hr o u g h t h e  c e ntr al  3- 5  m m  p orti o n f or t h e 
t hi n n est  m ar k et e d l e ns (- 3. 0 0 D l e ns,  0. 0 8 4  m m  c e nt er t hi c k n ess).
1  L er m a n,  S.,  R a di a nt  E n er g y  a n d t h e  E y e,  M a c Mill a n,  N e w  Y or k,  1 9 8 0,  p.  5 8,  ﬁ  g ur e  2- 2 1
2  W a xl er,  M.,  Hit c hi n s,  V. M.,  O pti c al  R a di ati o n  a n d  Vi s u al  H e alt h,  C R C  Pr e s s,  B o c a  R at o n,  Fl ori d a, 
1 9 8 6,  p.  1 9,  ﬁ  g ur e  5
W A R NI N G:  U V  a b s or bi n g  c o nt a ct l e n s e s  ar e  N O T  s u b stit ut e s f or 
pr ot e cti v e  U V  a b s or bi n g  e y e w e ar,  s u c h  a s  U V  a b s or bi n g  g o g gl e s 
or  s u n gl a s s e s  b e c a u s e t h e y  d o  n ot  c o m pl et el y  c o v er t h e  e y e  a n d 
s urr o u n di n g  ar e a.  T h e  p ati e nt  s h o ul d  c o nti n u e t o  u s e  U V  a b s or bi n g 
e y e w e ar  a s  dir e ct e d.
A C TI O N S
I n it s  h y dr at e d  st at e, t h e  c o nt a ct l e n s,  w h e n  pl a c e d  o n t h e  c or n e a,  a ct s  a s  a 
r efr a cti n g  m e di u m t o f o c u s li g ht r a y s  o n t h e r eti n a.
T h e  U V  Bl o c ki n g f or t h e s e l e n s e s  a v er a g e s  9 7 % i n t h e  U V B r a n g e  of  2 8 0  n m t o 
3 1 5  n m  a n d  8 2 % i n t h e  U V A r a n g e  of  3 1 6  n m t o  3 8 0  n m f or t h e  e ntir e  p o w er 
r a n g e.
T R A N S MI T T A N C E  C U R V E S
1- D AY  A C U V U E ®   M OI S T
Br a n d  C o nt a ct  L e ns es*
2 4  Y R.  O L D  H U M A N 
C O R N E A 1
2 5  Y R.  O L D  H U M A N
C R Y S T A L LI N E  L E N S 2
5

N O T E:  L o n g-t er m  e x p o s ur e t o  U V r a di ati o n i s  o n e  of t h e ri s k f a ct or s 
a s s o ci at e d  wit h  c at ar a ct s.  E x p o s ur e i s  b a s e d  o n  a  n u m b er  of f a ct or s 
s u c h  a s  e n vir o n m e nt al  c o n diti o n s ( altit u d e,  g e o gr a p h y,  cl o u d  c o v er)  a n d 
p er s o n al f a ct or s ( e xt e nt  a n d  n at ur e  of  o ut d o or  a cti viti e s).  U V- Bl o c ki n g 
c o nt a ct l e n s e s  h el p  pr o vi d e  pr ot e cti o n  a g ai n st  h ar mf ul  U V r a di ati o n. 
H o w e v er,  cli ni c al  st u di e s  h a v e  n ot  b e e n  d o n e t o  d e m o n str at e t h at 
w e ari n g  U V- Bl o c ki n g  c o nt a ct l e n s e s r e d u c e s t h e ri s k  of  d e v el o pi n g 
c at ar a ct s  or  ot h er  e y e  di s or d er s.  T h e  E y e  C ar e  Pr of e s si o n al  s h o ul d  b e 
c o n s ult e d f or  m or e i nf or m ati o n.
I N DI C A TI O N S ( U S E S)
1- D A Y  A C U V U E ®   M OI S T  Br a n d  C o nt a ct  L e n s e s  ar e i n di c at e d f or  d ail y 
di s p o s a bl e  w e ar f or t h e  o pti c al  c orr e cti o n  of r efr a cti v e  a m etr o pi a ( m y o pi a  a n d 
h y p er o pi a) i n  p h a ki c  or  a p h a ki c  p er s o n s  wit h  n o n- di s e a s e d  e y e s  w h o  m a y  h a v e 
1. 0 0 D  or l e s s  of  a sti g m ati s m.
1- D A Y  A C U V U E ®   M OI S T  Br a n d  C o nt a ct  L e n s e s f or  A S TI G M A TI S M  ar e i n di c at e d 
f or  d ail y  di s p o s a bl e  w e ar f or t h e  o pti c al  c orr e cti o n  of r efr a cti v e  a m etr o pi a ( m y o pi a 
a n d  h y p er o pi a) i n  p h a ki c  or  a p h a ki c  p er s o n s  wit h  n o n- di s e a s e d  e y e s  w h o  m a y 
h a v e  0. 5 0 D t o  3. 0 0 D  of  a sti g m ati s m.
1- D A Y  A C U V U E ®   M OI S T  Br a n d  M U L TI F O C A L  C o nt a ct  L e n s e s  ar e i n di c at e d 
f or  d ail y  di s p o s a bl e  w e ar f or t h e  o pti c al  c orr e cti o n  of  di st a n c e  a n d  n e ar  vi si o n i n 
pr e s b y o pi c  p h a ki c  or  a p h a ki c  p er s o n s  wit h  n o n- di s e a s e d  e y e s  w h o  m a y  h a v e 
4. 0 0 D  of  A D D  p o w er  or l e s s  a n d  0. 7 5 D  or l e s s  of  a sti g m ati s m.
T h e l e n s e s  c o nt ai n  a  U V  Bl o c k er t o  h el p  pr ot e ct  a g ai n st tr a n s mi s si o n  of  h ar mf ul 
U V r a di ati o n t o t h e  c or n e a  a n d i nt o t h e  e y e.
W h e n  pr e s cri b e d f or  d ail y  di s p o s a bl e  u s e,  n o  cl e a ni n g  or  di si nf e cti o n i s r e q uir e d. 
L e n s e s  s h o ul d  b e  di s c ar d e d  u p o n r e m o v al.
C O N T R AI N DI C A TI O N S ( R E A S O N S  N O T  T O  U S E) 
D O  N O T  U S E t h e s e l e n s e s  w h e n  a n y  of t h e f oll o wi n g  c o n diti o n s  e xi st:
•    A c ut e  or  s u b a c ut e i n ﬂ  a m m ati o n  or i nf e cti o n  of t h e  a nt eri or  c h a m b er  of 
t h e  e y e.
•    A n y  e y e  di s e a s e, i nj ur y,  or  a b n or m alit y t h at  aff e ct s t h e  c or n e a, 
c o nj u n cti v a,  or  e y eli d s.
•    S e v er e i n s uf ﬁ  ci e n c y  of l a cri m al  s e cr eti o n ( dr y  e y e).
•    C or n e al  h y p o e st h e si a (r e d u c e d  c or n e al  s e n siti vit y).
6

•    A n y  s y st e mi c  di s e a s e t h at  m a y  aff e ct t h e  e y e  or  b e  e x a g g er at e d  b y 
w e ari n g  c o nt a ct l e n s e s.
•    All er gi c r e a cti o n s  of  o c ul ar  s urf a c e s  or  a d n e x a t h at  m a y  b e i n d u c e d  or 
e x a g g er at e d  b y  w e ari n g  c o nt a ct l e n s e s  or  u s e  of  c o nt a ct l e n s  s ol uti o n s.
•    O c ul ar irrit ati o n  d u e t o  all er gi c r e a cti o n s  w hi c h  m a y  b e  c a u s e d  b y  u s e 
of  c o nt a ct l e n s  s ol uti o n s (i. e., r e w etti n g  dr o p s) t h at  c o nt ai n  c h e mi c al s  or 
pr e s er v ati v e s ( s u c h  a s  m er c ur y,  T hi m er o s al,  et c.) t o  w hi c h  s o m e  p e o pl e 
m a y  d e v el o p  a n  all er gi c r e s p o n s e.
•    A n y  a cti v e  c or n e al i nf e cti o n ( b a ct eri al, f u n g al,  pr ot o z o al,  or  vir al).
•   If  e y e s  b e c o m e r e d  or irrit at e d.
W A R NI N G S
P ati e nt s  s h o ul d  b e  a d vi s e d  of t h e f oll o wi n g  w ar ni n g s  p ert ai ni n g t o 
c o nt a ct l e n s  w e ar:
E Y E  P R O B L E M S, I N C L U DI N G  C O R N E A L  U L C E R S,  C A N  D E V E L O P 
R A PI D L Y  A N D  L E A D  T O  L O S S  O F  VI SI O N. I F  T H E  P A TI E N T 
E X P E RI E N C E S:
•   E y e  Di s c o mf ort,
•   E x c e s si v e  T e ari n g,
•   Vi si o n  C h a n g e s,
•   L o s s  of  Vi si o n,
•    E y e  R e d n e s s,  or
•    Ot h er  E y e  Pr o bl e m s,
T H E  P A TI E N T  S H O U L D  B E I N S T R U C T E D  T O I M M E DI A T E L Y 
R E M O V E  T H E  L E N S E S  A N D  P R O M P T L Y  C O N T A C T  T H E  E Y E  C A R E 
P R O F E S SI O N A L.
•    W h e n  pr e s cri b e d f or  d ail y  w e ar,  p ati e nt s  s h o ul d  b e i n str u ct e d  n ot t o  w e ar 
t h eir l e n s e s  w hil e  sl e e pi n g.  Cli ni c al  st u di e s  h a v e  s h o w n t h at  w h e n l e n s e s 
ar e  w or n  o v er ni g ht, t h e ri s k  of  ul c er ati v e  k er atiti s i s  gr e at er t h a n  a m o n g 
t h o s e  w h o  d o  n ot  w e ar t h e m  o v er ni g ht.3
•    St u di e s  h a v e  s h o w n t h at  c o nt a ct l e n s  w e ar er s  w h o  ar e  s m o k er s  h a v e  a 
hi g h er i n ci d e n c e  of  a d v er s e r e a cti o n s t h a n  n o n s m o k er s.
•    Pr o bl e m s  wit h  c o nt a ct l e n s e s  or l e n s  c ar e  pr o d u ct s  c o ul d r e s ult i n 
s eri o u s i nj ur y t o t h e  e y e.  P ati e nt s  s h o ul d  b e  c a uti o n e d t h at  pr o p er  u s e 
a n d  c ar e  of  c o nt a ct l e n s e s  a n d l e n s  c ar e  pr o d u ct s  ar e  e s s e nti al f or t h e 
s af e  u s e  of t h e s e  pr o d u ct s.
7

