Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



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Investigator Agreement:

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, all applicable regulatory authority regulations, and conditions of approval 
imposed by the reviewing IRB or regulatory authority.

I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations.

I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or 
other sources provided by the Sponsor.

I understand the potential risks and side effects of the investigational product(s).

I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection.

I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies.

I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments.
Have you ever been disqualified as an Investigator by any Regulatory Authority?
No        Yes
Have you ever been involved in a study or other research that was terminated?
No        Yes
If yes, please explain here:
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
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Table of Contents
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................5
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................13
5
INTRODUCTION.............................................................................................................23
5.1
Rationale and Background ................................................................................23
5.2
Purpose of the Study..........................................................................................24
5.3
Risks and Benefits.............................................................................................24
6
STUDY OBJECTIVES......................................................................................................25
6.1
Primary Objective(s) .........................................................................................25
6.2
Secondary Objective(s) .....................................................................................25
6.4
Safety Objective(s)............................................................................................26
7
INVESTIGATIONAL PLAN ............................................................................................26
7.1
Study Design .....................................................................................................26
8
STUDY POPULATION ....................................................................................................28
8.1
Inclusion Criteria...............................................................................................28
8.2
Exclusion Criteria..............................................................................................29
8.3
Rescreening of Subjects ....................................................................................31
9
TREATMENTS ADMINISTERED...................................................................................31
9.1
Investigational Product(s)..................................................................................31
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9.3
Treatment Assignment/Randomization .............................................................36
9.4
Treatment masking ............................................................................................37
9.5
Accountability Procedures.................................................................................39
9.6
Changes to concomitant medications, treatments/ procedures..........................39
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................40
10.1
Informed Consent and Screening ......................................................................41
10.2
Description of Study Procedures and Assessments...........................................41
10.2.1
Demographics....................................................................................41
10.2.2
Medical History and Concomitant Medications................................41
10.2.3
Investigational Product compliance ..................................................41
10.2.4
Adverse Event Collection: Safety Assessment..................................42
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................42
10.2.6
Device Deficiencies: Safety Assessment...........................................42
10.2.7
Visual Acuity: Effectiveness Assessment..........................................42
10.5
Discontinued Subjects .......................................................................................43
10.5.1
Screen Failures ..................................................................................43
10.5.2
Discontinuations................................................................................44
10.5.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................44
10.6
Clinical Study Termination................................................................................44
10.6.1
Follow-up of subjects after study participation has ended ................45
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................45
11.1
General Information ..........................................................................................45
11.2
Monitoring for AEs............................................................................................48
11.3
Procedures for Recording and Reporting ..........................................................48
11.5
Unmasking of the Study Treatment...................................................................51
11.6
Follow-Up of Subjects with AEs.......................................................................51
11.7
Pregnancy in the Clinical Study........................................................................51
12 ANALYSIS PLAN ............................................................................................................52
12.1
Subject Evaluability...........................................................................................52
12.2
Analysis Sets .....................................................................................................52
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12.2.1
Safety Analysis Set............................................................................52
12.2.2
Full Analysis Set................................................................................52
12.2.3
Per Protocol Analysis Set ..................................................................53
12.3
Demographic and Baseline Characteristics.......................................................53
12.4
Effectiveness Analyses ......................................................................................53
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................53
12.4.1.1
Statistical Hypotheses........................................................53
12.4.1.2
Analysis Methods ..............................................................54
12.4.2
Analysis of Secondary Effectiveness Endpoints ...............................54
12.4.2.1
Statistical Hypotheses........................................................54
12.4.2.2
Analysis Methods ..............................................................54
12.6
Safety Analyses .................................................................................................56
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................57
13.1
Subject Confidentiality......................................................................................57
13.2
Completion of Source Documents and Case Report Forms..............................58
13.3
Data Review and Clarifications.........................................................................59
13.4
Sponsor and Monitoring Responsibilities .........................................................59
13.5
Regulatory Documentation and Records Retention ..........................................60
13.6
Quality Assurance and Quality Control.............................................................60
14 ETHICS .............................................................................................................................60
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................11
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Table 3–1
Schedule of Study Procedures and Assessments .............................................20
Table 6–1
Primary Objective(s)........................................................................................25
Table 6–2
Secondary Objective(s)....................................................................................25
Table 6–4
Safety Objective(s)...........................................................................................26
Table 9–1
Test Product .....................................................................................................31
Table 9–2
Control Product................................................................................................34
List of Figures
Figure 7-1
Flowchart of Study Visits.................................................................................27
Figure 11–1
Categorization of All AEs................................................................................45
Figure 11–2
Categorization of All SAE ...............................................................................46
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1
GLOSSARY OF TERMS
Names of test product(s)
Throughout this document, test product(s) will be referred to 
as 
soft contact lenses or 
contact lenses 
Name of Control Product(s)
CooperVision® BIOFINITY® (comfilcon A) soft contact 
lenses (Biofinity contact lenses or Biofinity)
Adverse Device Effect
(ADE)
Adverse event related to the use of an investigational 
medical device (test product) or control product. 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 product or 
control product.
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 product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
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.
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Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
Enrolled Subject
Any subject who signs an informed consent form for 
participation in the study.
Interventional Clinical Trial
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of
data.
Investigational Product (IP)
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form.
Malfunction
Failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Randomized Subjects
Any subject who is assigned a randomized treatment.
Serious Adverse Device 
Effect (SADE)
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
Serious Adverse Event 
(SAE)
Adverse event that led to any of the following:

Death.
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
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 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.
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.
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
Fetal distress, fetal death, or a congenital abnormality 
or birth defect.
Refer to Section 11 for additional SAEs.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks.
Refer to Section 11 for additional Significant Non-Serious 
AEs.
Unanticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk 
management file.
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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Abbreviation
Definition
OS
Left eye
OU
Both eyes
PP
Per protocol analysis set
SADE 
Serious adverse device effect
SAE 
Serious adverse event
SD
Standard deviation
SiHy 
Silicone hydrogel
SOP
Standard operating procedure
UCDVA
Uncorrected distance visual acuity
US / USA
United States of America
USV
Unscheduled visit
VA 
Visual acuity
vs
Versus 
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 All study lenses will be worn for at least 5 days per week and 
8 hours per day in a daily wear modality (eg, will not be worn while sleeping). 
 
. Regardless of whether the subject is randomized to the test or the control 
group, CLEAR CARE Cleaning & Disinfecting Solution (CLEAR CARE) must be used for 
cleaning and disinfection. 
 
 
 
 
 
 
 
 
 
Investigational 
product type
Medical Device
Study type
Interventional
Investigational 
products
Test Product: 
 soft contact lens
Control Product: Biofinity soft contact lens
Purpose and 
rationale
The purpose of this clinical study is to evaluate the safety and 
performance of the investigational 
 soft contact lens 
compared to the commercially available Biofinity soft contact 
lens, when worn in a daily wear modality, by assessing visual 
acuity as the primary endpoint.
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Objective(s)
The primary effectiveness objective is to demonstrate 
noninferiority of 
 compared to Biofinity in CLCDVA at 
Week 1 Follow-up.
The secondary effectiveness objective is to demonstrate 
noninferiority of 
 compared to Biofinity in the percentage 
of subjects achieving CLCDVA 20/20 or better, in each eye, at 
Week 1 Follow-up.
Endpoint(s)
Primary Effectiveness

Mean contact lens corrected distance visual acuity 
(CLCDVA, Snellen converted to logMAR) in each eye at 
Week 1 Follow-up 
Secondary Effectiveness

Percentage of subjects achieving CLCDVA 20/20 or better 
in each eye, at Week 1 Follow-up
 
 
 
 
 
 
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Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessment(s)
Effectiveness

VA with study lenses (Snellen distance)
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Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
This will be a prospective, randomized,
 
controlled, double-masked, parallel-group, daily wear 
clinical study. Subject participation in the study will be 
approximately 3 – 4 months with approximately 3 months of 
exposure to study lenses.
Subject population
Volunteer subjects aged 18 or over who are adapted daily wear 
frequent replacement soft contact lens wearers, excluding Biofinity 
habitual wearers, have at least 3 months of soft contact lens 
wearing experience, and who wear their habitual lenses at least 
5 days per week and at least 8 hours per day. 
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)

