Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Protocol Title: Clinical Evaluation of etafilcon A Contact Lenses Using a Novel 
Manufacturing Technology
Protocol CR-6324
Version: 2.0, Amendment 1.0
Date: April 26, 2019
Investigational Products: etafilcon A
Key Words: Words: etafilcon A, mold process, daily disposable
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, or 
as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc.  Any supplemental information that may be added to this 
document is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and 
must be kept in confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study...................................................................................................................... 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 16 
2.1. 
Objectives................................................................................................................. 16 
2.2. 
Endpoints.................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria...................................................................................................... 19 
3.3. 
Exclusion Criteria..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 22 
5.1. 
Test Article Allocation............................................................................................. 22 
5.2. 
Masking.................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION............................................................................................. 23 
6.1. 
Identity of Test Articles............................................................................................ 23 
6.2. 
Ancillary Supplies/Products..................................................................................... 24 
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6.3. 
Administration of Test Articles................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS.............................................................................................. 26 
7.1. 
Time and Event Schedule......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 27 
VISIT 1 ........................................................................................................................... 27 
VISIT 2 ........................................................................................................................... 32 
VISIT 3 ........................................................................................................................... 34 
VISIT 4 ........................................................................................................................... 38 
FINAL EVALUATION.................................................................................................. 40 
7.3. 
Unscheduled Visits................................................................................................... 40 
7.4. 
Laboratory Procedures ............................................................................................. 41 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 41 
8.1. 
Completion Criteria.................................................................................................. 41 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 41 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 42 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 42 
11. 
STUDY TERMINATION ........................................................................................... 43 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 43 
13. 
ADVERSE EVENTS................................................................................................... 45 
13.1. 
Definitions and Classifications............................................................................. 45 
13.2. 
Assessing Adverse Events.................................................................................... 47 
13.2.1. 
Causality Assessment.................................................................................... 47 
13.2.2. 
Severity Assessment...................................................................................... 48 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 48 
13.4. 
Reporting Adverse Events.................................................................................... 49 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 49 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 50 
13.4.3. 
Event of Special Interest ............................................................................... 50 
13.5. 
Reporting of Pregnancy........................................................................................ 50 
14. 
STATISTICAL METHODS........................................................................................ 51 
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14.1. 
General Considerations......................................................................................... 51 
14.2. 
Sample Size Justification...................................................................................... 51 
14.3. 
Analysis Populations ............................................................................................ 52 
14.4. 
Level of Statistical Significance........................................................................... 53 
14.5. 
Primary Analysis .................................................................................................. 53 
14.6. 
Secondary Analysis .............................................................................................. 53 
14.7. 
Other Exploratory Analyses ................................................................................. 54 
14.8. 
Interim Analysis ................................................................................................... 54 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 54 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 55 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 55 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 55 
15.2. 
Subject Record...................................................................................................... 55 
16. 
DATA MANAGEMENT............................................................................................. 56 
16.1. 
Access to Source Data/Document ........................................................................ 56 
16.2. 
Confidentiality of Information.............................................................................. 56 
16.3. 
Data Quality Assurance........................................................................................ 56 
17. 
MONITORING............................................................................................................ 57 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 57 
18.1. 
Study-Specific Design Considerations ................................................................. 57 
18.2. 
Investigator Responsibility................................................................................... 57 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 58 
18.4. 
Informed Consent ................................................................................................. 59 
18.5. 
Privacy of Personal Data ...................................................................................... 60 
19. 
STUDY RECORD RETENTION................................................................................ 61 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 61 
21. 
PUBLICATION........................................................................................................... 62 
22. 
