Evaluation of the CooperVision, Inc. Invigor A and Invigor B Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear
Phase: NA
Conditions: Myopia, Hyperopia, Astigmatism
Sponsor: CooperVision, Inc.



 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
T A B L E O F C O N T E N T S  
T A B L E O F C O N T E N T S  
2  
A B B R E VI A TI O N S  
6  
D E FI NI TI O N S  
7  
1  
B A C K G R O U N D  
8  
2  
S T U D Y O BJ E C TI V E  
8  
3  
I N V E S TI G A TI O N A L P R O D U C T S 
8  
3. 1  
I n v esti gati o nal Le ns Na mes a n d Descri pti o ns 
8  
3. 2  
Le ns Pac ka gi n g a n d La b eli n g 
9  
3. 3  
Le ns Pr o d u ct Acc o u nta bilit y 
9  
3. 4  
I n dicati o ns f or Us e 
9  
3. 5  
S u bject A dj u nct Pr o d ucts t o be Use d i n t he St u d y 
9  
3. 6  
Occ u pati o nal H azar ds a n d Safe Ha n dli n g  
1 0  
3. 7  
St ora ge R e q uire me nts a n d E x pirati o n Dati n g 
1 0  
3. 8  
D osa ge a n d A d mi nistrati o n 
1 0  
3. 9  
Trai ni n g f or Us e of t he St u d y Pr o d ucts 
1 0  
3. 1 0  
S ur gical a n d/ or Me dical Pr oce d ures  
1 0  
4  
J U S TI FI C A TI O N F O R T H E S T U D Y 
1 0  
4. 1  
Liter at ure Re vie w  
1 0  
4. 2  
S u m mar y of Pr ecli nical St u dies  
1 0  
4. 3  
S u m mar y of Pr e vi o us Cli nical St u dies  
1 0  
4. 4  
P ote ntial Ris ks a n d Be nefits f or H u ma n S u bjects  
1 1  
5  
C LI NI C A L S T U D Y D E SI G N  
1 1  
5. 1  
I n v esti gat or/ Site Selecti o n a n d Q ualificati o n 
1 1  
5. 2  
Meas ures t o A v oi d Bias 
1 2  
5. 3  
Ra n d o mizati o n 
1 2  
5. 4  
St u d y E n d p oi nts  
1 2  
5. 4. 1  
Safet y E n d p oi nts  
1 2  
5. 4. 2  
Efficac y E n d p oi nts 
1 3  
5. 5  
Met h o ds a n d Ti mi n g f or Assessi n g, Rec or d i n g a n d A nal yzi n g Data  
1 3 
5. 6  
E q ui p me nt Use d f or Ass ess me nts 
1 3  
5. 7  
I n v esti gati o nal Le ns a n d C o m parat or 
1 4  
5. 7. 1  
I n v esti gati o nal Test Le ns es 
1 4  
5. 7. 2  
C o m parat or C o ntr ol Le nses 
1 4  
5. 7. 3  
E x p os ure t o St u d y Le ns es  
1 4  
5. 7. 4  
C o nc o mita nt Me dicati o n/ Treat me nt  
1 4  
5. 7. 5  
A ntici pate d N u m ber of St u d y Le ns es Use d  
1 4  
5. 7. 6  
Assess me nt of C o m plia nce 
1 5  
5. 8  
St u d y M aterial A cc o u nta bilit y  
1 5  
5. 9  
I nf or me d C o nse nt 
1 5  
5. 1 0  
St u d y S u bjects 
1 6  
5. 1 0. 1  S u bject Hist or y I n cl usi o n Criteria  
1 6  
5. 1 0. 2  S u bject Hist or y E x cl usi o n Criteria  
1 6  
5. 1 0. 3  Refracti ve Assess me nt I n cl usi o n Criteria  
1 7  
5. 1 0. 4  Oc ular H ealt h Assess m e nt E x cl usi o n Criteria  
1 7  
5. 1 0. 5  Le ns Fitti n g a n d Trai ni n g - Dis pe nsi n g I ncl usi o n Criteria 
1 7  
5. 1 0. 6  V ul nera ble P o p ulati o ns 
1 8  
5. 1 1  
S u bject Disc o nti n uati o n 
1 8  
5. 1 2  
Pr oce d ure f or Re placi n g S u bjects  
1 8  
5. 1 3  
D urati o n of t he I n v esti gati o n 
1 8
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5. 1 4  
Pre mat ure St u d y T er mi n ati o n or S us pe nsi o n 
1 8  
5. 1 5  
Data M o nit ori n g C o m mittee I nf or m ati o n 
1 8  
6  
S T U D Y P R O C E D U R E S  
1 8  
6. 1  
E nr oll me nt Pr oce d ures 
1 8  
6. 2  
Scree ni n g, Ra n d o mizati o n/ Trial Fitti n g, Trai ni n g/ Dis pe nsi n g  
1 9  
6. 2. 1  
Scree ni n g  
1 9  
6. 2. 2  
Ra n d o mizati o n/ Trial Fitti n g  
1 9  
6. 2. 3  
Trai ni n g/ Dis pe nsi n g  
1 9  
6. 3  
St u d y Visit Sc he d ule a n d Pr oce d ures 
2 0  
6. 3. 1  
Sc he d ule d Visit Wi n d o ws 
2 0  
6. 3. 2  
U nsc he d ule d Visits 
2 0  
6. 3. 3  
Detaile d Des cri pti o n of St u d y Visits a n d Cli nical Meas ure me nts  
2 0  
6. 3. 4  
Rec or di n g S o urce Data  
2 5  
6. 3. 5  
C orrecti o ns or C ha n ges t o St u d y Data 
2 5  
6. 4  
Criteria a n d Pr oce d ures f or S u bject E xit 
2 6  
6. 4. 1  
Reas o ns F or E xit 
2 6  
6. 4. 2  
Data t o be c ollecte d at E xit  
2 7  
6. 4. 3  
Visit Re q uire me nts f or S u bjects E xite d Pri or t o St u d y C o m pleti o n   
2 7 
6. 5  
A d verse E v e nt Re p orti n g a n d Ma na ge m e nt 
2 8  
6. 6  
Criteria f or St u d y C o m pl eti o n  
2 8  
6. 7  
Me dical Care f or S u bjects after St u d y C o m pleti o n  
2 8  
7  
S T U D Y M O NI T O RI N G  
2 8  
7. 1  
M o nit ori n g Pla ns 
2 8  
7. 2  
Access t o S o urce Dat a a n d S o urce Data Verificati o n  
2 8  
8  
S T A TI S TI C A L C O N SI D E R A TI O N S  
2 9  
8. 1  
St u d y Desi g n, a n d A n al ytical Met h o d  
2 9  
8. 2  
Sa m ple Size J ust ificati o n 
2 9  
8. 3  
A nal ysis & Pr oce d ures 
2 9  
8. 4  
Pri mar y Safet y E n d p oi nt 
2 9  
8. 5  
Pri mar y Efficac y E n d p oi nt 
3 0  
8. 6  
A d diti o nal E n d p oi nt A nal ysis 
3 1  
8. 6. 1  
Sec o n dar y Saf et y E n d p oi nts 
3 1  
8. 6. 2  
Sec o n dar y Efficac y E n d p oi nts 
3 1  
8. 7  
A d diti o nal Statistical C o nsi derati o n  
3 1  
8. 7. 1  
I nteri m A nal ysis 
3 1  
8. 7. 2  
St u d y C o m pleti o n or Ter mi nati o n  
3 1  
8. 7. 3  
Pr oce d ures f or Re p orti n g De viati o ns fr o m t he Statistical Pla n  
3 2  
8. 7. 4  
S pecificati o ns of S u b gr o u ps f or A nal ysis 
3 2  
8. 7. 5  
Pr oce d ures f or A cc o u nti n g f or All Data 
3 2  
8. 7. 6  
Treat me nt of Missi n g, U n use d or S p uri o us Data 
3 2  
8. 7. 7  
J ustificati o n f or E x cl u di n g D ata fr o m t he T esti n g of t he H y p ot hesis  
3 2 
8. 7. 8  
Mi ni m u m/ Ma xi m u m N u m ber of S u bjects at Eac h I n v esti gati o nal Site   
3 2 
8. 7. 9  
Fact ors W hic h Ma y C o m pr o mise O utc o mes or I nt er pret ati o n of Res ults  
3 2  
9  
D A T A M A N A G E M E N T  
3 2  
9. 1  
Pr oce d ures f or D ata Re vi e w, Data Clea ni n g, Iss ui n g a n d R es ol vi n g Q u eries  
3 2  
9. 2  
Pr oce d ures f or V ali dati o n of Electr o nic D ata bas es  
3 3  
9. 3  
Data Ar c hi vi n g  
3 3  
9. 4  
Rete nti o n Peri o d 
3 3  
9. 5  
Ot her As pects of Q ualit y Ass ura nce 
3 4  
1 0  C LI NI C A L I N V E S TI G A TI O N A L P L A N D E VI A TI O N S  
3 4
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A B B R E VI A TI O N S A N D D E FI NI TI O N S  
 
A B B R E VI A TI O N S 
A E  
A d verse E v e nt  
C F R  
C o de of Fe d er al Re g ul ati o ns  
C R F  
Case Re p ort F or m  a n d eC R F f or Electr o ni c F or ms  
C R O  
C o ntract Resear c h Or ga nizati o n  
D 
Di o pter 
D W  
Dail y Wear  
F D A   
U. S. F o o d & Dr u g A d mi nistrati o n 
F R S   
F oresi g ht Re g ulat or y Strate gies, I nc.  
G C P  
G o o d Cli nical Practices  
HI P A A   
Healt h I ns ura nce P orta bilit y a n d A cc o u nta bilit y A ct 
I B 
Cli n ical I n vesti gat or’s Br oc h ure 
I C D  
I nf or me d C o nse nt D o c u me nt 
I D E 
I n v esti gati o nal De vice E x e m pti o n 
I R B/I E C 
I nstit uti o nal/I n d e pe n d e nt Re vie w B o ar d  / I n de p e n de nt Et hics C o m mittee  
I S O  
I nter nati o nal Sta n dar ds Or ga nizati o n 
M K  
Micr o bial Ker atitis  
M P S  
M ulti - P ur p ose Disi nfecti o n Le ns C are S yste m  
O H R P  
Office f or H u ma n R esearc h Pr otecti o ns  
O H S R 
Office f or H u ma n S u bjects Researc h  
P HI  
Pr otecte d Healt h I nf or mati o n  
Q A   
Q ualit y Ass ur a nce 
Q C   
Q ualit y C o ntr ol 
S A E   
Seri o us A d verse E v e nt / Seri o us A d verse E x perie nce 
S C L  
H y dr o gel  C o ntact Le ns  
S H C L   
Silic o ne H y dr o gel C o ntact Le ns 
S O P   
Sta n dar d O per ati n g Pr o ce d ure 
U A D E  
U na ntici pate d A d v erse D e vice Effect  
U S A D E  
U na ntici pate d Seri o us A d verse D e vice Effect  
V A  
Vis ual Ac uit y  
 
