Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses 
 
Protocol CR-6395  
 
Version: 3.0 
                            
Date:  28 July 2020 
 
 
Investigational Products: etafilcon A with PVP cosmetic lenses  
 
Key Words: etafilcon A with PVP cosmetic lenses, daily disposable, dispensing, logMAR 
visual acuity, subjective vision 
 
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  
PROTOCOL TITLE, NUMBER, VERSION ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 18 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives ................................................................................................................. 18 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale ............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
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 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 24 
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 ....................................................................................... 28 
VISIT 1 ........................................................................................................................... 28 
VISIT 2 ........................................................................................................................... 33 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 39 
FINAL EVALUATION .................................................................................................. 40 
7.3. 
Unscheduled Visits ................................................................................................... 41 
7.4. 
Laboratory Procedures ............................................................................................. 42 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 42 
8.1. 
Completion Criteria .................................................................................................. 42 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 42 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 43 
9.1. 
Systemic Medications .............................................................................................. 43 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 44 
11. 
STUDY TERMINATION ........................................................................................... 45 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 45 
13. 
ADVERSE EVENTS ................................................................................................... 47 
13.1. 
Definitions and Classifications ............................................................................. 47 
13.2. 
Assessing Adverse Events .................................................................................... 49 
13.2.1. 
Causality Assessment .................................................................................... 49 
13.2.2. 
Severity Assessment ...................................................................................... 49 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 50 
13.4. 
Reporting Adverse Events .................................................................................... 51 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 51 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
52 
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13.4.3. 
Event of Special Interest ............................................................................... 52 
13.5. 
Reporting of Pregnancy ........................................................................................ 52 
14. 
STATISTICAL METHODS ........................................................................................ 53 
14.1. 
General Considerations ......................................................................................... 53 
14.2. 
Sample Size Justification ...................................................................................... 53 
14.3. 
The POWER procedure was used to conduct the power analysis for both the 
primary and secondary endpoint.  The total number of subjects needed to test both the 
primary and secondary hypothesis is 39. Analysis Populations ......................................... 53 
14.4. 
Level of Statistical Significance ........................................................................... 54 
14.5. 
Primary Analysis .................................................................................................. 54 
14.6. 
Secondary Analysis .............................................................................................. 54 
14.7. 
Other Exploratory Analyses ................................................................................. 54 
14.8. 
Interim Analysis ................................................................................................... 55 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 55 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 55 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 56 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 56 
15.2. 
Subject Record ...................................................................................................... 56 
15.3 
ClinicalTrials.gov ................................................................................................. 57 
16. 
DATA MANAGEMENT............................................................................................. 57 
16.1. 
Access to Source Data/Document ........................................................................ 57 
16.2. 
Confidentiality of Information.............................................................................. 57 
16.3. 
Data Quality Assurance ........................................................................................ 57 
17. 
CLINICAL MONITORING ........................................................................................ 58 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 58 
18.1. 
Study-Specific Design Considerations ................................................................. 58 
18.2. 
Investigator Responsibility ................................................................................... 58 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 59 
18.4. 
Informed Consent ................................................................................................. 60 
18.5. 
Privacy of Personal Data ...................................................................................... 61 
19. 
STUDY RECORD RETENTION................................................................................ 62 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 62 
21. 
PUBLICATION ........................................................................................................... 63 
22. 
REFERENCES ............................................................................................................ 63 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 64 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 73 
APPENDIX C: ASIAN EYE CRITERIA ASSESSMENT PROCEDURE ........................... 74 
APPENDIX D: HULA HOOP AND COSMETIC LENS FIT ASSESSMENT .................... 75 
APPENDIX E: 
 ....................................... 78 
 Lens Fitting Characteristics .................................................................................. 79 
 Subject Reported Ocular Symptoms .................................................................... 86 
 Front and Back Surface Lens Deposit Grading Procedure .................................. 88 
 Determination of Distance Spherocylindrical Refractions ................................... 94 
 Biomicroscopy Scale .......................................................................................... 101 
 Keratometry ........................................................................................................ 107 
 Distance and Near Visual Acuity Evaluation ..................................................... 109 
, Distance LogMAR Visual Acuity Measurement Procedure .............................. 114 
 Patient Reported Outcomes ................................................................................ 118 
 White Light Lens Surface Wettability ............................................................... 120 
Visual Acuity Chart Luminance and Room Illumination Testing ..................... 122 
Appendix F: COVID-19 Risk Mitigation Guidelines (VWI-0081) ...................................... 128 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 138 
 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 14 
 
