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



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Investigator Agreement:

I have read the clinical study described herein, recognize its confidentiality, and agree 
to conduct the described trial in compliance with Good Clinical Practice (GCP), the 
ethical principles contained within the Declaration of Helsinki, this protocol, all 
applicable regulatory authority regulations, and conditions of approval imposed by the 
reviewing IRB or regulatory authority.

I will supervise all testing of the device involving human subjects and ensure that the 
requirements relating to obtaining informed consent and IRB review and approval are 
met in accordance with applicable local and governmental regulations.

I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or other 
sources provided by the Sponsor.

I understand the potential risks and side effects of the investigational product(s).

I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection.

I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies.

I agree to ensure that all associates, colleagues, and employees assisting in the conduct 
of the study are informed of their obligations in meeting the above commitments.
Have you ever been disqualified as an Investigator by any Regulatory Authority?
No        Yes
Have you ever been involved in a study or other research that was terminated?
No        Yes
If yes, please explain here:
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
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Table of Contents
Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens...............1
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................5
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................11
3
PROTOCOL SUMMARY.................................................................................................13
4
PROTOCOL AMENDMENTS .........................................................................................22
4.1
Amendments......................................................................................................22
5
INTRODUCTION.............................................................................................................23
5.1
Rationale and Background ................................................................................23
5.2
Purpose of the Study..........................................................................................23
5.3
Risks and Benefits.............................................................................................24
6
STUDY OBJECTIVES......................................................................................................25
6.1
Primary Objective(s) .........................................................................................25
6.2
Secondary Objective(s) .....................................................................................25
6.4
Safety Objective(s)............................................................................................25
7
INVESTIGATIONAL PLAN ............................................................................................25
7.1
Study Design .....................................................................................................25
7.2
Rationale for Study Design ...............................................................................27
7.3
Rationale for Duration of Treatment/Follow-Up...............................................27
7.4
Rationale for Choice of Control Product...........................................................27
7.5
Data Monitoring Committee..............................................................................27
8
STUDY POPULATION ....................................................................................................27
8.1
Inclusion Criteria...............................................................................................28
8.2
Exclusion Criteria..............................................................................................29
8.3
Rescreening of Subjects ....................................................................................30
9
TREATMENTS ADMINISTERED...................................................................................30
9.1
Investigational Product(s)..................................................................................30
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9.2
Other Medical Device or Medication Specified for Use During the Study ......35
9.3
Treatment Assignment/Randomization .............................................................36
9.4
Treatment Masking............................................................................................36
9.5
Accountability Procedures.................................................................................38
9.6
Changes to Concomitant Medications, Treatments/Procedures ........................39
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................39
10.1
Informed Consent and Screening ......................................................................40
10.2
Description of Study Procedures and Assessments...........................................41
10.2.1
Demographics....................................................................................41
10.2.2
Medical History.................................................................................41
10.2.3
Investigational Product Compliance..................................................41
10.2.4
Adverse Event Collection: Safety Assessment..................................41
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................41
10.2.6
Device Deficiencies: Safety Assessment...........................................41
10.2.7
Visual Acuity: Effectiveness Assessment..........................................42
10.3
Additional Study Assessments ..........................................................................42
10.4
Unscheduled Visits ............................................................................................42
10.5
Discontinued Subjects .......................................................................................43
10.5.1
Screen Failures ..................................................................................43
10.5.2
Discontinuations................................................................................43
10.5.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................44
10.6
Clinical Study Termination................................................................................44
10.6.1
Follow-up of Subjects After Study Participation Has Ended ............45
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................45
11.1
General Information ..........................................................................................45
11.2
Monitoring for AEs............................................................................................48
11.3
Procedures for Recording and Reporting ..........................................................48
11.4
Return Product Analysis....................................................................................51
11.5
Unmasking of the Study Treatment...................................................................51
11.6
Follow-Up of Subjects with AEs.......................................................................51
11.7
Pregnancy in the Clinical Study........................................................................51
12 ANALYSIS PLAN ............................................................................................................52
12.1
Subject Evaluability...........................................................................................52
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12.2
Analysis Sets .....................................................................................................52
12.3
Demographic and Baseline Characteristics.......................................................52
12.4
Effectiveness Analyses ......................................................................................53
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................53
12.4.1.1
Statistical Hypotheses........................................................53
12.4.1.2
Analysis Methods ..............................................................53
12.4.2
Analysis of Secondary Effectiveness Endpoints ...............................54
12.4.2.1
Statistical Hypotheses and Model......................................54
12.4.2.2
Analysis Methods ..............................................................54
12.5
Handling of Missing Data .................................................................................54
12.6
Safety Analyses .................................................................................................55
12.7
Interim Analyses and Reporting........................................................................55
12.8
Sample Size Justification...................................................................................55
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................55
13.1
Subject Confidentiality......................................................................................55
13.2
Completion of Source Documents and Case Report Forms..............................56
13.3
Data Review and Clarifications.........................................................................57
13.4
Sponsor and Monitoring Responsibilities .........................................................57
13.5
Regulatory Documentation and Records Retention ..........................................58
13.6
Quality Assurance and Quality Control.............................................................58
14 ETHICS .............................................................................................................................58
15 REFERENCES ..................................................................................................................60
15.1
References Applicable for All Clinical Studies.................................................60
15.1.1
US References Applicable for Clinical Studies.................................60
15.2
Additional References for This Clinical Study..................................................60
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................11
Table 3–1
Schedule of Study Procedures and Assessments .............................................18
Table 6–1
Primary Objective(s)........................................................................................25
Table 6–2
Safety Objective(s)...........................................................................................25
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Table 9–1
Test Product .....................................................................................................30
Table 9–2
Control Product................................................................................................33
List of Figures
Figure 7-1
Flowchart of Study Visits.................................................................................26
Figure 11–1
Categorization of All AEs................................................................................45
Figure 11–2
Categorization of All SAE ...............................................................................46
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1
GLOSSARY OF TERMS
Names of Test Product(s)
Throughout this document, test product(s) will be referred to 
as 
soft contact lenses or 
contact lenses 
Name of Control Product(s)
CooperVision® BIOFINITY® soft contact lenses (Biofinity 
contact lenses or Biofinity)
Adverse Device Effect
(ADE)
Adverse event related to the use of an investigational 
medical device (test product) or control product. Note: This 
definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the test product or 
control product.
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
(test product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
Device Deficiency
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Note: 
This definition includes malfunctions, use errors, and 
inadequate labeling.
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Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
Enrolled Subject
Any subject who signs an informed consent form for 
participation in the study.
Interventional Clinical Trial
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of 
data.
Investigational Product
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form.
Malfunction
Failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Randomized Subjects
Any subject who is assigned a randomized treatment.
Serious Adverse Device 
Effect (SADE)
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
Serious Adverse Event 
(SAE)
Adverse event that led to any of the following:

