Clinical Assessment of a Regimen of AIR OPTIX® Plus HYDRAGLYDE® Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care Solutions
Phase: NA
Conditions: Refractive Errors, Myopia, Hypermetropia
Sponsor: Alcon, a Novartis Company

Page 1 of 62
a Novartis company
Short Title
Clinical Assessment of a HYDRAGLYDE® Regimen
Long Title
Clinical Assessment of a Regimen of AIR OPTIX® plus HYDRAGLYDE®
Silicone Hydrogel Lenses and HYDRAGLYDE® Containing Lens Care
Solutions
Protocol Number:
Study Phase:
Sponsor Name and 
Address:
Test Product:
US IND# / EudraCT
Indication Studied:
Investigator Agreement:
LCW773-P001 / NCT03026257
N/A
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Air Optix® plus HydraGlyde®
CLEAR CARE® PLUS/AOSEPT® PLUS with HydraGlyde® 
Cleaning and Disinfecting Solution
OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution
N/A
Contact Lens Wear and Care
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
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Protocol - Clinical
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Page 2 of 62
Name:
Address:
Alcon - Business Use Only 
 
Effective Date:  
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Protocol - Clinical
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Page 3 of 62
1
SYNOPSIS
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
Test Product:
AIR OPTIX plus 
HYDRAGLYDE (AOHG)
CLEAR CARE
Plus/AOSEPT Plus with 
HYDRAGLYDE (CCP)
OPTI-FREE PUREMOIST
(OFPM)
Study Phase:
1
2
3
4
N/A
Active Ingredient:
N/A
Protocol Title:
Clinical Assessment of a Regimen of AIR OPTIX PLUS
HYDRAGLYDE Silicone Hydrogel Lenses and 
HYDRAGLYDE Containing Lens Care Solutions
Investigator(s)/ No. of
Sites:
Approximately 8 sites
Center Location(s)/ 
United States (US), Germany, Canada
Duration of Treatment:
30 days (-0,+3 days)
No. of Subjects
Planned approximately 256 randomized (64/habitual lens type) 
to achieve required 240 completed subjects. Approximately 
14-50 subjects per site will be randomized. Randomization will 
be stratified by habitual lens type and by tear film status at 
screening.
Study Population: 
Volunteer adult subjects with normal eyes who are habitual 
silicone hydrogel (SiHy) lens wearers (Biofinity, Vita, Ultra, 
and Oasys) and habitual multi-purpose solution (MPS) users 
 
 
 
Objective(s):
Primary Objective:
To demonstrate that worn AOHG lenses cleaned and disinfected 
with HYDRAGLYDE containing lens solutions (HGLC), 1) 
OFPM and 2) CCP, for the recommended replacement period 
will have less cholesterol uptake compared to each of the 
control habitual SiHy lenses (Biofinity, Vita, Ultra, and Oasys) 
cleaned and disinfected with habitual MPS (HMPS).
Alcon - Business Use Only 
 
Effective Date:  
Document:  
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TDOC-0052732
Protocol - Clinical
19-Dec-2016

Page 4 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
Safety:
Collect and describe Biomicroscopy findings, adverse events
(AEs), and device deficiencies. 
Methodology:
Multi-center, prospective, randomized, controlled, parallel-
group, observer-masked and quasi-subject-masked study.
Treatments:
Test Products:
AOHG spherical contact lenses
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Protocol - Clinical
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Page 5 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
Route of Administration: Lenses will be dispensed by the 
unmasked study staff member so 
that the subject does not see the lens 
label and remains masked to the 
details of the lens. 
Subjects to use the lenses as 
instructed by the study coordinator, 
according to the instructions for use.
Duration of Treatment:
Subjects will wear the lenses 
bilaterally for a total duration of 
30 (+3) days under a daily wear 
modality.
The lenses will be removed every 
night during the study.
Parameters:
Lenses will be available in the 
following parameters:
Material: Lotrafilcon B, 33% water 
content with plasma surface 
treatment
Base curve: 8.6 millimeters (mm)
Diameter: 14.2 mm
Power range: 
+8.00 Diopters (D) to -12.00 D 
(0.50 D steps above +6.00 D 
and -10.00) Lenses will be worn 
daily wear and cared for (up to 
32 cleaning and disinfecting cycles) 
with CCP or OFPM as randomized.
Bausch + Lomb (B&L) Sensitive 
Eyes® Plus Saline will be provided 
as a rinsing solution to those 
randomized to CCP. 
Test lens care solutions will be over 
labeled to mask the brand. See the 
Manual of Procedures (MOP) for 
detailed instructions for use of test 
lens care products.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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TDOC-0052732
Protocol - Clinical
19-Dec-2016

Page 6 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
Control Products:
Habitual Spherical SiHy Lenses:
Bausch + Lomb ULTRA™Contact 
Lenses with MoistureSeal™
Technology (Samfilcon A) (Ultra)
Material: samfilcon A, 46% water 
content
Base curve: 8.5 mm
Diameter: 14.2 mm
Power range: +6.00 D to -12.00 D
(0.50 D steps above -6.00 D)
Johnson & Johnson ACUVUE®
VITA™Brand Contact Lenses
(Vita)Material: senofilcon C, 41% 
water content
Base curve: 8.4, 8.8 mm
Diameter: 14.0 mm
Power range: +8.00 D to -12.00 D
(0.50 D steps above +/-6.00 D)
Johnson & Johnson ACUVUE®
OASYS® Brand 2-Week with 
HYDRACLEAR® PLUS (Oasys)
Material: senofilcon A, 38% water 
content
Base curve: 8.4, 8.8 mm
Diameter: 14.0 mm
Power range: +8.00 D to -12.00 D
(0.50 D steps above +/-6.00 D)
Biofinity
Material: comfilcon A, 48% water 
content
Base curve: 8.6 mm
Diameter: 14.0 mm
Power range: +8.00 D to -12.00 D 
(0.50 D steps after +/-6.00 D)
Route of Administration: Lenses will be dispensed by the 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
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1.0; CURRENT; Most-Recent; Effective
TDOC-0052732
Protocol - Clinical
19-Dec-2016

