Clinical Study of OPTI-FREE® PureMoist® for Presbyopic Contact Lens Wearers
Phase: NA
Conditions: Presbyopia
Sponsor: Alcon, a Novartis Company

Page 1 of 55
a Novartis company
Short Title:
Opti-Free® PureMoist® for Presbyopic Contact Lens Wearers
Long Title:
Clinical Study of Opti-Free® PureMoist® for Presbyopic Contact Lens 
Wearers
Protocol Number:
Study Phase:
Sponsor Name and 
Address:
Investigational Product:
US IND# / EudraCT
Indication Studied:
Investigator Agreement:
LCO115-P001 / NCT02965820
N/A
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Opti-Free® PureMoist® (OFPM)
N/A
Cleaning and disinfection of soft contact lenses
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described trial in 
compliance with Good Clinical Practice (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
Address:
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1
SYNOPSIS
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
Investigational 
Product:
Opti-Free PureMoist
(OFPM)
Study Phase:
1
2
3
4
N/A
Protocol Title:
Clinical Study of Opti-Free PureMoist for Presbyopic Contact Lens 
Wearers
Investigator(s)/ No. of 
Sites:
Approximately 8 sites
Center Location(s)/ 
United States
No. of Subjects
Required: 110 
completed
Planned: approximately 
120 randomized
(approximately 8 to 20
subjects per site)
Duration of Treatment:
30 ± 3 days per period each product (up to 66 days total)
Study Population: Current presbyopic soft contact lens wearers (2-week /monthly 
replacement modalities only) with symptoms of contact lens induced dryness and using a 
non-Alcon multi-purpose solution.
Objectives:
The overall objective of this study is to demonstrate the benefit of 
OFPM compared to non-HYDRAGLYDE multipurpose contact lens 
solutions in presbyopes currently wearing soft contact lenses and 
experiencing symptoms of dryness. 
The primary objective is to demonstrate superiority of OFPM when 
compared to the subject’s habitual multipurpose solution (HMPS) in 
reducing symptoms of contact lens induced dryness after 30 days of 
use, based on responses to the CLDEQ-8 (abbreviated Contact Lens 
Dry Eye Questionnaire).
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
Methodology:
This is a prospective, randomized, crossover (2-treatment, 2-period), 
observer-masked, and quasi-subject-masked study.
Treatments:
Investigational 
Product:
OFPM
Route of 
Administration:
Thoroughly wet each side of the lens with 
OFPM solution. Rub the lens for 20 
seconds. Rinse each side of the lens for 10 
seconds with a steady stream of OFPM
solution. Fill your Alcon lens case with 
fresh OFPM solution.
Refer to MOP for detailed instructions for 
use in the package insert.
Duration of Treatment:The subject will wear their habitual lens 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
brand (following manufacturer 
recommended replacement) on a daily wear 
basis for 30 ± 3 days using OFPM daily to 
care for their lenses.
Dosage:
Up to 32 cleaning and disinfecting cycles 
will be used for the study.
Control Article:
Habitual Multi-purpose Solution
Route of 
Administration:
Refer to MOP for detailed instructions for 
use in the package inserts.
Duration of Treatment:The subject will wear their habitual lens 
brand (following manufacturer 
recommended replacement) on a daily wear 
basis for 30 ± 3 days using their habitual 
solution daily to care for their lenses.
Dosage:
Up to 32 cleaning and disinfection cycles 
will be used for the study.
Subject Selection:
Inclusion Criteria:
1. Age 45-65 (both inclusive) and must sign the informed 
consent.
2. Current adapted two-week/monthly replacement soft contact 
lens wearers (at least 2 months) with symptoms of contact 
lens induced dryness as defined by the Symptomatology 
(Eligibility) Pre-screening questionnaire. 
Note: Subject may be wearing multifocal contact lenses or 
single vision contact lenses prescribed for monovision or for 
distance only.
3. Requires a near spectacle ADD of +0.50 or greater.
4. Best corrected visual acuity (BCVA) to 20/30 or better in 
each eye at distance at Visit 1.
5. Willing to wear lenses for a minimum of 5 days per week 
6 hours per day, and attend all study visits.
6. Currently using a non-Alcon multi-purpose solution (MPS) to 
care for their lenses (at least 2 months).
7. Uses digital devices (eg, smart phone, tablet, laptop 
computer, or desktop computer) for 20 consecutive minutes 
at least twice a week and willing to continue the same pattern 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
for the duration of the study as assessed at Pre-screening.
Exclusion Criteria:
1. Extended wear (sleeps in lenses one or more nights per 
week).
2. Any anterior segment infection, inflammation, disease, or 
abnormality that contraindicates contact lens wear as 
determined by the Investigator.
3. Any use of systemic medications or ocular medications for 
which contact lens wear could be contraindicated, as 
determined by the Investigator, including use of any topical 
ocular medications that would require instillation during 
contact lens wear.
4. Monocular subjects (only 1 eye with functional vision) or 
subjects fit with only 1 lens.
5. A known sensitivity to any ingredients in OFPM.
6. Biomicroscopy findings observed during the Visit 1 slit-lamp 
examination that are moderate (grade 3) or worse in either 
eye. 
7. Prior refractive surgery (eg, laser assisted in situ 
keratomileusis [LASIK] and photorefractive keratectomy 
[PRK]).
8. History of herpetic keratitis, ocular surgery, or irregular 
cornea.
9. A pathological dry eye that precludes contact lens wear.
10. Use of mechanical eyelid therapy or eyelid scrubs within 
14 days before Visit 1 and not willing to discontinue during 
the study.
11. Enrollment of the Investigator or his/her staff, family 
members of the Investigator, family members of the 
Investigator's staff, or individuals living in the households of 
these individuals.
12. Enrollment of more than 1 member of the same household in 
the study.
13. Participation in any clinical study within 30 days of Visit 1.
14. Subjects who are currently using or have not discontinued 
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Pa ge 6 of 5 5
S p o ns or:
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 
7 6 1 3 4- 2 0 9 9
Pr ot oc ol N u m ber: L C O 1 1 5 -P 0 0 1
Restasis ® , Xii dra ® or a t o pical ster oi d wit hi n t he past 7 da y s.
Assess me nts:

C L -i n d uce d dr yness s y m pt o ms as meas ure d b y C L D E Q - 8

S y m pt o mat ol o g y  pre-scree ni n g q uesti o n naire







Bi o micr osc o p y

S nelle n vis ual ac uit y

A Es a n d de vice deficie ncies
St atistic al Met h o ds:
Pl a n ne d A n al ysis
T hree a nal ys is sets will be defi ne d: safet y, f ull, a n d per pr ot oc ol 
( P P). T he safet y  a nalys is set will i ncl u de all s u bjects/e yes e x p ose d t o 
a n y st u d y le ns care pr o d ucts e val uate d i n t his st u d y. T he f ull a nalys is 
set ( FA S) is t he set of all ra n d o mize d s u bjects w h o are e x p ose d t o 
a n y st u d y le ns care pr o d ucts. T he P P  a nalys is set is a s u bset of all 
ra n d o mize d s u bjects a n d e xcl u des t h ose w h o meet t he critical 
de viati o n criteria as s pecifie d i n t he De via ti o ns a n d E val ua bilit y Pla n 
( D E P). T he FA S will ser ve as t he pri mar y  a nalys is set f or all efficac y 
e val uati o ns.
All data fr o m e val ua ble s u bjects will be i ncl u de d i n t he ef ficac y 
a nal ys is; n o i m p utati o n f or missi n g val ues will be perf or me d.
Ef ficac y:
To  a d dress t he pri mar y efficac y o bjecti ve, pla n ne d a nalys es are 
s u m marize d bel o w.
E n d p oi nt
C o m p aris o n
St atistic al Met h o d
P RI M A R Y
C L D E Q -8 ( Da y  3 0)
O F P M vs 
H M P S
S u peri orit y  
Mi xe d ef fect re peate d 
meas ure m o del. 
Baseli ne sc ore as a 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7

Page 7 of 55
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
covariate.
 