Successful wear of spherical daily wear frequent 
replacement soft contact lenses for distance correction in 
both eyes during the past 3 months for a minimum of 5 days 
per week and 8 hours per day

Manifest cylinder ≤ 0.75 D in each eye
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
Best spectacle corrected visual acuity (using manifest 
refraction) of 20/20 or better in each eye
 
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night per 
week) over the last 3 months prior to enrollment

Monovision or multifocal contact lens wearers

Habitually wearing Biofinity lenses
Data analysis 
 
 
To address the primary and secondary effectiveness objectives, 
data from a pre-determined subset of subjects (see Section 12) 
from CLY935-C010 will be combined with the current study, and 
all planned analyses will be performed on this combined set as 
summarized below:
Endpoint
Comparison
Statistical Method 
Primary
Mean CLCDVA
(Week 1
Follow-up)
vs Biofinity
Noninferiority 
(margin = 
0.10 logMAR)
Mixed effects 
repeated measures 
model
Secondary
Proportion of
subjects with
CLCDVA of 20/20
or better in both
eyes (Week 1
Follow-up)
vs Biofinity 
Noninferiority
(margin = 0.10)
Generalized linear 
mixed model
 
No inferential testing will be carried out for safety endpoints.
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 Biofinity, daily wear, 
Associated materials
CLEAR CARE will be used for daily cleaning and disinfection.
 
 
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.
Refer to the IB for additional information.
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority of 
 
compared to Biofinity in CLCDVA at 
Week 1 Follow-up.
Mean CLCDVA in each eye at Week 1 
Follow-up.
6.2
Secondary Objective(s)
Table 6–2
Secondary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority of 
 
compared to Biofinity in the percentage of 
subjects achieving CLCDVA 20/20 or better 
in each eye, at Week 1 Follow-up.
Percentage of subjects achieving CLCDVA 
20/20 or better in each eye at Week 1 
Follow-up.
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6.4
Safety Objective(s)
Table 6–3
Safety Objective(s)
Objective(s)
Endpoint(s)
Duty of care and evaluation of safety profile 
of the investigational products.
AEs
Biomicroscopy findings
Device deficiencies
7
INVESTIGATIONAL PLAN
7.1
Study Design
This will be a prospective, randomized,
 controlled, double-
masked, parallel-group, daily wear clinical study.
This clinical study will engage approximately 16 clinic sites to enroll approximately 
160 subjects with approximately 10 - 15 subjects per site. 
Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 
Follow-up, Month 1 Follow-up, and Month 3 Follow up/Exit. The total expected duration of 
participation for each subject is approximately 3-4 months with approximately 3 months of 
exposure to study lenses in this daily wear study. Subjects will be randomized to wear either 
the test 
contact lenses in both eyes or the control Biofinity contact lenses in both 
eyes.
Following randomization, study lenses will be dispensed to the subject.
 
 
Subjects will wear the lenses while awake in a daily wear modality. CLEAR CARE will be 
used for daily cleaning and disinfection. 
 
 
 
.
 
 
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8
STUDY POPULATION
The study population consists of adult male or female subjects (aged 18 or over), with 
non-diseased eyes, who require optical correction for refractive ametropia
 
 
 
The intended study population consists of volunteer subjects who are frequent replacement 
daily wear soft contact lens wearers, excluding Biofinity habitual wearers, who have at least 
3 months of contact lens wearing experience, and who wear their habitual lenses at least 
5 days per week and 8 hours per day. 
 
 
 
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
At least 18 years of age.
2.
Able to understand and sign an IRB/IEC approved Informed Consent form.
3.
Willing and able to attend all scheduled study visits as required per protocol.
4.
Successful wear of frequent replacement spherical daily wear soft contact lenses for 
distance correction in both eyes during the past 3 months for a minimum of 5 days 
per week and 8 hours per day.
5.
Manifest cylinder ≤ 0.75 D in each eye.
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12.
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment.
 
14.
Monovision or multifocal contact lens wearers.
 
 
 
18.
Any habitual wear of Biofinity lenses.
 
 
.
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Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. 
 