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A B B R E VI A TI O N S A N D D E FI NI TI O N S  
D E FI NI TI O N S 
 
Pri nci p al I n vesti g at o r: ( PI) 
A d ul y lice ns e d a n d pr o p erl y trai ne d i n di vi d ual res p o nsi ble f or t he c o n d uct of t he cli nical 
st u d y at t he st u d y site. If a trial is c o n d ucte d b y a tea m of i n di vi d uals at a trial site, t he 
Pri nci pal I n v esti gat or is t he res p o nsi ble lea d er of t he tea m.  T he PI  m ust ha v e t he q ualificati o n 
of a n O pt o metrist or O p ht hal m ol o gist.  
S u b -I n vesti g at or: ( SI) A n i n di vi d ual me m ber of t he cli nical st u d y tea m d esi g nat e d a n d 
s u per vise d b y t he pri nci p al i n vesti gat or. T h e i n di vi d ual is a ble t o perf or m critical  st u d y-
relate d pr o ce d ur es a n d/ or t o ma ke i m p orta nt st u d y- relate d d ecisi o ns.  T hese pr o perl y trai ne d 
i n di vi d uals ma y be st u d y c o or di nat ors, resi de nts, researc h fell o ws or pr o perl y q ualifie d a n d 
lice nse d O pt o metrists or O p ht hal m ol o gists.  
Lice nse d I n vesti g at or:  F or t he p ur p os e of t his pr ot oc ol a Li ce nse d I n vesti gat or will be a n 
O pt o metrist or O p ht hal m ol o gist w h o p ossesses a c urre nt lice nse i n g o o d sta n di n g f or t h e 
State w here h e/s he is c urre ntl y practici n g  a n d partici pati n g i n t he cli nical st u d y.   
I n vesti g at or: F or t he p ur p oses of t his pr ot oc ol, a n I n v esti gat or will be a n y of t he i n di vi d uals 
descri be d i n t he d efi niti o ns a b o ve of Pri nci pal I n v esti gat or a n d S u b-I n vesti gat or.  
D at a C ollecti o n a n d E ntr y:  D ata c ollect i o n a nd e ntr y m a y be perf or m e d b y t he Pri nci pal 
I n v esti gat or or a n y of t he vari o us le vels of q ualifie d S u b-I n v esti gat ors.  O nl y t he PI or a 
pr ofessi o nall y lice nse d O pt o metrist or O p ht hal m ol o gist SI m a y re vie w t he re vie w visit data 
e ntere d a n d c o m plete t he si g nat ur e f or m at t he c o m pleti o n of t he visit .  
I n vesti g ati on al M ateri als:  T he materials e v al uat e d i n t he cli nical st u d y will be desi g nate d as 
eit her t he Test or C o ntr ol material.  T he T est material will be a  ne w mat erial t hat has n ot bee n 
pre vi o usl y clear e d or d eter mi ne d t o be s u bsta ntiall y e q ui val e nt usi n g t he F D A’s 5 1 0( k) 
re vie w pr o cess.  T h e material desi g nate d as t he C o ntr ol will ha ve pre vi o usl y bee n re vie w b y 
F D A a n d h as recei ve d a clear a nce u n d er t he F D A’s 5 1 0( K) re vie w pr o cess.        
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1  B A C K G R O U N D 
H y dr o gel  C o ntact Le ns es  ( S C Ls) a n d Silic o ne H y dr o gel C o ntact Le nses ( S H C L s) 
ha ve bee n de vel o p e d a n d mar kete d wit h a n u m ber of wear a n d care m o d alities t o meet 
a variet y of o c ular h ealt h a n d c o n ve nie n ce n ee ds.  T hese m o dalities i ncl u de t he 
peri o ds of le ns use a n d dis p osal w herei n le ns es are w or n f or m o nt hs, wee ks, or o ne 
da y pri or t o  dis p osal. Le nses use d f or m ore t ha n a si n gle use re q uire t h e use of 
access or y le ns care s yste ms ( m ulti ple or si n gle b ottles) f or le ns clea ni n g, o ver ni g ht 
st ora ge, disi nfecti o n a n d le ns ri nsi n g pri or t o re peate d i nserti o n. 
T he S p o ns or has de vel o p e d a silic o ne h y dr o gel c o ntact le ns material f or us e i n a  
rec o m me n de d o n e m o nt h re place me nt m o dalit y.  T he material c h aracteristi cs of t his 
f or m ulati o n place t he material i nt o t he F D A Classificati o n f or Silic o ne H y dr o gel 
materials of  Gr o u p 5. Usi n g t his i nf or mati o n t he st u d y is desi g ne d t o e v al uate t he ne w 
C o o per Visi o n silic o ne h y dr o gel c o ntact le ns m aterial ( Test Le ns) t o de m o nstrate 
s u bsta ntial e q ui vale nce t o a material i n t he sa me class  ( C o ntr ol Le ns). 
2  
S T U D Y O B J E C TI V E  
T he o bjecti ve of t his e v al uat i o n is t o pr o vi de e vi de nce s u p p orti n g t he clai m t hat t he 
perf or ma n ce of t he Test Le ns  is s u bsta ntiall y e q ui vale nt t o t hat of t he C o ntr ol Le ns  
w he n use d i n a o n e m o nt h  rec o m me n de d re place me nt, dail y w ear m o dalit y. 
Base d o n pre vi o us e v al uati o ns of t his le ns desi g n a n d material  f or m ulati o n a n d 
p u blis he d i nf or mati o n o n t he perf or m a nce of ot her c o ntact le nses mar kete d f or si milar 
uses, a n d base d o n t h e F D A Pre mar k et N otificati o n 5 1 0( k) G ui da nce D oc u me nt f or 
Dail y Wear C o ntact Le ns es ( Ma y 1 9 9 4) t his is a n o n- si gnifica nt ris k st u d y.  
3  
I N V E S TI G A TI O N A L P R O D U C T S 
B ot h I n vi g or A a n d I n vi g or B le ns es are silic o ne h y dr o gel c o ntact le ns es. T hey will 
be use d f oll o wi n g a dail y wear  s c he d ule wit h  a rec o m me n de d re place me nt s c he d ule 
of o ne m o nt h.   
3. 1  
I n vesti g ati o n al Le ns N a me s a n d Descri pti o n s 
B ot h I n vi g or A a n d I n vi g or B silic o ne h y dr o gel c o ntact le nses are ma n ufact ure d b y 
C o o per Visi o n, I n c.  Eac h st u d y le ns has a n o n-i o nic s urface a n d re q uires n o s urface 
treat me nt t o i m part wetta bilit y. 
Eac h le ns t y pe will be a v aila ble i n t he f oll o wi n g p o wers a n d dia m eters: 
Le ns P o w er s:  
 
- 0. 5 0 D t o - 6. 0 0 D ( 0. 2 5 D ste ps) 
- 6. 5 0 D t o - 8. 0 0 D ( 0. 5 0 D ste ps)
Le ns Dia meter s:  
1 4. 2m m
Base C ur v e:  
Eac h le ns t y pe h as a si n gle base c ur ve. T he b ase 
c ur ve of t h e I n vi g or A le ns is 8. 5 m m a n d t he 
I n vi g or B is 8. 6 m m.
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3. 2  
Le ns P ac k a gi n g a n d L a beli n g  
Eac h le ns blister pac k is la bele d wit h p o wer, dia m eter, bas e c ur v e, l ot n u m ber, 
e x pirati o n date, q ua ntit y, le ns na me, sterilit y met h o d/stat us a n d ma n ufact uri n g 
l ocati o n.  T he blister  a n d o uter pac k a gi n g is i de ntifie d as i n vesti gati o nal pr o d uct wit h  
t he state me nt, “ Ca uti o n-I n vesti gati o nal de vi ce, Li mite d b y Fe deral ( or U S) la w t o 
I n v esti gati o nal use”. 
3. 3  
Le ns Pr o d uct A cc o u nt a bilit y  
Test a n d C o ntr ol  le nses will be trac ke d t hr o u g h t he use of bas e c ur v e, p o wer a n d  l ot 
n u m bers i m pri nte d o n t he la bel . All  le nses recei v e d b y t h e i n vesti gati o nal sites will be 
verifie d a gai nst t he e ncl ose d  pac ki n g sli p . All  le nses dis pe nse d t o t he st u d y s u bjects 
d uri n g t he i n vesti gati o n will be rec or d e d o n I n ve nt or y C o ntr ol- Le ns  f or m.  T he site 
wil l be res p o nsi ble f or i n ve nt or y m a na ge m e nt, li mite d access st ora ge a n d c o nti n ue d 
i n ve nt or y acc o u nt a bilit y. T he st u d y m o nit or will rec o ncile i n ve nt ori es re m ai ni n g at 
t he sites a gai nst  pr o d uct r elease d t o, recei ve d b y t h e sites a n d use d d uri n g t h e 
i n vesti gatio n. Pr oce d ures f or t he st u d y pr o d uct acc o u nta bilit y  are d etaile d i n Secti o n 
5. 8 . 
3. 4  
I n dic ati o ns f or Use 
B ot h Test  a n d C o ntr ol le nses are i nte n d e d t o be use d as dail y wear  le nses f or t he 
c orrecti o n of vis ual ac uit y i n pers o ns wit h n o n- disease d e yes wit h n o m ore t ha n 1. 5 0  
di o pters  of refracti ve asti g matis m  wit h a rec o m me n de d re place me nt peri o d of o ne 
m o nt h.   
3. 5  
S u bject A dj u nct Pr o d ucts t o be Use d i n t he St u d y  
T he Test  a n d C o ntr ol le nses are d esi g n e d f or fre q ue nt re placeme nt.  
J o h ns o n & J o h ns o n Bli n k Re vita Le ns ® M ulti p ur p ose Disi nfecti n g S ol uti o n  will be 
t he pri mar y m ulti - p ur p ose le ns care s yste m f or t his st u d y. Alc o n Clear Care ® 
Clea ni n g a n d Disi nfecti o n S ol uti o n will be use d as a n alter nati ve f or t h ose s u bjects 
w h o ha ve a hist or y of, or prese nt wit h, se nsiti vities or re d uce d weari n g ti mes 
ass ociate d wit h c h e micall y pres er ve d  m ulti -p ur p ose le ns care s yste ms . S u bjects ma y 
be s witc he d fr o m J o h ns o n & J o h ns o n Bli n k Re vita Le ns ® M ulti p ur p ose Disi nfecti n g 
S ol uti o n t o t he Alc o n C lear Care ® Clea ni n g a n d Disi nfecti o n S ol uti o n , if re q uire d 
d ue t o s y m pt o ms. Me nic o n Lacri p ure will be dis pe nse d at t he lice ns e d i n vesti gat ors 
discre ti o n t o be use d as a ri nsi n g s ol uti o n f oll o wi n g disi nfecti o n wit h Alc o n Clear 
Care ® a n d pri or t o le ns i nserti o n.  Mi n or s ol uti o n relate d s y m pt o ms or s u bjecti ve 
fi n di n gs d o n ot q ualif y as a n a d vers e e v e nt u nless acc o m pa ni e d b y t he pres e nce of a 
gr a de 3 or great er slit la m p fi n di n g. 
I n v esti gati o nal Sites will be pr o vi de d  wit h  E ye - C e pt, a n o n-pres er ve d si n gl e d ose 
re wetti n g dr o ps c o ntai ni n g an a q ue o us s ol uti o n of s o di u m c hl ori de a n d b ori c aci d. 
E ye -Ce pt  Re wetti n g Dr o ps are t he o nl y re wetti n g dr o ps t hat ma y  b e use d b y st u d y 
s u bjects.   
T he use of o ver- t he-c o u nter (O T C ) artifici al te ars  w hile w e ari n g le nses  is 
pr o hi bite d i n t his st u d y.  
 