 
 
 
 
 
 
 
 
 
 
Safety:
Each safety variable will be summarized descriptively. Adverse 
events (AEs) will be classified as treatment-emergent, based on 
treatment-specific exposure, or pre-treatment. Count and percentage 
will be provided by relationship to device, and separate tables will be 
generated for ocular and nonocular AEs. Counts and percentages in 
each grade category will be presented for each biomicroscopy 
parameter. Device deficiencies will also be tabulated. Supporting 
subject listings describing details of each safety variable will be 
provided. Listings describing details of AEs reported prior to usage 
of the study solutions will be presented separately from the safety 
analysis for the treatment-emergent AEs.
Sample Size 
Justification:
Sample size calculations for the primary endpoint are summarized 
below (one-sided α=0.05).
Endpoint
Assumptions
Power
N
Primary
CLDEQ-8
SD=10
(paired 
differences)
80%
Detectable 
difference=3
36 per each 
of the 2
crossover 
sequences
 
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Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number: LCO115-P001
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1.1
Amendments
Amendment 1
Purpose of Amendment: To implement revisions based on the change in Exclusion Criteria
Rationale: To align with study specific requirements  
Current Study Status: Study execution
Case Report Form Revision Required:
Yes
X No
Informed Consent Modifications Required:
Yes
X No
Applicable Investigators:
X All
Selected (list below)
Itemized Changes:
Change 
Rationale 
Section 8.2: Exclusion Criteria
number 14
Change from:
Subjects who are currently using or have 
not discontinued RESTASIS within the 
past 7 days.
To
Subjects who are currently using or have 
not discontinued RESTASIS, XIIDRA or 
a topical steroid within the past 7 days.
To include range of concurrent products 
prohibited to use in the study.
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1.2
Glossary of Terms for Safety
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device (test article). Note: For subjects, 
this definition includes events related to the test article, the control 
article, or the procedures involved. For users or other persons, 
this definition is restricted to events related to the test article.
Adverse Device 
Effect (ADE)
Adverse event related to the use of an investigational medical 
device (test article) or control article. Note: This definition 
includes adverse events 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 
adverse event or medical device malfunction has occurred.
Non-serious Adverse 
Event
Adverse event that does not meet the criteria for a serious adverse 
event.
Serious Adverse 
Event (SAE)
Adverse event that led to any of the following: 
Death.
A serious deterioration in the health of the subject that either 
resulted in:
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.
Any potentially sight-threatening event or permanent impairment 
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Page 11 of 55
to a body structure or a body function.
In-patient hospitalization or prolonged hospitalization.
Note: Planned hospitalization for a pre-existing condition, without 
serious deterioration in health, is not considered a serious adverse 
event. 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 adverse events. 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.
A medical or surgical intervention to prevent a) or b)
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 
(SADE)
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event.
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 (HIV) or Creutzfeldt-Jacob Disease (CJD).
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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2
OVERVIEW OF STUDY PLAN
Visit 1
Visit 2
Visit 3
USV
Procedure/Assessment
Screening & 
Baseline
Period 1/ Day 1
Period 1 
Day 30 ± 3 
Follow-Up 
Period 2/
Day 1
Period 2
Day 30 ± 3
Follow-Up/ 
Exit
Unscheduled 
Visit
Pre-Screening 
questionnaire 
(symptomatology, 
digital device use, and 
HMPS identification)a
X (before 
consent)
Informed consent
X
Collect demographics 
and activities
X
Medical and lens/lens 
care history
X
Concomitant 
medications/ changes in 
concomitant 
medications
X
X
X
X
Subjective (manifest) 
refractiona
X
(X)
(X)
(X)
BCVAa
X
(X)
(X)
(X)
Inclusion/exclusion
X
Randomization
X
Dispense a new pair of 
habitual lenses and 
assign/dispense the 
study lens care solution 
per randomization. 
Educate on instructions 
for use. 
X
X
(X)
Snellen VA with lenses
Xb
Xb, d
Xd
(X)
Biomicroscopy
X
X
X
X
CLDEQ-8 
Questionnaire
Xc
X
X
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Visit 1
Visit 2
Visit 3
USV
Procedure/Assessment
Screening & 
Baseline
Period 1/ Day 1
Period 1 
Day 30 ± 3 
Follow-Up 
Period 2/
Day 1
Period 2
Day 30 ± 3
Follow-Up/ 
Exit
Unscheduled 
Visit
Assess AEs
Xe
X
X
Assess device 
deficiencies
X
X
X
X
Document wear time 
compliance (days, 
hours) and lens care 
compliancea
X
X
(X)
Exit form
(X)
(X)
X
(X)
aSource only
bWith new lenses being dispensed at the visit
cBased on habitual regimen
dWith lenses worn for the study period.
eAEs are collected from the time of informed consent. 
(X)= as needed.
AEs=adverse events, BCVA=best corrected visual acuity, CLDEQ-8=Contact Lens Dry Eye Questionnaire-8, 
HMPS=Habitual multi-purpose solution, IRB=Institutional review board, USV=unscheduled visit, VA=visual acuity
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3
ABBREVIATIONS
Abbreviation
Definition
ADD
Added magnifying power
ADE
Adverse device effect
AE
Adverse event
ALDOX
Myristamidopropyl dimethylamine
BCVA
Best corrected visual acuity
CI
Confidence interval
CJD
Creutzfeldt-Jacob Disease
CL
Confidence limit or contact lens
CLDEQ-8
Contact Lens Dry Eye Questionnaire-8
CRF
Case report form
CSM
Clinical site monitor
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
EDTA
Ethylenediaminetetraacetic acid
EOBO
Ethylene oxide and butylene oxide
EudraCT
European Clinical Trials Database
FAS
Full analysis set
fl. oz.
Fluid ounce
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System 
HIV
Human immunodeficiency virus
HMPS
Habitual multi-purpose solution
IEC
Independent ethics committee
ICH
International Council for Harmonization of Technical Requirements 
for Pharmaceuticals for Human Use
ID
Identification 
IND
Investigational new drug
IRB
Institutional review board
LASIK
Laser assisted in situ keratomileusis
MedDRA®
Medical Dictionary for Regulatory Activities
mL
Milliliter
MOP
Manual of procedures
MPS
Multi-purpose solution
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Abbreviation
Definition
N/A
Not applicable
n
Number
OFPM
Opti-Free Puremoist Multi-Purpose Contact Lens Solution
POLYQUAD
polyquaternium-1
PP
Per protocol
PRK
Photorefractive keratectomy
SADE
Serious adverse device effect
SAE
Serious adverse event
SD
Standard deviation
SDV
Source data verification
US
United States of America
USV
Unscheduled visit
VA
Visual acuity
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4
TABLE OF CONTENTS
1
SYNOPSIS ..........................................................................................................................2
1.1
Amendments....................................................................................................................9
Amendment 1.............................................................................................................................9
1.2
Glossary of Terms for Safety.........................................................................................10
2
OVERVIEW OF STUDY PLAN ......................................................................................12
3
ABBREVIATIONS ...........................................................................................................14
4
TABLE OF CONTENTS...................................................................................................16
List of Tables............................................................................................................................18
List of Figures..........................................................................................................................18
5
INTRODUCTION.............................................................................................................19
5.1
Study Rationale and Background..................................................................................19
5.2
Known and Potential Risks ...........................................................................................19
5.3
Potential Benefits ..........................................................................................................20
6
ETHICS .............................................................................................................................21
7
PROTOCOL AMENDMENTS .........................................................................................23
8
SUBJECT POPULATION.................................................................................................24
8.1
Inclusion Criteria...........................................................................................................24
8.2
Exclusion Criteria..........................................................................................................24
9
TREATMENTS ADMINISTERED ..................................................................................26
9.1
Identity of Study Treatments.........................................................................................26
9.2
Usage.............................................................................................................................28
9.3
Accountability Procedures ............................................................................................28
9.4
Subject Confidentiality and Methods Used to Minimize Bias......................................29
10 STUDY PROCEDURES...................................................................................................30
10.1
Outline of Study ............................................................................................................30
10.2
Visits and Examinations................................................................................................32
10.2.1
VISIT 1 – SCREENING/BASELINE & PERIOD 1/DAY 1 VISIT.........................32
10.2.2
VISIT 2 – PERIOD 1/Day 30 & PERIOD 2/DAY 1.................................................33
10.2.3
VISIT 3 – Period 2/ DAY 30 /EXIT..........................................................................34
10.3
Unscheduled Visits........................................................................................................35
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10.4
Discontinued Subjects and Screen Failures...................................................................35
10.5
Clinical Study Termination............................................................................................36
11 ANALYSIS PLAN ............................................................................................................38
11.1
Subject Evaluability ......................................................................................................38
11.2
Analysis Data Sets.........................................................................................................38
11.2.1
Safety Analysis Set....................................................................................................38
11.2.2
Full Analysis Set........................................................................................................38
11.2.3
Per Protocol Analysis Set ..........................................................................................38
11.3
Demographic and Baseline Characteristics...................................................................38
11.4
Efficacy Analyses..........................................................................................................39
11.4.1
Primary Efficacy........................................................................................................39
11.4.1.1
Statistical Hypotheses............................................................................................39
11.4.1.2
Analysis Methods ..................................................................................................39
11.4.2
Secondary Efficacy....................................................................................................39
11.4.2.1
Statistical Hypotheses............................................................................................40
11.4.2.2
Analysis Methods ..................................................................................................40
40
42
42
11.5
Handling of Missing Data .............................................................................................43
43
11.7
Safety Analysis..............................................................................................................43
11.8
Health Economics..........................................................................................................44
11.9
