Clinical Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens
Phase: NA
Conditions: Myopia
Sponsor: Alcon Research



Page 2 of 56
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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8.3
Rescreening of Subjects ....................................................................................25
9
TREATMENTS ADMINISTERED...................................................................................25
9.1
Investigational Product(s)..................................................................................26
9.3
Treatment Assignment / Randomization ...........................................................29
9.4
Treatment Masking............................................................................................30
9.5
Accountability Procedures.................................................................................32
9.6
Changes to concomitant medications, treatments/ procedures..........................33
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................33
10.1
Informed Consent and Screening ......................................................................34
10.2
Description of Study Procedures and Assessments...........................................34
10.2.1
Demographics....................................................................................34
10.2.2
Medical History.................................................................................34
10.2.3
Investigational Product Compliance..................................................35
10.2.4
Habitual Lens Information ................................................................35
10.2.5
Habitual VA Assessment (Snellen)....................................................35
10.2.11 Randomization...................................................................................36
10.2.12 Study Lenses VA Assessment (logMAR) ..........................................36
10.2.21 AE Collection....................................................................................37
10.2.22 Device Deficiencies...........................................................................37
10.3
Unscheduled Visits ............................................................................................38
10.4
Discontinued Subjects .......................................................................................38
10.4.1
Screen Failures ..................................................................................38
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10.4.2
Discontinuations................................................................................38
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................39
10.5
Clinical Study Termination................................................................................39
10.5.1
Follow-up of subjects after study participation has ended ................40
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................40
11.1
General Information ..........................................................................................40
11.2
Monitoring for Adverse Events .........................................................................43
11.3
Procedures for Recording and Reporting ..........................................................43
11.4
Return Product Analysis....................................................................................45
11.5
Unmasking of the Study Treatment...................................................................46
11.6
Follow-Up of Subjects with Adverse Events.....................................................46
11.7
Pregnancy in the Clinical Study........................................................................47
12 ANALYSIS PLAN ............................................................................................................47
12.1
Subject Evaluability...........................................................................................47
12.2
Analysis Sets .....................................................................................................47
12.2.1
Safety Analysis Set............................................................................47
12.2.2
Full Analysis Set................................................................................47
12.3
Demographic and Baseline Characteristics.......................................................48
12.4
Effectiveness Analyses ......................................................................................48
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................48
12.4.1.1
Statistical Hypotheses........................................................48
12.4.1.2
Analysis Methods ..............................................................48
12.5
Handling of Missing Data .................................................................................50
12.6
Safety Analyses .................................................................................................50
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................52
13.1
Subject Confidentiality......................................................................................52
13.2
Completion of Source Documents and Case Report Forms..............................52
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13.3
Data Review and Clarifications.........................................................................53
13.4
Sponsor and Monitoring Responsibilities .........................................................53
13.5
Regulatory Documentation and Records Retention ..........................................54
13.6
Quality Assurance and Quality Control.............................................................54
14 ETHICS .............................................................................................................................54
15 REFERENCES ..................................................................................................................56
15.1
References Applicable for All Clinical Studies.................................................56
15.1.1
US References Applicable for Clinical Studies.................................56
15.2
References for This Clinical Study....................................................................56
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 .............................................16
Table 6–1
Primary Objective(s)........................................................................................20
Table 6–3
Safety Objective(s)...........................................................................................21
Table 9–1
Test Product .....................................................................................................26
Table 9–2
Control Product................................................................................................28
List of Figures
Figure 11-1
Categorization of All Adverse Events..............................................................40
Figure 11-2
Categorization of All Serious Adverse Events...............................................411
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1
GLOSSARY OF TERMS
Names of test product(s)
Throughout this document, test product(s) will be referred to 
as 
(LID018869)
Name of Control Product(s)
CooperVision® Biofinity® contact lenses (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, 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
BCVA
Best corrected visual acuity
Biofinity
CooperVision Biofinity contact lenses
CFR
Code of Federal Regulations
CLEAR CARE
CLEAR CARE® disinfection solution
CI
Confidence Interval
COL
Clinical Operations Lead
CSM
Clinical Site Manager
D
Diopter(s)
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full Analysis Set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System
ICF
Informed consent form
IB
Investigational Brochure
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional Review Board
IRT
Interactive Response Technology
ISO
International Organization for Standardization
LID
Lens identification
LogMAR
Logarithm of the minimum angle of resolution
mm
Millimeter
MOP
Manual of Procedures
N/A
Not applicable
OD
Right eye
OS
Left eye
PP
Per Protocol
SAE
Serious adverse event
SADE
Serious adverse device effect
SD
Standard deviation
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
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3
PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product:
 (LID018869)
Control Product: CooperVision® Biofinity® contact lenses (Biofinity)
Purpose and 
rationale
The rationale for this study is to assess the clinical performance of the 
investigational 
 contact lens over 30 days of daily wear.
Objective(s)
The primary objective of this study is to evaluate visual acuity (VA) of 
the investigational 
 contact lens.
 