Page 7 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
unmasked study staff member(s) so 
that the subject does not see the lens 
label and will remain masked to the 
details of the lens.
Subjects will use the lenses as 
instructed by the coordinator, 
according to the instructions for use.
Duration of Treatment:
Subjects will wear the lenses 
bilaterally for a total duration of 
30 days (-0, +3 days). Oasys lenses 
will be replaced (masked 
dispensing) at Day 15 ±1 day.
The lenses will be removed every 
night during the study.
Parameters:
The lenses will be available in the 
powers offered by each brand that 
are inclusive of the powers offered 
by AOHG (+8.00 D to -12.00 D).
The lenses will be worn as daily 
wear and cared for with subject’s 
HMPS (up to 32 cleaning and 
disinfection cycles). The HMPS will 
be purchased by the subject 
(confirmed by the site) or purchased 
by the site and used in the 
commercial packaging according to 
the product’s instructions for use.
Subject Selection:
Inclusion Criteria:
1. Subjects must be at least 18 years of age and sign the 
inform consent document
2. Subjects’ vision must be correctable to 0.1 (logMAR) or 
better in each eye at distance with habitual lenses at 
Visit 1.
3. Manifest cylinder (at screening) less than or equal to 
0.75 D in each eye and spectacle add < +0.50 D in each 
eye.
4. Current full-time wearer (during the past 1 month for a 
minimum of 5 days per week and 6 hours per day) of 
spherical samfilcon A, comfilcon A, or senofilcon C 
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TDOC-0052732
Protocol - Clinical
19-Dec-2016

Page 8 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
monthly replacement lenses or senofilcon A 2-week 
replacement lenses within the power range of lens 
powers available for the test AOHG spherical lenses. 
5. Current user (for the past 1 month) of an MPS 
(excluding OFPM) to care for their lenses. 
6. Willing to answer text messages on a daily basis during 
the study. 
7. Willing to discontinue artificial tears during the study 
and rewetting drops on the days of study visits. 
8. Uses digital devices (eg, smart phone, tablet, laptop 
computer, or desktop computer) for 20 consecutive 
minutes at least twice a week and willing to continue the 
same pattern for the duration of the study.
Exclusion Criteria:
1. Habitual lens wear in an extended wear modality 
(routinely sleeping in lenses overnight for 1 or more 
nights per week).
2. Unstable tear film with a NIKBUT < 6 seconds in either 
eye without lenses. 
3. Any anterior segment infection, inflammation, disease or 
abnormality that contraindicates contact lens wear as 
determined by the Investigator (within 7 days of 
enrollment, or current).
4. History of herpetic keratitis, corneal surgery or irregular 
cornea.
5. Prior refractive surgery (eg, laser assisted in situ 
keratomileusis and photorefractive keratectomy).
6. Any use of systemic or ocular medications for which 
contact lens wear could be contraindicated as determined 
by the Investigator. 
7. Subjects who are currently using or have not 
discontinued Restasis®, XiidraTM and/or topical steroids 
within the past 7 days.
8. Use of mechanical eyelid therapy or eyelid scrubs within 
14 days before Visit 1 and not willing to discontinue 
during the study.
9. Biomicroscopy findings that are abnormal or graded 
moderate (Grade 3) or severe (Grade 4) at Visit 1. 
10. Monocular subjects (only one eye with functional 
vision) or subjects fit with only one lens.
11. Known pregnancy or lactating. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
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Printed By: 
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Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0052732
Protocol - Clinical
19-Dec-2016

Pa ge 9 of 6 2
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:
1 2. E nr oll me nt of site staff or fa mil y / h o use h ol d me m bers of 
t he site staff w h o are liste d o n t he st u d y pers o n nel l o g as 
ha vi n g a r ole i n t he e xec uti o n of t his st u d y . 
1 3. Partici pati o n i n a n y  cli nical st u d y wit hi n 3 0 da ys of Visit 
1.
Assess me nts:
Pri m ar y Effic ac y:

T otal C h olester ol U pta ke t o be assesse d o n w or n ri g ht 
( O D) le nses c ollecte d at Da y 3 0
S afet y:

Bi o micr osc o p y

A Es

De vice Deficie ncies
St atistic al Met h o ds:
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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
Pla n ne d A nal ys is
T hree a nal ys is sets will be defi ne d, Safety, F ull,  
 
. T he Safet y A nal ysis Set will i ncl u de all 

Page 10 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
subjects/eyes exposed to any test or control products evaluated 
in this study. The Full Analysis Set (FAS) will consist of all 
subjects randomized and exposed. 
 
 
 The FAS will serve as 
the primary analysis dataset for all efficacy evaluations. 
All data from evaluable subjects will be included in the efficacy 
analysis; no imputation for missing values will be performed.
To address the primary efficacy objective, planned analyses are 
summarized below:
Endpoint
Comparison
Statistical Method
PRIMARY
Ex vivo total 
cholesterol uptake 
(Day 30)
AOHG/OFPM and 
AOHG/CCP vs 
Ultra, Biofinity, 
Vita, and Oasys 
Superiority
 
 
 
 
 
 
 
 
 
A sequential gatekeeping strategy will be implemented to 
control multiplicity, by testing the primary efficacy hypotheses 
first for both HYDRAGLYDE regimen comparisons; 
 
 
 
 
 
 
Alcon - Business Use Only 
 
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TDOC-0052732
Protocol - Clinical
19-Dec-2016

Page 11 of 62
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
 
Safety
Each safety variable will be summarized descriptively. AEs will 
be classified as treatment-emergent or pre-treatment. Counts and 
percentages will be provided by relationship to regimen, 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 describing details of 
each safety variable will be provided. No inferential testing will 
be performed for safety analysis. 
Sample Size Justification
Sample size calculations for attaining the specified power at 
one-sided α=0.05 for each of the relevant efficacy endpoints are 
summarized below:
Endpoint
Assumptions
Power
N
PRIMARY
Ex vivo total 
cholesterol 
uptake
Expected difference = 
3.26
Common standard 
deviation (SD) = 3.12
97%
25 /group
(based on t-test of equal 
means)
 
1.1
Glossary of Terms for Safety
Adverse Event (AE)
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). Note: For subjects, 
this definition includes events related to the test article, the control 
article, or the procedures involved. For users or other persons, 
this definition is restricted to events related to the test article.
Adverse Device 
Adverse event related to the use of an investigational medical 
device (test article) or control article. Note: This definition 
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TDOC-0052732
Protocol - Clinical
19-Dec-2016

Pa ge 1 2 of 6 2
Ef fect ( A D E)
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.
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.
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.
Pr o d uct C o m plai nt
A n y  oral, electr o nic, or writte n c o m m u nicati o n t hat alle ges 
deficie ncies relate d t o t he i de ntit y  (la beli n g), q ualit y, d ura bilit y, 
relia bilit y, safety,  effecti ve ness, or perf or ma nce of a mar kete d 
pr o d uct, i ncl u di n g fail ure of t he pr o d uct, la beli n g or pac ka gi n g t o 
meet s pecificati o ns, w het her or n ot t he pr o d uct is relate d t o or 
ca use d t he alle ge d deficie nc y. A c o m plai nt m a y  alle ge t hat a n 
a d verse e ve nt or me dical de vice malf u ncti o n has occ urre 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: L ife-t hreate ni n g mea ns t hat t he i n di vi d ual was at 
i m me diate ris k of deat h fro m t he e ve nt as it occ urre d, ie, it 
d oes n ot i ncl u de a n e ve nt w hic h h y p ot heticall y mi g ht ha ve 
ca use d deat h ha d it occ urre d i n a m ore se vere f or m.
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: Pla n ne d h os pitalizati o n f or a pre -e xisti n g c o n diti o n, 
wit h o ut seri o us deteri orati o n i n healt h, is n ot c o nsi dere d a 
seri o us a d verse e ve nt. I n ge neral, h os pitalizati o n si g nifies 
t hat t he i n di vi d ual re mai ne d at t he h os pital or e mer ge nc 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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6

