Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses
Phase: NA
Conditions: Refractive Errors, Ametropia, Astigmatism
Sponsor: Alcon Research



D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
I n v esti gat or A gree m e nt: 
•  
I h a ve rea d t he cli nical st u d y des cri be d h erei n, r ec o g nize its c o nfi de ntialit y, a n d 
a gree t o c o n d uct t he des cri be d trial i n c o m plia nce wit h G o o d Cli nical Practice 
( G C P), t he et hical pri nci ples c o ntai ne d wit hi n t he Declarati o n of Helsi n ki, t his 
pr ot oc ol, all a p plica ble re g ulat or y a ut h orit y re g ulati o ns, a n d c o n diti o ns of a p pr o val 
i m p ose d b y t he re vie wi n g I R B or re g ulat or y a ut h orit y. 
•  
I will s u per vise all testin g of t he d e vice i n v ol vi n g h u ma n s u bjects a n d e ns ure t hat 
t he re q uire m e nts relati n g t o o btai ni n g i nf or me d c o nse nt a n d I R B re vie w a n d 
a p pr o val are met i n acc or da nce wit h a p plica ble l ocal a n d g o ver n me nt al re g ulati o ns.  
•  
I h a ve rea d a n d u n dersta n d t he a p pr o priat e use of t he i n vesti gati o nal pr o d u ct(s) as 
descri be d i n t he pr ot o c ol, c urre nt i n vesti gat or’s br oc h ure , pr o d u ct i nf or mati o n, or 
ot her s o urces pr o vi de d b y t he s p o ns or. 
•  
I u n d ersta n d t he p ote ntial ris ks a n d si de effects of t he i n vesti gati o nal pr o d uct(s). 
•  
I a gree t o mai ntai n a de q u ate a n d acc urate rec or ds i n acc or da nce wit h g o v er n me nt 
re g ulati o ns a n d t o ma ke t h ose rec or ds a vaila bl e f or i ns pecti o n. 
•  
I a gree t o c o m pl y wit h all ot her re q uire m e nts re gar di n g t he o bli gati o ns of cli nical 
i n vesti gat ors a n d all ot her perti ne nt re q uire me nts of t he s p o ns or a n d g o ver n me nt 
a ge ncies.  
•  
I a gree t o e ns ure t hat all ass ociates, c ollea g ues, a n d e m pl o yees assisti n g i n t he 
c o n d uct of t he st u d y are i nf or me d of t heir o bli gati o ns i n meeti n g t he a b o v e 
c o m mit me nts. 
Ha ve y o u e v er bee n dis q ual ifie d as a n i n vesti gat or b y a n y Re g ulat or y A ut h orit y?  
 N o        Yes  
Ha ve y o u e v er bee n i n v ol ve d i n a st u d y or ot h er researc h t hat was ter mi nat e d?  
 N o        Yes  
If yes, pleas e e x plai n here: 
 
 
Pri nci pal I n v esti gat or:  
 
Si g nat ure  
 
 
 
 
 
Date  
Na me a n d pr ofessi o nal 
p ositi o n:  
 
A d dress:  
 
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Ta ble of C o nte nts  
De vice Pr ot oc ol f or C L A 3 0 6 -P 0 0 1  ........................................................................................... 1  
Ta ble of C o nte nts  ....................................................................................................................... 3  
List of Ta bles .............................................................................................................................. 5  
List of Fi g ures  ............................................................................................................................ 6  
1  G L O S S A R Y O F T E R M S  .................................................................................................... 7  
2  LI S T O F A C R O N Y M S A N D A B B R E VI A TI O N S  ........................................................... 1 1  
3  P R O T O C O L S U M M A R Y  ................................................................................................. 1 3  
4  P R O T O C O L A M E N D M E N T S  ......................................................................................... 2 2  
4. 1  
A me n d me nts  ...................................................................................................... 2 2  
5  I N T R O D U C TI O N ............................................................................................................. 2 3  
5. 1  
Rati o nale a n d Bac k gr o u n d  ................................................................................ 2 3  
5. 2  
P ur p ose of t he St u d y .......................................................................................... 2 3  
5. 3  
Ris ks a n d Be nefits  ............................................................................................. 2 3  
6  S T U D Y O BJ E C TI V E S  ..................................................................................................... 2 5  
6. 1  
Pri mar y O b j ecti ve(s) ......................................................................................... 2 5  
6. 2  
Sec o n dar y O bj ecti ve(s)  ..................................................................................... 2 5  
 
 
6. 4  
Safet y O bjecti ve(s)  ............................................................................................ 2 6  
7  I N V E S TI G A TI O N A L P L A N ............................................................................................ 2 6  
7. 1  
St u d y Desi g n  ..................................................................................................... 2 6  
7. 2  
Rati o nale f or St u d y D esi g n  ............................................................................... 2 7  
7. 3  
Rati o nale f or D urati o n of Treat me nt/ F oll o w -U p ............................................... 2 8  
7. 4  
Rati o nale f or C h oice of C o ntr ol Pr o d uct  ........................................................... 2 8  
7. 5  
Data M o nit ori n g C o m mittee  ............................................................................. 2 8  
8  S T U D Y P O P U L A TI O N  .................................................................................................... 2 8  
8. 1  
I n cl usi o n Criteria  ............................................................................................... 2 8  
8. 2  
E x cl usi o n Criteria  .............................................................................................. 2 9  
8. 3  
Rescree ni n g of S u bjects  .................................................................................... 3 0  
9  T R E A T M E N T S A D MI NI S T E R E D  .................................................................................. 3 1  
9. 1  
I n v esti gati o nal Pr o d uct(s).................................................................................. 3 1  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
9. 2  
Ot her Me dic al De vic e or Me dicati o n S pecifie d f or Use D uri n g t he St u d y  ...... 3 5  
9. 3  
Treat me nt Assi g n me nt / Ra n d o mizati o n  ........................................................... 3 5  
9. 4  
Treat me nt mas ki n g  ............................................................................................ 3 6  
9. 5  
Acc o u nta bilit y Pr oce d ures  ................................................................................ 3 8  
9. 6  
C ha n ges t o c o nc o mita nt me dicati o ns, treat me nts/ pr oce d ures  .......................... 3 8  
1 0  S T U D Y P R O C E D U R E S A N D A S S E S S M E N T S  ............................................................. 3 9  
1 0. 1  I nf or me d C o nse nt a n d Scree ni n g ...................................................................... 3 9  
1 0. 2  Descri pti o n of St u d y Pr oce d ures a n d Ass ess me nts  ........................................... 3 9  
1 0. 2. 1  
De m o gra p hics  .................................................................................... 3 9  
1 0. 2. 2  
Me dical Hist or y  ................................................................................. 3 9  
1 0. 2. 3  
I n vesti gati o nal Pr o d uct c o m plia nce  .................................................. 3 9  
1 0. 2. 4  
A d verse E v e nt C ollecti o n: Safet y Assess me nt  .................................. 3 9  
1 0. 2. 5  
Slit La m p Bi o micr osc o p y: Safet y Assess me nt  .................................. 4 0  
1 0. 2. 6  
De vice D eficie ncies: Safet y Assess me nt  ........................................... 4 0  
1 0. 3  U nsc he d ule d Visits  ............................................................................................ 4 0  
1 0. 4  Disc o nti n ue d S u bjects  ....................................................................................... 4 0  
1 0. 4. 1  
Scree n Fail ures  .................................................................................. 4 0  
1 0. 4. 2  
Dis c o nti n uati o ns  ................................................................................ 4 1  
1 0. 4. 3  
Sc he d ule of Pr oce d ures a n d Assess me nts f or S u bj ects Disc o nti n ue d 
fr o m I n vesti gati o nal Pr o d uct ............................................................. 4 1  
1 0. 5  Cli nical St u d y Ter mi nati o n ................................................................................ 4 1  
1 0. 5. 1  
F oll o w -u p of s u bjects aft er st u d y p artici pati o n has e n de d  ................ 4 2  
1 1  A D V E R S E E V E N T S A N D D E VI C E D E FI CI E N CI E S  ................................................... 4 2  
1 1. 1  Ge neral I nf or m ati o n  .......................................................................................... 4 2  
1 1. 2  M o nit ori n g f or A d verse E ve nts  ......................................................................... 4 3  
1 1. 3  Pr oce d ures f or Rec or di n g a n d Re p orti n g  .......................................................... 4 4  
1 1. 4  Ret ur n Pr o d uct A nal ysis  .................................................................................... 4 6  
1 1. 5  U n mas ki n g of t h e St u d y Treat me nt  ................................................................... 4 6  
1 1. 6  F oll o w -U p of S u bjects wit h A d verse E v e nts  .................................................... 4 6  
1 1. 7  Pre g n a nc y i n t he Cli nical St u d y  ........................................................................ 4 7  
1 2  A N A L Y SI S P L A N  ............................................................................................................ 4 7  
1 2. 1  S u bject E val ua bilit y  .......................................................................................... 4 7  
1 2. 2  A nal ysis Sets  ..................................................................................................... 4 8  
1 2. 2. 1  
Safet y A n al ysis Set  ............................................................................ 4 8  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 2. 2  
F ull A nal ysis Set  ................................................................................ 4 8  
 
 
1 2. 3  De m o gra p hic a n d Baseli ne C haracteristics  ....................................................... 4 8  
1 2. 4  Effecti ve ness A nal yses  ...................................................................................... 4 8  
1 2. 4. 1  
A nal ysis of Pri mar y Effecti ve ness E n d p oi nt(s)  ................................ 4 9  
1 2. 4. 1. 1  
Statistical H y p ot heses  ........................................................ 4 9  
1 2. 4. 1. 2  
A nal ysis Met h o ds  .............................................................. 4 9  
1 2. 5  Ha n dli n g of Missi n g Dat a  ................................................................................. 5 1  
1 2. 6  Safet y A n al ys es  ................................................................................................. 5 2  
1 2. 7  I nteri m A nal ys es a n d Re p orti n g ........................................................................ 5 2  
1 2. 8  Sa m ple Siz e J ustificati o n ................................................................................... 5 3  
1 3  D A T A H A N D LI N G A N D A D MI NI S T R A TI V E R E Q UI R E M E N T S  ............................... 5 3  
1 3. 1  S u bject C o nfi de ntialit y  ...................................................................................... 5 3  
1 3. 2  C o m pleti o n of S o urce D oc u me nts a n d Case Re p ort F or ms  .............................. 5 4  
1 3. 3  Data Re vie w a n d Clarificati o ns  ......................................................................... 5 5  
1 3. 4  S p o ns or a n d M o nit ori n g Res p o nsi bilities  ......................................................... 5 5  
1 3. 5  Re g ulat or y D oc u me ntati o n a n d Rec or ds Rete nti o n  .......................................... 5 6  
1 3. 6  Q ualit y Ass ura n ce a n d Q ualit y C o ntr ol ............................................................. 5 6  
1 4  E T HI C S  ............................................................................................................................. 5 6  
1 5  R E F E R E N C E S  .................................................................................................................. 5 8  
 
List of Ta bles  
Ta ble  2 -1  
List of Acr o n y ms a n d A b bre viati o ns Use d i n T his Pr ot oc ol  ........................... 1 1  
Ta ble  3 -1  
Sc he d ule of St u d y Pr oce d ures a n d Assess me nts  ............................................. 1 9  
Ta ble  6 -1  
Pri mar y O bj ecti ve(s)  ........................................................................................ 2 5  
 
 
Ta ble  6 -3  
Safet y O bjecti ve(s)  .......................................................................................... 2 6  
Ta ble  9 -1  
Test Pr o d uct  ..................................................................................................... 3 1  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Ta ble  9 -2  
C o ntr ol Pr o d uct  ................................................................................................ 3 3  
 
 
 
List of Fi g ures  
Fi g ure 7 -1  
Fl o wc hart of St u d y Visits  ................................................................................ 2 7  
Fi g ure  1 1 -1  
Cate g orizati o n of All A d verse E ve nts  .............................................................. 4 2  
Fi g ure  1 1 -2  
Cate g orizati o n of All Seri o us A d verse E ve nts  ................................................. 4 3  
 