•   T h e  o v er all ri s k  of  ul c er ati v e  k er atiti s  m a y  b e r e d u c e d  b y  c ar ef ull y 
f oll o wi n g  dir e cti o n s f or l e n s  c ar e.
3 N e w  E n gl a n d  J o ur n al  of  M e di ci n e,  S e pt e m b er  2 1,  1 9 8 9;  3 2 1 ( 1 2),  p p.  7 7 3- 7 8 3
S p e ci ﬁ  c I n str u cti o n s f or  U s e  a n d  W ar ni n g s:
•   W at er  A cti vit y
I n str u cti o n f or  U s e
D o  n ot  e x p o s e  c o nt a ct l e n s e s t o  w at er  w hil e  w e ari n g t h e m.
W A R NI N G:
W at er  c a n  h ar b or  mi cr o or g a ni s m s t h at  c a n l e a d t o  s e v er e i nf e cti o n, 
vi si o n l o s s,  or  bli n d n e s s. If l e n s e s  h a v e  b e e n  s u b m er s e d i n  w at er  w h e n 
p arti ci p ati n g i n  w at er  s p ort s  or  s wi m mi n g i n  p o ol s,  h ot t u b s, l a k e s,  or 
o c e a n s, t h e  p ati e nt  s h o ul d  b e i n str u ct e d t o  di s c ar d t h e m  a n d r e pl a c e 
t h e m  wit h  a  n e w  p air.  T h e  E y e  C ar e  Pr of e s si o n al  s h o ul d  b e  c o n s ult e d f or 
r e c o m m e n d ati o n s r e g ar di n g  w e ari n g l e n s e s  d uri n g  a n y  a cti vit y i n v ol vi n g 
w at er.
P R E C A U TI O N S
S p e ci al  Pr e c a uti o n s f or  E y e  C ar e  Pr of e s si o n al s:
•    D u e t o t h e  s m all  n u m b er  of  p ati e nt s  e nr oll e d i n  cli ni c al i n v e sti g ati o n  of 
l e n s e s,  all r efr a cti v e  p o w er s,  d e si g n  c o n ﬁ  g ur ati o n s,  or l e n s  p ar a m et er s 
a v ail a bl e i n t h e l e n s  m at eri al  ar e  n ot  e v al u at e d i n  si g ni ﬁ  c a nt  n u m b er s. 
C o n s e q u e ntl y,  w h e n  s el e cti n g  a n  a p pr o pri at e l e n s  d e si g n  a n d 
p ar a m et er s, t h e  E y e  C ar e  Pr of e s si o n al  s h o ul d  c o n si d er  all  c h ar a ct eri sti c s 
of t h e l e n s t h at  c a n  aff e ct l e n s  p erf or m a n c e  a n d  o c ul ar  h e alt h, i n cl u di n g 
o x y g e n  p er m e a bilit y,  w ett a bilit y,  c e ntr al  a n d  p eri p h er al t hi c k n e s s,  a n d 
o pti c  z o n e  di a m et er.
T h e  p ot e nti al i m p a ct  of t h e s e f a ct or s  o n t h e  p ati e nt’s  o c ul ar  h e alt h 
s h o ul d  b e  c ar ef ull y  w ei g h e d  a g ai n st t h e  p ati e nt’s  n e e d f or r efr a cti v e 
c orr e cti o n; t h er ef or e, t h e  c o nti n ui n g  o c ul ar  h e alt h  of t h e  p ati e nt  a n d l e n s 
p erf or m a n c e  o n t h e  e y e  s h o ul d  b e  c ar ef ull y  m o nit or e d  b y t h e  pr e s cri bi n g 
E y e  C ar e  Pr of e s si o n al.
•    P ati e nt s  w h o  w e ar t h e s e l e n s e s t o  c orr e ct  pr e s b y o pi a  u si n g  m o n o vi si o n 
( or  m o di ﬁ  e d  m o n o vi si o n  u si n g  1- D A Y  A C U V U E®   M OI S T  Br a n d 
M U L TI F O C A L)  m a y  n ot  a c hi e v e t h e  b e st  c orr e ct e d  vi s u al  a c uit y f or  eit h er 
f ar  or  n e ar  vi si o n.  Vi s u al r e q uir e m e nt s  v ar y  wit h t h e i n di vi d u al  a n d  s h o ul d 
b e  c o n si d er e d  w h e n  s el e cti n g t h e  m o st  a p pr o pri at e t y p e  of l e n s f or  e a c h 
p ati e nt.
8

•   Fl u or e s c ei n,  a  y ell o w  d y e,  s h o ul d  n ot  b e  u s e d  w hil e t h e l e n s e s  ar e  o n 
t h e  e y e s.  T h e l e n s e s  a b s or b t hi s  d y e  a n d  b e c o m e  di s c ol or e d.  W h e n e v er 
ﬂ  u or e s c ei n i s  u s e d i n  e y e s, t h e  e y e s  s h o ul d  b e  ﬂ  u s h e d  wit h  a  st eril e 
s ali n e  s ol uti o n t h at i s r e c o m m e n d e d f or i n- e y e  u s e.
•   E y e  C ar e  Pr of e s si o n al s  s h o ul d i n str u ct t h e  p ati e nt t o r e m o v e l e n s e s 
i m m e di at el y if t h e  e y e s  b e c o m e r e d  or irrit at e d. 
E y e  C ar e  Pr of e s si o n al s  s h o ul d  c ar ef ull y i n str u ct  p ati e nt s  a b o ut t h e 
f oll o wi n g  c ar e r e gi m e n  a n d  s af et y  pr e c a uti o n s.
H a n dli n g  Pr e c a uti o n s:
•    B ef or e l e a vi n g t h e  E y e  C ar e  Pr of e s si o n al’s  of ﬁ  c e, t h e  p ati e nt  s h o ul d 
b e  a bl e t o  pr o m ptl y r e m o v e t h e l e n s e s  or  s h o ul d  h a v e  s o m e o n e  el s e 
a v ail a bl e  w h o  c a n r e m o v e t h e l e n s e s f or  hi m  or  h er.
•    D O  N O T  u s e if t h e  st eril e  bli st er  p a c k a g e i s  o p e n e d  or  d a m a g e d.
•    Al w a y s  w a s h  a n d ri n s e  h a n d s  b ef or e  h a n dli n g l e n s e s.  D o  n ot  g et 
c o s m eti c s, l oti o n s,  s o a p s,  cr e a m s,  d e o d or a nt s,  or  s pr a y s i n t h e  e y e s  or 
o n t h e l e n s e s. It i s  b e st t o  p ut  o n l e n s e s  b ef or e  p utti n g  o n  m a k e u p.
•    D O  N O T t o u c h  c o nt a ct l e n s e s  wit h t h e  ﬁ  n g er s  or  h a n d s if t h e  h a n d s  ar e 
n ot fr e e  of f or ei g n  m at eri al s,  a s  mi cr o s c o pi c  s cr at c h e s  of t h e l e n s e s  m a y 
o c c ur,  c a u si n g  di st ort e d  vi si o n  a n d/ or i nj ur y t o t h e  e y e.
•    C ar ef ull y f oll o w t h e  h a n dli n g, i n s erti o n, r e m o v al,  a n d  w e ari n g i n str u cti o n s 
i n t h e  P ati e nt I n str u cti o n  G ui d e f or t h e s e l e n s e s  a n d t h o s e  pr e s cri b e d  b y 
t h e  E y e  C ar e  Pr of e s si o n al.
•    Al w a y s  h a n dl e l e n s e s  c ar ef ull y  a n d  a v oi d  dr o p pi n g t h e m.
•    N e v er  u s e t w e e z er s  or  ot h er t o ol s t o r e m o v e l e n s e s fr o m t h e l e n s 
c o nt ai n er.  Sli d e t h e l e n s  u p t h e  si d e  of t h e  b o wl  u ntil it i s fr e e  of t h e 
c o nt ai n er.
•    D o  n ot t o u c h t h e l e n s  wit h  ﬁ  n g er n ail s.
L e n s  W e ari n g  Pr e c a uti o n s:
•   If t h e l e n s  sti c k s ( st o p s  m o vi n g)  o n t h e  e y e, f oll o w t h e r e c o m m e n d e d 
dir e cti o n s i n “ C ar e f or  Sti c ki n g ( N o n- M o vi n g)  L e n s e s.”  T h e l e n s  s h o ul d 
m o v e fr e el y  o n t h e  e y e f or t h e  c o nti n u e d  h e alt h  of t h e  e y e. If  n o n-
m o v e m e nt  of t h e l e n s  c o nti n u e s, t h e  p ati e nt  s h o ul d  b e i n str u ct e d t o 
i m m e di at el y  c o n s ult  hi s  or  h er  E y e  C ar e  Pr of e s si o n al.
•    N e v er  w e ar l e n s e s  b e y o n d t h e  p eri o d r e c o m m e n d e d  b y t h e  E y e  C ar e 
Pr of e s si o n al.
9

•   T h e  p ati e nt  s h o ul d  b e  a d vi s e d t o  n e v er  all o w  a n y o n e  el s e t o  w e ar t h eir 
l e n s e s.  T h e y  h a v e  b e e n  pr e s cri b e d t o  ﬁ t t h eir  e y e s  a n d t o  c orr e ct t h eir 
vi si o n t o t h e  d e gr e e  n e c e s s ar y.  S h ari n g l e n s e s  gr e atl y i n cr e a s e s t h e 
c h a n c e  of  e y e i nf e cti o n s.
•   If  a er o s ol  pr o d u ct s,  s u c h  a s  h air s pr a y,  ar e  u s e d  w hil e  w e ari n g l e n s e s, 
e x er ci s e  c a uti o n  a n d  k e e p  e y e s  cl o s e d  u ntil t h e  s pr a y  h a s  s ettl e d.
•    A v oi d  all  h ar mf ul  or irrit ati n g  v a p or s  a n d f u m e s  w hil e  w e ari n g l e n s e s.
L e n s  C ar e  Pr e c a uti o n s:
•   T h e  p ati e nt  s h o ul d  b e i nf or m e d t h at  n o  cl e a ni n g  or  di si nf e cti o n i s  n e e d e d 
w h e n l e n s e s  ar e  w or n f or  d ail y  di s p o s a bl e  w e ar.  P ati e nt s  s h o ul d  al w a y s 
di s p o s e  of l e n s e s  w h e n r e m o v e d  a n d  h a v e  s p ar e l e n s e s  or  s p e ct a cl e s 
a v ail a bl e.
Ot h er  T o pi c s t o  Di s c u s s  wit h  P ati e nt s:
•    Al w a y s  c o nt a ct t h e  E y e  C ar e  Pr of e s si o n al  b ef or e  u si n g  a n y  m e di ci n e i n 
t h e  e y e s.
•    C ert ai n  m e di c ati o n s,  s u c h  a s  a nti hi st a mi n e s,  d e c o n g e st a nt s,  di ur eti c s, 
m u s cl e r el a x a nt s, tr a n q uili z er s,  a n d t h o s e f or  m oti o n  si c k n e s s  m a y  c a u s e 
dr y n e s s  of t h e  e y e, i n cr e a s e d l e n s  a w ar e n e s s,  or  bl urr e d  vi si o n.  S h o ul d 
s u c h  c o n diti o n s  e xi st,  pr o p er r e m e di al  m e a s ur e s  s h o ul d  b e  pr e s cri b e d. 
•    Or al  c o ntr a c e pti v e  u s er s  c o ul d  d e v el o p  vi s u al  c h a n g e s  or  c h a n g e s i n 
l e n s t ol er a n c e  w h e n  u si n g  c o nt a ct l e n s e s.  P ati e nt s  s h o ul d  b e  c a uti o n e d 
a c c or di n gl y.
•    A s  wit h  a n y  c o nt a ct l e n s, f oll o w- u p  vi sit s  ar e  n e c e s s ar y t o  a s s ur e t h e 
c o nti n ui n g  h e alt h  of t h e  p ati e nt’s  e y e s.  T h e  p ati e nt  s h o ul d  b e i n str u ct e d 
a s t o  a r e c o m m e n d e d f oll o w- u p  s c h e d ul e.
W h o  S h o ul d  K n o w  T h at t h e  P ati e nt i s  W e ari n g  C o nt a ct  L e n s e s ?
•    P ati e nt s  s h o ul d i nf or m  all  d o ct or s ( H e alt h  C ar e  Pr of e s si o n al s)  a b o ut 
b ei n g  a  c o nt a ct l e n s  w e ar er.
•    P ati e nt s  s h o ul d  al w a y s i nf or m t h eir  e m pl o y er  of  b ei n g  a  c o nt a ct l e n s 
w e ar er.  S o m e j o b s  m a y r e q uir e  u s e  of  e y e  pr ot e cti o n  e q ui p m e nt  or  m a y 
r e q uir e t h at t h e  p ati e nt  n ot  w e ar  c o nt a ct l e n s e s.
1 0

