Clinical Safety and Effectiveness Assessment of an Investigational Frequent Replacement Silicone Hydrogel Lens
Phase: NA
Conditions: Refractive Ametropia
Sponsor: Alcon Research



Page 2 of 78
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, and any conditions of approval imposed by the Institutional Review Board 
and/or the FDA, and all applicable regulatory requirements including 21 CFR 
Parts 50 (Protection of Human Subjects), 54 (Financial Disclosure), 56 (Institutional 
Review Boards), and 812 (Investigational Device Exemptions).

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 Safety and Effectiveness Assessment of an Investigational Frequent Replacement 
Silicone Hydrogel Lens .......................................................................................................1
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................6
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................12
4
PROTOCOL AMENDMENTS .........................................................................................24
5
INTRODUCTION.............................................................................................................38
5.1
Rationale and Background ................................................................................38
5.2
Purpose of the Study..........................................................................................38
5.3
Risks and Benefits.............................................................................................39
6
STUDY OBJECTIVES......................................................................................................40
6.1
Primary Objective(s) .........................................................................................40
6.2
Secondary Objective(s) .....................................................................................40
6.4
Other Safety Objective(s)..................................................................................40
7
INVESTIGATIONAL PLAN ............................................................................................40
7.1
Study Design .....................................................................................................40
7.2
Rationale for Study Design ...............................................................................42
7.3
Rationale for Duration of Treatment/Follow-Up...............................................42
7.4
Rationale for Choice of Control Product...........................................................43
7.5
Data Monitoring Committee..............................................................................43
8
STUDY POPULATION ....................................................................................................43
8.1
Inclusion Criteria...............................................................................................44
8.2
Exclusion Criteria..............................................................................................45
8.3
Rescreening of Subjects ....................................................................................46
9
TREATMENTS ADMINISTERED...................................................................................46
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9.1
Investigational Product(s)..................................................................................46
9.2
Other Medical Device or Medication Specified for Use During the Study ......51
9.3
Treatment Assignment / Randomization ...........................................................51
9.4
Treatment masking ............................................................................................52
9.5
Accountability Procedures.................................................................................54
9.6
Changes to concomitant medications, treatments/ procedures..........................54
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................55
10.1
Informed Consent and Screening ......................................................................56
10.2
Description of Study Procedures and Assessments...........................................56
10.2.1
Demographics....................................................................................57
10.2.2
Medical History.................................................................................57
10.2.3
Investigational Product compliance ..................................................57
10.2.4
Adverse Event Collection: Safety Assessment..................................57
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................57
10.2.6
Device Deficiencies: Safety Assessment...........................................57
10.3
Additional Study Assessments: Effectiveness and Safety Assessment .............57
10.4
Unscheduled Visits ............................................................................................59
10.5
Discontinued Subjects .......................................................................................59
10.5.1
Screen Failures ..................................................................................59
10.5.2
Discontinuations................................................................................60
10.5.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................60
10.6
Clinical Study Termination................................................................................60
10.6.1
Follow-up of subjects after study participation has ended ................61
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................61
11.1
General Information ..........................................................................................61
11.2
Monitoring for Adverse Events .........................................................................64
11.3
Procedures for Recording and Reporting ..........................................................64
11.4
Return product analysis .....................................................................................66
11.5
Unmasking of the Study Treatment...................................................................67
11.6
Follow-Up of Subjects with Adverse Events.....................................................67
11.7
Pregnancy in the Clinical Study........................................................................67
12 ANALYSIS PLAN ............................................................................................................68
12.1
Subject Evaluability...........................................................................................68
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12.2
Analysis Sets .....................................................................................................68
12.3
Demographic and Baseline Characteristics.......................................................68
12.4
Effectiveness Analyses ......................................................................................68
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................69
12.4.1.1
Statistical Hypotheses........................................................69
12.4.1.2
Analysis Methods ..............................................................69
12.6
Safety Analyses .................................................................................................70
12.6.1
Analysis of Primary Safety Endpoint(s)............................................70
12.6.1.1
Statistical Hypotheses........................................................71
12.6.1.2
Analysis Methods ..............................................................71
12.6.2
Analysis of Other Safety Endpoints ..................................................71
12.6.2.1
Statistical Hypotheses........................................................71
12.6.2.2
Analysis Methods ..............................................................71
12.7
Interim Analyses and Reporting........................................................................72
12.8
Sample Size Justification...................................................................................72
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................72
13.1
Subject Confidentiality......................................................................................72
13.2
Completion of Source Documents and Case Report Forms..............................73
13.3
Data Review and Clarifications.........................................................................74
13.4
Sponsor and Monitoring Responsibilities .........................................................74
13.5
Regulatory Documentation and Records Retention ..........................................75
13.6
Quality Assurance and Quality Control.............................................................75
14 ETHICS .............................................................................................................................75
15 REFERENCES ..................................................................................................................77
15.1
References applicable for all clinical studies ....................................................77
15.1.1
US references applicable for clinical studies.....................................77
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List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................11
Table 3–1
Schedule of Study Procedures and Assessmentsα............................................20
Table 6–1
Primary Objective(s)........................................................................................40
Table 6–2
Other Safety Objective(s) ................................................................................40
Table 9–1
Test Product .....................................................................................................46
Table 9–2
Control Product................................................................................................49
Table 10–1
Study Visits ......................................................................................................55
Table 12–1
Historical Extended Wear Study AE Rates......................................................72
List of Figures
Figure 7-1
Flowchart of Study Visits.................................................................................42
Figure 11–1
Categorization of All Adverse Events..............................................................61
Figure 11–2
Categorization of All Serious Adverse Events.................................................62
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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® 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.
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
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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.