Pa ge 1 3 of 6 2
war d f or o bser vati o n a n d/ or treat me nt ( us uall y i n v ol vi n g a n 
o ver ni g ht sta y ) t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h y sicia n's office or a n o ut- patie nt setti n g. C o m plicati o ns 
t hat occ ur d uri n g h os pitalizati o n are a d verse e ve nts. If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her 
seri o us criteria, t he e ve nt is seri o us. W he n i n d o u bt as t o 
w het her “ h os pitalizati o n” occ urre d, t he e ve 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 nal 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.
Seri o us P u blic Healt h 
T hreat
A n y  e ve nt ty pe w hic h res ults i n i m mi ne nt ris k of deat h, seri o us 
deteri orati o n i n state of healt h, or seri o us ill ness t hat re q uires 
pr o m pt re me dial acti o n. T his w o ul d i ncl u de: E ve nts t hat are of 
si g nifica nt a n d u ne x pecte d nat ure s uc h t hat t he y bec o me alar mi n g 
as a p ote ntial p u blic healt h hazar d, e g, h u ma n i m m u n o deficie n c y 
vir us or Cre utzfel dt -Jac o b Disease.
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 
res p 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, la pses, a n d mista kes. A n 
u ne x pecte d p h y si ol o gical res p o nse of t he s u bject d oes n ot i n itself 
c o nstit ute a use err or.
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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6

Pa ge 1 4 of 6 2
2
O V E R VI E W O F  S T U D Y P L A N
Visit 1  
Visit 2  
Visit 3
Visit 4 / 
E xit
U S V   
Pr oce d ure/ Assess me nt
Scree ni n g 
D a y 1 -
I nserti o n
1- 7 da ys fr o m 
Visit 1. 
N o le nses 
w or n o n d ay 
of t he visit
D a y 1: 
8 hrs ( ± 3 0 
mi n)
D a y 3 0
( +3 d a ys): 
8 hrs ( ± 3 0 
mi n) / E xit
U nsc he d ule d 
Visit  
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

Bi o micr osc o p y ( N ote: c o nj u ncti val 
stai ni n g c o n d ucte d at desi g nate d 
sites o nl y)
Ra n d o mize Eli gi ble S u bjects

Dis pe nse assi g ne d st u d y le nses i n 
a mas ke d ma n ner
g
()
C ollect le nses f or s hi ppi n g a n d
a nal yses

()
E xit F or m
()
()
()

()
Assess A d verse E ve nts
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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6

Pa ge 1 5 of 6 2
( B ot h o bser ve d a n d re p orte d)
Assess De vice Deficie ncies
 
 
 

  
  
  c Wit h o ut le nses at baseli ne t o deter mi ne eli gi bilit y.
 
  d A Es are c ollecte d fr o m t he ti me of i nf or me d c o nse nt.  
 
  
  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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
Le nses 
als o dis pe nse d at Da y 1 5 ± 1 i n office f or s u bjects assi g ne d t o c o nti n ue weari n g Oas ys.