Death.
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
A serious deterioration in the health of the subject that 
either resulted in:
a. a life-threatening illness or injury.
Note: Life-threatening means that the 
individual was at immediate risk of death from 
the event as it occurred, ie, it does not include 
an event which hypothetically might have 
caused death had it occurred in a more severe 
form.
b. any potentially sight-threatening event or 
permanent impairment to a body structure or a 
body function.
c. in-patient hospitalization or prolonged 
hospitalization.
Note: Planned hospitalization for a pre-
existing condition, without serious 
deterioration in health, is not considered a 
serious adverse event. In general, 
hospitalization signifies that the individual 
remained at the hospital or emergency ward 
for observation and/or treatment (usually 
involving an overnight stay) that would not 
have been appropriate in the physician's office 
or an out-patient setting. Complications that 
occur during hospitalization are adverse 
events. If a complication prolongs 
hospitalization or fulfills any other serious 
criteria, the event is serious. When in doubt as 
to whether “hospitalization” occurred, the 
event should be considered serious.
d. a medical or surgical intervention to prevent 
a) or b). 
e. any indirect harm as a consequence of 
incorrect diagnostic test results when used 
within manufacturer’s instructions for use.
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
Fetal distress, fetal death, or a congenital abnormality or 
birth defect.
Refer to Section 11 for additional SAEs.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks.
Refer to Section 11 for additional Significant Non-Serious 
AEs.
Unanticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
management file.
Use Error
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error.
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Abbreviation
Definition
SAE 
Serious adverse event
SADE 
Serious adverse device effect
SiHy 
Silicone hydrogel
SOP
Standard operating procedure
US/USA
United States of America
USAN
United States Adopted Name
USV
Unscheduled visit
VA 
Visual acuity
vs
Versus 
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Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessment(s) 
Effectiveness