Pr ot oc ol Pa ge 9 of 1 0 1
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
 
3. 6  
Occ u p ati o n al H az ar ds a n d S afe H a n dli n g  
N o s pecific o cc u pati o nal hazar ds ha ve b ee n i de ntifie d w it h t he use of c o ntact le nses.  
Use of le nses i n dr y or d ust y e n vir o n me nts is disc o ura ge d.  T h e use of le ns es w hile 
s wi m mi n g or s oa ki n g i n h ot t u bs is pr o hi bite d d uri n g t his st u d y. H a n dli n g of c o nt act 
le nses s h o ul d al w a ys be d o ne wit h cle a n a n d  dr y  h a n ds .  
3. 7  
St or a ge Re q uire me nts a n d E x pir ati o n D ati n g 
It is rec o m me n de d t hat all le nses a n d s ol uti o ns be st ore d at r o o m te m perat ure o ut of 
direct s u nli g ht. T he y s h o ul d n ot be all o we d t o freeze pri or t o use or d uri n g o ver ni g ht 
st ora ge as t his ma y da ma ge t h e le ns materi al or s ol uti o ns f or m ulati o ns.  T he pr o d uct 
e x pirati o n  date is pri nte d o n t he i m me diate le ns a n d s ol uti o n pac k a gi n g.  
3. 8  
D os a ge a n d A d mi nistr a ti o n 
C o ntact le nses ar e user a p plie d de vices. O nl y o ne st u d y c o ntact le ns per e ye at a n y 
o ne ti me is all o we d.  
3. 9  
Tr ai ni n g f or Use of t he St u d y Pr o d ucts  
T he st u d y s u bjects m ust  be i nstr ucte d  a n d d eter mi ne d t o be c o m pete nt b y t he 
i n vesti gati o nal site as t o t he pr o per h a n dli n g, i nserti o n a n d re m o val tec h ni q ues, use 
a n d re place me nt of car e s yste ms a n d t he pr o per acc o u nti n g a n d dis p osal of t he use d  
le nses. Trai n i n g will be i n acc or d a nce wit h t he i nf or mati o n pr o vi de d i n A p pe n di x H 
f or eac h pr o d uct.  Patie nt care i ns tr u cti o ns will be pr o vi de d t o t he s u bject at t he ti me 
of i nitial le ns dis pe nsi n g.  
3. 1 0  S ur gic al a n d/ or Me dic al Pr o ce d ures  
N o s pecific s ur gi cal  pr oce d ures are re q uire d as a p art of t his i n vesti gati o n.  Sta n dar d 
o p ht hal m ic e x a mi nati o n pr oce d ures will be perf or me d d uri n g t he st u d y visits.   
4  
J U S TI FI C A TI O N F O R T H E S T U D Y 
4. 1  
Liter at ure R e vie w  
A re vie w of t he literat ur e ass ociate d wit h h y dr o gel a n d silic o ne h y dr o gel c o ntact 
le nses has  i n dicate d t hat t he use of c o nt act le nses is a safe a n d effecti ve m ea ns of 
c orrecti n g vis u al ac uit y i n pers o ns wit h n o n-disease d e yes.   
4. 2  
S u m m ar y of Precli nic al St u dies  
T o xic ol o gical a n d micr o bi ol o gical testi n g as liste d i n  t he U nite d States F o o d & Dr u g 
A d mi nistrati o ns’ ( F D A ) Pre mar ket N otificati o n 5 1 0( k) G ui da nce D oc u m e nt f or Dail y 
Wear C o ntact Le nses ( Ma y 1 9 9 4) as w ell as t he a p pr o priate n or mati ve g ui da nce 
d oc u me nts f o u n d i n I S O 1 4 5 3 4  ha ve bee n perf or me d o n t he Test Le ns material.  T he 
material has  bee n f o u n d t o be s uita ble f or cli nical st u dies base d o n t he res ults of t his 
testi n g. S u m maries of t hese res ults  ha ve b ee n pr o vi de d t o t he I R B wit hi n t he 
I n v esti gat or Br oc h ur e as part of t he pr ot oc ol re vie w. T his i nf or mati o n will als o be 
i ncl u de d f or I n v esti gat or re vie w wit h i n t he Site Bi n der. T he C o ntr ol Le ns is a n F D A-
clear e d de vice;  t heref ore, n o a d diti o nal precli nical st u dies ha ve bee n p erf or me d o n 
t his le ns pri or t o t his cli nical i n vesti gati o n. 
4. 3  
S u m m ar y of Pre vi o us Cli nic al St u dies 
Pr ot oc ol Pa ge 1 0 of 1 0 1
Please ref er t o t he  I n v esti gat or Br o c h ure f or a s u m mar y of t he pre vi o us cli nical 
i n vesti gati o ns c o n d uct e d f or t he le nses us e d i n t his st u d y. 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
•  Slit La m p Bi o micr osc o p e or Vi de osc o p e  
* * Cali brati o ns rec or ds re q ui re d t o be mai ntai ne d i n I n vesti gati o nal Site 
files.  
Gra di n g scal es f or r ec or di n g t he o bser vati o ns are pr o vi de d i n A p pe n di x E . 
 
5. 7  
I n vesti g ati o n al Le ns  a n d C o m p ar at o r 
T his st u d y has o ne i n vesti gati o nal ( T est) silic o ne h y dr o gel c o ntact le ns, a n d o ne F D A 
clear ed c o m parat or ( C o ntr ol) silic o ne h y dr o gel c o ntact le ns. 
5. 7. 1  I n vesti g ati o n al Test  Le nses  
T he Test Le ns  is an i n vesti gati o nal  c o ntact le ns  ma n ufact ure d b y 
C o o per Visi o n I n c.    
5. 7. 2  C o m p ar at or C o nt r ol  Le nses  
T he C o ntr ol Le ns is a c o ntact le ns c urre ntl y m ar k ete d a n d  ma n ufact ure d b y 
C o o per Visi o n I n c.  T he C o ntr ol L e ns w as c h ose n beca use it has b ee n cleare d 
b y F D A f or dail y wear  wit h a  fre q ue nt re place me nt a n d has a k n o w n safet y 
pr ofile.  
5. 7. 3  E x p os ure t o St u d y Le nses  
St u d y s u bj ects ar e dis pe nse d wit h eit her t he Test  or t he C o ntr ol le nses. T he 
s u bjects will use t he le nses f or dail y w ear  wit h fre q ue nt re place me nt sc h e d ule 
of o ne m o nt h.  If nee de d, t he lice nse d i n vesti gat or ma y a dj ust t he re place me nt 
sc he d ule t o a s h orter re pl ace me nt sc h e d ule t o i m pr o ve t he weari n g e x perie nce 
or oc ular h ealt h of t he s u bject. Reas o ns f or prescri bi n g a s h ort er re place me nt  
c ycle will be d oc u m e nte d o n t he co m me nts secti o n of t he e C R Fs. T he 
s u bject’s t otal e x p os ure t o t he le nses will be base d o n eac h s u bject’s re p orte d 
dail y le ns w eari n g ti me , a vera ge da ys w or n per w ee k a n d le n gt h of ti me i n t he 
st u d y. 
5. 7. 4  C o nc o mit a nt Me dic ati o n/ Tre at me nt  
N o c o nc o mita nt me dicati o ns or treat me nts are pla n ne d f or use i n t his st u d y. 
5. 7. 5  A ntici p ate d N u m ber of St u d y Le nses  Use d  
It is a ntici pate d t hat ap pr o xi matel y 6 0 0 Test Le ns es will be use d b y 6 0 
s u bjects ( 1 2 0 e yes) a n d a p pr o xi matel y 3 0 0 C o ntr ol L e ns es will be use d b y 3 0 
s u bjects ( 6 0 e yes) d uri n g t he t hree- m o nt h st u d y peri o d. 
T he n u m ber of le ns es pr ojecte d f or us e b y b ot h t he Test  a n d t he C o ntr ol 
s u bjects o ver t he d ur ati o n of t he st u d y (a vera ge 1 0 le nses per s u bject) is base d 
o n t he fact t hat t h e le ns es are i nte n de d t o b e discar de d  at t he M o nt h 1, M o nt h 
2 a n d M o nt h 3 visits .  T heref ore , eac h su bject s uccessf ull y c om pleti n g t h e 
st u d y is e x pecte d t o use a mi ni m u m of 3 le nses per e ye, si x ( 6) le nses i n t otal, 
d uri n g t he 3- m o nt h ( 9 1 Da y) peri o d.  I n a d diti o n, s u bjects ma y re place le nses 
f or a variet y of r eas o ns d uri n g t he st u d y, raisi n g t he le ns usa ge t otals. Reas o ns 
f or all le ns re pl ace me nts i ncl u di n g sc he d ul e d re pl ace me nts will be ca pt ure d o n 
t he Le ns Usa ge Car ds. T hese car ds will be iss ue d t o t he st u d y s u bjects as 
nee de d  a n d re vie we d b y t he st u d y c o or di nat or at eac h st u d y f oll o w- u p visit.  
Pr ot oc ol Pa ge 1 4 of 1 0 1