Fetal distress, fetal death, or a congenital abnormality 
or birth defect.
Refer to Section 11 for additional SAEs.
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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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2
LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
ADE 
Adverse device effect
AE 
Adverse event
Apps
Applications (ie, smartphone software applications)
 
Biofinity contact lens
Biofinity (comfilcon A) soft contact lenses 
CFR 
Code of Federal Regulations
CLEAR CARE
CLEAR CARE Cleaning & Disinfecting Solution
CLVA
Contact lens corrected visual acuity
COL
Clinical operations lead
CRF
Case report form
CSM
Clinical site manager
CTT
Clinical trial team
d
Days
D 
Diopter(s)
D/C
Discontinue
eCRF 
Electronic case report form
EDC 
Electronic data capture
FDA 
US Food and Drug Administration
GCP 
Good Clinical Practice
hrs
Hours
IB 
Investigator’s brochure
ICF 
Informed consent form
ICH
International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use
IEC 
Independent ethics committee
IP 
Investigational product
IRB 
Institutional review board
IRT
Interactive response technology
ISO 
International Organization for Standardization
LacriPure 
Menicon LacriPure, Preservative Free Saline
 
logMAR
Logarithm of the minimum angle of resolution
contact lens
 soft contact lenses
mm 
Millimeter
MOP
Manual of procedures
N/A 
Not applicable
NCT
National Clinical Trial
OFPM MPDS
OPTI-FREE® PureMoist® Multi-Purpose Disinfecting Solution
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acuity as specified in the inclusion criteria, will then be randomized in a 1:1 manner to either 
receive 
 or Biofinity lenses for use throughout the duration of the study.
Following randomization, study lenses will be dispensed to the subject. Subjects will be 
provided with sufficient lens supplies to follow a weekly replacement schedule until the next 
visit.
All subjects will wear the study lenses in an extended wear modality, while awake and asleep 
for up to 6 nights/7 days of continuous wear with one night of no lens wear. This wearing 
schedule will be repeated throughout the course of the trial. Subjects assigned to 
 or 
Biofinity contact lenses will insert a new pair of study lenses each week and discard them at 
the end of the week.
Problem lenses (if any) will not be discarded but collected by the subject and returned to the 
investigational site. Regardless of whether the subject is randomized to the test or the control 
group, CLEAR CARE® Cleaning & Disinfecting Solution (CLEAR CARE) and Menicon 
LacriPure, Rinsing & Insertion Saline (LacriPure or equivalent) will be permitted for use if 
the subject must remove the lens for any reason. Systane® Preservative-Free Eye Drops 
(Systane) will also be permitted but should only be used if necessary and is the only product 
permitted for use in the eye.
Investigational 
product type
Device
Study type
Interventional
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Investigational 
products
Test Product: 
soft contact lens
Control Product: Biofinity soft contact lens
Purpose and
rationale
The purpose of this clinical trial is to evaluate the safety and 
performance of the 
 soft contact lens compared to the 
commercially available Biofinitysoft contact lens, by assessing
ocular serious and significant non-serious adverse device effects as 
the primary safety variable and visual acuity as the primary
effectiveness variable.
Objective(s)
The objective of this study is to demonstrate safety and 
effectiveness of 
 soft contact lenses as compared to 
Biofinity soft contact lenses, when both study lenses are worn for 
extended wear (6 nights/7 days of continuous wear followed by 
1 night of no lens wear) and replaced on a weekly basis.
Endpoint(s)
Primary Effectiveness

Distance VA (Snellen)
Primary Safety

Proportion of ocular serious and significant non-serious 
ADEs
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Other Safety

AEs (non-serious, non-significant)

Biomicroscopy findings

Device deficiencies
Assessment(s) 
Effectiveness
Distance VA with study lenses (Snellen)
Distance VA with habitual correction (Snellen)
Manifest refraction
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Safety

AEs

Biomicroscopy findings

Device deficiencies
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Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)

Successful wear of spherical daily wear or extended wear 
frequent replacement soft contact lenses in both eyes 
during the past 3 months for a minimum of 5 days per 
week. Habitual daily or extended wear subjects must have 
regularly worn their lenses for at least 10 hours per day.
Additionally, extended wear lens wearers must have 
regularly worn their lenses for a minimum of 1 night per 
week. 