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3
ABBREVIATIONS
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
ANOVA
Analysis of variance
AOHG
AIR OPTIX plus HYDRAGLYDE
B&L
Bausch + Lomb
Biofinity
CooperVision® Biofinity® Contacts
CCP
CLEAR CARE Plus/AOSEPT Plus with HYDRAGLYDE
CE
Conformité Européene
CI
Confidence interval
CL
Confidence limit
CRF
Case report form
CSR
Clinical study report
D
Diopters
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
EOBO
Polyoxyethylene -polyoxybutylene
FDA
US Food and Drug Administration
fl. Oz.
Fluid ounces
GCP
Good Clinical Practice
HGLC
HYDRAGLYDE containing lens solutions
HMPS
Habitual multipurpose solution
Hrs
Hours
IEC
Independent ethics committee
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
ID
Identification
IRB 
Institutional review board
LCS
Lens care system
MedDRA®
Medical Dictionary for Regulatory Activities
Min
Minute(s)
ml
Milliliter
mm
Millimeters
MOP
Manual of procedures
MPS
Multipurpose Solution
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Abbreviation
Definition
N/A
Not applicable
Oasys
Johnson & Johnson ACUVUE® OASYS® Brand 2-Week with 
HYDRACLEAR® PLUS
OD
Right eye
OFPM
OPTI-FREE PUREMOIST
OS
Left eye
Rx
Prescription
SADE
Serious adverse device effect
SAE
Serious adverse event
SD
Standard deviation
SiHy
Silicon hydrogel
SMS
Short message service
Ultra
Bausch + Lomb ULTRA™Contact Lenses with MoistureSeal™
Technology (Samfilcon A) 
US
United States
VA
Visual acuity
Vita
Johnson & Johnson ACUVUE® VITA™Brand Contact Lenses
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4
TABLE OF CONTENTS
Clinical Assessment of a Regimen of AIR OPTIX® plus HYDRAGLYDE® Silicone Hydrogel 
Lenses and HYDRAGLYDE® Containing Lens Care Solutions............................1
1
SYNOPSIS .............................................................................................................3
1.1
Glossary of Terms for Safety............................................................................11
2
OVERVIEW OF STUDY PLAN..........................................................................14
3
ABBREVIATIONS...............................................................................................16
4
TABLE OF CONTENTS......................................................................................18
List of Tables............................................................................................................................20
List of Figures..........................................................................................................................20
5
INTRODUCTION................................................................................................21
5.1
Study Rationale and Background .....................................................................21
5.2
Known and Potential Risks ..............................................................................22
5.3
Potential Benefits..............................................................................................23
6
ETHICS ................................................................................................................24
7
PROTOCOL AMENDMENTS ............................................................................26
8
SUBJECT POPULATION....................................................................................27
9
TREATMENTS ADMINISTERED......................................................................28
9.1
Identity of Study Treatments ............................................................................28
9.2
Usage ................................................................................................................31
32
32
10
STUDY PROCEDURES ......................................................................................34
34
10.2
Visits and Examinations ...................................................................................34
10.2.1
Visit 1 – Screening........................................................................................34
10.2.2
Visit 2 (1-7 Days from Visit 1) – Day 1 Insertion Visit................................36
10.2.3
Visit 3 - Day 1: after approximately 8 hrs (± 30 mins).................................38
10.2.4
Visit 4 - Day 30: Exit....................................................................................40
41
10.4
Discontinued Subjects ......................................................................................42
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10.5
Clinical Study Termination...............................................................................42
11
ANALYSIS PLAN ...............................................................................................44
11.1
Subject Evaluability..........................................................................................44
11.2
Analysis Data Sets............................................................................................44
11.2.1
Safety Data Set .............................................................................................44
11.2.2
Full Analysis Data Set ..................................................................................44
45
11.3
Demographic and Baseline Characteristics......................................................45
11.4
Efficacy Analyses .............................................................................................45
11.4.1
Primary Efficacy...........................................................................................45
45
46
11.4.2
Secondary Efficacy.......................................................................................46
11.4.2.1
Statistical Hypotheses...............................................................................46
11.4.2.2
Analysis Methods .....................................................................................46
46
.48
49
11.5
Handling of Missing Data ................................................................................50
50
11.7
Safety Analysis .................................................................................................50
11.8
Health Economics.............................................................................................51
51
52
12
ADVERSE EVENTS............................................................................................53
12.1
General Information .........................................................................................53
12.2
Monitoring for Adverse Events ........................................................................54
12.3
Procedures for Recording and Reporting AEs and SAEs.................................54
12.4
Intensity and Causality Assessments................................................................56
12.5
Return product analysis ....................................................................................57
12.6
Unmasking of the Study Treatment..................................................................57
12.7
Follow-Up of Subjects with Adverse Events....................................................57
12.8
Pregnancy in the Clinical Trial.........................................................................58
13
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ..................59
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13.1
Completion of Source Documents and Case Report Forms.............................59
13.2
Data Review and Clarifications........................................................................60
13.3
Regulatory Documentation and Records Retention .........................................60
13.4
Clinical Trial Results ........................................................................................60
14
References.............................................................................................................61
15
APPENDIX...........................................................................................................62
List of Tables
Table 9-1
Study Treatment OFPM and CCP....................................................................29
List of Figures
Figure 12–1
Categorization of All Adverse Events..............................................................53
Figure 12-2
Categorization of All Serious Adverse Events.................................................54
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5
INTRODUCTION
5.1
Study Rationale and Background
HYDRAGLYDE (polyoxyethylene-polyoxybutylene), developed by Alcon Laboratories, Inc., 
is a proprietary surfactant with a large hydrophilic component that brings moisture to lens 
surfaces. HYDRAGLYDE technology is used in premium lens care solution products from 
Alcon, including OPTI-FREE PUREMOIST MULTI-PURPOSE DISINFECTING
SOLUTION, and AOSEPT PLUS with HYDRAGLYDE Cleaning and Disinfecting Solution 
(marketed as CLEAR CARE PLUS with HYDRAGLYDE Moisture Matrix in the US). These 
lens care products are specially designed to improve the wettability of reusable SiHy lenses; 
which are particularly prone to surface de-wetting (Keir 2013).
The AIR OPTIX brand of SiHy contact lenses (lotrafilcon B with plasma surface technology) 
has been shown to resist lipid deposition better than other SiHy contact lenses and maintain 
good surface wettability even after 30 days of wear (Nash 2014). However, switching to 
HYDRAGLYDE containing lens care products has been shown to significantly improve 
patient-reported comfortable lens wear time when used to clean and disinfect AIR OPTIX 
Aqua contact lenses (TDOC-0051197 CSR for Protocol LCD913-P001 and TDOC-0013454
CSR for Protocol C-09-074).
In order to provide the benefits of this surfactant on the first day of wear, HYDRAGLYDE 
(0.04% EOBO-41 polyoxyethylene-polyoxybutylene) has been added to the packaging 
solution of AIR OPTIX Aqua lenses. The addition of HYDRAGLYDE to the packaging 
solution of AIR OPTIX plus HYDRAGLYDE lenses has shown to interact with the lens 
surface and significantly improve the wetting substantivity of the lens (Lemp 2016), 
providing a longer lasting moisture effect.
The overall objective of this clinical study is to compare the on-eye performance of a 
HYDRAGLYDE regimen of lenses and lens care with a regimen of marketed SiHy lenses 
and marketed multipurpose solutions that do not contain HYDRAGLYDE.
 
 
 
 
 
 
 
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Pa ge 2 2 of 6 2
 M ulti p ur p ose s ol uti o ns are co m m o nl y  use d 
disi nfecti o n s y ste ms i n t he mar ket place a n d are i ncl u de d i n m ost pri vate la bel s ol uti o ns; 
t heref ore, t he y are a reas o na ble c o ntr ol t o t he test s ol uti o ns i n t his st u d y, w hic h are a 
h y dr o ge n per o xi de base d s ol uti o n a n d a P O LY Q U A D/ A L D O X preser ve d M P S
b ot h 
c o ntai ni n g H Y D R A G LY D E f or l o n ger lasti n g le ns s urface wetta bilit y  t o f urt her re d uce li pi d 
de p ositi o n a n d pr o m ote tear fil m sta bilit y .
5. 2
K n o w n a n d P ote nti al Ris ks
Safet y  i nf or mati o n o n A O H G, O F P M , a n d C C P ma y be f o u n d i n t he pr o d ucts’ la beli n g. T he 
I n vesti gat or s h o ul d a d vise s u bjects of t he f oll o wi n g ge neral war ni n gs a n d preca uti o ns wit h 
c o ntact le ns wear, i ncl u di n g t he f oll o wi n g:

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. 

E y e pr o ble ms, i ncl u di n g i nfecti o n, c or neal ulcers, c or neal ne o vasc ularizati o n , or iritis 
ca n de vel o p ra pi dl y a n d lea d t o l oss of visi o n if left u natte n de d. 

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 wi t h c o ntact le ns wear, 
es peciall y w he n le nses are w or n o ver ni 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/ or n o nc o m plia nce wit h re gi me n. T he A O H G c o ntact 
le nses are f or daily use a n d are t o be care d f or wit h C C P or O F P M at t he e n d of eac h da y.
S u bjects w h o fail t o f oll o w t he i nstr ucti o ns f or re placi n g a n d cari n g f or t heir c o ntact le ns es
c o ul d e x perie nce a n e ye i nfecti o n of t he c or nea or i nj ur y. A c or neal ulcer c o ul d de vel o p 
ra pi dl y a n d lea d t o l oss of visi o n. A n i m pr o perl y fitte d c o ntact le ns m a 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. 
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 1 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 i ncl u di n g m uc o p ur ule nt disc har ge

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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
Oc ular h y pere mia

Pa ge 2 3 of 6 2

P h ot o p h o bia

B ur ni n g, sti n gi n g, itc hi n g, or ot her pai n ass ociate d wit h t he e y es