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
    
5. 7. 6  Assess me nt of C o m pli a nce   
S u bject c o m plia nce t o t he dail y weari n g s c he d ule a n d fre q u e nc y of l e n s 
re place me nt will be assesse d b y t h e i n vesti gati o nal sites d uri n g eac h st u d y 
f oll o w- u p visit.  
A n y s u bject f o u n d t o be n o n- c o m plia nt wit h t he st u d y pr ot oc ol will be 
rei nstr ucte d as t h e c orrect pr oce d ures.  If t he lice nse d i n vesti gat or b elie ves t he 
s u bject is u n willi n g or u n a ble t o be c o m plia nt, t he lice nse d i n vesti gat or ma y 
e xit t he s u bject at a n y ti me.  If t he s u bject c o nti n ues wit h n o n-c o m plia nt 
be ha vi or at t he n e xt sc he d ule d visit , t he s u bject s h o ul d be e xite d fr o m t he 
st u d y. 
5. 8  
St u d y M ateri al Acc o u nt a bili t y 
All st u d y le nses m ust be i n ve nt orie d u p o n recei pt b y t he i n vesti gati o nal site a n d 
st ore d i n a sec ure area, s e gr e gate d fr o m a n y ot her materials, a n d iss ue d o nl y as 
directe d i n t he pr ot o c ol. 
T he i n vesti gati o nal site m ust d oc u me nt t he dis pe nsi n g a n d ret ur n ( u n use d le nses 
o nl y ) of eac h i n vesti gati o nal le ns ( Test a n d C o ntr ol) f or eac h s u bject usi n g t he 
I n v e nt or y C o ntr ol-Le ns  f or m pr o vi de d i n eac h s u bject’s st u d y rec or d o n t he ta blet. 
St u d y s u bj ects m ust disc o nti n ue weari n g t he st u d y le nses at t he e xit visit a n d all use d 
le nses re gar dless of a ge m ust be discar de d  at t he e xit visit .  All u n use d le nses m ust be 
ret ur ne d t o t he i n vesti gati o nal site a n d rec or de d o n t he s u bject’s I n ve nt or y C o ntr ol-
Le ns f or m .  T he le ns es dis pe nse d per e ye m ust be e q ual t o t he s u m of the le nses 
ret ur ne d pl us t he le ns es use d a n d discar de d d uri n g t he st u d y.    
I n v esti gati o nal material acc o u nta bilit y will be c h ec ke d b y t he st u d y m o nit or d uri n g a 
site cl ose o ut visit .  All u n use d le nses, n ot dis pe nse d or ret ur ne d b y t he st u d y s u bjects, 
m ust be retai ne d at t he st u d y site u ntil acc o u nt a bilit y has bee n c hec ke d a n d rec o ncile d 
b y t he st u d y m o nit or.  A n y discre pa n cies i n st u d y le ns acc o u nta bilit y m ust be 
e x plai ne d a n d d oc u me nte d b y t he  st u d y c o or di nat or.  After t he st u d y m o nit or has 
verifie d materi al acc o u nt a bilit y, a n y u n use d mat erials will be ret ur ne d t o F R S or t he 
S p o ns or u nless t he pri nci pal i n vesti gat or is ot her wise directe d i n writi n g b y F R S or 
t he st u d y S p o ns or. 
5. 9  
I nf or me d C o nse nt 
A le gall y c o nstit ute d I nf or me d C o nse nt D oc u me nt  (I C D) m ust be pres e nte d t o t he 
s u bject wit h s ufficie nt ti me t o rea d, as k q u esti o ns a n d recei ve a ns wers t o ma ke a n 
i nf or me d decisi o n r e gar di n g partici p ati o n i n t he st u d y.  T he I nf or m e d C o nse nt 
D oc u me nt m ust be u n derst o o d a n d si g ne d b y eac h st u d y s u bject pri or t o t he s u bjec t 
bei n g e nr olle d i n t he st u d y.  T he i n di vi d ual e x plai ni n g t he I nf or me d C o nse nt 
D oc u me nt  m ust ha ve f ull k n o wle d ge of t he pr ot oc ol, m ust be a ut h orize d b y t he 
pri nci pal i n vesti gat or t o e x plai n t he pr ot oc ol re q uire me nts t o t he s u bject  a n d m ust 
si g n t he d oc u me nt.  A lice nse d i n vesti gat or m ust als o si g n t he Inf or me d C o nse nt 
D oc u me nt a n d pr o vi de a c o p y t o t he s u bject pri or t o treat me nt. 
Pr ot oc ol Pa ge 1 5 of 1 0 1
 
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
5. 1 0  St u d y S u bjects  
T he dis pe nse d st u d y p o p ulati o n will i ncl u de u p t o 9 0  s u bjects w h o re q uire a bilateral 
visi o n c orrecti o n ( 1 8 0  e yes) ra n d o mize d i nt o t he st u d y c o ntact le nses i n a rati o of t w o 
t o o ne ( 2: 1) Test t o C o ntr ol s u bjects.  T his s h o ul d res ult i n a st u d y p o p ulati o n of 
a p pr o xi matel y 6 0 Test  s u bjects a n d 3 0  C o ntr ol s u bjects. 
T he c o m plete d  s u bject p o p ulati o n is e x pecte d t o i ncl u de at least 5 0  T est  s u bjects a n d 
2 5  C o ntr ol s u bjects.  T here ar e n o pr o visi o ns f or re placi n g ra n d o mize d s u bjects w h o 
are disc o nti n ue d fr o m t he st u d y.  
T o be eli gi ble f or st u d y m ateri al  r a n d o miz ati o n, a s u bject m ust h a ve A L L of t he 
I ncl usi o n Criteri a a n d h a ve N O N E of t he E xcl usi o n  Criteri a  f or i niti al 
scree ni n g/s u bject hist or y, refr acti ve ass ess me nt a n d oc ul ar he alt h fi n di n gs.  T o 
be eli gi ble f or le ns dis pe nsi n g, t he s u bject m ust h a ve  at le ast 2 0/ 3 0 V A i n e ac h 
e ye wit h t he st u d y le ns a n d t he lice nse d i n vesti gat or m ust j u d ge  t he fit as 
acce pt a ble or o pti m al . 
5. 1 0. 1  S u bject Hist or y I ncl usi o n Criteri a 
Pri or t o bei n g c o nsi dere d eli gi ble t o partici p ate i n t his st u d y, eac h s u bject 
M U S T : 
1.  Be at least 1 8 years of a ge as of t he d ate of e v al uati o n f or t he st u d y.  
2.  H a ve: 
a.  Re a d t he I nf or me d C o nse nt  D oc u me nt  
b.  B ee n gi ve n a n e x pl a n ati o n of t he I nf or me d C o nse nt D oc u me nt  
c. In dic ate d u n derst a n di n g of t he I nf or me d C o nse nt  D oc u me nt  
d.  S i g ne d t he I nf or me d C o nse nt D oc u me nt 
3.  Be willi n g a n d a ble t o a d here t o t he i nstr ucti o ns pr o vi de d b y t he 
i n vesti gati o nal site a n d b e willi n g a n d a ble t o kee p all s pecifie d 
a p p oi nt me nts. 
4.  Be a n a da pte d, fre q u e nt re place m e nt , c urre nt  f ull-ti me silic o ne h y dr o gel or 
s oft c o ntact le ns wearer. A n a da pte d f ull-ti me w earer is defi n e d as w eari n g 
c o ntact le nses at least 5 d a ys p er  w ee k  f or at least 8 h o urs per da y f or at 
least o ne m o nt h pri or t o partici pati o n i n t he st u d y.  
5.  P ossess or o btai n pri or t o dis pe nsi n g, weara ble a n d vis uall y f u ncti o nal 
( 2 0/ 4 0 or better) e ye glass es.  
6.  Be i n g o o d ge n eral h ealt h, base d o n his/ her k n o wle d ge. 
5. 1 0. 2  S u b ject Hist or y E xcl usi o n Criteri a  
S u bjects ma y n ot be e nr olle d i n t his st u d y if a n y of t he f oll o wi n g a p pl y:  T he 
s u bject is c urre ntl y or h as:  
1.  Weari n g le ns es i n a m o n o visi o n m o dalit y a n d is u n willi n g t o be fit wit h 
dista nce le nses i n b ot h e yes f or t he d urati o n of t he st u d y .  N O T E:  
S u bjects m a y n ot w e ar l e nses i n a m o n o visi o n m o d alit y at a n y ti me 
d uri n g t he st u d y as it will i nterfere wit h t he vis u al ac uit y a n al ysis.  
2.  P o or pers o nal h y gie ne. 
3.  A n y acti ve partici pati o n i n a n ot her cli nical trial d uri n g t his trial or wit hi n 
3 0 da ys pri or t o t his st u d y. 
4.  
Pr ot oc ol Pa ge 1 6 of 1 0 1
T o t he best of t he s u bject’s k n o wle d ge, s he is c urre ntl y pre g na nt, is 
lactati n g or is pla n ni n g a pre g na nc y wit hi n t he ne xt 3 m o nt hs. 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
5.  A me m ber, r elati ve or h o use h ol d me m ber of t he i n vesti gat or(s) or of t he 
i n vesti gati o nal offi ce staff.  
6.  A  k n o w n se nsiti vit y t o t he i n gre die nts use d i n t he M P S a p pr o ve d f or use i n 
t he st u d y a n d is u na bl e or u n willi n g t o use t he alter nate care s yste m. 
7.  Ha d p re vi o us r efr acti ve s ur ger y; or c urre nt or pre vi o us ort h o kerat ol o g y 
treat me nt. 
8.  A p ha kic or pse u d o p h a kic.  
9.  Oc ular or s yste mic disease s uc h as, b ut n ot li mite d t o: a nteri or u veitis or 
iritis ( past or prese nt), gl a uc o ma, Sj ö gre n’s s y n dr o me, l u p us 
er yt h e mat os us, scler o d er ma, kerat oc o n us or u nc o ntr olle d dia betes . 
1 0.  T he nee d f or t o pical oc ul ar me dicati o ns or a n y  s yste mic me dicati o n w hic h 
mi g ht i nterfere wit h c o nt act le ns wear or re q uire t he le nses t o be re m o ve d 
d uri n g t he d a y. 
1 1.  A k n o w n hist or y of c or n eal h y p oest hesia (re d u ce d c or neal s e nsiti vit y), 
c or neal ulcer, c or neal i nfiltrates , iritis, bacterial  or f u n gal i nfecti o ns. 
1 2.  A hist or y of p a pillar y c o nj u ncti vitis t hat has i nterfere d wit h c o ntact le ns 
wear.  
5. 1 0. 3  Ref r acti ve Ass ess me nt I ncl usi o n  Criteri a  
D oes t he s u bject  
1.  Re q uire s pectacle le ns p o wers bet w ee n - 0. 5 0 a n d - 8. 0 0 di o pters s p here 
wit h n ot  m ore t ha n 1. 50 di o pte r of refracti ve asti g matis m a n d be willi n g t o 
wear c o ntact le ns es c orrecte d f or t heir f ull dista nce prescri pti o n i n b ot h 
e yes.  
2.  Ha ve ma nif est refracti o n S nelle n vis ual ac uit y e q u al t o or better t ha n 2 0/ 2 5 
i n eac h e ye. 
5. 1 0. 4  Oc ul ar He alt h Assess me nt E xcl usi o n Criteri a  
D oes t he s u bject ha v e  
1.  Cli nicall y  si g nifica nt ( gra de 2, 3 or 4) a nteri or s e g me nt a b n or malities; or 
t he prese n ce of a n y i nfecti o n of t he e ye, li ds, or ass ociate d str uct ures.  
2.  Pat h ol o gical dr y e ye or ass ociate d dr y e ye s y m pt o ms wit h decreas e d tear 
le vels a n d p u nct uate st ai ni n g > Gra d e 2  
3.  Pter y gi u m 
4.  C or neal scars wit hi n t he vis ual a xis  
5.  Ne o vasc ularizati o n or g h ost vessels > 1. 0 m m i n fr o m t he li m b us 
6.  Gia nt pa pillar y c o nj u ncti vitis of > Gra de 2  
7.  A n y i nfla m mati o ns s uc h as a nteri or u v eitis or iritis  
8.  Se b orr heic ecz e ma, se b orr heic c o nj u ncti vitis or ble p haritis 
5. 1 0. 5  Le ns Fitti n g a n d Tr ai ni n g -Dis pe nsi n g I ncl usi o n Criteri a  
1.  D oes t he s u bject ac hie ve S nelle n vis ual ac uit y of 2 0/ 3 0 or better wit h t he 
st u d y le ns a n d t he lice nse d i n vesti gat or j u d ges t he fit as acce pta ble or 
o pti ma l i n eac h e ye?  
2.  Has t he s u bject bee n c o m pletel y trai ne d i n t he use of t he le ns care s yste m?  
3.  Is t he s u bj ect pr ofici e nt i n t he i nserti o n a n d re m o v al of t he le nses? 
 