Manifest cylinder ≤ 0.75 D in each eye.
 
 
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Currently pregnant or breast-feeding

Monovision contact lens wearers
Data analysis and 
sample size 
justification
In adherence to the reporting format as specified in the ISO 
clinical standard and FDA 510(k) guidance documents, 
effectiveness and safety data of the primary cohort will be 
presented separately based upon subject study status of Completed 
or Discontinued.
The primary safety analysis is to assess noninferiority of 
 
contact lenses when compared to Biofinity contact lenses for the 
proportion of ocular serious and significant non-serious ADEs, 
with a pre-defined margin of 0.05 (5%). A generalized linear 
model with a logit link function will be used, and a one-sided 95% 
upper confidence limit (UCL) will be calculated for the difference 
in proportions between treatments (
 minus Biofinity).
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No formal hypotheses are formulated for the primary effectiveness
endpoint of distance VA; hence, no inferential testing will be 
performed. Descriptive summary statistics will be provided for the 
Snellen categories as well as the converted logMAR values. 
The sample size calculation was based on previous extended wear 
clinical studies which evaluated five currently marketed silicone 
hydrogel lenses. Assuming that the expected difference between 
test and control is 0 and that the control proportion is 0.045, a 
sample size of 213 per group will provide 80% power to reject the 
null hypothesis of inferiority in test compared to control, with a 
noninferiority margin of 0.05 (5%).
Key words
 Biofinity, extended wear
Associated materials
CLEAR CARE and LacriPure (or equivalent) will be permitted if 
the subject must remove their lens(es) for any reason. Systane will 
be also be permitted but should only be used if necessary.
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Table 3–1
Schedule of Study Procedures and Assessmentsα
Procedure/Assessment
Baseline
Follow-Up Visits
Exit
Early 
Exit
USV
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7
Visit 8
Visit 9
Day 1
Dispense
24 hrs
Day 2
± 4 hrs
1-week 
Day 7
± 2 d
1-month 
Day 30
± 4 d
2-months 
Day 60
± 7 d
3-months 
Day 90
± 7 d
6-months 
Day 189
-7 / + 14 d
9-months 
Day 270
± 14 d
12-months 
Day 365
± 14 d
Informed Consent

-
-
-
-
-
-
-
-
-
-
Demographics

-
-
-
-
-
-
-
-
-
-
Medical History including
pregnancy1










()
Concomitant Medications










()
Inclusion/Exclusion

-
-
-
-
-
-
-
-
-
-
Habitual lens information 
(brand / manufacturer, 
modality, power, wear success, 
habitual lens care brand) 

-
-
-
-
-
-
-
-
-
-
Distance VA w/ habitual 
correction (Snellen)

-
-
-
-
-
-
-


()
Manifest refraction

()
()
()
()
()
()
()


()
Keratometry

-
-
-
-
-

-


()
Biomicroscopy2











Determine study lens fit and 
power for each eye using 
Sponsor provided trial fitting 
sets. O/R as necessary.

-
-
-
-
-
-
-
-
-
-
Order study lenses 

()
()
()
()
()
()
()
-
-
()
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Procedure/Assessment
Baseline
Follow-Up Visits
Exit
Early 
Exit
USV
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7
Visit 8
Visit 9
Day 1
Dispense
24 hrs
Day 2
± 4 hrs
1-week 
Day 7
± 2 d
1-month 
Day 30
± 4 d
2-months 
Day 60
± 7 d
3-months 
Day 90
± 7 d
6-months 
Day 189
-7 / + 14 d
9-months 
Day 270
± 14 d
12-months 
Day 365
± 14 d
IP Dispense 

()
()
()
()
()
()
()
-
-
()
Distance VA w/ study lenses  
(Snellen)











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Procedure/Assessment
Baseline
Follow-Up Visits
Exit
Early 
Exit
USV
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Visit 6
Visit 7
Visit 8
Visit 9
Day 1
Dispense
24 hrs
Day 2
± 4 hrs
1-week 
Day 7
± 2 d
1-month 
Day 30
± 4 d
2-months 
Day 60
± 7 d
3-months 
Day 90
± 7 d
6-months 
Day 189
-7 / + 14 d
9-months 
Day 270
± 14 d
12-months 
Day 365
± 14 d
Symptoms, problems & 
complaints4











Study lens and accessories 
return log
()