Interim Analyses............................................................................................................44
11.10 Sample Size Justification...............................................................................................44
12 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................46
12.1
General Information ......................................................................................................46
12.2
Monitoring for Adverse Events.....................................................................................47
12.3
Procedures for Recording and Reporting......................................................................48
12.4
Intensity and Causality Assessments.............................................................................49
12.5
Return product analysis.................................................................................................50
12.6
Unmasking of the Study Treatment...............................................................................50
12.7
Follow-Up of Subjects with Adverse Events ................................................................50
12.8
Pregnancy in the Clinical Trial......................................................................................51
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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS...............................52
13.1
Completion of Source Documents and Case Report Forms..........................................52
13.2
Data Review and Clarifications.....................................................................................53
13.3
Regulatory Documentation and Records Retention......................................................53
13.4
Clinical Trial Results.....................................................................................................53
14 References .........................................................................................................................54
15 APPENDIX .......................................................................................................................55
List of Tables
Table 9-1
Study Treatments .............................................................................................26
List of Figures
Figure 10–1
Diagram of Study Design ................................................................................31
Figure 12–1
Categorization of All Adverse Events..............................................................46
Figure 12-2
Categorization of All Serious Adverse Events.................................................47
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5
INTRODUCTION
5.1
Study Rationale and Background
Silicone hydrogel contact lenses pose unique challenges for contact lens care solutions; the
solutions must efficiently remove tear lipid deposits and keep the hydrophobic silicone 
material wettable at the surface. 
Opti-Free PureMoist solution is a sterile, buffered, aqueous solution containing sodium 
citrate, sodium chloride, boric acid, sorbitol, aminomethylpropanol, disodium EDTA
(ethylenediaminetetraacetic acid), 2 wetting agents (TETRONIC® 1304 and HydraGlyde 
Moisture Matrix [EOBO-41-polyoxyethylene- polyoxybutylene]) with POLYQUAD 
(polyquaternium-1) 0.001% and ALDOX (myristamidopropyl dimethylamine) 0.0006%
preservatives. HydraGlyde Moisture Matrix is a proprietary multi-functional block 
copolymer that is primarily designed for wetting and lubricating silicone hydrogel lenses.
The purpose of this study is to demonstrate the benefit of OFPM in presbyopic contact lens 
wearers with symptoms of dryness as compared to their HMPS. The primary objective is to 
demonstrate superiority of OFPM compared to the subject’s HMPS in reducing symptoms of 
contact lens-related dryness after 30 days of use, based on responses to the CLDEQ-8 
(abbreviated Contact Lens Dry Eye Questionnaire).
This market support study is designed to provide continued reasonable assurance of the 
effectiveness of OFPM in a specified population of symptomatic presbyopic soft contact lens 
wearers that fall under the indication of the product. The effectiveness endpoint was 
identified based on the findings from another post-approval study in a general population of 
symptomatic soft contact lens wearers who were habitually using Multi-Purpose Solutions to 
care for their lenses. Biguanide preserved multi-purpose solutions are commonly used 
disinfection systems in the marketplace and are included in most private label solutions; 
therefore, they are a reasonable control to the test solution in this study, which is a 
POLYQUAD/ALDOX preserved multipurpose disinfecting system including a wetting agent 
that may benefit some soft lens wearers.
5.2
Known and Potential Risks
Contraindications, warnings, important safety information, and adverse reactions for OFPM
may be found in product labeling.
The risks with contact lens wear are increased with a pre-existing or active ocular infection or 
inflammation, improper lens fit, and noncompliance with regimen. It is essential that contact 
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lens care users follow directions and all labeling instructions for proper use of their contact 
lenses and lens care products, including the lens case. Subjects who are noncompliant and fail 
to follow the instructions for cleaning, storage, and disinfection of their contact lenses could 
experience an eye infection or injury. A corneal ulcer could develop rapidly and lead to loss 
of vision. Overall, the potential risks associated with use of the subject’s HMPS and OFPM 
are similar when used as indicated.
Potential side effects for test and control the solutions are the same and include: eyes sting, 
burn or itch (irritation), comfort is less than when lens was first placed on the eye, feeling of 
something in the eye (foreign body, scratched area), excessive watering (tearing) of the eye, 
unusual eye secretions, redness of the eye, reduced sharpness of vision (poor visual acuity), 
blurred vision, rainbows or halos around objects, sensitivity to light (photophobia), or dry 
eyes.
5.3
Potential Benefits
OFPM is indicated for use in the daily cleaning, reconditioning, rinsing, removing protein 
deposits, reducing lipid deposition, chemical (not heat) disinfection, and storage of silicone 
hydrogel and soft (hydrophilic) contact lenses as recommended by an eye care practitioner. 
Based on known product information, in the opinion of Alcon, the benefits gained by the use 
of the formulation outweigh the risks associated with its use.
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6
ETHICS
This clinical study will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with the International Council for Harmonization of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice (GCP) 
Consolidated Guideline and other regulations as applicable. The Investigator and all clinical 
study staff will conduct the clinical study in compliance with the protocol. The Investigator 
will ensure that all personnel involved in the conduct of the study are qualified to perform 
their assigned responsibilities through relevant education, training, and experience.
Before clinical study initiation, this protocol, the informed consent form, MOP, any other 
written information given to subjects, and any advertisements planned for subject recruitment 
must be approved by an Independent Ethics Committee/Institutional Review Board 
(IEC/IRB). The Investigator must provide documentation of the IEC/IRB approval to the 
Sponsor. The approval must be dated and must identify the applicable protocol, amendments 
(if any), informed consent form, MOP, all applicable recruiting materials, written information 
for subject, and subject compensation programs. The IEC/IRB must be provided with a copy 
of the Investigator’s Brochure, any periodic safety updates, and all other information as 
required by local regulation and/or the IEC/IRB. At the end of the study, the Investigator will 
notify the IEC/IRB about the study’s completion. The IEC/IRB also will be notified if the 
study is terminated prematurely. Finally, the Investigator will report to the IEC/IRB on the 
progress of the study at intervals stipulated by the IEC/IRB.
Voluntary informed consent will be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any Screening or other study-related procedures. The 
Investigator must have a defined process for obtaining consent. Specifically, the Investigator, 
or designee, will explain the clinical study to each potential subject and the subject must 
indicate voluntary consent by signing and dating the approved informed consent form. The 
subject must be provided an opportunity to ask questions of the Investigator, and if required 
by local regulation, other qualified personnel. The Investigator must provide the subject with 
a copy of the consent form written in a language the subject understands. The consent 
document must meet all applicable local laws and will provide subjects with information 
regarding the purpose, procedures, requirements, and restrictions of the study, along with any 
known risks and potential benefits associated with the investigational product, the available 
compensation, and the established provisions for maintaining confidentiality of personal, 
protected health information. Subjects will be told about the voluntary nature of participation 
in the study and will be provided with contact information for the appropriate individuals 
should questions or concerns arise during the study. The subject also will be told that their 
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records may be accessed by appropriate authorities and Sponsor-designated personnel. The 
Investigator must keep the original, signed copy of the consent and must provide a duplicate 
copy to each subject.
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7
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the IEC/IRB prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions. 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study may be 
required by the IRB to sign the approved, revised informed consent form. 
This is the first amended version of protocol LCO115-P001.
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8
SUBJECT POPULATION
Approximately 120 subjects (approximately 8 to 20 subjects per site) are to be randomized at 
approximately 8 United States (US) sites to achieve approximately 110 subjects completed. 
An advertisement may be used to aid recruitment. The advertisement will be submitted to the 
IEC/IRB for approval. The IRB approved Pre-screening questionnaire will be provided 
before taking the consent.
The enrollment for the study is planned for 6 weeks. The expected duration of subject 
participation in the study (3 scheduled visits) is 30 ± 3 days per study period (up to 66 days 
total). The complete inclusion and exclusion criteria are presented in Section 8.1 and 
Section 8.2.
8.1
Inclusion Criteria
1. Age 45-65 (both inclusive) and must sign the informed consent.
2. Current adapted two-week/monthly replacement soft contact lens wearers (at least 
2 months) with symptoms of contact lens induced dryness as defined by the 
Symptomatology (Eligibility) Pre-screening questionnaire. 
Note: Subject may be wearing multifocal contact lenses or single vision contact lenses 
prescribed for monovision or for distance only.
3. Requires a near spectacle ADD of +0.50 or greater.
4. Best corrected visual acuity (BCVA) to 20/30 or better in each eye at distance at 
Visit 1.
5. Willing to wear lenses for a minimum of 5 days per week 6 hours per day, and attend 
all study visits.
6. Currently using a non-Alcon MPS to care for their lenses (at least 2 months).
7. Uses digital devices (eg, smart phone, tablet, laptop computer, or desktop computer) 
for 20 consecutive minutes at least twice a week and willing to continue the same 
pattern for the duration of the study as assessed at Pre-screening.
8.2
Exclusion Criteria
1. Extended wear (sleeps in lenses one or more nights per week).
2. Any anterior segment infection, inflammation, disease, or abnormality that 
contraindicates contact lens wear as determined by the Investigator.
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3. Any use of systemic medications or ocular medications for which contact lens wear 
could be contraindicated, as determined by the Investigator, including use of any 
topical ocular medications that would require instillation during contact lens wear.
4. Monocular subjects (only 1 eye with functional vision) or subjects fit with only 1 lens.
5. A known sensitivity to any ingredients in OFPM.
6. Biomicroscopy findings observed during the Visit 1 slit-lamp examination that are 
moderate (grade 3) or worse in either eye. 
7. Prior refractive surgery (eg, LASIK and PRK).
8. History of herpetic keratitis, ocular surgery, or irregular cornea.
9. A pathological dry eye that precludes contact lens wear.
10. Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and 
not willing to discontinue during the study.
11. Enrollment of the Investigator or his/her staff, family members of the Investigator, 
family members of the Investigator's staff, or individuals living in the households of 