Pr ot oc ol Pa ge 1 7 of 1 0 1
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
 
5. 1 0. 6  V ul ner a ble P o p ul ati o ns  
T his st u d y i ncl u des n o s p ecific v ul nera ble p o p ulati o ns.  All s u bjects are 
e x pecte d t o be at t he a ge of maj orit y as defi ne d b y t he State  or C o m m o n wealt h 
of t he i n vesti gati o nal site  a n d ha ve t he a bilit y t o freel y c o nse nt t o partici pate 
i n t he st u d y. 
 
5. 1 1  S u bject Disc o nti n u ati o n  
A s u bject’s st u d y p artici pati o n ma y b e disc o nti n ue d at a n y ti me if, i n t he o pi ni o n of 
t he s u bject, t he lice nse d i n vesti gat or, t h e I R B, or t he S p o ns or, it is t he best i nterests 
of t he s u bject.  A n y f e male s u bjects w h o bec o m e pre g na nt d uri n g t he st u d y m ust 
i m me diatel y discl ose t his fact t o t he lice nse d i n vesti gat or a n d will be i m me diatel y 
e xite d fr o m t he st u d y. 
5. 1 2  Pr o ce d ure f or R e pl aci n g S u bjects  
T here is n o pr o ce d ur e f or re placi n g t he st u d y s u bjects w h o meet all t he 
i ncl usi o n/e x cl usi o n criteria f or ra n d o mizati o n.  T h e e nr olle d st u d y p o p ulati o n 
i ncl u des a s ur pl us of s u bj ects t o acc o u nt f or t he e x pecte d  scree n fail ures a n d 
disc o nti n ue d s u bjects. 
5. 1 3  D ur ati o n of t he I n vesti g ati o n 
T he o ver all d urati o n of t he i n vesti gati o nal st u d y will i ncl u de t he st u d y e nr oll me nt 
peri o d of a p pr o xi matel y 4 wee ks, pl us t he s u bject mi ni m u m f oll o w- u p peri o d of 9 1 
da ys ( u p t o 1 5 wee ks ), res ulti n g i n a n o verall st u d y d urati o n of a p pr o xi matel y 1 9 
wee ks.  
5. 1 4  Pre m at ure St u d y Ter mi n ati o n or S us pe nsi o n  
T he cli nical st u d y ma y b e s us pe n de d or t er mi nate d b y t he S p o ns or a n d/ or t he 
re vie wi n g I R B at a n y ti m e if, i n t he o pi ni o n of t he S p o ns or or t he I R B, it is i n t he best 
i nterests of t he st u d y p artici pa nts. 
If t he decisi o n is ma de t o ter mi nate t he st u d y, all sites will be n otifie d t o call i n t he 
st u d y s u bjects, perf or m a fi nal st u d y e x a mi nati o n, c ollect all of  t he st u d y materials 
a n d c o m plete st u d y e xit f or ms a n d d oc u me ntati o n. 
5. 1 5  D at a M o nit ori n g C o m mittee I nf or m ati o n 
T here is n o D ata M o nit ori n g C o m mittee f or t his i n vesti gati o n.  Dat a re vi e w f or safet y 
will be t he res p o nsi bilit y of t he Me dical M o nit or.  
 
6  
S T U D Y P R O C E D U R E S 
6. 1  
E nr oll me nt Pr o ce d ures  
Eac h s u bject w h o is c o nsi dere d f or t h e st u d y m ust be prese nt e d wit h t he I nf or me d 
C o nse nt D oc u me nt, all o we d s ufficie nt ti me t o rea d t he d oc u me nt, as k a n y q uesti o ns 
t hat ma y arise a n d/ or h a v e t he d oc u me nt a n d t h e c o nse nt e x plai ne d t o t he m, a n d t he n 
si g n t he I nf or me d C o nse nt Doc u me nt pri or t o bei n g e x a mi ne d f or eli gi bilit y f or t he 
st u d y. 
If t he s u bject is u na ble t o rea d t he d o c u me nt b ut is a ble t o u n dersta n d t he i nf or mati o n, 
t he c o nse nt ma y be prese nte d a n d e x plai ne d b y a lice nse d
Pr ot oc ol Pa ge 1 8 of 1 0 1
 i n vesti gat or i n t h e prese n ce 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
of a wit ness.  If t h e s u bject u n dersta n ds a n d is i n a gree me nt, all t hree ( lice nse d 
i n vesti gat or, s u bject a n d wit ness) m ust si g n t he d o c u me nt.  
T he I nf or m e d C o nse nt D oc u me nt m ust be u n derst o o d a n d si g n e d b y eac h st u d y 
s u bject pri or t o t he s u bject bei n g e nr olle d i n t he st u d y.  T he i n di vi d ual e x plai ni n g t he 
I nf or me d C o nse nt D o c u me nt  m ust ha ve f ull k n o wle d ge of t he st u d y pr ot o c ol, ha ve 
bee n a ut h orize d b y t he pri nci pal i n vesti gat or a n d m ust als o si g n t he I nf or m e d C o nse nt 
D oc u me nt.   A c o p y of t his d oc u me nt will be pr o vi de d t o eac h s u bject a n d a  c o p y will 
be retai ne d i n t he st u d y Site Bi n der. 
All s u bjects w h o si g n a n I nf or me d C o nse nt  D oc u me nt  are c o nsi dere d t o be 
e nr olle d i nt o t he Cli nic al St u d y ( “ P oi nt of E nr oll me nt ”).  
6. 2  
Scree ni n g,  R a n d o miz ati o n/ Tri al Fitti n g , Tr ai ni n g/Dis pe nsi n g  
6. 2. 1  Scree ni n g  
T he s u bject’s oc ul ar a n d ge n eral h ealt h hist or y will be re vie w e d wit h t he s u bject  
a gai nst t he hist orical i ncl usi o n/e x cl usi o n criteria .  If t he s u bject meets all t he 
hist orical  i ncl usi o n a n d has n o ne of t he e x cl usi o n criteria, t he e x a m ma y pr ocee d t o 
t he c ollecti o n of r efracti ve a n d oc ular healt h i nf or mati o n.  A lice nse d i n vesti gat or will 
t he n re vie w t he i n cl usi o n/e x cl usi o n criteria f or t hese areas.  
6. 2. 2  R a n d o miz ati o n / Tri al Fitti n g 
If a s u bject is f o u n d t o be eli gi ble a n d e x presses i nterest i n partici pati n g i n t he st u d y, 
t he s u bject will be ra n d o mize d i nt o o ne of t he st u d y materials. T he a p pr o priatel y 
ra n d o mize d material will be place d o n t h e s u bject ’s e yes b y t he st u d y c o or di nat or or 
b y t he s u bject u n der t he st u d y c o or di nat or’s s u per visi o n.  A n e val uati o n of t he le ns 
vis ual ac uit y , o v er r efr acti o n, res ulti n g vis ual ac uit y a n d l e ns fit will be perf or me d b y 
a lice nse d i n vesti gat or f oll o wi n g 1 0 mi n utes of a d a ptati o n. U p t o t hree le ns es per e ye  
ma y b e use d t o o pti mize t he vis ual ac uit y.    
S u bjects ca n o nl y b e c o nsi dere d f or l e ns trai ni n g/dis pe nsi n g if: 
1.  T he y h a ve a n acce pta bl e or o pti mal fit as j u d ge d b y a lice nse d i n vesti gat or 
a n d 
2.  T heir S nelle n V is ual A c uit y wit h t he st u d y le ns es is e q ual t o or better t ha n 
2 0/ 3 0 i n eac h e ye.  
6. 2. 3  Tr ai ni n g/ Dis pe nsi n g  
If t he s u bject meets t he i ncl usi o n criteria f or t he fitti n g visit, t he site ma y b e gi n 
trai ni n g t he s u bject i n t he use of t he st u d y care s ol uti o ns a n d t he tec h ni q ues f or 
i nserti o n a n d re m o val of t he le nses.  T he s u bject m ust de m o nstrat e a pr ofi cie nc y i n 
t he i nserti o n a n d re m o val of t he st u d y le ns es as w ell as a n u n dersta n di n g of t he use of 
t he assi g n e d care s yste m. Dis pe nsi n g will be c o nsi dere d t o be t he act of all o wi n g t he 
s u bject t o lea ve t he office wit h t he le nses a n d care syste m  as t he y ha ve m astere d t he 
act of i n de pe n d e nt le ns care.  F oll o w- u p visits s h o ul d be sc he d ule d pri or t o all o wi n g 
t he s u bject t o lea ve t he office.  
I n cl usi o n criteria f or t he Trai ni n g/ Dis pe nsi n g Visit are 
1.  T he s u bject m ust de m o nstrate a n u n dersta n di n g o f t he use of t he st u d y care 
s yste m pr o vi de d t o t he m. 
2.  T he s u bject m ust de m o nstrate t he a bilit y t o h a n dle, i nsert a n d re m o ve t h e le nses. 
Pr ot oc ol Pa ge 1 9 of 1 0 1
 