()
Adverse events










()
Device deficiencies










()
Exit Form
()
()
()
()
()
()
()
()


()
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α See Section 26 of the MOP (Manual of Procedures) for a chronological order of procedures per visit
() assessment performed as necessary, eg, decrease of VA by 2 lines or more with IP.
USV=Unscheduled Visit
1 Pregnancy to be self-reported by subject
4 Symptoms, problems, and complaints will include burning/stinging, itching, lens awareness, dryness, discomfort, blurred vision, fluctuating/variable vision, 
halo, lens needs cleaning, redness, excessive tearing, secretions, photophobia, and other (description required). The response will be recorded as “present” or 
“absent”.
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4
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions. 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC.
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At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
5.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Biofinity contact lenses are approved for extended wear for up to 6 nights/7 days 
of continuous wear. Further details on any known potential risks and benefits can be found in 
the package insert.
Material properties and design characteristics of the investigational (not approved by the 
FDA) 
 contact lenses are consistent with successful contact lens wear. To date, 
supportive results from preclinical tests and documented rationale for applicability of test 
results, and the previous clinical studies, described in the IB, provide a basis for the 
anticipated acceptable performance and safety profile of the 
 contact lenses for up to 
6 continuous nights of extended wear with planned weekly replacement in the upcoming 
12-month registration study. This study will evaluate any long term or new risks with the 
extended wear of 
 contact lenses and how these risks compare to a marketed 
extended wear control lens. A summary of the known and potential risks and benefits 
associated with 
 contact lenses is presented in the IB. The potential harms associated 
with on-eye exposure to the new lens materials include toxicity response, blurred vision, and 
ocular discomfort.
Under the conditions of a clinical study, which include compliance with subject selection 
criteria, oversight by study Investigators, adequate informed consent, subject instructions, 
scheduled lens wear/replacement, and frequent follow-up visits, risks to study subjects are 
controlled and minimized. Site personnel will educate subjects on proper hygiene and lens 
handling, and compliance with the use of contact lenses according to the protocol. Subjects 
should be instructed not to wear contact lenses while swimming due to increased risk of 
infection. Site personnel should advise the subjects to remove contact lenses and return for 
prompt follow-up of symptoms such as ocular discomfort, foreign body sensation, excessive 
tearing, vision changes, or hyperemia.
Refer to the IB for additional information.
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6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate safety and effectiveness of the 
 contact lens as compared to 
Biofinity contact lens, when both study 
lenses are worn for extended wear (up to 
6 nights/7 days of continuous wear followed 
by 1 night of no lens wear) and replaced on 
a weekly basis.
Primary Safety

Proportion of ocular serious and 
significant non-serious ADEs
Primary Effectiveness 

Distance VA (Snellen)
6.2
Secondary Objective(s)
Not Applicable
6.3
Exploratory Objective(s)
Not Applicable
6.4
Other Safety Objective(s)
Table 6–2
Other Safety Objective(s)
Objective(s)
Endpoint(s)
Duty of care and evaluation of safety profile 
of the investigational products. 
AEs
Device deficiencies
Biomicroscopy findings
7
INVESTIGATIONAL PLAN
7.1
Study Design
This will be a prospective, randomized, 
 controlled, 
double-masked, parallel-group, extended wear clinical study.
This clinical trial will engage approximately 45 clinic sites to enroll approximately 
812 subjects 
 
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Sites will be identified and notified prior to study start.
Subjects will be expected to attend 9 office visits: Baseline/Dispense, 24-hour follow-up, 
1-week follow-up, 1-month follow-up, 2-month follow-up, 3-month follow-up, 6-month 
follow up, 9-month follow-up and 12-month follow-up/Exit. The total expected duration of 
participation for each subject is approximately 12 months in this extended 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 be 
provided with sufficient lens supplies to follow a weekly replacement schedule until the next 
scheduled visit.
Subjects will wear the lenses while awake and asleep for up to 6 nights/7 days of continuous
wear in an extended wear modality. CLEAR CARE and LacriPure (or equivalent) will be 
permitted if the subject must remove their lens(es) for any reason. Systane will be also 
permitted but should only be used if necessary and is the only product permitted for use in the 
eye.
The study outline is provided in Figure 7-1 below:
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Figure 7-1
Flowchart of Study Visits
7.2
Rationale for Study Design 
In this clinical trial, the safety and performance of the investigational 
 contact lens 
will be compared to the commercially available Biofinity contact lens in a double-masked, 
parallel-group design with approximately 12 months of exposure. The study is designed 
primarily following the recommendations for a new extended wear contact lens material from 
ISO 11980:2012 and the US FDA 510(k) guidance document for reporting format. 
7.3
Rationale for Duration of Treatment/Follow-Up
The duration of exposure and follow-up duration are in compliance with the recommended 
guidance from ISO 11980:2012. 
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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 to attend all scheduled study visits as required per protocol.
4.
Willing and able to wear assigned study lenses as required per protocol.
5.
Successful wear of spherical daily wear or extended wear soft contact lenses in both 
eyes during the past 3 months for a minimum of 5 days per week. Habitual daily 
wear and extended wear subjects must have worn their lenses at least 10 hours per 
day. Additionally, the extended wear lens wearers must have worn their lenses 
overnight at least one night per week.
6.
Manifest cylinder ≤ 0.75 D in each eye.
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8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria are not eligible for participation in this study.
1.
Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the Investigator.
2.
Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the Investigator.
3.
History of ocular or intraocular surgery, including refractive surgery and / or 
irregular cornea; current or previous orthokeratology treatment; or any wear of RGP 
contact lenses in the past 12 months.
9.
Daily disposable contact lens wearers.
11.
Currently pregnant or breast-feeding.
12.
Monovision contact lens wearers.
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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)
(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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Product description 
and parameters 
available for this 
study