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 7  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1  G L O S S A R Y O F T E R M S  
Na mes of test pr o d u ct(s)  
T hr o u g h o ut t his d oc u me nt, test pr o d uct(s) will be referre d t o 
as P R E CI SI O N 1 f or Asti g mati s m or P 1f A. 
Na me of C o ntr ol Pr o d uct(s)  T hr o u g h o ut t his d oc u me nt, c o ntr ol pr o d uct(s) will be 
referre d t o as 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 or A Mf A.  
A d verse D e vice Effect  
( A D E) 
A d verse e ve nt rel ate d t o t he use of a n i n vesti gati o nal 
me dical de vice  (test pr o d uct) or c o ntr ol pr o d uct. N ote: T his 
defi niti o n i ncl u des a dverse eve nts res ulti n g fr o m i ns ufficie nt 
or i n a de q u ate i nstr ucti o ns f or use, de pl oy me nt, 
i m pl a nt ati o n, i nst all ati o n, or o per ati o n; a ny m alf u ncti o n; 
a n d use err or or i nte nti o n al mis use of t h e test pr o d uct or 
c o ntr ol pr o d uct.  
A d verse E v e nt  ( A E) 
A n y u nt o w ar d me dical occ urre nce, u ni nte n de d disease 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 s u bjects, users or ot her pers o ns, 
w het her or n ot relate d t o t he i n v esti gati o nal me dical de vice 
(test pr o d uct). N ote: F or s u bjects, t his defi niti o n i ncl u des 
eve nts rel ate d t o t he t est pr o d uct, t he c o ntr ol pr o d uct, or t he 
pr oce d ures i nv olve d. F or users or ot her pers o ns, t his 
defi niti o n is restricte d t o eve nts rel ate d t o t he  t est pr o d uct. 
Re q uire me nts f or re p orti n g A d verse E ve nts i n t he st u d y ca n 
be f o u n d i n Secti o n 1 1.  
De vice D eficie n c y  
I n a de q uac y of a me dical de vice wit h res p ect t o its i de ntit y, 
q ualit y, d ura bilit y, relia bilit y, safet y, or perf or ma n ce. N ote: 
T his defi niti o n i ncl u des m alf u ncti o ns, use err ors, a n d 
i n a de q u ate l a beli n g. 
Re q uire me nts f or re p orti n g De vice Deficie ncies i n t he st u d y 
ca n be f o u n d i n Secti o n 1 1.  
E nr olle d S u bject  
A n y s u bject w h o si g ns a n i nf or me d c o nse nt f or m f or 
partici pati o n i n t he st u d y.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
I nter ve nti o nal Cli nical Trial A res earc h trial t hat pr os pecti vel y assi g ns, w het her 
ra n d o ml y or n ot, h u ma n partici pa nts or gr o u ps of h u ma ns t o 
o ne or m ore h ealt h -relate d i nter ve nti o ns t o e val uat e t he 
effects o n healt h o utc o m es, a n d/ or a researc h tri al i n w h ic h 
dia g n ostic or m o nit ori n g pr oce d ures be y o n d sta n d ar d of care 
are c o n d u cte d a n d  ge nerate o utc o mes f or use i n a n al ysis of 
data.   
I n v esti gati o nal Pr o d uct (I P) 
Is d efi ne d as a pre ve ntati ve ( vacci ne), a t hera pe uti c ( dr u g or 
bi ol o gic), de vi ce, dia g n ostic, or  palliati ve use d as a test or 
c o ntr ol pr o d uct i n a cli ni cal trial, i ncl u di n g a pr o d uct wit h a 
mar keti n g a ut h orizati o n w he n use d or asse m ble d 
(f or m ulate d or pac k a ge d) i n a wa y differe nt fr o m t he 
a ut h orize d f or m, or w he n use d f or a n u n a ut h orize d 
i n dicati o n, or w he n use d t o gai n f urt her i nf or m ati o n a b o ut 
t he a ut h orize d f or m. 
Malf u ncti o n  
Fail ure of a me dical de vi ce t o perf or m i n acc or da nce wit h its 
i nte n de d p ur p ose w he n use d i n acc or da nce wit h t he 
i nstr ucti o ns f or use or cli nical i n vesti gati o n pla n. 
N o n seri o us A d v erse E v e nt 
A d verse e ve nt t hat d oes n ot meet t he criteria f or a seri o us 
a d verse e ve nt.  
Pr o d uct C o m plai nts  
A n y oral, electr o nic, or writte n c o m m u nicati o n t hat alle ges 
deficie nci es relat e d t o t he i de ntit y (la b eli n g), q ualit y, 
d ura bilit y, relia bilit y, safet y, effecti ve ness, or p erf or ma nce 
of a mar k ete d pr o d uct, i n cl u di n g fail ure of t he pr o d uct, 
la beli n g or pac k a gi n g t o meet s pecificati o ns, w het her or n ot 
t he pr o d uct is relate d t o or ca use d t h e alle ge d d eficie nc y. A 
c o m plai nt ma y alle ge t hat  a n a d verse e ve nt or m e dical 
de vice malf u n cti o n has o cc urre d.  
Ra n d o mize d S u bjects  
A n y s u bject w h o is assi g ne d a ra n d o mize d treat me nt.  
Seri o us A d vers e De vi ce 
Effect ( S A D E)  
A d verse d e vice effect t hat has res ulte d i n a n y of t h e 
c o nse q ue nces c h aracteristic o f a seri o us a d v erse e ve nt. 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 9  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Seri o us A d vers e E ve nt 
( S A E) 
A d verse e ve nt t h at le d t o a n y of t he f oll o wi n g:  
•  
Deat h.  
•  
A seri o us det eri orati o n i n t he healt h of t he s u bject 
t hat eit her res ulte d i n: 
a. a life-t hreate ni n g ill ness or i nj ur y. 
N ote: Life -t hre ate ni n g me a ns t h at t he 
i n divi d u al w as at i m me di ate risk of de at h fr o m 
t he eve nt as it occ urre d, i.e., it d oes n ot 
i ncl u de a n eve nt w hic h hy p ot hetic ally mi g ht 
h ave c a use d d e at h h a d it occ urre d i n a m ore 
severe f or m. 
b.  a n y p ot e ntiall y si g ht -t hreate ni n g e ve nt 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.  
c. i n patie nt h os pitalizati o n or pr ol o n ge d 
h os pitalizati o n.  
N ote: Pl a n ne d h os pit aliz ati o n f or a 
pre existi n g c o n diti o n, wit h o ut seri o us 
deteri or ati o n i n he alt h, is n ot c o nsi dere d a 
seri o us a dverse eve nt. I n ge ner al, 
h os pit aliz ati o n si g nifies t h at t he i n divi d u al 
re m ai ne d at t he h os pit al or e mer g e ncy w ar d 
f or o bserv ati o n a n d/ or tre at me nt ( us u ally 
i nv olvi n g a n over ni g ht st ay) t h at w o ul d n ot 
h ave bee n a p pr o pri ate i n t he p hysici a n's office 
or a n o ut p atie nt setti n g. C o m plic ati o ns t h at 
occ ur d uri n g h os pit aliz ati o n are a dverse 
eve nts. If a c o m plic ati o n pr ol o n gs 
h os pit aliz ati o n or f ulfills a ny ot her seri o us 
criteri a, t he eve nt is seri o us. W h e n i n d o u bt as 
t o w het her “ h os pit aliz ati o n ” occ urre d, t he 
eve nt s h o ul d be c o nsi d ere d seri o us.  
d.  a me dical or s ur gical i nter ve nti o n t o pre ve nt 
a) or b).  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 0  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
e. a n y i n direct har m as a c o nse q ue nce of 
i nc orrect dia g n ostic test r es ults w he n use d 
wit hi n ma n ufact urer ’s i nstr ucti o ns f or use. 
•  
Fetal distress, f etal deat h, or a c o n ge nital a b n or malit y 
or birt h defect.  
Refer t o Secti o n 11 f or a d diti o n al S A Es.  
Seri o us P u blic Healt h 
T hreat  
A n y e ve nt t y pe w hic h res ults i n i m mi ne nt ris k of deat h, 
seri o us deteri or ati o n i n state of healt h, or seri o us ill ness t hat 
re q uires pr o m pt r e me dial acti o n. T his w o ul d i ncl u de: E ve nts 
t hat are of si g nifica nt a n d u ne x pecte d nat ure s u c h t hat t he y 
bec o me al ar mi n g as a p ot e ntial p u blic healt h hazar d, e. g., 
h u ma n i m m u n o deficie nc y vir us ( HI V) or Cre u tzfel dt-J ac o b 
Disease ( CJ D) . 
Use Err or  
Act or o missi o n of a n act t hat res ults i n a differe nt me dical 
de vice res p o nse t ha n i nte n de d b y m a n ufact urer or e x pecte d 
b y user. N ote: T his defi niti o n i ncl u des sli ps, l a pses, a n d 
mist akes. A n u nex p ecte d p hysi ol o gic al res p o nse of t he 
s u bject d oes n ot i n itself c o nstit ute a use err or.  
 
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 1  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
2  LI S T O F A C R O N Y M S A N D A B B R E VI A TI O N S  
Ta ble  2 -1  
List of Acr o n y ms a n d A b bre vi ati o ns Use d i n T his Pr ot oc ol  
A b bre vi ati o n  
Defi niti o n  
A D E  
A d verse d e vice effect  
A Mf A  
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 
A E  
A d verse e ve nt  
B C V A  
Best c orrecte d vis ual ac uit y  
C F R  
C o de of fe deral r e g ulati o ns  
CI  
C o nfi de nce i nter val  
C R F  
Case re p ort f or m  
C O L  
Cli nical O perati o ns Lea d  
C S M  
Cli nical Site Ma na ger  
C T T  
Cli nical Trial Tea m  
D  
Di o pter  
e C R F 
Electr o nic case re p ort f or m  
E D C  
Electr o nic data ca pt ur e  
F A S  
F ull a nal ysis set  
F D A  
F o o d a n d dr u g a d mi nistrati o n  
G C P  
G o o d cli nical practice  
I C F 
I nf or me d c o ns e nt f or m 
I C H 
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h ni cal Re q uire me nts 
f or P har mace uticals f or H u ma n Use  
I E C 
I n d e pe n de nt et hics c o m mittee 
I P 
I n v esti gati o nal pr o d uct 
I R B 
I nstit uti o nal re vie w b o ar d 
I S O 
I nter nati o nal Or ga nizati o n f or Sta n dar dizati o n 
 
 
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 O P  
Ma n ual of pr o ce d ures  
N/ A  
N ot a p plica ble  
NI  
N o ni nferi orit y  
O D  
Ri g ht e ye  
O S  
Left e ye  
O U  
B ot h e yes  
P 1f A  
P R E CI SI O N 1 f or Asti g matis m  
P P  
Per pr ot oc ol  
S A E  
Seri o us a d verse e ve nt  
S A D E  
Seri o us a d verse d e vice effect  
S D  
Sta n dar d de viati o n  
Se q  
Se q ue nce  
S O P  
Sta n dar d o perati n g pr oce d ure  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
A b bre vi ati o n  
Defi niti o n  
U S  / U S A 
U nite d States  
U V  
U ltra vi olet 
V A  
Vis ual ac uit y  
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
3  P R O T O C O L S U M M A R Y  
T his is a pr os pecti ve, d o u ble -mas ke d, ra n d o mize d, cr oss o ver cli nical st u d y. S u bjects will be 
e x p ose d t o b ot h test a n d c o ntr ol le nses t o be w or n bilaterall y i n d ail y dis p osa ble wear 
m o dalit y. Gr o u p assi g n me nt rati o will be 1: 1 wit h a si n gle cr oss o ver.  
A p pr o xi matel y 8  sites i n t he U S A will e nr oll a p pr o xi matel y 1 1 0 s u bjects. S u bjects will be 
ra n d o mize d t o wear b ot h t he test P 1f A a n d t he c o ntr ol A Mf A . S u bjects will be e x pecte d t o 
atte n d 4 visits: ( 1) Scree ni n g/ Tri al le ns fitti n g a n d e val uati o n, ( 2) Bas eli ne/ Dis pe nse Le ns  1, 
( 3) Wee k 1  F oll o w -u p L e ns 1/ D is pe nse L e ns 2, a n d ( 4) W ee k 1 F oll o w -u p L e ns 2/ E xit.  
F oll o wi n g ra n d o mizati o n, st u d y le nses wil l be or d ere d f or eac h s u bject. Le nses will be 
dis pe nse d a n d s u bjects will wear t he st u d y le nses i n a dail y wear , dail y dis p osa ble m o dalit y 
f or u p t o 1 1 da ys.   
I n vesti g ati o n al 
pr o d uct t y pe  
De vic e  
St u d y t y pe  
I nter ve nti o nal 
I n vesti g ati o n al 
pr o d ucts  
Test  Pr o d uct : P R E CI SI O N 1 f or Asti g matis m c o ntact le nses 
( ver ofilc o n A) 
C o ntr ol  Pr o d uct : 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  
(etafilc o n A) 
P ur p ose a n d 
r ati o n ale 
T o c o m pare t h e cli nical p erf or ma n ce of P 1f A c o nt act le nses wit h 
A Mf A c o ntact le nses usi n g s u bjecti ve e n d p oi nts. 
 
 
O bjecti ve(s)  
T he pri mar y o bjecti ve of t his st u d y is t o de m o nstrate 
n o ni nferi orit y i n t he vis u al ac uit y ( V A) at dista nce w he n weari n g 
P 1f A c o nta ct le nses c o m pare d t o A Mf A c o ntact le nses.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
 
 
 
E n d p oi nt(s)  
 
Pri mar y Eff ecti ve ness  
•  
Dista nce V A (l o g M A R) wit h st u d y le nses  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Safet y  
•  
A d verse e ve nts  
•  
Bi o micr osc o p y fi n di n gs  
•  
De vice d eficie ncies  
Assess me nt(s)  
Effecti ve n ess  
•  
Dista nce vis ual ac uit y ( L o g M A R) wit h st u d y le ns es 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
Me dical Hist or y/ C o n c o mita nt Me dicati o ns  
Safet y  
•  
A d verse e ve nts  
•  
Bi o micr osc o p y fi n di n gs  
•  
De vice d eficie ncies  
St u d y Desi g n  
T his will be a pr os pecti v e, ra n d o mize d, c o ntr olle d, d o u ble -
mas ke d, cr oss o ver, dail y dis p osa ble wear cli nical st u d y. S u bject 
partici pati o n i n t he st u d y will be a p pr o xi matel y 1 1 da ys eac h f or 
t w o differe nt le ns es, t otali n g a p pr o xi matel y 22  d a ys of e x p os ure t o 
st u d y le nses. 
S u bject p o p ul ati o n  
V ol u nteer s u bjects a ge d 1 8 or o ver w h o are h a bit ual t oric s oft 
c o ntact le ns wearers (e x cl u di n g c urre nt/ pre vi o us P 1f A a n d A Mf A 
c o ntact le ns ha bit ual w earers), h a ve at least 3 m o nt hs of c o ntact 
le ns weari n g e x perie nce, a n d w h o wear t heir h a bit ual le nses at 
least 5 da ys per wee k a n d at least 1 0 h o urs per da y. 
Pla n ne d n u m ber of s u bjects e nr olle d/c o nse nte d: A p pr o xi matel y 
1 1 0  
Pla n ne d n u m ber of c o m plete d s u bjects:  1 0 0  
Ke y i ncl usi o n 
criteri a  
( See Secti o n 8. 1 f or a 
c o m plete list of 
i ncl usi o n criteria) 
•  S uccessf ul wear of t ori c s oft c o ntact le nses i n b ot h e yes f or 
a mi ni m u m of 5 da ys per wee k a n d 1 0 h o urs per da y d uri n g 
t he past 3 m o nt hs. 
Ke y e xcl usi o n 
criteri a  
( See Secti o n 8. 2 f or a 
•  C urre nt/ pre vi o us P 1 f A a n d A Mf A c o ntact le ns ha bit ual 
wearers a n d a n y c urre nt s p herical m o n o visi o n a n d 
m ultif ocal c o ntact le ns w earers.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 7  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
c o m plete list of 
e x cl usi o n  criteria)  
•  Weari n g h a bit ual c o ntact le nses i n a n e xte n de d wear 
m o dalit y (r o uti nel y slee pi n g i n le nses f or at least 1 ni g ht 
per wee k) o ver t he last 3 m o nt hs pri or t o e nr oll me nt.  
D at a a n al ysis a n d 
s a m ple size 
j ustific ati o n 
Pl a n ne d D at a A n al ysis  
 
