Clinical Biocompatibility Evaluation of Contact Lens Coatings
Phase: NA
Conditions: Refractive Errors, Ametropia
Sponsor: Alcon Research

Page 1 of 54
a Novartis company
Short Title
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Long Title
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Protocol Number:
Study Phase:
Sponsor Name and 
Address:
Investigational Product:
US IND# / EudraCT
Indication Studied:
Investigator Agreement:
CLY935-E002 / NCT03034928
N/A
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Monthly contact lens with Coating 1 
 Monthly 
contact lens with Coating 2 
N/A
Contact lens wear
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described trial in 
compliance with Good Clinical Practice (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
<May be entered into the document or written/typed in later>
Address:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Page 2 of 54
1
SYNOPSIS
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLY935-E002
Investigational 
Product:
Monthly contact lens with
Coating 1
 
Monthly contact lens with 
Coating 2 
Study Phase:
1
2
                      
3
4
                      
N/A
Active Ingredient:
N/A
Protocol Title:
Clinical Biocompatibility Evaluation of Contact Lens Coatings
Investigator(s)/ No. of Sites:Approximately 2
Center Location(s)/ 
US
No. of Subjects
Required to complete: 32
Planned to enroll: approximately 35
Duration of Treatment:
2 hours (-15 min / +1 hr) exposure per crossover period
Study Population:
Volunteer subjects aged 18 or over who are soft contact lens 
wearers, have at least 3 months of contact lens wearing 
experience, and who wear their habitual lenses at least 5 days per 
week and at least 8 hours per day.
Objective(s):
The primary objective is to evaluate corneal staining observed 
after 2 hours of wear with coated monthly lenses against 
PureVision™lenses, all pre-cycled with OPTI-FREE® RepleniSH®
multi-purpose disinfection solution.
Methodology:
Double-masked, randomized, contralateral, crossover, active 
controlled study
Treatments:
Test Lenses:
Test 1 (T1) 
Monthly contact lens with Coating 1 
pre-cycled with OPTI-
FREE RepleniSH multi-purpose 
disinfection solution 
Test 2 (T2) 
Monthly contact lens with Coating 2 
pre-cycled with OPTI-
FREE RepleniSH multi-purpose 
disinfection solution 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Page 3 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLY935-E002
(Alcon Laboratories, Inc., USA)
Route of Administration:
Test and control lenses will be 
dispensed for contralateral wear 
according to randomization. 
Test lenses will have investigational 
labeling prior to pre-cycling. Lenses 
will be dispensed by a qualified 
unmasked study staff member in 
such a fashion that the subject and 
masked site personnel do not see the 
lens label and remain masked to the 
details of the lens. 
Subjects will use lenses as instructed 
by the Investigator or delegate, 
Duration of Treatment:
Subjects will wear a total of 2 pairs
of lenses. Each pair will be worn 
approximately 2 hours with 2 to 
8 days between pairs.
Dosage:
Both test lens types:
Parameters to be available for use in 
this study will be within the 
following ranges:
Base curve: 8.0 to 9.0 mm
Diameter: 13.8 to 14.6 mm
Power Range: 0.00 ± 0.50 D
Subjects will wear spectacles over 
test lenses for vision correction as 
needed. Replacement lenses are 
allowed during lens fitting only. 
Once lens fitting is completed, no 
additional lenses will be provided to 
the subject. Subjects will return to 
the investigative site the same day 
for lens removal.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Page 4 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLY935-E002
Control Lens:
PureVision contact lenses (balafilcon 
A; Bausch & Lomb, Inc., USA)
pre-cycled with OPTI-FREE 
RepleniSH multi-purpose 
disinfection solution
Route of Administration:
Test and control lenses will be 
dispensed for contralateral wear 
according to randomization. 
Control lenses will be marketed 
product in original commercial
blister foil packaging prior to 
pre-cycling. Lenses will be dispensed 
by a qualified unmasked study staff 
member in such a fashion that the 
subject and masked site personnel do 
not see the lens label and remain 
masked to the details of the lens. 
Subjects will use lenses as instructed 
by the Investigator or delegate, 
according to the instructions for use 
contained in the Package Insert 
 
Duration of Treatment:
Subjects will wear a total of 2 pairs
of lenses. Each pair will be worn 
approximately 2 hours with 2 to 
8 days between pairs.
Dosage:
Parameters to be available for use in 
this study:
Base curve: 8.6 mm
Diameter: 14.0 mm
Power Range: 0.00 ± 0.50 D
Subjects will wear spectacles over 
control lenses for vision correction as 
needed. Replacement lenses are 
allowed during lens fitting only. 
Once lens fitting is completed, no 
additional lenses will be provided to 
the subject. Subjects will return to 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Pa ge 5 of 5 4
S p o ns or:
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 
7 6 1 3 4- 2 0 9 9
Pr ot oc ol N u m ber: C L Y 9 3 5 -E 0 0 2
t he i nvesti gati ve site t he sa me da y  
f or le ns re m o val.
S u bject Selecti o n:
I ncl usi o n Criteri a:
1.
A ge 1 8 y ears or o ver .
2.
A ble t o u n dersta n d a n d m ust si g n a n I nf or me d C o nse nt 
d oc u me nt t hat has bee n a p pr o ve d b y a n I nstit uti o nal Re vie w 
B oar d.
3.
S uccessf ul wearer of s p herical s oft c o ntact le nses i n b ot h e y es 
f or a mi ni m u m of 5 da y s per wee k a n d 8 h o urs per da y d uri n g 
t he past 3 m o nt hs.
4.
Ma nifest c y li n der less t ha n or e q ual t o 1. 5 0 D i n eac h e ye.
5.
Best C orrecte d Vis ual Ac uit y  ( B C V A) 2 0/ 2 5 or better i n eac h 
e ye.
6.
V A wit h ha bit ual s pectacles 2 0/ 4 0 O U or better a n d willi n g t o 
wear s pectacles as nee de d d uri n g t he was h o ut peri o d a n d 
d uri n g st u d y le ns e x p os ure.
E xcl usi o n Criteri a:
1.
A n y  a nteri or se g me nt i nfecti o n, i nfla m mati o n, a b n or malit y or 
disease (i ncl u di n g s ys te mic) t hat c o ntrai n dicates c o ntact le ns 
wear, as deter mi ne d b y t he I n vesti gat or.
2.
A n y  use of sys te mic or oc ular me dicati o ns f or w hic h c o ntact 
le ns wear c o ul d be c o ntrai n dicate d, as deter mi ne d b y t he 
I n vesti gat or.
3.
Hist or y  of refracti ve s ur ger y or pla n t o ha ve refracti ve s ur ger y  
d uri n g t he st u d y or irre g ular c or nea i n eit her e ye.
4.
Oc ular or i ntra -oc ular s ur ger y  (e xcl u di n g place me nt of 
p u nctal pl u gs) wit hi n t he pre vi o us 1 2 m o nt hs or pla n ne d
d uri n g t he st u d y.
5.
Bi o micr osc o p y fi n di n gs at scr ee ni n g t hat are m o derate 
( gra de 3) or hi g her a n d/ or:

C or neal vasc ularizati o n t hat is mil d ( gra de 2) or 
hi g her.

C or neal stai ni n g:
T y pe 2 ( macr o p u nctate) or greater c or neal 
stai ni n g i n a ny re gi o n i n eit her e ye.
S u m of t he t ypes of c or neal stai ni n g greater 
t ha n or e q ual t o 4 acr oss all 5 c or neal 
re gi o ns (ce ntral, nasal, te m p oral, s u peri or, 
i nferi or) i n eit her e ye. 