Water content target: 55% ±2%

Power range: 
o
-0.50 to -6.00 D (0.25 D steps)
o
Additional powers (provisional): -6.50 to -8.00 D 
(0.50 D steps)
o
+0.50 D to +4.00 D (0.25 D/0.50 D steps)

Base curve target: 8.4 (±0.2 mm)

Diameter: 14.2 mm
Formulation
Silicone hydrogel. Additional details can be found in the 
 
extended wear IB.
Usage

Wear:
o
Extended Wear

Up to 6 nights/7 days continuous wear (awake 
and asleep) and must sleep 1 night without 
lenses.
o
Bilateral

Exposure: ~12 months 

Replacement period: Planned replacement each week over the 
course of the study duration. Subjects will wear a fresh pair of 
lenses in alignment with weekly planned replacement schedule.
o
For planned replacement, lenses will be replaced even if 
one or both of the lenses have not been used for the full 
1-week wearing schedule. 

Lens Care: CLEAR CARE, LacriPure (or equivalent), Systane, 
and OFPM MPDS as needed.

Additional details can be found in the MOP
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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
Labeling description

Lens Foil label includes:
-
identifier
-
base curve
-
diameter
-
manufacturing protocol number
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information

Provided in boxes of up to 18 lenses per power per box, 
identified with the following:
-
a color coded label stating the protocol number
-
identifier
-
power
-
an investigational use only statement
-
tracking number
Storage conditions
Stored at room temperature.
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Supply

Fitting sets and spare lenses will be provided by the Sponsor 
before the start of the trial to be used during Visit 1.

Study lenses will be provided to the site for each subject as per 
the Investigator’s order form. The site will dispense the study 
lenses to the subject at Visit 1, and according to the planned 
lens replacement schedule throughout the study. Refer to the 
MOP for a detailed description.
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%

Power range: 
o
-0.50 to -6.00 D (0.25 D steps)
o
Additional powers (provisional): -6.50 to -8.00 D (0.50 
D steps)
o
+0.50 D to +4.00 D (0.25 D/ 0.50 D steps)

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
Extended Wear –

Up to 6 nights/7 days continuous wear (awake 
and asleep) and must sleep 1 night without 
lenses.
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o
Bilateral

Exposure: ~12 months 

Replacement period: Planned replacement each week over the 
course of the study duration. Subjects will wear a fresh pair of 
lenses in alignment with weekly planned replacement schedule.
o
For planned replacement, lenses will be replaced even if 
one or both of the lenses have not been used for the full 
1-week wearing schedule.

Lens Care: CLEAR CARE, LacriPure (or equivalent), Systane, 
and OFPM MPDS as needed.

Additional details can be found in the MOP
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. 
Labeling description

Lens Foil label includes:
-
identifier
-
base curve
-
diameter
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information

Provided in boxes of up to 18 lenses per power per box, 
identified with the following:
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-
a color coded label stating the protocol number
-
identifier
-
power
-
an investigational use only statement
-
tracking number
Storage conditions
Stored at room temperature.
Supply

Fitting sets and spare lenses will be provided by the Sponsor 
before the start of the trial to be used during Visit 1. 

Study lenses will be provided to the site for each subject as per 
the Investigator’s order form. The site will dispense the study 
lenses to the subject at Visit 1, and according to the planned 
lens replacement schedule throughout the study. Refer to the 
MOP for a detailed description. 
More information on the test product can be found in the IB; information on the control 
product can be found in the Package Insert.
9.2
Other Medical Device or Medication Specified for Use During the 
Study
Other than the pre-specified CLEAR CARE, LacriPure (or equivalent), Systane rewetting 
drops, and OFPM MPDS, no other medical devices or medications are required to be used in 
conjunction with the treatments during the clinical study.
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 manner to receive either the 
 or Biofinity
contact lenses, respectively. 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio
 
Subjects will be assigned a treatment arm according to the randomization list 
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uploaded in the IRT system. The randomization list will be generated and maintained by the 
Study Sponsor.
At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the treatment arms. The Investigator’s delegate will access the respective system after 
confirming that the subject meets all the eligibility criteria. A randomization number will be 
automatically assigned to the subject according to the subject randomization list but will not 
be communicated to the site user. The EDC/IRT integration system will inform the site user 
of the treatment assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use 
or Biofinity contact 
lenses for the duration of the 12-month treatment period.
 