T o a d dress t he pri mar y 
 
o bjecti ve  pla n ne d a n al yses are s u m marize d bel o w : 
 
E n d p oi nt  
C o m p aris o n  
St atistic al M o del  
Pri mar y  
Dista nce V A  
P 1f A vs A Mf A  
N o ni nferi orit y  
( NI) 
Mi xe d effect re peate d  
meas ures  
NI mar gi n = 0. 0 5 l o g M A R  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Ke y w or ds  
1 8 years  of  a ge, Dail y Dis p osa ble T oric S oft C o ntact Le nses, 
vis ual ac uit y, refracti ve c orrecti o n  
Ass oci ate d m ateri als  T he use of mar kete d re wetti n g dr o ps will n ot be p er mitte d.  
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 1 9  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Ta ble  3 -1  
Sc he d ule of St u d y Pr oce d ures a n d Assess me nts  
Pr o ce d ure / Assess me nt  
Visit 1  
Scree ni n g  / Trial 
L e ns F itti n g a n d  
E val uati o n  
Visit 2  
Baseli ne /  
Dis pe nse Le ns  1  
Visit 3  
Wee k 1 F oll o w -u p 
Le ns 1  / Dis pe nse 
Le ns  2  
Visit 4  
W ee k 1 F oll o w -u p 
Le ns 2  / E xit  
U nsc he d ule d 
Visit  
E arl y 
E xit  
 
 
4 -2 / + 2 da ys after Visit 1 
8 -0/ + 3 da ys after Visit 2  
8 -0/ + 3 da ys after Visit 3  
N/ A  
N/ A  
I nf or me d C o nse nt 
X  
- 
- 
- 
- 
- 
De m o gra p hics  
X  
- 
- 
- 
- 
- 
Me dical Hist or y  ∞ 
X  
X  
X  
X  
( X ) 
X  
C o nc o mita nt Me dicati o ns  ∞ 
X  
X  
X  
X  
( X ) 
X  
I ncl usi o n / E xcl usi o n 
X  
- 
- 
- 
- 
- 
Ha bit ual le ns i nf or mati o n ( bra n d, 
p o wer)  
X  
- 
- 
- 
- 
- 
V A wit h ha bit ual c o ntact le ns 
c orrecti o n ( O D, O S, L o g M A R 
dista nce) *  
X  
- 
- 
X  
- 
X  
Kerat o metr y *  
X  
- 
- 
- 
- 
- 
Ma nifest refracti o n * ( O D, O S; 
s p here, c yli n der, a xis) 
X  
- 
( X ) 
(X )  
( X ) 
 X  
B C V A *  (O D, O S  l o g M A R dista nce 
wit h Ma nifest refracti o n ) 
X  
- 
( X ) 
(X ) 
( X ) 
X  
Bi o micr osc o p y  
X  
X  
X  
X  
( X  ) 
X  
Trial le ns fitti n g a n d  e val uati o n *  
X  
- 
- 
- 
- 
- 
Ra n d o mize  
X  
- 
- 
- 
- 
- 
Or der st u d y le nses  
X  
- 
- 
- 
- 
- 
Dis pe nse/ pr o vi de st u d y le nses *  
- 
X  
X  
- 
( X  ) 
- 
I nsert st u d y le nses 
- 
X  
X  
- 
- 
- 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 0  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Pr o ce d ure / Assess me nt  
Visit 1  
Scree ni n g  / Trial 
L e ns F itti n g a n d  
E val uati o n  
Visit 2  
Baseli ne /  
Dis pe nse Le ns  1  
Visit 3  
Wee k 1 F oll o w -u p 
Le ns 1  / Dis pe nse 
Le ns  2  
Visit 4  
W ee k 1 F oll o w -u p 
Le ns 2  / E xit  
U nsc he d ule d 
Visit  
E arl y 
E xit  
 
 
4 -2 / + 2 da ys after Visit 1 
8 -0/ + 3 da ys after Visit 2  
8 -0/ + 3 da ys after Visit 3  
N/ A  
N/ A  
V A (l o g M A R dista nce) wit h st u d y 
le nses, O D, O S 
- 
X    
X  (le ns 1 a n d 2)   
X    
( X  ) 
X  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 1  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Pr o ce d ure / Assess me nt  
Visit 1  
Scree ni n g  / Trial 
L e ns F itti n g a n d  
E val uati o n  
Visit 2  
Baseli ne /  
Dis pe nse Le ns  1  
Visit 3  
Wee k 1 F oll o w -u p 
Le ns 1  / Dis pe nse 
Le ns  2  
Visit 4  
W ee k 1 F oll o w -u p 
Le ns 2  / E xit  
U nsc he d ule d 
Visit  
E arl y 
E xit  
 
 
4 -2 / + 2 da ys after Visit 1 
8 -0/ + 3 da ys after Visit 2  
8 -0/ + 3 da ys after Visit 3  
N/ A  
N/ A  
A Es  
X  
X  
X  
X  
( X ) 
X  
De vice Deficie ncies  
X  
X  
X  
X  
( X ) 
X  
E xit F or m  
- 
- 
- 
X  
- 
X  
( X) assess me nt p erf or me d as necessar y, e. g.,  decrease of V A b y 2 li nes or m ore wit h i n vesti gati o nal pr o d uct (I P)  
* S o urce o nl y  
∞ A ll oc ular a n d tar gete d s yst e mic me dicati o ns/ me dical hist or y 
 
  
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
4  P R O T O C O L A M E N D M E N T S  
M o dificati o n of t he pr ot o c ol is pr o hi bite d wit h o ut pri or writte n a gree me nt i n t he f or m of a 
pr ot oc ol a me n d me nt. All a me n d me nts m ust be create d b y t he st u d y s p o ns or a n d m ust be 
a p pr o ve d b y t he I R B/I E C a n d gl o bal a n d re gi o nal Healt h A ut h orities, as a p plica bl e, pri or t o 
i m ple me ntati o n e x ce pt w he n re q uir e d t o miti gate i m me diate safet y ris ks or w he n t he c h a n ges 
i n v ol ve o nl y l o gistical or a d mi nistrati ve re visi o ns.  
A me n d me nts ma y n ecessitate t hat t he i nf or me d c o nse nt a n d ot her st u d y -relate d material b e 
re vise d. If t h e c o nse nt f or m is re vise d, all s u bjects c urre ntl y e nr olle d i n t he st u d y m ust si g n 
t he a p pr o ve d, re vise d i nf or me d c o nse nt (re-c o nse nt) , as re q uir e d b y t he I R B/I E C. 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
 
5  I N T R O D U C TI O N 
5. 1  R ati o n ale a n d B ac k gr o u n d  
I n t his cli nical st u d y, t h e cli nical perf or ma nce of P 1f A c o nt act le ns will be c o m pare d t o 
A Mf A c o ntact le ns 
 
 T he i nte n de d use of t his c o ntact le ns is f or visi o n 
c orrecti o n. T heref ore, t he meas ure me nt of dista n ce V A is pla n n e d as t he pri mar y 
effecti ve ness v aria ble. 
 
 
 
 
 
 
5. 2  P ur p ose of t he St u d y  
T he p ur p ose of t his cli nical st u d y is t o de m o nstrate n o ni nferi orit y i n t he vis u al ac uit y at 
dista nce w he n weari n g P 1f A c o nt act le nses c o m p are d t o A Mf A c o ntact le nses. 
 
 
 
 
At t he e n d of t he st u d y, a cli nical st u d y re p ort will be pre pare d i n acc or da n ce wit h a p plica ble 
re g ulat or y re q uire me nts a n d sta n dar ds. 
 
 
 
5. 3  Ris ks a n d Be nefits  
T he cli nical i n vesti gati o n pr ocess ris ks are ma na ge d t hr o u g h a p pr o priate trai ni n g a n d 
m o nit ori n g acc or di n g t o t he pr ot oc ol -s pecific m o nit ori n g pla n. I n v esti gati o nal de vice ris ks, 
i ncl u di n g ris ks ass ociat e d wit h use of de vice a n d met h o ds a n d pr oce d ures f or a p plicati o n of 
de vice, are defi ne d i n t he pac ka ge i nsert  a n d/ or pr o d uct la beli n g a n d are m a na ge d t hr o u g h 
re vie w of s afet y assess me nts o utli ne d i n t his pr ot oc ol.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
C o ntact le nses ma y offer i m pr o ve d peri p heral visi o n a n d t he c o n ve ni e nce of n ot weari n g 
s pectacles. M aterial pr o p erties a n d desi g n c h aract eristics of P 1f A c o ntact l e nses are feat ures 
c o nsiste nt wit h s uccessf ul c o ntact le ns wear.  
P 1f A a n d A Mf A c o nta ct le nses are f or d ail y wear use u n der a d ail y dis p osa ble wear m o d alit y; 
f urt her det ails o n a n y k n o w n p ote ntial ris ks a n d be nefits ca n b e f o u n d i n t h e pac k a ge i nsert. 
P 1f A a n d A Mf A c o nta ct le nses are n ot i nte n de d f or use wit h a  clea ni n g/ disi nfecti n g s ol uti o n, 
a n d t he bi oc o m pati bilit y wit h le ns care s ol uti o ns a n d a n y ass ociate d cli nical effects are 
u n k n o w n.  
A s u m mar y of t he k n o w n p ote ntial ris ks a n d be nefits ass ociate d wit h P 1f A c o ntact le nses ca n 
be f o u n d i n t he pac k a ge i nsert. Ris ks are mi ni mize d b y c o m plia nce wit h t he eli gi bilit y 
criteria a n d st u d y pr oce d ures, a n d t hr o u g h cl ose s u per visi o n b y a lice nse d cli nicia n d uri n g 
e x p os ure t o t he st u d y le nses. T he p ote ntial har ms ass ociate d wit h o n -e ye e x p os ure t o t he ne w 
le ns materials incl u de t o xicit y res p o ns e, bl urre d visi o n, a n d oc ular disc o mf ort. I n ge neral, 
w he n w or n f or dail y dis p osa ble wear, t he ris ks wit h P 1f A c o ntact le nses are a ntici pate d t o be 
si milar t o ot her mar kete d s oft c o ntact le nses w or n f or dail y dis p osa ble wear.  
T here m a y als o be u n k n o w n ris ks t o use P 1f A . A n y ris k t o s u bjects i n t his cli nical st u d y will 
be mi ni miz e d b y c o m plia nce wit h t he eli gi bilit y criteria a n d st u d y pr oce d ures, cli nical  
o versi g ht , a n d m o nit ori n g . 
Refer t o t he pr o d u ct la bel f or a d diti o nal i nf or mati o n.   
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
6  S T U D Y O B J E C TI V E S  
6. 1  Pri m ar y O bjecti ve(s)  
Ta ble  6 -1  
Pri m ar y O bjecti ve(s)  
O bjecti ve(s)  
E n d p oi nt(s)  
De m o nstrate n o ni nferi orit y i n V A  at 
dista nce w he n weari n g P 1f A c o ntact le ns es 
c o m pare d t o A Mf A c o nt act le nses.  
Dista nce V A (l o g M A R) wit h st u d y le nses  
 
6. 2  Sec o n d ar y O bjecti ve(s)  
N ot a p plica ble.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
6. 4  S afet y O bjecti ve(s)   
Ta ble  6 -3  
S afet y O bjecti ve(s)  
O bjecti ve(s)  
E n d p oi nt(s)  
D ut y of care a n d e val uati o n of safet y pr ofile 
of t he i n vesti gati o nal pr o d ucts. 
A Es  
Bi o micr osc o p y fi n di n gs  
De vice d eficie ncies  
 
7  I N V E S TI G A TI O N A L P L A N 
7. 1  St u d y Desi g n  
T his is a pr os pecti ve, d o u ble -mas ke d, ra n d o mize d, cr oss o ver cli nical st u d y. S u bjects will be 
e x p ose d t o b ot h test a n d c o ntr ol le nses t o be w or n bilateral l y i n d ail y dis p osa ble wear  
m o dalit y . Gr o u p assi g n me nt rati o will be 1: 1 wit h a si n gle cr oss o ver.  
E x p os ure t o st u d y le ns es will be 8 da ys, u p t o a m a xi m u m of 1 1 da ys. 
 
