Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Phase: NA
Conditions: Myopia, Refractive Errors
Sponsor: Alcon Research

Page 1 of 39
___________________________________________________________________________
Title:
Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
Investigator Agreement:
CLE383-C006 / CLE383-C006
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Daily Disposable T2 Soft Contact Lenses (DD T2)
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described trial in 
compliance with Good Clinical Practice (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
Address:
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1
PROTOCOL SYNOPSIS
Trial Sponsor
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Name of Test Product
DD T2
Name of Control 
Product
CooperVision® clariti® 1 day (Clariti 1 Day)
Title of Trial
Clinical Comparison of Two Daily Disposable Soft Contact Lenses
Protocol Number
CLE383-C006
Number of Sites
Country
~1
US
Planned Duration of 
Exposure 
~20 days total duration
•
Test Product: 8 days (-1/+2 days)
•
Control Products: 8 days (-1/+2 days)
Number of Subjects 
Target to complete: 20
Planned to enroll: ~22
Study Population
Volunteer subjects aged 18 or over who are soft daily disposable 
contact lens wearers (excluding current Clariti 1 Day wearers), have at 
least 3 months of contact lens wearing experience, and who wear their 
habitual lenses at least 5 days per week and at least 8 hours per day.  
Objectives
The primary objective of this study is to evaluate the overall 
performance of DD T2 lenses when compared to Clariti 1 Day lenses.
Endpoints
Primary Effectiveness

Overall quality of vision
Safety

AEs

Biomicroscopy findings

Device deficiencies
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Assessments
Effectiveness
-
VA (Snellen distance)
-
Overall quality of vision
Safety
-
AEs
-
Biomicroscopy
-
Device deficiencies
Study Design
Prospective
Single-masked 
(trial subject)
Single-masked (Investigator)
Double-masked
Open-label
Other
Single group
Parallel group
Crossover
Other 
Contralateral
Bilateral
Monocular lens wear
Randomized
This is a randomized, prospective crossover study design. 
Approximately 22 subjects will be randomized to 1 of the 2 lens 
sequences consisting of 2 crossover sequences of test vs. control.  
Subjects will wear the assigned study Lens 1 bilaterally for 
approximately 1 week before crossing over into the assigned study 
Lens 2 bilaterally for approximately 1 week.  
Study Visits:  
1. Baseline/Dispense Lens 1
2. Day 8 (-1/+2 days) follow-up Lens 1/Dispense Lens 2
3. Day 8 (-1/+2 days) follow-up Lens 2/Exit
Test Product Details
Primary component/material
Product Name
DD T2
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LID Number
LID006841
Manufacturer
Alcon
Other 
The lenses will be available in 
-1.75 D to -4.50 D (0.25 D steps)
Control Product Details
Primary component/material
somofilcon A
Product Name
Clariti 1 Day
LID Number
LID014044
Manufacturer
CooperVision
Other
The lenses will be available in 
-1.75 D to -4.50 D (0.25 D steps)
Inclusion Criteria
1. Subject must be at least 18 years of age. 
2. Subject must be able to understand and must sign an ICF that has 
been approved by an IRB.
3. Successful wear of daily disposable spherical soft contact lenses in
both eyes for a minimum of 5 days per week and 8 hours per day 
during the past 3 months.
4. Manifest cylinder ≤ 0.75 D in each eye.
5. BCVA 20/25 or better in each eye.
6. Subject must be willing to stop wearing their habitual contact 
lenses for the duration of study participation.  
Exclusion Criteria
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 refractive surgery or plan to have refractive surgery 
during the study or irregular cornea in either eye.
4. Ocular or intraocular surgery (excluding placement of punctal 
plugs) within the previous 12 months or planned during the study.
5. Biomicroscopy findings at screening that are moderate (Grade 3) or 
higher and/or corneal vascularization that is mild (Grade 2) or 
higher.
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 trial.
9. Current or history of intolerance, hypersensitivity, or allergy to any 
component of the study products.
10. 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.
11. Any use of topical ocular medications and artificial tear or 
rewetting drops that would require instillation during contact lens 
wear.
12. The Investigator, his/her staff, family members of the Investigator, 
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family members of the Investigator’s staff, or individuals living in 
the households of the aforementioned persons may not participate 
in the study. 
13. Participation of the subject in a clinical trial within the previous 30 
days or currently enrolled in any clinical trial.
14. Currently wearing Clariti 1 Day contact lenses.
15. Habitually wearing monovision or multifocal lenses during the last 
3 months.
Associated Materials
Lubrication/re-wetting drops will not be permitted.
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Table 1–1
Schedule of Study Procedures and Assessments
Procedure/ 
Assessment
Visit 1, Day 1 
Visit 2, Week 1:
Day 8 of lens wear
(-1/+2 days) 
Visit 3, 
Week 2:
Day 8 of lens 
wear
(-1/+2 days) 
Unscheduled
Visit
Early Exit
Baseline/
Dispense 
Lens 1
Follow-up 
Lens 1
Dispense 
Lens 2
Follow-up 
Lens 2/
Exit
Informed Consent