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
C or neal stai ni n g c o veri n g ≥ 2 0 % i n a n y 

Pa ge 6 of 5 4
S p o ns or:
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 
7 6 1 3 4- 2 0 9 9
Pr ot oc ol N u m ber: C L Y 9 3 5 -E 0 0 2
c or neal re gi o n i n eit her e ye.
6.
C urre nt or hist or y  of pat h ol o gically dr y e ye i n eit her e ye
t hat, i n t he o pi ni o n of t he I nvesti gat or , w o ul d precl u de
c o ntact le ns wear .
7.
C urre nt or hist or y  of her petic keratitis i n eit her e ye.
8.
E y e i nj ur y i n eit her e ye wit hi n 1 2 wee ks i m me diatel y  pri or 
t o e nr oll me nt f or t his trial.
9.
Hist or y  of i nt olera nce or h yperse nsiti vit y  t o a ny
c o m p o ne nt of t he st u d y le nses or s ol uti o ns.
1 0. Weari n g ha bit ual c o ntact le nses i n a n e xte n de d wear
m o dalit y  (r o uti nely 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.
1 1. A n y  use of t o pical oc ular me dicati o ns a n d artificial tear or
re wetti n g dr o ps t hat w o ul d re q uire i nstillati o n d uri n g
c o ntact le ns wear.
1 2. T he I n vesti gat or, his/ her staff, fa mily me m ber s of t he
I n vesti gat or, fa mily me m bers of t he I n vesti gat or’s staff, or
i n di vi d uals li vi n g i n t he h o use h ol ds of t he af ore me nti o ne d
pers o ns ma y  n ot partici pate i n t he st u d y.
1 3. Partici pati o n of t he s u bject i n a cli nical trial wit hi n t he
pre vi o us 3 0 da y s or c urrentl y  e nr olle d i n a ny cli nical trial.
Assess me nts:
Pri m ar y Effic ac y :
C or neal stai ni n g:
Assesse d i n eac h of 5 c or neal re gi o ns (ce ntral, s u peri or,
i nferi or, nasal a n d te m p oral)
o
T y pe

0 n o ne

1 micr o p u nctate

2 macr o p u nctate

3 c oalesce d macr o p u nctate

4 patc h (≥ 1 m m)
o
Area: 0 -1 0 0 %

1 % i ncre me nts fr o m 0 % t o 9 %

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
1 0 % i ncre me nts fr o m 1 0 % t o 1 0 0 %

Pa ge 7 of 5 4
S p o ns or:
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 
7 6 1 3 4- 2 0 9 9
Pr ot oc ol N u m ber: C L Y 9 3 5 -E 0 0 2
S afet y:
A d verse e ve nts
Bi o micr osc o p y
De vice deficie ncies
E n d p oi nts:
Pri m ar y Effic ac y:

A vera ge % area of c or neal stai ni n g 
S afet y :

Bi o micr osc o p y fi n di n gs

A d verse e ve nts 

De vice deficie ncies
St atistic al Met h o ds:
Pla n ne d A nal ys is:
T w o a nal ys is sets will be defi ne d, safety a n d f ull a nal ysis sets. 
T he safet y a nal ys is 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 ns e val uate d i n t his st u d y. T he f ull a nal ysis set ( F A S) 
will i ncl u de all ra n d o mize d s u bjects w h o are e x p ose d a n d sat isf y a 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
pre -defi ne d set of criteria. All efficac y  e val uati o ns will be base d 

Page 8 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLY935-E002
upon the FAS.
The primary endpoint is the average corneal staining area, where 
the average is taken over five regions and expressed in percentage. 
Data will be presented by each test coating with the corresponding 
control lens worn contralaterally. Summary statistics will be 
provided. No hypotheses are formulated; therefore, no inferences 
will be made.
 
 
All data from evaluable subjects will be included in the efficacy 
analysis, and no imputation for missing values will be performed.
Each safety variable will be summarized descriptively. Adverse 
events will be classified as treatment-emergent or pre-treatment. 
Counts and percentages will be provided by relationship to device, 
and separate tables will be generated for ocular and nonocular 
AEs. Counts and percentages in each grade category will be 
presented for each biomicroscopy parameter. Device deficiencies 
will also be tabulated. Supporting subject listings will be provided 
as applicable. No inferential testing will be performed for safety 
analysis.
Sample Size Justification
The proposed sample size of 32 is adapted from Andrasko (2008)
and allows for a balanced allocation of lens sequences.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Pa ge 9 of 5 4
2
O V E R VI E W O F  S T U D Y P L A N
Pr oce d ure/ Assess me nt
Visit 1
Scree ni n g / 
B aseli ne /
P air 1 
Dis pe nse 
Visit 2
P air 1 F oll o w -
u p 2 hrs                   
(-1 5 mi n / + 1 hr) 
Visit 3
B aseli ne /                 
P air 2 
Dis pe nse                       
( + 2 t o 8 da ys)
Visit 4
P air 2 F oll o w -
u p / E xit 2 hrs            
(-1 5 mi n / + 1 hr) 
U nsc he d .
I nf or me d C o nse nt

-
-
-
-
De m o gra p hics

-
-
-
-
Me dical Hist or y
 

 


C o nc o mita nt Me dicati o ns
 

 


I ncl usi o n/ E xcl usi o n

-
-
-
-
Ra n d o mize s u bject

-
-
-
-
Reassess c or neal healt h 
( )
-

-
-
V A w/ s pectacles1 ( O D, 
O S, O U as nee de d , 
S nelle n dista nce)




()
Ma nifest refracti o n 
1

() 
() 
() 
()
B C V A 1 (O D, O S, 
S nelle n dista nce wit h 
ma nifest refracti o n ) 

() 
() 
() 
()
Bi o micr osc o p y 
[i ncl u di n g C or neal 
Stai ni n g , per re gi o n
(t ype, area) ]2


 


Dis pe nse st u d y  le nses

-

-
-
A Es 
 

 


A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Pa ge 1 0 of 5 4
Pr oce d ure/ Assess me nt
Visit 1
Scree ni n g / 
B aseli ne /
P air 1 
Dis pe nse 
Visit 2
P air 1 F oll o w -
u p 2 hrs                   
(-1 5 mi n / + 1 hr) 
Visit 3
B aseli ne /                 
P air 2 
Dis pe nse                       
( + 2 t o 8 da ys)
Visit 4
P air 2 F oll o w -
u p / E xit 2 hrs            
(-1 5 mi n / + 1 hr) 
U nsc he d .
De vice deficie ncies
 

 


E xit F or m
() 
() 
()

()
1 S o urce o nl y  
2 Pri mar y e n d p oi nt
 
(
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
) assess me nt perf or me d as nee de d

Page 11 of 54
3
ABBREVIATIONS AND GLOSSARY
3.1
Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
BCVA
Best corrected visual acuity
CRF, eCRF
Case report form, electronic case report form
D
Diopter(s)
D/C
Discontinue
EDC
Electronic data capture
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good clinical practice
GPCMS
Global Product Complaint Management System
hr(s)
Hour(s)
IB
Investigator’s brochure
ICF
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
IEC
Independent ethics committee
IP
Investigational product
IRB 
Institutional review board
MedDRA®
Medical Dictionary for Regulatory Activities
min
Minute(s)
mm
Millimeter(s)
MR
Manifest refraction
N/A
Not applicable
ODf
Right eye
OS
Left eye
OU
Both eyes
SAE
Serious adverse event
SADE
Serious adverse device effect
SiHy
Silicone hydrogel
Unsched
Unscheduled
VA
Visual acuity
3.2
Glossary of Terms
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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1.0; CURRENT; Most-Recent; Effective
TDOC-0053056
Protocol - Clinical
09-Dec-2016

Pa ge 1 2 of 5 4
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 (test article). 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 test article, t he c o ntrol 
article, or t he pr oce d ur es 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 test article.
A d verse De vice 
Ef fect ( A D E)
A d verse e ve nt relate d t o t he use of a n i n vesti gati o nal me dical 
de vice (test article) or c o ntr ol article. N ote: T his defi niti o n 
i ncl u des a dverse eve nts res ulti n g fro 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 he test article or c o ntrol article.
A ntici pate d Seri o us 
A d verse De vice 
Ef fect ( A S A D E)
Seri o us a d verse de vice effect w hic h b y its nat ure, i nci de nce, 
se verity or o utc o me has bee n i de ntifie d i n t he ris k ma na ge me nt 
file.
De vice Deficie nc y
I na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. N ote: T his defi niti o n 
i ncl u des m alf u ncti o ns, use errors, a n d i n a de q u ate l a beli n g.
I n vesti gati o nal 
Pr o d uct
I n vesti gati o nal pr o d uct i ncl u des test a n d c o ntr ol le nses.
Malf u ncti o n
Fail ure of a me dical de vice t o meet its perf or ma nce s pecificati o ns 
or ot her wise perf or m as i nte n de d. Perf or ma nce s pecificati o ns 
i ncl u de all clai ms ma de i n t he la beli n g of t he de vice. T he i nte n de d 
perf or ma nce of t he de vice refers t o t he i nte n de d use f or w hic h t he 
de vice is la bele d or mar kete d.
N o n -seri o us A d verse 
E ve 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.
Seri o us A d verse 
E ve nt ( S A E)
A d verse e ve nt t hat le d t o a n y  of t he f oll o wi n g: 

Deat h.

A seri o us deteri 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 fro m t he eve nt as it occ urr e d, ie, 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 de at h h a d it occ urre d i n a m ore severe f or m.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Pa ge 1 3 of 5 4
b)
a n y p ote 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 uct 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 pr e-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 der e 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 ge ncy 
w ar d f or o bserv ati o n a n d/ or tr e 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 dere 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 ).
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 res ults w he n use d wit hi n ma n ufact urer’s i nstr ucti o ns 
f or use.