 
 
 
S u bjects will be e x pecte d t o atte n d 4 office visits: ( 1) Scree ni n g/ Trial le ns fitti n g a n d 
e val uati o n, ( 2) Bas eli ne/ Dis p e nse Le ns 1, ( 3) 1 Wee k F oll o w -u p Le ns 1/ Dis pe nse Le ns 2, a n d 
( 4) 1  Wee k F oll o w -u p Le ns 2/ E xit. T he t otal e x pecte d d urati o n of partici p ati o n i n t his st u d y is 
a p pr o xi matel y 1 m o nt h.  
T his cli nical st u d y will e n ga ge a p pr o xi matel y 8  cli nic sites t o e nr oll a p pr o xi matel y 
1 1 0  s u bjects wit h a p pr o xi matel y 1 5-2 2 s u bjects per site.  
T his is a d o u ble -mas ke d st u d y desi g n w herei n t he s u bjects a n d t he i n vesti gat or (t o t he best of 
t he site’s a bilit y) will be mas ke d t o t he details of t he st u d y pr o d u cts. Mi n or differe nces i n 
le ns c ol or, scri be m ar ks , a n d le ns t hic k ness pr ofile bet wee n t he st u d y le ns es c o ul d res ult i n 
p ote ntial i na d verte nt u n mas ki n g of t he i n v esti gat or. A n u n mas ke d st u d y staff me m b er will 
pre pare t he c o nt act le nses f or dis pe nsi n g. All eff orts will be ta ke n t o ke e p t he i n vesti gat or 
mas ke d.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
7. 3  R ati o n ale f or D ur ati o n of T re at me nt/ F oll o w -U p  
T he d urati o n of pr o d u ct use is i n acc or da nce wit h pr o d uct la beli n g.  
7. 4  R ati o n ale f or C h oice of C o ntr ol P r o d uct 
T he A Mf A c o ntact le ns was c h ose n as t he c o ntr ol pr o d uct beca use t his le ns is a pr o per de vi ce 
t o c o m pare P 1f A wit h re gar d t o V A 
 B ot h t he P 1f A a n d A Mf A are 
dail y dis p osa ble c o ntact l e nses t hat are i nte n de d f or t he o ptical c orrecti o n of refracti ve 
a metr o pia ( m y o pia a n d h y p er o pia) i n p ha ki c a n d a p ha kic pers o ns wit h n o n di sease d e yes. 
7. 5  D at a M o nit ori n g C o m mittee  
N ot a p plica ble.  
8  S T U D Y P O P U L A TI O N  
T he st u d y p o p ulati o n c o nsists of male a n d fe male s u bjects ( a ge d 1 8 or o ver ) wit h a dia g n osis 
of a metr o pia a n d asti g m atis m . It is ai me d t o e nr oll (c o nse nt) a p pr o xi matel y 1 1 0  s u bjects i n 
a p pr o xi matel y 8  sites i n t he U nite d States, wit h a tar get of 1 5 -2 2  treate d s u bjects per site. 
Site -s pecific tar gets ma y var y  base d u p o n  i n di vi d u al site ca pa bilities. Esti mate d ti me nee de d 
t o recr uit s u bjects f or t he st u d y is a p pr o xi matel y 3 wee ks . Beca use  a 1 0 % s cree ni n g fail ure 
rate is e x pecte d, a p pr o xi matel y 1 1 0  s u bj ects are e x pecte d t o be e nr olle d. 
8. 1  I ncl usi o n Criteri a 
Writte n i nf or me d c o nse nt m ust be o btai ne d bef ore a n y st u d y s pecific ass ess me nt is 
perf or me d. U p o n si g ni n g i nf or me d c o nse nt, t he s u bject is  c o nsi dere d e nr oll e d i n t he st u d y.  
S u bjects eli gi ble f or i n cl usi o n i n t his st u d y m ust f ulfill all  of t he f oll o wi n g criteria:  
1.  
S u bject m ust be a ble t o u n dersta n d a n d si g n a n I R B/I E C a p pr o v e d inf or me d co nse nt 
f or m.  
2.  
S u bject m ust be at least 1 8 years of  a ge.  
3.  
Willi n g a n d a ble t o atte n d all sc he d ule d st u d y visits as re q uire d p er pr ot oc ol.  
4.  
S uccessf ul wear er of t ori c s oft c o ntact le ns es i n b ot h e yes f or a mi ni m u m of 5 da ys 
per wee k a n d 1 0 h o urs p er da y d uri n g t he past 3 m o nt hs.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 2 9  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
8. 2  E xcl usi o n C riteri a 
S u bjects f ulfilli n g a n y  of t he f oll o wi n g criteria are n ot eli gi ble f or p artici pati o n  i n t his st u d y. 
1.  
C urre nt/ pre vi o us P R E CI SI O N 1 f or Asti g matis m a n d 1 -Da y Ac u v ue M oist f or 
Asti g matis m c o ntact le ns ha bit ual wearers a n d a n y c urre nt s p herical m o n o visi o n a n d 
m ultif ocal c o ntact le ns w earers.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 0  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 1.  
Weari n g h a bit ual c o ntact le nses i n a n e xte n de d wear m o dalit y (r o uti nel y sle e pi n g i n 
le nses f or at least 1 ni g ht per wee k) o ver t he last 3 m o nt hs pri or t o e nr oll me nt. 
Wo me n of c hil d beari n g p ote ntial or w o me n w h o are pre g n a nt at t he ti me of st u d y e ntr y are 
n ot e x cl u de d fr o m partici pati o n. See Secti o n 1 1. 7  f or f urt her details re gar di n g pre g na nc y i n 
t his st u d y.  
8. 3  Rescree ni n g of S u bjects  
Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 1  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
9  T R E A T M E N T S A D MI NI S T E R E D  
9. 1  I n vesti g ati o n al Pr o d uct(s) 
Test Pr o d uct(s):  
P R E CI SI O N 1 f or Asti g matis m c o ntact le nses, Alc o n 
C o ntr ol Pr o d uct(s) (If a p plic a ble):  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, 
J o h ns o n & J o h ns o n 
Ta ble  9 -1  
Test Pr o d uct  
Test Pr o d uct  
P R E CI SI O N 1 f or Asti g matis m c o ntact le nses ( P 1f A)  
 
Ma n ufact ur er  
Alc o n La b orat ories, I nc.  
6 2 0 1 S o ut h Free wa y  
F ort W ort h, Te x as 7 6 1 3 4 -2 0 9 9  
U S A  
I n dic ati o n f or use 
a n d i nte n de d 
p ur p ose i n t he 
c urre nt st u d y  
P R E CI SI O N 1 f or Asti g m atis m ( ver ofilc o n A)  t oric s oft c o ntact 
le nses are i n dicate d f or t he o ptical c orrecti o n of refracti ve 
a metr o pia ( m y o pia a n d h y p er o pia) i n p ha ki c or a p ha kic pers o ns 
wit h n o n disease d e yes wit h 6. 0 0 D or less of asti g matis m. T he 
le nses are l e nses are i nte n de d t o be w or n o n ce ( dail y dis p osa ble 
wear) a n d  t he n discar de d at t he e n d of eac h weari n g peri o d. 
Wit hi n t he c urre nt st u d y t he le nses will be use d acc or di n g t o t heir 
a p pr o ve d i nte n de d p ur p ose  a n d i n dicati o ns f or use.  
Pr o d uct descri pti o n 
a n d para m eters 
a vaila ble f or t his 
st u d y 
•  Ma terial: ver ofilc o n A  
•  Water c o nte nt : 5 1 %  
•  P o wer ra n ge:   
o  S p here: -0. 7 5 t o -4. 0 0 D i n 0. 2 5 D ste ps  
o  C yli n d er: -0. 7 5 D a n d -1. 2 5 D  
o  A xis: 1 0º, 8 0º, 9 0º, 1 0 0º, 1 7 0º,  a n d 1 8 0º  
•  Base c ur ve  ( m m): 8. 5  
•  Dia meter  ( m m): 1 4. 5  
•  Ot her:  N/ A  
F or m ulati o n  
Refer t o pac ka ge i ns ert  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Usa ge  
•  Wear:  
o  Dail y Dis p osa bl e Wear  
o  Bilater al 
•  Re place me nt peri o d: Dail y Dis p osa ble  
•  E x p os ure: At least 1 0  h o urs per da y,  e ver y d a y. 
 
 
 
 
•  Le ns Care: N/ A  
N u m ber/ A m o u nt of 
p r o d uct t o be 
p r o vi de d t o t he 
s u bject 
A s ufficie nt a m o u nt of le nses will be dis pe nse d at Visit 2 a n d 
Visit  3 t o eac h s u bject t o be re place d dail y fr o m t he dis pe nse visit 
u ntil t he sc he d ule d f oll o w -u p visit.  
Pac ka gi n g 
descri pti o n  
Blister f oil pac k . 
La b eli n g d escri pti o n  •  Le ns F oil la bel i ncl u des:  
- 
material na me a n d i de ntifier  
- 
base c ur ve  
- 
dia meter  
- 
pac ki n g s ol uti o n  
- 
p o wer  
- 
l ot n u m ber 
- 
e x pirati o n date  
- 
c o nte nt state me nt  
- 
i n vesti gati o nal de vice state me nt 
- 
s p o ns or i nf or mati o n 
•  Pr o vi de d i n cart o ns of a p pr o xi matel y 1 2 le ns es per p o wer per 
cart o n, i de ntifie d wit h t h e f oll o wi n g: 
- 
a c ol or c o d e d la bel stati n g t he pr ot o c ol n u m ber  
- 
material i de ntifier  
- 
p o wer  
- 
a n i n vesti gati o nal us e o nl y state me nt  
- 
trac ki n g n u m ber 
St ora ge c o n diti o ns  
St ore d at r o o m te m perat ure.   

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
S u p pl y  
•  Base d o n t h e i n vesti gat or’s le ns or der f or m, t he s p o ns or will 
se n d st u d y le ns es t o t he site f or eac h s u bject. T h e site will 
pr o vi de t he st u d y l e nses t o t he s u bject at Visit 2  a n d Visit 3 . 
Refer t o t he M O P f or a d etaile d descri pti o n.  
 
Ta ble  9 -2  
C o ntr ol Pr o d uct  
C o ntr ol Pr o d uct(s)  
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, J o h ns o n & J o h ns o n 
 
Ma n ufact ur er  
J o h ns o n & J o h ns o n Visi o n Care, I nc. 
7 5 0 0 Ce nt uri o n Par k wa y  
J ac ks o n ville, F L 3 2 2 5 6 
U S A  
I n dic ati o n f or Us 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 c o ntact le nses are 
i n dicate d f or dail y dis p os a ble wear f or t h e o ptical c orrecti o n of 
refracti ve a m etr o pia ( m y o pia a n d h y per o pia) i n p ha kic or a p h a kic 
pers o ns wit h n o n disease d e yes w h o ma y h a ve 0. 5 0 t o 3. 0 0  D of 
asti g matis m. T he le nses c o ntai n a U V bl oc ker t o hel p pr otect 
a gai nst tra ns missi o n of har mf ul U V ra diati o n t o t he c or nea a n d i n t o 
t he e ye. W he n pres cri be d f or dail y dis p osa ble use, n o clea ni n g or 
disi nfecti o n is re q uire d. Le ns es s h o ul d be discar de d u p o n re m o val.  
Wit hi n t he c urre nt st u d y t he le nses will be use d acc or di n g t o t heir 
a p pr o ve d i nte n de d p ur p ose a n d i n dicati o ns f or use.  
Pr o d uct descri pti o n 
a n d para m eters 
a vaila ble f or t his 
st u d y 
•  Material: etafilc o n A  
•  Water c o nte nt : 5 8 % 
•  P o wer ra n ge:  
o  S p here: -0. 7 5 t o -4. 0 0 D i n 0. 2 5 D ste ps  
o  C yli n d er: -0. 7 5 D a n d -1. 2 5 D  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
o  A xis: 1 0º, 8 0º, 9 0º, 1 0 0º, 1 7 0º, a n d 1 8 0º  
•  Base c ur ve  ( m m): 8. 5  
•  Dia meter  ( m m): 1 4. 5  
•  Ot her:  N/ A  
F or m ulati o n  
Refer t o pac ka ge i ns ert.  
Usa ge  
•  Wear:  
o  Dail y Dis p osa bl e Wear  
o  Bilateral  
•  Re place me nt peri o d: Dail y Dis p osa ble  
•  E x p os ure: At least 1 0 h o urs per da y, e ver y d a y. 
 
 
 
 
•  Le ns Care: N/ A  
N u m ber/ A m o u nt of 
Pr o d uct t o be 
Pr o vi de d t o t he 
s u bject 
A s ufficie nt a m o u nt of le nses will be dis pe nse d at Visit 2 a n d 
Visit  3 t o eac h s u bject t o be re place d dail y fr o m t he dis pe nse visit 
u ntil t he sc he d ule d f oll o w -u p visit.  
Pac ka gi n g 
descri pti o n  
Blister f oil pac k . 
La b eli n g d escri pti o n  •  Le ns F oil la bel i ncl u des:  
- 
material na me a n d i de ntifier  
- 
base c ur ve  
- 
dia meter  
- 
pac ki n g s ol uti o n 
- 
p o wer  
- 
l ot n u m ber 
- 
e x pirati o n date  
- 
c o nte nt state me nt  
- 
i n vesti gati o nal de vice state me nt 
- 
s p o ns or i nf or mati o n 
•  Pr o vi de d i n cart o ns of a p pr o xi matel y 1 2 le ns es per p o wer per 
cart o n, i de ntifie d wit h t h e f oll o wi n g:  
- 
a c ol or c o d e d la bel stati n g t he pr ot o c ol n u m ber  
- 
material i de ntifier  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
- 
p o wer  
- 
a n i n vesti gati o nal us e o nl y state me nt  
- 
trac ki n g n u m ber 
St ora ge c o n diti o ns  
St ore d at r o o m te m perat ure.  
S u p pl y  
•  Base d o n t h e i n vesti gat or’s le ns or der f or m, t he s p o ns or will 
se n d st u d y le ns es t o t he site f or eac h s u bject. T h e site will 
pr o vi de t he st u d y l e nses t o t he s u bject at Visit 2 a n d Visit 3. 
Refer t o t he M O P f or a d etaile d descri pti o n.  
 
M ore i nf or mati o n o n t he test pr o d uct  ca n b e f o u n d i n t he  P 1f A  Pac ka ge I ns ert ; inf or mati o n 
o n t he c o ntr ol pr o d uct c a n be f o u n d i n t he A Mf A Pac ka ge I ns ert.  
9. 2  Ot her Me dic al De vice or Me dic ati o n S pecifie d f or Use D uri n g t he 
St u d y  
N o ot her me dical d e vices or me dicati o ns are re q uire d t o be use d i n c o nj u n cti o n wit h t he 
treat me nts d uri n g t he cli nical st u d y. 
9. 3  Tre at me nt A ssi g n me nt / R a n d o miz ati o n  
S u bjects will be ra n d o mize d i n a 1: 1  rati o t o recei ve treat me nt i n cr oss o ver se q ue nce as 
f oll o ws: 
Se q ue nce  
E D C/r a n d o miz ati o n i nte gr ati o n s yste m  
Le ns N a me  
Se q ue nce 1  
 
P 1f A/ A Mf A  
Se q ue nce 2  
 
A Mf A/ P 1f A  
 
O nl y after si g ni n g t he I C F, a s u bject will be assi g ne d a s u bject n u m ber b y t he electr o nic d ata 
ca pt ure s yste m.  
A ra n d o mizati o n list will be ge nerate d usi n g a v ali date d s yst e m t hat a ut o mates t he ra n d o m 
assi g n me nt of treat me nt (le ns se q ue nce) t o ra n d o mizati o n n u m bers i n t he s pecifie d rati o. 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
S u bjects will be assi g ne d treat me nt (le ns se q ue nce) acc or di n g t o t he ra n d o mizati o n list 
u pl oa de d i n t he ra n d o mizati o n s yste m. T he ra n d o mizati o n list will be ge nerate d a n d 
mai ntai ne d b y  t h e st u d y s p o ns or. 
At Visit 1 , all eli gi ble s u bjects will be ra n d o mize d via t he E D C/ra n d o mizati o n i nte grati o n 
s yste m t o o ne of t he treat me nt le ns se q ue nces. T he i n vesti gat or’s d ele gat e will access t he 
res pecti ve s yste m after c o nfir mi n g t hat the s u bject meets all t he eli gi bilit y criteria. A 
ra n d o mizati o n n u m ber will be a ut o maticall y assi g ne d t o t he s u bject acc or di n g t o t he s u bject 
ra n d o mizati o n list b ut will n ot be c o m m u nicate d t o t he site user. T h e E D C/ra n d o mizati o n 
i nte grati o n s yste m will i nf or m t he site user of t h e treat me nt le ns se q u e nce assi g n me nt t o be 
dis pe nse d t o t he s u bject.  
9. 4  Tre at me nt m as ki n g  
T his st u d y is d o u ble -mas ke d, wit h s u bjects ra n d o mize d t o use P 1f A or A Mf A i n a cr oss o ver 
fas hi o n f or a p pr o xi matel y 1 w ee k eac h . 
 