REFERENCES ............................................................................................................ 62 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 63 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 70 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 71 
APPENDIX D: 
.................................... 100 
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS .................................. 101 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING.................. 109 
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 LENS FITTING CHARACTERISTICS............................................................ 114 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS....................... 121 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
............................................................................................................................................... 123 
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 129 
 BIOMICROSCOPY SCALE ............................................................................. 136 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 142 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 147 
 PATIENT REPORTED OUTCOMES .............................................................. 151 
 WHITE LIGHT LENS SURFACE WETTABILITY........................................ 153 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 155 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 161 
 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS
Table 1: Target number of subjects by arm and phase ........................................................... 22 
Table 2: Test Articles.............................................................................................................. 23 
Table 3: Ancillary Supplies .................................................................................................... 24 
Table 4: Time and Events ....................................................................................................... 26 
Table 5: 1-week CLUE comfort and vision for 1 Day ACUVUE MOIST in historical studies
................................................................................................................................................ .51 
Table 6: Power Analysis for CLUE scores............................................................................. 52 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Clinical Evaluation of etafilcon A Contact Lenses Using a Novel Manufacturing 
Technology
Protocol Number: CR-6324
Version: 2.0, Amendment 1.0
Date: April 26, 2019
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name:  Brian Pall, OD, MS, FAAO
Title: Senior Principal Research Optometrist
Address: 7500 Centurion Parkway, Suite 100, Mail W-2A, Jacksonville, FL 32256
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor 
may be contacted during business hours for adverse event questions. General study related 
questions should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations,4 ICH 
guidelines,2 ISO 14155,1 and the Declaration of Helsinki.3
Author
See Electronic Signature Report
Brian Pall, OD, MS, FAAO
Sr. Principal Research Optometrist
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Reviewer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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SYNOPSIS  
Protocol Title
Clinical Evaluation of etafilcon A Contact Lenses Using a 
Novel Manufacturing Technology
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Phase 0: Feasibility Study
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products:
x
etafilcon A contact lenses made with a novel 
manufacturing technology (Test) 
x
etafilcon A contact lenses made with the current 
manufacturing technology (Control).
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable
Objectives 
To evaluate the clinical performance of etafilcon A contact 
lenses made with a new manufacturing technology as 
compared to etafilcon A contact lenses made with the existing 
manufacturing technology.
Study Endpoints
Co-primary endpoint(s):
x
Overall comfort after 1-week of lens wear
x
Overall quality of vision after 1-week of lens wear
Secondary endpoint(s):  
x
Monocular distance visual performance
x
Average daily wear time (in hour)
Additional Endpoints:
x
Slit lamp findings
x
Subject reported ocular symptoms
x
Lens fitting characteristics
x
Lens wettability
x
Adverse events
Study Design
This study is a feasibility, multi-site, randomized, double-
masked, 2×2 crossover design, 1-week dispensing study.  
Subjects will wear bilaterally both Test and Control lenses in a 
random order for 1-week each as a daily disposable modality 
with a wash-out period of 1 week between the wearing 
periods.  
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
Up to 100 eligible subjects will be enrolled and randomized 
into the study to ensure that approximately 90 subjects 
complete as cohort.
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Study Duration
The study will last approximately 7 weeks and include an 
enrollment period of 3 weeks.
Anticipated Study 
Population
Healthy male and female volunteers (at least 18 and not more 
than 70 years old) who are habitual wearers of daily 
disposable contact lenses (approximately 80% 1-Day 
ACUVUE Moist, approximately 20% other daily disposable 
hydrogel contact lens brands) and have a spectacle 
astigmatism of <0.75D in both eyes.  
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria after Screening
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age 
(including 70) at the time of screening.
4. The subject must be a habitual and adapted wearer of 
hydrogel daily disposable brand contact lenses in both
eyes (at least 1 month of daily wear).
5. The subject must have normal eyes (i.e., no ocular 
medications or infections of any type).
Inclusion Criteria after Baseline
6. The 
subject’s 
required 
spherical 
contact 
lens 
prescription must be in the range of -0.50 to -6.00 D in 
each eye.
7. The subject’s refractive cylinder must be < 0.75D in 
each eye.
8. The subject must have best corrected visual acuity of 
20/25 or better in each eye.
Exclusion Criteria after Screening
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
1. Currently pregnant or lactating (subjects who become 
pregnant during the study will be discontinued).
2. Any systemic disease, autoimmune disease, or use of 
medication that may interfere with contact lens wear.  
3. Any previous, or planned, ocular or interocular surgery 
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(e.g., radial keratotomy, PRK, LASIK, etc.).
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product 
clinical trial within 14 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or 
a contagious immunosuppressive disease (e.g., HIV, by 
self-report).
10. Suspicion of or recent history of alcohol or substance 
abuse.
11. History of serious mental illness.  
12. History of seizures.
13. Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician)
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal 
distortion 
15. Any Grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the Food and 
Drug Administration (FDA) classification scale 
16. Any previous history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer 
or round peripheral scar), or any other ocular 
abnormality that may contraindicate contact lens wear.