TABLE OF CONTENTS  
Table 1: Test Articles .............................................................................................................. 23 
Table 2: Ancillary Supplies .................................................................................................... 24 
Table 3: Time and Events ....................................................................................................... 26 
Table 4: Disallowed systemic medications (less than 6 months of continual use). ................ 43 
Table 5: 
 Historical CLUE Vision Scores- 1-Week Follow-up Evaluation………...53 
 
 
 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses 
Protocol Number:  CR-6395 
Version: 3.0 
Date:   28 July 2020    
 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
 
MEDICAL MONITOR 
 
Title: Senior Principal Research Optometrist 
Address: 7500 Centurion Parkway, Suite 100 
 
Email: mbishop4@its.jnj.com 
 
 
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 signatures below constitutes the approval of this protocol and the attachments and provide 
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/Study 
Responsible 
Clinician 
 
 
 
 
See Electronic Signature Report 
 
 
 
 
Senior Principal Research Optometrist,  
Clinical Science, R&D 
 
DATE 
 
Clinical Operations 
Manager 
 
 
See Electronic Signature Report 
 
 
 
 
Clinical Operations Manager,  
Clinical Operations, R&D 
 
DATE 
 
 
Biostatistician 
 
 
See Electronic Signature Report 
 
 
 
 
Biostatistician III,  
Clinical Sciences, R&D  
 
DATE 
 
 
Data Management  
 
 
See Electronic Signature Report 
 
 
 
 
 
 
 
 
Medical Safety 
Officer 
 
Clinical Project Manager, Data and 
Systems, R&D 
 
 
 
 
See Electronic Signature Report 
 
DATE 
 
 
Medical Safety Officer 
 
DATE 
 
 
Reviewer 
 
 
See Electronic Signature Report 
 
 
 
   
DATE 
 
 
 
  Clinical Fellow, R&D 
 
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SYNOPSIS  
Protocol Title 
Clinical Evaluation of Daily Disposable Etafilcon A 
Cosmetic Contact Lenses 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Confirmatory phase, Phase 3   
Trial Registration 
This study will be registered on ClinicalTrials.gov based on 
the following: confirmatory study meets the requirements for 
registration.   
Test Article(s) 
Investigational Products: etafilcon A with cosmetic pattern 
 
Wear and Replacement 
Schedules 
Wear Schedule: Daily Wear 
Replacement Schedule: Daily Disposable 
Objectives  
The primary objective of this study is to evaluate high 
luminance/high contrast visual performance (Logarithm of 
Minimal 
Angle 
of 
Resolution 
[logMAR]) 
of 
two 
investigational cosmetic lenses at lens fitting.  
 
 
 
Additional assessments will include:   
• Subjective Vision (CLUE) 
• Subjective Comfort (CLUE) 
• Subjective Handling (CLUE) 
• logMAR objective vision (high luminance/low 
contrast and low luminance/high contrast) 
• Mechanical Lens fit 
• Cosmetic Lens fit/Hula Hoop 
• Ocular Physiology   
Study Endpoints 
Primary endpoint:  
LogMAR visual acuity at fitting using ETDRS charts (CTP-
2059). 
 
 
Other observations (descriptively summarized for each lens 
type) will include: 
Subjective Vision (CLUE)     
Subjective Comfort (CLUE) 
Subjective Handling (CLUE) 
logMAR objective vision (high luminance/low contrast and 
low luminance/high contrast) 
Mechanical Lens fit 
Cosmetic Lens fit/Hula Hoop 
Ocular Physiology   
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Study Design 
This will be a randomized, double-masked, bilateral, 
cross-over, 2 treatment by 2 period dispensing study.  There 
will be 4 visits.  There will be a 2 to5 day washout period 
between treatments.   
 