-
-
-
-
-
Demographics

-
-
-
-
-
Medical History

-
-
-
-
-
Concomitant 
Medications

()
-
()
()
()
Inclusion/
Exclusion

-
-
-
-
-
Habitual lens
(brand, power)*

-
-
-
-
-
VA w/ habitual 
correction
(OD, OS, Snellen
distance)*

-
-

()

Biomicroscopy


-



Dispense study 
lenses

-

-
-
-
VA w/ study lenses
(OD, OS, Snellen
distance)




()
()
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Procedure/ 
Assessment
Visit 1, Day 1 
Visit 2, Week 1:
Day 8 of lens wear
(-1/+2 days) 
Visit 3, 
Week 2:
Day 8 of lens 
wear
(-1/+2 days) 
Unscheduled
Visit
Early Exit
Baseline/
Dispense 
Lens 1
Follow-up 
Lens 1
Dispense 
Lens 2
Follow-up 
Lens 2/
Exit
Subjective rating 
with study lenses: 
•
•
 
•
•
•
overall quality of 
vision
•
 
•
-

-



AEs 





Device deficiencies 





Exit Form
()
()
()
()

() assessment performed as necessary, eg, decrease of VA by 2 lines or more with investigational product (IP)
* Source only
ᵼComments, optional
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1.1
Abbreviations
Table 1–2
Table of Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
ASADE
Anticipated serious adverse device effect
AE
Adverse event
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
D
Diopter
DD
Daily disposable
eCRF
Electronic case report form
EDC
Electronic data capture
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
ICF
Informed consent form
IEC
International ethics committee
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LID
Lens identification
mm
Millimeter
MOP
Manual of procedures
MR
Manifest refractioin
N/A
Not applicable
OD
Right eye
OS
Left eye
OU
Both eyes
SAE
Serious adverse event
SADE
Serious adverse device effect
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
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2
TABLE OF CONTENTS
Clinical Comparison of Two Daily Disposable Soft Contact Lenses ........................................1
1
PROTOCOL SYNOPSIS ....................................................................................................2
Clinical Comparison of Two Daily Disposable Soft Contact Lenses ........................................2
1.1
Abbreviations ......................................................................................................8
2
TABLE OF CONTENTS.....................................................................................................9
List of Tables............................................................................................................................11
List of Figures..........................................................................................................................11
3
INTRODUCTION.............................................................................................................12
3.1
Study Rationale and Purpose.............................................................................12
3.2
Trial Objective...................................................................................................12
3.3
Risks and Benefits.............................................................................................12
3.4
Subject Population.............................................................................................13
3.5
Outline of Study ................................................................................................13
4
TREATMENTS ADMINISTERED...................................................................................13
4.1
Identity of Study Treatments .............................................................................13
4.2
Accountability Procedures.................................................................................15
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................15
5.1
Visits and Examinations ....................................................................................15
5.1.1
Visit 1 (Day 1) – Baseline/Dispense Lens 1......................................15
5.1.2
Visit 2, Week 1 [Day 8 (-1/+2 Days)] – Follow-up Lens 1/Dispense 
Lens 2 ................................................................................................18
5.1.3
Visit 3, Week 2 [Day 8 (-1/+2 Days)] – Follow-up Lens 2/Exit........20
5.2
Unscheduled Visits ............................................................................................21
5.3
Discontinued Subjects .......................................................................................22
5.4
Clinical Study Termination................................................................................22
6
ANALYSIS PLAN ............................................................................................................23
6.1
Subject Evaluability...........................................................................................23
6.2
Analysis Data Sets.............................................................................................23
6.2.1
Safety Analysis Set............................................................................23
6.3
Demographic and Baseline Characteristics.......................................................23
6.4
Effectiveness Analyses ......................................................................................24
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6.4.1
Primary Effectiveness........................................................................24
6.4.1.1
Statistical Hypotheses........................................................24
6.4.1.2
Analysis Methods ..............................................................24
6.4.2
Secondary Effectiveness....................................................................24
24
25
25
6.5
Subgroup Analyses ............................................................................................25
6.6
Handling of Missing Data .................................................................................25
6.7
Multiplicity........................................................................................................25
6.8
Safety Analysis ..................................................................................................25
6.9
Interim Analyses................................................................................................26
26
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................26
7.1