these individuals.
12. Enrollment of more than 1 member of the same household in the study.
13. Participation in any clinical study within 30 days of Visit 1.
14. Subjects who are currently using or have not discontinued RESTASIS, XIIDRA or a 
topical steroid within the past 7 days.
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9
TREATMENTS ADMINISTERED
Upon completing the Pre-screening Questionnaire and satisfying the relevant pre-screening 
criteria, subjects will sign informed consent and then be considered enrolled into the study. A 
subject ID number will be assigned to enrolled subjects by entering the subject into the 
electronic data capture (EDC) system. Subjects eligible after Screening at Visit 1 will be 
randomized (1:1) to receive either OFPM or HMPS to care for their lenses in Period 1 of the 
study. For Period 2, the contact lens solution that was not allocated for use in Period 1 will be 
dispensed. Throughout the study, designated unmasked site personnel at the investigational 
site will be responsible for the accounting of all study products and will ensure that the study 
products are not used in any unauthorized manner.
9.1
Identity of Study Treatments
Investigational Product: 
OFPM
Control Product: 
HMPS
OFPM will be supplied in sterile 10 fl. oz. (300 mL) filled bottles with investigational 
labelling. A new lens case will be supplied with each bottle.
Table 9-1
Study Treatments
Properties
OFPM (Test product)
HMPS (Control product)
Administration
Subjects will use OFPM to store 
and disinfect their contact lenses 
as instructed by the study team 
member(s) dispensing the solution 
and according to the instructions 
for use.
Subjects will use their HMPS to 
store and disinfect their contact 
lenses as instructed by the study 
team member(s) dispensing the 
solution and according to the 
instructions for use.
Duration of 
Treatment
The subject will wear their 
habitual lens brand (following 
manufacturer recommended 
replacement) on a daily wear 
modality for 30 ± 3 days using 
OFPM daily to care for their 
lenses.
The subject will wear their 
habitual lens brand (following 
manufacturer recommended 
replacement) on a daily wear 
modality for 30 ± 3 days using 
their habitual solution daily to 
care for their lenses.
Quantity/Dosage
Up to 32 cleaning and disinfecting 
cycles will be used for the study.
Up to 32 cleaning and disinfection 
cycles will be used for the study.
Supply
OFPM will be supplied sterile, in 
10 fl. oz. (300 mL) filled bottles 
HMPS will either be:
1) Purchased by the subject and 
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Properties
OFPM (Test product)
HMPS (Control product)
with investigational labelling. A 
new lens case will be supplied 
with each bottle.
The study kit will contain one 
bottle of the test article (bottle 
will be re-labeled), and green and 
white screw top case. The product 
is manufactured by Alcon 
Laboratories in Fort Worth, Texas.
Note: Habitual rewetting drops 
may be used as needed throughout 
the study. Rewetting drop use 
frequency will be collected at 
baseline and follow-up.
reimbursed. The unmasked 
site personnel must confirm a 
new bottle of the HMPS 
identified at pre-screening is 
purchased by the subject and 
used for the assigned study 
period.
2) Purchased by the site 
according to the HMPS 
identified at pre-screening and 
dispensed to the subject for 
use during the assigned study 
period.
HMPS will be dispensed/used in 
commercial packaging. The 
manufacturer information for each 
product can be found in the 
package insert.
Note: Habitual rewetting drops 
may be used as needed throughout 
the study. Rewetting drop use 
frequency will be collected at 
baseline and follow-up.
OFPM will be provided in the commercial bottle but will be re-labeled. Included on the 
investigational labels for the randomized product will be the kit number, protocol number, fill 
volume, storage conditions, the indicator “Disinfecting Solution” and a statement that the 
product is for investigational use only. OFPM should be stored at room temperature.
More information on the OFPM or HMPS can be found in the Product Labeling. Refer to the 
MOP for product labels.
The new label will be sufficient to mask the OFPM, thus maintaining the subject masking to 
brand. A designated unmasked staff member at the site will be assigned to dispense the sealed 
test kit and the HMPS to ensure Investigator masking. Unmasked site personnel cannot 
conduct study specific procedures.
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9.2
Usage
Subjects will use the study contact lens solutions according to the instructions provided by 
the unmasked coordinator who dispenses the study lens solutions. Each treatment period 
(Period 1 and Period 2) will last for 30 (± 3) days. In addition to dispensing the randomized 
study contact lens solutions at the respective visit, subjects will be dispensed and fitted with a 
new pair of their habitual silicone hydrogel contact lenses (including an extra pair of lenses 
for 2 week replacement between visits, if required for use in each treatment period). The lens 
dispensations and all planned and unplanned lens replacements must be documented in the 
source.
9.3
Accountability Procedures
Designated unmasked site personnel will dispense the study contact lens solutions (re-labeled 
OFPM and the site/subject purchased commercially labeled HMPS) in accordance with their 
assigned subject ID number and the randomization treatment order allocated to them. The 
identity of the test product will not be revealed to the subject and the order of use of the test 
and control products will not be revealed to the Investigator. It will not be possible to 
maintain full subject masking due to the nature of the cleansing devices, but the brand name 
will be masked for the test solution. During the study, the investigational site must maintain 
records of study treatment dispensation and collection by the unmasked personnel for each 
subject. This record must be made available to the designated study monitors 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 a 
detailed explanation. Study contact lens cleaning devices associated with a device deficiency 
or with any product-related AEs must be returned to the Sponsor or manufacturer (for 
comparator/reference product). Refer to Section 12 for additional information on the 
reporting of device deficiencies or product-related AEs.
At the conclusion of the study, the Investigator will be responsible for returning all used and 
unused study supplies unless otherwise instructed by the Sponsor.
Upon receipt of the test products (OFPM test solution kits) from Alcon, the unmasked 
coordinator will conduct an inventory. During the study, the unmasked coordinator must 
maintain records of study treatment dispensation and collection for each subject including 
study solutions (test OFPM or purchased control HMPS). This record must be made available 
to the study monitor for the purposes of verifying the accounting of clinical supplies. Any 
discrepancies and/or deficiencies between the observed disposition and the written account 
must be recorded along with an explanation. At the conclusion of the study, the Investigator 
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will be responsible for returning all used and unused study supplies unless otherwise 
instructed by the Sponsor.
9.4
Subject Confidentiality and Methods Used to Minimize Bias
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Sponsor will collect a copy of the 
enrollment log without any identifying subject information. All documents submitted to the 
Sponsor will identify the subjects exclusively by subject ID and demographic information. 
No other personally identifying information should be transmitted to the Sponsor.
The intent of masking is to limit the occurrence of conscious and unconscious bias in the 
conduct and interpretation of the clinical study. Bias could arise from the influence that the 
knowledge of a specific treatment assignment may have on the recruitment and allocation of 
subjects, their subsequent care, the assessment of end points, the handling of withdrawals, 
and so on. The essential aim of masking, therefore, is to prevent identification of the test 
article(s) by the Investigator, subject, and others associated with the conduct of the study until 
all such opportunities for bias have passed.
This study is Investigator-masked and subject quasi-masked (masked to test solution brand 
only), with subjects randomized to the order in which they will use OFPM and their HMPS 
for 30 ± 3 days each. The Investigator will not be aware of the specific treatment being 
administered and the subject will not be aware of the brand of the test solution. Alcon study 
personnel will be masked, with the exception of the following: Study monitor, Lead CSM, 
and person responsible for generating the randomization schedule. This level of masking will 
be maintained throughout the conduct of the study. Subjects will be assigned treatment order 
based on the randomization schedule; it will be blocked to ensure a balance of study 
treatment allocations within investigational sites. The randomization scheme will be 
generated and maintained by the Sponsor. 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 treatment sequence assignment for a specific subject.
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10 STUDY PROCEDURES
10.1 Outline of Study
Prior to informed consent and scheduling the Screening visit, subjects will be given the 
Pre-screening Questionnaire (Symptomatology Questionnaire, Digital Device Use assessment 
and HMPS Identification Tool). These may be administered via a combination of phone, 
email, or in person; (Note: the HMPS Identification Tool is visual). Once the subject 
completes the questionnaire and the replies indicate the subject to be eligible to proceed then 
informed consent must be obtained from the subject before any procedure specified by this 
protocol is initiated, including Screening procedures at Visit 1. The original signed informed 
consent must be maintained with the subject’s file whether they pass or fail Screening. A 
copy of the signed informed consent form will be provided to the subject. Data from the 
Pre-screening Questionnaire will not be entered into to the electronic case report forms 
(eCRFs) but will stay in the subject file as source documents for monitoring of both 
randomized subjects and screen failures. Those who pass pre-screening and sign informed 
consent may attend the Screening visit (Section 10.2.1).
Subjects who are scheduled to attend the Screening visit must have a new bottle of the HMPS 
identified during pre-screening ready for possible dispensing at the end of the Screening visit 
after randomization. This can be accomplished in two ways for the study: 
1) The subject purchases a new bottle of the HMPS and brings it to the Screening visit. In 
this case the subject will be reimbursed for their purchase. The unmasked coordinator 
must confirm the solution purchased was the HMPS identified during pre-screening and 
that it is not expired. If HMPS is randomized to be used for Period 2, the site will 
maintain the purchased HMPS at the site for the subject until Period 2;
2) The site purchases the subject’s HMPS and dispenses to the subject according to the 
randomization schedule.
Adverse events (AEs)/serious adverse events (SAEs) and device deficiencies will be assessed 
and reported at all scheduled and unscheduled study visits for each subject from the time of 
informed consent.
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Figure 10–1
Diagram of Study Design
Presbyopic contact lens wearers
Pre-Screening Questionnaire
Screening/
Baseline
(Visit 1)
HMPS 
Period 1, 30 days ± 3days
(Visit 2)
OFPM Period 2, 
30 days ± 3days
(Visit 3)
HMPS 
Period 2, 
30 days ± 3days
(Visit 3)
OFPM 
Period 1, 30 days ± 3days
(Visit 2)
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10.2 Visits and Examinations
10.2.1 VISIT 1 – SCREENING/BASELINE & PERIOD 1/DAY 1 VISIT
1.
If the pre-screened eligible subject was asked to purchase a new bottle of their own 
HMPS, then the site should ensure the HMPS purchased matches the HMPS 
identified at pre-screening and is not expired. If this does not occur, the Screening 
visit should be rescheduled. 
2
Have the subject read, sign, and date the IEC/IRB approved informed consent 
document. Additionally, have the individual obtaining consent from the subject and a 
witness, if applicable, sign and date the informed consent document. Provide a 
photocopy of the signed document to the subject and place the original signed 
document in the subject’s chart.
3
Enter the subject into the EDC system to obtain a subject ID. 
Note: A subject ID is needed for all subjects who sign an informed consent form 
(including screen failures). 
4
Obtain demographic information, medical and lens/lens care history (including 
confirmed HMPS), typical activities performed while being active, concomitant 
medications/ changes in concomitant medications 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.
5
Have subject complete Subjective Questionnaires based on habitual lenses and care 
system (CLDEQ-8, 
 