Disallowed 
Medications/Interventions 
Disallowed medications include any medication that may 
interfere with contact lens wear (at the investigator’s 
discretion).  
Measurements and 
Procedures
Subjective assessments, physiological responses, fitting 
characteristics.
Microbiology or Other 
Laboratory Testing
None
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Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, will result in stopping further dispensing 
investigational product.  In the event of a UADE or SAE, the 
Sponsor Medical Monitor may unmask the treatment regimen 
of subject(s) and may discuss this with the Principal 
Investigator before any further subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Sterile rewetting drops
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CWT
Comfortable Wear Time
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HLLC
High Luminance With Low Contrast Charts
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted In Situ Keratomileusis
LLHC
Low Luminance With High Contrast Charts
LogMAR
Logarithm of Minimal Angle of Resolution
MPMVA
Maximum Plus To Maximum Visual Acuity
OD
Right Eye
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
PI
Principal Investigator
PIG
Patient Instruction Guide
PP
Predictive Probability
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
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QA
Quality Assurance
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
WT
Wear Time
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1.
INTRODUCTION AND BACKGROUND 
In the spirit of continuous improvement, JJVC has identified a new manufacturing 
technology for etafilcon A. The purpose of this clinical trial is to demonstrate whether this 
new manufacturing technology has any clinically relevant impact on the clinical performance 
of the contact lens.
1.1.
Name and Descriptions of Investigational Products  
The investigational products are:
x
etafilcon A contact lenses made with a new manufacturing technology (Test).
x
etafilcon A contact lenses made with the current manufacturing technology (Control).
1.2.
Intended Use of Investigational Products 
The intended use of the investigative products is for correcting refractive error.  During the 
study, each test article will be worn bilaterally in daily wear, daily disposable modality for at 
least 8 hours per day for approximately 1 week.
1.3.
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.  For the most comprehensive nonclinical information regarding etafilcon A 
refer to the latest version of the Investigator’s Brochure (IB).  
1.4.
Summary of Known Risks and Benefits to Human Subjects 
For the most comprehensive risk and benefit information regarding etafilcon A product refer 
to the latest version of the Investigator’s Brochure (IB).  
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
See Package Inserts for 1-DAY ACUVUE® MOIST. (APPENDIX C: PACKAGE INSERT 
(APPROVED PRODUCT).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
Primary Objective(s)
To evaluate the clinical performance of etafilcon A contact lenses made with a new 
manufacturing technology as compared to etafilcon A contact lenses made with the existing 
manufacturing technology in the following areas:
x
Overall comfort  
x
Overall quality of vision
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Secondary Objective(s)
To evaluate the clinical performance of etafilcon A lenses made with a new manufacturing 
technology by comparison to etafilcon A lenses made with the manufacturing technology in
the following areas:
x
Monocular distance visual performance (in logMAR)
x
Average daily wear time (in hours)
2.2.
Endpoints  
Primary Endpoint(s)
CLUE Comfort and Vision Scores:
The co-primary endpoints for this study are subjective assessment of comfort and quality of 
vision after 7±2 days of wearing the study lenses as a daily disposable. 
Subjective assessment of comfort and vision will be performed using the Contact Lens User 
ExperienceTM (CLUE) questionnaire.  CLUE is a validated patient reported outcomes (PRO) 
questionnaire used to assess patient experience attributes of soft contact lenses (comfort, 
vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 
years of age.  CLUE composite scores are derived using Item Response Theory (IRT) and 
follow a normal distribution with a population average score of 60 (SD 20), where higher 
scores indicate a more favorable/positive response.  A 5-point increase in an average CLUE 
score translates into 10% shift in the distribution of scores for the population of soft 
disposable contact lens wearers.
Secondary Endpoint(s) 
Average daily wear time (in hours):
Average daily wear time will be calculated as the number of hours between subjects reported 
time of insertion and time of removal of the study lenses, on an average day, at 1-Week 
Follow up evaluation.
Visual performance
Visual performance will be calculated as monocular contact lens-corrected distance visual 
acuity using a logMAR visual acuity scale.  This will be evaluated under both high 
luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters 
from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1 Week Follow-up
visit. 