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
6. 3  
St u d y Visit Sc he d ule  a n d Pr oce d ures  
T he st u d y d urati o n is pla n ne d f or a p pr o xi matel y t hree m o nt hs  f or eac h s u bject wit h 
e x a mi nati o ns at t he I nitial visit, Fitti n g Visit,  Trai ni n g/ Dis pe nsi n g visit, a n d 
Sc he d ule d f oll o w u p visits at  wee k - 1, w ee k -2, m o nt h- 1, m o nt h- 2 a n d m o nt h- 3.  T he 
dis pe nsi n g visit date is t he basis f or sc h e d uli n g all f oll o wi n g visits  a n d f or t he p ur p ose 
of c o u nti n g s c he d ule d f oll o w u p visits t his is c o nsi dere d da y 0 of t he st u d y .   F or t he 
p ur p ose of c o u nti n g le ns weari n g da ys i n t he st u d y, t he d a y t he s u bject starts t o wear 
t he st u d y le nses is da y 1 of le ns wear. T he w ee k -1, wee k -2 a n d  m o nt hl y f oll o w u p 
vi sits will ha ve visit wi n d o ws t hat are b ase d o n t h e dis pe nsi n g visit date as da y 0.  
6. 3. 1  Sc he d ule d Visit Wi n d o ws  
T h e wee k - 1, wee k- 2 a nd m o nt hl y f oll o w u p visits will ha ve visit wi n d o ws t hat 
are bas e d o n t he ti me fr o m t he dis pe nsi n g visit date as f oll o ws: 
 
 
T a bl e 1 : E x a mi n ati o n Visit Wi n d o ws 
D a ys f r o m Dis pe nsi n g  ( D a y 0) 
 
E arliest  
L atest  
Wee k 
1  
5  
9  
Wee k 
2  
1 2  
1 6  
M o nt h 
1  
2 6  
3 4  
M o nt h 
2  
5 6  
6 4  
M o nt h 
3  
9 1  
1 0 5  
Sc he d ule d visits will be t he first visit wit hi n t he visit wi n d o w w here t he 
s u bject prese nts w eari n g le nses.  Visit sc he d ules will be calc ulate d at t he ti me 
of dis pe nsi n g b y t he ta bl et s oft ware a n d a v aila ble t o t he i n vesti gati o nal site f or 
sc he d uli n g f oll o w- u p visits. 
6. 3. 2  U nsc he d ule d Visits  
S u bjects w h o prese nt wit h o ut weari n g le nses wit hi n  a visit wi n d o w, a visit t hat 
fall o utsi de of t he s pecifi e d visit wi n d o ws or re peat visits wit hi n a visit  
wi n d o w  will be classifie d as u nsc he d ule d visits f or a nal ysis p ur p oses. T h e 
U nsc he d ule d visit e x a mi nati o n m ust be c o m plete d as m uc h as  p ossi ble a n d t he 
reas o n f or t he u nsc h e d ule d visit m ust be rec or de d. 
6. 3. 3  Det aile d Descri pti o n of St u d y Visits a n d Cli nic al Me as ure me nts  
T he data t o be c ollecte d a n d t he f or ms t o be c o m plete d at eac h st u d y visit are 
prese nte d i n Fi g ures 1 a n d 2 a n d i n Ta ble 2 a n d T a ble 3 . 
 
Pr ot oc ol Pa ge 2 0 of 1 0 1
 
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
6. 3. 4  Rec or di n g S o urce D at a  
Electr o nic ta blet (i O S or A n dr oi d) e ntr y usi n g  
s oft ware  will be per f or me d i n 
lie u of pa per.  N otes or p a per rec or ds s h o ul d a v oi de d w he ne v er p ossi ble.  All pa per 
rec or d k ee pi n g m ust be s ca n ne d a n d pr o vi de d  
 f or attac h me nts t o t he 
a p pr o priate visit f or ms .  Sites are e nc o ura ge d t o e nter all st u d y d ata directl y o n t he 
electr o nic ta bl et d uri n g t he s u bject visit.   
If f or a n y reas o n st u d y n otes are rec or de d o n pa p er t he n otes m ust be si g n e d a n d date d 
a n d place d i n t he s u bject’s me dical rec or d as a s o urce d oc u m e nt.  C o pies of t his 
i nf or mati o n s h o ul d be pr o vi de d  
 f or attac h me nt t o t he st u d y visit f or ms. E nter 
all st u d y data as re q uir e d f or eac h visit.  U pl oa d of t he st u d y d ata t o t he ce ntral st u d y 
data base will be p erf or me d a ut o maticall y d uri n g t he st u d y visit or ma n uall y at t he 
c o m pleti o n of t he st u d y visit. Eac h pa ge  of eac h visit f or m e x ce pt f or t he I n ve nt or y 
C o ntr ol- Le ns  f or m, m ust be re vie w e d  b y t he lice nse d i n vesti gat or pri or t o acce pti n g 
a n d si g n-off of t h e s o urce d oc u me nts. All visit f or ms re mai n o n t he electr o nic de vice 
u ntil t he c o m pleti o n of t he st u d y.  F oll o w i n g t h e st u d y c o m pleti o n a n d rec o nciliati o n 
of all q ueries ; a D V D wit h P D F c o pies of t he site Case Re p ort F or ms  will be s u p plie d 
t o t he st u d y site.     
W he n usi n g pa per d oc u me nts, ball p oi nt pe n wit h per m a ne nt bl ue or blac k i n k m ust 
al wa ys be use d w he n r ec o r di n g dat a o n st u d y-rel ate d d oc u me nts.  Pe ncil or felt-ti p 
pe ns M A Y N O T  be us e d.   
Writi n g s h o ul d be d o ne fir ml y a n d le gi bl y t o e ns ure t hat t he n otati o ns ca n easil y b e 
rea d, wit h n o stra y, c o nf usi n g or o bsc uri n g m ar ks.  T he i n vesti gati o nal site is 
res p o nsi ble f or e ns uri n g t hat t he s o urce d o c u me nts are le gi ble a n d c o m plete. 
N O T E:   If a n y st u d y i nf or mati o n is c ollecte d usi n g a n a ut o mate d piece of e q ui p me nt, 
t he i nf or mati o n s h o ul d be rec or de d directl y o nt o t he e ntr y scree n fr o m t he i nstr u me nt 
dis pla y or pri nte d o ut p ut.   
If t he a ut o mate d i nstr u m e nt H A S a pri nte d o ut p ut, t he pri nte d o ut p ut M U S T be ke pt 
i n t he s u bject’s me dical file as a s o urce d oc u me nt wit h t he s u bject n u m ber, date of 
rec or di n g a n d si g n at ure of t he a ut h orize d i n di vi d ual c o m pleti n g t he test. F or t her mal 
pa per w h os e i ma ge is u nsta ble, a c o p y of t h e pri nt o ut ca n be pr o d u ce d wit h t he sa me 
i nf or mati o n pri nte d a n d si g ne d o n t he c o p y pa ge s o as t o be a n ori gi nal d oc u me nt. A 
c o p y m ust be s u p plie d  
 f or attac h me nt t o t h e a p pr o pri ate e C R F.     
Le ns Re pl ace m e nt Car d M ust be ke pt wit h t he s u bject’s I nf or m e d C o nse nt d oc u me nt 
i n t he site bi n der as a s o urce d oc u m e nt.  
6. 3. 5  C orrecti o ns or C h a n ges t o St u d y D at a 
As wit h all visit i nf or mati o n, t he lice nse d i n vesti gat ors d o n ot h a ve access t o vie w  
t he st u d y i n vesti gati o nal pr o d uct i nf or mati o n.  A n y c orrecti o ns t o t he i n ve nt or y 
i nf or mati o n ca n o nl y be perf or me d b y t h os e w h o are desi g n ate d as “ St u d y 
C o or di nat ors” u n der t he D uties a n d Res p o nsi bilities detaile d i n t he  
Site 
Pers o n nel & D ele gati o n L o g.  
C orrecti o ns or c h a n ges ma y b e ma de t o all t he re mai ni n g data e ntere d o nt o a n 
electr o nic ta bl et pri or t o or f oll o wi n g acce pta nce a n d s y n c hr o nizati o n .  C orrecti o ns or 
c ha n ges t hat nee d t o be ma de t o data after t he d ata has bee n a p pr o v e d b y t he lice nse d 
i n vesti gat or wil l be p erf or me d usi n g t he q u er y f u n cti o n of t he a p plicati o n . C orrecti o ns 
ma y b e attri b uta ble t o a n y site pers o n nel a ut h orize d t o e nter dat a.  Fi nal acce pta nce of 
a n y q u eries  a n d t he c h a n ges c o ntai ne d wit hi n, 
Pr ot oc ol Pa ge 2 5 of 1 0 1
m ust be a p pr o ve d b y  t he si g nat ure of  

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
t he lice nse d i n vesti g at or w h o c o m plete d t he o ri gi n al visit or if t hat pers o n is n o 
l o n ger a vaila ble, t h e Pri nci pal I n vesti gat or  ma y si g n i n t heir a bs e nce.   
T he data will be c h a n ge d i n t he data base wit h a c o m plete hist or y trac ki n g of all 
i nf or mati o n c o ntai ni n g t h e c han ge, t he pers o n m a ki n g t he c h a n ge, t he d ate a n d ti me 
of t he c ha n ge a n d t he reas o n f or t he c h a n ge. T his i nf or mati o n will be mai ntai ne d i n 
t he data base as part of a data e ntr y a u dit trails.  O nce re vi e we d a n d a p pr o v e d b y t h e 
lice nse d i n vesti gat or t he c orrecte d case re p ort f or m i ma ge will be a vaila bl e t o t he 
i n vesti gati o nal site f or i n cl usi o n i n t he s u bject’s me dical rec or d.  
 