A D V E R S E  R E A C TI O N S
T h e  p ati e nt  s h o ul d  b e i nf or m e d t h at t h e f oll o wi n g  pr o bl e m s  m a y  o c c ur 
w h e n  w e ari n g  c o nt a ct l e n s e s:
•   T h e  e y e  m a y  b ur n,  sti n g,  a n d/ or it c h.
•   T h er e  m a y  b e l e s s  c o mf ort t h a n  w h e n t h e l e n s  w a s  ﬁ r st  pl a c e d  o n t h e 
e y e.
•   T h er e  m a y  b e  a f e eli n g  of  s o m et hi n g i n t h e  e y e (f or ei g n  b o d y,  s cr at c h e d 
ar e a).
•   T h er e  m a y  b e t h e  p ot e nti al f or  s o m e t e m p or ar y i m p air m e nt  d u e t o 
p eri p h er al i n ﬁ ltr at e s,  p eri p h er al  c or n e al  ul c er s,  or  c or n e al  er o si o n.  T h er e 
m a y  b e t h e  p ot e nti al f or  ot h er  p h y si ol o gi c al  o b s er v ati o n s,  s u c h  a s l o c al 
or  g e n er ali z e d  e d e m a,  c or n e al  n e o v a s c ul ari z ati o n,  c or n e al  st ai ni n g, 
i nj e cti o n, t ar s al  a b n or m aliti e s, iriti s,  a n d  c o nj u n cti viti s,  s o m e  of  w hi c h  ar e 
cli ni c all y  a c c e pt a bl e i n l o w  a m o u nt s.
•   T h er e  m a y  b e  e x c e s si v e  w at eri n g,  u n u s u al  e y e  s e cr eti o n s,  or r e d n e s s 
of t h e  e y e.
•    P o or  vi s u al  a c uit y,  bl urr e d  vi si o n, r ai n b o w s  or  h al o s  ar o u n d  o bj e ct s, 
p h ot o p h o bi a,  or  dr y  e y e s  m a y  al s o  o c c ur if t h e l e n s e s  ar e  w or n 
c o nti n u o u sl y  or f or t o o l o n g  a ti m e.
T h e  p ati e nt  s h o ul d  b e i n str u ct e d t o  c o n d u ct  a  si m pl e  3- p art  s elf- e x a mi n ati o n  at 
l e a st  o n c e  a  d a y.  T h e y  s h o ul d  a s k t h e m s el v e s:
•    H o w  d o t h e l e n s e s f e el  o n  m y  e y e s ?
•    H o w  d o  m y  e y e s l o o k ?
•    H a v e I  n oti c e d  a  c h a n g e i n  m y  vi si o n ? 
If t h e  p ati e nt r e p ort s  a n y  pr o bl e m s,  h e  or  s h e  s h o ul d  b e i n str u ct e d t o 
I M M E DI A T E L Y  R E M O V E  T H E  L E N S. If t h e  pr o bl e m  or  di s c o mf ort  st o p s, t h e 
p ati e nt  s h o ul d  di s c ar d t h e l e n s  a n d  pl a c e  a  n e w fr e s h l e n s  o n t h e  e y e.
If  aft er i n s erti n g t h e  n e w l e n s, t h e  pr o bl e m  c o nti n u e s, t h e  p ati e nt  s h o ul d  b e 
dir e ct e d t o I M M E DI A T E L Y  R E M O V E  T H E  L E N S  A N D  C O N T A C T  HI S  O R  H E R 
E Y E  C A R E  P R O F E S SI O N A L.
T h e  p ati e nt  s h o ul d  b e  a d vi s e d t h at  w h e n  a n y  of t h e  a b o v e  s y m pt o m s  o c c ur, 
a  s eri o u s  c o n diti o n  s u c h  a s i nf e cti o n,  c or n e al  ul c er,  n e o v a s c ul ari z ati o n,  or iriti s 
m a y  b e  pr e s e nt.  H e  or  s h e  s h o ul d  b e i n str u ct e d t o  s e e k i m m e di at e  pr of e s si o n al 
i d e nti ﬁ  c ati o n  of t h e  pr o bl e m  a n d  pr o m pt tr e at m e nt t o  a v oi d  s eri o u s  e y e  d a m a g e.
1 1

G E N E R A L  FI T TI N G  G UI D E LI N E S
A.   P ati e nt  S el e cti o n
P ati e nt s  s el e ct e d t o  w e ar t h e s e l e n s e s  s h o ul d  b e  c h o s e n  b a s e d  o n: 
•  M oti v ati o n t o  w e ar l e n s e s 
•  A bilit y t o f oll o w i n str u cti o n s r e g ar di n g l e n s  w e ar
•  G e n er al  h e alt h 
•  A bilit y t o  a d e q u at el y  h a n dl e  a n d  c ar e f or t h e l e n s e s 
•  A bilit y t o  u n d er st a n d t h e ri s k s  a n d  b e n e ﬁ t s  of l e n s  w e ar
P ati e nt s  w h o  d o  n ot  m e et t h e  a b o v e  crit eri a  s h o ul d  n ot  b e  pr o vi d e d  wit h  c o nt a ct 
l e n s e s. 
B.   Pr e- ﬁ tti n g  E x a mi n ati o n
I niti al  e v al u ati o n  of t h e  p ati e nt  s h o ul d  b e gi n  wit h  a t h or o u g h  c a s e  hi st or y 
t o  d et er mi n e if t h er e  ar e  a n y  c o ntr ai n di c ati o n s t o  c o nt a ct l e n s  w e ar.  D uri n g 
t h e  c a s e  hi st or y, t h e  p ati e nt’s  vi s u al  n e e d s  a n d  e x p e ct ati o n s  s h o ul d  b e 
d et er mi n e d  a s  w ell  a s  a n  a s s e s s m e nt  of t h eir  o v er all  o c ul ar,  p h y si c al,  a n d 
m e nt al  h e alt h. 
Pr e c e di n g t h e i niti al  s el e cti o n  of tri al  c o nt a ct l e n s e s,  a  c o m pr e h e n si v e  o c ul ar 
e v al u ati o n  s h o ul d  b e  p erf or m e d t h at i n cl u d e s,  b ut i s  n ot li mit e d t o, t h e 
m e a s ur e m e nt  of  di st a n c e  a n d  n e ar  vi s u al  a c uit y,  di st a n c e  a n d  n e ar r efr a cti v e 
pr e s cri pti o n (i n cl u di n g  d et er mi ni n g t h e  pr ef err e d r e a di n g  di st a n c e f or 
pr e s b y o p e s),  k er at o m etr y,  a n d  bi o mi cr o s c o pi c  e v al u ati o n. 
B a s e d  o n t hi s  e v al u ati o n, if it i s  d et er mi n e d t h at t h e  p ati e nt i s  eli gi bl e t o  w e ar 
t h e s e l e n s e s, t h e  E y e  C ar e  Pr of e s si o n al  s h o ul d  pr o c e e d t o t h e l e n s  ﬁ tti n g 
i n str u cti o n s  a s  o utli n e d  b el o w. 
C.  I niti al  P o w er  D et er mi n ati o n
A  s p e ct a cl e r efr a cti o n  s h o ul d  b e  p erf or m e d t o  e st a bli s h t h e  p ati e nt’s  b a s eli n e 
r efr a cti v e  st at u s  a n d t o  g ui d e i n t h e  s el e cti o n  of t h e  a p pr o pri at e l e n s  p o w er. 
R e m e m b er t o  c o m p e n s at e f or  v ert e x  di st a n c e if t h e r efr a cti o n i s  gr e at er t h a n 
± 4. 0 0 D.
D.    B a s e  C ur v e  S el e cti o n ( Tri al  L e n s  Fitti n g)
T h e f oll o wi n g tri al l e n s e s  s h o ul d  b e  s el e ct e d f or  p ati e nt s r e g ar dl e s s  of 
k er at o m etr y r e a di n g s.  H o w e v er,  c or n e al  c ur v at ur e  m e a s ur e m e nt s  s h o ul d  b e 
p erf or m e d t o  e st a bli s h t h e  p ati e nt’s  b a s eli n e  o c ul ar  st at u s. 
1 2

• 
1- D A Y  A C U V U E ®   M OI S T:  8. 5  m m/ 1 4. 2  m m
• 
1- D A Y  A C U V U E ®   M OI S T f or  A S TI G M A TI S M:  8. 5  m m/ 1 4. 5  m m
• 
1- D A Y  A C U V U E ®   M OI S T  M U L TI F O C A L:  8. 4  m m/ 1 4. 3  m m
T h e tri al l e n s  s h o ul d  b e  pl a c e d  o n  e a c h  of t h e  p ati e nt’s  e y e s  a n d  e v al u at e d 
aft er t h e  p ati e nt  h a s  a dj u st e d t o t h e l e n s e s.
1.    Crit eri a  of  a  Pr o p erl y  Fit  L e n s
A  pr o p erl y  ﬁ t l e n s  will  c e nt er  a n d  c o m pl et el y  c o v er t h e  c or n e a (i. e.,  n o 
li m b al  e x p o s ur e),  h a v e  s uf ﬁ  ci e nt  m o v e m e nt t o  pr o vi d e t e ar  e x c h a n g e 
u n d er t h e  c o nt a ct l e n s  wit h t h e  bli n k,  a n d  b e  c o mf ort a bl e.  T h e l e n s 
s h o ul d  m o v e fr e el y  w h e n  m a ni p ul at e d  di git all y  wit h t h e l o w er li d,  a n d t h e n 
r et ur n t o it s  pr o p erl y  c e nt er e d  p o siti o n  w h e n r el e a s e d.
2.    Crit eri a  of  a  Fl at  Fitti n g  L e n s
A  ﬂ  at  ﬁ tti n g l e n s  m a y  e x hi bit  o n e  or  m or e  of t h e f oll o wi n g  c h ar a ct eri sti c s: 
d e c e ntr ati o n, i n c o m pl et e  c or n e al  c o v er a g e (i. e., li m b al  e x p o s ur e), 
e x c e s si v e  m o v e m e nt  wit h t h e  bli n k  a n d/ or  e d g e  st a n d off. If t h e l e n s i s 
j u d g e d t o  b e  ﬂ  at  ﬁ tti n g, it  s h o ul d  n ot  b e  di s p e n s e d t o t h e  p ati e nt.
3.    Crit eri a  of  a  St e e p  Fitti n g  L e n s
A  st e e p  ﬁ tti n g l e n s  m a y  e x hi bit  o n e  or  m or e  of t h e f oll o wi n g 
c h ar a ct eri sti c s: i n s uf ﬁ  ci e nt  m o v e m e nt  wit h t h e  bli n k,  c o nj u n cti v al 
i n d e nt ati o n,  a n d r e si st a n c e  w h e n  p u s hi n g t h e l e n s  u p  di git all y  wit h 
t h e l o w er li d. If t h e l e n s i s j u d g e d t o  b e  st e e p  ﬁ tti n g, it  s h o ul d  n ot  b e 
di s p e n s e d t o t h e  p ati e nt.
If t h e i niti al tri al  b a s e  c ur v e i s j u d g e d t o  b e  ﬂ  at  or  st e e p  ﬁ tti n g, t h e  alt er n at e 
b a s e  c ur v e, if  a v ail a bl e,  s h o ul d  b e tri al  ﬁ t  a n d  e v al u at e d  aft er t h e  p ati e nt  h a s 
a dj u st e d t o t h e l e n s.  T h e l e n s  s h o ul d  m o v e fr e el y  w h e n  m a ni p ul at e d  di git all y 
wit h t h e l o w er li d,  a n d t h e n r et ur n t o  a  pr o p erl y  c e nt er e d  p o siti o n  w h e n 
r el e a s e d. If r e si st a n c e i s  e n c o u nt er e d  w h e n  p u s hi n g t h e l e n s  u p, t h e l e n s i s 
ﬁ tti n g ti g htl y  a n d  s h o ul d  n ot  b e  di s p e n s e d t o t h e  p ati e nt.
E.   Fi n al  L e n s  P o w er ( S p h eri c al)
A  s p h eri c al  o v er-r efr a cti o n  s h o ul d  b e  p erf or m e d t o  d et er mi n e t h e  ﬁ  n al l e n s 
p o w er  aft er t h e l e n s  ﬁ t i s j u d g e d  a c c e pt a bl e.  T h e  s p h eri c al  o v er-r efr a cti o n 
s h o ul d  b e  c o m bi n e d  wit h t h e tri al l e n s  p o w er t o  d et er mi n e t h e  ﬁ  n al l e n s 
pr e s cri pti o n.  T h e  p ati e nt  s h o ul d  e x p eri e n c e  g o o d  vi s u al  a c uit y  wit h t h e 
c orr e ct l e n s  p o w er  u nl e s s t h er e i s  e x c e s si v e r e si d u al  a sti g m ati s m.
1 3