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 7  of 5 8  
Alc o n –  B usi ness Use O nl y  
T his le vel of mas ki n g will be mai ntai ne d t hr o u g h o ut t he c o n d uct of t he st u d y. U n mas ki n g 
will occ ur o nl y after all pla n ne d st u d y d ata ha v e b ee n vali date d, a n d t he dat a base l oc ke d.  
Mas ke d st u d y p ers o n nel m ust a v oi d see ki n g i nf or mati o n t hat ma y c o m pr o mise mas ki n g. 
I n t he e ve nt of a me dical e mer ge n c y w here t he k n o wle d ge of s u bject treat me nt is re q uire d, a n 
i n di vi d ual i n vesti gat or will ha ve t he a bilit y t o u n mas k t he treat me nt assi g n me nt f or a s pecific 
s u bject. If ti me all o ws, t h e a p pr o priate st u d y s p o ns or re prese ntati ve s h o ul d be c o ntact e d pri or 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
t o u n mas ki n g. T he st u d y s p o ns or m ust be i nf or me d of all cases i n w hic h t h e c o de was br o ke n 
a n d of t he cir c u msta nces i n v ol ve d. A d diti o nall y, t he st u d y s p o ns or ma y b e re q uire d t o 
u n mas k t he i nf or mati o n i n or der t o f ulfill e x pe dite d re g ulat or y re p orti n g re q uire me nts.  
9. 5  Acc o u nt a bilit y Pr oce d ures  
 U p o n recei pt of t he I Ps, t he i n vesti gat or’s dele gate m ust c o n d uct a n i n ve nt or y. D uri n g t he 
st u d y, u n mas k e d staff m ust pr o vi de t he I Ps t o t he s u bjects i n acc or da nce wit h t heir 
ra n d o mizati o n assi g n me nt. T hr o u g h o ut t he st u d y, t he i n vesti gat or or dele gate m ust mai ntai n 
rec or ds of I P dis pe nsati o n a n d c ollecti o n f or eac h s u bject. T his rec or d m ust be ma de 
a vaila ble t o t he st u d y m o nit or f or t he p ur p oses of verif yi n g t he acc o u nti n g of I P s u p plies. 
A n y discre pa n cies a n d/ or deficie nci es bet wee n t he o b ser ve d dis p ositi o n a n d t he writte n 
acc o u nt m ust be rec or de d al o n g wit h a n e x pla nati o n. All I Ps se nt t o t he i n v esti gat or m ust be 
acc o u nte d f or b y st u d y s p o ns or pers o n nel, a n d i n n o case be us e d i n a n u na ut h orize d 
sit uati o n. 
It is t he i n vesti gat or’s res p o nsibilit y t o e ns ure t hat:  
•  
All st u d y pr o d ucts are acc o u nte d f or a n d n ot use d i n a n y u n a ut h orize d ma n ner  
•  
All use d f oils a n d u n use d s u p plies are ret ur ne d b y eac h s u bject  
•  
All u n use d pr o d ucts are a vaila ble f or ret ur n t o t he st u d y s p o ns or, as directe d 
•  
A n y st u d y le n ses ass ociate d wit h a de vice d eficie nc y or wit h a n y pr o d u ct -relate d 
a d verse e ve nt ( i.e., A D E or S A D E) are ret ur ne d t o t he st u d y s p o ns or f or i n vesti gati o n, 
u n less ot her wise directe d b y t he s p o ns or. Refer t o Secti o n 1 1 of t his pr ot oc ol f or 
a d diti o nal i nf or ma ti o n o n t he re p orti n g of de vi ce d eficie nci es a n d A Es a n d t he ret ur n 
of st u d y pr o d u cts ass ociate d wit h t hese e ve nts.  
T he i n vesti gat or is res p o nsi ble f or pr o per dis p ositi o n of all u n use d I Ps at t he c o ncl usi o n of 
t he st u d y, acc or di n g t o t he i nstr ucti o ns pr o vide d i n t he M O P.  
9. 6  C h a n ges t o c o nc o mit a nt me dic ati o ns, tre at me nts/ pr oce d ures  
After t he s u bject is e nr olle d i nt o t he st u d y, t h e i n vesti gat or m ust i nstr uct t h e s u bject t o n otif y 
t he st u d y site a b o ut: 
•  
A n y n e w me dic ati o ns  
•  
Alterati o ns i n d ose or d ose sc he d ules f or c urre nt me dicati o ns  
•  
A n y me di cal pr oce d ure or h os pitalizati o n t hat occ urre d or is pla n ne d  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 3 9  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
A n y n o n dr u g t hera pi es (i ncl u di n g p h ysical t hera p y a n d bl o o d tra nsf usi o ns)  
T he i n vesti gat or m ust d oc u me nt t his i nf or mati o n i n t he s u bject ’s s o urce d o c u me nts. 
1 0  S T U D Y  P R O C E D U R E S A N D A S S E S S M E N T S  
1 0. 1  I nf or me d C o nse nt a n d Scree ni n g 
T he i n vesti gat or or del e gate m ust e x plai n t he p ur p ose a n d nat ur e of t he st u d y, a n d ha v e t he 
s u bject rea d, si g n, a n d d ate t he I R B/I E C-a p pr o ve d i nf or me d c o nse nt d oc u m e nt. T he s u bject 
m ust si g n t he I C F B E F O R E a n y st u d y -s p ecific pr oce d ures or assess me nts ca n be p erf or m e d, 
i ncl u di n g st u d y-s pecific scree ni n g pr oce d ures. A d diti o nall y, ha v e t he i n di vi d ual o btai ni n g 
c o nse nt fr o m t he s u bject a n d a wit ness, if a p plica ble, si g n a n d d ate t he i nf or me d c o nse nt 
d oc u me nt.  
T he i n vesti gat or or del e gate m ust pr o vi de a c o p y of t he si g n e d d oc u me nt t o t he s u bject a n d 
place t he ori gi nal si g ne d d oc u me nt i n t he s u bject ’s c hart, or pr o vi d e d oc u me ntati o n as 
re q uire d b y l oc al re g ulati o ns. 
1 0. 2  Descri pti o n of St u d y Pr oce d ures a n d Ass ess me nts 
Detaile d descri pti o ns of assess me nts a n d pr oce d ures are pr o vi de d i n t he M O P. T he 
i n vesti gat or is r es p o nsi ble f or e ns uri n g res p o nsi bilities f or all pr oce d ures a n d assess me nts are 
dele gate d t o a p pr o priatel y q ualifie d site pers o n nel.  
1 0. 2. 1  De m o gr a p hics  
O bt ai n de m o gra p hic i nf or mati o n i ncl u di n g a ge, race, et h nicit y, a n d se x.  
1 0. 2. 2  Me dic al Hist or y  
Me dical hist or y a n d c o n c o mita nt me dicati o ns will be c ollecte d i n t he e C R F as o utli ne d i n t he 
M O P.  
1 0. 2. 3  I n vesti g ati o n al Pr o d uct c o m pli a nce 
Re vie w s u bject c o m plia n ce wit h t he I P  usa ge a n d a dj u nct pr o d uct usa ge a n d c ollect all use d 
a n d u n use d st u d y I Ps a n d ot her pr o d ucts t hat were dis pe nse d.  
1 0. 2. 4  A d verse E ve nt C ollecti o n: S afet y Assess me nt  
Assess a n d rec or d a n y a d verse e v e nts t hat are o bser ve d or re p orte d , i ncl u di n g t h ose 
ass ociate d wit h c h a n ges i n c o nc o mita nt me dicati o n d osi n g  si nce t he pre vi o us visit i n t he 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 0  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
s u bject s o urce d o c u me nts. See Secti o n 1 1 f or f urt her details re gar di n g A E c ollecti o n a n d 
re p orti n g. 
1 0. 2. 5  Slit  L a m p Bi o micr osc o p y: S afet y Assess me nt  
Bi o micr osc o p y e x a mi nati o n of t he c or nea, c o nj u n cti va, iris/a nteri or c h a m ber, a n d le ns m ust 
be perf or me d i n b ot h e yes bef ore i nstillati o n of a n y dia g n ostic e ye dr o ps  ( d ye). 
1 0. 2. 6  De vice Deficie ncies: S afet y Assess me nt  
Assess a n d rec or d a n y D e vice D eficie ncies t hat are r e p ort e d or o bser ve d  si nce t he pre vi o us 
visit . Re q uire me nts f or re p orti n g de vice deficie nci es i n t he st u d y ca n be f o u n d i n Secti o n 1 1 . 
De vice d eficie n cies o n c o m parat or le nses s h o ul d be re p ort e d per t he m a n ufact ur er ’s 
g ui deli nes.  
1 0. 3  U nsc he d ule d Visits  
If a s u bject visit occ urs b et wee n a n y re g ularl y sc h e d ule d visits, t his visit m ust be d oc u me nte d 
as a n U nsc h e d ule d Visit. D uri n g all u nsc he d ule d visits, t he i n vesti gat or m ust c o n d uct t he 
f oll o wi n g pr oce d ures:  
•  
C ollect A d vers e E ve nt i nf or mati o n  
•  
Rec or d c h a n ges i n me d ic al c o n diti o n or c o nc o mita nt me dicati o n  
T he i n vesti gat or ma y perf or m a d diti o nal pr oce d ures f or pr o per dia g n osis a n d treat me nt of t he 
s u bject. T he i n vesti gat or m ust d oc u me nt t his i nf or mati o n i n t he s u bject ’s case hist or y s o urce 
d oc u me nts.  
If d uri n g a n U ns che d ule d Visit t he s u bject is disc o nti n ui n g t he I P or disc o nti n ui n g fr o m t he 
st u d y, t he i n v esti gat or m ust c o n d uct E xit pr oce d ures acc or di n g t o  Ta bl e  3 -1 , as p ossi ble. 
1 0. 4  Disc o nti n ue d S u bjects  
1 0. 4. 1  Scree n F ail ures  
S u bjects w h o were e x cl u de d fr o m t he st u d y aft er si g ni n g t he i nf or me d c o nse nt a n d pri or t o 
ra n d o mizati o n t o pr o d uct/ dis pe nse of st u d y pr o d uct. 
T he i n vesti gat or m ust d oc u me nt t he reas o n f or scree n fail ure i n t he s u bject ’s s o urce 
d oc u me nts.  
S u bject n u m bers m ust n ot be re -use d.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 1  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 0. 4. 2  Disc o nti n u ati o ns  
Disc o nti n ue d s u bjects are i n di vi d uals w h o v ol u ntaril y wit h dr a w or are wit h dra w n fr o m t he 
st u d y b y t he i nvesti gat or  after si g ni n g t he i nf or me d c o nse nt f or m. 
S u bject n u m bers of disc o nti n ue d s u bjects m ust n ot be re -us e d.  
S u bjects ma y disc o nti n ue fr o m st u d y or st u d y tr eat me nt at a n y ti me f or a n y reas o n. S u bjects 
ma y als o be disc o nti n ue d fr o m st u d y tr eat me nt at a n y ti me if, i n t he o pi ni o n of t he 
i n vesti gat or, c o nti n ue d tr eat me nt p oses a ris k t o t h eir healt h. 
F or s u bjects disc o nti n ui n g fr o m t he st u d y, t he i n vesti gat or m ust c o m plete all E xit pr oce d ures 
acc or di n g t o  Ta ble  3 -1 , if t he s u bject is willi n g a n d a ble, a n d if i n t he o pi ni o n of t he 
i n vesti gat or it is safe f or t he s u bject t o d o s o. 
T he i n vesti gat or m ust d oc u me nt t he reas o n f or st u d y or treat me nt disc o nti n uati o n i n t he 
s u bject’s s o urce d oc u me nts. 
To e ns ure t he s afet y of all s u bjects w h o disc o nti n ue earl y, i n vesti gat ors m ust assess eac h 
s u bject a n d, if necessar y, a d vise t he m of a n y t hera pies a n d/ or me dical pr o ce d ures t hat ma y b e 
nee de d t o mai ntai n t heir healt h.  
1 0. 4. 3  Sc he d ule of Pr oce d ures a n d Assess me nts f or S u bjects Disc o nti n ue d 
fr o m I n vesti g ati o n al Pr o d uct  
Ot her t ha n scree n fail ures, if a s u bject disc o nti n ues fr o m t he st u d y, t he s u bj ect s h o ul d 
u n der g o a n E arl y E xit Visit. Refer t o  Ta ble  3 -1 . 
1 0. 5   Cli nic al St u d y Ter mi n ati o n  
T he st u d y s p o ns or reser ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he st u d y i n 
its e ntiret y at a n y ti me. 
If t he cli nical st u d y is pre mat urel y t er mi nate d or s us pe n de d b y t he st u d y s p o ns or:  
•  
T he st u d y s p o ns or m ust:  
o  I m me diat el y n otif y t he i n vesti gat or(s) a n d s u bs e q u e ntl y pr o vi de 
i nstructi o ns f or st u d y ter mi nati o n.  
o  I nf or m t he i n vesti gat or a n d t he re g ulat or y a ut h o rities of t he 
ter mi nati o n/s us pe nsi o n a n d t he reas o n(s) f or t h e ter mi nati o n/s us pe nsi o n.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
T he i n vesti gat or m ust:  
o  Pr o m ptl y n otif y t he I R B/I E C of t h e ter mi nati o n or s us pe nsi o n a n d of t he 
reas o ns.  
o  Pr o vi de s u bjects wit h rec o m me n dati o ns f or p ost st u d y treat me nt opti o ns as 
nee de d.  
T he i n vesti gat or ma y ter mi nate t he site ’s partici p ati o n i n t he st u d y f or reas o na ble ca us e. 
1 0. 5. 1  F oll o w -u p of s u bjects after st u d y p artici p ati o n h as e n de d  
F oll o wi n g t his st u d y, t he s u bject will ret ur n t o t heir e ye care pr ofessi o nal f or t heir r o uti ne e ye 
care. 
1 1  A D V E R S E E V E N T S A N D D E VI C E D E FI CI E N CI E S  
C o m pre he nsi ve a d verse e ve nt data will be c ollect e d i n t he s u bject s o urce rec or ds. All A Es 
will be re p orte d i n t he e C R F ; h o we ver , a d verse e v e nt details c ollecte d will be deter mi ne d 
base d o n t he t y pe of  A E ( oc ular or s yste mic) , if seri o us criteri o n is met , relati o ns hi p t o t he I P, 
or if a s u bject disc o nti n u es d ue t o t he A E. F urt h er i nstr ucti o ns f or re p ort i n g are det aile d i n t he 
M O P a n d t he C R F c o m pl eti o n g ui deli nes.   
1 1. 1  Ge ner al I nf or m ati o n  
A n A E is a n y u nt o w ar d me dical occ urre n ce, u ni nte n de d disease 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 s u bjects, users, or ot her pers o ns, 
w het her or n ot relate d t o t he i n vesti gati o nal me dical de vice (t est pr o d uct). Refer t o t he 
Gl ossa r y of Ter ms a n d fi g ures bel o w f or cat e g ories of A Es a n d S A Es. 
Fi g ure  11 -1  
C ate g oriz ati o n of All A d verse E ve nts  
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
Fi g ure  11 -2  
C ate g oriz ati o n of All Seri o us A d verse E ve nts  
 
