Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



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Table of Contents
Clinical Performance of a Silicone Hydrogel Following Six Nights of Extended Wear...........1
Table of Contents .......................................................................................................................2
List of Tables..............................................................................................................................4
List of Figures............................................................................................................................5
1
GLOSSARY OF TERMS ....................................................................................................6
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................10
3
PROTOCOL SUMMARY.................................................................................................12
5
INTRODUCTION.............................................................................................................21
5.1
Rationale and Background ................................................................................21
5.2
Purpose of the Study..........................................................................................22
5.3
Risks and Benefits.............................................................................................22
6
STUDY OBJECTIVES......................................................................................................23
6.1
Primary Objective..............................................................................................23
6.2
Secondary Objective..........................................................................................23
6.4
Safety Objective ................................................................................................24
7
INVESTIGATIONAL PLAN ............................................................................................24
7.1
Study Design .....................................................................................................24
7.2
Rationale for Study Design ...............................................................................25
7.4
Rationale for Choice of Control Product...........................................................26
7.5
Data Monitoring Committee..............................................................................26
8
STUDY POPULATION ....................................................................................................26
8.1
Inclusion Criteria...............................................................................................26
8.2
Exclusion Criteria..............................................................................................27
8.3
Rescreening of Subjects ....................................................................................28
9
TREATMENTS ADMINISTERED...................................................................................28
9.1
Investigational Products ....................................................................................28
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12.2
Analysis Sets .....................................................................................................46
12.3
Demographic and Baseline Characteristics.......................................................46
12.4
Effectiveness Analyses ......................................................................................46
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................46
12.4.1.1
Statistical Hypotheses........................................................46
12.4.1.2
Analysis Methods ..............................................................46
12.5
Handling of Missing Data .................................................................................47
12.6
Safety Analyses .................................................................................................47
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................48
13.1
Subject Confidentiality......................................................................................48
13.2
Completion of Source Documents and Case Report Forms..............................49
13.3
Data Review and Clarifications.........................................................................50
13.4
Sponsor and Monitoring Responsibilities .........................................................50
13.5
Regulatory Documentation and Records Retention ..........................................51
13.6
Quality Assurance and Quality Control.............................................................51
14 ETHICS .............................................................................................................................51
15 REFERENCES ..................................................................................................................53
15.1
References applicable for all clinical studies ....................................................53
15.1.1
US references applicable for clinical studies.....................................53
15.2
References for this clinical study ......................................................................53
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................10
Table 3–1
Schedule of Study Procedures and Assessments .............................................15
Table 6–2
Safety Objective...............................................................................................24
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Table 9–1
Test Product .....................................................................................................28
Table 9–2
Control Product................................................................................................30
List of Figures
Figure 11–1
Categorization of All Adverse Events..............................................................39
Figure 11-2
Categorization of All Serious Adverse Events.................................................40
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1
GLOSSARY OF TERMS
Names of test product
Throughout this document, the test product will be referred 
to as 
Name of Control Product(s)
Biofinity® (comfilcon A) soft contact lenses, referred to as
Biofinity
Adverse Device Effect
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
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
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.

A serious deterioration in the health of the subject 
that either resulted in:
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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.
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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 
(USADE)
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
 
Biofinity
Biofinity (comfilcon A) soft contact lenses 
CFR 
Code of Federal Regulations
CRF
Case report form
CSM
Clinical site manager
CTT
Clinical trial team
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
GPCMS
Global Product Complaint Management System
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
 
LCSM
Lead clinical site manager
LID
Lens identification 
logMAR
Logarithm of the minimum angle of resolution
mm 
Millimeter
MOP
Manual of procedures
n
Number
N/A 
Not applicable
OD
Right eye
OS 
Left eye
SAE 
Serious adverse event
SADE 
Serious adverse device effect
SD
Standard deviation
SiHy 
Silicone hydrogel
SLE
Slit-lamp examination
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Abbreviation
Definition
SOP
Standard operating procedure
US / USA
United States of America
USADE 
Unanticipated serious adverse device effect
VA 
Visual acuity
vs
Versus 
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3
PROTOCOL SUMMARY
This will be a prospective, randomized, controlled, double-masked, contralateral wear 
clinical trial.
Approximately 2 sites in the US will enroll approximately 22 subjects. Subjects will be 
randomized to wear the test 
 lens in one eye and the control Biofinity lens in the 
other eye. Subjects will be expected to attend 3 visits: Baseline/Dispense, 1-Day Follow-up, 
and 1-Week Follow-up/Exit.
Following randomization during the Baseline/Dispense Visit, study lenses will be dispensed 
to the subject. All study lenses are to be worn overnight for approximately 6 nights. Subjects 
will be expected to wear the study lenses continuously in an extended wear modality. 
 