E x a m pl e  1
Di a g n o sti c l e n s: 
- 2. 0 0 D
S p h eri c al  o v er-r efr a cti o n:  
- 0. 2 5 D
Fi n al l e n s  p o w er:  
- 2. 2 5 D
E x a m pl e  2
Di a g n o sti c l e n s: 
- 2. 0 0 D
S p h eri c al  o v er-r efr a cti o n:  
+ 0. 2 5 D
Fi n al l e n s  p o w er:  
- 1. 7 5 D
If  vi si o n i s  a c c e pt a bl e,  p erf or m  a  slit l a m p  e x a mi n ati o n t o  a s s e s s  a d e q u at e  ﬁ t 
( c e ntr ati o n  a n d  m o v e m e nt). If t h e  ﬁ t i s  a c c e pt a bl e,  di s p e n s e t h e l e n s e s  a n d 
i n str u ct t h e  p ati e nt t o r et ur n i n  o n e  w e e k f or r e a s s e s s m e nt ( s e e P A TI E N T 
M A N A G E M E N T   s e cti o n).
All  p ati e nt s  s h o ul d  b e  s u p pli e d  wit h  a  c o p y  of t h e  P A TI E N T 
I N S T R U C TI O N  G UI D E f or t h e s e l e n s e s.  C o pi e s  ar e  a v ail a bl e f or 
d o w nl o a d  at  w w w. a c u v u e. c o m.
Alt h o u g h  m o st  a s p e ct s  of t h e  ﬁ tti n g  pr o c e d ur e  ar e i d e nti c al f or  all t y p e s  of  s oft 
c o nt a ct l e n s e s, i n cl u di n g t ori c l e n s e s, t h er e  ar e  s o m e  a d diti o n al  st e p s  a n d/ or 
r ul e s t o f oll o w t o  a s s ur e t h e  pr o p er  ﬁ t  of t ori c l e n s e s. 
T h e  o nl y  n e w  st e p s  y o u  m u st f oll o w i n  pr e s cri bi n g  1- D A Y  A C U V U E ®   M OI S T 
f or  A S TI G M A TI S M  ar e t h at  y o u  m u st  d et er mi n e t h e  st a bilit y, r e p e at a bilit y,  a n d 
drift  a n gl e  of t h e l e n s  a xi s  s o t h at  y o u  c a n  pr e s cri b e t h e  c orr e ct l e n s  a xi s f or t h e 
p ati e nt. 
A.  H o w t o  D et er mi n e  L e n s  C yli n d er  a n d  A xi s  Ori e nt ati o n
1.   L o c at e t h e  Ori e nt ati o n  M ar k s 
T o  h el p  d et er mi n e t h e  pr o p er  ori e nt ati o n  of t h e t ori c l e n s,  y o u’ll  ﬁ  n d t w o 
pri m ar y  m ar k s  a p pr o xi m at el y  1  m m fr o m t h e l e n s  e d g e r e pr e s e nti n g t h e 
v erti c al  p o siti o n  o n  o p p o sit e  e n d s  of t h e l e n s  at  6  a n d  1 2  o’ cl o c k ( Fi g.  1). 
B e c a u s e  of t h e l e n s’  b all a sti n g  s y st e m,  eit h er  m ar k  c a n r e pr e s e nt t h e  v er-
ti c al  p o siti o n  – t h er e i s  n o “t o p”  a n d “ b ott o m”  a s i n  a  pri s m- b all a st e d l e n s. 
Y o u  d o n’t  n e e d t o  vi e w  b ot h  m ar k s t o  a s s e s s  ori e nt ati o n;  si m pl y l o o k f or t h e 
6  o’ cl o c k  m ar k  a s  y o u  w o ul d  wit h  a  pri s m- b all a st e d l e n s.
T O RI C  FI T TI N G  G UI D E LI N E S
1 4

     Fi g ur e  1
Y o u’ll  n e e d  a  slit l a m p  bi o mi cr o s c o p e  wit h  a  1 t o  2  m m  p ar all el e pi p e d 
b e a m t o  hi g hli g ht t h e  m ar k s  w h e n t h e l e n s i s  ﬁ tt e d t o t h e  e y e.  T h er e  ar e  a 
n u m b er  of t e c h ni q u e s  y o u  c a n  u s e t o i m pr o v e t h e  vi si bilit y  of t h e  6  o’ cl o c k 
m ar k.  U si n g  a  p ar all el e pi p e d  b e a m  a n d  m e di u m  m a g ni ﬁ  c ati o n ( 1 0 x  or  1 5 x), 
sl o wl y  p a n  d o w n t h e l e n s, l o o ki n g j u st  b el o w t h e  dir e ct ill u mi n ati o n  at t h e 
r etr oill u mi n at e d  ar e a.  B a c kli g hti n g t h e  m ar k t hi s  w a y  s h o ul d  m a k e it  m or e 
vi si bl e.  S o m eti m e s  m a ni p ul ati n g t h e l o w er li d  m a y  b e  n e c e s s ar y t o  u n c o v er 
t h e  m ar k.
2.   O b s er v e  L e n s  R ot ati o n  a n d  St a bilit y 
O b s er v e t h e  p o siti o n  a n d  st a bilit y  of t h e “ b ott o m”  m ar k. It  u s u all y  st a bili z e s 
at t h e  6  o’ cl o c k  p o siti o n. If it  d o e s,  c al c ul ati o n  of t h e l e n s  p o w er  will  b e 
str ai g htf or w ar d.  T h e  6  o’ cl o c k  p o siti o n i s  n ot  a “ m u st”;  h o w e v er, t h e 
a b s ol ut e r e q uir e m e nt i s t h at t h e  a xi s  p o siti o n  b e  st a bl e  a n d r e p e at a bl e. 
T h e  m ar k  m a y  st a bili z e  s o m e w h at l eft  or ri g ht ( drift)  of t h e  v erti c al  m eri di a n 
a n d  still  e n a bl e  y o u t o  ﬁ t  a t ori c l e n s f or t h at  e y e,  a s l o n g  a s t h e l e n s  al w a y s 
r et ur n s t o t h e  s a m e “ drift  a xi s”  p o siti o n  aft er  s ettli n g.  T h e  d e vi ati o n  c a n 
b e  c o m p e n s at e d f or i n t h e  ﬁ  n al  pr e s cri pti o n.  Y o ur  o bj e cti v e i s t o  e n s ur e 
t h at  w h at e v er  p o siti o n t h e i niti al l e n s  a s s u m e s  n e ar  6  o’ cl o c k, t hi s  p o siti o n 
m u st  b e  st a bl e  a n d r e p e at a bl e.  Wit h f ull  e y e  m o v e m e nt  or  h e a v y  bli n k,  y o u 
m a y  s e e t h e  m ar k s  s wi n g  a w a y,  b ut t h e y  m u st r et ur n  q ui c kl y t o t h e  ori gi n al 
st a bl e  p o siti o n. If t h e l e n s  d o e s  n ot r et ur n  q ui c kl y,  y o u  m a y  n e e d t o  s el e ct 
a  diff er e nt l e n s. 
3.   A s s e s si n g  R ot ati o n 
I m a gi n e t h e  e y e  a s  a  cl o c k  di al  a n d  e v er y  h o ur r e pr e s e nt s  a  3 0° i nt er v al. If 
t h e  ori e nt ati o n  m ar k  of t h e i niti al l e n s  st a bili z e s  s o m e w h at l eft  or ri g ht  of t h e 
v erti c al  p o siti o n, t h e  ﬁ  n al l e n s  will  ori e nt  o n t h e  e y e  wit h t h e  s a m e  d e vi ati o n. 
Y o u  c a n  u s e  a n  a xi s r eti c ul e i n t h e  slit l a m p  or  u s e  a li n e- s cri b e d l e n s i n  a 
s p e ct a cl e tri al fr a m e t o  m e a s ur e  or  e sti m at e t h e “ drift  a n gl e”  of t h e  c yli n d er 
a xi s. 
T o  c o m p e n s at e f or t hi s “ drift,”  m e a s ur e  or  e sti m at e t h e “ drift,” t h e n  a d d 
or  s u btr a ct it fr o m t h e r efr a cti v e  a xi s t o  d et er mi n e t h e  c orr e ct  c yli n d er 
a xi s.  U s e t h e  L A R S ( L eft  A d d,  Ri g ht  S u btr a ct)  m et h o d t o  d et er mi n e  w hi c h 
dir e cti o n t o  c o m p e n s at e.
   
1 5

B.  Fi n al  L e n s  P o w er
W h e n t h e  di a g n o sti c l e n s  h a s it s  a xi s  ali g n e d i n t h e  s a m e  m eri di a n  a s t h e 
p ati e nt’s r efr a cti v e  a xi s,  a  s p h er o c yli n dri c al  o v er-r efr a cti o n  m a y  b e  p erf or m e d 
a n d  vi s u al  a c uit y  d et er mi n e d.  H o w e v er, i n t h e  c a s e  of  cr o s s e d  a x e s,  s u c h  a s 
w h e n t h e  di a g n o sti c l e n s  a xi s i s  diff er e nt fr o m t h e  s p e ct a cl e  c yli n d er  a xi s, it i s 
n ot  a d vi s a bl e t o  p erf or m  a f ull  s p h er o c yli n dri c al  o v er-r efr a cti o n  b e c a u s e  of t h e 
dif ﬁ  c ult y i n  c o m p uti n g t h e r e s ult a nt  p o w er.  A  s p h eri c al  o v er-r efr a cti o n  wit h o ut 
c yli n d er r efr a cti o n  m a y  b e  p erf or m e d.
If t h e r e q uir e d  c yli n d er  c orr e cti o n f all s  b et w e e n t w o  a v ail a bl e  c yli n d er  p o w er s, 
it i s r e c o m m e n d e d t o  pr e s cri b e t h e l o w er  c yli n d er  p o w er l e n s.  S e e  b el o w f or 
i n str u cti o n s  o n  h o w t o  d et er mi n e t h e  ﬁ  n al l e n s  p o w er.
1.   F or t h e  S p h er e 
If  s p h er e  al o n e  or  c o m bi n e d  s p h er e  a n d  c yli n d er  R x  >  4. 0 0 D,  c o m p e n s at e 
f or  v ert e x  di st a n c e. If  s p h er e  al o n e  or  c o m bi n e d  s p h er e  a n d  c yli n d er 
R x  <  ± 4. 0 0 D,  v ert e x  c o m p e n s ati o n i s  n ot  n e c e s s ar y.
2.   F or t h e  C yli n d er
A dj u st t h e  a xi s  b y t h e  drift  a n gl e  u si n g t h e  L A R S  m et h o d.  C h o o s e  a  c yli n d er 
t h at i s  ≤  0. 5 0 D fr o m t h e r efr a cti v e  c yli n d er.
3.   C a s e  E x a m pl e s
E x a m pl e  1
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 2. 5 0 D / - 1. 2 5 D  x  1 8 0°  2 0/ 2 0
O. S. - 2. 0 0 D / - 1. 0 0 D  x  1 8 0°  2 0/ 2 0
C h o o s e  a  di a g n o sti c l e n s f or  e a c h  e y e  wit h  a xi s  1 8 0°.  Pl a c e t h e l e n s  o n 
e a c h  e y e  a n d  all o w  a  mi ni m u m  of  3  mi n ut e s f or it t o  e q uili br at e,  b a s e d  o n 
t h e  p ati e nt’s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s  h a s  n ot  y et  st a bili z e d, 
r e c h e c k  u ntil  st a bl e.
C h e c k t h e  ori e nt ati o n  of t h e  a xi s  m ar k. If t h e  b ott o m  a xi s  m ar k i s i n t h e  6 
o’ cl o c k  p o siti o n  o n  b ot h  e y e s,  c h o o s e t h e  a p pr o pri at e  c yli n d er  a s li st e d 
pr e vi o u sl y. If t h e l e n s  h a s  n ot  y et  st a bili z e d, r e c h e c k  u ntil  st a bl e.
H er e i s t h e  R x  pr e s cri b e d:
O. D. - 2. 5 0 D / - 1. 2 5 D  x  1 8 0°
O. S. - 2. 0 0 D / - 0. 7 5 D  x  1 8 0°
1 6