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 y e

P o or V A / bl urre d visi o n

Rai n b o ws or hal os ar o u n d o bjects

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  of t he a b o ve si g ns or s ym pt o ms are 
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. I n a d diti o n, t he 
I n vesti gat or s h o ul d a d vise s u bjects of p ossi ble oc ular dr y ness, i ncrease d le ns 
a ware ness/i nt olera nce, a n d vis ual c ha n ges wit h c o nc o mita nt me dicati o ns or d uri n g 
pre g na nc y. 
It is i m p orta nt f or O F P M a n d C C P users t o f oll o w directi o ns a n d all la beli n g i nstr ucti o ns f or 
pr o per use, i ncl u di n g use of t he le ns case. S u bjects w h o are n o nc o m plia nt a n d fail t o f oll o w 
t he i nstr ucti o ns f or clea ni n g, st ora ge, a n d disi nfecti o n of t heir c o ntact le nses c o ul d e x perie nce 
a n e ye i nfecti o n or i nj ur y. C o ntact le ns wearers u nfa miliar wit h a hy dr o ge n per o xi de s ol uti o n 
( C C P) c o ul d i na dverte ntl y use t he per o xi de s ol uti o n as a l u bricati n g/re wetti n g dr o p or ri nse 
t heir c o ntact le nses pri or t o i nserti o n, res ulti n g i n c he mical b ur n d ue t o t he u n ne utralize d 
per o xi de s ol uti o n. A d diti o nall y , usi n g t he wr o n g le ns c u p, o verfilli n g t he le ns c u p wit h 
per o xi de s ol uti o n or disi nfecti n g t he le nses f or less t ha n t he s pecifie d ti me ca n res ult i n 
i nc o m plete ne utralizati o n of t he per o xi de s ol uti o n. In s uc h cases, a d verse oc ular ef fects s uc h 
as disc o mf ort, b ur ni n g, sti n gi n g, pai n, i nfla m mati o n or irritati o n as well as c he mical b ur n or 
irritati o n t o t he fi n gers ma y occ ur. T hese a d verse effects are us uall y te m p orar y, a n d users 
s h o ul d be i nstr ucte d t o i m me diatel y fl us h t he e yes or fi n gers wit h sali ne or water s h o ul d t his 
occ ur. O verall, t he p ote ntial ris ks ass ociate d wit h use of t he s u bject’s Ha bit ual Si H y/ M P S, 
A O H G/ O F P M, a n d A O H G/ C C P  are si milar w he n use d as i n dicate d.
5. 3
P ote nti al Be nefits
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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
C o ntact le nses ma y  offer i m pr o ve d peri p heral visi o n a n d t he c o n ve nie nce of n ot weari n g 
s pectacles. Pr o per use of le ns care s ol uti o ns ca n pr o m ote safe a n d c o mf orta ble le ns wear.  
Material pr o perties a n d desi g n c haracteristics of c o ntact le nses a n d le ns care s ol uti o ns use d i n 
t his st u d y are feat ures c o nsiste nt wit h t he s uccessf ul c o ntact le ns wear.

Page 24 of 62
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 Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) E6 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 (and/or legal representative, 
as applicable) 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 designee, 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 
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records may be accessed by appropriate 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. 
Amendments may necessitate that the informed consent form and other study-related 
materials be revised. If the informed consent form is revised, all subjects currently enrolled in 
the study may be required by the IRB to sign the approved, revised informed consent form. 
There are no amendments, as this is the original version of protocol LCW773-P001.
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8
SUBJECT POPULATION
The study population includes approximately 256 subjects to be randomized at approximately 
8 sites, with approximately 14 to 50 subjects randomized per site. To participate in the study, 
subjects must be 18 years old or older, current full-time wearer 
 
 of samfilcon A, comfilcon A, senofilcon C 
monthly replacement or senofilcon A 2-week replacement spherical lenses within the power 
range of lens powers available for the test AOHG, and currently using (during the past 
1 month) a MPS (excluding OFPM) to care for their lenses. Approximately 64 subjects per 
habitual lens type will be randomized and recruitment of brands by sites will be competitive.
Subjects must sign the informed consent form. Subjects must be willing to discontinue 
artificial tears during the study and rewetting drops on the days of study visits,
 
 
 The complete inclusion and exclusion criteria are presented in Section 1.
The enrollment for the study is planned for approximately 8 weeks. The expected duration of 
subject participation in the study is up to 40 days and treatment will be 30 (+3) days for all 
subjects 
 
An advertisement may be used to aid recruitment. If an advertisement is required, the 
advertisement will be submitted to the IRB for approval.
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9
TREATMENTS ADMINISTERED
Upon signing the informed consent, subjects will be considered enrolled in the study and a 
subject identification (ID) number will be assigned by entering the subject into the electronic 
data capture (EDC) system by a designated staff member at the investigational site(s). The 
qualified subject will be randomized and assigned to either AOHG or Habitual SiHy lenses in 
a 1:1 ratio. Subjects in the AOHG lens group will be further randomized and assigned to 
either OFPM or CCP in a 1:1 ratio. 
Throughout the study, the designated unmasked site personnel will be responsible for the 
accounting of all study products and will ensure that the study products are not used in any 
unauthorized manner.
9.1
Identity of Study Treatments
Test Products:
AIR OPTIX plus HYDRAGLYDE (AOHG)
OPTI-FREE PUREMOIST (OFPM)
CLEAR CARE Plus/AOSEPT Plus with 
HYDRAGLYDE (CCP)
Control Products:
Johnson & Johnson ACUVUE® OASYS® Brand 2-
Week with HYDRACLEAR® PLUS (Oasys)
Johnson & Johnson ACUVUE® VITA™Brand Contact 
Lenses (Vita)
Bausch + Lomb ULTRA™Contact Lenses with 
MoistureSeal™Technology (Samfilcon A) (Ultra)
CooperVision® Biofinity® Contacts (Biofinity)
Habitual MPS (HMPS)
The study lenses will be procured by the investigational site(s). All study lenses are 
Conformité Européene (CE)-marked, FDA and Health Canada approved, and will be sourced 
from commercial stock, including commercial packaging and labelling. Assigned lenses will 
be masked to the Investigator and subject. This will be accomplished by an unmasked 
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coordinator dispensing the commercially packaged study lenses assigned to the subject with 
the blister label removed. 
OFPM will be supplied in sterile 10 fl. Oz. (300 mL) filled bottles with investigational 
labelling. A new lens case will be supplied with each bottle. 
CCP will be supplied in sterile 12 fl. Oz. (355 mL) filled bottles with investigational 
labelling. A new lens case will be supplied with each bottle.
Table 9-1
Study Treatment OFPM and CCP
Properties
OFPM (Test product)
CCP (Test product)
HMPS (Control 
product)
Administration
Subjects will use 
OFPM to store and 
disinfect their contact 
lenses as instructed by 
the study site 
personnel, dispensing 
the solution according 
to the instructions for 
use. 
Subjects will use CCP 
to store and disinfect 
their contact lenses as 
instructed by the study 
site personnel, 
dispensing the solution 
according to the 
instructions for use.
Subjects will use their 
HMPS to store and 
disinfect their contact 
lenses as instructed by
the study site 
personnel, dispensing 
the solution according 
to the instructions for 
use.
Duration of 
Treatment
The subject will wear 
their assigned lenses 
in a daily wear 
modality for 30 (+3) 
days using OFPM 
daily to care for their 
lenses. 
The subject will wear 
their assigned lenses 
in a daily wear 
modality for 30 (+3) 
days using CCP daily 
to care for their lenses.
The subject will wear 
their assigned lenses 
in a daily wear 
modality for 30 (+3) 
days using their 
HMPS daily to care 
for their lenses.
Quantity/Dosa
ge
Up to 32 cleaning and 
disinfecting cycles 
will be used for the 
study.
Up to 32 cleaning and 
disinfecting cycles 
will be used for the 
study.
Up to 32 cleaning and 
disinfecting cycles 
will be used for the 
study. 
Supply
OFPM will be 
supplied sterile, in 
10 fl. Oz. (300 mL) 
filled bottles with 
CCP will be supplied 
sterile, in 12 fl. Oz.
(355 mL) filled bottles
with investigational 
HMPS will either be:
1) Purchased by the 
subject and 
reimbursed. The 
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investigational 
labelling. A new lens 
case will be supplied 
with each bottle.
The product is 
manufactured by 
Alcon Laboratories in 
Fort Worth, Texas.
The study kit will 
contain one bottle of 
the test solution (bottle 
will be re-labeled), 
and green and white 
screw top case. 
 