Other Endpoint(s)
Slit Lamp Findings
Frequency and severity by eye of slit lamp findings (SLFs) including conjunctival injection,
corneal edema, corneal neovascularization, corneal staining, tarsal abnormalities or any other
complications.  SLFs will be evaluated at fitting and post-fitting evaluation visits including
unscheduled visits.
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Subject’s Reported Ocular Symptoms
Frequency and severity by eye of subject’s reported ocular symptoms and problems with the
study lens at fitting and post-fitting evaluation visits including unscheduled visits.
Lens Fitting characteristics
Frequency by eye of mechanical lens fitting characteristics including lens centration and lens
movement and overall lens fitting acceptability at fitting and 1-week follow-up evaluations. 
Lens wettability:
Frequency and Grade by eye of lens wettability at 1-Week Follow-up evaluation. 
The following will be monitored and descriptively evaluated
x
Adverse events
x
Reasons for discontinuation
x
Lens damage
2.3.
Hypotheses 
This is a feasibility study and all the hypotheses are exploratory in nature.
Primary Hypotheses:
There are two co-primary hypotheses in this study. Both of them must be met to satisfy the 
primary objective of the study.
1. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
comfort score at the follow-up visit.  A non-inferiority margin of -5 points will be 
used.
2. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
vision score at the follow-up visit.  A non-inferiority margin of -5 points will be used.
Secondary Hypotheses:
1. The Test lens will be non-inferior to the Control lens with respect to logMAR visual 
performance (using ETDRS visual acuity charts) at the follow-up visit.  A non-
inferiority margin of 0.05 logMAR will be used.
2. The Test lens will be non-inferior to the Control lens with respect to average daily 
wear time at 1-week follow-up visit.  A non-inferiority margin of 1 hour will be used.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (approximately 80% 1 
Day ACUVUE MOIST, approximately 20% any other brand of hydrogel daily disposable 
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contact lens) and have a spectacle astigmatism of <0.75 D in both eyes.  Up to 100 subjects 
will be enrolled to ensure approximately 90 subjects successfully complete the study.  
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age (including 70) at the time of 
screening.
4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand 
contact lens in both eyes (at least 1 month of daily wear).
5. The subject must have normal eyes (i.e., no ocular medications or infections of any 
type).
Inclusion Criteria after Baseline
6. The subject’s required spherical contact lens prescription must be in the range of 
-0.50 to -6.00 D in each eye.
7. The subject’s refractive cylinder must be < 0.75 D in each eye.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from 
participating in the study: 
Exclusion Criteria after Screening:
1. Currently pregnant or lactating (subjects who become pregnant during the study 
will be discontinued).
2. Any systemic disease, autoimmune disease, or use of medication that may 
interfere with contact lens wear.  
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, 
PRK, LASIK, etc.).
4. Any ocular infection.
5. Any corneal distortion resulting from previous hard or rigid gas permeable 
contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 14 days 
prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
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9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious 
immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse.
11. History of serious mental illness.  
12. History of seizures.
13. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician)
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular abnormalities that are known to 
interfere with contact lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent 
styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal 
distortion.
15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) 
on the FDA classification scale.
16. Any previous history or signs of a contact lens-related corneal inflammatory event 
(e.g., past peripheral ulcer or round peripheral scar), or any other ocular 
abnormality that may contraindicate contact lens wear.
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week 
dispensing study.  Subjects will wear bilaterally both Test and Control lenses in a random 
order for 1-week each as a daily disposable modality with a wash-out period of 1 week
between the wearing periods.  
Period 1:
At study Visit 1, subjects will be consented and screened for inclusion/exclusion criteria.  If a 
subject is found to meet all eligibility criteria (see Section 3.4.), they will be randomly 
assigned to either Test/Control or Control/Test sequence using 1:1 ratio (i.e. 1/2 of subjects 
on the Test/Control sequence and 1/2 on the Control/Test sequence). Subjects will fit the 
first pair of lens in both eyes based on the sequence assigned; otherwise, the subject will be 
deemed ineligible for this study. Subjects will be advised to wear the study lenses at least 8 
hours a day for a minimum of 5 days.
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Successfully dispensed subjects at the Visit 1 will be scheduled for a follow-up visit (Visit 2).  