 
Endpoint(s)
Primary Effectiveness 
Distance VA (logMAR) with study lenses
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Safety

Adverse events (AEs)

Biomicroscopy findings

Device deficiencies
Assessment(s)
Effectiveness

Distance VA (logMAR) with study lenses
Safety
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
AEs 

Biomicroscopy

Device deficiencies
Study Design
This is a prospective, randomized, crossover, double masked study
comparing visual acuity with investigational 
 contact lenses vs. 
Biofinity contact lenses. 
Subjects will be expected to attend 4 visits. The total duration of a 
subject’s participation in the study is ~60 days, which includes ~30 days 
of exposure to the test product and ~30 days of exposure to the control 
product. Subjects will be expected to wear their study contact lenses for 
typical number of hours as they do for with their habitual contact lenses, 
at least 5 days per week, over a 30 day period per study lens. On Visit 2 
and Visit 4, subjects will be expected wear study lenses between 6 - 8 
hours at time of visit and prior to lens removal. 
 
All contact lenses will be prescribed according to the subject’s 
prescription. CLEAR CARE® disinfection solution will be used during 
the duration of the study.
Subject 
population
Volunteer subjects aged 18 years or older who are current wearers of 
spherical weekly/monthly soft contact lenses in both eyes with at least 
3 months wearing experience, with a minimum wearing time of 5 days 
per week and 10 hours per day.
Planned number of subjects enrolled/consented:  ~65
Planned number of completed subjects:  58
Key inclusion 
criteria
(See Section 8.1 
for a complete 
list of inclusion 
criteria)

Subjects must be ≥ 18 year of age

Current wearers of spherical weekly/monthly soft contact lenses 
in both eyes with at least 3 months wearing experience, with a 
minimum wearing time of 5 days per week and 10 hours per day
Key exclusion 
criteria

Current or prior habitual Biofinity contact lens wearers in the 
past 3 months
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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
There are no amendments. This is the first version of the protocol. 
5
INTRODUCTION
5.1
Rationale and Background
Daily wear contact lenses are worn during waking hours for a full day and then removed for 
cleaning and disinfection prior to reinsertion the following day. Frequent replacement daily 
wear contact lenses are replaced according to the product package insert provided by the 
contact lens manufacturer.
 
 
 
 
 
In this clinical study, the clinical performance of the investigational 
 contact lens will 
be assessed and the 
 contact lens will be compared to the commercially available 
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Biofinity contact lens in a crossover design, both to be worn in a daily wear modality and 
replaced on a monthly basis.
5.2
Purpose of the Study
The purpose of this study is to assess the clinical performance of the investigational 
 
