One-month Clinical Comparison of Silicone Hydrogel Monthly Lenses in High Lipid Depositors
Phase: NA
Conditions: Refractive Error
Sponsor: Alcon Research

Page 1 of 59
Short Title
Clinical comparison of silicone hydrogel monthly lenses
Long Title
One-month clinical comparison of silicone hydrogel monthly lenses in high 
lipid depositors
Protocol Number:
Study Phase:
CLL541-P001/ NCT03169153
Not applicable
Sponsor Name and 
Address:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Investigational Product:
AIR OPTIX® plus HydraGlyde (AOHG)
US IND#/EudraCT
Not applicable
Indication Studied:
Contact Lens Wear
Investigator Agreement:
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described study in 
compliance with Good Clinical Practice (GCP), ISO 14155: 
2011 Clinical investigation of medical devices for human 
subjects, 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:
Address:
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Page 2 of 59
1
SYNOPSIS
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Investigational 
Product:
AIR OPTIX plus 
HydraGlyde (AOHG)
Study Phase:
1
2
3
4
N/A - Post market
Active Ingredient: 
N/A
Protocol Title:
One-month clinical comparison of silicone hydrogel monthly 
lenses in high lipid depositors
Investigator(s)/No. of Sites: 1 
Center Location(s)
United Kingdom
No. of Subjects
Required: 70 completed (35/sequence)
Planned: Approximately 78 randomized and approximately 
140 screened/enrolled
Duration of Treatment: 
30 (+3) days per period
Study Population: 
Volunteer subjects at least 18 years of age who wear monthly 
replacement silicone hydrogel lens and are classified as high lipid 
depositors. Other eligibility criteria must also be met.
Objectives:
Primary Objective
The primary aim of the study is to confirm that a silicone hydrogel 
contact lens that attracts lower levels of total lipids in vitro
(AOHG) also attracts lower levels of total lipids in vivo compared 
with a silicone hydrogel contact lens with high in vitro lipid 
attraction (ACUVUE® VITA® (VITA)) in habitual high lipid 
depositor lens wearers. Therefore, the primary objective is to 
demonstrate superiority of AOHG compared with VITA in total 
lipid uptake (total of surface and bulk uptake) after 30 days of 
wear by high lipid depositors.
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Safety:
To collect and describe Biomicroscopy Findings, Adverse Events
(AEs), and Device Deficiencies 
Methodology:
Single-site, prospective, randomized (lens sequence), 
double-masked crossover study
Treatments:
Investigational Product:
AOHG (Manufacturer: Alcon 
Laboratories, Inc.)
Lenses are Conformité Européenne
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
(CE) marked and will be used as per 
their CE marking. 
Route of Administration:
The lenses will be dispensed by a
trained unmasked study staff member
so that neither the subject nor the 
Investigator will be able to see the 
lens label and hence, will remain 
masked to the identity of the lens.
The trained unmasked study staff
member will not conduct any of the 
safety and effectiveness assessments
after randomization, 
 
 
 
 
 
Subjects will use the lenses as
instructed by the investigational site, 
according to the instructions for use.
Duration of Lens Wear:
Subjects will wear the lenses 
bilaterally for a total duration of 
30 (+ 3) days under a daily wear 
modality for the specific study 
period. 
The lenses will be removed every 
night and cared for with the subject’s
habitual lens care solution. 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Dosage:
Lenses will be available in the
following parameters:
Material: Sphere lotrafilcon B (33% 
water) with plasma surface treatment
Base curve: 8.6 millimeters (mm)
Diameter: 14.2 mm
Rx Range: +6.00 D to -8.00 D 
(0.25 D steps) and -8.50 D 
to -12.00 D and +6.50 D to +8.00 D 
(0.50 D steps)
Control Product:
ACUVUE VITA (Manufacturer: 
Johnson and Johnson Vision Care, 
Inc.)
Lenses are CE-marked and will be 
used as per their CE marking. 
Route of Administration:
The lenses will be dispensed by a 
trained unmasked study staff 
member so that neither the subject 
nor the Investigator will be able to 
see the lens label and hence, will 
remain masked to the identity of the 
lens.
The trained unmasked study staff 
member will not conduct any of the 
safety and effectiveness assessments
after randomization,
 
 
Subjects will use the lenses as 
instructed by the investigational site, 
according to the instructions for use.
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Page 6 of 59
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Duration of Lens Wear:
Subjects will wear the lenses 
bilaterally for a total duration of 
30 (+3) days under a daily wear 
modality for the specific study 
period. 
The lenses will be removed every 
night and cared for with the subject’s 
habitual lens care solution. 
Dosage:
Lenses will be available in the 
following parameters:
Material: senofilcon C, 41% water 
content
Base curve: 8.4, 8.8 mm 
Diameter: 14.0 mm
Rx Range: –0.50 D to -6.00 D 
(0.25 D steps), -6.50 D to -12.00 D 
(0.50 D steps), +0.50 D to +6.00 D 
(0.25 D steps) and +6.50 D to 
+8.00 D (0.50 D steps)
Screening Product
Lenses are CE-marked and will be 
used as per their CE marking. 
Route of Administration:
Subjects will use the lenses as 
instructed by the Study Coordinator 
or Investigator, according to the 
instructions for use.
Duration of Lens Wear:
Subjects will wear the lenses 
bilaterally for a total duration of 
10 hours (± 30 minutes), after which 
the lenses will be removed to assess 
lipid uptake of OD lenses. 
Alcon - Business Use Only 
 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Dosage:
Lenses will be available in the 
following parameters:
Material: balafilcon A, 36% water 
content 
Base curve: 8.6 mm 
Diameter: 14.0 mm
Rx Range: 8.6 mm base curve:
+6.00 D to -12.00 D (0.25 steps, 
0.50 D steps above -6.00 D)
Subject Selection:
Inclusion Criteria:
1. Subjects must be at least 18 years of age and sign the Informed 
Consent Form
2. Best Corrected Visual Acuity (BCVA) of at least 0.1 logMAR 
in each eye at Visit 1
3. Manifest cylinder (at Visit 1) less than or equal to 0.75 D in 
each eye
4. Successful current wearer (during the past 2 months for a 
minimum of 5 days per week and 8 hours per day) of monthly 
replacement silicone hydrogel lenses within the power range of 
lens powers available for the screening and study lenses
5. Screening 
lenses worn 10 hours (± 30 minutes) 
exhibiting high lipid uptake (see Manual of Procedures) 
 