General Information ..........................................................................................28
7.2
Monitoring for Adverse Events .........................................................................31
7.3
Procedures for Recording and Reporting ..........................................................32
7.4
Return product analysis .....................................................................................34
7.5
Follow-up of Subjects with Adverse Events .....................................................34
7.6
Pregnancy in the Clinical Study........................................................................34
8
CONFIDENTIALITY, BIAS, AND MASKING...............................................................34
8.1
Subject Confidentiality and Methods Used to Minimize Bias..........................34
8.2
Unmasking of the Study Treatment...................................................................35
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................35
9.1
Completion of Source Documents and Case Report Forms..............................35
9.2
Data Review and Clarifications.........................................................................36
9.3
Regulatory Documentation and Records Retention ..........................................36
10 ETHICS AND COMPLIANCE.........................................................................................37
10.1
Compliance........................................................................................................37
10.2
Institutional Review Board (IRB) .....................................................................37
11 PROTOCOL AMENDMENT HISTORY..........................................................................38
12 REFERENCES ..................................................................................................................38
12.1
References applicable for all clinical trials .......................................................38
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12.1.1
US references applicable for clinical trials........................................39
12.2
References for this clinical trial.........................................................................39
List of Tables
Table 1–1
Schedule of Study Procedures and Assessments ...............................................6
Table 1–2
Table of Abbreviations.......................................................................................8
Table 4–1
Description of Test and Control Products........................................................14
Table 7-1
Terms and Definitions......................................................................................26
List of Figures
Figure 7–1
Categorization of All AEs................................................................................29
Figure 7-2
Categorization of All Serious Adverse Events.................................................29
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3
INTRODUCTION
3.1
Study Rationale and Purpose
The purpose of this study is to obtain on-eye performance data to inform contact lens product 
development and to further evaluate product performance in the intended population. The 
primary endpoint was selected to fulfill 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. Clariti 1 Day contact lenses were chosen as 
the control product because these lenses have the same wear modality. The new contact lens 
in development is intended for the optical correction of refractive myopia in persons with 
non-diseased eyes.
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate 
to a product that is subsequently approved or cleared for marketing.
3.2
Trial Objective
The primary objective of this study is to evaluate the overall performance of DD T2 lenses 
when compared to Clariti 1 Day lenses.
3.3
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. 
The new contact lens in development and the control contact lens are not intended for use 
with a cleaning/disinfecting solution, and the biocompatibility with lens care solutions and 
any associated clinical effects are unknown.
A summary of the known potential risks and benefits associated with the new contact lens in 
development can be found in the Investigator’s Brochure. There may also be unknown risks 
with the use of the new contact lens. Risks are minimized by compliance with the eligibility 
criteria and study procedures, and through close supervision by a licensed clinician during 
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exposure to the study lenses. The potential harms associated with on-eye exposure to the new 
lens materials include toxicity response, blurred vision and ocular discomfort. In general, the 
risks with the new contact lens in development are anticipated to be similar to other marketed 
daily disposable soft contact lenses.
The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while 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.
3.4
Subject Population
The study population includes approximately 22 volunteer subjects to be enrolled at 
approximately 1 site. The study population will consist of subjects with normal eyes (other 
than the need for optical correction for myopia), and who are adapted, existing wearers of 
daily disposable soft contact lenses in both eyes.
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1
of this protocol. Rescreening of subjects is not allowed in this study.
3.5
Outline of Study
This will be a prospective, randomized, crossover, double-masked study comparing 2 contact 
lenses. The expected duration of subject participation in the study is approximately 20 days, 
with 3 scheduled visits. The study is expected to be completed in approximately 5 weeks.
4
TREATMENTS ADMINISTERED
This is a crossover study design. Subjects will be randomized to 1 of the 2 lens sequences, as 
described below:
Sequence 1: DD T2 →Clariti 1 Day
Sequence 2: Clariti 1 Day →DD T2 
4.1
Identity of Study Treatments
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Table 4–1
Description of Test and Control Products
Test Lens
Control Lens
LID Number
LID006841
LID014044
Lens
DD T2
Clariti 1 Day
Material
somofilcon A
Water Content
56%
Base Curve (mm)
8.3
8.6
Diameter (mm)
14.2
14.1
Rx powers to be available in 
this study
-1.75 to -4.50 D 
(0.25 D steps)
-1.75  to -4.50 D
(0.25 D steps)
Packaging, Labeling, and 
Supply