The follow-up visit will occur approximately 7±2 days after the Visit 1.  Unscheduled 
follow-up visits may occur during the study.  At this visit, CLUE comfort and vision, slit 
lamp findings will be captured.
Wash-out period:
After completion of Visit 2, there is a 7 to 9 day washout period during which subjects may 
use their habitual products.
Period 2:
Following the washout period, the subject returns for Visit 3 and post-washout baseline 
evaluation will take place prior to lens fitting.  After baseline evaluation, subject will be 
fitted and dispensed with the second pair of lens in the assigned sequence.  Subjects will be 
advised to wear the study lenses at least 8 hours a day for a minimum of 5 days.
Visit 4 takes place 7±2 days after Visit 3, at which CLUE comfort and vision, slit lamp 
findings, final evaluation will take place.
Both study lenses will be worn as a daily disposable modality.  JJVC will provide the 
investigational sites with sufficient quantities of study lenses and supplies to complete the 
study.
4.2.
Study Design Rationale 
The crossover study design will allow each subject to evaluate both the Test and Control 
lenses and will help to reduce potential intra-subject variation.  To reduce any potential 
carryover effect, a 7 to 9 day washout period was considered between the wearing periods.
Both lenses will be worn as daily disposable modality, therefore 1-week wearing period was 
considered sufficiently longer to assess the primary and secondary objectives of the study.
4.3.
Enrollment Target and Study Duration 
Up to 100 subjects will be initially enrolled and approximately 90 are targeted to complete 
the study. 
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (approximately 80% 1 
Day ACUVUE MOIST, approximately 20% any other brand of hydrogel daily disposable 
contact lens) and have a spectacle astigmatism of <0.75 D in both eyes.  
The Investigator is responsible for ensuring that all subjects entering the study conform to 
subject selection criteria.  The number of subjects targeted for randomization and completion 
are as follows:
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Table 1: Target number of subjects by arm and phase
Test/Control
Control/Test
Total
Randomization
50
50
100
Completion
45
45
90
Number of sites
6
6
6
Subjects/site (Min-Max)
5-10
5-10
10-20
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover 
design.  A computer-generated randomization scheme will be used to randomly assign 
subjects, in block of 2, to one of the two possible lens wear sequences: Test/Control or 
Control/Lens.  The random scheme will be generated using the PROC PLAN procedure from 
Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC).
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization:
x
Informed consent has been obtained
x
Subject meets all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected.
5.2.
Masking 
This is a double-masked study where subjects, investigators are masked to the identity of the 
study lenses during the study period.  Every attempt will be made to keep the other clinical 
trial personnel involved in the study (e.g. data management, biostatistician) unaware of the 
identity of the study lenses.
The identity of the study lenses will be masked by over labeling the blister packs with a label 
containing the study number, lot number, sphere power, expiration date and the 
randomization codes.  Only the personnel involved in the over labeling and the statistician 
generating the randomization scheme will have access to the decode information translating 
the randomization codes into Test and Control groups.  The Biostatistician performing the 
interim analysis will have access to the decode information to run the interim analysis.  The 
medical monitor will also have access to the decode information in case breaking the mask is 
necessary for the urgent medical treatment of a subject.
Under normal circumstances, the mask should not be broken until all subjects have 
completed the study and the database is finalized.  Otherwise, the mask should be broken 
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6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
Lenses that are being collected will be stored wet (using saline solution) in separate glass 
vials with labels that minimally contain study number, date, subject number, and eye from 
which the lens was removed.
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records. 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study 
site personnel listed on the Site Delegation Log.  All test articles must be accounted.  This 
includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits 
2. What was returned to the Investigator unused
3. The number and reason for unplanned replacements  
The Investigator will collect all unused test articles from the subjects at the end of the 
subject’s participation. Subject returned unused test articles must be separated from the 
clinical study inventory of un-dispensed test articles, and must be labeled with the subject 
number and date of return.  Following final reconciliation of test articles by the monitor, the 
Investigator or monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information.
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x Subject withdrawal of consent
x Subject not compliant to protocol 
x Subject lost to follow-up
x Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant)
x Subject develops significant or serious adverse events causing discontinuation of 
study lens wear 
x Subjects who have experienced a Corneal Infiltrative Event (CIE)
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x Subject misses any study visits
x Subject not compliant with study lens wear schedule 
x Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort, or unacceptable fit.