 
Devic e Defi cie ncies  
A de vic e defi cie nc y ma y or ma y n ot be ass ociat e d wit h patie nt har m (i.e., A D E or S A D E); 
h o we ver, n ot all A D Es or S A D Es are d u e t o a de vi ce defi cie nc y. T he i n v esti gat or s h o ul d 
deter mi ne t he a p plica ble cate g or y f or t he i de ntifie d or s us pect de vice defi cie nc y  a n d re p ort 
a n y p atie nt har m se p arat el y. E x a m ples of de vice deficie nci es i ncl u de t he f oll o wi n g:  
•  
Fail ure t o meet pr o d uct s pecificati o ns (e. g., i nc orrect le ns p o wer/ dia meter/ base 
c ur ve/c ol or)  
•  
Le ns cl o u d y  
•  
Le ns s urface/e d ge defect  
•  
Tor n le ns d uri n g ha n dli n g/i n  pac k  
•  
Pac ka gi n g deficit (e. g., misla bele d pr o d uct)  
•  
S us pect pr o d uct c o nta mi nati o n  
•  
Lac k of perf or m a nce  
1 1. 2  M o nit ori n g f or A d verse E ve nts  
At eac h visit, after t he s u bject has ha d t he o p p ort u nit y t o s p o nta ne o usl y me nti o n a n y 
pr o ble ms, t he i n vesti gat or s h o ul d i n q ui re a b o ut A Es b y as ki n g t he sta n d ar d q uesti o ns s h o w n 
bel o w a n d re p ort as a p pli ca ble:  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
“Ha ve y o u h a d a n y h ealt h pr o ble ms si nce y o ur last st u d y visit? ” 
•  
“Ha ve t h ere b ee n a n y c h a n ges i n t he me dici nes y o u ta ke si nce y o ur l ast st u d y visit? ” 
I n a d diti o n, c ha n ges i n a ny pr ot oc ol -s pecific p ar a meters a n d/ or q uesti o n n aires e val uate d 
d uri n g t he st u d y are t o be re vie we d b y t h e i n vesti gat or. A n y u nt o war d ( u nfa v ora ble a n d 
u ni nte n de d) c ha n ge i n a pr ot oc ol -s pecific p ar a meter or q uesti o n n aire res p o nse t hat is 
cli nicall y rele vant, i n t he o pi ni o n of t he i n vesti gat or, is t o be re p orte d as a n A E. T hes e 
cli nicall y rele va nt c ha n ges will be re p orte d re gar dless of ca usalit y.  
1 1. 3  Pr oce d ures f or Rec or di n g a n d Re p orti n g  
A Es are c ollecte d fr o m t he ti me of i nf or me d c o ns e nt A n y pree xisti n g me di cal c o n diti o ns or 
si g ns/s y m pt o ms pres e nt i n a s u bject pri or t o t he st art of t he st u d y (i.e., b ef ore i nf or me d 
c o nse nt is si g ne d) are n ot c o nsi dere d A Es i n t he st u d y a n d s h o ul d b e rec or de d i n t he Me dical 
Hist or y secti o n of t he e C R F.  
I n a d diti o n, te m p orar y lens a ware ness or vis ual c h a n ges d uri n g t he fitti n g pr ocess are n ot 
c o nsi dere d A Es if t he i n v esti gat or assesses t hat t he s y m pt o m(s) ca n reas o na bl y res ol v e wit hi n 
t he a ntici pate d a d a ptati o n peri o d.  
F or eac h rec or de d e v e nt, t he A D Es a n d S A Es d oc u me ntati o n m us t i ncl u de: date of 
occ urre nce, se verit y, treat me nt (if a p plica ble), o ut c o me, a n d ass ess me nts of t he seri o us ness 
a n d ca usalit y. I n a d diti o n, t he i n vesti gat or m ust d o c u me nt all de vice d eficie ncies re p ort e d or 
o bser ve d wit h test a n d c o ntr ol pr o d ucts o n t he De vice Defi cie nc y e C R F. T h e site m ust s u b mit 
all a vaila ble i nf or mati o n o n A D Es, S A Es, a n d d e vice defici e ncies t o t he st u d y s p o ns or 
i m me diatel y as f oll o ws: 
•  
All S A Es m ust be re p orte d i m me diatel y ( wit hi n 2 4 h o urs) of t he i n vesti gat or’s or 
site’s a ware ness.  
•  
A D E s t hat d o n ot meet seri o us ness criteria a n d d e vice defici e ncies m ust be re p orte d 
wit hi n 1 0 cale n dar da ys of t he i n vesti gat or’s or site’s a ware ness.  
•  
A pri nte d c o p y of t he c o m plete d Seri o us A dverse Eve nt a n d A dverse Device Effect 
a n d/ or Devi ce D eficie ncy  e CR F  m ust be i ncl u de d wit h pr o d uct ret ur ns.  
•  
A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble. 
•  
D oc u me nt a n y c h a n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
D oc u me nt all rele v a nt i nf or mati o n fr o m Disc har ge S u m mar y, A ut o ps y Re p ort, 
Certificate of Deat h, et c., if a p plica ble, i n narrati v e secti o n of t he A d verse De vice 
Effect (f or relate d A Es) a n d Seri o us A dverse Eve nt  e C R F. 
N ote:  S h o ul d t he E D C s yste m bec o me n o n o perati o nal, t he site m ust c o m plete t he a p pr o priate 
pa per Seri o us A d verse E ve nt a n d A d verse De vice Effect a n d/ or De vice Deficie nc y F or m. T he 
c o m plete d f or m is e maile d t o t he st u d y s p o ns or at 
 f or U S acc or di n g 
t o t he ti meli nes o utli ne d ab o ve; h o we v er, t he re p orte d i nf or mati o n m ust be e ntere d i nt o t he 
E D C s yste m o nce it bec o mes o perati o nal.  
St u d y s p o ns or re prese ntati ves ma y be c o ntact e d f or a n y pr ot oc ol -relate d q u esti o n a n d t heir 
c o ntact i nf or mati o n is pr o vi de d i n t he Ma n ual of Pr oce d ures t h at acc o m p a nies t his pr ot oc ol. 
F urt her, d e pe n di n g u p o n t he nat ure of t h e A E or de vice deficie nc y b ei n g re p orte d, t he st u d y 
s p o ns or ma y re q uest c o pies of a p plica bl e p orti o ns of t he s u bject’s me dical r ec or ds. T h e 
i n vesti gat or m ust als o re p ort all A Es a n d d evice d eficie nci es t hat c o ul d ha ve le d t o a S A D E 
acc or di n g t o t he re q uire me nts of re g ulat or y a ut h orities or I R B/I E C.  
I nte nsit y a n d C a us alit y Assess me nts 
W here a p pr o pri ate, t he i n vesti gat or m ust assess t h e i nte nsit y (se v erit y) of t he A E b ase d o n 
me dical j u d g m e nt wit h c o nsi derati o n of a n y s u bjecti ve s y m pt o m(s), as defi ne d bel o w:  
I nte nsity ( Severity) 
Mil d  
A n A E is mil d if t he s u bject is a ware of b ut ca n easil y t olerate t h e si g n or 
s y m pt o m. 
M o derate  
A n A E is m o derate if t he si g n or s y m pt o m res ults i n disc o mf or t si g nifica nt 
e n o u g h t o ca use i nterfere nce wit h t he s u bject ’s us ual acti vities. 
Se vere  
A n A E is se vere if t he si g n or s y m pt o m is i nca pacitati n g a n d res ults i n t he 
s u bject’s i na bilit y t o w or k or e n ga ge i n t heir us ual acti vities. 
F or e v er y A E i n t he st u d y, t he i n vesti gat or m ust assess t he ca usalit y ( Relat e d or N ot Relate d 
t o t he me dical de vice or st u d y pr oce d ure). A n ass ess me nt of ca us alit y will als o be perf or me d 
b y st u d y s p o ns or utilizi n g t he sa m e defi niti o ns, as s h o w n bel o w:  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
C a us ality  
Relate d  
A n A E cl assif ie d as r elat e d ma y be eit her defi nitel y relate d or p ossi bl y rel ate d 
w here a direct ca use a n d effect rel ati o ns hi p wit h t he me dical de vice or st u d y 
pr oce d ure has n ot bee n d e m o nstrate d, b ut t here is a reas o n a ble p ossi bilit y t hat 
t he A E w as ca us e d b y t he me dical de vice or st u d y pr oce d ure.  
N ot Relate d  A n A E cl assifie d as n ot relate d ma y eit her be defi nitel y u nrel ate d or si m pl y 
u nli kel y t o be relate d (i.e., t here are ot her m ore li k el y ca uses f or t he A E).  
T he st u d y s p o ns or will assess t he A Es a n d m a y u p gra de t he i n vesti gat or’s assess me nt of 
seri o us ness a n d/ or ca usalit y. T h e st u d y s p o ns or will n otif y t h e i n vesti gat or of a n y A Es t hat is 
u p gra de d fr o m n o nseri o us t o seri o us or fr o m u nrel ate d t o relate d.  
1 1. 4  Ret ur n Pr o d uct A n al ysis   
St u d y s p o ns or re prese ntati ves a n d t heir c o ntact i nf or mati o n are pr o vi d e d i n t he M O P t hat 
acc o m pa ni es t his pr ot oc ol.  
Alc o n pr o d ucts ass oci ate d wit h de vice defi cie ncies a n d/ or pr o d uct r elate d A Es s h o ul d be 
ret ur ne d a n d m ust i ncl u de t he C o m plai nt #, w hic h will be pr o vi de d b y st u d y s p o ns or after t he 
case is e ntere d i n t he st u d y s p o ns or ’s Gl o bal Pr o d uct C o m plai nt Ma na ge me nt S yste m 
( G P C M S). 
1 1. 5  U n m as ki n g of t he St u d y Tre at me nt  
Mas ke d i nf or mati o n o n t he i de ntit y of t he assi g n e d me dical de vice s h o ul d n ot be discl ose d 
d uri n g t he st u d y. If t he tr eat me nt c o de n ee ds t o be br o ke n i n t he i nterest of s u bject safet y, t he 
i n vesti gat or is e n c o ura ge d t o c o ntact a n a p pr o priat e st u d y s p o ns or re prese nt ati ve pri or t o 
u n mas ki n g t he i nf or m ati o n if t here is s uffi cie nt ti me. De pe n d e nt u p o n t he i n di vi d ual 
circ u msta nces (i.e., m e di cal e mer ge nc y), t he c o d e ma y b e br o ke n pri or t o c o ntact wit h t he 
st u d y s p o ns or. T he st u d y s p o ns or m ust be i nf or me d of all cases i n w hic h t h e c o de was br o ke n 
a n d of t he cir c u msta nces i n v ol ve d. A d diti o nall y, t he st u d y s p o ns or ma y b e re q uire d t o 
u n mas k t he  i nf or mati o n i n or der t o f ulfill e x pe dite d re g ulat or y re p orti n g re q uire me nts. 
1 1. 6  F oll o w -U p of S u bjects wit h A d verse E ve nts  
T he i n vesti gat or is res p o nsi ble f or a de q u ate a n d s afe me dical care of s u bjects d uri n g t he 
st u d y a n d f or e ns uri n g t h at a p pr o priat e me dical care a n d rele va nt f oll o w-u p pr oce d ures are 
mai ntai ne d after t h e st u d y.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 7  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
T he i n vesti gat or s h o ul d pr o vi de t he st u d y s p o ns or wit h a n y n e w safet y i nf or mati o n ( w hic h 
i ncl u des ne w A Es a n d c h a n ges t o pre vi o usl y re p orte d A Es) t hat ma y affect t he safet y 
e val uati o n of t he de vi ce. F or A Es t hat are u nres ol v e d/ o n g oi n g at ti me of s u bject e xit fr o m 
st u d y, a n y a d diti o nal i nf or mati o n recei ve d at f oll o w-u p s h o ul d be d oc u me nte d i n t he e C R Fs 
u p t o st u d y c o m pleti o n (i.e., data bas e l oc k).  
All c o m plai nts recei ve d after t his t i me peri o d will be c o nsi dere d a n d pr o cesse d as 
s p o nta ne o us (f oll o wi n g t he p ost mar ket  vi gila nce pr oce d ures) a n d s h o ul d b e c o m m u nicate d 
t o t he me dical de vice’s ma n ufact ur er as p er l ocal re q uire me nts. 
T he i n vesti gat or s h o ul d als o re p ort c o m plai nts o n n o n -Alc o n pr o d ucts (i. 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 ) directl y t o t he ma n ufact ur er as p er t he 
ma n ufact ur er ’s i nstr ucti o ns or l ocal re g ulat or y re q uire me nts. 
1 1. 7  Pre g n a nc y i n t he Cli nic al St u d y  
Wo me n of c hil d beari n g p ote ntial or w o me n w h o are pre g n a nt at t he ti me of st u d y e ntr y are 
n ot e x cl u de d fr o m partici pati o n. Pre g n a nc y s h o ul d be i ncl u de d i n t he Pre g n a nc y e C R F w he n 
a pre g na nt w o m a n e nters t he st u d y or if a w o ma n bec o mes pre g na nt d uri n g t he st u d y. 
Pre g n a nc y is n ot re p orta ble as a n A E; h o we ver, c o m plicati o ns m a y be re p orta ble a n d will be 
deci de d o n a case -b y -cas e basis.  
1 2  A N A L Y SI S P L A N  
C o nti n u o us varia bles will be s u m marize d usi n g t he n u m ber of o bs er vati o ns, mea n, sta n dar d 
de viati o n ( S D), me dia n, mi ni m u m, a n d ma xi m u m, as well as c o nfi de nce i nter vals ( CIs) or 
c o nfi de nce li mits w here a p plica ble. Cate g orical v aria bles will be s u m mari ze d wit h 
fre q ue n cies a n d p erce nta ges fr o m eac h cate g or y. 
A n y d e viati o ns t o t he a nal ysis pla n will be u p date d d uri n g t he c o urse of t he st u d y as part of a 
pr ot oc ol a me n d me nt or will be detaile d i n t he cli nical st u d y re p ort.  
1 2. 1  S u bject E v al u a bilit y  
Fi nal s u bject e v al ua bilit y m ust be deter mi ne d pri or t o brea ki n g t he c o de f or mas ke d 
treat me nt (le ns se q u e nce) assi g n me nt a n d l o c ki n g t he data bas e, base d u p o n t he d e viati o ns 
a n d eval ua bilit y p la n ( D E P). 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 2  A n al ysis Sets  
1 2. 2. 1  S afet y A n al ysis Set  
Safet y a nal yses will be c o n d ucte d usi n g t he s afet y a nal ysis s et o n a treat me nt -e mer ge nt basis. 
As s uc h, t he safet y a nal ysis set will i ncl u de all s u bjects/e yes e x p ose d t o a n y st u d y le nses 
e val uate d i n t his st u d y, 
 