6
Remove lenses and perform subjective (manifest) refraction. For details refer to 
MOP.
7
Perform BCVA assessment. For details refer to MOP.
8
Perform biomicroscopy assessments using slit-lamp examination scales. For details 
refer to MOP. Review inclusion/exclusion criteria to determine if the subject 
qualifies to be randomized into the study.
9
Only for subjects qualifying to be included in the study, confirm randomization by 
entering details of eligibility into the EDC system and obtain study solution 
assignment for each period.
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Pa ge 3 3 of 5 5
1 0
Dis pe nse a ne w pair of ha bit ual le nses a n d perf or m S nelle n V A wit h ne w le nses 
bei n g dis pe nse d at t he visit. F or details refer t o M O P. F or t w o- wee k re place me nt 
le ns wearers, pr o vi de t he s u bject a n e xtra pair of st u d y le nses f or re place me nt at 
2 wee ks. C o ntact t he s u bject at a p pr o xi matel y  1 5 ± 1 da y s of t he st u d y peri o d t o 
re mi n d t he s u bject t o re place t heir le nses a n d d oc u me nt date of re place me nt i n t he 
s o urce.
1 1
U n mas ke d c o or di nat or t o assi g n/ dis pe nse t he st u d y le ns care s ol uti o n f or Peri o d 1 
per ra n d o mizati o n sc he me. 
1)
H M P S p urc hase d b y t he s u bject or pr o vi de d b y t he site – or-
2)
I n vesti gati o nal Mas ke d O F P M Kit wit h Kit # .
E d ucate o n i nstr ucti o ns f or use.
1 2
Assess a n d rec or d a n y a d verse e ve nts ( A Es) t hat are re p orte d or o bser ve d fr o m t he 
ti me of i nf or me d c o nse nt (see Secti o n 1 2 ).
1 3
Rec or d a n y d e vice d eficie ncies t hat are o bser ve d or re p orte d.
1 4
Sc he d ule Visit 2 ( Peri o d 1 F oll o w -u p) t o ta ke place o n Da y  3 0 ± 3 da y s (sc he d ule d 
2 9 ( ± 3) da y s after Visit 1. 
Pr o vi de s u bject wit h V isit 2 re mi n der i nstr ucti o ns:

T he s u bject s h o ul d bri n g t he use d le ns case f or t he st u d y  peri o d, al o n g wit h 
t heir dis pe nse d st u d y le ns care pr o d uct use d d uri n g t he st u d y peri o d.
1 0. 2. 2 VI SI T  2 – P E RI O D 1/ D a y 3 0 & P E RI O D 2/ D A Y 1
1
D oc u me nt wear ti me c o m plia nce ( da y s, h o urs) a n d le ns care c o m plia nce. C ollect 
use d st u d y  le ns care pr o d uct fr o m t he s u bject.
2
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns si nce V isit 1.
3
Ha ve s u bject c o m plete t he S u bjecti ve Q uesti o n naire base d o n le nses w or n a n d st u d y  
s ol uti o n use d d uri n g t he 3 0 da y st u d y peri o d ( C L D E Q-8, 
 
 
4
C o n d uct S nelle n V A  wit h w or n le nses. F or details refer t o M O P. 
5
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7

Pa ge 3 4 of 5 5
6
Re m o ve le nses a n d perf or m bi o micr osc o p y  assess me nts usi n g slit -la m p e xa mi nati o n 
scales. F or details a n d or der of stai ni n g pr oce d ures, refer t o M O P.
7
Perf or m s u bjecti ve ( ma nifest) refracti o n assess me nt a n d B C V A assess me nt (as 
nee de d). F or details refer t o M O P.
8  
Assess a n d rec or d A Es t hat are o bser ve d or re p orte d (see Secti o n 1 2 ).
9
Rec or d a n y d e vice d eficie ncies t hat are o bser ve d or re p orte d.
1 0
Dis pe nse a ne w pair of ha bit ual le nses a n d perf or m S nelle n V A wit h ne w le nses 
bei n g dis pe nse d at t he visit. F or details refer t o M O P . F or t w o-wee k re place me nt 
le ns wearers, pr o vi de t he s u bject a n e xtra pair of st u d y le nses f or re place me nt at t w o 
wee ks. C o ntact t he s u bject at a p pr o xi matel y  1 5 ± 1 da y s of t he st u d y peri o d t o 
re mi n d t he s u bject t o re place t heir le nses a n d d oc u me nt date of re place me nt i n t he 
s o urce.
1 1
U n mas ke d c o or di nat or t o assi g n/ dis pe nse t he st u d y le ns care s ol uti o n f or Peri o d 2 
per ra n d o mizati o n sc he me. 
1)
H M P S p urc hase d b y t he s u bject or pr o vi de d b y t he site – or-
2)
I n vesti gati o nal Mas ke d O F P M Kit wit h Kit # . 
E d ucate o n i nstr ucti o ns f or use.
1 2
Sc he d ule Visit 3 ( Peri o d 2 F oll o w -u p) t o ta ke place o n Da y  3 0 ± 3 da y s (sc he d ule d 
2 9 ( ± 3) da y s after Visit 2. 
Pr o vi de s u bject wit h V isit 3 re mi n der i nstr ucti o ns:

T he s u bject s h o ul d bri n g t he use d le n s case f or t he st u d y peri o d, al o n g wit h 
t he dis pe nse d st u d y le ns care pr o d uct use d d uri n g t he st u d y  peri o d.
1 0. 2. 3 VI SI T  3 – Peri o d 2/ D A Y 3 0 / E XI T
1
D oc u me nt wear ti me c o m plia nce ( da y s, h o urs) a n d le ns care c o m plia nce. C ollect 
use d st u d y  le ns care pr o d uct fr o m t he s u bject.
2
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns si nce V isit 2.
3  
Ha ve s u bject c o m plete t he S u bjecti ve Q uesti o n naire base d o n le nses w or n a n d test 
s ol uti o n use d d uri n g t he 3 0-d a y  st u d y peri o d ( C L D E Q-8, 
 
 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7

Pa ge 3 5 of 5 5
4
C o n d uct S nelle n V A  wit h w or n le nses. F or details refer t o M O P. 
5
6
Re m o ve le nses a n d perf or m bi o micr osc o p y  assess me nts usi n g slit-la m p e xa mi nati o n 
scales. F or details a n d or der of stai ni n g pr oce d ures, refer t o M O P. 
7
Perf or m s u bjecti ve ( ma nifest) refracti o n assess me nt a n d B C VA assess me nt (as 
nee de d). F or details refer t o M O P.
8  
Assess a n d rec or d A Es t hat are o bser ve d or re p orte d (see Secti o n 1 2 ).
9
Rec or d a n y de vice d eficie ncies t hat are o bser ve d or re p orte d.
1 0
E xit t he s u bject fr o m t he st u d y .
1 0. 3 U nsc he d ule d Vi sits
A n y  visit t hat occ urs bet wee n t he re g ularly sc he d ule d visits m ust be d oc u me nte d i n t he 
u nsc he d ule d v isit pa ges of t he eC R F . D uri n g all u nsc he d ule d visits, t he f oll o wi n g pr oce d ures 
s h o ul d be c o n d ucte d:

D oc u me nt wear ti me c o m plia nce ( da y s, h o urs) a n d le ns care c o m plia nce.

O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.

Perf or m S nelle n V A wit h le nses (as nee de d).

Perf or m s u bjecti ve ( ma nifest) refracti o n (as nee de d).

Perf or m B C V A assess me nt (as n ee de d).

Perf or m bi o micr osc o p y .

Rec or d a n y A Es or d e vice deficie ncies t hat are o bser ve d or re p orte d.

Re place le nses a n d dis pe nse a d diti o nal st u d y  le ns care s ol uti o n f or t he st u d y peri o d if 
nee de d (as nee de d). Rec or d all u n pla n ne d le ns re place me nt dates i n t he s o urce.