Visit 1: Baseline and eligibility, insert treatment #1, logMAR 
vision, post-fit questionnaire, lens fit assessment.  Dispense 
treatment #1 for 6 (±1) days 
 
Visit 2: Follow-up on treatment #1: Subjective questionnaire, 
logMAR vision, lens fit, and physiology assessment.  
Washout for 2 to 5 days 
 
Visit 3: Insert treatment #2, logMAR vision, post-fit 
questionnaire, lens fit assessment.  Dispense treatment #3 for 
6 (±1) days 
 
Visit 4: Follow-up on treatment #2: Subjective questionnaire, 
logMAR vision, lens fit.  Final evaluation. 
  
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations. 
Sample Size 
Up to 50 subjects will be enrolled with the aim of 
approximately 40 subjects completing.   
Study Duration 
The study is expected to last up to 2 months.  The enrollment 
period will also be up to 3 months.   
Anticipated Study 
Population 
We will aim to recruit up to 50 female subjects, ages 18 to 29 
(inclusive).  Subject must be habitual contact lens wearers 
who have purchased and worn cosmetic/circle contact lenses 
in the last 6 months.   
We will aim for 60% of the subjects to be self-reported as 
Asian with Asian eye characteristics 
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Eligibility Criteria 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form  
2. Females between 18 and 29 (inclusive) years of age at 
the time of screening 
3. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol (i.e. willing to wear 
only the study lenses and not use habitual lenses 
during the dispensing periods) 
4. Be a current soft contact lens wearer in both eyes with 
a minimum of 6 hours/day and 5 days/week over the 
last month by self-report 
5. Be a current wearer of cosmetic/circle lenses in the last 
6 months, by self-report.  
6. The subject must be willing to be photographed and/or 
video-taped 
 
Inclusion Criteria After Baseline  
7. The subject’s vertex corrected spherical equivalent 
distance refraction must be in the range of -1.00 D 
to -6.00 D (inclusive) in each eye 
8. The subject’s refractive cylinder must be less than or 
equal to 0.75 D (inclusive) in each eye 
9. Have spherical best corrected visual acuity of 20/25 or 
better in each eye  
 
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Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Currently pregnant or lactating 
2. Any systemic disease (eg, Sjögren’s Syndrome), 
allergies, 
infectious 
disease 
(eg, 
hepatitis, 
tuberculosis), contagious immunosuppressive diseases 
(eg, HIV), autoimmune disease (eg rheumatoid 
arthritis), or other diseases, by self-report, which are 
known to interfere with contact lens wear and/or 
participation in the study (at the investigators 
discretion)  
3. Use of systemic medications (eg, chronic steroid use) 
that are known to interfere with contact lens wear (at 
the investigators discretion)  
4. Any previous, or planned (during the study) ocular 
surgery (eg, radial keratotomy, PRK, LASIK, etc.) 
5. Any previous history or signs of a contact lens-related 
corneal inflammatory event (eg, past peripheral ulcer 
or round peripheral scar), or any other ocular 
abnormality that would contraindicate contact lens 
wear (at the investigators discretion) 
6. Participation in any contact lens or lens care product 
clinical trial within seven (7) days prior to study 
enrollment. 
7. Employee or family members of clinical site (eg, 
Investigator, Coordinator, Technician) Exclusion 
Criteria after Baseline 
 
Eligibility after Baseline: 
8. 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 (at the investigators discretion) 
9. Clinically significant (Grade 3 or 4 on FDA scale) 
tarsal abnormalities, bulbar injection, corneal edema, 
corneal vascularization, corneal staining, or any other 
abnormalities 
of 
the 
cornea 
which 
would 
contraindicate contact lens wear. 
 
Disallowed 
Medications/Interventions 
See section 9.1 
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Measurements and 
Procedures 
logMAR visual acuity, PRO questionnaires (comfort, vision, 
and handling), lens fit assessment, cosmetic lens fit 
assessment/hula hoop assessment, and safety parameters (slit 
lamp findings, entrance/exit visual acuity).   
Microbiology or Other 
Laboratory Testing 
None 
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 
Tears Naturale re-wetting drops, FluStrips fluorescein strips, 
Bausch & Lomb Sensitive Eyes plus Saline, or alternative 
products approved by the Sponsor. 
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 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
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 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
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PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
PVP 
 
 
Polyvinylpyrrolidone 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
 
 
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1. INTRODUCTION AND BACKGROUND 
Cosmetic contact lenses can have patterns of varying size and opacities.  When designing these 
cosmetic patterns, it is important to test the performance in a dispensing study on a cosmetic 
lens wearing population. 
 