Blister foil pack

Foil label includes at a 
minimum:
- material name and/or 
identifier
- base curve
- diameter
- manufacturing protocol 
number
- packing solution
- power
- lot number
- expiration date
- content statement
- investigational device 
statement
- Sponsor information
- country of origin

Provided in boxes of 12 
lenses per power per 
box, identified with the 
following at a minimum:
- a color coded label 
stating the protocol 
number
- identifier
- power
- an investigational use 
only statement
- tracking number

Lenses should be stored 
at room temperature.

Blister foil pack

Foil label includes at a 
minimum:
- material name and/or 
identifier
- base curve
- diameter
- packing solution
- power
- lot number
- expiration date
- content statement
- investigational device 
statement
- Sponsor information
- country of origin

Provided in boxes of 12 
lenses per power per box,  
identified with the following 
at a minimum:
- a color coded label stating 
the protocol number
- identifier
- power
- an investigational use only 
statement
- tracking number

Lenses should be stored at 
room temperature.
Usage

Wear:
o
Daily wear
o
Bilateral, crossover group

Replacement period: Daily Disposable

Exposure: At least 8 hours per day, at least 5 days per week 
over the study treatment duration. 

Lens Care: N/A
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4.2
Accountability Procedures
Upon receipt of the study lenses, the Investigator or delegate will conduct an inventory. 
Designated study staff will provide the study lenses to the subjects in accordance with their 
randomization schedule. Throughout the study, the Investigator or delegate must maintain 
records of study treatment dispensation and collection for each subject. This record must be 
made available to the study monitor for the purposes of verifying the accounting of clinical 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. 
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 
adverse event [ie, ADE or SADE] are returned to the Study Sponsor for investigation. 
Refer to Section 7.3 of this protocol for additional information on the reporting of 
device deficiencies and AEs and the return of study products associated with these 
events.
5
STUDY PROCEDURES AND ASSESSMENTS
5.1
Visits and Examinations
5.1.1
Visit 1 (Day 1) – Baseline/Dispense Lens 1
1
Explain the purpose and nature of the study, and have the subject read, sign, and date 
the IRB-approved informed consent document. Additionally, have the individual 
obtaining consent from the subject and a witness, if applicable, sign and date the 
informed consent document. Provide a photocopy of the signed document to the 
subject and place the original signed document in the subject’s chart. After signing 
the ICF, a subject will be assigned a subject number by the EDC system. A signed 
informed consent document defines the point of enrollment.
2
Obtain demographic information and medical history, 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.
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3
4
Perform Snellen VA with habitual correction.

OD, OS, distance only, contact lenses

Over-refraction (only needed if VA is reduced)
Record habitual lens information (brand, power).
5
6
7
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:
Limbal hyperemia
Bulbar hyperemia
Corneal staining
Conjunctival staining
Palpebral conjunctival observations
Corneal epithelial edema
Corneal stromal edema
Corneal vascularization
Conjunctival compression/indention
Chemosis
Corneal infiltrates
Other findings
8
Determine study lens powers based upon the manifest refraction and habitual lens 
powers.
9
Review inclusion/exclusion criteria to determine if the subject qualifies to be
randomized into the study. If subject qualifies, request randomization. If subject does 
not qualify, exit the subject from the study as a screen failure.
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10
Based upon the randomized treatment sequence assignment, have the subject insert 
the appropriate study lenses.
Keep all lidding foils of lenses used during lens fit process for study lens 
accountability.
Follow procedures to maintain masking. 
11
 