7. Willing to discontinue artificial tears during the study and 
rewetting drops on the days of study visits
Exclusion Criteria:
1. Habitual lens used in an extended wear modality (routinely 
sleeping in lenses overnight for 1 night per week or more) during 
the past 2 months
2. Habitually wearing AIR OPTIX AQUA, AIR OPTIX plus 
HydraGlyde, ACUVUE OASYS®, or ACUVUE VITA as contact 
lenses during the past 2 months
3. Any anterior segment infection, inflammation, disease or 
abnormality that contraindicates contact lens wear (within 7 days 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
of enrolment, or current)
4. History of herpetic keratitis, corneal surgery, or irregular cornea
5. Any use of systemic or ocular medications for which contact 
lens wear could be contraindicated as determined by the 
Investigator 
6. Any abnormal (Grade 3 or greater) ocular condition observed 
during the Biomicroscopy examination at Visit 1, Visit 2, or 
Visit 3 (prior to randomization)
7. Monocular subjects (only one eye with functional vision) or 
subjects fit with only one lens 
8. Known pregnancy and lactation
9. Enrolment of investigational site staff or family/household 
members of the investigational site staff who are listed on the 
study personnel log as having a role in the execution of this study 
10. Participation in any clinical study within 30 days of Visit 1 
Assessments:
Effectiveness:
1. Ex vivo lipid uptake of total lipids and individual lipid
classes (surface and bulk)
Safety:
1. Biomicroscopy Findings
2. AEs
3. Device Deficiencies 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Statistical Methods:
Planned Analysis
Three analysis sets will be defined. The Safety Analysis Set will 
include all subjects/eyes exposed to any study lenses (AOHG or 
VITA). The Full Analysis Set (FAS) will consist of all 
randomized subjects who are exposed to study lenses (AOHG or 
VITA).The Per Protocol (PP) Analysis Set will be a subset of all 
randomized subjects and exclude data/subjects which meet any of 
the critical deviation or non-evaluable criteria as specified in the 
Deviations and Evaluability Plan (DEP). The FAS will serve as 
the primary analysis dataset for all effectiveness evaluations. 
All data from evaluable subjects will be included in the respective 
effectiveness analysis, and no imputation for missing values will 
be performed.
Effectiveness
The planned analysis to address the primary effectiveness 
objective is summarized below:
Primary Endpoint
Comparison
Statistical Method
Total lipid uptake 
(total of surface and 
bulk uptake) 
(Day 30)
Superiority
Mixed-effect 
repeated-measures with 
terms for lens, period, 
sequence, and subject.
Superiority concluded if 
1-sided p-value < 0.05
 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: CLL541-P001
Safety
Each safety variable will be summarized descriptively. AEs will 
be classified as pre-treatment, treatment-emergent, or between-
period. Counts and percentages will be provided by relationship to 
lens, 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 the safety analysis. 
Sample Size Calculation
Sample size calculation for the primary effectiveness endpoint 
(1-sided, α=0.05) is summarized below:
Primary 
Endpoint
Assumptions
Power
N/sequence
group
Total lipid 
uptake
(total of surface 
and bulk uptake)
SD paired 
differences = 13.88
Detectable difference = 10
80%
7
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1.1
Amendments
Amendment 2
Purpose of Amendment: The purpose of this amendment is to address the following items:
Change 1: To expand the time period between Visit 2 and Visit3.
Rationale: The rationale for this change is to allow the laboratory enough time to conduct the 
evaluation of screening lenses for lipid uptake.
Case Report Form Revision Required:
Yes
X No
Informed Consent Modifications Required:
X Yes
No
Applicable Investigators:
X All
Selected (list below)
Itemized Changes:
Protocol Section
Information Changed
Section 2 (Page 14)
Overview of Study Plan
Changed from:
Visit 3
(Period 1)/
Visit 5
(Period 2)
Day 1-Insertion
1 to 14 days from Visit 2 
and Visit 4 respectively
No lenses worn 
Changed to:
Visit 3
(Period 1)/
Visit 5
(Period 2)
Day 1-Insertion
Within 80 days from Visit 2 
and 1 to 14 days from Visit 4,
respectively
No lenses worn 
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Section 10.2.2
(Page 24)
Visits and 
Examinations:
Visit 2
(Screening 2)
Table items #8
Changed from:
Schedule Visit 3 for eligible subjects to take place 1 to 14 days 
after Visit 2. Instruct subjects on study compliance requirements. 
Subjects can wear spectacles or their habitual lenses between Visit 
2 and Visit 3. Inform subjects not to wear lenses on the day of 
Visit 3 and to not use rewetting drops on the day of the visit. 
Artificial tears must not be used during the study.
Changed to:
Schedule Visit 3 for eligible subjects to take place within 80 days
after Visit 2. Instruct subjects on study compliance requirements. 
Subjects can wear spectacles or their habitual lenses between Visit 
2 and Visit 3. Inform subjects not to wear lenses on the day of 
Visit 3 and to not use rewetting drops on the day of the visit. 
Artificial tears must not be used during the study.
Change 2:  To update the name of the screening lenses.
Rationale:  The rationale for this name change is to describe more specifically the screening 
product name for alignment with other study documents.
Case Report Form Revision Required:
Yes
X No
Informed Consent Modifications Required:
Yes
X No
Applicable Investigators:
X All
Selected (list below)
Itemized Changes:
Protocol Section
This change was implemented throughout the entire document
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Amendment 1
Purpose of Amendment: The purpose of this amendment is to:
1) Clarify the Primary Objective in Section 1 of the protocol.
2) Clarify and elaborate further the background and rationale of this study in Section 5 
of the protocol.
3) Update the References in Section 14 of the protocol to correspond to the updated 
background and study rationale in Section 5.
Rationale:  The rationale for this amendment is to elaborate on the study background and 
rationale, clarify the aim and primary study objective, and update study references.
Current Study Status:  Planned; No subjects enrolled at this time
Case Report Form Revision Required:
Yes
X No
Informed Consent Modifications Required:
Yes
X No
Applicable Investigators:
X All
Selected (list below)
Itemized Changes:
Protocol Section
Information Changed
Section 1 (Page 2)
Synopsis
Primary Objective
Changed from:
The primary objective is to demonstrate superiority of AOHG 
compared with ACUVUE® VITA® (VITA) in total lipid 
uptake (total of surface and bulk uptake) after 30 days of wear 
by high lipid depositors.
Changed to:
The primary aim of the study is to confirm that a silicone 
hydrogel contact lens that attracts lower levels of total lipids 
in vitro (AOHG) also attracts lower levels of total lipids in 
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Page 14 of 59
vivo compared with a silicone hydrogel contact lens with high 
in vitro lipid attraction (ACUVUE® VITA® (VITA)) in 
habitual high lipid depositor lens wearers. Therefore, the 
primary objective is to demonstrate superiority of AOHG 
compared with VITA in total lipid uptake (total of surface and 
bulk uptake) after 30 days of wear by high lipid depositors.
Section 5.1 (Page 24)
Study Rationale and 
Background
Revised entire section to elaborate on the background and 
rationale of the study.
Section 14 (Page 59)
References
Updated all references to coincide with fully revised study 
rationale and background in Section 5.1.
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Pa ge 1 5 of 5 9
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
( Peri o d 1)/
Visit 5
( Peri o d 2)
Visit 4
( Peri o d 1)/
Visit 6
( Peri o d 2)/
St u d y E xit
U S V
Assess me nt
Scree ni n g 1/
B aseli ne
H a bit u al 
le nses w or n
Scree ni n g 2
1 t o 7 da ys 
fr o m Visit 1
A fter 1 0 h
( ± 3 0 mi n) 
wear of
D a y 1- I nserti o n
Wit hi n 8 0 da ys
fr o m Visit 2 a n d
1 t o 1 4 da ys 
fr o m Visit 4 
res pecti vel y
N o le nses w or n 
D a y 3 0
( + 3 d a ys) 
A fter 1 0 h 
( ± 3 0 mi n ) wear
of st u d y le nses
E arl y E xit
I nf or me d C o nse nt

Ra n d o mizati o n
a
D e m o gra p hics

Me dical Hist or y/ C L wear 
hist or y

C o nc o mita nt Me dicati o ns





I ncl usi o n/ E xcl usi o n



C o n d uct a s p herical o ver -
refracti o n a n d o pti mize t he 
R x as re q uire d
b

L o g M A R V A wit h le nses
b


()
B C V A wit h Ma nifest 
Refracti o n c
 


 

Bi o micr osc o p y 
 


 

Assess Le ns Fit 

c, 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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7

Pa ge 1 6 of 5 9
Visit 1  
Visit 2
Visit 3
( Peri o d 1)/
Visit 5
( Peri o d 2)
Visit 4
( Peri o d 1)/
Visit 6
( Peri o d 2)/
St u d y E xit
U S V
Assess me nt
Scree ni n g 1/
B aseli ne
H a bit u al 
le nses w or n
Scree ni n g 2
1 t o 7 da ys 
fr o m Visit 1
A fter 1 0 h
( ± 3 0 mi n) 
wear of
D a y 1- I nserti o n
Wit hi n 8 0 da ys
fr o m Visit 2 a n d
1 t o 1 4 da ys 
fr o m Visit 4 
res pecti vel y
N o le nses w or n 
D a y 3 0
( + 3 d a ys) 
A fter 1 0 h 
( ± 3 0 mi n ) wear
of st u d y le nses
E arl y E xit
Pr o vi de 
le nses f or 1 0 h ( ± 3 0 mi n) 
of w ear o n t he da y of 
Visit 2

C ollect 1 0 -h w or n 
le nses f or 
ex viv o t otal li pi d u pta ke 
a nal ysis
f
C ollect st u d y le nses f or all 
ex viv o li pi d u pta ke 
a nal yses

C o m plete E xit F or m
()
()
()

()
Assess A Es ( o bser ve d a n d 
re p orte d)
g


 