6. 4  
Criteri a a n d Pr oce d ures f or S u bject E xit  
A s u bject’s st u d y p artici pati o n ma y b e disc o nti n ue d at a n y ti me if, i n t he o pi ni o n of 
t he s u bject, a lice ns e d In vesti gat or , t h e I R B, or t he S p o ns or, it is i n t he best i nterests 
of t he s u bject.  A n y f e male s u bjects w h o bec o m e pre g na nt d uri n g t he st u d y m ust 
i m me diatel y discl ose t his fact t o a lice ns e d i n vesti gat or a n d will be i m me diatel y 
disc o nti n ue d fr o m t he st u d y. 
U p o n disc o nti n uati o n fr o m t he st u d y, s u bjects m ust ret ur n all u n use d st u d y le nses t o 
t he i n vesti gati o nal site. 
6. 4. 1  Re as o ns F o r E xit 
0.  St u d y C o m plete d  
P ossi ble reas o ns f or disc o nti n uati o n i ncl u de: 
1.  Scree n Fail ure – t h e s u bject d oes n ot meet t he pr ot oc ol s pecifie d i ncl usi o n 
criteria or h as o ne or m ore of t he e x cl usi o n criteria prese nt.  
1. 1. Pre vi o us Hist or y  
1. 2. Refracti ve Assess me nt  
1. 3. Oc ular H ealt h Assess me nt  
1. 4. Trial Le ns Fitti n g  
1. 5. Trial Le ns  V A  
1. 6. Trial Le ns C o mf ort  
1. 7. S u bject was u na ble t o i nsert/re m o ve le ns es or use care s yste m  
1. 8. Lice nse d I n v esti gat or D ecisi o n  
1. 9. S u bject Decisi o n  
2.  U nacce pta ble  Le ns Fit  – t he s u bject is e xite d fr o m t he st u d y d ue t o a n 
u nacce pta ble le ns fit  at a visit f oll o wi n g dis pe nsi n g.  
3.  U nacce pta ble Vis ual A c uit y  – t he s u bject is u na ble t o o btai n or mai ntai n 
acce pta ble vis ual ac uit y wit h t he st u d y le nses  at a visit f oll o wi n g 
dis pe nsi n g . 
4.  U nacce pta ble Le ns C o mf ort  – t he s u bject is e xite d fr o m t he st u d y f or 
c o mf ort reas o ns at a visit f oll o wi n g dis pe nsi n g . 
5.  O bjecti ve Oc ul ar Fi n di n gs – t he s u bject has bee n e xite d fr o m t he st u d y d u e 
t o o bjecti ve oc ular fi n di n gs t hat are n ot s pecificall y cite d as a d verse 
e ve nts.  T he r eas o n f or disc o nti n uati o n s h o ul d i n dicate t he relati o ns hi p 
(relate d, u nrelate d or u n k n o w n) of t he fi n di n gs t o t he st u d y le ns es.  
Pr ot oc ol Pa ge 2 6 of 1 0 1
T he 
reas o n f or disc o nti n uati o n m ust be rec or d e d i n t he c o m me nts secti o n of t he 
E xit F or m.  

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
6.  A d verse E v e nt  – t he s u bject has bee n re p orte d t o ha ve a n a d vers e e ve nt 
a n d was disc o nti n ue d d u e t o t he a d vers e e v e nt.  
7.  Ot her : S u bject Decisi o n  – t he s u bject deci des f or reas o ns ot her t h a n t h ose 
liste d t o e xit fr o m t he st u d y.  T he reas o n m ust be rec or de d i n t he 
c o m me nts secti o n of t he E xit f or m. 
8.  Ot her : Li ce nse d in v esti gat or, s p o ns or or I R B Decisi o n – t he s u bject is 
e xite d fr o m t he st u d y bas e d o n a decisi o n b y t he li ce nse d in vesti gat or , t he 
S p o ns or or t he re vie wi n g I R B.  T he reas o n f or dis c o nti n uati o n m ust be 
rec or d e d i n t he c o m me nts secti o n of t he E xit F or m. 
9.  Pr ot oc ol De viati o n  – t he s u bject or t he i n vesti gati o nal site is re peate dl y 
f o u n d t o be i n de viati o n of t he st u d y pr ot oc ol.  
N O T E:   S u bjects w h o bec o me pre g n a nt w hile e nr olle d i n t he st u d y m ust 
n otif y a lice nse d  in vesti gat or a n d be disc o nti n ue d fr o m t he st u d y as a 
Pr ot oc ol D e vi ati o n. 
1 0.  L ost t o F oll o w- u p – t h e s u bject fails t o ret ur n f or f oll o w- u p visits .  T o 
classif y a s u bject as “ L ost t o F oll o w-u p” atte m pts  m ust be ma de t o reac h 
t he s u bject b y t h e a p pr o priate mea ns of c o m m u nicati o n f or t his s u bject.  
T his ma y i ncl u de p h o n e, fa x, e mail or te xt messa gi n g. Faili n g t o reac h t h e 
s u bject wit h a n y of t hese a p pr oac h es, t he site s h o ul d atte m pt t o n otif y t h e 
s u bject b y a certifie d em ail  t o t heir last k n o w n a d dress  wit h a ret ur n 
recei pt.  D etails of t he att e m pts t o c o ntact t he s u bject a n d if a v aila ble, the 
details of w h y t he s u bject is c o nsi dere d L ost t o F oll o w- u p m ust be 
rec or d e d i n t he c o m me nts secti o n of t he E xit- L ost to F oll o w U p f or m. 
6. 4. 2  D at a t o be c ollecte d  at E xit  
A c o m plete f oll o w - u p e x a mi nati o n s h o ul d be d oc u me nte d f or eac h s u bject o n 
t he date of e xit.  If t he s u bject is l ost t o f oll o w- u p, t he Exit - L ost T o F oll o w U p 
f or m s h o ul d be c o m plete d wit h t he date of t he last visit s u bject see n as t he e xit 
date.  
6. 4. 3  Visit R e q uire me nts  f or S u bjects E xite d Pri o r t o St u d y C o m pleti o n 
S u bjects w h o disc o nti n ue t he use of t he assi g ne d st u d y le ns  f or a n a d vers e 
e ve nt or oc ular fi n di n gs m ust be f oll o we d as acti v e s u bjects u ntil t he c o n diti o n 
has res ol ve d, r et ur ne d t o pre-st u d y stat us or i n t he o pi ni o n of t he lice nse d 
i n vesti gat or w arr a nts n o a d diti o nal f oll o w- u p as t he o utc o me has bec o me 
per ma ne nt.     
If t he s u bject m ust be f oll o we d be y o n d t he 3 m o nt h st u d y peri o d, u ns c he d ule d 
visits m ust be c o n d ucte d u ntil t he c o n diti o n has res ol ve d, ret ur ne d t o pre- st u d y 
stat us or i n t he o pi ni o n of t he lice nse d i n vesti gat or warra nts n o f urt her f oll o w-
u p as t he o utc o me  has b ec o me per ma n e nt.   
If t he res ol uti o n has n ot occ urre d wit hi n 6 wee ks f oll o wi n g t he st u d y e n d-date, 
t he s u bject will be e xite d fr o m t he st u d y b ut m ust c o nti n ue t o be f oll o we d b y 
t he lice nse d i n vesti gat or u ntil t he c o n diti o n has res ol ve d, ret ur ne d t o pre-st u d y 
stat us or i n t he o pi ni o n of t he lice nse d i n vesti gator  warra nts n o f urt her f oll o w-
u p as t he o utc o me  has b ec o me per ma n e nt.  
Pr ot oc ol Pa ge 2 7 of 1 0 1
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
If t he trial is ter mi nate d, all acti ve s u bjects will be br o u g ht i n f or a cl ose o ut 
e x a mi nati o n, t he i n vesti gati o nal pr o d uct a n d s u p plies will be  c ollecte d a n d t he 
s u bjects disc o nti n ue d fr o m t he st u d y. 
8. 7. 3  Pr o ce d ures f or R e p orti n g De vi ati o ns fr o m t he St atistic al Pl a n  
Pr ot oc ol de viati o ns will be trac k e d a n d e v al uate d f or p ossi ble effects o n t h e st u d y 
o utc o mes a nal ysis.  De vi ati o ns deter mi ne d t o create q uesti o na ble or pr o ble matic data 
will be i de ntifie d a n d t he s pecific dat a e x cl u de d fr o m t he a nal ysis.  
8. 7. 4  S pecific ati o ns of S u b gr o u ps f or A n al ysis  
T here are n o s p ecific s u b gr o u p a nal yses pla n n e d f or t his st u d y data.   
8. 7. 5  Pr o ce d ures f or A cc o u nti n g f or All D at a  
T he st u d y re p ort will i ncl u de all data prese nte d i n s u m mar y ta bl es or detail e d listi n gs.  
A visit acc o u nti n g ta bl e will i de ntif y misse d visits b y c o h ort ( I n vi g or A or I n vi g or B) 
a n d Stat us ( C o m plete d or Disc o nti n ue d). 
8. 7. 6  Tre at me nt of Missi n g, U n use d or S p uri o us D at a  
T he a nal ysis set will be t he f ull a nal ysis set, w hic h c o nsists of all s u bjects ra n d o mize d 
i nt o t he st u d y wit h a n act ual le ns dis pe nse d.  Disc o nti n ue d s u bject data will be 
a nal yze d s e par atel y fr o m t he c o m plete d s u bject data.  
Missi n g data will be acc o u nt e d f or i n t he sa m ple si ze acc o u nti n g.  
8. 7. 7  J ustific ati o n f or E xcl u di n g D at a fr o m t he Testi n g of t he H y p ot hesis 
Pr ot oc ol de viati o ns deter mi ne d t o create q u esti o na ble or pr o ble m atic data will be 
i de ntifie d a n d t he s pecific data e x cl u de d fr o m t he a nal ysis.  A n y d a ta e x cl u de d fr o m 
t he st u d y a n al ysis will be i de ntifie d a n d a writte n j ustificati o n file d. 
8. 7. 8  Mi ni m u m /M a xi m u m N u m ber of S u bjects at E ac h I n vesti g ati o n al Site 
Eac h i n vesti gati o nal site is e x pecte d t o e nr oll a mi ni m u m of 1 2 s u bjects a n d at 
S p o ns or a n d F R S’s re q uest ma y e nr oll  u p t o a ma xi m u m of 2 4 s u bjects. 
8. 7. 9  F act ors W hic h M a y C o m pr o mis e O utc o mes or I nter pret ati o n of Res ults  
T he fact ors w hic h ma y c o m pr o mise t he o utc o mes of t he st u d y or t he i nter pretati o n of 
t he st u d y r es ults are:  
•  T o o fe w s u bjects, eit her Test Le ns  ( <5 0 s u bjects) or C o ntr ol Le ns ( <2 5  s u bjects), 
w h o fail t o c o m plete t he 9 1 da y ti me p oi nt . 
•  L oss of a n i n vesti gati o nal site. 
•  Si g nifica nt pr ot oc ol d e viati o ns b y s u bjects or i n v esti gati o nal sites.  
•  Eac h of t he a b o ve ite ms c o ul d ha ve a si g nifica nt effect o n t he d ata t o be e v al uate d, 
t here b y ma ki n g a n al ysis pr o ble matical. 
9  
D A T A M A N A G E M E N T 
9. 1  Pr o ce d ures f or D at a Re vie w, D at a Cle a ni n g , Iss ui n g a n d Res ol vi n g Q ueries 
T he pr oce d ures f or data r e vie w, data b ase cl ea ni n g a n d q uer y ma n a ge me nt are all s pecifi e d 
i n t he Data Ma nage me nt Pla n o n file 
. 
 