Fetal distress, fetal 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 1 2 f or a d diti o n al S A Es.
Seri o us A d verse 
De vice Ef fect 
( S A D E)
A d verse de vice ef fect t hat has res ulte d i n a n y of t he c o nse q ue nces 
c haracteristic of a seri o us a d verse e ve nt.
Si g nifica nt N o n -
Seri o us A d verse 
E ve nt
A si g nifica nt n o n-seri o us a d verse e ve nt is a s y m pt o matic, de vice -
relate d, n o n-si g ht t hreate ni n g a d verse e ve nt t hat warra nts 
disc o nti n uati o n of a n y  c o ntact le ns wear f or greater t ha n or e q ual 
t o 2 wee ks.
Refer t o Secti o n 1 2 f or a d diti o n al Si g nific a nt N o n-Seri o us A Es.
U na ntici pate d 
Seri o us A d verse 
De vice Ef fect 
( U S A D E)
Seri o us a d verse de vice effect w hic h b y its nat ure, i nci de nce, 
se verity or o utc o me has n ot bee n i de ntifie d i n t he ris k ma na ge me nt 
file.
Use Err or
Act or o missi o n of a n act t hat res ults i n a dif fere nt me dical de vice 
resp o nse t ha n i nte n de d b y  ma 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 pecte 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 error.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
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4
TABLE OF CONTENTS
Clinical Biocompatibility Evaluation of Contact Lens Coatings...............................................1
1
SYNOPSIS ..........................................................................................................................2
2
OVERVIEW OF STUDY PLAN.........................................................................................9
3
ABBREVIATIONS AND GLOSSARY ............................................................................11
3.1
Abbreviations ................................................................................................................11
3.2
Glossary of Terms..........................................................................................................11
4
TABLE OF CONTENTS...................................................................................................14
List of Figures..........................................................................................................................16
5
INTRODUCTION.............................................................................................................17
5.1
Study Rationale and Background..................................................................................17
5.2
Known and Potential Risks ...........................................................................................17
5.3
Potential Benefits...........................................................................................................19
6
ETHICS .............................................................................................................................20
7
PROTOCOL AMENDMENTS .........................................................................................22
8
SUBJECT POPULATION.................................................................................................23
9
TREATMENTS ADMINISTERED...................................................................................24
9.1
Identity of Study Treatments .........................................................................................24
9.2
Usage.............................................................................................................................25
9.3
Accountability Procedures.............................................................................................25
9.4
Subject Confidentiality and Methods Used to Minimize Bias......................................25
10 STUDY PROCEDURES...................................................................................................27
10.1
Outline of Study ............................................................................................................27
10.2
Visits and Examinations ................................................................................................27
10.2.1
Visit 1 (Day 1) – Screening/Baseline/Pair 1 Dispense ..............................................27
10.2.2
Visit 2 [Day 1, 2 hours (-15 min/+1 hour)] – Pair 1 Follow-up ................................30
10.2.3
Visit 3 (+ 2 to 8 Days) –Baseline/Pair 2 Dispense ....................................................31
10.2.4
Visit 4 [same day as Visit 3, 2 hours (-15 min/+1 hour)] – Pair 2 Follow-up / Exit .33
10.3
Unscheduled Visits ........................................................................................................35
10.4
Discontinued Subjects ...................................................................................................35
10.5
Clinical Study Termination............................................................................................35
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10.6
Enrollment Stopping Criteria ........................................................................................36
11 ANALYSIS PLAN ............................................................................................................38
11.1
Subject Evaluability.......................................................................................................38
11.2
Analysis Data Sets.........................................................................................................38
11.2.1
Safety Analysis Set....................................................................................................38
11.2.2
Full Analysis Set........................................................................................................38
11.3
Demographic and Baseline Characteristics...................................................................38
11.4
Efficacy Analyses ..........................................................................................................39
11.4.1
Primary Efficacy........................................................................................................39
11.4.1.1
Statistical Hypotheses............................................................................................39
11.4.1.2
Analysis Methods ..................................................................................................39
11.4.2
Secondary Efficacy....................................................................................................39
11.4.2.1
Statistical Hypotheses............................................................................................39
11.4.2.2
Analysis Methods ..................................................................................................39
.40
40
40
11.5
Handling of Missing Data .............................................................................................40
11.6
Multiplicity....................................................................................................................40
11.7
Safety Analysis ..............................................................................................................40
11.8
Health Economics..........................................................................................................41
11.9
Interim Analyses............................................................................................................41
11.10 Sample Size Justification...............................................................................................41
12 ADVERSE EVENTS ........................................................................................................42
12.1
General Information ......................................................................................................42
12.2
Monitoring for Adverse Events .....................................................................................45
12.3
Procedures for Recording and Reporting AEs and SAEs..............................................46
12.4
Intensity and Causality Assessments.............................................................................47
12.5
Return Product Analysis................................................................................................48
12.6
Unmasking of the Study Treatment...............................................................................48
12.7
Follow-Up of Subjects with Adverse Events.................................................................48
12.8
Pregnancy in the Clinical Trial......................................................................................49
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................50
13.1
Completion of Source Documents and Case Report Forms..........................................50
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13.2
Data Review and Clarifications.....................................................................................50
13.3
Regulatory Documentation and Records Retention ......................................................51
14 PUBLICATION PLAN......................................................................................................52
15 REFERENCES ..................................................................................................................53
16 APPENDIX .......................................................................................................................54
List of Figures
Figure 12–1
Categorization of All Adverse Events..............................................................42
Figure 12-2
Categorization of All Serious Adverse Events.................................................43
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Pa ge 1 7 of 5 4
5
I N T R O D U C TI O N
5. 1
St u d y R ati o n ale a n d B ac k gr o u n d
T he o bjecti ve of t his st u d y  is t o e val uate s urface c oati n g ca n di dates f or a ne w fre q ue nt 
re place me nt ( m o nt hl y) silic o ne h ydr o gel ( Si H y ) s oft c o ntact le ns.
Ne w Si H y  materials c o nti n ue t o be de vel o pe d p ossessi n g u ni q ue material pr o perties a n d 
s u peri or o xy ge n tra ns missi bilit y  o ver c o ntact le nses ma de wit h c o n ve nti o nal h ydr o gel 
materials. A ne w le ns is bei n g de vel o pe d i n a n eff ort t o mai ntai n pr ol o n ge d perf or ma nce b y 
pr o vi di n g a d ura ble s urface al o n g wit h a n i n here ntl y wetta ble c ore le ns material. Fre q ue nt 
re place me nt le nses w or n i n a dail y  wear m o dalit y are re m o ve d ni g htl y a n d s oa ke d i n a le ns 
care s ol uti o n f or clea ni n g a n d disi nfecti o n. O ne c o nsi derati o n i n t he de vel o p me nt of m o nt hl y 
re place me nt le nses is t he u pta ke a n d release of le ns care s ol uti o n preser vati ves. T his cli nical 
trial is a n i nitial assess me nt of bi oc o m pati bilit y of 2 c oate d le ns ca n di dates w hic h ha ve bee n 
pre -c ycle d wit h O P TI -F R E E Re ple ni S H m ulti -p ur p ose disi nfecti o n s ol uti o n (Test 1 a n d Test 
2) . T he pri mar y  f oc us of t he st u d y  will be o n c or neal stai ni n g as a res ult of p ote ntial 
preser vati ve u p ta ke a n d release. C or neal stai ni n g will be assesse d after a p pr o xi matel y 2 h o urs 
of le ns wear a n d c o m pare d t o a c o ntr ol le ns k n o w n t o de m o nstrate cli nical bi oc o m pati bilit y .
T he c o ntact le ns bei n g de vel o pe d is i nte n de d f or t he o ptical c orrecti o n of refracti ve a metr o pia
i n pers o ns wit h n o n-disease d e y es. Pla n o ( ± 0. 5 0 D) le nses will be use d f or t his st u d y
re q uiri n g s u bjects t o wear s pectacles f or visi o n c orrecti o n.
5. 2
K n o w n a n d P ote nti al Ris ks
A s u m mar y of t he k n o w n a n d p ote ntial ris ks a n d be nefits ass ociate d wit h 
 a n d 
 le nses ca n be f o u n d i n t he I n vesti gat or ’s Br oc h ure (I B- 0 1 5 0). Base d u p o n t he 
res ults fr o m precli nical testi n g, 
 a n d 
 le nses are n o n -t o xic a n d 
bi oc o m p ati ble f or o n -e ye use. T he c oati n gs bei n g e val uate d i n t his st u d y ha ve n ot y et bee n 
e val uate d i n cli nical trials. Ris ks are mi ni mize d t hr o u g h cl os e 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 i ncl u de a t o xicit y  res p o nse, bl urre d visi o n, a n d oc ular 
disc o mf ort. I n ge neral, t he ris ks wit h 
 a n d 
 le nses are a ntici pate d t o 
be si milar t o ot her mar kete d dail y  wear c o ntact le nses. S u bjects s h o ul d be a d vise d of t he 
f oll o wi n g war ni n gs a n d preca uti o ns t hat ha ve bee n i de ntifie d f or t he 
 a n d  
 
 le nses base d u p o n cli nical e x perie nce wit h mar kete d c o ntact le nses:

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
Seri o us e y e i nj ur y, scarri n g of t he c or nea, a n d l oss of visi o n ma y res ult fr o m pr o ble ms 
ass ociate d wit h weari n g c o ntact le nses a n d usi n g le ns care pr o d ucts.