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled)
x
Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the subject.
An additional subject will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: See Section 3.3  
Concomitant therapies that are disallowed include: See Section 3.3  
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
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immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.   
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.  
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
monitors, and site personnel, etc. 
The following are not considered product quality 
complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
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x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations 
where there is no deficiency alleged by the subject
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in 
use is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.)
x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if 
available), or rationale if product is not available for return (Refer to 
for test article return instructions)
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented.
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13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – 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. 
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved.
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study 
2. Was present prior to the study, but worsened during the study. This would include 
any condition resulting from concomitant illnesses, reactions to concomitant 
medications, or progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening 
event, a significant persistent or permanent change, impairment, damage, or 
disruption to the subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article 
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
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x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  
However, the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, 
which necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device.
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Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly.  Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1)
x
Causality or Relatedness – i.e. the relationship between the test article, study 
treatment or study procedures and the adverse event (not related; unlikely related; 
possibly related; related - see definition in Section 13.2.1)
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and 
the test article. The test article relationship for each adverse event should be determined by 
the investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. 
An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded
x
Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship 
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge
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13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject.  The 
assessment of severity is made irrespective of test article, study treatment or study procedure 
relationship or seriousness of the event and should be evaluated according to the following 
scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. 
All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following:
x
Adverse event (diagnosis not symptom)
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
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x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate 
Assessment eCRF.  Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature.  If cultures are collected, the date of culture 
collection and laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. 
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study 
visit date, should be followed to resolution of the adverse event or until referral to an 
appropriate health care provider, as recommended by the Investigator. Non-ocular adverse 
events that are not related to the test article, study treatment, or study procedures may be 
recorded as “ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or 
telephone as soon as possible and no later than 24 hours from discovery for any serious 
/significant adverse events, and 2 days from discovery for any non-significant adverse event.  
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements (Section 13.4.2).  The report will comment whether the 
adverse event was considered to be related to the test article, study treatment or study 
procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported.
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When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received.  The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect.  This report is in addition to 
the immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
forth by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines 
set forth by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines. 
13.4.3. Event of Special Interest 
None
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event.  Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
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will not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur 
secondary to systemic hormonal changes, and not due to unforeseen health risks to the 
mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor.  
A general description of the statistical methods to be implemented in this clinical trial is 
outlined below.  A stand-alone Statistical Analysis Plan (SAP) with more details will be 
finalized before the interim analysis is undertaken.
All data summaries and statistical analyses will be performed using the SAS software 
Version 9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results 
for each subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD], 
median, minimum and maximum).  Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
14.2. Sample Size Justification 
The plan is to enroll at total of 100 subjects with a target of 90 subjects to complete the study. 
This is a feasibility study and the sample size was not based on any empirical power 
calculation. The sample size was considered sufficiently large to gain first insight of the 
performance of the Test lens with respect to comfort and vision.
There are no historical data available on how the Test lens will perform against the Control 
lens.  Assuming a sample size of 90 subjects, the statistical power was calculated for 
different scenarios of effect size on CLUE scores (Δ), standard deviation (σ) and inter-
subject correlation (ρ) using two-sided 5% significance level.  The results are summarized 
below:
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Table 5: Statistical Power by effect size, intra-class correlation and standard deviation
Effect size
(Δ)
Inter-subject
correlation (ρ)
Power (%)
σ = 21
Power (%)
σ = 24
0
0.3
50.9
37.9
0.5
65.0
49.8
0.7
85.7
71.4
2.5
0.3
84.5
69.8
0.5
94.0
83.5
0.7
99.5
96.6
5
0.3
97.8
91.1
0.5
99.7
97.4
0.7
99.9
99.9
The power analysis was conducted using the PROC POWER procedure available in SAS for 
paired tests.
The possible range of standard deviation were considered based on the available historical 
data summarized below for the Control lens.