 
 
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
soft contact lenses
Control Product(s) (If applicable):
Biofinity (comfilcon A) soft contact lenses
Table 9–1
Test Product
Test Product
soft contact lenses (
 contact lens) (LID018869)
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
The intended use of this contact lens is for vision correction.
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Storage conditions
Stored at room temperature.
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Table 9–2
Control Product
Control Product(s)
Biofinity (comfilcon A) soft contact lenses (Biofinity contact lens)
(LID010221)
Manufacturer
CooperVision
Indication for Use
The intended use of this contact lens is for vision correction.
Product description 
and parameters 
available for this 
study

Material: comfilcon A

Water content: 48%
 

Base curve: 8.6 mm

Diameter: 14.0 mm
Formulation
Silicone Hydrogel. Additional details can be found in the Biofinity 
package insert.
Usage

Wear:
o
Daily Wear

During waking hours only.
 
 
o
Bilateral

Exposure: At least ~8 hours per day and ~5 days per week over 
a ~3-month exposure period.
 
 
 
 
 
 
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
Lens Care: CLEAR CARE (mandatory), 
 

 
Number/Amount of 
Product to be 
Provided to the 
subject
At each study visit, sites will ensure that subjects are given adequate 
lenses to last until the next planned study visit, allowing for planned 
and unplanned lens replacements.
Packaging 
description
Blister foil pack.
Storage conditions
Stored at room temperature.
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More information on the test product can be found in the IB; information on the control 
product can be found in the Package Insert. 
 
 
 
9.3
Treatment Assignment/Randomization
Subjects will be randomized in a 2:1 manner to receive either the 
 or Biofinity 
contact lenses, respectively. 
 
 
 
 
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10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2 Description of Study Procedures and Assessments
 
 
.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History and Concomitant Medications
Collect medical history information, 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. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications.
10.2.3 Investigational Product compliance
Review subject compliance with the IP usage 
 
 
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10.5.2 Discontinuations
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after signing the informed consent. 
Subject numbers of discontinued subjects must not be re-used.
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
Investigator, continued treatment poses a risk to their health.
 
 
 
 
 
 
 
 
10.6 Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time.
If the clinical study is prematurely terminated or suspended by the Study Sponsor: 

The Study Sponsor must:
o
Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination.
o
Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension. 
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
Hypopyon

Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥ 50% of corneal surface area
Significant Non-Serious AE
A significant non-serious AE is a device-related, non-sight threatening AE that warrants 
discontinuation of any contact lens wear for greater than or equal to 2 weeks. In addition, the 
Investigator must report any occurrence of the following as a Significant Non-Serious 
Adverse Event:

Peripheral non-progressive non-infectious ulcers

All symptomatic corneal infiltrative events

Corneal staining score greater than or equal to Grade 3 
 

Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks

Neovascularization score greater than or equal to Grade 2 
 
 
 
Device Deficiencies
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with subject harm (ie, ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The Investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any 
subject harm separately. 
 
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11.2 Monitoring for AEs
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
 
 
 
 
 
11.3 Procedures for Recording and Reporting
AEs are collected from the time of informed consent.
 
 
 
 
 
 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and control products on the Device Deficiency eCRF.
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
ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the Investigator’s or site’s awareness.

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the Investigator’s or site’s awareness.

A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.

Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.

Document all relevant information from Discharge Summary, Autopsy Report, 
Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF.
 
 
.
 
 
 
 
 
 
 
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:
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11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. 
 
 
 
 
 
 
11.6 Follow-Up of Subjects with AEs
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. 
 
 
 
 
 
 
 
 
 
11.7 Pregnancy in the Clinical Study
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. 
 
 
 
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12 ANALYSIS PLAN
Data from a subset of subjects in the CLY935-C010 study will be combined with data from 
this study. This combined set will serve as the basis for all planned analyses for the primary 
and secondary effectiveness objectives. Subjects in CLY935-C010 will be included in the 
combined set only if they satisfy the following criterion:

BCVA of 20/20 or better in each eye at the Screening/Baseline/Dispense Visit
 
 
 
 
 
 
.
12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked treatment 
(lens) assignment and locking the database, 
 