12
Evaluate the study lenses by performing the following:
Snellen VA with study lenses (OD and OS, at distance)*
Over-refraction if necessary to determine the best contact lens-corrected VA 
and final study lens power(s)
*VA w/study lenses must be 20/40 OU or better for subject to leave the office
13
14
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects (including those 
that screen fail) from the time of signature of informed consent.
15
Dispense study lenses (Lens 1). Provide the subject with written and verbal
instructions on lens wear.
16
Schedule Visit 2 to take place on Day 8 (-1/+2 days) of lens wear (Lens 1).
17
Note: If for some reason a subject is unable to wear a study lens for the duration of this visit 
window, instruct the subject to return to the site for an Unscheduled Visit as well as lens 
removal on site, if possible. The subject should then be scheduled to return to the clinic for 
Visit 2 (if possible) or exited from the study.
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5.1.2
Visit 2, Week 1 [Day 8 (-1/+2 Days)] – Follow-up Lens 1/Dispense 
Lens 2
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any device deficiencies or AEs including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s).
3
Review subject compliance with lens wear and adjunct product usage. 
4
Administer Subjective Questionnaire to assess the following: 




Subjective overall quality of vision, OU


5
Evaluate the study lenses by performing the following:
Snellen VA with study lenses (OD and OS, at distance)
6
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7
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:
Limbal hyperemia
Bulbar hyperemia
Corneal staining
Conjunctival staining
Palpebral conjunctival observations
Corneal epithelial edema
Corneal stromal edema
Corneal vascularization
Conjunctival compression/indention
Chemosis
Corneal infiltrates
Other findings
8
Based upon the randomized treatment sequence assignment, have the subject insert 
the Lens 2 study lenses to be evaluated.
Note: Keep all lidding foils of lenses used during lens fit process for study lens 
accountability.
9
 
10
Evaluate the study lenses by performing the following:
Snellen VA with study lenses (OD and OS, at distance)*
Over-refraction if necessary to determine the best contact lens-corrected VA
and final study lens power(s)
*VA w/study lenses must be 20/40 OU or better for subject to leave the office
11
12
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from 
the time of signature of informed consent regardless of their enrollment status 
(screen failure or randomized).
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13
Dispense study lenses (Lens 2). Provide the subject with written and verbal
instructions on lens wear.
14
Schedule Visit 3 to take place on Day 8 (-1/+2 days) of lens wear (Lens 2).
15
Note: If for some reason a subject is unable to wear a study lens for the duration of this 
visit window, instruct the subject to return to the site for an Unscheduled Visit as well as 
lens removal on site, if possible. The subject should then be scheduled to return to the clinic 
for Visit 3 (if possible) or exited from the study.
5.1.3
Visit 3, Week 2 [Day 8 (-1/+2 Days)] – Follow-up Lens 2/Exit 
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any device deficiencies or AEs including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s).
3
Review subject compliance with lens wear and adjunct product usage. 
4
Administer Subjective Questionnaire to assess the following: 




Subjective overall quality of vision, OU



5
Evaluate the study lenses by performing the following:
Snellen VA with study lenses (OD and OS, at distance)
6
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7
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:
Limbal hyperemia
Bulbar hyperemia
Corneal staining
Conjunctival staining
Palpebral conjunctival observations
Corneal epithelial edema
Corneal stromal edema
Corneal vascularization
Conjunctival compression/indention
Chemosis
Corneal infiltrates
Other findings
8
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from 
the time of signature of informed consent regardless of their enrollment status
(screen failure or randomized).
9
Perform Snellen VA with habitual correction.
OD, OS, distance only, contact lenses
Note: If this VA with habitual correction shows a decrease of 2 lines or more versus
Visit 1 baseline VA with habitual correction, then BCVA with MR is required to 
confirm a potential loss in VA for AE reporting requirements (see Section 7).
10
Exit the subject from the study.
5.2
Unscheduled Visits
Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject 
requires an Unscheduled Visit, he/she must be advised to return to the office wearing the 
study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated 
in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must 
conduct the following procedures: 