 
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contacted prior to unmasking. Unmasking must be done according to the instructions 
provided for the study IRT system.
9.5
Accountability Procedures
Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the 
study, unmasked designated study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the unmasked designated study 
staff must maintain records of IP dispensation and collection for each subject. This record 
must be made available to the study monitor for the purposes of verifying the accounting of 
IP supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. All IPs sent to the Investigator 
must be accounted for by Study Sponsor personnel, and in no case be used in an unauthorized 
situation.
It is the Investigator’s responsibility to ensure that:

All study products are accounted for and not used in any unauthorized manner

All used foils and unused supplies are returned by each subject

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 and the return of study 
products associated with these events.

Every effort should be made to return opened and unopened investigational lenses 
from those subjects lost to follow-up.

All supplies are to be retrieved from the subject at the final visit. If a subject misses the 
final visit, all efforts MUST be made to reschedule the final visit provided it is 
scheduled within the visit window.
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP.
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:
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
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 9 office visits, as shown in Table 10-1.
Table 10–1
Study Visits
Visit #
Visit Type
Visit Day
Visit Window
Visit 1
Baseline/Dispense
Day 1
N/A
Visit 2
24-Hour Follow-Up Visit
Day 2
Hours 20–28
Visit 3
1-Week Follow-Up Visit
Day 7
Days 5–9
Visit 4
1-Month Follow-Up Visit
Day 30
Days 26–34
Visit 5
2-Month Follow-Up Visit
Day 60
Days 53–67
Visit 6
3-Month Follow-Up Visit
Day 90
Days 83–97
Visit 7
6-Month Follow-Up Visit
Day 189
Days 182–203
Visit 8
9-Month Follow-Up Visit
Day 270
Days 256–284
Visit 9
12-Month Follow-Up / Exit Visit
Day 365
Days 351–379
Unscheduled Visits and Early Termination Visits are allowed, if necessary.
At the Baseline/Dispense Visit, study lenses will be trial fit using the fitting sets supplied by 
the Sponsor, and the correct contact lens power for the individual subject will be determined. 
Sites will be provided with adequate lens supply to dispense the first pair of study lenses 
during Visit 1.
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The Sponsor will send study lenses for each subject to the site after receiving an order from 
the Investigator. The Investigator will complete the order forms as and when needed to 
provide a consistent stream of lens supply for each subject enrolled in this clinical study. 
At the Baseline/Dispense Visit, study lenses will be dispensed to the subject. All subjects will 
wear the study lenses in an extended wear modality, while awake and asleep for up to 
6 nights/7 days of continuous wear with one night of no lens wear. This wearing schedule 
will be repeated throughout the course of the trial. The wearing schedule assignment for 
either test or control lens should be preserved as much as possible unless there are safety 
reasons that necessitate a modification to the wearing schedule assignment.
Subjects assigned to wearing 
 or Biofinity contact lenses will insert a new pair of 
study lenses each week and discard them at the end of the week. Problem lenses (if any) will 
not be discarded but collected by the subject and returned to the investigational site. 
 
 
VA 
will be measured at all visits, and any decrease of 2 or more lines from the Baseline/Dispense
Visit to any follow-up visit should be explained by the Investigator. Keratometry will be 
performed at the Baseline/Dispense, 6-Month, and Exit Visits, and manifest refraction will be 
performed at the Baseline/Dispense and Exit Visits.
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, the individual obtaining consent 
from the subject and a witness, if applicable, must 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
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel.
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10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
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 and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed.
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.
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, including those 
associated with changes in concomitant medication dosing since the previous visit.
Requirements for reporting device deficiencies in the study can be found in Section 11. 
10.3 Additional Study Assessments: Effectiveness and Safety Assessment
The following are additional study assessments. Refer to the MOP for further details.