labelling. A new lens 
case will be supplied 
with each bottle.
The product is 
manufactured by 
Alcon Laboratories in 
Fort Worth, Texas.
The study kit will 
contain one bottle of 
the test solution (bottle 
will be re-labeled), 
and the lens cup that 
contains platinum disk 
for neutralization of 
the solution. 
Marketed sterile saline 
(B&L SENSITIVE 
EYES PLUS SALINE 
in commercial 
packaging) will be 
provided separate 
from the kit by the 
unmasked study 
coordinator to each 
subject to use for 
rinsing lenses and 
cases as needed. 
unmasked site 
personnel must 
confirm at Visit 2 
that the solution 
purchased by the 
subject was the 
HMPS identified 
during screening 
and that is not 
expired. 
2) Purchased by the 
site according to 
the HMPS 
identified during 
screening and 
dispensed to the 
subject for use 
during the study.
HMPS will be 
dispensed/used in 
commercial 
packaging. The 
manufacturer 
information for each 
product can be found 
in the package insert. 
 
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OFPM and CCP will be provided in the commercial bottle but will be re-labeled in local 
language. Included on the investigational labels for the randomized product will be the kit 
number, protocol number, fill volume, storage conditions, the indicator “Disinfecting 
Solution” and a statement that the product is for investigational use only. OFPM and CCP 
should be stored at room temperature or below. 
Additionally, the following warning will be included on the investigational label for CCP: 
“IMPORTANT: Misuse will result in burning and stinging. Use only lens case provided. Do 
not remove lenses from the lens case for at least 6 hours. The solution needs time to 
neutralize. Never rinse lens with product prior to insertion. Red snap cap means product is 
not for direct use on eye.”
More information on the OFPM, CCP, or HMPS can be found in the Product Labeling. Refer 
to the MOP for product labels for OFPM and CCP.
The new label will be sufficient to mask the OFPM and CCP, thus maintaining the subject 
masking to brand. A designated unmasked staff member (other than the Investigator) at the 
site will be assigned to dispense the sealed test kit and the HMPS to ensure Investigator 
masking. Unmasked site personnel cannot conduct study specific procedures.
9.2
Usage
The subjects will use the study lenses bilaterally according to the Instructions for Use 
provided by the product manufacturer, as instructed by the designated site personnel.  All 
study lenses will be dispensed by a trained, unmasked staff member and provided to the 
subjects. 
The subjects will wear the assigned lenses (AOHG or Habitual SiHy) 
 
. Subjects assigned to the senofilcon A 2-week replacement lenses 
will be asked to return to the site to be dispensed in a masked manner 
 
. All unplanned lens replacements must be documented in EDC.
Subjects assigned to the AOHG lenses will be instructed to care for the lenses daily using 
either OFPM or CCP, according to randomized assignment of product. Subjects assigned 
CCP will be provided with B&L SENSITIVE EYES PLUS SALINE as a rinsing solution. 
AOHG lens care solutions will be provided by the Sponsor. Subjects assigned to the Habitual 
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SiHy lenses will be instructed to care for the lenses daily using their HMPS according to the 
products’ instructions for use. A new bottle of the HMPS to be used for the study will either 
be purchased by the subjects and confirmed by the masked investigational site personnel or 
purchased by the site.
 
 
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10
STUDY PROCEDURES
10.2
Visits and Examinations
10.2.1
Visit 1 – Screening
Note: Potential subjects should be instructed to attend Visit 1 (Screening) 
wearing their habitual contact lenses and to bring their HMPS (used or unused 
bottle).  
1
Have the subject or legally authorized representative read, sign, and date the 
IEC-approved informed consent document. 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.
2
Enter the subject into EDC in order to obtain their 5-digit subject ID number. 
Note: Obtain subject ID number for all subjects who signed an informed 
consent form (including screen failures).
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3
Obtain demographic information, contact lens and lens care history, 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.
4
5
6
7
8
9
Perform biomicroscopy assessment using slit-lamp examination scales. For 
details and order of staining procedures, refer to MOP.  
10
Assess and record any AEs that are observed or reported from the time of 
informed consent (see Section 12). 
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11
Review inclusion/exclusion criteria to determine if the subject qualifies to be 
randomized in the study. The unmasked site personnel must confirm 
randomization by entering applicable details of eligibility in the EDC system 
and obtain assignment of study lens/lens care treatment group.
12
Schedule Visit 2 (Day 1 Insertion) within 1-7 days of Visit 1 (Screening).
13
Remind subjects that spectacles or habitual contact lenses/lens care solutions 
can continue to be used until the day prior to Visit 2. Habitually worn lenses 
can be returned or a new pair dispensed.  
 