Assess De vice Deficie ncies
 


 

a) Ra n d o mizati o n t o be perf or me d after t he Bi o micr osc o p y e xa mi nati o n
b ) Visit 1 wit h ha bit ual le nses
 
c) S o urce d oc u me nt o nl y
e) Wi t h 
le nses 
f) C o nfir m sc he d uli n g of Visit 3 after 
ex viv o li pi d a nal ysis is c o m plete a n d eli gi bilit y 
c o nfir me d 
g ) A Es will be c ollecte d fr o m t he ti me of I nf or me d C o nse 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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
) As nee de d or if a 2 -li ne c ha n ge i n C o ntact Le ns C orrecte d l o g M A R V A is o bser ve d
A E = a d verse e ve nt, B C VA = Best C orrecte d V is ual Ac uit y , C L = c o ntact le ns, 
 
, h = h o ur s, l o g M A R = l o garit h mic Mi ni m u m A n gle of Res ol uti o n, mi n = mi n ute s, 
, U S V = u nsc he d ule d visit , VA = vis ual ac uit y 

Page 17 of 59
3
ABBREVIATIONS AND GLOSSARY OF TERMS
3.1
List of abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
AOHG
AIR OPTIX plus HydraGlyde 
BCVA
Best corrected visual acuity
CE
Conformité Européenne
CL
Contact lens
D
Diopter
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full analysis set
GCP
Good Clinical Practice
h
Hours
ICH
International Council for Harmonization of Technical Requirements for 
Pharmaceuticals for Human Use
ID
Identification
IEC
Independent ethics committee
ISO
International Organization for Standardization
logMAR
Logarithmic minimum angle of resolution
MedDRA
Medical Dictionary for Regulatory Activities
µg
Microgram
min
Minutes
mm
Millimeter
NI
Noninferiority
OD
Right eye
OS
Left eye
OU
Both eyes
PP
Per protocol 
Rx
Prescription
SADE
Serious adverse device effect
SAE
Serious adverse event
SD
Standard deviation
USV
Unscheduled visit
VA
Visual acuity
 
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Abbreviation
Definition
VITA
ACUVUE VITA
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3.2
Glossary of Terms
Adverse Event 
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 
Effect
Adverse event related to the use of an investigational medical device 
(test article) or control article. 
Note: This definition includes AEs resulting from insufficient or 
inadequate instructions for use, deployment, implantation, 
installation, or operation; any malfunction; and use error or 
intentional misuse of the test article or control article.
Device Deficiency
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 
Note: This definition includes malfunctions, use errors, and 
inadequate labeling.
Malfunction
Failure of a medical device to meet its performance specifications or 
otherwise perform as intended. Performance specifications include 
all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed.
Product Complaint
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, durability, 
reliability, safety, effectiveness, or performance of a marketed 
product, including failure of the product, labeling or packaging to 
meet specifications, whether or not the product is related to or 
caused the alleged deficiency. A complaint may allege that an AE or 
medical device malfunction has occurred.
Non-Serious Adverse 
Event
Adverse event that does not meet the criteria for a serious adverse 
event.
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Serious Adverse 
Event 
Adverse event that led to any of the following: 
- Death 
- A serious deterioration in the health of the subject that either 
resulted in: 
a) A life-threatening illness or injury 
Note: Life-threatening means that the individual was at immediate 
risk of death from the event as it occurred, ie, it does not include an 
event which hypothetically might have caused death had it occurred 
in a more severe form.
b) Any potentially sight-threatening event or permanent impairment 
to a body structure or a body function 
c) In-patient hospitalization or prolonged hospitalization 
Note: Planned hospitalization for a pre-existing condition, without 
serious deterioration in health, is not considered an SAE. In general, 
hospitalization signifies that the individual remained at the hospital 
or emergency ward for observation and/or treatment (usually 
involving an overnight stay) that would not have been appropriate in 
the physician's office or an out-patient setting. Complications that 
occur during hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred, the 
event should be considered serious.
d) A medical or surgical intervention to prevent a) or b) 
e) Any indirect harm as a consequence of incorrect diagnostic test 
results when used within manufacturer’s instructions for use 
- Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Refer to Section 12 for additional SAEs.
Serious Adverse 
Device Effect 
Adverse device effect that has resulted in any of the consequences 
characteristic of an SAE. 
Serious Public Health 
Threat
Any event type which results in imminent risk of death, serious 
deterioration in state of health, or serious illness that requires prompt 
remedial action. This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
public health hazard, eg, human immunodeficiency virus or 
Creutzfeldt-Jacob Disease.
Use Error
Act or omission of an act that results in a different medical device 
response than intended by manufacturer or expected by user. 
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in itself 
constitute a use error.
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4
TABLE OF CONTENTS
1
SYNOPSIS ..........................................................................................................................2
1.1
Amendments..................................................................................................................11
2
OVERVIEW OF STUDY PLAN.......................................................................................15
3
ABBREVIATIONS AND GLOSSARY OF TERMS........................................................17
3.1
List of abbreviations......................................................................................................17
3.2
Glossary of Terms..........................................................................................................19
4
TABLE OF CONTENTS...................................................................................................21
List of Figures..........................................................................................................................23
5
INTRODUCTION.............................................................................................................24
5.1
Study Rationale and Background..................................................................................24
5.2
Known and Potential Risks ...........................................................................................25
5.3
Potential Benefits...........................................................................................................27
6
ETHICS .............................................................................................................................28
7
PROTOCOL AMENDMENTS .........................................................................................30
8
SUBJECT POPULATION.................................................................................................31
9
TREATMENTS ADMINISTERED...................................................................................32
9.1
Identity of Study Treatments .........................................................................................32
9.2
Usage.............................................................................................................................32
9.3
Accountability Procedures.............................................................................................33
9.4
Subject Confidentiality and Methods Used to Minimize Bias......................................33
10 STUDY PROCEDURES...................................................................................................35
10.1
Outline of the Study.......................................................................................................35
10.2
Visits and Examinations ................................................................................................36
10.2.1
Visit 1 (Screening 1/Baseline)...................................................................................36
10.2.2
Visit 2 (Screening 2)..................................................................................................37
10.2.3
Visit 3 (Day 1-Insertion Period 1) .............................................................................38
10.2.4
Visit 4 (Day 30 Period 1)...........................................................................................39
10.2.5
Visit 5 (Day 1-Insertion Period 2) .............................................................................40
10.2.6
Visit 6 (Day 30 Period 2 - Last Study Visit – Exit)...................................................41
10.3
Unscheduled Visits ........................................................................................................42
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10.4
Screen Failures ..............................................................................................................42
10.5
Discontinued Subjects ...................................................................................................42
10.6
Clinical Study Termination............................................................................................43
11 ANALYSIS PLAN ............................................................................................................44
11.1
Subject Evaluability.......................................................................................................44
11.2
Analysis Data Sets.........................................................................................................44
11.2.1. Safety Analysis Set.......................................................................................................44
11.2.2 Full Analysis Set ...........................................................................................................44
11.2.3. Per Protocol Analysis Set.............................................................................................44
11.3
Demographic and Baseline Characteristics...................................................................44
11.4
Effectiveness Analyses ..................................................................................................44
11.4.1. Primary Effectiveness Analysis....................................................................................45
11.4.1.1. STATISTICAL HYPOTHESES................................................................................45
11.4.1.2. ANALYSIS METHODS ...........................................................................................45
11.4.2. Secondary Effectiveness Analysis................................................................................45
.46
.47
.48
11.5. Handling of Missing Data...............................................................................................48
48
11.7. Safety Analysis................................................................................................................49
11.8. Health Economics ...........................................................................................................50
11.9. Interim Analyses .............................................................................................................50
11.10 Sample Size Justification ...............................................................................................50
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................51
12.1
General Information ......................................................................................................51
12.2
Monitoring for Adverse Events .....................................................................................53
12.3
Procedures for Recording and Reporting ......................................................................53
12.4
Return Product Analysis................................................................................................55
12.5
Unmasking of the Study Treatment...............................................................................56
12.6
Follow-Up of Subjects with Adverse Events.................................................................56
12.7
Pregnancy in the Clinical Study....................................................................................56
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................57
13.1
Completion of Source Documents and Case Report Forms..........................................57
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13.2
Data Review and Clarifications.....................................................................................57
13.3
Regulatory Documentation and Records Retention ......................................................58
13.4
Quality Assurance and Quality Control.........................................................................58
14 REFERENCES ..................................................................................................................59
List of Figures
Figure 10–1
Study Diagram .................................................................................................35
Figure 12–1
Categorization of all Adverse Events...............................................................51
Figure 12-2
Categorization of all Serious Adverse Events..................................................52
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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
Dr y ness is t he m ost c o m m o n c o m p lai nt of c o ntact le ns wearers a n d is t he pri mar y reas o n f or 
c o ntact le ns wear disc o nti n uati o n ( Yo u n g 2 0 11). Silic o ne h y dr o gel c o ntact le nses ha ve 
bec o me t he sta n dar d of care f or c o ntact le ns c orrecti o n , as t hat class of material pr o vi des 
o x y ge n tra ns missi b ilit y t o a le vel t hat f ulfills t he o x yge n re q uire me nt f or u nc o m pr o mise d 
a nteri or e ye p h ysi ol o g y. Des pite t heir desira ble p h ysi ol o gical a n d mec ha nical pr o perties, 
silic o ne h ydr o gel c o ntact le nses ha ve bee n ass ociate d wit h i ncrease d s p oliati o n b y  tear fil m 
li pi ds ( Maissa 2 0 1 4, J o nes 2 0 0 3), a n d i n s o me cases re d uce d wetta bilit y ( Keir 2 0 1 3), beca use 
of t he i ncl usi o n of h y dr o p h o bic sil o xa ne c o m p o ne nts i nt o t he materials.  
I n or der t o c o u nter t he hy dr o p h o bic effect of silic o ne material o n i n viv o c o ntact le ns 
we tta bilit y, s urface-base d a p pr oac hes s uc h as plas ma s urface tec h n ol o g y  or i nc or p orati o n of 
wetti n g a ge nts ha ve bee n use d t o e n ha nce t he wetta bilit y  a n d oc ular bi oc o m pati bilit y of 
silic o ne h ydr o gel c o ntact le nses. I t has bee n s h o w n t hat t hese a p pr oac hes are dif fere ntially 
eff ecti ve at re d uci n g li pi d de p ositi o n b ot h i n vitro ( P uc ker 2 0 1 0) a n d ex viv o ( Nas h 2 0 1 4, 
Z ha o 2 0 0 9); a n d f or a gi ve n le ns material, t here is a lar ge variati o n i n li pi d u pta ke a m o n gst 
t he p o p ulati o n ( Maissa 2 0 1 4). 
It is desira ble t o u n dersta n d h o w li pi d de p ositi o n af fects t he cli nical perf or ma nce of t he 
le nses o ver t he re place me nt peri o d; h o we ver, s o me ke y q uesti o ns of cli nical i m p orta nce 
re mai n u na ns were d. F or e xa m ple:

W here d oes li pi d de p ositi o n occ ur?
o
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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
A t t he s urface, i n t he b ul k, or b ot h? 
A ns wers t o t hese q uesti o ns c o ul d lea d t o scie ntificall y base d a d vice i n c h o osi n g c o ntact 
le nses f or hea vy de p osit ors , a n d t o date n o i nf or mati o n is a vaila ble.
I n or der t o u n dersta n d t he effect of li pi d de p ositi o n o n 
 silic o ne 
h y dr o gel le nses o ver a f ull m o nt h of wear , 2 m o nt hl y  re place me nt silic o ne h ydr o gel le nses 
wit h dif fere nt wetta bilit y i m pr o ve me nt a p pr oac hes will be st u die d: l otrafilc o n B le nses wit h 
plas ma s urface treat me nt ( Alc o n Air O pti x pl us H y dra Gl y de; A O H G) a n d se n ofilc o n C 

Pa ge 2 5 of 5 9
le nses wit h a d de d i nter nal wetti n g a ge nt (Jo h ns o n &J o h ns o n Ac u v ue V ita; VI T A ). It has bee n 
s h o w n t hat t hese 2 le ns materials de p osit li pi ds t o a dif fere nt de gree; t he test l otrafilc o n B 
le nses te n d t o resist li pi d de p ositi o n w hile t he c o ntr ol se n ofilc o n le nses te n d t o u pta ke li pi ds 
t o a greater de gree ( Nas h 2 0 1 4, Z ha o 2 0 0 9). A d diti o nall y , a p o p ulati o n of k n o w n li pi d 
de p osit ors will be tar gete d f or e nr oll me nt i n or der t o a p pr o priatel y assess t he patie nt 
p o p ulati o n of i nterest. 
 
 
 
I n s u m mar y, t he ai m of t he prese nt st u d y is t o c o m pare t he  
 la b orat or y 
perf or ma nce of A O H G a n d VI T A i n hi g h li pi d de p osit ors t o u n dersta n d t he li pi d de p ositi o n 
l ocati o n a n d pr ofile of eac h le ns after 3 0 da ys of wear 
 
5. 2
K n o w n a n d P ote nti al Ris ks
T he partici pa nts i n t his st u d y  will b e c urre nt dail y wearers of 1-m o nt h re place me nt 
C E -mar ke d silic o ne hy dr o gel c o ntact le nses. Partici pati o n i n t he st u d y  will n ot res ult i n a 
c ha n ge of treat me nt as t he y will c o nti n ue t o wear differe nt t ypes of 1 -m o nt h re place me nt 
C E -mar ke d silic o ne hy dr o gel c o ntact le nses u n der t he sa me c o n diti o ns a n d usi n g t heir 
ha bit ual le ns care s ys te m. He nce, partici pati o n i n t he st u d y d oes n ot i ncrease t he p ote ntial 
ris ks ass ociate d wit h dail y c o ntact le ns wear. Safet y i nf or mati o n details o n t he st u d y c o ntact 
le nses are f o u n d o n t he ma n ufact urer’s users’ leaflets, w hic h will be s u p plie d t o t he 
partici pa nts. I n a d diti o n, t he I n vesti gat or will a d vise partici pa nts of t he ge neral war ni n gs a n d 
preca uti o ns ass ociate d wit h c o ntact le ns wear: 

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 ncrease t he ris k of c or neal ulcers wit h c o ntact le ns wear , 
es peciall y w he n l e nses are w or n o ver ni g ht or w hile slee pi 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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
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 wit h t h ose w h o d o n ot 
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 active 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. 

Pa ge 2 6 of 5 9
S u bjects will be i nstr ucte d t o use st u d y  le nses as dail y wear acc or di n g t o t he I nstr ucti o ns f or 
Use a n d/ or f oll o wi n g t he i nstr ucti o ns fr o m t he I n vesti gat or . S u bjects wh o 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 nses c o ul d e x perie nce a n e ye i nfecti o n of t he c or nea 
or a n e y e 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 ma y affect c or neal cur 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 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 i ncl u di n g m uc o p ur ule nt disc har ge

Oc ular h y pere mia

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

Less c o mf ort t ha n w he n t he le ns was first place d o n t he e y e

P o or vis ual ac uit y / bl urre d visi o n

Rai n b o ws or hal os ar o u n d o bjects

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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
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 is
n otice d. A seri o us c o n diti o n s uc h as c or neal ulcer, i nfecti o n, or iritis may 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 ynes s, i ncrease d le ns 
a ware ness/i nt olera nce, 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. 
T he I n vesti gat or m ust assess f or oc ular c ha n ges t o deter mi ne w het her t o disc o nti n ue or 
restrict le ns wear, e g, oc ular i nfecti o ns, tarsal pa pillar y c han ges, l ocal or ge neralize d c or neal 
e de ma, e pit helial micr oc ysts, e pit helial stai ni n g, i nfiltrates, ne o vasc ularizati o n, e n d ot helial 
p ol y me gat his m, c o nj u ncti val i njecti o n, a n d iritis.