E xit t he s u bject fr o m t he st u d y  (if s u bject is disc o nti n ui n g at t he u nsc he d ule d visit).
If t he s u bject is disc o nti n ui n g at t he u nsc he d ule d visit, t he Earl y E xit visit e C R F s h o ul d be 
c o m plete d rat her t ha n t he e C R F f or m f or a n u nsc he d ule d v isit.
1 0. 4 D isc o nti n ue d S u bjects a n d Scree n F ail ur es
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7
Disc o nti n ue d s u bjects are t h ose w h o wit h dra w or are wit h dra w n fr o m t he st u d y  after bei n g 
ra n d o mize d. S u bjects ma y disc o nti n ue fr o m t he st u d y at a n y ti me f or a ny reas o n. S u bjects 

Pa ge 3 6 of 5 5
ma y  als o be disc o nti n ue d fr o m t he st ud y  at a n y ti me if, i n t he o pi ni o n of t he I n vesti gat or, 
t heir c o nti n ue d partici pati o n p oses a ris k t o t heir healt h. Disc o nti n ue d s u bjects will n ot be 
re place d (ie, t heir s u bject n u m bers will n ot be re-assi g ne d/re -use d).
If a s u bject is i de ntifie d n ot t o f ulfill t he eli gi bilit y criteria f or st u d y i ncl usi o n d uri n g t he 
Scree ni n g visit ( V isit 1), t he s u bject will be scree n faile d a n d will n ot partici pate a n y f urt her 
i n t he st u d y. T he E D C syste m will be u p date d t o c o nfir m t he s u bject is a scree n fail ure. T he 
I n vesti gat or will e x plai n t o t he s u bject t he reas o n(s) w h y eli gi bilit y was n ot met a n d pr o vi de 
a p pr o priate i nf or mati o n/treat me nt, if re q uire d. T he E xit f or m will be c o m plete d f or all 
disc o nti n ue d s u bjects a n d scree n fail ures.
S h o ul d a s u bject e x hi bit a n y  cli nicall y rele va nt si g ns, sy m pt o ms, or ot her cli nical 
o bser vati o ns t hat p ossi bl y  c o ul d be ass ociate d wit h s us pecte d se nsiti vit y or i nt olera nce t o o ne 
of t he st u d y  treat me nts, t he I n vesti gat or m ust d oc u me nt t h ose o bser vati o ns o n a n A E F or m. 
O bser vati o ns m ust al s o be re p orte d f or occ urre nces n ot ass ociate d wit h a ny st u d y  treat me nt 
(see Secti o n 1 2. 3 , Pr oce d ures f or Rec or di n g a n d Re p orti n g A Es a n d S A Es).
A 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 3/ E xit. 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 m ust be i de ntifie d a n d ca pt ure d i n E D C. 
Fi nall y , t o e ns ure t he safet y of all s u bjects w h o disc o nti n ue early,  In vesti gat ors s h o ul d assess 
eac h s u bject a n d, if necessar y, a d vise t he m of a ny t hera pies a n d/ or me dical pr oce d ures t hat 
mi g ht be nee de d t o mai ntai n t heir healt h.
1 0. 5 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 ur el 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 n d t he reas o n(s) 
f or t he ter mi nati o n/s us pe nsi o n. 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/IR B of t he 
ter mi nati o n or 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 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 ud e :

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

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7
Safet y  c o ncer ns

Pa ge 3 7 of 5 5

S uf ficie nt data s u g gesti n g lac k of efficac y

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 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 his/ her site f or reas o na ble ca use. If t he 
S p o ns or ter mi nates t he st u d y  f or safet y reas o ns, it will i m me diatel y n otif y t he I n vesti gat or(s) 
b y  tele p h o ne a n d s u bse q ue ntl y will 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 38 of 55
11 ANALYSIS PLAN
Continuous variables will be summarized for the observed values using the number of 
observations, mean, SD, median, minimum and maximum, as well as CIs or CLs 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 
care sequence assignment and locking the database.
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 the newly dispensed habitual 
lenses for the study disinfected with at least one study lens product evaluated in this study. 
For treatment-emergent safety analyses, subjects/eyes will be categorized under the actual 
lens care product exposed.
11.2.2 Full Analysis Set
The FAS is the set of all randomized subjects who are exposed to at least one of the study 
lens care products as defined for the Safety Analysis Set.
11.2.3 Per Protocol Analysis Set
The PP analysis set is a subset of all randomized subjects and excludes all data/subjects 
which have met any of the critical deviation criteria identified in the DEP.
11.3 Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, and race) will be summarized on the safety, 
full, and PP analysis sets. Baseline characteristics on habitual lens and lens care information 
as well as activities, CLDEQ-8, 
, 
 
 will be summarized on the full and PP 
analysis sets. Due to the crossover design, demographic and baseline data will be presented 
by lens care sequence group and overall.
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11.4 Efficacy Analyses
This study defines one primary endpoint 
 All efficacy 
evaluations will use the FAS as the primary analysis set. 
 
 
For all planned inferential analyses, alternative models/methods may be considered if 
convergence cannot be achieved.
11.4.1 Primary Efficacy
The primary objective of this study is to demonstrate superiority of OFPM when compared to 
HMPS in reducing dryness symptomatology as measured by CLDEQ-8.
The corresponding endpoint is the score (range 0 to 37) from CLDEQ-8, obtained by adding 
the numerical responses to each of the 8 items, collected at the Day 30 follow-up for each 
product (Visit 2 and Visit 3).
11.4.1.1 Statistical Hypotheses
The null and alternative hypotheses are formulated as follows:
H0: µ(OFPM) – µ(HMPS) ≥ 0
Ha: µ(OFPM) – µ(HMPS) < 0
where µ(OFPM) and µ(HMPS) denote the mean CLDEQ-8 score for OFPM and HMPS, 
respectively, at the Day 30 follow-up.
11.4.1.2 Analysis Methods
A mixed effect repeated measures model will be fit to test these hypotheses, including terms 
for lens care solution, period, sequence group, and baseline CLDEQ-8 as fixed effects and 
subject as a random effect. Lens care difference (OFPM minus HMPS) and the corresponding 
one-sided 95% upper confidence limit will be provided.
11.4.2 Secondary Efficacy
No secondary efficacy objective is defined for this study.
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Page 40 of 55
11.4.2.1 Statistical Hypotheses
Not applicable
11.4.2.2 Analysis Methods
Not applicable
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Page 43 of 55
11.5 Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the efficacy analysis.
11.7 Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms. In 
addition to an overall presentation of AEs, reports will be generated for serious AEs. AEs 
leading to study discontinuation will be identified. Individual subject listings will be 
provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lens care solutions.
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Page 44 of 55
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥2 grades from 
baseline to any subsequent visit will be presented. Baseline is defined as Visit 1. A supportive 
listing will be generated which will include all biomicroscopy data from the affected visit for 
those eyes experiencing the increase of ≥2 grades, with the following variables: lens care 
solution, Investigator, subject, age, sex, visit, eye, parameter, baseline value, and value at the 
visit.
Two listings (prior to exposure of investigational products, and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiencies category will be tabulated. 
No inferential testing will be done for safety analysis.
11.8 Health Economics
Not applicable.
11.9 Interim Analyses
Not applicable.
11.10 Sample Size Justification
Sample size calculation for each of the relevant efficacy endpoints is described below. 
Primary Efficacy:
Sample size calculation for the primary efficacy hypothesis on decrease in symptomatology is 
based on published data (Chalmers 2012). With an assumed SD for paired differences of 10, a 
sample size of 36/sequence will provide 80% power to detect a difference of 3 at one-sided 
α=0.05.
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Page 46 of 55
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 investigational medical device (test article). Refer to the 
Glossary of Terms for categories of AEs and SAEs.
Figure 12–1
Categorization of All Adverse Events
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Pa ge 4 7 of 5 5
Fi g ur e 1 2- 2
C ate g oriz ati o n o f All Seri o us A d verse E ve nts
A n y  ot her p ote ntiall y si g ht-t hreate ni n g e ve nt ma y als o be c o nsi dere d seri o us base d o n t he 
j u d g me nt of t he I n vesti gat or a n d s h o ul d be re p orte d a p pr o priately as deli neate d i n 
Secti o n 1 2. 3 .
Device Deficie ncies
A de vice deficie nc y  ma y or ma y n ot be ass ociate d wit h s u bject har m (ie, A D E or S A D E); 
h o we ver , n ot all A D Es or S A D Es are d ue t o a de vice deficie nc y . T he I n vesti gat or s h o ul d 
deter mi ne t he a p plica ble cate g or y  f or t he i de ntifie d or s us pect de vice deficie nc y  a n d re p ort 
a n y s u bject har m se paratel y. 