 F or treat me nt-
e mer ge nt s afet y a n al yses, s u bjects/e yes will be cat e g orize d u n der t he act ual st u d y le nses 
e x p ose d  i n t he c orres p o n di n g le ns se q u e nce. 
1 2. 2. 2  F ull A n al ysis Set  
T he f ull a nal ysis set ( F A S) is t he set of all ra n d o mize d s u bjects w h o are e x p ose d t o a n y st u d y 
le nses e val uat e d i n t his st u d y. 
 
 
 
1 2. 3  De m o gr a p hic a n d B aseli ne C h ar acteristics  
De m o gra p hic i nf or mati o n will be s u m marize d b y le ns se q ue nce a n d o verall. Fre q ue ncies a n d 
perce nt a ges will be prese nte d f or cate g orical varia bles s uc h as se x, a ge gr o u p, race, a n d 
et h nicit y. N u m ber of o bs er vati o ns, mea n, S D, me dia n, mi ni m u m, a n d ma xi m u m will be 
prese nte d f or c o nti n u o us varia bles s uc h as a ge.  
1 2. 4  Effecti ve ness A n al yses  
T his st u d y  defi nes 1 pri mar y, 
 effecti ve n ess 
e n d p oi nt . All effecti ve n ess e val uati o ns will use t he F A S as t he pri mar y a n al ysis set. 
S u p p orti ve a nal ys es of t h e pri mar y a n d k e y e x pl orat or y effecti ve n ess e n d p oi nts will b e 
c o n d ucte d usi n g t he P P a nal ysis set o nl y if t he n u m ber of s u bjects e x cl u de d fr o m t he P P 
a nal ysis s et e x cee ds 5 % of t he F A S.  
T he pri mar y effecti ve ness e n d p oi nt of dista nce V A will be teste d at o n e -si de d α  =  0. 0 5 f or 
n o ni nferi orit y 
 
 
 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 4 9  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 4. 1  A n al ysis of Pri m ar y Effecti v e ness E n d p oi nt(s)  
T he pri mar y o bje cti ve of t his st u d y is t o de m o nstrate n o ni nferi orit y i n t he V A at dista nce 
w he n weari n g P 1f A c o nt act le nses c o m p are d t o A Mf A c o nt act le nses. T h e pri mar y  e n d p oi nt 
is dista nce V A wit h st u d y le nses, c ollecte d f or eac h e ye i n l o g M A R. 
1 2. 4. 1. 1  St atistic al H y p ot heses  
T he n ull a n d alter nati ve h y p ot hes es are f or m ulate d i n ter ms of t he pre d efi n e d mar gi n of 0. 0 5 
f or n o ni nferi orit y: 
H 0: μ (T)  –  μ (C)  ≥ 0. 0 5  
H a: μ (T)  –  μ (C)  < 0. 0 5  
w here μ (T)  a n d μ (C)  de n ot e t he mea n dista nce V A f or P 1f A a n d A Mf A, res p ecti vel y, o n t he 
l o g M A R scal e. 
1 2. 4. 1. 2  A n al ysis Met h o ds  
A mi x e d effect re p eate d meas ures m o del will be utilize d t o test t hese h y p ot heses. T he m o del 
will i ncl u de ter ms f or le ns, visit, le ns b y visit i nteracti o n, p eri o d, a n d s e q ue nce. Wit hi n -
s u bject c orrelati o n d ue t o e ye a n d t he cr oss o ver desi g n will als o be acc o u nt e d f or i n t he 
m o del. Le ns differe nce ( P 1f A mi n us A Mf A) a n d t he c orres p o n di n g o ne -si d e d 9 5 % u p per 
c o nfi de nce li mit will be c o m p ute d. N o ni nferi orit y i n di sta nce V A will be declare d if u p p er 
c o nfi de nce li mit is less t ha n 0. 0 5.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 0  of 5 8  
 