Table 6: 1-week CLUE comfort and vision for 1 Day ACUVUE MOIST in historical studies
CLUE Comfort
CLUE Vision
N
Mean
STD
N
Mean
STD
66
56.38
24.655
66
65.04
22.824
68
63.87
24.693
68
65.17
22.110
138
58.72
22.643
138
61.24
20.643
142
57.21
21.341
142
61.71
19.345
142
60.10
26.356
142
63.52
23.652
70
72.05
21.487
70
72.81
20.624
Total
626
60.49
23.93
626
63.99
21.67
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Subjects who return to Visits 2 and 4 out of the prescribed visit 
window will be excluded from the cohort population. Justification of excluding subjects with 
protocol deviations in the Per-Protocol Population set will be documented in a memo to file.
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Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from 
study or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analysis  
The co-primary endpoints for this study are the CLUE comfort and the CLUE vision scores 
evaluated after 1-week of lens wear.  The primary analysis will be conducted on per-protocol 
and ITT populations.  
CLUE Comfort and Vision scores
CLUE comfort and vision scores will be analyzed separately using a Bayesian repeated 
measurement random-effects model to compare between Test and Control lenses.  Each 
regression model will include baseline values, lens type, lens wearing sequence and lens 
wearing period as fixed effects and investigational site as random effect.  Other subject 
characteristics such as age, gender and will also be included as fixed effects when 
appropriate.  Unstructured covariance matrix will be used to model the residual errors among 
observations within subjects.  Non-informative prior distributions will be used for the 
coefficients in the models as well as for the error terms.  Independent vague normal 
N(0,1000) priors will be used for the regression coefficients, inverse gamma IG(0.001, 
0.001) for the variance of the random effect site and inverse Wishart for the residual errors.  
The Metropolis sampler algorithm as implemented in the SAS MCMC Procedure will be 
used to carry out parameter estimation.  Results will be reported as regression coefficient 
mean estimates with credible intervals. 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows:
ܪ0: Δ < -5
ܪܣ: Δ ≥ -5
where Δ is the CLUE score mean difference between Test lens and Control lens (Test minus 
Control).  Non-inferiority will be declared if the lower bound of the credible interval of the 
mean difference between Test and Control is greater than -5.
14.6. Secondary Analysis  
Visual Performance
Monocular distance visual performance in logMAR scale will be analyzed using a Bayesian 
repeated measurement random-effects model to compare between Test and Control lenses.  
The regression model will include baseline values, lens type, lens wearing sequence and lens 
wearing period as fixed effects; and investigational site and patient as random effects.  Other 
subject characteristics such as age, gender and will also be included as fixed effects when 
appropriate. Unstructured covariance matrix will be used to model the residual errors among 
observations within same eye and subject across wearing periods.  Non-informative prior 
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distributions will be used for the coefficients in the models as well as for the error terms.  
Independent vague normal N(0,1000) priors will be used for the regression coefficients, 
inverse gamma IG(0.001, 0.001) for the variance of the random effect site and inverse
Wishart for the residual errors.  The Metropolis sampler algorithm as implemented in the 
SAS MCMC Procedure will be used to carry out parameter estimation.  Results will be 
reported as regression coefficient mean estimates with credible intervals. 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows:
ܪ0: Δ > 0.05
ܪܣ: Δ ≤ 0.05
where Δ is the mean difference in logMAR between Test lens and Control lens (Test minus 
Control).  Non-inferiority will be declared if the upper bound of the credible interval of the 
mean difference between Test and Control is less than 0.05.  
Average Daily Wearing Time
Average daily wear time will be analyzed using the same Bayesian model described in the 
primary analysis.
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows:
ܪ0: Δ < -1
ܪܣ: Δ ≥ -1
where Δ is the mean difference in average daily wearing time between Test lens and Control 
lens (Test minus Control).  Non-inferiority will be declared if the lower bound of the credible 
interval of the mean difference between Test and Control is greater than -1.  
14.7. Other Exploratory Analyses  
A subgroup analysis will be conducted by considering only subjects who are habitual users of 
1 Day ACUVE Moist.  Further Bayesian analysis on the primary endpoints will be conducted 
by incorporating historical control data (see Table 6).
14.8. Interim Analysis  
No interim analysis is planned.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
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random.  To evaluate the impact of missing data, sensitivity analysis may be considered by 
automatically sampling all missing values and incorporating them in the Markov chain for 
the parameters using the PROC MCMC procedure.