Fail ure t o meet pr o d uct s pecificati o ns 

S ol uti o n cl o u d y

Pac ka gi n g deficit (e g, misla bele d pr o d uct, ta m pere d seal, lea ki n g b ottle/c o ntai ner)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
1 2. 2 M o nit ori n g f o r A d verse E ve nts
At eac h v isit, after t he s u bject has ha d t he o p p ort u nit y t o s p o nta ne o usly me nti o n a n y 
pr o ble ms, t he I n vesti gat or s h o ul d i n q uire a b o ut A Es b y  as ki n g t he sta n dar d q uesti o ns:

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7
“ 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?”

Pa ge 4 8 of 5 5

“ Have t here bee n a n y c ha n ges i n t he me dici nes y o u ta ke si nce y o ur last st u d y  Visit?”
C ha n ges i n a n y pr ot oc ol- s pecific param eters a n d q uest io n n aires e va lua te d d uri n g th e stu d y  
are to be re vie we d b y t he I n ve sti gato r. An y  u nt o war d ( u nfa v ora ble a n d u ni nte n de d) c ha n ge i n
a pr ot ocol- s pecific param eter or qu esti o nn aire res p on se t hat is clin icall y rele van t, i n t he 
o pi ni o n of t he I n vesti gat or , is t o be re po rte d as a n A E . T hese cli nicall y relev a nt c han ges wi ll 
be re p orte d reg ar dless of causa 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 are c ollecte d fr o m t he ti me of i nf or me d c o nse nt. A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s ym pt o ms prese nt i n a s u bject pri or t o t he start of t he st u d y  (ie, bef ore i nf or me d 
c o nse nt is si g ne d) are n ot c o nsi dere d A Es i n t he st u d y  a n d s h o ul d be rec or de d i n t he Me dical 
Hist or y  secti o n of t he e C R F.

All S A Es m ust be re p orte d i m me diatel y  ( wit hi n 2 4 h o urs) of t he I n vesti gat or ’s or 
site’s a ware ness. 

A D Es t hat d o n ot meet seri o us ness criteria a n d de vice deficie ncies m ust be re p orte d 
wit hi n 1 0 cale n dar da y s of t he I n vesti gat or ’s or site’s a ware ness. 

A pri nte d c o p y of t he c o m plete d Seri o us A dverse Eve nt a n d A dverse Device Ef fect 
a n d/ or D evice D eficie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns.

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F 
as s o o n as t he data bec o me a vaila ble.

D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.

D oc u me nt all rele va nt i nf or mati o n fr o m Disc har ge S u m mar y, A ut o ps y  Re p ort, 
Certificate of Deat h , etc, if a p plica ble, i n narrati ve secti o n of t he A d verse De vice 
Ef fect (f or relate d A Es) a n d Seri o 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 site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device 
Deficie ncy
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7
F or m. T he c o m plete d f or m is fa xe d or e maile d t o t he St u d y  S p o ns or at 
 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 y ste m o nce it bec o mes o perati o nal.
A n y  AEs a n d d e vice d eficie ncies f or n o n- st u d y mar kete d de vices/ pr o d ucts will be c o nsi dere d 
a n d pr ocesse d as s p o nta ne o us (f oll o wi n g t he p ost mar ket vi gila nce pr oce d ures) a n d s h o ul d be 
c o m m u nicate d t o t he de vice’s/ pr o d uct’s ma n ufact urer as per l ocal re q uire me nts.

Page 49 of 55
Study Sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the Manual of Procedures that accompanies 
this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
12.4 Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
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Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related.
12.5 Return product analysis 
Study Sponsor representatives and their contact information are provided in the Manual of 
Procedures that accompanies this protocol. 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS).
12.6 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. If the treatment code needs to be broken in the interest of subject safety, the 
Investigator is encouraged to contact an appropriate Study Sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (ie, medical emergency), the code may be broken prior to contact with the 
Study Sponsor. The Study Sponsor must be informed of all cases in which the code was 
broken and of the circumstances involved. Additionally, the Study Sponsor may be required 
to unmask the information in order to fulfill expedited regulatory reporting requirements.
12.7 Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
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The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
All complaints received after this time period will be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
12.8 Pregnancy in the Clinical Trial
Pregnancy should be included in the Medical History section of the eCRF when a woman 
becomes pregnant during the study. Pregnancy is not reportable as an AE; however, 
complications may be reportable and will be decided on a case–by-case basis.
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Pa ge 5 2 of 5 5
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 o cati 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 site m o nit or. If 
electr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter mi ne d i n a d va nce 
of starti n g t he st u d y.  At a mi ni m u m, s o urce d oc u me nts s h o ul d i ncl u de t he f oll o wi n g 
i nf or mati o n f or eac h s u bject:

S u bject i de ntificati o n ( na me, se x, race/et h nicit y)

D oc u me ntati o n of s u bject eli gi bilit y

Date of i nf or me d c o nse nt

Dates of v isits

D o c u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

Tr ial me dicati o n acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ori es 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 trial c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble

Pre -scree ni n g Q uesti o n naire Res p o nses

Ma nifest Refracti o n a n d B C V A (as nee de d)

C o m plia nce wit h st u d y  a n d st u d y re gi me n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 4 4
P r o t o c o l  -  C l i n i c a l
0 3-Ja n- 2 0 1 7
Pla n ne d a n d u n pla n ne d le ns re place me nt dates
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 eC R F are c o nsiste nt wit h t he ori gi nal s o urce data. 
Electr o nic C R Fs (e C R Fs) will be pr o vi de d t o t he sites; o nl y  desi g nate d i n di vi d uals ma y 
c o m plete t he C R Fs. T he e C R Fs will be s u b mitte d at re g ular i nter vals base d u p o n t he cli nical 
trial v isit 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 

Page 53 of 55
that the eCRFs are accurate and complete. No subject identifiers should be recorded on the 
eCRFs beyond subject number, and demographic information.
Deviations from this protocol, regulatory requirements, and GCP must be recorded in the 
study records. An explanation of the deviation should be included, as applicable. In addition, 
corrective and preventive action should be identified, implemented, and documented within 
the study records.
13.2 Data Review and Clarifications
Targeted eCRF data will be reviewed against the subject’s source data by the study monitors 
according to the SDV plan to ensure completeness and accuracy. After monitoring has 
occurred at the clinical sites 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).
13.4 Clinical Trial Results
All data and discoveries arising out of the study, patentable or non-patentable, shall be the 
sole property of Alcon, Inc. Alcon reserves the right of prior review of any publication or 
presentation of information related to the study. Alcon may use these data now and in the 
future for presentation or publication at Alcon’s discretion or for submission to government 
regulatory agencies.
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14 References
Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye 
Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 
2012;89(10):1435-42.
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15 APPENDIX
Not applicable.
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Version:  
Status:  
Printed By: 
Print Date:  
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2.0; Most-Recent; Effective; CURRENT
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03-Jan-2017