Pa ge 1 8 of 5 4

E y e pr o ble ms, i ncl u di n g c or neal ulcers, ca n de vel o p ra pi dl y a n d lea d t o l oss of visi o n.

N o nc o m plia nce wit h le ns wear i nstr ucti o ns ma y  i ncrease t he ris k of de vel o pi n g a 
seri o us e ye i nfecti o n. 

S m o ki n g a n d/ or s wi m mi n g i ncreases t he ris k of c or neal ulcers wit h c o ntact le ns wear , 
es peciall y w he n le nses are w or n o ver n i g ht or w hile slee pi n g.

T he ris k of ulcerati ve keratitis has bee n s h o w n t o be greater a m o n g users w h o wear 
t heir le nses o ver ni g ht c o m pare d t o t h ose w h o d o n ot wear t he m o ver ni g ht. 
T he ris ks wit h c o ntact le ns wear are i ncrease d wit h a pre- e xisti n g or acti ve oc ular i nfecti o n or
i nfla m mati o n, i m pr o per le ns fit, a n d n o nc o m plia nce wit h re gi me n. T he 
 a n d 
 
 le nses are f or dail y wear use a n d s u bjects w h o slee p i n le nses a n d/ or fail t o f oll o w t he 
i nstr ucti o ns f or re placi n g t heir c o ntact le ns c o uld e x perie nce a n e y e i nfecti o n of t he c or nea or 
i nj ur y. A n i m pr o perl y  fitte d c o ntact le ns ma y affect c or neal c ur vat ure a n d res ult i n visi o n 
fl uct uati o ns u p o n le ns re m o val. A c or neal ulcer c o ul d de vel o p ra pi dly a n d lea d t o l oss of 
visi o n. T he c o m pati bilit y  of 
 a n d 
 le nses wit h le ns care s ol uti o ns has 
n ot bee n teste d cli nicall y ; bi oc o m pati bilit y or a n y ass ociate d cli nical effects are u n k n o w n.
P ote ntial seri o us c o m plicati o ns wit h c o ntact le ns wear are us uall y  acc o m pa nie d b y o ne or
m ore of t he f oll o wi n g si g ns or s y m pt o ms:

M o derate t o se vere e y e pai n n ot relie ve d b y re m o vi n g t he le ns

F orei g n b o d y se nsati o n

E xcessi ve teari n g/ oc ular secreti o ns

H y pere mia

B ur ni n g, sti n gi n g, or itc hi n g

C o mf ort is less c o m pare d t o w he n t he le ns was first place d o n t he e ye

P o or vis ual ac uit y / bl urre d visi o n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
Feeli n g of dr y ness
S u bjects s h o ul d be i nstr ucte d t o re m o ve t he le nses if a n y  o ne of t he a b o ve si g ns or sy m pt o ms
is n otice d. A seri o us c o n diti o n s uc h as a c or neal ulcer, i nfecti o n, or iritis ma y be prese nt, a n d
ma y  pr o gress ra pi dl y. Less seri o us reacti o ns s uc h as a brasi o ns, i nfiltrates, a n d bacterial
c o nj u ncti vitis m ust be ma na ge d t o a v oi d m ore seri o us c o m plicati o ns.

Page 19 of 54
5.3
Potential Benefits
While contact lenses with optical power may offer improved peripheral vision and the 
convenience of not wearing spectacles, this study will use plano (±0.50 D) lenses and the 
subject must wear spectacles for vision correction. By participating in this study subjects will 
contribute to the development of advanced contact lenses for improving successful contact 
lens wear. There is no intended clinical benefit to the subject.
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6
ETHICS
This clinical study will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with the International Council for Harmonization (ICH) E6 
Good Clinical Practice (GCP) Consolidated Guideline and other regulations as applicable. 
The Investigator and all clinical study staff will conduct the clinical study in compliance with 
the protocol. The Investigator will ensure that all personnel involved in the conduct of the 
study are qualified to perform their assigned responsibilities through relevant education, 
training, and experience.
Before clinical study initiation, this protocol, the informed consent form (and assent form, if
applicable), any other written information given to subjects, and any advertisements planned 
for subject recruitment must be approved by an Independent Ethics Committee/Institutional 
Review Board (IEC/IRB). The Investigator must provide documentation of the IEC/IRB 
approval to the Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IEC/IRB must be provided with a copy of the Investigator’s Brochure, any periodic safety 
updates, and all other information as required by local regulation and/or the IEC/IRB. At the 
end of the study, the Investigator will notify the IEC/IRB about the study’s completion. The 
IEC/IRB also will be notified if the study is terminated prematurely. Finally, the Investigator 
will report to the IEC/IRB on the progress of the study at intervals stipulated by the IEC/IRB.
Voluntary informed consent will be obtained from every subject prior to the initiation of any 
screening or other study-related procedures. The Investigator must have a defined process for 
obtaining consent. Specifically, the Investigator, or delegate, will explain the clinical study to 
each potential subject and the subject must indicate voluntary consent by signing and dating 
the approved informed consent form. The subject must be provided an opportunity to ask 
questions of the Investigator, and if required by local regulation, other qualified personnel. 
The Investigator must provide the subject with a copy of the consent form written in a 
language the subject understands. The consent document must meet all applicable local laws 
and will provide subjects with information regarding the purpose, procedures, requirements, 
and restrictions of the study, along with any known risks and potential benefits associated 
with the investigational product, the available compensation, and the established provisions 
for maintaining confidentiality of personal, protected health information. Subjects will be told 
about the voluntary nature of participation in the study and will be provided with contact 
information for the appropriate individuals should questions or concerns arise during the 
study. The subject also will be told that their records may be accessed by appropriate 
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authorities and Sponsor-designated personnel. The Investigator must keep the original, signed 
copy of the consent and must provide a duplicate copy to each subject.
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7
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the IEC/IRB prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions. 
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8
SUBJECT POPULATION
The study population includes approximately 35 subjects to be enrolled at approximately
2 sites. To participate in the study, a subject must be 18 years or older and a successful wearer 
of spherical soft contact lenses in a daily wear modality during the past 3 months for a 
minimum of 5 days per week and 8 hours per day. The complete inclusion and exclusion 
criteria are presented in Section 1. The expected duration of subject participation in the study 
is 3 to 9 days (4 visits on 2 study days).
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9
T R E A T M E N T S A D MI NI S T E R E D
U p o n e ntr y  i nt o t he st u d y, s u bjects will be assi g ne d n u m bers i n t he a p pr o priate n u merical 
se q ue nce by desi g nate d staf f at eac h i nvesti gati o nal site. Q ualif y i n g su bjects will be 
ra n d o mize d i n a 1: 1: 1: 1 ma n ner t o o ne of t he f oll o wi n g le ns se q ue nces, where eac h pair 
c o nsists of a test a n d a co ntr ol le ns :

Test 1 ( O D)/ C o ntr ol ( O S) → C o ntr ol ( O D)/ Test 2 ( O S)

Test 2 ( O D)/ C o ntr ol ( O S) → C o ntr ol ( O D)/ Test 1 ( O S)

C o ntr ol ( O D)/ Test 1 ( O S) → Test 2 ( O D)/ C o ntr ol ( O S)

C o ntr ol ( O D)/ Test 2 ( O S) → Test 1 ( O D)/ C o ntr ol ( O S)
T hr o u g h o ut t he st u d y,  t he I n vesti gat or will be res p o nsi ble f or t he acc o u nti n g of all st u d y 
c o ntact le nses a n d will e ns ure t hat t he st u d y c o ntact le nses are n ot use d i n a n y u na ut h orize d 
ma n ner .
9. 1
I de ntit y of St u d y Tr e at me nts
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
Te st Le nses:
M o nt hl y  c o ntact le ns wit h C oati n g 1
 pre -c ycle d wit h 
O P TI -F R E E Re ple ni S H m ulti -p ur p ose disi nfecti o n s ol uti o n (Test 1)
M o nt hl y  c o ntact le ns wit h C oati n g 2 
 pre -c ycle d wit h 
O P TI -F R E E Re ple ni S H m ulti -p ur p ose disi nfecti o n s ol uti o n (Test 2 )
C o ntr ol L e nses:
P ure V isi o n c o ntact le nses pre -c ycle d wit h O P TI -F R E E Re ple ni S H 
m ulti -p ur p ose disi nfecti o n s ol uti o n ( C o ntr ol)
B ot h test le nses 
will be pr o vi de d i n blister f oil pac ka gi n g wit h 
i n vesti gati o nal la beli n g, w hic h i ncl u des at a mi ni m u m t he f oll o wi n g: p o wer , base c ur ve, 
dia meter , l ot n u m ber, e x pirati o n date, a n d i n vesti gati o nal use state me nt. Pri or t o 
c o m me nce me nt of t he st u d y, t he I n vesti gat or will recei ve sets of 
 a n d 
 
 le nses f or pre -c ycli n g, fitti n g a n d dis pe nsi n g.
P ure V isi o n is a mar kete d pr o d uct . Le nses f or t he st u d y will be pr o vi de d i n ori gi nal blister f oil 
pac ka gi n g wit h c o m mercial la beli n g, w hic h i ncl u des at a mi ni m u m: bra n d na me, material, 
ma n ufact urer , p o wer , base c ur ve, dia meter, l ot n u m ber a n d e x pirati o n date . Pri or t o 
c o m me nce me nt of t he st u d y, t he I n vesti gat or will recei ve a set of P ure Visi o n le nses for pre -
c ycli n g, fitti n g a n d dis pe nsi n g.