VA with study lenses (Snellen distance)

VA with habitual correction (Snellen distance)

Manifest refraction

BCVA (Snellen distance with manifest refraction)
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Key Inclusion 
Criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)

Successful wear of spherical daily wear frequent replacement 
soft contact lenses for distance correction in both eyes during 
the past 3 months for a minimum of 5 days per week and 8 
hours per day.

Manifest cylinder ≤ 0.75 D in each eye
Key Exclusion 
Criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Wearing habitual contact lenses in an extended wear modality 
(routinely sleeping in lenses for at least 1 night per week) over 
the last 3 months prior to enrollment.

Monovision contact lens wearers

Habitually wearing Biofinity lenses
Data Analysis and 
Sample Size 
Justification
In adherence to the reporting format as specified in the ISO
clinical standard and FDA 510(k) guidance documents, 
effectiveness and safety data will be presented separately based 
upon subject study status of Completed or Discontinued.
No formal hypotheses are formulated for the primary effectiveness 
endpoint; hence, no inferential testing will be performed. 
Descriptive statistics will be provided on the Snellen categories as 
well as the converted logMAR values. Similarly, all supportive 
endpoints will be summarized descriptively according to each
measurement scale.
Sample size is based upon ISO clinical standard and FDA 510(k) 
requirements with the recommendations of at least 50 subjects in 
the Test group, in a 2:1 Test to Control ratio.
Key Words
Biofinity, daily wear, registration
Associated 
Materials
CLEAR CARE will be used for daily cleaning and disinfection. 
 
 
 
 
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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.
4.1
Amendments
Amendment 1
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There are no immediate plans to submit the results of this study for publication;
 
 
5.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of 
contact lenses are 
features consistent with successful contact lens wear. Based upon nonclinical testing and 
documented rationale for applicability of test results, 
contact lenses are assessed to 
be non-toxic and biocompatible for on-eye use. 
In the US, Biofinity contact lenses have approved indications for use for both daily wear and 
extended wear for up to 6 continuous nights. Further details on any known potential risks and 
benefits can be found in the product package insert.
A summary of the known potential risks and benefits associated with 
contact lenses 
can be found in the IB. The potential harms associated with on-eye exposure to the new lens 
materials include toxicity response, blurred vision, and ocular discomfort. In general, when 
worn for daily wear, the risks with 
contact lenses are anticipated to be similar to 
other marketed soft contact lenses worn for daily wear.
There may also be unknown risks to the use of 
 contact lenses. Any risk to subjects in 
this clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, clinical oversight, and monitoring. Site personnel will educate subjects on proper 
hygiene, lens handling, and compliance with the use of contact lenses for daily wear 
according to the protocol. Subjects should be instructed not to wear contact lenses while 
swimming due to increased risk of infection or while sleeping. 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)
Evaluate VA of the investigational 
 
soft contact lens compared to the 
commercially available Biofinity soft 
contact lens.
Primary Effectiveness 