contact lens over 30 days of daily wear. The primary endpoint was selected to address the 
primary objective of the study. Procedures for measurement of these endpoints were selected 
based on common practice for these assessments. The design of this study is justified based 
upon preclinical and clinical testing, as described within the Investigator’s Brochure. 
Biofinity contact lenses were chosen as the control product because these lenses have the 
same wear modality and replacement schedule.
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
5.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of the contact lens in development 
are features consistent with successful contact lens wear.
Based upon non-clinical testing and/or documented rationale for applicability of test results 
to the IP, the new contact lens in development is assessed to be non-toxic and biocompatible 
for on-eye use.
Biofinity contact lenses are commercially available for daily wear use under a monthly wear
modality; further details on any known potential risks and benefits can be found in the 
package insert.
A summary of the known potential risks and benefits associated with the 
 contact 
lens in development can be found in the Investigator’s Brochure. Risks are minimized by 
compliance with the eligibility criteria and study procedures, clinical oversight and 
monitoring, and through close supervision by a licensed clinician during exposure to the 
study lenses. 
 
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The site personnel will educate subjects on proper hygiene and lens handling, as well as
compliance with the use of contact lenses according to the protocol. Subjects should be 
instructed not to wear contact lenses while sleeping or swimming. The site personnel will 
also 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.
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
To evaluate VA of the investigational 
 contact lens.
Distance VA (OD, OS; logMAR)
6.2
Secondary Objective(s)
Not Applicable.
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6.4
Safety Objective(s)
Table 6–3
Safety Objective(s)
Objective(s)
Endpoint(s)
Describe the safety profile of the study 
products

AEs

Biomicroscopy findings

Device deficiencies
7
INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, interventional, randomized, crossover, double masked study evaluating 
visual acuity of the investigational 
 contact lens. Habitual spherical weekly/monthly 
soft contact lens wearers will be randomized in 1 of the 2 crossover sequences. Subjects and 
investigators will be masked. 
 
 
Subjects will be expected to attend 4 office visits. All study contact lenses will be prescribed 
according to subject’s prescription. CLEAR CARE contact lens solution will be used 
throughout the duration of the study.
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7.3
Rationale for Duration of Treatment/Follow-Up
Subjects will wear each study product bilaterally for approximately 30 days. 
 
 
 
7.4
Rationale for Choice of Control Product
Biofinity contact lenses were chosen as the control product because these lenses have the 
same wear modality and replacement schedule.
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of male and female subjects age 18 years or older who are 
current wearers of spherical weekly/monthly soft contact lenses in both eyes with at least 
3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours 
per day. Subjects who are current or prior habitual Biofinity contact lens wearers in the past 3 
months will be excluded. It is aimed to enroll (consent) approximately 65 subjects in 
approximately 5 sites in the U.S., with a target of 58 completed subjects. Site-specific targets 
may vary based upon individual site capabilities. Estimated time needed to recruit subjects 
for the study is approximately 4 weeks
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 ≥ 18 years of age.
2. Subject must be able to understand and sign an IRB/IEC approved Informed Consent 
form.
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3. Willing and able to attend all scheduled study visits as required per protocol.
4. Current wearers of any commercial spherical weekly/monthly soft contact lenses in 
both eyes with at least 3 months wearing experience, with a minimum wearing time of 
5 days per week and 10 hours per day.
8.2
Exclusion Criteria
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13. Monovision contact lens wearers.
14. Current or prior habitual Biofinity contact lens wearers in the past 3 months prior to 
consent.
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. 
 
 
 
 
 
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
9
TREATMENTS ADMINISTERED
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lens in the provided lens care solution and wear their habitual 
spectacles.

Exposure: Typical contact lens wearing hours, at least 5 days
per week, over a 30 day period per study lens.

Lens Care: Lenses will be cleaned and disinfected with CLEAR 
CARE
Number/Amount of 
product to be 
provided to the 
subject
Subjects will insert study lenses at Visit 1 and Visit 3 at the site. No 
spare lenses will be provided to the subject. 
Packaging 
description
Blister foil pack
Storage conditions
Lens to be stored at room temperature.
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Table 9–2
Control Product
Control Product(s)
Biofinity contact lens
Manufacturer
CooperVision
Indication for Use
The intended use of this product 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 F (0.25 D steps)

Base curve (mm): 8.6

Diameter (mm): 14.0
Formulation
Silicone Hydrogel. For additional details, please refer to the 
Biofinity package insert.
Usage

Wear:
o
Daily Wear
o
Bilateral
o
Crossover according to randomization

Replacement period: 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. Until the 
replacement lens is obtained, the subject must store the fellow 
lens in the provided lens care solution and wear their habitual 
spectacles.