 
 
Subjects randomized to habitual SiHy/MPS must have a new bottle of the 
HMPS, identified during screening, ready for dispensing at Visit 3. This can be 
accomplished in two ways for the study: 
1)
The subject purchases a new bottle of the HMPS and brings it to 
Visit 2. In this case the subject will be reimbursed for their purchase. 
The unmasked coordinator must confirm the solution purchased was 
the HMPS identified during screening and that it is not expired. The 
unmasked coordinator will dispense the purchased HMPS at Visit 3.
2)
The site purchases the subject’s HMPS and the unmasked coordinator
dispenses to the subject at Visit 3.
10.2.2
Visit 2 (1-7 Days from Visit 1) – Day 1 Insertion Visit
1
Obtain information on any changes in medical health and/or the use of 
concomitant medications since previous visit.
2
Perform biomicroscopy assessment using slit-lamp examination scales with 
no conjunctival/corneal staining procedures. Refer to MOP for details.
3
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4
Unmasked coordinator to dispense randomized study lenses. Record time of 
lens insertion. 
5
6
7
8
9
10
Assess and record any AEs that are observed or reported (see Section 12). 
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11
Record any Device Deficiencies that are observed or reported (see 
Section 12). 
12
10.2.3
Visit 3 - Day 1: after approximately 8 hrs (± 30 mins) 
Note: Subjects must respond to the 8 hrs text message questionnaire prior to 
proceeding with Visit 3.
1
Obtain information on any changes in medical health and/or the use of 
concomitant medications since previous visit.
2
3
Perform biomicroscopy assessment with lenses on the eye using slit-lamp 
examination scales with no conjunctival/corneal staining procedures. Refer to 
MOP for details.
4
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5
6
Unmasked coordinator to assign and dispense study lens care solutions
-
Ensure test solutions are provided per randomized group assignment -
masked label to subjects.
-
HMPS to be purchased by subject or provided by site. Subject/site will 
be reimbursed. Site to confirm correct unexpired HMPS dispensed if 
subject is purchasing the HMPS. 
-
Review product instructions for use with subjects.
Educate subjects assigned to CCP product and B&L SENSITIVE EYES 
PLUS SALINE on the use of correct lens case with the product.
7
Assess and record any AEs that are observed or reported (see Section 12). 
8
Record any Device Deficiencies that are observed or reported (see 
Section 12). 
9
Unmasked coordinator to instruct subjects assigned the 2-week replacement 
lenses to return to site on Day 15 (±1 Day).
Schedule lens replacement in office.
Collect initial 2-week lenses. Refer to MOP for details.
Unmasked coordinator to dispense replacement 2-week lenses. 
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10
10.2.4
Visit 4 - Day 30 (+3 days): 8 hrs (±30 min)/Exit
Note: Ensure subjects answered the 6 hrs text message questionnaire based on 
lenses worn during Day 30 prior to proceeding with Visit 4.
1
 
 
2
Obtain information on any changes in medical health and/or the use of 
concomitant medications since Visit 3.
3
4
5
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6
7
8
Assess and record any AEs that are observed or reported (see Section 12). 
9
Record any device deficiencies that are observed or reported (see Section 12). 
10
Collect worn study lenses for shipment and analysis. Record time of lens 
removal. Refer to MOP for details.
11
Exit the subject from the study.
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10.4
Discontinued Subjects
Discontinued subjects are those who withdraw or are withdrawn from the study after being 
randomized. 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).
If a subject is identified not to fulfill the eligibility criteria for study inclusion during the 
Screening visit 
, the subject will be screen failed and will not participate any further 
in the study. The EDC system will be updated to confirm the subject is a screen failure. The 
Investigator will explain to the subject the reason(s) why eligibility was not met and provide 
appropriate information/treatment, if required. The Exit form will be completed for all 
discontinued subjects and screen failures.
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. 
Observations must also be reported for occurrences not associated with any study treatment 
(see Section 12.3, Procedures for Recording and Reporting AEs and SAEs).
Any subject who exits early from the study should undergo all procedures outlined at 
/Exit. Additionally, the Exit Form must be completed and the reason for 
discontinuation must be identified and captured in EDC. 
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 
investigational site or terminate the study in its entirety at any time, for reasonable cause. 
Reasons for the closure of an investigational site or termination of a study may include: 
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Pa ge 4 3 of 6 2

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

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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
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 I n vesti gat or(s) 
b y  tele p h o ne a n d s u bse q ue ntl y will pro 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.

Page 44 of 62
11
ANALYSIS PLAN
11.1
Subject Evaluability
The final subject evaluability will be determined prior to breaking the code for masked 
treatment assignment and locking the database. 
11.2
Analysis Data Sets
11.2.1
Safety Data Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
The safety analysis set will include all subjects/eyes exposed to the study lens and/or the 
study lens care system (LCS) evaluated in this study as a regimen. For treatment-emergent 
safety analyses, subjects/eyes will be categorized under the actual lens or regimen exposed.
11.2.2
Full Analysis Data Set
The FAS is the set of all randomized subjects who are exposed to a study lens on Day 1 or a 
study regimen (lens and LCS) thereafter.
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11.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the safety, full, 
 
 
 
11.4
Efficacy Analyses
This study defines one primary endpoint 
. All efficacy 
evaluations will use the FAS as the primary analysis set. 
 
 
 
11.4.1
Primary Efficacy
The primary objective of this study is to demonstrate less cholesterol uptake with each of the 
test regimens (AOHG/OFPM, AOHG/CCP) compared to each of the control regimens 
(Biofinity/HMPS, Vita/HMPS, Ultra/HMPS, Oasys/HMPS). 
The corresponding endpoint is the cholesterol uptake (deposits) measured from worn lenses 
at Day 30 (2-week wear of Oasys and 30-day wear for other), for each of the test and control 
regimens. OD lenses from approximately 25 subjects per regimen will be analyzed for the ex 
vivo analysis.
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11.4.2
Secondary Efficacy
No secondary efficacy objective is defined for this study.
11.4.2.1
Statistical Hypotheses
Not applicable.
11.4.2.2
Analysis Methods
Not applicable.
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11.5
Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the efficacy analysis.
11.7
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Data will be presented by regimen, T/C and T1/T2/C1/C2/C3/C4.
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms. In 
addition to an overall presentation of AEs, relationship to regimen (lens and/or LCS) will be 
identified. Serious AEs will also be tabulated separately. Individual subject listings will be 
provided, as necessary. 
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Additionally, individual subject listings will be provided for AEs that occur after signing 
informed consent but prior to exposure to study regimens (lens and/or LCS).
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) to any subsequent visits will be presented. A supportive listing will be 
generated which will include all biomicroscopy data from the affected visit for those eyes 
experiencing the increase of ≥2 grades, with the following variables: regimen, Investigator, 
subject, age, sex, visit, eye, parameter, baseline value, and value at the visit.
Frequency counts will be tabulated for each device deficiency category. Additionally, 
2 listings will be provided: prior to exposure to study regimens (lens and/or LCS) and 
treatment-emergent.
No inferential testing will be done for safety analysis.
11.8
Health Economics
Not applicable.
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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 for categories of AEs and SAEs.
Figure 12–1
Categorization of All Adverse Events
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Pa ge 5 4 of 6 2
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
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?”