 
 
 
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: 
soft contact lenses
Control Product: Biofinity (comfilcon A) soft contact lenses
Purpose and 
rationale
The purpose of this clinical study is to evaluate the on-eye 
performance of the investigational 
lens compared to the 
commercially available Biofinity lens following 1 week of 
extended wear.
Objective
The primary objective is to assess 
 
performance of the 
 soft contact lens when worn in an 
extended wear modality (ie, up to 6 nights of continuous wear) as 
compared to Biofinity soft contact lens.
Endpoints
Primary Effectiveness

Distance VA (Snellen)
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Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessments
Effectiveness

VA (Snellen distance) with IP
 
 
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Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
This will be a prospective, randomized, controlled, double-
masked, contralateral clinical trial. Subject participation in the 
study will be approximately 1 week with approximately six nights
of extended wear.
Subject population
Volunteer subjects aged 18 or over who are soft contact lens 
wearers, excluding Biofinity habitual wearers, have at least 
3 months of contact lens wearing experience, and who wear their 
habitual lenses at least 5 days per week and in an extended wear 
modality a minimum of 1 night per week. 
 
 Pregnant 
and breastfeeding women are excluded from this study.
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)

Successful wear of spherical soft contact lenses in both eyes 
during the past 3 months for a minimum of 5 days per week 
and in an extended wear modality a minimum of 1 night per 
week.

Best corrected VA 20/25 or better in each eye.
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Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Current Biofinity lens wearer.
Data analysis and 
sample size 
justification
No formal hypotheses are formulated for the primary effectiveness 
endpoint of VA; hence no inferential testing will be performed.
Descriptive summary statistics will be provided on the Snellen 
categories as well as the converted logMAR values. 
 
 
 
Key words
 Biofinity, extended wear, 6 nights
 
 
  
Table 3–1
Schedule of Study Procedures and Assessments
Procedure/ Assessment
Visit 1, Day 1: 
Baseline/Dispense
Visit 2, Day 2:
1-Day Follow-up
24 hours after 
Visit 1 (±4 hours)
Visit 3, Week 1:
1-Week 
Follow-up/Exit
7 days (-1 day) of 
lens wear
Unsched
Visit
Ideally subjects 
should be seen 
within 4 hours of 
awakening.
Informed Consent

-
-
-
Demographics

-
-
-
Medical History

-
-
-
Concomitant 
Medications

()
()
()
Inclusion/
Exclusion

-
-
-
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.
.
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5
INTRODUCTION
5.1
Rationale and Background
 
 
 
 
 
 
 
 
 
 
 
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6.4
Safety Objective
Table 6–2
Safety Objective
Objective
Endpoints
evaluation of performance and safety 
profile of the test lens.
AEs
Device deficiencies
Biomicroscopy findings
7
INVESTIGATIONAL PLAN
7.1
Study Design
This will be a prospective, randomized, controlled, double-masked, contralateral wear 
clinical trial.
Approximately 2 sites in the US will enroll approximately 22 subjects. Subjects will be 
randomized to wear the test 
 lens in one eye and the control Biofinity lens in the 
other eye. Subjects will be expected to attend 3 visits: Baseline/Dispense, 1-Day Follow-up, 
and a 1-Week Follow-up/Exit.
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er 
establish proof of principle for extended wear in this novel silicone hydrogel lens.
7.4
Rationale for Choice of Control Product
Biofinity was chosen as the control product 
 to 
compare to 
 with regard to effectiveness and safety. Both 
 and Biofinity are 
silicone hydrogel lenses
d for 
 continuous wear. 
The Biofinity lenses are indicated for the optical correction of refractive ametropia (myopia 
and hyperopia) in phakic or aphakic persons with non-diseased eyes.
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of adult male and female subjects (aged 18 or over), with 
non-diseased eyes, who require optical correction for refractive ametropia. It is aimed to 
enroll approximately 22 subjects in approximately 2 US sites. Estimated time needed to 
recruit subjects for the study is approximately 3 weeks. The intended study population 
consists of volunteer subjects aged 18 or over who are 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 in an extended wear 
modality. 
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be at least 18 years of age and able to understand and sign an IRB/IEC 
approved Informed Consent form.
2.
Willing to attend all scheduled study visits as required per protocol.
3.
Successful wear of spherical soft contact lenses in both eyes during the past 
3 months for a minimum of 5 days per week and in an extended wear modality a 
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minimum of 1 night per week.
5.
Best spectacle corrected visual acuity 20/25 or better in each eye.
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 which contact 
lens extended wear could be contraindicated, as determined by the Investigator 
and/or history of irregular cornea.
4.
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; or presence of corneal 
infiltrate(s).
5.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
6.
Current or history of herpetic keratitis in either eye.
7.
Eye injury in either eye within twelve weeks immediately prior to enrollment for this 
trial.
8.
Current or history of intolerance, hypersensitivity or allergy to any component of the 
study products.
9.
Current Biofinity lens wearer.
10.
Any use of topical ocular medications and artificial tear or rewetting drops that 
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would require instillation during contact lens wear.
11.
Currently pregnant or breast-feeding.
12.
The Investigator, his/her staff, family members of the Investigator, family members 
of the Investigator’s staff, or individuals living in the households of the 
aforementioned persons may not participate in the study.
13.
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial.
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Products
Replacement lenses will not be provided to the subject. In the event a lens needs to be 
replaced, the subject must return to the site for a replacement lens. 
Test Product:
 soft contact lenses
Control Product:
Biofinity (comfilcon A) soft contact lenses
Table 9–1
Test Product
Test Product
 soft contact lenses (LID011121)
Manufacturer
Alcon Laboratories,
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.
Product description 
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and parameters 
available for this 
study
Formulation
Silicone Hydrogel. Additional details can be found in the IB.
Usage