E x a m pl e  2
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 3. 0 0 D / - 1. 0 0 D  x  9 0°  2 0/ 2 0
O. S. - 4. 7 5 D / - 2. 0 0 D  x  9 0°  2 0/ 2 0
C h o o s e  di a g n o sti c l e n s e s  of - 3. 0 0 D / - 0. 7 5 D  x  9 0° f or t h e ri g ht  e y e  a n d 
- 4. 5 0 D / - 1. 7 5 D  x  9 0° f or t h e l eft  e y e, t h e  n e ar e st l e n s e s  a v ail a bl e t o t h e 
s p h eri c al  p o w er  a n d  a xi s  n e e d e d.  F or t h e l eft  e y e,  si n c e t h e  m a nif e st 
r efr a cti o n  c all e d f or - 4. 7 5 D,  c o m p e n s ati n g f or  v ert e x  di st a n c e t h e  s p h er e 
i s r e d u c e d  b y  0. 2 5 D t o - 4. 5 0 D.  T h e  c yli n d er  p o w er  will  b e - 1. 7 5 D.  Pl a c e 
t h e l e n s  o n  e a c h  e y e  a n d  all o w  a  mi ni m u m  of  3  mi n ut e s f or it t o  e q uili br at e, 
b a s e d  o n t h e  p ati e nt' s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s  h a s  n ot  y et 
st a bili z e d, r e c h e c k  u ntil  st a bl e.
Ri g ht  E y e
T h e  ori e nt ati o n  m ar k  o n t h e ri g ht l e n s r ot at e s l eft fr o m t h e  6  o’ cl o c k  p o siti o n 
b y  1 0°  a n d r e m ai n s  st a bl e i n t hi s  p o siti o n.  C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d  b e  d o n e  a s f oll o w s:
C o m p e n s at e t h e  1 0°  a xi s  drift  b y  a d di n g it t o t h e  m a nif e st r efr a cti o n  a xi s.
H er e i s t h e  R x  pr e s cri b e d:
O. D. - 3. 0 0 D / - 0. 7 5 D  x  1 0 0°
L eft  E y e
T h e  ori e nt ati o n  m ar k  o n t h e l eft l e n s r ot at e s ri g ht fr o m t h e  6  o’ cl o c k  p o siti o n 
b y  1 0°  a n d r e m ai n s  st a bl e i n t hi s  p o siti o n.  C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d  b e  d o n e  a s f oll o w s:
C o m p e n s at e f or t h e  1 0°  a xi s  drift  b y  s u btr a cti n g it fr o m t h e  m a nif e st 
r efr a cti o n  a xi s. 
H er e i s t h e  R x  pr e s cri b e d:
O. S. - 4. 5 0 D / - 1. 7 5 D  x  8 0° 
If  vi si o n i s  a c c e pt a bl e,  p erf or m  a  slit l a m p  e x a mi n ati o n t o  a s s e s s  a d e q u at e 
ﬁ t ( c e ntr ati o n  a n d  m o v e m e nt). If  ﬁ t i s  a c c e pt a bl e,  di s p e n s e t h e l e n s e s 
i n str u cti n g t h e  p ati e nt t o r et ur n i n  o n e  w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T  M A N A G E M E N T   s e cti o n).
All  p ati e nt s  s h o ul d  b e  s u p pli e d  wit h  a  c o p y  of t h e  P A TI E N T 
I N S T R U C TI O N  G UI D E f or t h e s e l e n s e s.  C o pi e s  ar e  a v ail a bl e f or 
d o w nl o a d  at  w w w. a c u v u e. c o m.
1 7

A.   Pr e s b y o pi c  N e e d s  A s s e s s m e nt  &  P ati e nt  E d u c ati o n
M ultif o c al  c o nt a ct l e n s e s  m a y  pr o d u c e  c o m pr o mi s e t o  vi si o n  u n d er  c ert ai n 
cir c u m st a n c e s  a n d t h e  p ati e nt  s h o ul d  u n d er st a n d t h at t h e y  mi g ht  n ot  ﬁ  n d 
t h eir  vi si o n  a c c e pt a bl e i n  s p e ci ﬁ  c  sit u ati o n s (i. e., r e a di n g  a  m e n u i n  a  di m 
r e st a ur a nt,  dri vi n g  at  ni g ht i n r ai n y/f o g g y  c o n diti o n s,  et c.).  T h er ef or e,  c a uti o n 
s h o ul d  b e  e x er ci s e d  w h e n t h e  p ati e nt i s  w e ari n g t h e  c orr e cti o n f or t h e  ﬁ r st 
ti m e  u ntil t h e y  ar e f a mili ar  wit h t h e  vi si o n  pr o vi d e d i n  vi s u all y  c h all e n gi n g 
e n vir o n m e nt s.  O c c u p ati o n al  a n d  e n vir o n m e nt al  vi s u al  d e m a n d s  s h o ul d 
b e  c o n si d er e d. If t h e  p ati e nt r e q uir e s  criti c al  vi s u al  a c uit y  a n d  st er e o p si s, it 
s h o ul d  b e  d et er mi n e d  b y tri al  w h et h er t hi s  p ati e nt  c a n f u n cti o n  a d e q u at el y 
wit h  1- D A Y  A C U V U E ®   M OI S T  M U L TI F O C A L.  W e ari n g t h e s e l e n s e s  m a y  n ot 
b e  o pti m al f or  a cti viti e s  s u c h  a s:
• 
Vi s u all y  d e m a n di n g  sit u ati o n s  s u c h  a s  o p er ati n g  p ot e nti all y  d a n g er o u s 
m a c hi n er y  or  p erf or mi n g  ot h er  p ot e nti all y  h a z ar d o u s  a cti viti e s;  a n d
• 
Dri vi n g  a ut o m o bil e s ( e. g.,  dri vi n g  at  ni g ht).  P ati e nt s  w h o  c a n n ot  m e et 
t h eir  st at e  dri v er’s li c e n s e r e q uir e m e nt s  wit h t h e  1- D A Y  A C U V U E®   M OI S T 
M U L TI F O C A L  s h o ul d  b e  a d vi s e d t o  n ot  dri v e  wit h t hi s  c orr e cti o n,  O R  m a y 
r e q uir e t h at  a d diti o n al  o v er- c orr e cti o n  b e  pr e s cri b e d.
1- D A Y  A C U V U E ®   M OI S T  M U L TI F O C A L i s  n ot r e c o m m e n d e d f or  p ati e nt s 
w h o  h a v e - 1. 0 0 D  or  gr e at er  of r efr a cti v e  c yli n d er  a s t hi s l e v el  of  u n c orr e ct e d 
c yli n d er  m a y l e a d t o  a d diti o n al  vi s u al  c o m pr o mi s e.  T h e s e l e n s e s  ar e  a v ail a bl e 
i n t h e f oll o wi n g  A D D  p o w er s: 
• 
L e n s “ L O W”  = l o w  n e ar  A D D l e n s ( M a x  A D D  + 1. 2 5) 
• 
L e n s “ MI D”  =  m e di u m  n e ar  A D D l e n s ( M a x  A D D  + 1. 7 5) 
• 
L e n s “ H G H”  =  hi g h  n e ar  A D D l e n s ( M a x  A D D  + 2. 5 0)
B.  I niti al  P o w er  D et er mi n ati o n
A  s p e ct a cl e r efr a cti o n  s h o ul d  b e  p erf or m e d t o  e st a bli s h t h e  p ati e nt’s  b a s eli n e 
r efr a cti v e  st at u s  a n d t o  g ui d e i n t h e  s el e cti o n  of t h e  a p pr o pri at e l e n s  p o w er. 
R e m e m b er t o  c o m p e n s at e f or  v ert e x  di st a n c e if t h e r efr a cti o n i s  gr e at er 
t h a n  ± 4. 0 0 D.  D et er mi n e t h e  s p h eri c al  e q ui v al e nt  di st a n c e  pr e s cri pti o n f or  a 
m ultif o c al  p ati e nt.  D et er mi n e t h e  e y e  d o mi n a n c e  u si n g  o n e  of t h e  m et h o d s 
b el o w:
M U L TI F O C A L  FI T TI N G  G UI D E LI N E S
1 8

M et h o d  1     D et er mi n e  w hi c h  e y e i s t h e “ si g hti n g  e y e.”  H a v e t h e  p ati e nt  p oi nt 
t o  a n  o bj e ct  at t h e f ar  e n d  of t h e r o o m.  C o v er  o n e  e y e. If t h e 
p ati e nt i s  still  p oi nti n g  dir e ctl y  at t h e  o bj e ct, t h e  e y e  b ei n g  u s e d i s 
t h e  d o mi n a nt ( si g hti n g)  e y e.
M et h o d  2     D et er mi n e  w hi c h  e y e  d o e s  n ot  a c c e pt  a d d e d  pl u s  p o w er.  Pl a c e  a 
+ 1. 0 0 D  h a n d- h el d tri al l e n s i n fr o nt  of  o n e  e y e  a n d t h e n t h e  ot h er 
w hil e t h e  di st a n c e r efr a cti v e  err or  c orr e cti o n i s i n  pl a c e f or  b ot h 
e y e s  w hil e t h e  p ati e nt i s  vi e wi n g t h e  di st a n c e  vi s u al  a c uit y  c h art. 
T h e  e y e  wit h t h e  pl u s  o v er it t h at t h e  p ati e nt  n oti c e s t h e  gr e at e st 
r e d u cti o n i n  vi si o n i s  d et er mi n e d t o  b e t h e  d o mi n a nt  e y e.
C.  S el e ct t h e I niti al  Tri al  L e n s 
1.   F or  e a c h  e y e,  s el e ct t h e tri al l e n s  di st a n c e  p o w er t h at i s  cl o s e st t o t h e 
p ati e nt’s  di st a n c e  s p h eri c al  e q ui v al e nt.  R e m e m b er t o  c o m p e n s at e f or 
v ert e x  di st a n c e if t h e r efr a cti o n i s  gr e at er t h a n  ± 4. 0 0 D.
2.   S el e ct t h e  n e ar  p o w er  of t h e l e n s  b a s e d  o n t h e  p ati e nt s  A D D r a n g e  a s 
f oll o w s: 
• 
A D D:  + 0. 7 5 D t o  + 1. 2 5 D  u s e  a l o w  n e ar  A D D ( L O W) l e n s  o n  e a c h  e y e 
• 
A D D:  + 1. 5 0 D t o  + 1. 7 5 D  u s e  a  m e di u m  n e ar  A D D ( MI D) l e n s  o n  e a c h 
e y e 
• 
A D D:  + 2. 0 0 D t o  + 2. 5 0 D  u s e  a  m e di u m  n e ar  A D D ( MI D)  o n t h e 
d o mi n a nt  e y e  a n d  a  hi g h  n e ar  A D D ( H G H) l e n s  o n t h e  n o n- d o mi n a nt 
e y e
3.   All o w t h e l e n s e s t o  s ettl e f or  a  mi ni m u m  of  1 0  mi n ut e s. 
4.   A s s e s s  di st a n c e  a n d  n e ar  vi si o n  bi n o c ul arl y  a n d  m o n o c ul arl y. 
5.   D e m o n str at e t h e  vi si o n  u n d er  v ari o u s li g hti n g  c o n diti o n s ( n or m al  a n d 
d e cr e a s e d ill u mi n ati o n)  a n d  at  di st a n c e, i nt er m e di at e,  a n d  n e ar. 
6.   M a k e  a dj u st m e nt s i n  p o w er  a s  n e c e s s ar y  b a s e d  o n t h e  di st a n c e  o v er-
r efr a cti o n.  T h e  u s e  of  h a n d- h el d tri al l e n s e s i s r e c o m m e n d e d.  C h e c k t h e 
i m p a ct  o n  di st a n c e  a n d  n e ar  vi si o n.
7. If  vi si o n i s  still  u n a c c e pt a bl e,  m a k e  a dj u st m e nt s i n  p o w er  a s  n e c e s s ar y 
( s e e " M ultif o c al  Tr o u bl e s h o oti n g"  b el o w). If  di st a n c e  a n d  n e ar  vi si o n 
ar e  a c c e pt a bl e,  p erf or m  a  slit l a m p  e x a mi n ati o n t o  a s s e s s  a d e q u at e 
ﬁ t ( c e ntr ati o n  a n d  m o v e m e nt). If  ﬁ t i s  a c c e pt a bl e,  di s p e n s e t h e l e n s e s 
i n str u cti n g t h e  p ati e nt t o r et ur n i n  o n e  w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T  M A N A G E M E N T   s e cti o n).
1 9