Distance VA with study lenses (Snellen)

Distance VA with habitual correction (Snellen)

Manifest refraction

Keratometry
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10.4 Unscheduled Visits
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the 
following procedures: 

Collect AE information, as applicable

Record changes in medical condition or concomitant medication

Collect device deficiency information, as applicable

Assess and record VAs

Perform biomicroscopy (assessments with or without lenses, as applicable)

Collect symptoms, problems, and complaints
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject according to Table 3-1. The Investigator must document this information in the 
subject’s case history source documents.
If, during an Unscheduled Visit, the subject is to discontinue IP or is discontinuing from the 
study, the Investigator must conduct Exit procedures according to Table 3-1, as possible.
10.5 Discontinued Subjects
10.5.1 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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10.5.2 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.
Subjects missing consecutive follow-up visits will be evaluated to determine if 
discontinuation may be necessary.
For subjects discontinuing from the study, the Investigator must complete all Exit procedures 
according to Table 3-1, if the subject is willing and able, and if in the opinion of the 
Investigator it is safe for the subject to do so.
The Investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents.
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health.
10.5.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product 
Other than screen failures, if a subject discontinues from the study, the subject should 
undergo an Early Exit Visit. Refer to Table 3-1.
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.
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
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
*NOTE: Culture samples (from the subject’s eyes, lenses, etc) must be taken at investigator’s 
discretion [as described in the MOP; and documented in the narrative section(s) of the 
corresponding ADE-SAE eCRF], for any suspected ocular infection, including infiltrates with 
overlying epithelial defect.
Significant Non-Serious Adverse Events
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 (Refer to MOP for grading 
scales)

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 (Refer to MOP for grading 
scales) 
The above events are based upon the categories provided in ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses.
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 
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Device Deficiency eCRF for the identified or suspect device deficiency and report any 
subject harm separately. Examples of device deficiencies include the following: 

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 Adverse Events
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?”
Changes in any protocol-specific parameters and/or questionnaires evaluated during the 
study are to be reviewed by the Investigator. Any untoward (unfavorable and unintended) 
change in a protocol-specific parameter or questionnaire response that is clinically relevant, 
in the opinion of the Investigator, is to be reported as an AE. These clinically relevant 
changes will be reported regardless of causality. 
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.
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the Investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period. 
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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.
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency
Form. The completed form is emailed to the Study Sponsor at 
according to the timelines outlined above; however, the reported information must be entered 
into the EDC system once it becomes operational.
Additionally, any AEs and device deficiencies for non-study marketed devices/products (ie, 
CLEAR CARE Cleaning and Disinfecting Solution, LacriPure (or equivalent), and Systane
preservative-free eye drops) will be considered and processed as spontaneous (following the 
postmarket vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question; their 
contact information is provided in the MOP that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
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).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related.
Additionally, the Study Sponsor shall immediately conduct an evaluation of any 
unanticipated adverse device effect, including anticipated adverse events that occur in 
unanticipated severity or frequency. The results of this evaluation will be reported to the
FDA, the IRB, and participating Investigators within 10 working days upon receiving 
notification of the effect.
11.4 Return product analysis
Investigational product associated with device deficiencies and/or product related AEs [ie, 
ADE or SADE] will be returned for investigation as detailed in the MOP.
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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. If the treatment code needs to be broken in the interest of subject safety, the 
Investigator is encouraged to contact an appropriate Study Sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (ie, medical emergency), the code may be broken prior to contact with the 
Study Sponsor. The Study Sponsor must be informed of all cases in which the code was 
broken and of the circumstances involved. Additionally, the Study Sponsor may be required 
to unmask the information in order to fulfill expedited regulatory requirements.
11.6 Follow-Up of Subjects with Adverse Events 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
Any additional data received up to 3 months after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements, as applicable.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
11.7 Pregnancy in the Clinical Study
Pregnancy is not reportable as an AE; however, complications may be reportable and will be 
decided on a case-by-case basis. Should a woman become pregnant during study 
participation, the pregnancy will be documented on the Medical History eCRF.
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12 ANALYSIS PLAN
Any deviations to the analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report.
All analyses will be conducted according to the applicable statistical analysis plan.
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.
12.2 Analysis Sets
Five analysis sets will be defined:
a) All Enrolled – all subjects signing the informed consent form
b) Enrolled Dispensed – subjects/eyes from All Enrolled that have been exposed to study 
lenses 
c) Enrolled Not Dispensed – subjects/eyes from All Enrolled that have not been exposed 
to study lenses 
d) Completed – Enrolled Dispensed subjects/eyes completing the study
e) Discontinued – Enrolled Dispensed subjects/eyes not completing the study
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 for 
the All Enrolled analysis set.
Baseline data will be summarized by lens group, for Completed and Discontinued analysis 
sets separately, as applicable.
12.4 Effectiveness Analyses
For the primary 
 endpoint , separate summaries will 
be prepared, when applicable, for the Completed and the Discontinued analysis sets as 
follows:

Completed Control (eyes/subjects)

Completed Test (eyes/subjects)
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
Discontinued Control (eyes/subjects)