Page 27 of 59
5.3
Potential Benefits
Material properties and design characteristics of contact lenses used in this study are features 
consistent with successful contact lens wear. This study provides participants with the 
opportunity to try new contact lenses which they may find preferable to their habitual lenses. 
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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 ICH E6 GCP Consolidated Guideline, ISO 14155: 2011 
Clinical investigation of medical devices for human subjects, and other regulations as 
applicable. The Investigator and all 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, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an Independent Ethics Committee (IEC). The Investigator must provide 
documentation of the IEC 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 must be provided any periodic safety updates, and all other 
information as required by local regulation and/or the IEC. At the end of the study, the 
Investigator will notify the IEC about the study’s completion. The IEC will also be notified if 
the study is terminated prematurely. Finally, the Investigator will report to the IEC on the 
progress of the study at intervals stipulated by the IEC.
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 Informed 
Consent Form 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 AOHG, VITA, 
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 authorities and Sponsor-designated 
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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 prior to implementation except when required to mitigate immediate safety risks 
or when the changes involve only logistical or administrative revisions. 
This is the second amended version of this protocol.
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8
SUBJECT POPULATION
The study population includes approximately 140 volunteer subjects to be screened (enrolled)
at 1 investigational site in the United Kingdom. Of the 140 screened subjects, approximately 
78 will be randomized to achieve 70 subjects to complete the study.
To participate in the study, subjects must be at least 18 years of age, with healthy eyes, be 
classified a high lipid depositor, and be successful current wearers of monthly replacement 
silicone hydrogel lenses within the power range of lens powers available for the screening 
and study lenses. The expected duration of subject participation in the study is approximately 
3 months. The complete inclusion and exclusion criteria are presented in Section 1.
Any advertisements that may be used to aid recruitment will be submitted to the IEC for 
approval prior to use. 
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Pa ge 3 2 of 5 9
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 si g ni n g t he I nf or me d C o nse nt F or m at Visit 1, s u bjects will be c o nsi dere d e nr olle d i n 
t he st u d y a n d a s u bject i de ntificati o n (I D) n u m ber will be assi g ne d b y e nteri n g t he s u bject 
i nt o t he electr o nic d ata c a pt ure ( E D C) sys te m b y a desi g nate d staff me m ber at t he 
i n vesti gati o nal site. At V isit 3 , eli gi ble s u bjects will be ra n d o mize d i n a 1 : 1 rati o t o wear 
A O H G i n Peri o d 1 a n d VI T A i n Peri o d 2, or t he ot her wa y ar o u n d ( VI TA i n Peri o d 1 a n d 
A O H G i n Peri o d 2) . T hr o u g h o ut t he st u d y, t he I nvesti gat or s h o ul d e ns ure t he u n mas ke d 
st u d y staff me m ber is res p o nsi ble f or t he acc o u nti n g of all scree ni n g a n d st u d y le nses a n d 
g uara ntees t hat t hey 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
T he s p herical c o ntact le nses t o be use d i n t he st u d y will be:

Scree ni n g Pr o d uct: 

I n vesti gati o nal Pr o d uct: AI R O P TI X pl us H y dra Gl y de

C o ntr ol Pr o d uct : A C U V U E VI T A
T he A O H G a n d VI T A le nses will be dis pe nse d i n a mas ke d ma n ner (re m o val of blister 
la bels) by a trai ne d u n mas ke d st u d y staf f me m ber s o t hat neit her t he s u bject n or t he 
I n vesti gat or ca n see t he le ns la bel a n d re mai n mas ke d t o t he details of t he le nses. All 
scree ni n g a n d st u d y le nses are C E-mar ke d a n d will be pr oc ure d b y t he i n vesti gati o nal site.
N o o ver -la belli n g is re q uire d. St ora ge c o n diti o ns f or t he scree ni n g a n d st u d y le nses are
d oc u me nte d i n t heir res pecti ve pac ka gi n g a n d la belli n g. 
9. 2
Us a 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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
T he s u bjects will use t he scree ni n g a n d st u d y le nses acc or di n g t o t he I nstr ucti o ns f or Use 
pr o vi de d b y t he pr o d uct ma n ufact urer , i n a d diti o n t o f oll o wi n g t he i nstr ucti o ns fr o m t he 
desi g nate d in vesti gati o nal site staff. A O H G a n d VI T A le nses will be pre pare d b y a trai ne d 
u n mas ke d st u d y  staff me m ber a n d dis pe nse d t o s u bjects. 
S u bjects will wear t he scree ni n g
le nses f or 1 0 h o urs ( ± 3 0 mi n utes) o n t he 
d a y of Scree ni n g 2, Vi sit 2. S u bjec ts will wear t he A O H G a n d VI T A le nses f or a t otal 
d urati o n of 3 0 da y s ( + 3 da y s) eac h u n der a dail y wear m o dalit y f or t he assi g ne d st u d y peri o d. 
T he le nses will be re m o ve d e ver y  ni g ht a n d care d f or wit h t he s u bject’s ha bit ual le ns care 
s ol uti o n. 