D.  M ultif o c al  Tr o u bl e s h o oti n g
U n a c c e pt a bl e  N e ar  Vi si o n
If it  h a s  b e e n  d et er mi n e d t h at  n o  c h a n g e i s r e q uir e d  b a s e d  o n t h e  o v er-
r efr a cti o n, t h e n  a d d  + 0. 2 5 D t o t h e  s p h eri c al  p o w er  of t h e  n o n- d o mi n a nt  e y e.
U n a c c e pt a bl e  Di st a n c e  Vi si o n
If it  h a s  b e e n  d et er mi n e d t h at  n o  c h a n g e i s r e q uir e d  b a s e d  o n t h e  o v er-
r efr a cti o n, t h e n  m a k e t h e  c h a n g e s  a s li st e d  b el o w:
• 
If t h e  p ati e nt i s  w e ari n g t w o " L O W"  A D D l e n s e s,  c h a n g e t h e  d o mi n a nt 
e y e t o  a  1- D A Y  A C U V U E ®   M OI S T  s p h er e l e n s  wit h  a  p o w er  e q u al t o t h e 
s p h eri c al  e q ui v al e nt  di st a n c e  pr e s cri pti o n.
• 
If t h e  p ati e nt i s  w e ari n g t w o " MI D"  A D D l e n s e s,  c h a n g e t h e  A D D  p o w er i n 
t h e  d o mi n a nt  e y e t o t h e " L O W"  A D D  p o w er.
• 
If t h e  p ati e nt i s  w e ari n g  a " MI D"  A D D l e n s i n t h e  d o mi n a nt  e y e  a n d  a 
" H G H"  A D D l e n s i n t h e  n o n- d o mi n a nt  e y e,  c h a n g e t h e  n o n- d o mi n a nt  e y e 
t o  a " MI D"  A D D l e n s  a n d  a d d  + 0. 2 5 D t o t h e  di st a n c e  p o w er.
E.  A d a pt ati o n
Vi s u all y  d e m a n di n g  sit u ati o n s  s h o ul d  b e  a v oi d e d  d uri n g t h e i niti al  w e ari n g 
p eri o d.  A  p ati e nt  m a y  at  ﬁ r st  e x p eri e n c e  s o m e  mil d  bl urr e d  vi si o n,  di z zi n e s s, 
h e a d a c h e s  a n d  a f e eli n g  of  sli g ht i m b al a n c e.  Y o u  s h o ul d  e x pl ai n t h e 
a d a pt ati o n al  s y m pt o m s t o t h e  p ati e nt.  T h e s e  s y m pt o m s  m a y l a st f or  a  bri ef 
mi n ut e  or f or  s e v er al  w e e k s.  T h e l o n g er t h e s e  s y m pt o m s  p er si st, t h e  p o or er 
t h e  pr o g n o si s f or  s u c c e s sf ul  a d a pt ati o n.
T o  h el p i n t h e  a d a pt ati o n  pr o c e s s, t h e  p ati e nt  c a n  b e  a d vi s e d t o  ﬁ r st  u s e t h e 
l e n s e s i n  a  c o mf ort a bl e, f a mili ar  e n vir o n m e nt  s u c h  a s i n t h e  h o m e.
S o m e  p ati e nt s f e el t h at  a ut o m o bil e  dri vi n g  p erf or m a n c e  m a y  n ot  b e  o pti m al 
d uri n g t h e  a d a pt ati o n  pr o c e s s.  T hi s i s  p arti c ul arl y tr u e  w h e n  dri vi n g  at  ni g ht. 
B ef or e  dri vi n g  a  m ot or  v e hi cl e, it  m a y  b e r e c o m m e n d e d t h at t h e  p ati e nt  b e 
a  p a s s e n g er  ﬁ r st t o  m a k e  s ur e t h at t h eir  vi si o n i s  s ati sf a ct or y f or  o p er ati n g 
a n  a ut o m o bil e.  D uri n g t h e  ﬁ r st  s e v er al  w e e k s  of  w e ar ( w h e n  a d a pt ati o n i s 
o c c urri n g), it  m a y  b e  a d vi s a bl e f or t h e  p ati e nt t o  o nl y  dri v e  d uri n g  o pti m al 
dri vi n g  c o n diti o n s.  Aft er  a d a pt ati o n  a n d  s u c c e s s  wit h t h e s e  a cti viti e s, t h e 
p ati e nt  s h o ul d  b e  a bl e t o  dri v e  u n d er  ot h er  c o n diti o n s  wit h  c a uti o n.
All  p ati e nt s  s h o ul d  b e  s u p pli e d  wit h  a  c o p y  of t h e  P A TI E N T 
I N S T R U C TI O N  G UI D E f or t h e s e l e n s e s.  C o pi e s  ar e  a v ail a bl e f or 
d o w nl o a d  at  w w w. a c u v u e. c o m.
2 0

A.  P ati e nt  S el e cti o n
1.  M o n o vi si o n  N e e d s  A s s e s s m e nt
F or  a  g o o d  pr o g n o si s, t h e  p ati e nt  s h o ul d  h a v e  a d e q u at el y  c orr e ct e d 
di st a n c e  a n d  n e ar  vi s u al  a c uit y i n  e a c h  e y e.  T h e  a m bl y o pi c  p ati e nt  or t h e 
p ati e nt  wit h  si g ni ﬁ  c a nt  a sti g m ati s m ( gr e at er t h a n  1. 0 0 D) i n  o n e  e y e  m a y  n ot 
b e  a  g o o d  c a n di d at e f or  m o n o vi si o n  c orr e cti o n  wit h t h e s e l e n s e s.
O c c u p ati o n al  a n d  e n vir o n m e nt al  vi s u al  d e m a n d s  s h o ul d  b e  c o n si d er e d. 
If t h e  p ati e nt r e q uir e s  criti c al  vi si o n ( vi s u al  a c uit y  a n d  st er e o p si s), it  s h o ul d 
b e  d et er mi n e d  b y tri al  w h et h er t hi s  p ati e nt  c a n f u n cti o n  a d e q u at el y  wit h 
m o n o vi si o n  c orr e cti o n.  M o n o vi si o n  c o nt a ct l e n s  w e ar  m a y  n ot  b e  o pti m al 
f or  a cti viti e s  s u c h  a s:
• 
Vi s u all y  d e m a n di n g  sit u ati o n s  s u c h  a s  o p er ati n g  p ot e nti all y  d a n g er o u s 
m a c hi n er y  or  p erf or mi n g  ot h er  p ot e nti all y  h a z ar d o u s  a cti viti e s;  a n d
• 
Dri vi n g  a ut o m o bil e s ( e. g.,  dri vi n g  at  ni g ht).  P ati e nt s  w h o  c a n n ot  m e et 
t h eir  st at e  dri v er’s li c e n s e r e q uir e m e nt s  wit h  m o n o vi si o n  c orr e cti o n 
s h o ul d  b e  a d vi s e d t o  n ot  dri v e  wit h t hi s  c orr e cti o n,  O R  m a y r e q uir e t h at 
a d diti o n al  o v er- c orr e cti o n  b e  pr e s cri b e d.
2.  P ati e nt  E d u c ati o n
All  p ati e nt s  d o  n ot f u n cti o n  e q u all y  w ell  wit h  m o n o vi si o n  c orr e cti o n.  P ati e nt s 
m a y  n ot  p erf or m  a s  w ell f or  c ert ai n t a s k s  wit h t hi s  c orr e cti o n  a s t h e y  h a v e 
wit h  s p e ct a cl e s ( m ultif o c al,  bif o c al, trif o c al, r e a d er s,  pr o gr e s si v e s).  E a c h 
p ati e nt  s h o ul d  u n d er st a n d t h at  m o n o vi si o n,  a s  w ell  a s  ot h er  pr e s b y o pi c 
alt er n ati v e s,  c a n  cr e at e  a  vi si o n  c o m pr o mi s e t h at  m a y r e d u c e  vi s u al  a c uit y 
a n d  d e pt h  p er c e pti o n f or  di st a n c e  a n d  n e ar t a s k s.  T h er ef or e,  c a uti o n 
s h o ul d  b e  e x er ci s e d  w h e n t h e  p ati e nt i s  w e ari n g t h e  c orr e cti o n f or t h e  ﬁ r st 
ti m e  u ntil t h e y  ar e f a mili ar  wit h t h e  vi si o n  pr o vi d e d i n  vi s u all y  c h all e n gi n g 
e n vir o n m e nt s ( e. g., r e a di n g  a  m e n u i n  a  di ml y lit r e st a ur a nt,  dri vi n g  at  ni g ht 
i n r ai n y/f o g g y  c o n diti o n s,  et c.).  D uri n g t h e  ﬁ tti n g  pr o c e s s, it i s  n e c e s s ar y f or 
t h e  p ati e nt t o r e ali z e t h e  di s a d v a nt a g e s  a s  w ell  a s t h e  a d v a nt a g e s  of  cl e ar 
n e ar  vi si o n,  a n d  str ai g ht  a h e a d  a n d  u p w ar d  g a z e t h at  m o n o vi si o n  c o nt a ct 
l e n s e s  pr o vi d e.
M O N O VI SI O N  FI T TI N G  G UI D E LI N E S
2 1