Distance VA (Snellen) with study 
lenses
6.2
Secondary Objective(s)
Not Applicable.
6.3
Exploratory Objective(s)
Not Applicable.
6.4
Safety Objective(s)
Table 6–2
Safety Objective(s)
Objective(s)
Endpoint(s)
Duty of care and evaluation of safety profile 
of the investigational products.
AEs
Biomicroscopy findings
Device deficiencies
7
INVESTIGATIONAL PLAN
7.1
Study Design
This will be a prospective, randomized,
 controlled, 
double-masked, parallel-group, daily wear clinical study.
This clinical study will engage approximately 8 clinic sites to enroll approximately 
120 subjects with approximately 15 subjects per site. 
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Subjects will be expected to attend 6 office visits: Screening/Baseline/Dispense, Week 1 
Follow-up, Week 2 Follow-up, Month 1 Follow-up, Month 2 Follow-up, and Month 3 
Follow-up/Exit. The total expected duration of participation for each subject is approximately
14 weeks with approximately 3 months of exposure to study lenses in this daily wear study. 
Subjects will be randomized to wear either the test 
contact lenses in both eyes or the 
control Biofinity contact lenses in both eyes.
Following randomization, study lenses will be dispensed to the subject. Subjects will be 
provided with sufficient lens supplies to follow a monthly replacement schedule until the next 
scheduled visit.
Subjects will wear the lenses while awake in a daily wear modality. CLEAR CARE will be 
used for daily cleaning and disinfection. 
 
 
 
The estimated time to recruit subjects for this study is approximately 6 weeks. The study is 
expected to take approximately 14 weeks for completion from the last patient first visit. The 
study outline is provided below:
Figure 7-1
Flowchart of Study Visits
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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;
4.
Current or previous orthokeratology treatment or has worn rigid gas permeable
lenses in the past 12 months.
5.
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; presence of corneal 
infiltrates.
6.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
7.
Current or history of herpetic keratitis in either eye.
8.
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
study.
9.
Current or history of intolerance, hypersensitivity, or allergy to any component of 
study lenses, lens care or associated materials for the study.
10.
Wearing daily disposable lenses over the last 3 months prior to enrollment.
11.
No prior experience with routine cleaning and disinfection.
12.
Wearing habitual contact lenses in an extended wear modality (routinely sleeping in 
lenses for at least 1 night per week) over the last 3 months prior to enrollment.
13.
Any use of habitual/prescribed topical ocular medications or artificial tear or 
rewetting drops (habitual) that would require instillation during study lens wear.
14.
Monovision or multifocal contact lens wearers.
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15.
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.
16.
Participation of the subject in a clinical study within the previous 30 days or 
currently enrolled in any clinical study.
17.
Any habitual wear of Biofinity contact lenses.
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case-by-case basis.
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
soft contact lenses
Control Product(s) (If applicable):
Biofinity (comfilcon A) soft contact lenses
Table 9–1
Test Product
Test Product
soft contact lenses 
 contact lens)
(LID018869)
Manufacturer
Alcon 
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
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Indication for Use 
and Intended 
Purpose in the 
Current Study 
The intended use of this contact lens is for vision correction.
Product Description 
and Parameters 
Available for this 
Study

 

Water content target: 55 ± 2%

Power range: -1.00 to -6.00 D (0.25 D steps)

Base curve: 8.4 mm (±0.2 mm)

Diameter: 14.2 mm (±0.2 mm)
Formulation
Silicone hydrogel. Additional details can be found in the 
IB.
Usage

Wear:
o
Daily Wear

During waking hours only.

Subjects will wear a fresh pair of lenses in 
alignment with monthly planned replacement 
schedule.
o
Bilateral

Exposure: At least ~8 hours per day and ~5 days per week over 
~3 month’s exposure period.

Replacement period: Monthly planned replacement over the 
course of the study duration.
o
Monthly replacement for this trial is defined as 27 –
35 days. 
o
For planned replacement, lenses will be replaced even if 
one or both of the lenses have not been used for the full 
month wearing schedule. 