Page 25 of 54
9.2
Usage
This study is a contralateral crossover study and qualifying subjects will wear 2 pairs of study 
lenses according to the randomized lens sequence assignment. All lenses will be pre-cycled in 
OptiFree RepleniSH multi-purpose disinfection solution.
Each pair of study lenses (one test and 
one control) will be dispensed to the subject for contralateral wear, to be worn for 2 hours   
(-15 min / +1 hour) and then collected from the subject. Wear time is defined as time from 
lens insertion to lens removal. Test and control lenses will only be available in 0.00 D ± 0.50
D, so while wearing study lenses subjects will wear habitual spectacles as needed for vision 
correction. Subjects will be instructed not to use topical ocular medications or lubricating 
drops during study lens wear. 
Subjects will be instructed not to wear any contact lenses for a washout period comprising the 
day prior to and day of study visits. Subjects may wear their habitual contact lenses between 
visit days except for during the washout period. 
Subjects will use and care for the study lenses as instructed by the Investigator or delegate, 
9.3
Accountability Procedures
Upon receipt of the investigational product (test and control lenses), the Investigator or 
delegate will conduct an inventory. Designated study staff will provide the study lenses to the 
subjects in accordance with their sequentially assigned subject numbers and the 
randomization schedule. During the study, the Investigator must maintain records of study 
lens dispensation and collection for each subject. This record must be made available to the 
study monitor for the purposes of verifying the accounting of clinical supplies. Any 
discrepancies and/or deficiencies between the observed disposition and the written account 
must be recorded along with an explanation. At the conclusion of the study, the Investigator 
will be responsible for returning all lidding foils, used and unused study lenses, and used and 
unused study supplies, unless otherwise instructed by the Sponsor.
9.4
Subject Confidentiality and Methods Used to Minimize Bias
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Sponsor will collect a copy of the 
enrollment log without any identifying subject information. All documents submitted to the 
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Page 26 of 54
Sponsor will identify the subjects exclusively by number and demographic information. No 
other personally identifying information should be transmitted to the Sponsor.
The intent of masking is to limit the occurrence of conscious and unconscious bias in the 
conduct and interpretation of the clinical study. Bias could arise from the influence that the 
knowledge of a specific treatment assignment may have on the recruitment and allocation of 
subjects, their subsequent care, the assessment of end points, the handling of withdrawals, 
and so on. The essential aim of masking, therefore, is to prevent identification of the 
treatments by the Investigator, subject, and others associated with the conduct of the study 
until all such opportunities for bias have passed.
This study is double-masked, with subjects randomized to use Test 1, Test 2, and Control in 
the assigned eyes and lens sequence. The Investigators, Investigators’ staff (other than 
unmasked study coordinators), subjects, and Sponsor personnel (other than the Lead Clinical 
Site Manager, site monitors and unmasked data managers) involved in reporting, obtaining, 
and/or reviewing the clinical evaluations will not be aware of the specific treatment being 
administered. This level of masking will be maintained throughout the conduct of the study. 
Subjects will be assigned lens sequence in numerical order; the randomization schedule will 
be blocked to ensure a balance of study lens sequence allocations within investigational sites. 
The randomization scheme will be generated and maintained by the Sponsor. Individual 
subjects may be unmasked only once all study data have been verified and validated and the 
database has been locked. In the event of a medical emergency where the knowledge of 
subject treatment is required, an individual Investigator will have the ability to unmask the 
lens sequence assignment for a specific subject.
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Protocol - Clinical
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Page 27 of 54
10 STUDY PROCEDURES
10.1 Outline of Study
This double-masked, randomized, contralateral, crossover, active controlled study will 
evaluate 2 surface coating candidates in subjects at least 18 years of age who are experienced 
wearers of spherical soft contact lenses and qualified according to all inclusion and exclusion 
criteria. Approximately 35 subjects will be enrolled and qualifying subjects will be 
randomized to wear 2 pair of study lenses and will attend 4 visits occurring on 2 different 
study days (2 visits per day, approximately 2 hours of wear time per lens pair). Visits 1 and 2 
(Pair 1 dispense and follow-up) occur on the same study day and 2 to 8 days later Visits 3 and 
4 (Pair 2 dispense and follow-up) occur. Subjects must not wear contact lenses for a washout 
period that includes the day of and day prior to study visits. 
10.2 Visits and Examinations
Study lenses must be pre-cycled with OPTI-FREE RepleniSH multi-purpose disinfection 
solution prior to dispensing. 
10.2.1 Visit 1 (Day 1) – Screening/Baseline/Pair 1 Dispense
1
Explain the purpose and nature of the study, and have the subject read, sign, and 
date the IRB-approved informed consent document (ICF). Additionally, have the 
individual obtaining consent from the subject and a witness, if applicable, sign and 
date the informed consent document. Provide a photocopy of the signed document to 
the subject and place the original signed document in the subject’s chart. After 
signing the ICF, a subject will be assigned a subject number by the EDC system. A 
signed ICF defines the point of enrollment.
2
Confirm the subject has not worn contact lenses on the day of and the day prior to 
the visit. If lenses have been worn, reschedule Visit 1 to allow for the washout 
period.
3
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications.
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Protocol - Clinical
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Pa ge 2 8 of 5 4
4
Perf or m S nelle n V A wit h ha bit ual s pectacles.

O D, O S, O U, dista nce o nl y
N ote: Dist a nce V A wit h h a bit u al s pect acles m ust be 2 0/ 4 0 O U or better f or t he s u bject t o 
q u alify f or t he st u dy.
5
Perf or m a ma nifest refracti o n.
6
Perf or m S nelle n B C V A wit h ma nifest refracti o n.

O D, O S, dista nce o nl y
N ote: Dist a nce B C V A m ust be 2 0/ 2 5 or better i n e ac h eye f or t he s u bject t o q u alify f or t he 
st u dy.
7
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g – 5 re gi o ns (t y pe, area)
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Pa ge 2 9 of 5 4
8
Re vie w i ncl usi o n/e xcl usi o n criteria t o deter mi ne if s u bject q ualifies f or partici pati o n 
i n t he st u d y. 

If s u bject q ualifies , c o nti n ue t o ra n d o mizati o n (ste p 9)

If a s u bject q ualifies acc or di n g t o all criteria e xce pt f or u nacce pta ble c or neal 
stai ni n g, t he y will be per mitte d t o ret ur n wit hi n 7 da ys t o be reassesse d. T he 
I n vesti gat or will deter mi ne if it is per missi ble f or t he s u bject t o use 
preser vati ve -free l u bricati n g dr o ps pri or t o ret ur ni n g f or reassess me nt . T he 
use of preser vati ve -free e ye dr o ps s h o ul d n ot be c o nsi dere d a treat me nt, b ut 
rat her a palliati ve meas ure t o re d uce c or neal stai ni n g, a n d as s uc h s h o ul d n ot 
tri g ger a n a d verse e ve nt. If u p o n re assess me nt c or neal stai ni n g re mai ns 
u nacce pta ble , e xit s u bject fr o m st u d y as a scree n fail ure.

If a s u bject d oes n ot q ualif y acc or di n g t o a n y criteri o n ot her t ha n 
u nacce pta ble c or neal stai ni n g , e xit s u bject fr o m st u d y as a scree n fail ure. 
9
Base d o n t he ra n d o mize d le ns se q ue nce assi g n me nt, ha ve t he s u bject i nsert Pair 1 
st u d y le nses, bei n g caref ul t o mai ntai n t he c orrect O D a n d O S le ns assi g n me nts.

Kee p all li d di n g f oils of le nses use d d uri n g le ns fit pr ocess f or st u dy le ns 
acc o u nt a bility.