12.2 Analysis Sets
12.2.1 Safety Analysis Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis.
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses
evaluated in this study, 
For treatment-emergent safety analyses, subjects/eyes will be categorized 
under the actual study lenses exposed.
12.2.2 Full Analysis Set
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study
lenses evaluated in this study, 
, and who have at least one 
post-baseline (post-Dispense) CLCDVA.
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12.2.3 Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that have 
met any of the critical deviation or evaluability criteria identified in the DEP.
12.3 Demographic and Baseline Characteristics
Demographic information, recent lens-wearing experience (including wear modality and 
wear success), and habitual lens information will be presented by lens group and overall.
Counts and percentages will be presented for categorical variables such as sex, age group, 
race, an ethnicity. Number of observations, mean, SD, median, minimum, and maximum will 
be presented for continuous variables such as age.
12.4 Effectiveness Analyses
This study defines 1 primary, 1 secondary,
 
 
 
 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary effectiveness objective is to demonstrate noninferiority of 
 compared to 
Biofinity in mean CLCDVA at Week 1 Follow-up.
The primary endpoint is the mean CLCDVA at Week 1 Follow-up. The corresponding 
assessment is collected with study lenses, in Snellen, for each eye. Conversion will be made 
to the logMAR scale. 
12.4.1.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 
(in logMAR scale) for noninferiority:
H0: μ(T) − μ(C) ≥ 0.10
Ha: μ(T) − μ(C) < 0.10
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where μ(T) and μ(C) denote the Week 1 Follow-up mean CLCDVA for 
and Biofinity 
contact lenses, respectively, on the logMAR scale.
12.4.1.2 Analysis Methods
A mixed effects repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, visit (Dispense, Week 1 Follow-up, Month 1 Follow-up, and 
Month 3 Follow-up), and lens-by-visit interaction as fixed effects,
 
 Within-subject correlation due to eye will 
also be accounted for in the model. Lens difference (
minus Biofinity) and the 
corresponding two-sided 95% CI will be computed for 1-Week Follow-up. Noninferiority in 
CLCDVA will be declared if the upper confidence limit is less than 0.10.
12.4.2 Analysis of Secondary Effectiveness Endpoints
The secondary effectiveness objective is to demonstrate noninferiority of 
 compared 
to Biofinity in the percentage of subjects achieving distance VA 20/20 or better, in each eye, 
at Week 1 Follow-up.
The corresponding endpoint is the percentage (proportion) of subjects with CLCDVA of 
20/20 or better, measured monocularly, in both OD and OS at Week 1 Follow-up.
12.4.2.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 
(10%) for noninferiority.
H0: P(T) – P(C) ≤ -0.10
Ha: P(T) – P(C) > -0.10
where P(T) and P(C) denote the proportion of subjects attaining at least 20/20 in CLCDVA at
Week 1 Follow-up in each eye (OD and OS) for 
and Biofinity contact lenses, 
respectively.
12.4.2.2 Analysis Methods
A binary variable will be defined for each subject to indicate whether the CLCDVA at Week 1 
Follow-up is no worse than 20/20 in both OD and OS, and the corresponding proportion will 
be computed for each lens using the number of subjects as the denominator.
 
 
. From the two-sided 95% CI on the lens difference (
 minus Biofinity), 
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noninferiority in proportion of subjects achieving 20/20 or better in CLCDVA in both eyes 
will be declared if the lower confidence limit is greater than -0.10.
 
 
 
 
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12.6 Safety Analyses
The safety endpoints are:

AEs

Biomicroscopy Findings

Device Deficiencies
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of AE as well as the other listed 
parameters.
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs 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 IP.
 
 
 
 
 
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Two listings for device deficiencies, prior to exposure of study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated.
No inferential testing will be done for safety analysis.
 
 
 
 
 
 
 
 
 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Subject Confidentiality
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.
 
. 
 
 
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13.2 Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site
monitors are appointed by the Study Sponsor and are independent of study site staff.
 
 
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13.5 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. 
 
 
 
 
 
 
13.6 Quality Assurance and Quality Control
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study 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 Study 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.
14 ETHICS
 
 
 
 
 
 
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
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corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited.
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 IRB/IEC. 
 
 
 
 
 
 
 
Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject. The Investigator must have a defined process for obtaining consent. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
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made publicly available on www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.
 
 
 
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Signature Page for V-CLN-0000052 v1.0
Signature Page for V-CLN-0000052 v1.0