Lens Care: CLEAR CARE (mandatory),
 

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 packages of approximately 6, 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 will be provided by the Sponsor before the start of 
the study to be used during Visit 1. The site will dispense the 
study lenses to the subject at Visit 1 from the fitting set. Fitting 
sets will be resupplied, as needed.

Based on the Investigator’s lens order form, the Sponsor will 
send study lenses (as well as spare lenses) to the site for each 
subject. The site will provide the study lenses to the subject at 
Visit 2, and at subsequent follow-up visits, as needed, to allow 
for both planned lens replacement schedule and any unplanned 
lens replacements 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: -1.00 to -6.00 D (0.25 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
Daily Wear

During waking hours only.
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
Subjects will wear a fresh pair of lenses in 
alignment with monthly planned replacement 
schedule.
o
Bilateral

Exposure: At least ~8 hours per day and ~5 days per week over 
~3 month’s exposure period.

Replacement period: Monthly planned replacement over the 
course of the study duration.
o
Monthly replacement for this trial is defined as 27 –
35 days.  
o
For planned replacement, lenses will be replaced even if 
one or both of the lenses have not been used for the full 
month wearing schedule. 

Lens Care: CLEAR CARE (mandatory), 
 

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
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-
content statement
-
investigational device statement
-
Sponsor information

Provided in packages of approximately 6, 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.
Supply

Fitting sets will be provided by the Sponsor before the start of 
the study to be used during Visit 1. The site will dispense the 
study lenses to the subject at Visit 1 from the fitting set. Fitting 
sets will be resupplied, as needed.

Based on the Investigator’s lens order form, the Sponsor will 
send study lenses (as well as spare lenses) to the site for each 
subject. The site will provide the study lenses to the subject at 
Visit 2, and at subsequent follow-up visits, as needed, to allow 
for both planned lens replacement schedule and any unplanned 
lens replacements 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), and Systane rewetting 
drops, no other ocular medical devices or medications are allowed to be used during the 
clinical study.
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9.3
Treatment Assignment/Randomization
Subjects will be randomized in a 2:1 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 
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 3-month treatment period. All members associated with the 
study (at the site and the Study Sponsor) will be masked to the assigned treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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This level of masking will be maintained throughout the conduct of the study. 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, 
individual Investigator(s) will have the ability to unmask the treatment assignment for a 
specific subject. If time allows, the appropriate Study Sponsor representative should be 
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, 
 designated study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the 
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.
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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 MOP for 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
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about:

Any new medications 

Alterations in dose or dose schedules for current medications 

Any medical procedure or hospitalization that occurred or is planned

Any non-drug therapies (including physical therapy and blood transfusions)
The Investigator must document this information in the subject’s case history source 
documents.
10 STUDY PROCEDURES AND ASSESSMENTS
Subjects will be expected to attend 6 office visits, as shown below.
Visit #
Visit Type
Visit Day
Visit Window
Visit 1
Screening/Baseline/Dispense
Day 1
N/A
Visit 2
Week 1 Follow-up Visit
Day 8
Days 6-10 
Visit 3
Week 2 Follow-up Visit
Day 15
Days 12–18
Visit 4
Month 1 Follow-up Visit
Day 30
Days 27–35
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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.
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. Requirements for 
reporting AEs in the study can be found in Section 11.
10.2.5 Slit-Lamp Biomicroscopy: Safety Assessment
A slit-lamp examination must be performed in both eyes before instillation of any diagnostic 
eye drops.
10.2.6 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed, since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11. 
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10.2.7 Visual Acuity: Effectiveness Assessment
VA with study lenses (OD, OS Snellen distance) is to be conducted at each study visit. 
 