F oll o w pr oce d ures t o m ai nt ai n m aski n g.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Page 30 of 54
13
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time 
of signature of informed consent including those that screen fail.
14
Dispense study lenses for approximately 2 hours of wear and instruct the subject to 
refrain from using any topical ocular medications or eye drops until they remove 
lenses at Visit 2. 
15
Schedule Visit 2 to take place 2 hours (-15 min/+1 hour) after Visit 1. 
10.2.2 Visit 2 [Day 1, 2 hours (-15 min/+1 hour)] – Pair 1 Follow-up
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any adverse events or device deficiencies that are observed or reported, 
including those associated with changes in concomitant medication dosing.
3
Review subject compliance with lens wear and adjunct product usage. 
6
Have subject remove study lenses. 
 
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Pa ge 3 1 of 5 4
8
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g – 5 re gi o ns (t y pe, area)
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
9
Perf or m S nelle n V A wit h ha bit ual s pectacles.
O D , O S, O U as nee de d , dista nce o nl y
N ote: If t his V A wit h s pect acle c orrecti o n s h o ws a decre ase of 2 li nes or m ore 
vers us Visit 1 b aseli ne V A wit h s pect acle c orrecti o n, t he n B C V A wit h M R is 
re q uire d t o c o nfir m a p ote nti al l oss i n V A f or A E re p orti n g re q uire me nts (see 
Secti o n 1 2).
1 0
Sc he d ule Visit 3 t o ta ke place 2 t o 8 da y s after Visit 2. Re mi n d s u bjects n ot t o wear 
c o ntact le nses o n t he da y of or pri or t o Visit 3.
1 0. 2. 3 Vi sit 3 (+ 2 t o 8 D a ys) – B aseli ne/ P air 2 Dis pe nse
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
2
Rec or d a n y a d verse e ve nts or de vice deficie ncies 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 ha n ges i n c o nc o mita nt me dicati o n d osi n g.
3
Re vie w s u bject c o m plia nce wit h was h o ut peri o d . If le nses ha ve bee n w or n, 
resc he d ule Visit 3 t o all o w f or t he was h o ut peri o d.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Pa ge 3 2 of 5 4
4
Perf or m S nelle n V A wit h ha bit ual s pectacles.
O D , O S, dista nce o nl y
N ote: If t his V A wit h s pect acle c orrecti o n s h o ws a decre ase of 2 li nes or m ore
vers us Visit 1 b aseli ne V A wit h s pect acle c orrecti o n, t he n B C V A wit h M R is
re q uire d t o c o nfir m a p ote nti al l oss i n V A f or A E re p orti n g re q uire me nts (see
Secti o n 1 2).
5
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g – 5 re gi o ns (t y pe, area)
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
6
Re vie w e xcl usi o n criteria ( # 5) relate d t o c or neal stai ni n g. 

If s u bject f ulfills criteria, g o t o ste p 7.

If s u bject s h o ws u nacce pta ble c or neal stai ni n g, t he y will be per mitte d t o 
ret ur n wit hi n 7 da ys t o be reassesse d . T he I n vesti gat or will deter mi ne if it is 
per missi ble f or t he s u bject t o use preser vati ve -free l u bricati n g dr o ps pri or t o 
ret ur ni n g f or reassess me nt . T he use of preser vati ve-free e ye dr o ps s h o ul d 
n ot be c o nsi dere d a treat me nt, b ut rat her a palliati ve meas ure t o re d uce 
c or neal stai ni n g, a n d as s uc h s h o ul d n ot tri g ger a n a d verse e ve nt. If u p o n 
reassess me nt c or neal stai ni n g re mai ns u nacce pta ble, disc o nti n ue t he s u bject 
fr o m t he trial.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Page 33 of 54
7
Based on the randomized lens sequence assignment, have the subject insert the Pair 
2 study lenses to be evaluated, being careful to maintain the correct OD and OS 
lens assignments.
Note: Keep all lidding foils of lenses used during lens fit process for study lens 
accountability.
11
Dispense study lenses for approximately 2 hours of wear and instruct the subject to 
refrain from using any topical ocular medications or eye drops until they remove 
lenses at Visit 4.
12
Schedule Visit 4 to take place 2 hours (-15 min/+1 hour) after Visit 3.
10.2.4 Visit 4 [same day as Visit 3, 2 hours (-15 min/+1 hour)] – Pair 2
Follow-up / Exit
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any adverse events or device deficiencies that are observed or reported, 
including those associated with changes in concomitant medication dosing.
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Protocol - Clinical
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Pa ge 3 4 of 5 4
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge. 
6
Ha ve s u bject re m o ve st u d y  le nses. 
 
8
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g – 5 re gi o ns (t y pe, area)
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
9
Perf or m S nelle n V A wit h ha bit ual s pectacles.

O D, O S, dista nce o nl y
N ote: If t his V A wit h s pect acle c orrecti o n s h o ws a decre ase of 2 li nes or m ore 
vers us Visit 1 b aseli ne V A wit h s pect acle c orrecti o n, t he n B C V A wit h M R is 
re q uire d t o c o nfir m a p ote nti al l oss i n V A f or A E re p orti n g re q uire me nts (see 
Secti o n 1 2).
1 0
E xit t he s u bject fr o m t he st u d y .
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6

Page 35 of 54
10.3 Unscheduled Visits
Any visit that occurs between the regularly scheduled visits must be documented in the 
Unscheduled Visit pages of the Case Report Form (CRF). During all unscheduled visits, the 
following procedures should be conducted: update medical history and concomitant 
medications, VA with spectacle correction 
 biomicroscopy 
 
, assess and collect any AEs or device deficiencies. 
If the subject is discontinuing at the unscheduled visit, all exit procedures must be completed 
(as possible) and the CRFs for Exit should be completed rather than the CRFs for an 
Unscheduled Visit.
10.4 Discontinued Subjects
Discontinued subjects are those who withdraw or are withdrawn from the study after signing 
the informed consent, including screen failures. Subjects may discontinue from the study at 
any time for any reason. Subjects may also be discontinued from the study at any time if, in 
the opinion of the Investigator, their continued participation poses a risk to their health. 
Discontinued subjects will not be replaced (ie, their subject numbers will not be 
re-assigned/re-used).
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the Investigator must document those observations on an AE Form.
Any subject who exits early from the study must undergo all procedures outlined at Visit 4, as 
applicable. Additionally, the Exit Form must be completed and the reason for discontinuation 
must be identified.
Finally, to ensure the safety of all subjects who discontinue early, Investigators should assess 
each subject and, if necessary, advise them of any therapies and/or medical procedures that 
might be needed to maintain their health.
10.5 Clinical Study Termination
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulatory authorities of the termination/ suspension and the reason(s) 
for the termination/suspension. The Investigator should promptly notify the IEC/IRB of the 
termination or suspension and of the reasons. The Sponsor reserves the right to close the 
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Pa ge 3 6 of 5 4
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, f or reas o na ble ca use. 
Reas o ns f or t he cl os ure of a n i n vesti gati o nal site or ter mi nati o n of a st u dy ma y  i ncl u de: 

S uccessf ul c o m pleti o n of t he st u d y

T he st u d y ’s e nr oll me nt g oals are met

T he I n vesti gat or fails t o c o m pl y  wit h t he pr ot oc ol or G C P g ui deli nes

Safet y  c o ncer ns

S uf ficie nt data s u g gesti n g lac k of efficac y

I na de q uate recr uit me nt of s u bjects b y t he I n vesti gat or
T he I n vesti gat or als o ma y ter mi nate t he st u d y at his/ her site f or reas o na ble ca use. If t he 
S p o ns or ter mi nates t he st u d y  f or safet y reas o ns, it will i m me diatel y n otif y t he In vesti gat or(s) 
b y  tele p h o ne a n d s u bse q ue ntl y will pr o vi de writte n c o nfir mati o n of a n d i nstr ucti o ns f or st u d y 
ter mi nati o n.
1 0. 6 E nr oll me nt St o p pi n g Criteri a
Pri or e x perie nce wit h first ti me e x p os ure of ne w c o ntact le ns materials i n dicates t he 
f oll o wi n g p ote ntial fi n di n gs:

Se vere, persiste nt b ur ni n g/sti n gi n g – o nset wit hi n sec o n ds f oll o wi n g le ns i nserti o n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
Se vere le ns a ware ness/ disc o mf ort or bl urre d visi o n wit h I P d ue t o ver y  p o or s urface
wetti n g – o nset: mi n utes t o h o urs f oll o wi n g le ns i nserti o n.
I n or der t o pr otect s u bject safet y, t he f oll o wi n g st o p pi n g criteria are esta blis he d f or t his 
cli nical st u d y: 
I F a p pr o xi matel y 2 0 % of s u bjects ( 7 s u bjects) e x perie nce fi n di n gs descri be d a b o ve 
f oll o wi n g c o ntact le ns wear a n d t he e ve nt(s) are dee me d t o be relate d t o st u d y  lens 
wear , T H E N e nr oll me nt of a d diti o nal s u bjects will be st o p pe d acr oss sites a n d a r o ot-
ca use a nal ys is of t he e ve nts will be c o n d ucte d. 
T he I n vesti gat or m ust re p ort t he a b o ve fi n di n gs t o t he S p o ns or i m me diatel y  b y tele p h o ne 
(refer t o Alc o n c o ntact list 
. If t he S p o ns or st o ps 
e nr oll me nt i n t he st u d y d ue t o t he a b o ve criteria, it will i m me diatel y n otif y t he I n vesti gat or(s) 
b y  tele p h o ne. T he I n vesti gat or s h o ul d pr o m ptl y n otif y t he I E C/I R B of t he i m ple me ntati o n of 
st o p pi n g r ules a n d reas o n(s). 