Wear:
o
Extended Wear – ~6 nights
o
Contralateral

Exposure: ~1 week 


Additional details can be found in the Manual of Procedures
Number/Amount of 
product to be 
provided to the 
subject
One lens per eye will be dispensed to the subject on Visit 1.
Packaging 
description
Blister foil pack 
Labeling description

Lens Foil label includes:
-
material name and/or 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 8 lenses per power per box, 
identified with the following:
-
a color coded label stating the protocol number
-
material identifier
-
power
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-
an investigational use only statement
-
tracking number
Storage conditions
Stored at room temperature.
Supply
All study lenses will be provided to the site. The site will dispense 
the study lenses to the subject at Visit 1.
Table 9–2
Control Product
Control Product
Biofinity (comfilcon A) soft contact lenses (Biofinity)
Manufacturer
CooperVision®
Indication for Use
The intended use of this contact lens is for vision correction.
Product description 
and parameters 
available for this 
study

Material: comfilcon A

Water content: 48%

Base curve: 8.6 mm

Diameter: 14.0 mm
Formulation
Silicone Hydrogel. Additional details can be found in the Biofinity 
package insert.
Usage

Wear:
o
Extended Wear – ~6 nights
o
Contralateral

Exposure: ~1 week

Additional details can be found in the Manual of Procedures
Number/Amount of 
Product to be 
Provided to the 
subject
One lens per eye will be dispensed to the subject on Visit 1.
Packaging 
description
Blister foil pack in commercial packaging
Labeling description

Lens Foil label includes:
-
material name 
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-
base curve
-
diameter
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
Manufacturer information
-
Country of origin
Storage conditions
Stored at room temperature.
Supply
. The site will dispense 
the study lenses to the subject at Visit 1.
 
 
 
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment with 
 or Biofinity in 
one eye and the other lens in the fellow eye, as indicated below:
Sequence 1: 
 (OD) / Biofinity (OS)
Sequence 2: Biofinity (OD) / 
 (OS)
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 (lens sequence) according to the randomization list 
 
. The randomization list will be generated and maintained by 
the Study Sponsor.
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At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the lens sequences. The Investigator or 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 (lens sequence) assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use 
 and Biofinity in 
either eye for the duration of the treatment period. 
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 Unmasking 
will occur only after all planned study data have been validated, and the database locked. 
Masked study personnel must avoid seeking information that may compromise masking. 
 
 
 
In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual Investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate Study Sponsor representative if time allows. 
Unmasking must be done according to the instructions provided for the study IRT system.
9.5
Accountability Procedures
Upon receipt of the IP, the Investigator or delegate must conduct an inventory. 
 