 
  
 
 
Refer to the MOP for additional details.
10.3 Additional Study Assessments
Additional effectiveness assessments will be conducted throughout the course of the study 
for. Refer to the MOP for details on each of these assessments.
Refer to Table 3–1.
10.4 Unscheduled Visits
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit or Early Exit as applicable. During all unscheduled visits, the 
Investigator must conduct the following procedures, as appropriate: 

Collect AE information, as applicable

Record changes in medical condition or concomitant medication, as applicable

Collect device deficiency information, as applicable

VA with habitual correction

Manifest refraction

BCVA with manifest refraction

Perform biomicroscopy (assessments with or without lenses, as applicable)

VA with study lenses
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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. Do 
not complete an Unscheduled Visit if a subject is exiting between scheduled study visits. An 
Early Exit assessment should be completed instead.
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.
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.
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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.
o
Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension. 

The Investigator 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.
The Investigator may terminate the site’s participation in the study for reasonable cause.
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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 (Visit 1) 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 AE
A significant non-serious AE is a device-related, non-sight threatening AE that warrants 
discontinuation of any contact lens wear for greater than or equal to 2 weeks. In addition, the 
Investigator must report any occurrence of the following as a Significant Non-Serious 
Adverse Event:

Peripheral non-progressive non-infectious ulcers

All symptomatic corneal infiltrative events

Corneal staining score greater than or equal to Grade 3 (Refer to MOP for grading 
scales)

Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit (Visit 1) 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 AEs
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
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. 
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
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and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and control products on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows:

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 msus.safety@alcon.com
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 products (ie, CLEAR 
CARE,
 be considered and processed as 
spontaneous (following the postmarket vigilance procedures) and should be communicated to 
the 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.
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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:
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.
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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 
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 AEs
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
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
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
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of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case-by-case basis.
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 
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 (not considering trial-fit lenses prior to randomization)
c) Enrolled Not Dispensed – subjects/eyes from All Enrolled that have not been exposed 
to study lenses (not considering trial-fit lenses prior to randomization)
d) Completed – Enrolled Dispensed subjects/eyes completing the study
e) Discontinued – Enrolled Dispensed subjects/eyes not complete 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.
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12.4 Effectiveness Analyses
For each of the primary and supportive effectiveness endpoints, separate summary tables will 
be prepared, when applicable, for the Completed and the Discontinued analysis sets as 
follows:

Completed Control (eyes/subjects)

Completed Test (eyes/subjects)

Discontinued Control (eyes/subjects)

Discontinued Test (eyes/subjects)
No inferential testing will be performed on effectiveness endpoints, and format of the 
reporting tables will follow 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 objective of this study is to evaluate visual acuity of the investigational 
 
soft contact lens compared to the commercially available Biofinity soft contact lens. 
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 of the primary effectiveness endpoint is planned.
 
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.
12.4.2.1 Statistical Hypotheses and Model
No hypothesis testing of the supportive effectiveness endpoints is planned.
12.4.2.2 Analysis Methods
For each of the supportive effectiveness endpoints, descriptive summary statistics will be 
computed according to the scale of measurement.
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.
Incidence and reasons for discontinuation by lens group will be tabulated at each visit and 
overall.
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12.6 Safety Analyses
The safety endpoints are:

AEs

Biomicroscopy findings

Device deficiencies
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of AE as well as the other listed 
parameters.
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 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.
12.7 Interim Analyses and Reporting
There are no plans to conduct an interim analysis.
12.8 Sample Size Justification
Sample size is based upon the following:

Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses –
at least 50 evaluable subjects to be followed for at least 3 months, for claim of 
substantial equivalence for a lens with different repeating monomer Units (new Parent 
USAN). In addition, a 2:1 ratio in Test vs Control evaluable subject allocation should 
be adopted.

ISO 11980:2012 – 50 completed subjects in Test, for 3 months. Either 2:1 or 1:1 ratio 
of Test to Control can be accepted.
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. 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 
personnel. The Investigator must keep the original, signed copy of the consent (file in 
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subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations. 
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available on www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.
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 Additional References for This Clinical Study

Premarket Notification [510((k)] Guidance Document for Daily Wear Contact Lenses, 
May 1994
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