Collect AE and device deficiency information

Assess and record changes in medical condition or concomitant medication 

Assess and record VAs
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
Perform biomicroscopy (assessments with or without lenses, as possible)
In addition, all procedures for Visit 3 (Follow-up Lens 2/Exit) should be completed (as 
possible). 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 study lenses or discontinuing 
from the study, the Investigator must conduct Exit procedures according to Table 1-1:
Schedule of Study Procedures and Assessments, as possible.
5.3
Discontinued Subjects
Discontinued subjects are those who withdraw or are withdrawn from the study after signing 
the informed consent, including screen failures. Subjects may discontinue from the study at 
any time for any reason. Subjects may also be discontinued from the study at any time if, in 
the opinion of the Investigator, their continued participation poses a risk to their health. 
Discontinued subjects will not be replaced (ie, their subject numbers will not be 
re-assigned/re-used).
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the Investigator must document those observations on an AE Form.
Any subject who exits early from the study (excluding screen failures) must undergo all 
procedures outlined at Visit 3, as applicable.
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.
5.4
Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time, for reasonable cause.
If the clinical study is prematurely terminated or suspended by the Study Sponsor:

The Study Sponsor must:
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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, as 
applicable.

The Investigator must:
o Promptly notify the IRB 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 a site’s participation in the study for reasonable cause.
6
ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
counts and percentages from each category. Any deviations to this 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.
6.1
Subject Evaluability
The final subject evaluability will be determined prior to breaking the code for masked 
treatment sequence assignment and locking the database, based on the Deviations and 
Evaluability Plan.
6.2
Analysis Data Sets
6.2.1
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 lens exposed in the corresponding lens sequence. 
6.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set. Baseline data pertaining to habitual lens 
 
 will be summarized on the Safety Analysis Set as well.
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6.4
Effectiveness Analyses
This study defines one primary endpoint 
 The Safety 
Analysis Set will serve as the primary set for all effectiveness analyses.
6.4.1
Primary Effectiveness
The primary objective of this study is to evaluate the overall performance of DD T2 lenses 
when compared to Clariti 1 Day lenses. The primary endpoint is the subjective rating of
overall quality of vision, collected binocularly on a scale of 1 (Poor) to 10 (Excellent) at the 
Day 8 Follow-up visits.
6.4.1.1
Statistical Hypotheses
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated.
6.4.1.2
Analysis Methods
Descriptive statistics will be provided. 
6.4.2
Secondary Effectiveness
No secondary objective or endpoint is defined for this study.
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6.5
Subgroup Analyses
It is not expected that demographic or baseline characteristics will have an impact on the 
study results in this study. No subgroup analyses are planned.
6.6
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 analysis.
6.7
Multiplicity
No multiplicity adjustment needs to be considered for the effectiveness endpoints since no 
formal hypothesis testing will be conducted.
6.8
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to 
study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual 
subject listings will be provided, as necessary. 
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Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lenses. 
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 (Visit 1) to any subsequent visit will be presented. A supportive listing will be 
generated which will include all biomicroscopy data from all visits for these eyes 
experiencing the increase.
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated. 
No inferential testing will be conducted for the safety analyses. 
6.9
Interim Analyses
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Table 7-1
Terms and Definitions
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.
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Adverse device effect 
(ADE)
AE related to the use of an investigational medical device (test 
product) or control product. 
Note: This definition includes AEs 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.
Anticipated serious 
adverse device effect 
(ASADE)
Serious ADE 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.
Malfunction
Failure of a medical device to meet its performance specifications 
or otherwise perform as intended. Performance specifications 
include all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed.
Non-serious adverse 
event
AE that does not meet the criteria for an SAE.
Serious adverse event 
(SAE)
AE that led to any of the following:

Death.

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 
an SAE. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an 
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overnight stay) that would not have been appropriate in the 
physician's office or an out-patient setting. Complications 
that occur during hospitalization are adverse events. If a 
complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be 
considered serious.
d) a medical or surgical intervention to prevent a) or b). 
e) any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer’s instructions 
for use.

Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Refer to Section 7.1 for additional SAEs.
Serious adverse 
device effect (SADE)
ADE that has resulted in any of the consequences characteristic of 
an SAE.
Significant non-
serious adverse event
A significant non-serious AE is a symptomatic, device-related, 
non-sight threatening AE that warrants discontinuation of any 
contact lens wear for greater than or equal to 2 weeks.
Refer to Section 7.1 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.
7.1
General Information
An AE is 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 article).
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Figure 7–1
Categorization of All AEs
Figure 7-2
Categorization of All Serious Adverse Events
Serious Adverse Events 
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:

An ocular infection including a presumed infectious ulcer with any of the following 
characteristics: 
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o
Central or paracentral location
o
Penetration of Bowman’s membrane
o
Infiltrates > 2 mm diameter
o
Iritis
o
Increase in intraocular pressure
o
Culture positive for microorganisms
o
Increasing size or severity at subsequent visits

Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification

Hypopyon

Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥ 50% of corneal surface area
Significant Non-Serious Adverse Events
A significant non-serious AE is a symptomatic, 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 AE:

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) [Grading scale is based on ISO 11980:2012 unless specified differently in 
MOP]

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 
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The above events are based upon the categories provided in the ISO 11980:2012 and the US 
FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses 
and Contact Lens Care Products. 
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 cloudy

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
7.2
Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
Additionally, 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. 
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7.3
Procedures for Recording and Reporting
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF.
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the Investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period. 

ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the Investigator’s or site’s awareness. 

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the Investigator’s or site’s awareness. 

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.
Any AEs and device deficiencies for non-study marketed devices/products will be considered 
and processed as spontaneous (following the postmarket vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question and their
contact information is provided in the MOP that accompanies this protocol.
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Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
medical judgment with consideration of any subjective symptom(s), as defined below:
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.
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7.4
Return product analysis
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. These 
products should be returned to the Sponsor at the end of the study, unless instructed otherwise 
by the Sponsor. 
7.5
Follow-up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after
this time period will be considered and processed as spontaneous 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.
7.6
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 
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
CONFIDENTIALITY, BIAS, AND MASKING
8.1
Subject Confidentiality and Methods Used to Minimize Bias
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 Sponsor will collect a copy of the 
enrollment log without any identifying subject information. All documents submitted to the 
Sponsor will identify the subjects exclusively by number and demographic information. No 
other personally identifying information should be transmitted to the Sponsor.
This study is double-masked with subjects randomized to use both DD T2 and the assigned 
control product (in a randomized sequence) for the duration of the treatment period. The 
Investigator and Sponsor personnel (other than site monitors, lead clinical site manager, 
person responsible for generating the randomization schedule, and unmasked clinical data 
managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be 
masked to the identity of the contact lens being administered. 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. Unmasked study personnel must not 
disseminate information that is potentially unmasking to any masked personnel. The masked 
and unmasked site personnel must coordinate all study activities as necessary to protect 
masking and minimize bias during the trial.
8.2
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 reporting requirements.
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
9.1
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 eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. 
Study 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. 
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At a minimum, source documents should include the following information for each subject:

Subject identification (name, sex, race/ethnicity)

Documentation of subject eligibility

Date of informed consent

Dates of visits

Documentation that protocol specific procedures were performed

Results of study parameters, as required by the protocol

IP accountability records

Documentation of AEs and other safety parameters (if applicable)

Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data.
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The Principal Investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number, and subject 
demographic information.
9.2
Data Review and Clarifications
Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source 
data will be completed by the site monitor to ensure completeness and accuracy. 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 eCRFs.
9.3
Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing 
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study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval).
10 ETHICS AND COMPLIANCE
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards.
10.1 Compliance
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.
10.2 Institutional Review Board (IRB)
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB.
Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all 
other information as required by local regulation and/or the IRB. At the end of the study, the 
Investigator must notify the IRB about the study’s completion. The IRB also must be notified 
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if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB.
Voluntary informed consent must be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other study-related procedures. The 
Investigator must have a defined process for obtaining consent. Specifically, the Investigator, 
or 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, 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 and must provide a duplicate copy to each 
subject according to local regulations. Following this study, the subject will return to their 
eye care professional for their routine eye care and contact lenses.
11 PROTOCOL AMENDMENT HISTORY
Version
Brief Description and Rationale
1
Initial Version of this document
12 REFERENCES
12.1 References applicable for all clinical trials
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
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12.1.1 US references applicable for clinical trials

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.
12.2 References for this clinical trial
Not applicable.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
04/20/2018 17:39:22
04/20/2018 01:47:45
04/19/2018 19:07:57
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