Page 33 of 59
Subjects will be instructed not to use artificial tears throughout the study and not to use
rewetting drops on the day of their study visits. Subjects should attend Visit 1 wearing their 
habitual lenses. Visit 2 should occur after 10 hours (± 30 minutes) of wear of 
lenses. Visit 4 and Visit 6 should occur after 10 hours (± 30) minutes of study lens wear. No 
lenses should be worn on the days of Visit 3 and Visit 5 until study lenses are dispensed at the 
study visit. 
Between Screening Visits 1 and 2, between Screening Visit 2 and Period 1-Day 1, and 
between Period 1-Day 30 and Period 2-Day 1, subjects may wear spectacles or return to 
habitual lens wear; however as a washout, no lenses are to be worn prior to the visits on the 
insertion days (Period 1-Day 1 and Period 2-Day 1). 
9.3
Accountability Procedures
Upon receipt of the study and screening lenses, the Investigator or designee will conduct an 
inventory. Unmasked study staff will prepare the study lenses for the subjects (by removing 
blister labels) in accordance with the randomized order assigned in EDC. The identity of the 
study lenses will not be revealed to the subject or the Investigator. 
During the study, the unmasked study staff member must maintain records of screening and 
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.
Alcon lenses associated with a Device Deficiency or with any product-related AEs must be 
returned to the Sponsor. Refer to Section 12 of this protocol for additional information on the 
reporting of Device Deficiency or product-related AEs, and to the Manual of Procedures for 
return address and instructions. 
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 number and date of birth
of each study participant. At the end of the study, the Sponsor will collect a copy of the 
enrollment log without any information identifying the subjects. All documents submitted to 
the Sponsor will identify the subjects exclusively by number and demographic information. 
No other personally identifying information should be transmitted to the Sponsor.
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The intent of masking is to limit the occurrence of conscious and unconscious bias in the 
conduct and interpretation of the study. Bias could arise from the influence that the 
knowledge of a specific lens assignment may have on the recruitment and allocation of 
subjects, their subsequent care, the assessment of endpoints, 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 receive 1 of 2 possible sequences 
of study lenses: AOHG then VITA, or VITA then AOHG. The Investigator, the subject, and 
the investigational site staff involved in reporting, obtaining, and/or reviewing the clinical 
evaluations will not be aware of the specific lens being worn. To achieve this, the study 
lenses will be fit and dispensed by a designated unmasked member of study staff not involved 
in the collection or measurement of any safety or effectiveness endpoints. From the Sponsor, 
Alcon study personnel will be masked, with the exception of a designated data manager, the 
lead monitor, the site monitor, and the person responsible for generating the randomization 
schedule. 
This level of masking will be maintained throughout the conduct of the study. Subjects will 
be assigned a lens sequence in numerical order. The randomization scheme will be generated 
and maintained by the Sponsor. Only when all study data have been verified and validated, 
and the database locked, will individual subjects be unmasked. 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 assignment for a specific subject.
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10 STUDY PROCEDURES
10.1 Outline of the Study
This is a prospective, randomized (lens sequence), double-masked, crossover study
(Figure 10-1). The study population will include approximately 78 randomized subjects who 
are high lipid depositors with normal eyes (other than correction for refractive error), at least 
18 years of age, and are successful current wearers of monthly replacement silicone hydrogel
contact lenses. 
At Visit 1, subjects will be assessed for their suitability based upon their habitual lens wear 
and if eligible, they will be dispensed 
lenses. Subjects should wear their 
lenses for 10 hours (± 30 minutes) on the day of Visit 2, at which the lenses 
will be removed and the total lipid uptake of those worn on the right eyes will be analyzed. If 
the total lipid uptake classifies the subject as a high lipid depositor, and all other 
inclusion/exclusion criteria are still met, the subject will continue and be randomized at Visit 
3. The subject will attend 3 additional visits and will wear the study lenses for 2 periods of 
30 (+3) days each.
Figure 10–1
Study Diagram
Screening 2
Evaluate 
lenses worn 
10 h (±30 min) 
for total lipid 
uptake
Day 1-30
AOHG
Day 1-30
VITA
Baseline/
Screening 1
Day 1-30
AOHG
Day 1-30
VITA
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10.2 Visits and Examinations
Full details of the assessments for this study are described in the CLL541-P001 Manual of 
Procedures. 
10.2.1 Visit 1 (Screening 1/Baseline)
1.
Explain the purpose and nature of the study, and have the subject or legally 
authorized representative read, sign, and date the IEC-approved Informed Consent 
Form. Additionally, have the individual obtaining consent from the subject and a 
witness, if applicable, sign and date the Informed Consent Form. Provide a 
photocopy of the signed document to the subject and place the original signed 
Informed Consent Form in the subject’s chart.
2.
Record and assess any AEs and Device Deficiencies that are reported or observed 
from the time of Informed Consent 
3.
Assign the subject a 5-digit Subject Number obtained from the EDC
Note: Assign subject numbers for all subjects who sign the Informed Consent 
Form (including screen failures)
4.
Obtain demographic information, habitual lens 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.
6.
Conduct a spherical over-refraction and optimize the Rx as required
7.
Assess monocular logMAR VA with habitual lenses (with and without spherical 
over-refraction) (only record habitual contact lens corrected VA without spherical 
over-refraction in EDC)
9.
Have the subjects remove habitual lenses 
10.
Assess biomicroscopy 
11.
Determine Manifest Refraction (sphero-cylindrical and best sphere) and measure 
monocular logMAR BCVA
12.
Assess inclusion/exclusion criteria
Note: Inclusion #5 (Screening 
lenses worn 10 hours [± 30 
minutes] exhibiting high lipid uptake) will be assessed after the lenses are 
collected at Visit 2
13.
Insert 
screening lenses (at least 10 minutes wearing time)
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14.
Verify contact lens fit and change 
screening lenses with different 
base curve if fit is not satisfactory
Conduct a spherical over-refraction and optimize the Rx as required 
15.
Assess monocular logMAR VA with 
lenses (with and without 
spherical over-refraction) (record in source)
17.
Remove 
trial screening lenses
18.
If subject is suitable for participation, provide a new pair of 
lenses (including information for use) to be worn before Visit 2 for 10 hours
(± 30 minutes) of wear on the day of Visit 2
19.
Schedule Visit 2 to take place 1 to 7 days after Visit 1. Instruct subjects on study 
compliance requirements. Subjects may wear spectacles or their habitual lenses 
until Visit 2. Remind the subject that on the day of Visit 2 to have worn the 
lenses for at least 10 hours (± 30 minutes) and to not use 
rewetting drops on the day of the visit. Artificial tears must not be used during the 
study 
10.2.2 Visit 2 (Screening 2)
1.
Obtain information on any changes in medical health, and/or the use of 
concomitant medications 
2.
Record any AEs, including those associated with changes in concomitant 
medication dosing and Device Deficiencies that are observed or reported
3.
Review subject compliance with lens wear (10 hours [± 30 minutes] of wear on 
day of visit) and confirm no use of artificial tears during the study as well as no 
use of rewetting drops on the day of study visit 
4.
Perform aseptic contact lens removal and storage in freezer of 10-hour worn 
lenses for ex vivo total lipid uptake analysis 
5.
Assess biomicroscopy 
6.
Assess monocular logMAR BCVA
7.
Confirm subject eligibility
Note: Confirm scheduling of Visit 3 after 
ex vivo lipid analysis is 
complete and eligibility confirmed
8.
Schedule Visit 3 for eligible subjects to take place within 80 days after Visit 2. 
Instruct subjects on study compliance requirements. Subjects can wear spectacles 
or their habitual lenses between Visit 2 and Visit 3. Inform subjects not to wear 
lenses on the day of Visit 3 and to not use rewetting drops on the day of the visit. 
Artificial tears must not be used during the study.
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10.2.3 Visit 3 (Day 1-Insertion Period 1)
1.
Obtain information on any changes in medical health and/or the use of concomitant 
medications 
2.
Record any AEs, including those associated with changes in concomitant
medication dosing and Device Deficiencies that are observed or reported
3.
Confirm subject compliance with no lens wear and confirm no use of artificial tears 
during the study as well as no use of rewetting drops on the day of study visit 
4.
Assess monocular logMAR BCVA
5.
Assess biomicroscopy 
6.
Confirm subject eligibility and randomize eligible subjects by entering details of 
eligibility into EDC system and obtain assignment of lens sequence
7.
Administer randomized study lenses no earlier than 15 minutes after 
biomicroscopy, record time of insertion
9.
Verify Lens Fit approximately 15 minutes after insertion
Note: if the fit of the control contact lens is not suitable the contact lens needs to be 
removed and the alternative base curve tried
10. Conduct a spherical over-refraction and optimize the Rx as required (binocular 
optimization)
11. Assess monocular logMAR VA with lenses (with and without spherical 
over-refraction) (record VA with study lenses and without spherical over-refraction 
in EDC)
17. Schedule Visit 4 to take place on Day 30 (+ 3). Instruct subjects on study 
compliance requirements and remind the subject to wear the lenses for 10 hours 
± 30 minutes on the visit day, and not to use artificial tears during the study period 
nor rewetting drops on the day of the visit. Instruct subjects to use habitual lens care 
to care for their lenses daily.
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10.2.4 Visit 4 (Day 30 Period 1)
1.
Obtain information on any changes in medical health and/or the use of concomitant 
medications 
2.
Record any AEs, including those associated with changes in concomitant
medication dosing and Device Deficiencies that are observed or reported
3.
Confirm subject compliance with lens wear and confirm no use of artificial tears 
during the study as well as no use of rewetting drops on the day of study visit
4.
Assess subjective acceptance of study lenses
5.
Assess monocular logMAR VA with lenses (with and without spherical 
over-refraction) (record VA with study lenses and without spherical over-refraction 
in EDC)
9.
Assess Lens Fit
10. Aseptic contact lens removal and storage in freezer of study lenses for ex vivo lipid 
uptake analysis ((total, individual, surface, bulk))
11. Assess biomicroscopy 
12. Assess monocular BCVA with Manifest Refraction 
13. Schedule Visit 5 to take place 1 to 14 days after Visit 4. Instruct subjects on study 
compliance requirements. Subjects can wear spectacles or their habitual lenses 
between Visit 4 and Visit 5. Inform subject not to wear lenses on the day of Visit 5,
to not use artificial tears during the study, and not to use rewetting drops on the day 
of the visit 
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10.2.5 Visit 5 (Day 1-Insertion Period 2)
1.
Obtain information on any changes in medical health and/or the use of concomitant 
medications 
2.
Record any AEs, including those associated with changes in concomitant
medication dosing and Device Deficiencies that are observed or reported
3.
Confirm subject compliance with no lens wear and confirm no use of artificial tears 
during the study as well as no use of rewetting drops on the day of study visit
4.
Assess monocular logMAR BCVA 
5.
Assess biomicroscopy
6.
Administer randomized study lenses no earlier than 15 minutes after 
biomicroscopy, record time of insertion
8.
Verify Lens Fit approximately 15 minutes after insertion
Note: if the fit of the control contact lens is not suitable the contact lens needs to be 
removed and the alternative base curve tried 
9.
Conduct a spherical over-refraction and optimize the Rx as required (binocular 
optimization)
10. Assess monocular logMAR VA with lenses (with and without spherical over-
refraction) (record VA with study lenses and without spherical over-refraction in 
EDC)
15. Schedule Visit 6 to take place at Day 30 (+3). Instruct subjects on study compliance
requirements. Inform subject to wear the lenses for 10 hours ± 30 minutes on the 
visit day and not to use artificial tears during the study period or rewetting drops on 
day of visit. Instruct to use habitual lens care to care for their lenses daily 
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10.2.6 Visit 6 (Day 30 Period 2 - Last Study Visit – Exit)
1.
Obtain information on any changes in medical health and/or the use of concomitant 
medications 
2.
Record any AEs, including those associated with changes in concomitant
medication dosing and device deficiencies that are observed or reported
3.
Confirm subject compliance with lens wear and confirm no use of artificial tears 
during the study as well as no use of rewetting drops on the day of study visit
4.
Assess subjective acceptance of study lenses
5.
Assess monocular logMAR VA with lenses (with and without spherical 
over-refraction) (record VA with study lenses and without spherical over-refraction 
in EDC)
9.
Assess Lens Fit
10. Aseptic contact lens removal and storage in freezer of study lenses for ex vivo lipid 
uptake analysis ((total, individual, surface, bulk))
11. Assess biomicroscopy 
12. Assess monocular BCVA with Manifest Refraction 
13. Exit subject from the study 
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10.3 Unscheduled Visits
Any visit that occurs between the regularly scheduled visits must be documented in the 
Unscheduled Visit pages of the electronic Case Report Form (eCRF). 
If a subject needs a lens replacement, an unscheduled visit should be performed. Subjects will 
not restart the study period in the case of an unscheduled lens replacement. 
During all unscheduled visits, the following procedures should be conducted: 
1.
Obtain information on any changes in medical health and/or the use of concomitant 
medications
2.
Record any AEs, including those associated with changes in concomitant
medication dosing and Device Deficiencies that are observed or reported
3.
Assess monocular logMAR VA with lenses (as needed)
4.
Assess monocular BCVA with Manifest Refraction
5.
Assess biomicroscopy
If the subject discontinues at the unscheduled visit, all the assessments listed for 
Visit 4/Visit 6 should be performed. The Exit Form should also be completed.
10.4 Screen Failures
Subjects who do not meet inclusion/exclusion criteria for study participation will be
considered screen failures and must not be re-screened.
10.5 Discontinued Subjects
Discontinued subjects will include those who withdraw or are withdrawn from the study after 
randomization at Visit 3. 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 could possibly be associated with suspected sensitivity or intolerance to one 
of the study lenses, the Investigator must document those observations on an AE Form.
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Pa ge 4 3 of 5 9
A n y  s u bject w h o e xits earl y fr o m t he st u d y s h o ul d u n der g o all pr oce d ures o utli ne d at 
Vi sit 4/ Visit 6. A d diti o nall y , t he E xit F or m m ust be c o m plete d a n d t he reas o n f or 
disc o nti n uati o n i de ntifie d. 
Fi nall y , I n vesti gat ors s h o ul d assess eac h s u bject t o e ns ure t he safety of t h ose w h o disc o nti n ue 
earl y, a n d, if necessar y, a d vise t he m of a ny t hera pies a n d/ or me di cal pr oce d ures t hat mi g ht be 
nee de d t o mai ntai n t heir healt h.
1 0. 6 Cli nic al St u d y Te r mi n ati o n
If t he cli nical st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he S p o ns or will i nf or m t he 
I n vesti gat or a n d t he re g ulat or y a ut h orities of t he ter mi nati o n/s us pe nsi o n a nd t he reas o ns 
t here of. 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 of t he ter mi nati o n /s us pe nsi o n a n d of 
t he reas o ns. T he S p o ns or reser ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he 
st u d y i n its e ntiret y at a n y ti me, f or a n y 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 d y 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 effecti ve ness