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an 
EDC system from Bioclinica.  An authorized data originator will enter study data into the 
eCRFs using the EDC system.  Data collected on equipment that is not captured in EDC will 
be formatted to the specification of the JJVC database manager and sent to JJVC for analysis.
External Date Sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit. Once completed, the eCRFs will be reviewed for accuracy 
and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
will be authorized to gain access to the subject recordation for the purposes of monitoring 
and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate 
and complete data collection. Data will be transmitted from the clinical site to a secure 
central database as forms are completed or updated, ensuring information accuracy, security, 
and confidentiality. After the final database lock, the Investigator will be provided with 
Individual Patient Profiles (IPP) including the full audit trail on electronic media in PDF 
format for all of the study data. The IPP must be retained in the study files as a certified 
copy of the source data for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
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x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, 
scientific data or other pertinent information is confidential and remains the property of 
JJVC.  The Investigator may use this information for the purposes of the study only. It is 
understood by the Investigator that JJVC will use information developed in this clinical study 
in connection with the development of the investigational product and therefore may disclose 
it as required to other clinical investigators and to regulatory agencies. In order to allow the 
use of the information derived from this clinical study, the Investigator understands that 
he/she has an obligation to provide complete test results and all data developed during this 
study to the Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the 
conduct of clinical trials.  The clinical sites will provide direct access to study-related source 
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data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained
x
Ensuring the rights and wellbeing of subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, 
during the study, subjects will be given any new information that may affect their decision to 
continue participation.  Subjects will be told that their consent to participate in the study is 
voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled.  Only subjects who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent voluntarily will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP 
is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
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18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol and, if applicable, amendments
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information) and amendments
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless 
not required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), the informed consent form, applicable recruiting materials, 
and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s)
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s).
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At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, 
applicable regulatory requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will 
be informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject.
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has 
been fully explained. The assent and consent forms must be signed before performance of 
any study-related activity. The assent and consent forms that are used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms 
should be in accordance with principles that originated in the Declaration of Helsinki,3
current ICH2 and GCP guidelines, applicable regulatory requirements, and Sponsor policy.  
Before entry into the study or pre-screening, the Investigator or an authorized member of the 
clinical site personnel must explain to the potential subject and parent and/or legal guardian 
the aims, methods, reasonably anticipated benefits, and potential hazards of the study or pre-
screening, and any discomfort it may entail. Subjects and parent and/or legal guardian will 
be informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. They will be informed that choosing not to participate will not affect 
the care the subject will receive.  
Finally, they will be told that the Investigator will maintain a subject identification register 
for the purposes of long-term follow-up if needed and that their records may be accessed by 
health authorities and authorized Sponsor personnel without violating the confidentiality of 
the subject, to the extent permitted by the applicable law(s) or regulations. By signing the 
assent and informed consent form, the subject is authorizing such access and agrees to be 
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contacted after study completion by health authorities and authorized Sponsor personnel for 
the purpose of obtaining consent for additional safety evaluations if needed.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable 
steps should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
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alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). 
The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. 
These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform 
the Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical 
Research Agreement.  The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol 
violations such as:
x
Continuing an ineligible subject in the study
x
Scheduling a study visit outside the subject’s acceptable visit range
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution
x
Case Report Form signature
x
Completion of any follow-up action items 
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21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor.
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
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PRO SPECIFICATION Version 1 Final  2018-12-19
Protocol 6324                 Johnson & Johnson Vision Care, Inc.                  Confidential
6
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
To be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-DAY ACUVUE® MOIST
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APPENDIX D: 
 
LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
LENS FITTING CHARACTERISTICS
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
BIOMICROSCOPY SCALE
DISTANCE AND NEAR VISUAL ACUITY EVALUATION
DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
PATIENT REPORTED OUTCOMES
WHITE LIGHT LENS SURFACE WETTABILITY
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
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 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
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 LENS FITTING CHARACTERISTICS 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
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FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
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 BIOMICROSCOPY SCALE 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
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 PATIENT REPORTED OUTCOMES 
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Page 1 of 1
Patient Reported Outcomes 
  
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 WHITE LIGHT LENS SURFACE WETTABILITY 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6324 Clinical Evaluation of etafilcon A Contact Lenses 
Using a Novel Manufacturing Technology
Version and Date: v2.0, Amendment 1.0 April 26, 2019
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and 
GCP guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion.
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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