Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens
Phase: NA
Conditions: Refractive Errors, Myopia, Hyperopia
Sponsor: Alcon Research



Page 2 of 63
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
Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens ...................................................1
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 .............................................................................................................24
5.1
Rationale and Background..................................................................................24
5.2
Purpose of the Study...........................................................................................24
5.3
Risks and Benefits...............................................................................................25
6
STUDY OBJECTIVES......................................................................................................26
6.1
Primary Objective(s)...........................................................................................26
6.2
Secondary Objective(s).......................................................................................26
6.4
Safety Objective(s)..............................................................................................26
7
INVESTIGATIONAL PLAN ............................................................................................27
7.1
Study Design.......................................................................................................27
7.4
Rationale for Choice of Control Product ............................................................28
7.5
Data Monitoring Committee...............................................................................29
8
STUDY POPULATION.....................................................................................................29
8.1
Inclusion Criteria ................................................................................................29
8.2
Exclusion Criteria ...............................................................................................30
8.3
Rescreening of Subjects......................................................................................32
9
TREATMENTS ADMINISTERED...................................................................................32
9.1
Investigational Product(s)...................................................................................32
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9.3
Treatment Assignment / Randomization.............................................................37
9.4
Treatment Masking .............................................................................................38
9.5
Accountability Procedures..................................................................................40
9.6
Changes to Concomitant Medications, Treatments/ Procedures.........................41
10 STUDY PROCEDURES AND ASSESSMENTS .............................................................41
10.1 Informed Consent and Screening........................................................................42
10.2 Description of Study Procedures and Assessments ............................................42
10.2.1
Demographics ...................................................................................43
10.2.2
Medical History and Concomitant Medications ...............................43
10.2.3
Investigational Product Compliance.................................................43
10.2.4
Adverse Event Collection: Safety Assessment .................................43
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment.................................43
10.2.6
Device Deficiencies: Safety Assessment ..........................................43
10.4 Discontinued Subjects.........................................................................................44
10.4.1
Screen Failures..................................................................................44
10.4.2
Discontinuations ...............................................................................45
10.4.3
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ......................................45
10.5 Clinical Study Termination.................................................................................45
10.5.1
Follow-Up of Subjects After Study Participation Has Ended...........46
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES....................................................46
11.1 General Information............................................................................................46
11.2 Monitoring for AEs.............................................................................................49
11.3 Procedures for Recording and Reporting............................................................49
11.5 Unmasking of the Study Treatment ....................................................................52
11.6 Follow-Up of Subjects with AEs ........................................................................52
11.7 Pregnancy in the Clinical Study..........................................................................52
12 ANALYSIS PLAN.............................................................................................................53
12.1 Subject Evaluability............................................................................................53
12.2 Analysis Sets.......................................................................................................53
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12.2.1
Safety Analysis Set ...........................................................................53
12.2.2
Full Analysis Set ...............................................................................53
12.2.3
Per Protocol Analysis Set..................................................................54
12.3 Demographic and Baseline Characteristics ........................................................54
12.4 Effectiveness Analyses........................................................................................54
12.4.1
Analysis of Primary Effectiveness Endpoint(s)................................54
12.4.1.1
Statistical Hypotheses..........................................................54
12.4.1.2
Analysis Methods................................................................55
12.4.2
Analysis of Secondary Effectiveness Endpoint ................................55
12.4.2.1
Statistical Hypotheses..........................................................55
12.4.2.2
Analysis Methods................................................................55
12.5 Handling of Missing Data...................................................................................57
12.6 Safety Analyses...................................................................................................57
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................58
13.1 Subject Confidentiality .......................................................................................58
13.2 Completion of Source Documents and Case Report Forms ...............................59
13.3 Data Review and Clarifications ..........................................................................60
13.4 Sponsor and Monitoring Responsibilities...........................................................60
13.5 Regulatory Documentation and Records Retention............................................61
13.6 Quality Assurance and Quality Control..............................................................61
14 ETHICS..............................................................................................................................61
15 REFERENCES ..................................................................................................................63
15.1 References Applicable for All Clinical Studies ..................................................63
15.1.1
US References Applicable for Clinical Studies ................................63
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)........................................................................................26
Table 6–2
Secondary Objective(s)....................................................................................26
Table 6–3
Safety Objective(s)...........................................................................................26
Table 9–1
Test Product .....................................................................................................32
Table 9–2
Control Product................................................................................................35
List of Figures
Figure 7-1
Flowchart of Study Visits.................................................................................28
Figure 11–1
Categorization of All AEs................................................................................46
Figure 11–2
Categorization of All SAE ...............................................................................47
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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
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
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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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 demonstrate 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.
Objective(s)
The primary effectiveness objective is to demonstrate 
noninferiority 
 
 compared to Biofinity in CLCDVA at 
Week 1 Follow-up.
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The secondary effectiveness objective is to demonstrate 
noninferiority 
 
 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 VA 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 14 weeks 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.

Best spectacle corrected visual acuity 20/20 or better in 
each eye.
 
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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 contact lens wearers

Habitually wearing Biofinity lenses
Data analysis and 
sample size 
justification
To address the primary and secondary effectiveness objectives, 
data from a pre-determined subset of subjects (see section 12) 
from CLL949-C009 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
 
 
 
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Key words
 Biofinity, daily wear,
Associated materials
CLEAR CARE Cleaning & Disinfecting Solution will be used for 
daily cleaning and disinfection.
 