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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
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 t he i n vesti gati o nal site f or a n y 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 reaso ns, it will i m me diatel y  n otif y t he 
I n vesti gat or by tele p h o ne a n d s u bse q ue ntl y 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.

Page 44 of 59
11 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum and maximum, as well as confidence intervals or 
confidence limits where applicable. Categorical variables will be summarized with counts 
and percentages from each category. Any deviations to this analysis plan will be updated 
during the course of the study as part of a protocol amendment or will be detailed in the 
clinical study report.
11.1 Subject Evaluability
The final subject evaluability will be determined prior to breaking the code for masked lens 
sequence assignment and locking the database, based upon the DEP.
11.2 Analysis Data Sets
11.2.1. Safety Analysis 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 any study lenses 
(AOHG or VITA) evaluated in this study. For treatment-emergent safety analyses, 
subjects/eyes will be categorized under the actual lens exposed. 
11.2.2 Full Analysis Set
The FAS is the set of all randomized subjects who are exposed to any study lenses (AOHG or 
VITA) evaluated in this study. 
11.2.3. Per Protocol Analysis Set
The PP Analysis Set is a subset of all randomized subjects and excludes all data/subjects that 
meet any of the critical deviation or non-evaluable criteria identified in the DEP.
11.3 Demographic and Baseline Characteristics
Demographic information (age and sex) will be summarized for the Safety, Full, and PP
Analysis Sets. Baseline characteristics on habitual lenses 
 and VA will
be summarized for the Full and the PP Analysis Sets. 
11.4 Effectiveness Analyses
This study defines 1 primary, 
 
endpoints. All effectiveness evaluations will use the FAS as the primary analysis set. 
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Supportive analyses of the primary 
 endpoints will be 
conducted using the PP Analysis Set only if the number of subjects excluded from the PP 
analysis set exceeds 5% of the FAS.
For all planned inferential analyses, alternative models/methods may be considered if 
convergence cannot be achieved.
11.4.1. Primary Effectiveness Analysis
The primary objective of this study is to demonstrate superiority of AOHG compared with 
VITA in total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high 
lipid depositors. 
The corresponding endpoint is the total amount of lipids (µg) absorbed/adsorbed and 
extracted (total of surface and bulk uptake) from worn test and control lenses at Day 30. Only 
OD lenses will be used for the ex vivo analysis. 
11.4.1.1. STATISTICAL HYPOTHESES
The null and alternative hypotheses are formulated as follows:
H0: µT – µC ≥ 0
Ha: µT – µC < 0
where µT and µC represent the mean total lipid uptake (total of surface and bulk uptake) 
measured from the test and control lenses, respectively. 
11.4.1.2. ANALYSIS METHODS
A mixed effect repeated measures model will be fit to test these hypotheses. To account for 
within-subject correlation due to crossover, the model will include terms for lens, period, and 
lens sequence group as fixed effects and subject as a random effect. Normality will be 
checked. If the normality assumption does not hold, a natural log transformation will be 
performed as loge(µg+1).
11.4.2. Secondary Effectiveness Analysis
No secondary effectiveness objective is defined for this study.
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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 effectiveness analysis. 
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Pa ge 4 9 of 5 9
11 . 7. S afet y A n al ysis
T he safet y e n d p oi nts f or t his st u d y are B i o micr osc o p y Fi n di n gs, A Es, a n d De vice 
Deficie ncies . 
Descri pti ve s u m maries (c o u nts a n d perce nta ges) f or oc ular a n d n o n oc ular A Es will be 
prese nte d b y M e dical Dicti o nar y f or Re g ulat or y Acti vities ( Me d D R A) Preferre d Ter ms. I n 
a d diti o n t o a n o verall prese ntati o n of A Es, relati o ns hi p t o le ns will be i de ntifie d. Seri o us 
A d verse E ve nts will als o be ta b ulate d se paratel y.  I n divi d ual s u bject listi n gs will be pr o vi de d, 
as necessar y. 
A d diti o nall y , i n di vi d ual s u bject listi n gs will be pr o vi de d f or A Es t hat :

O cc ur after si g ni n g t he I nf or me d C o nse nt F or m, b ut pri or t o e x p os ure t o test or c o ntr ol 
le nses ( pre-treat me 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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
Occ ur after la st e x p os ure t o Peri o d 1 le nses , b ut pri or t o e x p os ure t o Peri o d 2 le nses
( bet wee n-peri o d)
Eac h Bi o micr osc o p y para meter will be ta b ulate d b y  its gra de. C o u nts a n d perce nta ges of e yes 
t hat e x perie nce a n i ncrease of ≥2 gra des fr o m Visit 3/ Visit 5 t o a n y s u bse q ue nt visit wit hi n 
eac h peri o d will be prese nte d. A s u p p orti ve listi n g will be ge nerate d w hic h will i ncl u de all 
Bi o micr osc o p y data fr o m t he visits wit hi n eac h af fecte d peri o d f or t h ose e yes e x perie nci n g 
t he i ncrease of ≥2 gra des, wit h t he f oll o wi n g varia bles: le ns, I n vesti gat or , s u bject, a ge, se x, 
visit, e y e, para meter, baseli ne val ue, a n d val ue at t he visit.
Fre q ue nc y  c o u nts will be ta b ulate d f or eac h De vice Deficie nc y cate g or y. A d diti o nall y , 
2 listi n gs will be pr o vi de d: pri or t o e x p os ure t o st u d y le ns an d treat me nt -e mer ge nt.
N o i nfere ntial testi n g will be d o ne f or t he safety a nal ysis. 