B.  E y e  S el e cti o n
1.    O c ul ar  Pr ef er e n c e  D et er mi n ati o n  M et h o d s
G e n er all y, t h e  n o n- d o mi n a nt  e y e i s  c orr e ct e d f or  n e ar  vi si o n.  T h e f oll o wi n g 
t w o  m et h o d s f or  e y e  d o mi n a n c e  c a n  b e  u s e d.
M et h o d  1     D et er mi n e  w hi c h  e y e i s t h e “ si g hti n g  e y e.”  H a v e t h e  p ati e nt 
p oi nt t o  a n  o bj e ct  at t h e f ar  e n d  of t h e r o o m.  C o v er  o n e  e y e. 
If t h e  p ati e nt i s  still  p oi nti n g  dir e ctl y  at t h e  o bj e ct, t h e  e y e 
b ei n g  u s e d i s t h e  d o mi n a nt ( si g hti n g)  e y e.
M et h o d  2     D et er mi n e  w hi c h  e y e  will  a c c e pt t h e  a d d e d  p o w er  wit h t h e 
l e a st r e d u cti o n i n  vi si o n.  Pl a c e  a  h a n d- h el d tri al l e n s  e q u al t o 
t h e  s p e ct a cl e  n e ar  A D D i n fr o nt  of  o n e  e y e  a n d t h e n t h e  ot h er 
w hil e t h e  di st a n c e r efr a cti v e  err or  c orr e cti o n i s i n  pl a c e f or 
b ot h  e y e s.  D et er mi n e  w h et h er t h e  p ati e nt f u n cti o n s  b e st  wit h 
t h e  n e ar  A D D l e n s  o v er t h e ri g ht  or l eft  e y e.
2.    Ot h er  E y e  S el e cti o n  M et h o d s
Ot h er  m et h o d s i n cl u d e t h e “ R efr a cti v e  Err or  M et h o d”  a n d t h e “ Vi s u al 
D e m a n d s  M et h o d.”
R efr a cti v e  Err or  M et h o d
F or  a ni s o m etr o pi c  c orr e cti o n, it i s  g e n er all y  b e st t o  ﬁ t t h e  m or e  h y p er o pi c 
(l e s s  m y o pi c)  e y e f or  di st a n c e  a n d t h e  m or e  m y o pi c (l e s s  h y p er o pi c)  e y e 
f or  n e ar.
Vi s u al  D e m a n d s  M et h o d
C o n si d er t h e  p ati e nt’s  o c c u p ati o n  d uri n g t h e  e y e  s el e cti o n  pr o c e s s t o 
d et er mi n e t h e  criti c al  vi si o n r e q uir e m e nt s. If  a  p ati e nt’s  g a z e f or  n e ar t a s k s 
i s  u s u all y i n  o n e  dir e cti o n,  c orr e ct t h e  e y e  o n t h at  si d e f or  n e ar.
E x a m pl e:  A  s e cr et ar y  w h o  pl a c e s  c o p y t o t h e l eft  si d e  of t h e  d e s k  will 
f u n cti o n  b e st  wit h t h e  n e ar l e n s  o n t h e l eft  e y e.
C.   S p e ci al  Fitti n g  C h ar a ct eri sti c s
1.    U nil at er al  Vi si o n  C orr e cti o n
T h er e  ar e  cir c u m st a n c e s  w h er e  o nl y  o n e  c o nt a ct l e n s i s r e q uir e d.  A s  a n 
e x a m pl e,  a n  e m m etr o pi c  p ati e nt  w o ul d  o nl y r e q uir e  a  n e ar l e n s,  w h er e a s 
a  bil at er al  m y o p e  w o ul d r e q uir e  c orr e cti v e l e n s e s  o n  b ot h  e y e s. 
2 2

E x a m pl e s:
A  pr e s b y o pi c  e m m etr o pi c  p ati e nt  w h o r e q uir e s  a  + 1. 7 5 D  A D D  w o ul d 
h a v e  a  + 1. 7 5 D l e n s  o n t h e  n e ar  e y e  a n d t h e  ot h er  e y e l eft  wit h o ut 
c orr e cti o n.
A  pr e s b y o pi c  p ati e nt r e q uiri n g  a  + 1. 5 0 D  A D D  w h o i s - 2. 5 0 D  m y o pi c i n 
t h e ri g ht  e y e  a n d - 1. 5 0 D  m y o pi c i n t h e l eft  e y e  m a y  h a v e t h e ri g ht  e y e 
c orr e ct e d f or  di st a n c e  a n d t h e l eft  e y e  u n c orr e ct e d f or  n e ar.
2.    N e ar  A D D  D et er mi n ati o n
Al w a y s  pr e s cri b e t h e l e n s  p o w er f or t h e  n e ar  e y e t h at  pr o vi d e s  o pti m al 
n e ar  a c uit y  at t h e  mi d p oi nt  of t h e  p ati e nt’s  h a bit u al r e a di n g  di st a n c e. 
H o w e v er,  w h e n  m or e t h a n  o n e  p o w er  pr o vi d e s  o pti m al r e a di n g 
p erf or m a n c e,  pr e s cri b e t h e l e a st  pl u s ( m o st  mi n u s)  of t h e  p o w er s.
3.   Tri al  L e n s  Fitti n g
A tri al  ﬁ tti n g i s  p erf or m e d i n t h e  of ﬁ  c e t o  all o w t h e  p ati e nt t o  e x p eri e n c e 
m o n o vi si o n  c orr e cti o n.  L e n s e s  ar e  ﬁ t  a c c or di n g t o t h e  G E N E R A L 
FI T TI N G  G UI D E LI N E S  f or  b a s e  c ur v e  s el e cti o n  d e s cri b e d i n t hi s 
P a c k a g e I n s ert.
C a s e  hi st or y  a n d  a  st a n d ar d  cli ni c al  e v al u ati o n  pr o c e d ur e  s h o ul d  b e  u s e d 
t o  d et er mi n e t h e  pr o g n o si s.  D et er mi n e t h e  di st a n c e  c orr e cti o n  a n d t h e 
n e ar  c orr e cti o n.  N e xt,  d et er mi n e t h e  n e ar  A D D.  Wit h tri al l e n s e s  of t h e 
pr o p er  p o w er i n  pl a c e,  o b s er v e t h e r e a cti o n t o t hi s  m o d e  of  c orr e cti o n.
All o w t h e l e n s e s t o  s ettl e f or  a b o ut  2 0  mi n ut e s  wit h t h e  c orr e ct  p o w er 
l e n s e s i n  pl a c e.  W al k  a cr o s s t h e r o o m  a n d  h a v e t h e  p ati e nt l o o k  at 
y o u.  A s s e s s t h e  p ati e nt’s r e a cti o n t o  di st a n c e  vi si o n  u n d er t h e s e 
cir c u m st a n c e s.  T h e n  h a v e t h e  p ati e nt l o o k  at f a mili ar  n e ar  o bj e ct s  s u c h 
a s  a  w at c h f a c e  or  ﬁ  n g er n ail s.  A g ai n  a s s e s s t h e r e a cti o n.  A s t h e  p ati e nt 
c o nti n u e s t o l o o k  ar o u n d t h e r o o m  at  b ot h  n e ar  a n d  di st a n c e  o bj e ct s, 
o b s er v e t h e r e a cti o n s.  O nl y  aft er t h e s e  vi si o n t e st s  ar e  c o m pl et e d,  s h o ul d 
t h e  p ati e nt  b e  a s k e d t o r e a d  pri nt.  E v al u at e t h e  p ati e nt’s r e a cti o n t o l ar g e 
pri nt ( e. g., t y p e writt e n  c o p y)  at  ﬁ r st  a n d t h e n  gr a d u at e t o  n e w s pri nt  a n d 
ﬁ  n all y  s m all er t y p e  si z e s.
Aft er t h e  p ati e nt’s  p erf or m a n c e  u n d er t h e  a b o v e  c o n diti o n s i s  c o m pl et e d, 
t e st s  of  vi s u al  a c uit y  a n d r e a di n g  a bilit y  u n d er  c o n diti o n s  of  m o d er at el y 
di m ill u mi n ati o n  s h o ul d  b e  att e m pt e d.
2 3

A n i niti al  u nf a v or a bl e r e s p o n s e i n t h e  of ﬁ  c e,  w hil e i n di c ati v e  of  a  g u ar d e d 
pr o g n o si s,  s h o ul d  n ot i m m e di at el y r ul e  o ut  a  m or e  e xt e n si v e tri al  u n d er 
t h e  u s u al  c o n diti o n s i n  w hi c h  a  p ati e nt f u n cti o n s.
4.   A d a pt ati o n
Vi s u all y  d e m a n di n g  sit u ati o n s  s h o ul d  b e  a v oi d e d  d uri n g t h e i niti al  w e ari n g 
p eri o d.  A  p ati e nt  m a y  at  ﬁ r st  e x p eri e n c e  s o m e  mil d  bl urr e d  vi si o n, 
di z zi n e s s,  h e a d a c h e s,  a n d  a f e eli n g  of  sli g ht i m b al a n c e.  Y o u  s h o ul d 
e x pl ai n t h e  a d a pt ati o n al  s y m pt o m s t o t h e  p ati e nt.  T h e s e  s y m pt o m s  m a y 
l a st f or  a  bri ef  mi n ut e  or f or  s e v er al  w e e k s.  T h e l o n g er t h e s e  s y m pt o m s 
p er si st, t h e  p o or er t h e  pr o g n o si s f or  s u c c e s sf ul  a d a pt ati o n. 
T o  h el p i n t h e  a d a pt ati o n  pr o c e s s, t h e  p ati e nt  c a n  b e  a d vi s e d t o  ﬁ r st  u s e 
t h e l e n s e s i n  a  c o mf ort a bl e, f a mili ar  e n vir o n m e nt  s u c h  a s i n t h e  h o m e.
S o m e  p ati e nt s f e el t h at  a ut o m o bil e  dri vi n g  p erf or m a n c e  m a y  n ot  b e 
o pti m al  d uri n g t h e  a d a pt ati o n  pr o c e s s.  T hi s i s  p arti c ul arl y tr u e  w h e n 
dri vi n g  at  ni g ht.  B ef or e  dri vi n g  a  m ot or  v e hi cl e, it  m a y  b e r e c o m m e n d e d 
t h at t h e  p ati e nt  b e  a  p a s s e n g er  ﬁ r st t o  m a k e  s ur e t h at t h eir  vi si o n i s 
s ati sf a ct or y f or  o p er ati n g  a n  a ut o m o bil e.  D uri n g t h e  ﬁ r st  s e v er al  w e e k s  of 
w e ar ( w h e n  a d a pt ati o n i s  o c c urri n g), it  m a y  b e  a d vi s a bl e f or t h e  p ati e nt t o 
o nl y  dri v e  d uri n g  o pti m al  dri vi n g  c o n diti o n s.  Aft er  a d a pt ati o n  a n d  s u c c e s s 
wit h t h e s e  a cti viti e s, t h e  p ati e nt  s h o ul d  b e  a bl e t o  dri v e  u n d er  ot h er 
c o n diti o n s  wit h  c a uti o n.
D.  Ot h er  S u g g e sti o n s
T h e  s u c c e s s  of t h e  m o n o vi si o n t e c h ni q u e  m a y  b e f urt h er i m pr o v e d  b y  h a vi n g 
y o ur  p ati e nt f oll o w t h e  s u g g e sti o n s  b el o w:
•  H a v e  a t hir d  c o nt a ct l e n s ( di st a n c e  p o w er) t o  u s e  w h e n  criti c al 
di st a n c e  vi e wi n g i s  n e e d e d.
•  H a v e  a t hir d  c o nt a ct l e n s ( n e ar  p o w er) t o  u s e  w h e n  criti c al  n e ar 
vi e wi n g i s  n e e d e d.
•  H a v e  s u p pl e m e nt al  s p e ct a cl e s t o  w e ar  o v er t h e  m o n o vi si o n 
c o nt a ct l e n s e s f or  s p e ci ﬁ  c  vi s u al t a s k s  m a y i m pr o v e t h e  s u c c e s s  of 
m o n o vi si o n  c orr e cti o n.  T hi s i s  p arti c ul arl y  a p pli c a bl e f or t h o s e  p ati e nt s 
w h o  c a n n ot  m e et  st at e  dri v er’s li c e n si n g r e q uir e m e nt s  wit h  m o n o vi si o n 
c orr e cti o n.
•  M a k e  u s e  of  pr o p er ill u mi n ati o n  w h e n  c arr yi n g  o ut  vi s u al t a s k s.
2 4