Discontinued Test (eyes/subjects)
No inferential testing will be performed on effectiveness endpoints, and format of the 
reporting tables will reference FDA’s 510(k) guidance document (Clinical Appendix C, 
Summary of Reporting Tables) as well as the ISO guidance as specified in section A.3 
(Reporting of results) of ISO 11980:2012.
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary effectiveness endpoint is distance VA with study lenses, collected in Snellen, for 
each eye.  Conversion will be made to the logMAR scale.
12.4.1.1 Statistical Hypotheses
No hypothesis testing on the primary effectiveness endpoint is planned.
12.4.1.2 Analysis Methods
Summary statistics will be provided.
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12.6 Safety Analyses
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) and listings 
will be presented. Individual subject listings will be provided for AEs that occur after signing 
informed consent but prior to exposure to IP.
12.6.1 Analysis of Primary Safety Endpoint(s)
The primary safety endpoint is the proportion of ocular serious and significant non-serious 
ADEs, calculated as the number of eyes reporting at least one treatment-emergent device-
related ocular serious ADE or treatment-emergent device-related ocular significant 
non-serious ADE.
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12.6.1.1 Statistical Hypotheses
The null and alternative hypotheses for the primary analysis are:
H0: PT - PC ≥ 0.05
Ha: PT - PC < 0.05
where PT and PC denote the proportion of eyes reporting ocular serious and significant 
non-serious ADEs with 
 and Biofinity contact lenses, respectively.
12.6.1.2 Analysis Methods
A generalized linear model, with a logit link function, accounting for within-subject 
correlation will be fit. A one-sided 95% upper confidence limit (UCL) will be calculated for 
the difference in proportions between treatments (
 contact lens minus Biofinity
contact lens), and the null hypothesis will be rejected if UCL < 0.05.
12.6.2 Analysis of Other Safety Endpoints
Other safety endpoints include:

AE (non-serious, non-significant)

Biomicroscopy findings

Device deficiencies
12.6.2.1 Statistical Hypotheses
No hypothesis testing on the other safety endpoints is planned.
12.6.2.2 Analysis Methods
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities Preferred Terms, for Completed 
and Discontinued analysis sets. A listing containing details of the AEs will also be provided.
Each biomicroscopy parameter will be tabulated by its grade, on Completed and
Discontinued analysis sets. Frequency for each device deficiency category will be presented 
and a supporting listing will be provided.
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12.7 Interim Analyses and Reporting
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination.
12.8 Sample Size Justification
Sample size calculation was based on extended wear clinical studies from three PMA studies 
and one 52-week extended wear study 
 
that evaluated 5 currently marketed silicone hydrogel 
contact lenses. The weighted average, based on sample size, on the proportion of ocular 
serious and significant non-serious ADEs obtained from these five contact lenses was 0.045. 
Therefore, assuming that the expected difference between test and control is 0 and that the 
control proportion is 0.045, a sample size of 213 per group will provide 80% power to reject 
the null hypothesis of inferiority in test compared to control, with a noninferiority margin of 
0.05 (5%). 
Taking into consideration the exposure duration of 12 months, approximately 568 subjects 
will be randomized (284 test and 284 control) to compensate for approximately 25% drop-out 
rate.
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 
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confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study.
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.
If electronic records are maintained, the method of verification must be determined in
advance of starting the study. 
At a minimum, source documents include the following information for each subject:

Subject identification (name, sex, race/ethnicity)

Documentation of subject eligibility

Date of informed consent

Dates of visits

Documentation that protocol specific procedures were performed

Results of study parameters, as required by the protocol

IP accountability records
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
Documentation of AEs and other safety parameters (if applicable)

Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data.
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information. 
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.
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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.
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. Financial information is to be kept separately. 
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations.
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
This clinical study must be conducted in accordance with the ethical principles contained 
within: 

The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 

SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 

Notifications and timelines for reporting protocol deviations should be based upon
applicable Ethics Committee requirements
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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, 
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. The Investigator must provide documentation of the IRB/IEC 
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. 
Any Investigator who practices and intends to see study subjects at a hospital or university 
may require secondary review and approval by an IRB belonging to that institution. A copy 
of local or secondary IRB approvals should be provided to the Study Sponsor. The IRB/IEC 
must be provided with a copy of the IB, any periodic safety updates, and all other information 
as required by local regulation and/or the IRB/IEC. At the end of the study, the Investigator 
must notify the IRB/IEC about the study’s completion. The IRB/IEC also must be notified if 
the study is terminated prematurely. Finally, the Investigator must report to the IRB/IEC on 
the progress of the study at intervals stipulated by the 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. Specifically, 
the Investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
Investigator, and if required by local regulation, other qualified personnel. The Investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
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that their records may be accessed by appropriate authorities and Sponsor-designated 
personnel. The Investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations. 
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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