Page 37 of 54
Enrollment may be resumed upon determination of causality by the Sponsor Medical Expert 
or an independent medical expert and applicable IRB requirements completed.
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Pa ge 3 8 of 5 4
1 1 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 f or t he o bser ve d val ues usi n g t he n u m ber of 
o bser vati o ns, mea n, sta n dar d de viati o n, me dia n, mi ni m u m, a n d ma xi m u m. Cate g orical 
varia bles will be s u m marize d wit h c o u nts a n d perce nta ges fr o m eac h cate g or y .
1 1. 1 S u bject E v al u a bilit y
T he fi nal s u bject e val ua bilit y  will 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 assi g n me nt a n d l oc ki n g t he data base. 
1 1. 2
A n al ysis D at a Sets
1 1. 2. 1 S afet y A n al ysis Set
Safet y  a nalys es will be c o n d ucte d usi n g t he safet y a nal ys is set o n a treat me nt-e mer ge nt basis. 
As s uc h, t he safet y  a nalysis 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 ns
e val uate d i n t his st u d y. F or treat me nt-e mer ge nt safet y a nal ys es, s u bjects/e yes will be 
cate g orize d u n der t he act ual st u d y le ns recei ve d. 
1 1. 2. 2
F ull A n al ysis Set
T he F A S will i ncl u de all ra n d o mize d s u bjects w h o satisf y  t he f oll o wi n g criteria:

E x p ose d t o a n y  st u d y le ns 

N o bi o micr osc o p y fi n di n gs at scree ni n g as descri be d i n e xcl usi o n criteri o n # 5

N o c urre nt or hist or y  of pat h ol o gical dr y e ye i n eit her e ye (e xcl usi o n criteri o n # 6)

N o c urre nt or hist or y  of her petic keratitis i n eit her e y e (e xcl usi o n criteri o n # 7).

N o e ye i nj ur y i n eit her e ye wit hi n t wel ve wee ks i m me diatel y pri or t o e nr oll me nt f or 
t his trial (e xcl usi o n criteri o n # 8).

N o h ist or y of i nt olera nce or h yperse nsiti vit y  t o a n y c o m p o ne nt of t he st u d y le nses or 
s ol uti o ns (e xcl usi o n criteri o n # 9).
T hese critical de viati o n criteria will be i de ntifie d i n t he De viati o ns a n d E val ua bilit y  Pla n.
1 1. 3 De m o gr a p hic a n d B aseli ne C h ar acteristics
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
De m o gra p hic i nf or mati o n (a ge, se x, et h nicit y , race) will be s u m marize d o n safet y a n d f ull 
a nal ys is sets, b y le ns se q ue nce gr o u p.

Page 39 of 54
11.4 Efficacy Analyses
This study defines one primary endpoint and 
. The FAS will 
serve as the primary set for all efficacy analyses.
11.4.1 Primary Efficacy
The primary objective of this study is to evaluate corneal staining observed after 2 hours of 
wear with the following lenses: Test 1, Test 2, and Control.
The corresponding efficacy endpoint is the average of corneal staining areas observed 
(expressed as a percent) taken over the 5 regions: central, superior, nasal, inferior, and 
temporal.
11.4.1.1 Statistical Hypotheses
No inferences are to be made on the primary efficacy endpoint; therefore, no hypotheses are 
formulated.
A test coating will be considered successful if XTi < (XC+3) where XTi and XC are the 
observed average percent area of corneal staining for Test i (i=1, 2) and Control, respective.
11.4.1.2 Analysis Methods
Summary statistics will be provided. Data for the control lens will be separated into those 
collected with Test 1 worn on the contralateral eye and those collected with Test 2 worn on 
the contralateral eye.
11.4.2 Secondary Efficacy
No secondary efficacy objective/endpoint has been identified for this study.
11.4.2.1 Statistical Hypotheses
Not applicable.
11.4.2.2 Analysis Methods
Not applicable.
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Page 40 of 54
11.5 Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. 
11.6 Multiplicity
No multiplicity adjustment needs to be considered for the efficacy variables as no inferences 
will be made.
11.7 Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
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Page 41 of 54
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by MedDRA Preferred Terms. In addition to an overall presentation of AEs, reports 
will be generated for significant non-serious AEs, and serious AEs. AEs leading to study 
discontinuation will be identified. Individual subject listings will be provided, as necessary.
Pre-treatment and between-treatment-period AEs will be presented, with subject listings, 
separated from treatment-emergent AEs. A pre-treatment AE is an event that occurs after 
signing informed consent but prior to exposure to a study lens. A between-treatment-period 
AE is an event that occurs after last exposure to Period 1 study lens but prior to exposure to 
Period 2 study lens. 
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (Visit 1 for Period 1 and Visit 3 for Period 2) to any subsequent visit will be 
presented. A supportive listing will be generated which will include all biomicroscopy data 
from the affected period for these eyes experiencing the increase, with the following 
variables: lens, Investigator, subject, age, sex, visit, eye, parameter, baseline value, and value 
at the visit.
Two listings (prior to exposure of study lenses, treatment-emergent) of device deficiencies, as 
recorded on the Device Deficiency Form, will be provided. Additionally, each device 
deficiency category will be tabulated. 
No inferential testing will be done for safety analysis.
11.8 Health Economics
Not applicable.
11.9 Interim Analyses
Not applicable.
11.10 Sample Size Justification
No inferential testing is planned for this study; therefore, sample size/power calculation is not 
relevant. The proposed sample size of 32 is adapted from Andrasko (2008), which recruited 
30 successful hydrogel contact lens wearers for each of the lens-solution biocompatibility 
studies, and allows for a balance allocation of lens sequences.
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Version:  
Status:  
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Page 42 of 54
12 ADVERSE EVENTS
12.1 General Information
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test article). Refer to the 
Glossary of Terms, figures and descriptions below for categories of AEs and SAEs.
Note: Figures provide abbreviated descriptions; refer to sections below for full definitions.
Figure 12–1
Categorization of All Adverse Events
ADE
Device /
procedure-
related?
Symptomatic, 
Device-related, 
Non sight-
threatening, D/C 
Lens Wear?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
Significant     
Non-Serious AE
No
No
Yes
Yes
Yes
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Protocol - Clinical
09-Dec-2016

Pa ge 4 3 of 5 4
Fi g ur e 1 2- 2
C ate g oriz ati o n of All Seri o us A d verse E ve nts
S pecific E ve nts Rele v a nt t o t his Pr ot oc ol 
Seri o us A dverse Eve nts
I n a d diti o n t o re p orti n g all A Es (seri o us a n d n o n -seri o us) meeti n g t he defi niti o ns, t he 
I n vesti gat or m ust re p ort a n y occ urre nce of t he f oll o wi n g as a n S A E:

A n oc ular i nfecti o n i ncl u di n g a pr es u me d i nfecti o us ulcer wit h a n y of t he f oll o wi n g 
c haracteristics: 
o
Ce ntral or parace ntral l ocati o n
o
Pe netrati o n of B o w ma n’ s me m bra ne
o
I nfiltrates > 2 m m dia meter
o
Iritis
o
I ncrease i n i ntra oc ular press ure
o
C ult ure p ositi ve f or micr o or ga nis ms
o
I ncreasi n g size or se verit y at s u bse q ue nt visits
Al l S A E s
D e v i c e /
pr o c e d ur e 
r el at e d?
S A E
S A D E
A n tici p at e d ?
U n a nt i ci pat e d 
S A D E
N o
Y e s
N o
A n tici p at e d 
S A D E
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
Y e s

Pa ge 4 4 of 5 4

A n y  ce ntral or parace ntral c or neal e ve nt (s uc h as ne o vasc ularizati o n) t hat res ults i n 
per ma ne nt o pacificati o n

H y p o p y o n

H y p he ma

Ne o vasc ularizati o n wit hi n t he ce ntral 6 m m of t he c or nea

Per ma ne nt visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat fails t o res ol ve

U veitis (a nteri or , i nter me diate, or p osteri or)