 
 Throughout the study, the Investigator or delegate 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 
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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 (supplied by the Study Sponsor) are available for return to the 
Study Sponsor, as directed

Any study lenses associated with a device deficiency or with any product-related 
adverse event (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.
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
Changes in concomitant treatments after Visit 1 are not allowed unless needed for the proper 
medical care and treatment of the subject for a specific medical condition.
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.
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10 STUDY PROCEDURES AND ASSESSMENTS
Visit
Window
Visit 1, Day 1: Baseline/Dispense
N/A
Visit 2, Day 2: 1-Day Follow-Up
24 hours (±4 hours) after Visit 1
Visit 3, 1 Week: 1-Week Follow-Up/Exit
7 days (-1 day) of lens wear following 
insertion
Unscheduled Visits and Early Termination Visits are allowed, if necessary.
At the Baseline/Dispense Visit, study lenses will be dispensed contralaterally to the subject. 
All study lenses will be worn in an extended wear modality for approximately 6 nights. 
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 two or 
more lines from the Dispense Visit to any follow-up visits should be explained by the 
Investigator. 
 
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
10.2 Description of Study Procedures and Assessments
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
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 
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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 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 adverse events 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
SLE 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. Requirements for 
reporting device deficiencies in the study can be found in Section 11.
 
 
 
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10.3 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 Adverse Event information

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)
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The Investigator must document this information in the subject’s case history source 
documents.
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the Investigator must conduct Exit procedures according to Table 3-1, Schedule of 
Study Procedures and Assessments, as possible.
10.4 Discontinued Subjects
10.4.1 Screen Failures
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.
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, including screen failures. 
Subject numbers of discontinued subjects must not be re-used.
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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.
For subjects discontinuing from the study, the Investigator must complete all Exit procedures 
according to Table 3-1, Schedule of Study Procedures and Assessments, 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.
10.4.3 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, Schedule of Study Procedures and Assessments.
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(s) and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension. 

The Investigator(s) must:
o
Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons. 
o
Provide subjects with recommendations for post-study treatment options 
as needed.
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Figure 11-2
Categorization of All Serious Adverse Events
All SAEs
Device /
procedure 
related?
SAE
SADE
Anticipated?
Unanticipated 
SADE
No
Yes
No
Anticipated 
SADE
Yes
Serious Adverse Events
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:

An ocular infection including a presumed infectious ulcer with any of the following 
characteristics*: 
o
Central or paracentral location
o
Penetration of Bowman’s membrane
o
Infiltrates > 2 mm diameter
o
Iritis
o
Increase in intraocular pressure
o
Culture positive for microorganisms
o
Increasing size or severity at subsequent visits

Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification

Hypopyon
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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 [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 the 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 patient 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 patient 
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 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. 

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.
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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.
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 
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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 1 month 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.
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum and maximum. Categorical variables will be summarized 
with counts and percentages from each category. 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.
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12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked treatment
(lens sequence) assignment and locking the database, based upon the Deviations and 
Evaluability Plan.
12.2 Analysis Sets
Only 1 analysis set will be defined, namely the safety analysis set. It will include all eyes 
exposed to any study lenses evaluated in this study. 
Eyes will be analyzed based upon the lens exposed at the time of the clinical assessment. 
12.3 Demographic and Baseline Characteristics
Demographic information and habitual lens information will be presented by lens sequence 
and overall.
12.4 Effectiveness Analyses
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to assess 
 performance 
of the 
 soft contact lens when worn in an extended wear modality (ie, up to 6 nights 
of continuous wear) as compared to Biofinity soft contact lens. 
The primary endpoint is VA with study lenses, collected by eye.
12.4.1.1 Statistical Hypotheses
No hypothesis testing of the primary effectiveness endpoint is planned.
12.4.1.2 Analysis Methods
Summary statistics will be provided.
 
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12.5 Handling of Missing Data
All data obtained in evaluable subjects/eyes will be used. No imputation for missing values
will be carried out.
12.6 Safety Analyses
The safety endpoints are:
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
AEs

Biomicroscopy

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.
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be
presented by Medical Dictionary for Regulatory Activities Preferred Terms. A listing 
containing details of the AEs will also be provided.
Each biomicroscopy parameter will be tabulated by its grade.
Frequency for each device deficiency category will be presented and a supporting listing will
be provided.
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. 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.
 
 
 
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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.
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

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.
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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. 
 
 
 
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. 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. 
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
Notifications and timelines for reporting protocol deviations should be based upon
applicable Ethics Committee requirements
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. 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 
that their records may be accessed by appropriate authorities and Sponsor-designated 
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personnel. The Investigator must keep the original, signed copy of the consent (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
15.2 References for this clinical study
Not applicable. There are no references.
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Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
4.0; Most-Recent; Effective; CURRENT
TDOC-0054559
Protocol - Clinical
22-Aug-2018

                                                                                                                
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
4.0; Most-Recent; Effective; CURRENT
TDOC-0054559
Protocol - Clinical
22-Aug-2018