“ Ha ve t here b ee 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 bi o micr osc o py p ar a meters a n d/ or s u bject q uesti o n n air es e val uate d d uri n g t he 
st u d y are t o be re vie we d b y t 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 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. 
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 lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
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Pri nte d B y:  
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T D O C - 0 0 5 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
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 R F. 

Pa ge 5 5 of 6 2
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 Es 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 o bser ve d or 
re p orte 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:

All S A Es m ust be re p orte d i m me diatel y  ( wit hi n 2 4 h o urs) of t he I n v esti gat or ’s or 
site’s a ware ness. 

A D Es t hat d o n ot meet seri o us ness criteria a n d de vice deficie ncies m ust be re p orte d 
wit hi n 1 0 cale n dar da y s 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 Devi ce 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 M O P 
f or pr o d uct ret ur n details.

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 ble, i n narrati ve secti o n of t he A d verse De vice 
Ef fect (f or relate d A Es) a n d Seri o u s A d verse E ve nt e C R F .
N ote: S h o ul d t he E D C s yste m bec o me n o n - o perati o nal, t he site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device 
Deficie ncy F or m. T he c o m plete d f or m is e maile d t o t he St u d y  S p o ns or t o 
 acc or di n g t o t he ti meli nes o utli ne d a b o ve; h o we ver, t he re p orte d 
i nf or mati o n m ust be e ntere d i nt o t he E D C s yste m o nce it bec o mes o perati o nal.
A n y  AEs a n d de vice deficie ncies f or n o n -st u d y mar kete d de vices/ pr o d ucts will be c o nsi dere d 
a n d pr ocesse d as s p o nta ne o us (f oll o wi n g t he p ost mar ket vi gila nce pr oce d ures) a n d s h o ul d be 
c o m m u nicate d t o t he de vice’s/ pr o d uct’s ma n ufact urer as per l ocal re q uire 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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
St u d y S p o ns or  re prese nt ati ves m a y be c o nt acte d f or  a n y prot oc ol r el ate d q uesti o n a n d 
t heir c o nt act i nf or m ati o n is pro vi de d i n t he M O P
t h at acc o m p a nies t his prot oc ol.

Page 56 of 62
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 AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE 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.
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.
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12.5
Return product analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System.
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). 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). 
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.
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12.8
Pregnancy in the Clinical Trial
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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Pa ge 5 9 of 6 2
1 3
D A T A  H A N D LI N G A N D A D MI NI S T R A TI V E 
R E Q UI R E M E N T S
1 3. 1
C o m pleti o n of S o ur ce D oc u me nts a n d C ase Re p ort F or ms
T he nat ure a n d l ocati o n of all s o urce d oc u me nts will be i de ntifie d t o e ns ure t hat ori gi nal data 
re q uire d t o c o m plete t he C R Fs e xist a n d are accessi ble f or verificati o n b y t he site m o nit or. If 
electr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter mi ne d i n a d va nce 
of starti n g t he st u d y.  At a mi ni m u m, s o urce d oc u me nts s h o ul d i ncl u de t he f oll o wi n g 
i nf or mati o n f or eac h s u bject:

S u bject i de ntificati o n ( na me, se x, race/et h nicit y)

D oc u me ntati o n of s u bject eli gi bilit y

Date of i nf or me d c o nse nt

Dates of visits

D oc u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

Tr ial me dicati o n acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ories a n d t he use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y

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 2 7 3 2
P r o t o c o l  -  C l i n i c a l
1 9- Dec- 2 0 1 6
Date of trial c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u me nts be i de ntifia ble. Direct access 
t o s o urce d oc u me ntati o n ( me dical rec or ds) m ust be all o we d f or t he p ur p ose of verif yi n g t hat 
t he data rec or de d o n t he C R F are c o nsiste nt wit h t he ori gi nal s o urce data. 
Electr o nic C R Fs (e C R Fs) will be pr o vi de d t o t he sites; o nl y  desi g nate d i n di vi d uals ma y 
c o m plete t he e C R Fs. T he e C R Fs will be s u b mitte d at re g ular i nter vals base d u p o n t he cli nical 
trial visit sc he d ule. It is e x pecte d t hat all data re p orte d will ha ve c orres p o n di n g e ntries i n t he 
s o urce d oc u me nts a n d t hat t he Pri nci pal I n vesti gat or will re vie w t he re p orte d data a n d certif y 
t hat t he e C R Fs are acc urate a n d c o m plete. N o s u bject i dentifiers s h o ul d be rec or de d o n t he 
e C R Fs be yo n d s u bject n u m ber , a n d de m o gra p hic i nf or mati o n. 
De viati o ns fr o m t his pr ot oc ol, re g ulat or y  re q uire me nts, a n d G C P m ust be rec or de d i n t he 
st u d y rec or ds. A n e x pla nati o n of t he de viati o n s h o ul d be i ncl u de d, as a p pl ica ble. I n a d diti o n, 

Page 60 of 62
corrective and preventive action should be identified, implemented, and documented within 
the study records.
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.
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).
13.4
Clinical Trial Results
All data and discoveries arising out of the study, patentable or non-patentable, shall be the 
sole property of Alcon, Inc. Alcon reserves the right of prior review of any publication or 
presentation of information related to the study. Alcon may use these data now and in the 
future for presentation or publication at Alcon’s discretion or for submission to government 
regulatory agencies.
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14
References
Keir N, Jones L. Wettability and silicone hydrogel lenses: a review. Eye Contact Lens.
2013;39(1):100–8.
Lemp J, Myua L, Driver-Scott A, Alvord L. A comparison of two methods for assessing
wettability substantivity. Poster session presented at: Global Specialty Lens Symposium;
2016 Jan 26-29; Las Vegas, NV.
Nash WL, Gabriel MM. Ex vivo analysis of cholesterol deposition for commercially 
available silicone hydrogel contact lenses using a fluorometric enzymatic assay. Eye Contact 
Lens. 2014;40(5):277-82.
Clinical Study Report for Protocol C-09-074: SiHy MPDS FID 114675A compared to renu 
fresh MPS in symptomatic contact lens wearers. Fort Worth (TX): Alcon Research, Ltd.; 
2011 April. Technical Report No.: TDOC-0013454, Version 1.0.
Clinical Study Report for Protocol LCD913-P001: Comparison of two one-step hydrogen 
peroxide lens care solutions in symptomatic contact lens wearers. Fort Worth (TX): Alcon 
Research, Ltd.; 2016 September. Technical Report No.: TDOC-0051197, Version 2.0.
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15
APPENDIX
There are no appendices for this protocol. Please refer to the MOP.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
12/19/2016 19:07:40
12/19/2016 18:34:52
12/15/2016 23:52:09
12/15/2016 22:49:55
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