C or neal a brasi o n affecti n g ≥5 0 % of c or neal s urface area
Si g nific a nt N o n -Seri o us A dverse Eve nts
A si g nifica nt n o n-seri o us A E is a de vice-relate d, n o n- si g ht t hreate ni n g a d verse e ve nt t hat 
warra nts disc o nti n uati o n of a n y c o ntact le ns wear f or greater t ha n or e q ual t o 2 wee ks. I n 
a d diti o n, t he In vesti gat or m ust re p ort a n y  occ urre nce of t he f oll o wi n g as a Si g nifica nt 
N o n - Seri o us A d verse E ve nt:

Peri p heral n o n - pr o gressi ve n o n-i nfecti o us ulcers

All s y m pt o matic c or neal i nfiltrati ve e ve nts

De nse c oalesce nt c or neal stai ni n g, (e g, c or neal a brasi o n or f orei g n b o d y trac k) or 
patc h stai ni n g . *

Te m p orar y  visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C V A fr o m e nr oll me nt 
visit t hat persists f or 2 or m ore wee ks

Ne o vasc ularizati o n sc ore greater t ha n or e q ual t o gra de 2 
 
 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
T he a b ove eve nts ar e b ase d o n t he c ate g ories provi de d i n t he I S O 11 9 8 0 a n d t he U S F D A
Pr e m arket N otific ati o n ( 5 1 0(k)) G ui d a nce D oc u me nt f or D aily We ar C o nt act Le nses a n d 
C o nt act Le ns C ar e Pro d ucts. 
* T his criteri o n will be a p plie d t o n o n s ol uti o n -rel ate d c or ne al st ai ni n g. The pr ese nce of 
s ol uti o n-rel ate d c or ne al st ai ni n g is a n ex pecte d occ urre nce i n t his st u dy a n d t he ty pe a n d 
ar e a of t he c or ne al st ai ni n g will be d oc u me nte d i n t he C ase Re p ort F or m o n a differ e nt 
gr a di n g sc ale as n ote d i n S ecti o n 1 Sy n o psis/ Assess me nts . T heref ore, c or ne al st ai ni n g t h at is

Pa ge 4 5 of 5 4
pre d o mi n ately s ol uti o n- rel ate d (i n t he o pi ni o n of t he i nvesti g at or) will n ot be d oc u me nte d as 
a dverse eve nt .
Device Deficie ncies
A de vice deficie nc y  is i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. A de vice deficie nc y m a y  or ma y n ot be 
ass ociate d wit h patie nt har m (ie, 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 ue 
t o a de vice deficie nc y. T he I n vesti gat or s h o ul d deter mi ne t he a p plica ble cate g or y liste d i n t he 
De vice Deficie nc y  e C R F f or t he i de ntifie d or s us pect de vice deficie nc y a n d re p ort a ny patie nt 
har m se paratel y. E xa m ples of de vice deficie ncies 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/s ol uti o n cl o u d y

Le ns s urface/e d ge defect 

To r 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, ta m pere d seal, lea ki n g b ottle/c o ntai ner)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
1 2. 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 usly 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 uire a b o ut A Es b y  as ki n g t he sta n dar d q uesti o ns:

“ Ha ve y o u ha d a n y healt h pr o ble ms si nce y o ur last st u d y  visit?”

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
“ Ha ve t here bee n a n y c ha n ges i n t he me dici nes y o u ta ke si nce y o ur last st u d y  visit?”
C ha n ges i n a n y pr ot oc ol-s pecific para meters a n d/ or q uesti o n naires e val uate d d uri n g t he st u dy 
are t o be re vie we d b y t he 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 para meter or q uesti o n naire res p o nse t hat is cli nicall y rele va nt, 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 hese cli nicall y rele va nt c ha n ges will 
be re p orte d re gar dless of ca usalit y.

Pa ge 4 6 of 5 4
1 2. 3 Pr oce d ures f or Rec or di n g a n d Re p orti n g A Es a n d S A Es
A Es are c ollecte d fr o m t he ti me of i nf or me d c o nse nt .A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s ym pt o ms prese nt i n a s u bject pri or t o t he start of t he st u d y  (ie, bef 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 be rec or de d i n t he Me dical 
Hist or y  secti o n of t he e C RF.
I n a d diti o n, te m p orar y le ns a ware ness or vis ual c ha 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 vesti gat or assesses t hat t he s y m pt o m(s) ca n reas o na bl y  res ol ve wit hi n 
t he a ntici pate d a da ptati o n peri o d.
F or eac h rec or de d e ve nt, t he A D E s a n d S A Es d oc u me ntati o n m ust i ncl u de: date of 
occ urre nce, se verit y, treat me nt (if a p plica ble), o utc o me, a n d assess me nts of t he seri o us ness 
a n d ca usalit y. In a d diti o n, t he I n vesti gat or m ust d oc u me nt all de vice deficie ncies re p orte d or 
o bser ve d wit h test a n d c o ntr ol articles o n t he De vice Deficie nc y  e C R F. T he 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 de vice deficie ncies t o t he St u d y  S p o ns or 
i m me diatel y as f oll o ws:

A D Es or S A Es are d oc u me nte d o n t he Seri o us A dverse Eve nt a n d A dverse Device
Effect e C R F wit hi n 2 4 h o urs of t he I n vesti gat or ’s or site’s a ware ness. 

De vice deficie ncies are d oc u me nte d o n t he Device Deficie ncy e C R F wit hi n 2 4 h o urs 
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 Device Deficie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns. Refer t o 
Secti o n 1 2. 5 of t his pr ot oc ol 
 f or a d diti o nal i nf or mati o n 
o n ret ur ni n g pr o d uct.

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 ha 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 all rele va 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 etc, if a p plica b le, i n narrati ve secti o n of t he Seri o us A dverse Eve nt
a n d A dverse Device Effect 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 dverse Eve nt a n d A dverse Device Effect a n d/ or Device Deficie ncy
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 0 5 6
P r o t o c o l  -  C l i n i c a l
0 9- Dec- 2 0 1 6
F or m. T he c o m plete d f or m is fa xe d or e maile d t o t he St u d y S p o ns or at

Page 47 of 54
MSUS.safety@alcon.com according to the timelines outlined above; however, the reported 
information must be entered into the EDC system once it becomes operational.
Any AEs and device deficiencies for non-study marketed devices/products will be considered 
and processed as spontaneous (following the postmarket vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
12.4 Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity):
Mild
An event is mild if the subject is aware of, but can easily tolerate the sign or 
symptom.
Moderate
An event is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An event is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality:
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
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Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related.
12.5 Return Product Analysis
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint number which will be provided by Study Sponsor 
after the case is entered in the Study Sponsor’s Global Product Complaint Management 
System (GPCMS).
12.6 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (see Section 9.4 of this protocol for masking procedure). If the treatment 
code needs to be broken in the interest of subject safety, the Investigator is encouraged to 
contact an appropriate Study Sponsor representative prior to unmasking the information if 
there is sufficient time. Dependent upon the individual circumstances (ie, medical 
emergency), the code may be broken prior to contact with the Study Sponsor. The Study 
Sponsor must be informed of all cases in which the code was broken and of the 
circumstances involved. Additionally, the Study Sponsor may be required to unmask the 
information in order to fulfill expedited regulatory reporting requirements.
12.7 Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
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Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
12.8 Pregnancy in the Clinical Trial
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case-by-case basis.
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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor. If 
electronic records are maintained, the method of verification must be determined in advance 
of starting the study. At a minimum, source documents should include the following 
information for each subject:
Subject identification (name, sex, race/ethnicity)
Documentation of subject eligibility
Date of informed consent
Dates of visits
Documentation that protocol specific procedures were performed
Results of study parameters, as required by the protocol
Trial medication accountability records
Documentation of AEs and other safety parameters (if applicable)
Records regarding medical histories and the use of concomitant therapies prior to and during 
the study
Date of trial completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 
CRFs will be provided to the sites (paper or electronic); only designated individuals may 
complete the CRFs. The CRFs will be submitted at regular intervals based upon the clinical 
trial visit schedule. It is expected that all data reported will have corresponding entries in the 
source documents and that the Principal Investigator will review the reported data and certify 
that the CRFs are accurate and complete. No subject identifiers should be recorded on the 
CRFs beyond subject number, and demographic information. 
13.2 Data Review and Clarifications
The CRF data will be reviewed against the subject’s source data by the study monitors to 
ensure completeness and accuracy. After monitoring has occurred at the clinical sites and the 
CRFs have been submitted, additional data clarifications and/or additions may be needed. 
Data clarifications and/or additions are documented and are part of each subject’s CRFs.
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13.3 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing 
study monitoring. Financial information is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the latest marketing approval).
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14 PUBLICATION PLAN
The results of this study will not be submitted or offered for publication. 
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15 REFERENCES
Andrasko G, Ryen K. Corneal staining and comfort observed with traditional and silicone 
hydrogel lenses and multipurpose solution combinations. Optometry. 2008;79(8):444-54.
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16 APPENDIX
None
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
12/08/2016 23:28:25
12/08/2016 21:14:20
12/08/2016 21:09:59
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