Pr ot oc ol Pa ge 3 2 of 1 0 1
 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
A p pr o val of t he st u d y pr ot oc ol a n d i nf or me d c o ns e nt d oc u me nt m ust be o btai ne d fr o m a n 
a p pr o priate l e gall y c o nstit ute d I nstit uti o nal Re vie w B oar d (I R B) bef ore i n vesti gati o nal 
materials ca n b e rel ease d  a n d t he st u d y i nitiate d.  Re ne wal of t his a p pr o v al m ust be 
o btai ne d as re q uir e d b y t he I R B, b ut n ot less t ha n  a n n uall y.  
T he I R B m ust be i nf or m e d of all seri o us,  si g nifica nt a n d u na ntici pate d A d verse E ve nts 
wit hi n 5 w or ki n g da ys or  as state d i n t he I R B a p pr o val letter .  T he I R B m ust a p pr o ve all 
m o dificati o ns t o t he pr ot oc ol, t he I nf or me d C o nse nt D oc u me nt , or s u bject s ur ve ys pri or t o 
t he c ha n ges b ei n g i m ple me nte d.  I n a d diti o n, a d v ertise me nts f or s u bject recr uit me nt m ust 
be a p pr o ve d b y t h e I R B a n d S p o ns or pri or t o disse mi nati o n or use. 
A fi nal re p ort of i n vesti gati o nal site’s st u d y res ults m ust be s u b mitte d t o t he S p o ns or a n d 
t he I R B b y t he site’s pri n ci pal i n vesti gat or  wit hi n 3 m o nt hs of c o m pleti o n or ter mi nati o n  of 
t he st u d y al o n g wit h ot her re p orts as re q uire d i n t he st u d y d esi g n a n d b y t he I R B.  
( 2 1 C F R 8 1 2. 1 5 0(a) 6) 
1 1. 3  C o nfi de nti alit y  St ate me nt 
T his st u d y is c o nfi de ntial i n nat ure.  All i nf or mati o n gat h ere d d uri n g t his st u d y is 
pr o prietar y a n d s h o ul d be ma de a v aila ble o nl y t o t h ose i n di vi d uals directl y 
i n v ol ve d i n t he st u d y w h o ha ve a “ nee d t o k n o w ”. 
A ut h orize d reci pie nts of t his data i ncl u de: 
1. 
Pri nci pal I n v esti gat or(s) a n d S u b-I n vesti gat or(s) 
2. 
Ot her allie d healt h car e p ers o n nel  u n der directi o n of t he Pri nci pal I n vesti gat or(s) 
or S u b-I n vesti gat or (s) n ecessar y f or t he c o n d uct of t he st u d y  
3.  
I nstit uti o nal Re vie w B oar d pers o n nel 
4. 
E m pl o yees of t he S p o ns or w h o ha ve b ee n i de ntifie d as bei n g a ut h orize d t o 
recei v e or ha v e access t o st u d y i nf or mati o n. 
5.  
Desi g n ate d St u d y M o nit or (s) 
6.  
F D A or ot h er g o ver n me nt re g ul at or y a ge ncies 
All a b o ve pers o n n el w h o are pr o vi d e d wit h data c o ncer ni n g t his st u d y will be 
i nf or me d of its c o nfi de ntial a n d pr o prietar y nat ure.   
Release of t his data (t hr o u g h pr ese ntati o n, p u blicati o n or ot her writte n or oral 
c o m m u nicati o n) t o ot her t ha n t he a b o ve liste d pers o n nel re q uires t he pri o r  writte n 
per missi o n fr o m t he S p o ns or St u d y Direct or .  St u d y i n vesti gat ors a n d all office 
pers o n nel ar e pr o hi bite d fr o m ac k n o wl e d gi n g p artici pati o n i n t he st u d y t o i n di vi d uals 
a n d or ga nizati o ns e x ce pt t h ose liste d a b o ve.  T his i ncl u des sales re pres e ntati ves a n d 
ot her de part me nts a n d/ or s u bsi diaries of t he pare nt c o m pa n y of t he S p o ns or wit h o ut 
direct writte n per missi o n of t he S p o ns or. 
 
1 1. 4  M o nit ori n g a n d A u dits  
T he i n vesti gat or will all o w t he st u d y m o nit or(s) a n d a u dit ors fr o m F oresi g ht 
Re g ulat or y Strat e gies, I n c., S p o ns or re prese ntati v es a n d/ or I R B  me m bers  t o 
o bser ve pr o ce d ur es a n d i ns pect st u d y rec or ds a n d s u bjects’ me dical rec or ds 
t hr o u g h o ut t he st u d y t o v erif y pr ot oc ol c o m plia n ce, case re p ort c o m plete ness 
a n d i n vesti gati o nal mat erial acc o u nta bilit y.  
1 1. 5  I n vesti g at or Res p o nsi bilit y 
T he pri nci pa l 
Pr ot oc ol Pa ge 3 5 of 1 0 1
i n vesti gat or is res p o nsi ble f or f oll o wi n g t he cli nical 
i n vesti gati o nal pla n ( als o referre d t o as t he cli nical pr ot oc ol) as prese nte d 

 
Pr ot oc ol #: F C 1 6 0 3 2 2   V 1. 0 1 
 
 
 
herei n, i ncl u di n g pr ot oc ol c o m plia nce, a d v erse e v e nt a n d pr ot oc ol de viati o n 
re p orti n g, mai ntai ni n g d o c u me ntati o n a n d c o ntr ol o ver t he st u d y 
i n vesti gati o nal pr o d u cts a n d s u p plies, atte n di n g t o s u bject safet y, o versi g ht of 
s u b-i n vesti gat ors a n d i n vesti gati o nal site staff, a n d c o m m u nicati o ns wit h 
 
t he I R B, st u d y m o nit or a n d S p o ns or. 
If t he i n vesti gat or’s r e vie wi n g I R B wit h dra ws a p pr o val f or t he i n vesti gat or’s 
part of t he st u d y, t his m ust be re p orte d 
 wit hi n 5 
w or ki n g d a ys. Disc o nti n uati o n of t he st u d y s u bjects will be c o m plete d at t he 
directi o n of t he I R B a n d i n c o ns ultati o n wit h  
 t he st u d y S p o ns or.  
I nteri m st u d y r e p orts m ust be pr o vi de d b y t he pri nci pal i n vesti gat or t o t he I R B 
at a fr e q ue nc y re q uir e d b y t he i n di vi d ual I R B, b ut n ot less t ha n a n n uall y. 
A I R B fi nal re p ort m ust be c o m plete d b y t he pri n ci pal i n vesti gat or a n d a c o p y 
pr o vi de d t o t he S p o ns or, 
 a n d t he I R B u p o n c o m pleti o n of t he st u d y.  
 
1 1. 6  St ate me nt of I ns ur a nce t o be Pr o vi de d t o t he St u d y S u bjects  
T he i nf or me d c o ns e nt d o c u me nt  will c o ntai n a state me nt of i ns ura nce i n 
re gar ds t o c o v er a ge of a d verse e v e nts t o t he st u d y s u bjects.  
 
1 2  P U B LI C A TI O N P O LI C Y 
Eac h i n vesti gati o nal site partici pati n g i n t he st u d y ma y n ot re p ort o n t he st u d y res ults 
i n t heir site u ntil t he st u d y has b ee n c o m plet e d a n d all data verifie d.  T he S p o ns or 
reser v es t he ri g ht t o re vie w a n d c o m me nt o n a n y prese ntati o n, p u blicati o n or ot her 
writte n or oral c o m m u nicati o n pri or t o p u blicati o n or prese ntati o n .   
 
Pr ot oc ol Pa ge 3 6 of 1 0 1