 
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6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority 
 
 
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 
 
 
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.
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
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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 14-17 clinic sites to enroll approximately 
252 subjects with approximately 15-21 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 months 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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Figure 7-1
Flowchart of Study Visits
 
 
 
 
 
 
 
 
7.4
Rationale for Choice of Control Product
The Biofinity contact lens was chosen as the control product because this lens is a proper 
device to compare to 
 contact lens with regard to effectiveness and safety. Both the 
 contact lens and Biofinity contact lens are frequent replacement SiHy lenses and are 
to be prescribed for daily wear. The Biofinity contact lenses are indicated for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with 
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non-diseased eyes. The lenses are intended to be cleaned and disinfected daily when worn for 
daily wear and replaced monthly.
7.5
Data Monitoring Committee
Not Applicable
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 will be considered enrolled in the 
study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be at least 18 years of age.
2.
Subject must be able to understand and sign an IRB/IEC approved Informed 
Consent form.
3.
Willing and able to attend all scheduled study visits and wear the assigned study 
lenses as required per protocol.
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11.
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.
 
13.
Monovision wearers.
 
 
 
17.
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):
CooperVision® BIOFINITY® (comfilcon A) soft 
contact lenses
Table 9–1
Test Product
Test Product
 soft contact lenses 
(LID015385)
Manufacturer
Alcon Vision, LLC
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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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.
 
 
 
 
 

Lens Care/Accessories: CLEAR CARE (mandatory)
 
 
 
 
 
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Packaging 
description
Blister foil pack
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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 (target)

Diameter: 14.0 mm (target)
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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At Visit 1, all eligible subjects will be randomized 
 to one 
of the treatment arms. 
 
 
 
 
9.4
Treatment Masking
This study is double-masked, with subjects randomized to use 
or Biofinity contact 
lenses for the duration of the 3-month treatment period. 
 
 
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9.5
Accountability Procedures
It is the Investigator’s responsibility to ensure that:

All study products are accounted for and not used in any unauthorized manner

All unused products are available for return to the Study Sponsor, as directed

Any study lenses associated with a device deficiency or with any product-related AE 
(ie, ADE or SADE) are returned to the Study Sponsor for investigation, unless 
otherwise directed by the Sponsor. Refer to Section 11 of this protocol for additional 
information on the reporting of device deficiencies and AEs 
 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, 
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9.6
Changes to Concomitant Medications, Treatments/ Procedures
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about:

Any new medications 

Alterations in dose or dose schedules for current medications, 

Any medical procedure or hospitalization that occurred or is planned

Any non-drug therapies (including physical therapy and blood transfusions). 
The Investigator must document this information in the subject’s case history source 
documents.
10 STUDY PROCEDURES AND ASSESSMENTS
Subjects will be expected to attend 4 office visits, as shown below.
Visit #
Visit Type
Visit Day
Visit Window
Visit 1
Screening / Baseline / Dispense
Day 1
N/A
Visit 2
Week 1 Follow-up Visit
Day 7
Visit 3
Month 1 Follow-up Visit
Day 30
Visit 4
Month 3 Follow-up / Exit Visit
Day 95
 
 
 
 
 
 
 
 
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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 study lenses usage 
 
10.2.4 Adverse Event Collection: Safety Assessment
Assess and record any AEs that are observed or reported, including those associated with 
changes in concomitant medication dosing since the previous visit. Requirements for 
reporting AEs in the study can be found in Section 11.
10.2.5 Slit-Lamp Biomicroscopy: Safety Assessment
Slit-lamp examination of the cornea, iris/anterior chamber, and lens must be performed in 
both eyes before instillation of any diagnostic eye drops.
10.2.6 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11.
 
 
 
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10.4 Discontinued Subjects
10.4.1 Screen Failures
Screen failures are subjects who were excluded from the study after signing the informed 
consent, not meeting the inclusion/exclusion criteria, and prior to randomization to 
product/dispense of study product. 
The Investigator must document the reason for screen failure in the subject’s case history 
source documents.
Subject numbers must not be re-used.
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10.4.2 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.
 
 
 
 
 
 
 
 
10.5 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. Examples of device deficiencies include the following: 
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
Failure to meet product specifications (eg, incorrect lens power/diameter/base 
curve/color)

Lens cloudy

Lens surface/edge defect 

Torn lens during handling/in pack

Packaging deficit (eg, mislabeled product)

Suspect product contamination

Lack of performance
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. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF.
 
 
 
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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Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
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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 CLL949-C009 study will be combined with data from 
this study. This combined set will serve as the basis for all analyses detailed in this section. 
Subjects in CLL949-C009 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, based upon the Deviations and Evaluability Plan 
(DEP).
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 
, 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
 
 
 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary effectiveness objective is to demonstrate noninferiority 
 
 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, protocol as a random 
effect and baseline best corrected distance VA as a covariate. 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 CLCDA will be declared if the upper confidence limit is less than 0.10.
12.4.2
Analysis of Secondary Effectiveness Endpoint
The secondary effectiveness objective is to demonstrate noninferiority 
 
 compared 
to Biofinity in the percentage of subjects achieving CLCDVA 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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12.5 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 primary and secondary effectiveness analyses.
Incidence and reasons for discontinuation by lens group will be tabulated at each visit and 
overall.
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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13.3 Data Review and Clarifications
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF.
13.4 Sponsor and Monitoring Responsibilities
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements.
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site.
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 
Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role.
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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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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15 REFERENCES
15.1 References Applicable for All Clinical Studies

ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products -
Guidance for clinical investigations

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice
 
15.1.1 US References Applicable for Clinical Studies

21 CFR Part 11 - Electronic Records; Electronic Signatures

21 CFR Part 50 - Protection of Human Subjects

21 CFR Part 56 - Institutional Review Boards

21 CFR Part 812 - Investigational Device Exemptions

21 CFR Part 54 - Financial Disclosure by Clinical Investigators

The California Bill of Rights
 
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