Exposure: Typical contact lens wearing hours, at least 5 days 
per week, over a 30 day period per study lens.
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
Lens Care: Lenses will be cleaned and disinfected with CLEAR 
CARE
Number/Amount of 
Product to be 
Provided to the 
subject
Subjects will insert study lenses at Visit 1 and Visit 3 at the site. No 
spare lenses will be provided to the subject. 
Packaging 
description
Blister foil pack in commercial packaging.
Labeling description
Commercial labeling.
Storage conditions
Lenses to be stored at room temperature.
More information on the test product can be found in the 
 IB; more information 
on the control product can be found in the Biofinity package insert.
9.2
Other Medical Device or Medication Specified for Use During the 
Study
During the clinical study, the following contact lens solution is required in conjunction with 
the treatment:

CLEAR CARE contact lens solution
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment in a crossover sequence of Test 
product then Control product or Control product then Test product, respectively.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system.
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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 treatment (lens sequence) according to the randomization list uploaded in the 
randomization 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/randomization integration 
system to one of the lens sequences. 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/randomization 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 the 
 contact lenses and 
the Biofinity contact lenses for the duration of the 30-week treatment period. Subjects, the 
Investigator, and masked study personnel (site and Sponsor) will be masked to the assigned 
treatment sequence.
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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. 
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. Refer to 
Section 11.5.
9.5
Accountability Procedures
Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the 
study, the masked Investigator must designate unmasked staff to provide the IPs to the 
subjects in accordance with their randomization assignment. 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 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
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
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 
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
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 are expected to attend 4 clinic visits over a period of approximately 65 days. Study 
lenses will be provided to the subjects to take home for daily wear during the course of the 
trial.
Study randomization will occur at Visit 1 with assigned lenses provided to take home at 
Visit 1 and Visit 3. Study contact lens fitting will occur at Visit 1 for both study lenses. If a 
subject cannot be successfully fit (either study lens) according to the study lens fitting guides 
as determined by the Investigator, they will be required to exit from the study.
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10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
Ocular and non-ocular medical history will be collected at Visit 1 and documented in the 
source documents. CRF data collection will be Targeted:

Concomitant medications: All ocular medications, targeted systemic 
medications.

Medical History: All ocular history, targeted systemic history
In the source documents, concomitant medications and medical history must be fully 
documented. All relevant medical conditions, including currently active conditions, 
diagnosed chronic conditions, and conditions resolved within the past year will be 
documented. Habitual lens information and medications taken within 30 days prior to Visit 1 
will be recorded in the source documentation. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications. Throughout the subject’s participation, 
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obtain information on any changes in medical health and/or the use of concomitant 
medications and record in subject source documents.
10.2.3 Investigational Product Compliance
Review subject compliance with the IP usage and collect all used lidding foils, unused study 
IPs and other study products that were dispensed.
10.2.4 Habitual Lens Information
Collect habitual lens brand, power (source only), and care at Visit 1.
10.2.5 Habitual VA Assessment (Snellen)
Perform distance VA (Snellen), OD and OS, with habitual correction at Visit 1 and Visit 4. 
Capture data in source only.
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10.2.11Randomization
Unmasked site personnel will randomize eligible subjects according to the assigned sequence 
at Visit 1.
10.2.12Study Lenses VA Assessment (logMAR)
Perform distance VA (logMAR), OD and OS, with study lenses at Visits 1, 2, 3, and 4.
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10.2.21AE Collection
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit in the 
subject source documents. See Section 11 for further details regarding AE collection and 
reporting.
10.2.22Device Deficiencies
Assess and record any device deficiencies that are reported or observed, including those 
associated with changes in concomitant medication dosing since the previous visit.
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Requirements for reporting device deficiencies in the study can be found in Section 11.
Device deficiencies on comparator lenses should be reported per the manufacturer’s 
guidelines.
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 AE and device deficiency information