Alc o n –  B usi ness Use O nl y  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 1  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 5  H a n dli n g of Missi n g D at a  
All data o btai ne d i n e val ua ble s u bjects/e yes will be i ncl u de d i n t he a n al ysis. N o i m p utati o n 
f or missi n g val ues will be carrie d o ut f or t h e pri mar y a n d ke y e x pl orat or y effecti ve ness 
a nal ys es . 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 2  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 6  S afet y A n al ys es 
T he safet y e n d p oi nts are:  
•  
A Es  
•  
Bi o micr osc o p y fi n di n gs  
•  
De vice D eficie n cies  
T here are n o s afet y h y p ot heses pla n ne d i n t his st u d y. T he f oc us of t he s afet y a nal ysis will be 
a c o m pre h e nsi ve descr i pti ve assess me nt of occ urre nce of a d verse e v e nts as well as t he ot her 
liste d para meters. 
All A Es occ urri n g fr o m t he ti me a s u bject si g ns i nf or me d c o nse nt t o st u d y e xit will be 
acc o u nte d f or i n t he re p orti n g. Safet y a nal yses will be c o n d ucte d usi n g t he saf et y a n al ysis set 
o n a treat me nt -e mer ge nt basis. Descri pti ve s u m maries (fre q ue n cies a n d p erce nta ges) f or 
oc ular a n d n o n o c ular A Es will be prese nte d b y M e dical Dicti o nar y f or Re g ulat or y Acti vities  
( Me d D R A) Preferre d Ter ms. A Es lea di n g t o st u d y disc o nti n uati o n, si g nifica nt n o nseri o us 
A Es, a n d S A Es will be i de ntifie d. I n di vi d ual s u bject listi n gs will be pr o vi de d, as necess ar y.  
I n di vi d ual s u bject listi n gs will be pr o vi de d f or A Es t hat occ ur after si g ni n g i nf or me d c o nse nt 
b ut pri or t o e x p os ure t o I P.  
Eac h bi o micr osc o p y p ara meter will be ta b ulate d b y its gra d e. F or eac h bi o micr osc o p y 
para meter, c o u nts a n d p erce nta ges of e yes t hat e x perie nce a n i ncreas e of ≥ 2 gra des fr o m 
baseli ne (last assess me nt pri or t o st u d y le ns e x p os ure) t o a n y s u bse q ue nt visit wit hi n t he 
sa me peri o d will be prese nte d. A s u p p orti ve listi n g will be ge n erat e d w hic h will i ncl u de all 
bi o micr osc o p y d ata fr o m all visits wit hi n t he sa me peri o d f or t h ose e yes e x perie nci n g t he 
i ncreas e. 
T w o listi n gs f or de vi ce d eficie nci es, pri or t o e x p os ure t o st u d y c o ntact le ns es a n d treat me nt -
e mer ge nt, will be pr o vi de d. A d diti o nall y, eac h d e vice defici e nc y cate g or y will be ta b ulate d.  
N o i nfere ntial testi n g will be c o n d ucte d f or t he safet y a nal yses.  
1 2. 7  I nteri m A n al yses a n d Re p orti n g  
T here are n o pla ns t o c o n d uct a n i nteri m a nal ysis a n d n o criteria b y w hi c h t he st u d y w o ul d b e 
ter mi nate d earl y b ase d u p o n statistical deter mi nati o n. 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 3  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
1 2. 8  S a m ple Size J ustific ati o n  
Sa m ple siz e calc ulati o n is base d o n a pri or cli nical st u d y 
w hic h e val uat e d 
perf or ma n ce of P 1f A a n d A Mf A.  
P ri m ar y Effecti ve ness  
To de m o nstrate n o ni nferi orit y ( mar gi n = 0. 0 5 i n l o g M A R; ½ li ne i n S nelle n) i n dista nce V A 
as a o ne-t aile d h y p ot hesis wit h α = 0. 0 5, a n d usi n g a sta n dar d de viati o n of 0. 0 6 2 9  f or paire d 
differe nces, 8 0 % p o wer ca n be attai ne d wit h a sa m ple siz e of 1 2 (6  per se q u e nce).  
1 3  D A T A H A N D LI N G A N D A D MI NI S T R A TI V E R E Q UI R E M E N T S  
1 3. 1  S u bject C o nfi de nti alit y  
T he i n vesti gat or m ust e ns ure t hat t he s u bject ’s a n o n y mit y is mai ntai ne d t hr o u g h o ut t he 
c o urse of t he st u d y. I n partic ular, t he i n vesti gat or m ust kee p a n e nr oll me nt l o g wit h 
c o nfi de ntial i de ntif yi n g i nf or mati o n t hat c orres p o n ds t o t he s u bject n u m bers a n d i nitials of 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 4  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
eac h st u d y partici pa nt. At t he e n d of t he cli nical st u d y, t he st u d y s p o ns or will c ollect a c o p y 
of t he e nr oll me nt l o g wit h o ut a ny  i de ntifyi n g s u bject i nf or m ati o n. All d oc u me nts s u b mitte d 
t o t he st u d y s p o ns or will i de ntif y t he s u bjects e x cl usi vel y b y n u m ber a n d d e m o gra p hic 
i nf or mati o n. N o ot her pers o nall y i de ntif yi n g i nf or mati o n will be tra ns mitte d t o t he st u d y 
sp o ns or.  
T he st u d y sp o ns or m a y release a n o n y mize d st u d y data t o e xter nal researc h ers f or p ur p oses of 
f ut ure res earc h directl y relate d t o t he st u d y o bj ecti ves, or f ut ure researc h t h at is be y o n d t he 
sc o pe of t he c urre nt st u d y o bje cti ves. T he I nf or m e d C o nse nt F or m e x plai ns t his t o  st u d y 
s u bjects. A n o n y mizati o n mea ns t hat all i de ntifia ble i nf or mati o n will be re m o ve d fr o m t he 
dataset a n d all li n ks t o t he s u bjects i n t he st u d y will be re m o ve d. A n o n y miz ati o n of t he data 
will mai ntai n c o nfi de ntialit y of t he s u bjects w h o p artici pate i n t he st u d y s o t hat t he y ca n n ot 
be i de ntifie d b y e xter nal researc hers. T he a n o n y mize d data set will c o ntai n rec or ds fr o m all 
of t he s u bjects i n t he c urre nt st u d y, b ut t he a n o n y mizati o n pr ocess mi g ht c ha n ge t he dat a set 
i n s o me wa ys, s o e xter nal researc hers will be i nf or me d t hat t he y mi g ht n ot be a ble t o 
d u plicate s o me o f t he res ults fr o m t his st u d y. 
1 3. 2  C o m pleti o n of S o urce D oc u me nts a n d C ase Re p ort F or ms  
T he nat ure a n d l ocati o n of all s o urce d o c u me nts will be i de ntifie d t o e ns ure t hat ori gi nal dat a 
re q uire d t o c om plet e t he C R Fs e xist a n d are accessi ble f or verificati o n b y t he site m o nit or, 
a n d all discre p a ncies s hall be a p pr o priat el y d o c u m e nte d via t he q uer y res ol uti o n pr ocess. Site  
m o nit ors are a p p oi nte d b y t he stu d y sp o ns or a n d are i n de pe n d e nt of st u d y site staf f. 
If ele ctr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter mi ne d i n 
a d va nce of starti n g t he st u d y.  
At a mi ni m u m, s o urce d oc u me nts i ncl u de t he f oll o wi n g i nf or m ati o n f or eac h s u bject:  
•  
S u bject i de ntificati o n ( na me, se x, race/et h nicit y)  
•  
D oc u me ntati o n of s u bject eli gi bilit y  
•  
Date of i nf or m e d c o nse nt  
•  
Dates of visits  
•  
D oc u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were p erf or me d  
•  
Res ults of st u d y para met ers, as re q uire d b y t he pr ot oc ol  
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I P acc o u nt a bilit y rec or ds 
•  
D oc u me ntati o n of A Es a n d ot her safet y p ara m eters (if a p plica ble) 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 5  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
•  
Rec or ds re gar di n g me dical hist ories a n d t he use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y  
•  
Date of st u d y c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble  
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u m e nts be i de ntifi a ble. Direct access 
t o s o urce d oc u me nt ati o n ( me dical r ec or ds) m ust b e all o we d f or t he p ur p ose of verif yi n g t hat 
t he data rec or de d o n t he C R F are c o nsiste nt wit h t he ori gi n al s o urce d ata. 
O nl y desi g n ate d i n di vi d uals at t h e site will c o m plete t he C R Fs. T he C R Fs m ust be c o m plete d 
at re g ular i nter vals f oll o wi n g t he cli nical st u d y visit sc he d ule. It is e x pecte d t hat all data 
re p orte d h a ve c orres p o n di n g e ntries i n t he s o urce d oc u me nts. T he pri nci p al i n vesti gat or  is 
res p o nsi ble f or re vie wi n g a n d certif yi n g t hat t he C R Fs are acc urate a n d c o m plete. T he o nl y 
s u bject i de ntifiers rec or de d o n t he C R Fs will be s u bject n u m ber, a n d s u bject de m o gra p hic 
i nf or mati o n.  
1 3. 3  D at a Re vie w a n d Cl arific ati o ns  
A re vi e w of C R F d ata t o t he s u bject’s s o urce data will be c o m plete d b y t he site m o nit or t o 
e ns ure c o m plet e ness a n d acc urac y. After t he C R Fs ha ve bee n c o m plete d, a d diti o nal data 
clarificati o ns a n d/ or a d diti o ns ma y be nee de d as a res ult of t he data clea ni n g pr ocess. D ata 
clarificati o ns are d oc u m e nte d  a n d are part of eac h s u bject ’s C R F. 
1 3. 4  S p o ns or a n d M o nit ori n g Res p o nsi bilities  
T he st u d y sp o ns or will desi g nat e a m o nit or t o c o n d uct t he a p pr o pri ate site visits at t he 
a p pr o priate i nter vals a cc or di n g t o t he st u d y m o nit ori n g pla n . T he cli nical i n vesti gati o n will 
be m o nit ore d t o e ns ure t h at t he ri g hts a n d well -bei n g of t he s u bj ects are pr otecte d, t he 
re p orte d d ata are acc urate, c o m plete, a n d v erifia bl e fr o m t he s o urce d oc u m e nts, a n d t he st u d y 
is c o n d ucte d i n c o m plia n ce wit h t he c urre nt a p pr o ve d pr ot oc ol (a n d a me n d me nts[s], if 
a p plica ble), wit h c urre nt G C P, a n d wit h a p plica ble re g ulat or y re q uire me nts.  
T he site ma y n ot scree n s u bjects or perf or m t he i nf or me d c o nse nt pr o cess o n a n y s u bj ect  
u ntil it recei ves a n otificati o n fr o m a n a p pr o pri ate st u d y s p o ns or re pres e ntati ve t hat t he site 
ma y c o m me nce c o n d ucti n g st u d y acti vities . M o nit ori n g will be c o n d u cte d peri o dicall y w hile 
t he cli nical st u d y is o n g oi n g. M o nit ori n g m et h o ds ma y i ncl u d e site visits, tele p h o ne, writte n, 
fa x, a n d electr o nic c orres p o n de nce. Cl ose -o ut visits will ta ke place after t he last visit of t he 
last s u bject at t he site. 
A CI  ma y be i de ntifi e d b y t he st u d y s p o ns or t o r e vie w a n d e n d orse t he fi n al st u d y re p ort. I n 
cases w h ere a c o or di n ati n g i n vesti gat or is e n ga ge d , t he st u d y s p o ns or will select  t he 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 6  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
c o or di nati n g i n v esti gat or base d u p o n t heir e x perie nce, q ualificati o ns, acti ve st u d y 
partici pati o n, a n d t heir willi n g ness a n d a v a ila bilit y t o ta ke o n t his r ole. 
1 3. 5  Re g ul at or y D oc u me nt ati o n a n d Rec or ds Rete nti o n  
T he i n vesti gat or is re q uir e d t o mai ntai n u p-t o-date, c o m plete re g ulat or y d oc u me ntati o n as 
i n dicate d b y t he st u d y s p o ns or a n d t he i n vesti gat or’s files will be re vi e we d as part of t he 
o n g oi n g st u d y m o nit ori n g. Fi na ncial i nf or mati o n is t o be ke pt se paratel y.  
A d diti o nall y, t he i n vesti gat or m ust kee p st u d y rec or ds a n d s o urce d oc u me nts c o nsiste nt wit h 
t he ter ms of t he cli nical st u d y a gree me nt wit h t he st u d y s p o ns or. If t he i n vesti gat or retires, 
rel ocates, or f or a n y ot her reas o n wit h dra ws fr o m res p o nsi bilit y of kee pi n g t he st u d y rec or ds, 
t he n t he st u d y s po ns or  m ust be n otifie d a n d s uita ble arra n ge me nts ma de f or rete nti o n of st u d y 
rec or ds a n d s o urce d oc u me nts nee de d t o c o m pl y wit h nati o nal a n d i nter nati o nal re g ul ati o ns. 
1 3. 6  Q u alit y Ass ur a nce a n d Q u alit y C o ntr ol  
T he st u d y s p o ns or will sec ure a gree me nt fr o m all i n v ol ve d parties t o e ns ure direct access t o 
all st u d y rel ate d sites, s o urce dat a a n d d oc u m e nts, a n d re p orts f or t he p ur p ose of m o nit ori n g 
a n d a u diti n g b y t he st u d y s p o ns or, a n d i ns pecti o n b y d o mestic a n d f orei g n re g ulat or y 
a ut h orities. Q ualit y c o ntr ol will be a p plie d t o eac h sta ge of data ha n dli n g t o e ns ure t hat all 
data are relia ble a n d ha v e bee n pr ocesse d c orrectl y. A gree me nts ma de b y t h e st u d y s p o ns or 
wit h t he i n vesti gat or/i nstit uti o n a n d a n y ot her parti es i n v ol ve d i n t he cli nical st u d y will be 
pr o vi de d i n writi n g as part of t he pr ot oc ol or as a se parat e a gree me nt.  
1 4  E T HI C S  
T his cli nical st u d y m ust be c o n d ucte d i n acc or da n ce wit h t he et hical pri nci ples c o ntai ne d 
wit hi n:  
•  
T he D ecl arati o n of H elsi n ki , a n d i n c o m plia nce wit h t he I C H E 6 G C P C o ns oli date d 
G ui deli ne, I S O  1 4 1 5 5: 2 0 1 1, a n d t he a p plica ble U S F D A 2 1 C F R Re g ulati o ns.  
•  
S O Ps of t he st u d y s p o ns or a n d c o ntr act res earc h or ga nizati o ns partici pati n g i n t he 
c o n d uct of t he cli nic al st u d y a n d all ot her a p plica ble re g ulati o ns.  
•  
N otificati o ns a n d ti meli nes f o r re p orti n g pr ot oc ol de viati o ns s h o ul d be base d u p o n  
a p plica ble Et hics C o m mittee re q uir e me nts  
T he i n vesti gat or m ust e ns ure t hat all pers o n nel i n v ol ve d i n t he c o n d uct of t he st u d y are 
q ualifie d t o perf or m t heir assi g ne d res p o nsi bilities t hr o u g h rele va nt e d u cati o n, trai ni n g, a n d 
e x perie nce. T h e i n vesti gat or a n d all cli nical st u d y staff m ust c o n d uct t he cli nical st u d y i n 

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 7  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
c o m plia nce wit h t he pr ot oc ol. De viati o ns fr o m t his pr ot oc ol, re g ulat or y re q uire me nts a n d/ or 
G C P m ust be rec or de d a n d re p orte d t o t he s p o ns or pri or t o data bas e l oc k.  If nee de d, 
c orrecti ve a n d pre ve nti ve acti o n s h o ul d be i de ntifie d, i m ple me nte d, a n d d o c u me nte d wit hi n 
t he st u d y rec or ds. Us e of wai vers t o de viat e fr o m t he cli nical pr ot oc ol is pr o hi bite d. 
Bef ore cli nic al st u d y i nitiati o n, t his pr ot o c ol, t he i nf or me d c o ns e nt f or m , a n y ot her writte n 
i nf or mati o n gi ve n t o s u bj ects, a n d a n y a d vertise m e nts pla n ne d f or s u bject r ecr uit me nt m ust 
be a p pr o ve d b y a n I R B/I E C. T he i n vesti gat or m ust pr o vi de d oc u me ntati o n of t he I R B/I E C 
a p pr o val t o t he st u d y s p o ns or. T he a p pr o val m ust be date d a n d m ust i de ntif y t he a p plica ble 
pr ot oc ol, a me n d me nts (if a n y), i nf or me d c o nse nt f or m, asse nt f or m (if a n y), all a p plica ble 
recr uiti n g materi als, writte n i nf or mati o n f or s u bject, a n d s u bject c o m pe nsati o n pr o gra ms. T he 
I R B/I E C must be pr o vi d e d wit h a c o p y of t he Pac ka ge I nsert, a n y peri o dic safet y u p dates, 
a n d all ot her i nf or mati o n as re q uire d b y l o cal r e g ulati o n a n d/ or t he I R B/I E C. At t he e n d of 
t he st u d y, t h e i n vesti gat or m ust n otif y t he I R B/I E C a b o ut t he st u d y ’s c o m pleti o n. T he 
I R B/I E C als o m ust be n otifie d if t he st u d y is ter mi nate d pre mat urel y. Fi nall y, t he i n vesti gat or 
m ust re p ort t o t he I R B/I E C o n t he pr o gress of t he st u d y at i nter v als sti p ulate d b y t he 
I R B/I E C. 
Vol u ntar y i nf or me d c o ns e nt m ust be o btai ne d i n writi n g fr o m e v er y s u bject a n d t he pr ocess 
s hall be d oc u me nte d bef ore a n y pr oce d ure s pecific t o t he cli nical i n vesti gati o n is a p plie d t o 
t he s u bject. T he i n vesti gat or m ust ha ve a defi n e d pr ocess f or o btai ni n g c o ns e nt. S pecificall y, 
t he i n vesti gat or, or t heir dele gate, m u st e x plai n t he cli nical st u d y t o eac h p ote ntial s u bject a n d 
t he s u bject m ust i n dicate v ol u ntar y c o nse nt b y si g ni n g a n d d ati n g t he a p pr o ve d i nf or me d 
c o nse nt f or m. T h e s u bject m ust be pr o vi de d a n o p p ort u nit y t o as k q uesti o ns of t he 
i n vesti gat or, a n d if re q uire d b y l o cal re g ul ati o n, ot her q ualifie d p ers o n nel. T he i n vesti gat or 
m ust pr o vi de t he s u bject wit h a c o p y of t he c o ns e nt f or m writte n i n a la n g ua ge t he s u bject 
u n dersta n ds. T he c o nse nt d oc u me nt m ust meet all a p plica ble l ocal la ws a n d pr o vi de s u bjects 
wit h i nf or mati o n re gar di n g t he p ur p ose, pr oce d ures, re q uire m e nts, a n d restricti o ns of t he 
st u d y, al o n g wit h a n y k n o w n ris ks a n d p ote ntial be nefits ass ociat e d wit h t he I P a n d t he st u d y, 
t he a vaila ble c o m p e nsati o n, a n d t he esta blis he d pr o visi o ns f or mai ntai ni n g co nfi de ntialit y of 
pers o nal, pr otecte d healt h i nf or mati o n. S u bjects will be t ol d a b o ut t he v ol u ntar y n at ure of 
partici pati o n i n t he st u d y a n d m ust be pr o vi de d wit h c o ntact i nf or mati o n f or t he a p pr o priat e 
i n di vi d uals s h o ul d q uesti o ns or c o ncer ns arise d uri n g t he st u d y. T h e s u bject als o m ust be t ol d 
t hat t heir rec or ds ma y be accesse d b y a p pr o priate a ut h orities a n d s p o ns or-d esi g nat e d 
pers o n nel. T he i n v esti gat or m ust kee p t he ori gi nal, si g ne d c o p y of t he c o ns e nt (file i n 
s u bject’s me dical rec or ds) a n d m ust pr o vi de a d u plicate c o p y t o eac h s u bject acc or di n g t o 
l ocal re g ulati o ns.  

D oc u me nt I D:  
V -C L N -0 0 0 8 6 4 6  
Stat us: A p pr o ve d , Versi o n: 2 .0  
A p pr o ve d Date: 0 1 J u n 2 0 2 1  
P a ge 5 8  of 5 8  
 
Alc o n –  B usi ness Use O nl y  
T he st u d y s p o ns or ass ures t hat t he ke y d esi g n ele me nts of t his pr ot oc ol will be re gistere d o n 
w w w.cli nicaltrials. g o v as re q uire d b y c urre nt re g ul ati o ns a n d, if a p plica ble, ot her p u blic 
data bases as re q uir e d b y l ocal c o u ntr y re g ulati o ns. I n a d diti o n, res ults of t his st u d y w ill be 
ma de p u blicl y a vaila ble o n w w w.cli nicaltrials. g o v re gar dl ess of o utc o me as re q uire d b y 
c urre nt r e g ulati o ns a n d, if a p plica ble, i n ot her p u blic data bases as re q uir e d b y l ocal c o u ntr y 
re g ulati o ns. 
1 5  R E F E R E N C E S  
•  
2 1 C F R Part 1 1 - Electr o nic Rec or ds; Electr o ni c Si g nat ur es  
•  
2 1 C F R Part 5 0 - Pr otecti o n of H u ma n S u bjects  
•  
2 1 C F R Part 5 6 - I nstit uti o nal Re vie w B o ar ds 
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2 1 C F R Part 8 1 2 - I n vesti gati o nal D e vice E x e m pti o ns 
•  
2 1 C F R Part 5 4 - Fi na n cial Discl os ure b y Cli nical I n v esti gat ors