Page 50 of 59
11.8. Health Economics
Not applicable.
11.9. Interim Analyses
Not applicable.
11.10 Sample Size Justification
Sample sizes per sequence group required to attain 80% power at 1-sided, α=0.05 for the 
primary
 endpoints are shown below:
Endpoint
Assumptions
N/sequence group
Primary
Ex vivo total lipid 
uptake (total of 
surface and bulk 
uptake)
SD paired differences = 13.88
Detectable difference = 10
7
(based upon t-test for difference of 
means in 2x2 crossover design)
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12 ADVERSE EVENTS AND DEVICE DEFICIENCIES
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 study lenses. For categories of AEs and SAEs, refer to the 
Glossary of Terms (see also Figure 12-1 and Figure 12-2). 
Figure 12–1
Categorization of all Adverse Events
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Figure 12-2
Categorization of all Serious Adverse Events
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
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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 dard 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 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 ny pr ot oc ol- s pecific p ar am eters a n d q uest i o nn air es (if a p plic a ble) e val uate d 
d ur i n g th e stu d y  are to be re vie we d b y t he I n vesti gato r. An y  u nt o war d (u nf a v ora ble a n d 
u ni nte n de d) c ha n ge i n a pr ot oc ol- s pecific p ar am eter or qu esti o nn air e res p on se t hat is
clin ically rele va n t is t o be re po rte d as a n A E . T hese cli nicall y relev a nt c ha n ges wi ll b e
re p orte d reg ar dless of ca usa lit 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 will be 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) will n ot be 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. 
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 will n ot be 
c o nsi dere d A Es if t he I n ves ti gat or assesses t hat t he s ym 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 verse De vice Ef fects (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. I n a d diti o n, t he In 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 i n vesti gati o nal 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 S p o ns or i m me diatel y  as f oll o ws: 

All S A Es m ust be re p orte d i m me diatel y  ( wit hi n 2 4 h o urs) of t he I n vesti gat or ’s or 
i n vesti gati o nal site’s a ware ness

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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
A d verse de vice ef fects t hat d o n ot meet t he 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 
i n vesti gati o nal site’s a ware ness

Pa ge 5 4 of 5 9

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 Ef fect 
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 
C L L 5 4 1 -P 0 0 1 Ma n ual of Pr oce d ures
f or details o n t he ret ur n i nstr ucti o ns) 

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble

D oc u me nt a n y c 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 t he narrati ve secti o n of t he A d verse De vice 
Ef fect (f or relate d A Es) a n d Ser i o us 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 i n vesti gati o nal 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 Ef fect a n d/ or  
Device Deficie ncy F o r m. T he c o m plete d f or m is e m aile d t o t he S p o ns or  at 
ft w. me dic al _s afet y @ alc o n.c o m 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 d diti o nall y , a ny A Es a n d De vice Deficie ncies f or n o n -st u d y mar kete d pr o d ucts (ie, 
c o ntact le nses, 
) 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 pr o d uct’s ma n ufact urer as per l ocal re q uire me nts.
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 -rel ate d q uesti o n a n d t heir 
c o nt act i nf or m ati o n pro vi de d i n t he M a n u al of Pr oce d ures t h at acc o m p a nies t his 
pr ot oc ol. 
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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
F urt her , de pe n di n g u p o n t he nat ure of t he A E or de vice deficie nc y  bei n g re p orte d, t he 
S p o ns or ma y  re q uest c o pies of a p plica ble p orti o ns of t he s u bject’s me dical rec or ds. T he 
I n vesti gat or m ust als o re p ort all A Es a n d De vice Deficie ncies t hat c o ul d ha ve le d t o a Seri o us 
A d verse De vice Effect (S A D E ) acc or di n g t o t he re q uire me nts of re g ulat or y  a ut h orities or 
I E C.

Page 55 of 59
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
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 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 Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related. 
12.4 Return Product Analysis 
Sponsor representatives and their contact information are provided in the Manual of 
Procedures that accompanies this protocol. 
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Alcon study products associated with Device Deficiencies and/or product-related AEs should 
be returned and must include the Complaint # which will be provided by the Sponsor after 
the case is entered in the Sponsor’s Global Product Complaint Management System.
12.5 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 for details on the masking procedure). If the treatment code 
needs to be broken in the interest of subject safety, the Investigator is encouraged to contact 
an appropriate 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 Sponsor. The Sponsor must be informed of all cases in which 
the code was broken and of the circumstances involved. Additionally, the Sponsor may be 
required to unmask the information in order to fulfill expedited regulatory reporting 
requirements. 
12.6 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 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 the time of subject’s exit 
from the 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 post-market 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. 
12.7 Pregnancy in the Clinical 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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Pa ge 5 7 of 5 9
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 eC R Fs e xist a n d are accessi ble f or verificati o n b y  t he i n vesti gati o nal 
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 n tati 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

St u d y pr o d uct 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

Date of st u d y c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u 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 e C R F are c o nsiste nt wit h t he ori gi nal s o urce data. 
T he e C R Fs will be pr o vi de d t o t he i n vesti gati o nal site s; 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 
st u d y 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 de ntifiers 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. 
1 3. 2 D at a Re vie w a n d Cl arific ati o ns
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:  Effecti ve
Pri nte d B y:  
Pri nt Date:  
3. 0; M ost- Rece nt; Effecti ve; C U R R E N T
T D O C- 0 0 5 3 5 4 1
Pr ot oc ol - Cli nical
0 7- Dec- 2 0 1 7
T he e C R F data will be re vie we d a gai nst t he s u bject’ s s o urce data by t he st u d y  m o nit ors t o 
e ns ure c o m plete ness a n d acc urac y. After m o nit ori n g has occ urre d at t he i n vesti gati o nal sites 

Page 58 of 59
and the eCRFs 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 
eCRFs.
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).
The results of the study are intended for publication to support future product information. 
13.4 Quality Assurance and Quality Control
The Sponsor will be responsible for implementing and maintaining quality assurance and 
quality control systems to ensure the study is conducted and data are generated, documented 
and reported in compliance with the protocol, GCP and applicable regulatory requirements. 
The Sponsor will secure agreement from all involved parties to ensure direct access to the 
study-related investigational site, source data and documents, and reports for the purpose of 
monitoring and auditing by the Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Sponsor with 
the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
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14 REFERENCES
Jones L, Senchyna M, Glasier MA, Schickler J, Forbes I, Louie D, et al. Lysozyme and lipid 
deposition on silicone hydrogel contact lens materials. Eye and Contact Lens. 
2003;29(1S):S75–S9.
Keir N, Jones L. Wettability and silicone hydrogel lenses: a review. Eye Contact Lens. 
2013;39: 100–8.
Maissa C, Guillon M, Cockshott N, Garofalo RJ, Lemp JM, Boclair JW. Contact lens lipid 
spoliation of hydrogel and silicone hydrogel lenses. Optom Vis Sci. 2014;91(9):1071 83.
Nash W, Gabriel M. 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. 
Pucker AD, Thangavelu M, Nichols JJ. Enzymatic quantification of cholesterol and 
cholesterol esters from silicone hydrogel contact lenses. Invest Ophthalmol Vis Sci. 2010; 
51(6):2949-54.
Young G, Chalmers RL, Napier L, Hunt C, Kern J. Characterizing contact lens-related 
dryness symptoms in a cross-section of UK soft lens wearers. Cont Lens Anterior Eye. 
2011;34(2):64-70. 
Zhao Z, Carnt NA, Aliwarga Y, Wei X, Naduvilath T, Garrett Q, et al. Care regimen and lens 
material influence on silicone hydrogel contact lens deposition. Optom Vis Sci.
2009;86:251-59.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
12/07/2017 20:55:00
12/07/2017 20:49:17
12/07/2017 20:12:59
12/07/2017 20:11:04
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