Record changes in medical condition and concomitant medication

Perform biomicroscopy (assessments with or without study 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
Screen failures are subjects who were excluded from the study after signing the informed 
consent and prior to randomization.
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 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 
Any subjects discontinued from IP will be discontinued from the study and follow exit 
procedures.
10.5 Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time.
If the clinical study is prematurely terminated or suspended by the Study Sponsor: 

The Study Sponsor must:
o
Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination.
o
Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension. 

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.
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
Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥50% of corneal surface area
Significant Non-Serious Adverse Events
A significant non-serious AE is a device-related, non-sight threatening adverse event 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 on 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: 

Failure to meet product specifications (eg, incorrect lens power/diameter/base 
curve/color)

Lens/solution cloudy
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
Lens surface/edge defect 

Torn lens during handling/in pack 

Packaging deficit (eg, mislabeled product, tampered seal, leaking bottle/container)

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 shown 
below and report as applicable:

“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?”
In addition, 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 (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the subject’s 
Medical History.
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 
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:
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
ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the Investigator’s or site’s awareness. 

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the Investigator’s or site’s awareness. 

A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns. Please refer to 
the MOP for further details regarding 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.
Any AEs and device deficiencies for non-study marketed devices/products (ie, CLEAR 
CARE disinfection solution) will be considered and processed as spontaneous (following the 
post-market vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol-related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below:
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Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly 
related where a direct cause and effect relationship with the medical 
device or study procedure has not been demonstrated, but there is a 
reasonable possibility that the AE was caused by the medical device or 
study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or 
simply unlikely to be related (ie, there are other more likely causes for the 
AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related.
Furthermore, the Study Sponsor shall promptly 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
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
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Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS). 
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (refer to Section 9.4 Treatment Masking). 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 reporting requirements.
11.6 Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
Any additional data received up to 3 months after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
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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. 
 
 
 
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, SD, 
median, minimum, and maximum, as well as CIs or confidence limits where applicable. 
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.
12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked treatment 
sequence assignment and locking the database, based upon the Deviations and Evaluability 
Plan (DEP).
12.2 Analysis Sets
12.2.1 Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis.
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
evaluated in this study. For treatment-emergent safety analyses, subjects/eyes will be 
categorized under the actual study lenses exposed in the corresponding lens sequence.
12.2.2 Full Analysis Set
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study 
lenses evaluated in this study.
 
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12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens sequence and overall.
Counts and percentages will be presented for categorical variables such as sex, age group,
race, and ethnicity. Number of observations, mean, SD, median, minimum, and maximum
will be presented for continuous variables such as age.
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to evaluate the VA of the investigational 
 
contact lens. The primary endpoint is distance VA with study lenses, collected for each eye in 
logMAR.
12.4.1.1 Statistical Hypotheses
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated.
12.4.1.2 Analysis Methods
Descriptive statistics used for continuous variables will be presented.
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12.5 Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary 
 effectiveness
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 adverse events as well as the other 
listed parameters. 
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular 
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and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary.
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP.
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens exposure for each period) to any subsequent visit 
within the same period will be presented. A supportive listing will be generated which will 
include all biomicroscopy data from all visits within the same period for those eyes 
experiencing the increase.
Two listings for device deficiencies, prior to exposure of study contact lenses and 
treatment-emergent, will be provided. Additionally, each device deficiency category will be 
tabulated.
No inferential testing will be done for safety analysis.
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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.
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
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
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.
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.
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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.
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: 
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
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
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, Package Insert, 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 
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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 
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
15.2 References for This Clinical Study
Not applicable. There are no references.
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