M o n o vi si o n  ﬁ tti n g  s u c c e s s  c a n  b e i m pr o v e d  b y t h e f oll o wi n g  s u g g e sti o n s:
•  R e v er s e t h e  di st a n c e  a n d  n e ar  e y e s if  a  p ati e nt i s  h a vi n g tr o u bl e 
a d a pti n g.
•  R e ﬁ  n e t h e l e n s  p o w er s if t h er e i s tr o u bl e  wit h  a d a pt ati o n.  A c c ur at e 
l e n s  p o w er i s  criti c al f or  pr e s b y o pi c  p ati e nt s.
•  E m p h a si z e t h e  b e n e ﬁ t s  of  cl e ar  n e ar  vi si o n,  a n d  str ai g ht  a h e a d  a n d 
u p w ar d  g a z e  wit h  m o n o vi si o n.
T h e  d e ci si o n t o  ﬁ t  a  p ati e nt  wit h  m o n o vi si o n  c orr e cti o n i s  m o st  a p pr o pri at el y 
l eft t o t h e  E y e  C ar e  Pr of e s si o n al i n  c o nj u n cti o n  wit h t h e  p ati e nt  aft er  c ar ef ull y 
c o n si d eri n g t h e  p ati e nt’s  n e e d s.
All  p ati e nt s  s h o ul d  b e  s u p pli e d  wit h  a  c o p y  of t h e  P A TI E N T 
I N S T R U C TI O N  G UI D E f or t h e s e l e n s e s.  C o pi e s  ar e  a v ail a bl e f or 
d o w nl o a d  at  w w w. a c u v u e. c o m.
P A TI E N T  M A N A G E M E N T
•  F oll o w t h e  a c c e pt e d  st a n d ar d  of  c ar e i n  ﬁ tti n g  a n d f oll o wi n g  u p  wit h  y o ur 
p ati e nt,  e. g.,  A m eri c a n  O pt o m etri c  A s s o ci ati o n  st a n d ar d  of  c ar e. 
•  S c h e d ul e t h e  a p pr o pri at e f oll o w- u p  e x a mi n ati o n. 
•  Pr ef er a bl y,  at t h e f oll o w- u p  vi sit s, l e n s e s  s h o ul d  h a v e  b e e n  w or n f or  at 
l e a st  si x  h o ur s. 
•  Pr o vi d e t h e  p ati e nt  wit h  a  c o p y  of t h e  P A TI E N T I N S T R U C TI O N  G UI D E f or 
t h e s e l e n s e s,  w hi c h  c a n  b e f o u n d  at  w w w. a c u v u e. c o m.  R E VI E W  T H E S E 
I N S T R U C TI O N S  WI T H  T H E  P A TI E N T  S O  T H A T  H E  O R  S H E  C L E A R L Y 
U N D E R S T A N D S  T H E  P R E S C RI B E D  W E A RI N G  A N D  R E P L A C E M E N T 
S C H E D U L E S.
T h e  w e ari n g  s c h e d ul e  s h o ul d  b e  d et er mi n e d  b y t h e  E y e  C ar e  Pr of e s si o n al. 
R e g ul ar  c h e c k u p s,  a s  d et er mi n e d  b y t h e  E y e  C ar e  Pr of e s si o n al,  ar e  al s o 
e xtr e m el y i m p ort a nt.
P ati e nt s t e n d t o  o v er  w e ar t h e l e n s e s i niti all y.  T h e  E y e  C ar e  Pr of e s si o n al  s h o ul d 
e m p h a si z e t h e i m p ort a n c e  of  a d h eri n g t o t h e i niti al  m a xi m u m  w e ari n g  s c h e d ul e. 
M a xi m u m  w e ari n g ti m e  s h o ul d  b e  d et er mi n e d  b y t h e  E y e  C ar e  Pr of e s si o n al 
b a s e d  u p o n t h e  p ati e nt’s  p h y si ol o gi c al  e y e  c o n diti o n,  b e c a u s e i n di vi d u al 
r e s p o n s e t o  c o nt a ct l e n s e s  v ari e s. 
W E A RI N G  S C H E D U L E
2 5

T h e  m a xi m u m  s u g g e st e d  w e ari n g ti m e f or t h e s e l e n s e s i s:
D A Y
H O U R S
1
6- 8
2
8- 1 0
3
1 0- 1 2
4
1 2- 1 4
5  a n d  aft er
all  w a ki n g  h o ur s
T h e s e l e n s e s  ar e i n di c at e d f or  d ail y  di s p o s a bl e  w e ar  a n d  s h o ul d  b e  di s c ar d e d 
u p o n r e m o v al.
W h e n  di s p o s e d  of  aft er  a  si n gl e  d ail y  u s e, t h e s e l e n s e s  m a y r e d u c e t h e ri s k  of 
d e v el o pi n g  gi a nt  p a pill ar y  c o nj u n cti viti s. 4
W h e n  w or n  a s  a  d ail y  di s p o s a bl e l e n s, t h e s e l e n s e s  m a y  pr o vi d e i m pr o v e d 
c o mf ort f or  m a n y  p ati e nt s  w h o  e x p eri e n c e  mil d  di s c o mf ort  a n d it c hi n g 
a s s o ci at e d  wit h  all er gi e s  d uri n g  c o nt a ct l e n s  w e ar,  c o m p ar e d t o l e n s e s r e pl a c e d 
at i nt er v al s  of  gr e at er t h a n  2  w e e k s.
Cli ni c al r e s e ar c h  h a s  s h o w n t h at  w h e n  w or n  o n  a  d ail y  di s p o s a bl e  b a si s, t h e s e 
l e n s e s  m a y  pr o vi d e i m pr o v e d  c o mf ort f or  2  o ut  of  3  p ati e nt s  w h o r e p ort e d 
s uff eri n g fr o m  di s c o mf ort  a s s o ci at e d  wit h  all er gi e s  d uri n g  c o nt a ct l e n s  w e ar.
4 T h e  C L A O  J o ur n al,  J ul y  1 9 9 9,  V ol u m e  2 5,  N u m b er  3
T h e  E y e  C ar e  Pr of e s si o n al  s h o ul d r e vi e w  wit h  p ati e nt s t h at  n o  cl e a ni n g  or 
di si nf e cti o n i s  n e e d e d  wit h  d ail y  di s p o s a bl e l e n s e s.  P ati e nt s  s h o ul d  al w a y s 
di s p o s e  of l e n s e s  w h e n t h e y  ar e r e m o v e d  a n d  h a v e r e pl a c e m e nt l e n s e s  or 
s p e ct a cl e s  a v ail a bl e.
F or  c o m pl et e i nf or m ati o n  c o n c er ni n g  c o nt a ct l e n s  h a n dli n g  a n d  c ar e, r ef er t o 
t h e  P A TI E N T I N S T R U C TI O N  G UI D E f or t h e s e l e n s e s.  C o pi e s  ar e  a v ail a bl e f or 
d o w nl o a d  at  w w w. a c u v u e. c o m. 
C ar e f or  Sti c ki n g ( N o n- M o vi n g)  L e n s e s
D uri n g r e m o v al, if t h e l e n s  sti c k s t o t h e  e y e, t h e  p ati e nt  s h o ul d  b e i n str u ct e d 
t o  a p pl y  a f e w  dr o p s  of t h e r e c o m m e n d e d l u bri c ati n g  or r e w etti n g  s ol uti o n 
R E P L A C E M E N T  S C H E D U L E
L E N S  C A R E  DI R E C TI O N S
2 6

dir e ctl y t o t h e  e y e  a n d  w ait  u ntil t h e l e n s  b e gi n s t o  m o v e fr e el y  o n t h e  e y e  b ef or e 
r e m o vi n g it. If  n o n- m o v e m e nt  of t h e l e n s  c o nti n u e s  aft er  a f e w  mi n ut e s, t h e 
p ati e nt  s h o ul d  i m m e di at el y  c o n s ult t h e  E y e  C ar e  Pr of e s si o n al.
T h e  p ati e nt  s h o ul d  b e i nf or m e d t h at if  c h e mi c al s  of  a n y  ki n d ( h o u s e h ol d 
pr o d u ct s,  g ar d e ni n g  s ol uti o n s, l a b or at or y  c h e mi c al s,  et c.)  ar e  s pl a s h e d i nt o 
t h e  e y e s, t h e  p ati e nt  s h o ul d:   F L U S H  E Y E S I M M E DI A T E L Y  WI T H  T A P  W A T E R 
A N D I M M E DI A T E L Y  C O N T A C T  T H E  E Y E  C A R E  P R O F E S SI O N A L  O R  VI SI T  A 
H O S PI T A L  E M E R G E N C Y  R O O M  WI T H O U T  D E L A Y.
E a c h  U V- a b s or bi n g  st eril e l e n s i s  s u p pli e d i n  a f oil- s e al e d  pl a sti c  p a c k a g e 
c o nt ai ni n g  b uff er e d  s ali n e  s ol uti o n  wit h  p o vi d o n e.  T h e  pl a sti c  p a c k a g e i s  m ar k e d 
wit h t h e f oll o wi n g: 
• 
1- D A Y  A C U V U E ®   M OI S T:  b a s e  c ur v e,  p o w er,  di a m et er, l ot  n u m b er,  a n d 
e x pir ati o n  d at e
• 
1- D A Y  A C U V U E ®   M OI S T f or  A S TI G M A TI S M:  b a s e  c ur v e,  p o w er, 
di a m et er,  c yli n d er,  a xi s, l ot  n u m b er,  a n d  e x pir ati o n  d at e
• 
1- D A Y  A C U V U E ®   M OI S T  M U L TI F O C A L:  b a s e  c ur v e,  p o w er,  di a m et er, 
A D D  p o w er, l ot  n u m b er,  a n d  e x pir ati o n  d at e
All  s eri o u s  a d v er s e  e x p eri e n c e s  a n d  a d v er s e r e a cti o n s  o b s er v e d i n  p ati e nt s 
w e ari n g t h e s e l e n s e s  or  e x p eri e n c e d  wit h t h e s e l e n s e s  s h o ul d  b e r e p ort e d t o:
J o h n s o n  &  J o h n s o n  Vi si o n  C ar e, I n c.
7 5 0 0  C e nt uri o n  P ar k w a y
J a c k s o n vill e,  F L  3 2 2 5 6
U S A
Tel:  1- 8 0 0- 8 4 3- 2 0 2 0
w w w. a c u v u e. c o m
E M E R G E N CI E S
H O W  S U P P LI E D
R E P O R TI N G  O F  A D V E R S E  R E A C TI O N S
2 7

J o h n s o n & J o h n s o n Vi si o n C ar e, I n c.
7 5 0 0 C e nt uri o n P ar k w a y
J a c k s o n vill e, F L 3 2 2 5 6
U S A
Tel: 1- 8 0 0- 8 4 3- 2 0 2 0
w w w. a c u v u e. c o m
© J o h n s o n & J o h n s o n Vi si o n C ar e, I n c. 2 0 1 7
I n C a n a d a: J o h n s o n & J o h n s o n Vi si o n C ar e di vi si o n of J o h n s o n & J o h n s o n I n c.
I n U S A: J o h n s o n & J o h n s o n Vi si o n C ar e, I n c.
Pri nt e d i n U S A
R e vi si o n d at e: 0 7/ 1 7
R e vi si o n n u m b er: M- 0 7- 1 7- 0 2
1- D A Y A C U V U E ®  M OI S T a n d L A C R E O N®  ar e Tr a d e m ar k s of
J o h n s o n & J o h n s o n Vi si o n C ar e, I n c.

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
1 2 1 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
1 2 2 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
 
 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
1 2 3 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 
1 7. 5  A p pe n di x E: 
C or ne al I nfiltr ates E v al u ati o n F or m 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
1 2 4 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8 

Pr ot oc ol 8 8 5 Bi otr ue O N E da y f or Asti g matis m S oft C o ntact Le ns  
Valea nt Researc h & De vel o p me nt 
1 2 5 
Fi nal Cli nical St u d y Pr ot oc ol 
Versi o n 1. 0, A u g ust 2 3, 2 0 1 8