In the current study, we will collect objective and subjective performance measures of two 
investigational cosmetic soft contact lenses. 
1.1. Name and Descriptions of Investigational Products  
This study will include two types of cosmetic contact lenses.  The Control lens and the Test 
lens are both investigational products.  Further details about the test articles are found in 
Section 6 of this protocol. 
1.2. Intended Use of Investigational Products 
The intended use of the investigational product is to correct vision.  The investigational product 
contains a cosmetic pattern, so it also affects the visual appearance of the eye.  During this 
dispensing study, each lens type will be worn for approximately 1 week with a 2-5-day washout 
period between the treatments. 
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 
cosmetic contact lenses refer to the latest version of the Investigator’s Brochure (Etafilcon A 
Investigational Limbal Ring Contact Lenses with polyvinylpyrrolidone [PVP]). 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The following risks/adverse events can be associated with wearing soft contact lenses in 
general: 
• The eyes may burn, sting and/or itch. 
• There may be a feeling of something in the eye (foreign body, scratched area). 
• There may be the potential for some temporary impairment due to peripheral 
infiltrates, peripheral corneal ulcers and corneal erosion.   
• There may be the potential for other physiological observations, such as local or 
generalized edema, corneal neovascularization, corneal staining, injection, tarsal 
abnormalities, iritis and conjunctivitis, some of which are clinically acceptable in low 
amounts. 
• There may be excessive watering, unusual eye secretions, or redness of the eye. 
• Poor visual acuity, blurred vision, rainbows or halos around objects, photo-phobia, or 
dry eyes may also occur if the lenses are worn continuously or for too long a time. 
• Due to the reduction in light transmittance with cosmetically tinted lenses, some 
patients may experience visual symptoms while wearing the Study Contact 
Lenses.  In addition, some patients may experience reduced peripheral awareness due 
to the opaque iris pattern. 
 
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There is no direct benefit to the subjects for participating in the study, although they will be 
able to try out investigational cosmetic contact lenses.  The information from this study will 
aid if the further development and assessment of new potential cosmetic contact lenses.   
 
For the most comprehensive clinical information regarding etafilcon A cosmetic contact lenses 
with PVP refer to the latest version of the Investigator's Brochure (Etafilcon A Investigational 
Limbal Ring Contact Lenses with PVP). 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
There have been no serious or unanticipated adverse events and no loss of best correct VA 
reported in pervious etafilcon A with PVP cosmetic contact lens clinical studies.  There was 
one significant adverse event in 
 which was a small non-staining white corneal lesion.  
The site deemed this as not related to the study lenses as it was present prior to enrollment and 
stable at the final evaluation.  
 
 
 
For the most comprehensive clinical information regarding etafilcon A cosmetic contact lenses 
with PVP refer to the latest version of the Investigator's Brochure (Etafilcon A Investigational 
Limbal Ring Contact Lenses with PVP). 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Primary Objective 
The primary objective of this study is to evaluate the objective vision Logarithm of Minimal 
Angle of Resolution (logMAR) under high illuminance/high contrast lighting conditions of the 
investigational cosmetic study lenses post lens fitting. 
 
   
2.2. Endpoints  
Primary endpoint  
Visual Acuity (logMAR) 
Multiple assessments of monocular visual acuity will be made during the study, but the 
measurements made at post lens fitting using high contrast letters in bright illuminance 
conditions at distance (4 meters) will be the primary endpoint. VA will be assessed using 
ETDRS Charts. Additionally, visual acuity will be measured using high and low contrast charts 
in bright illuminance conditions. Visual acuity will also be measured using normal illumination 
and normal contrast charts, while wearing goggles. See 
 and 
 in Appendix 
E for details regarding the collection of visual acuity (logMAR). 
 
 
 
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Other Endpoints 
• Subjective Vision measured via. CLUE 
• Subjective Comfort measured via. CLUE 
• Subjective Handling measured via. CLUE 
• high illumination/low contrast visual acuity 
• low illumination/high contrast visual acuity 
• Mechanical Lens fit 
• Cosmetic Lens fit 
• Hula Hoop 
• Ocular Physiology 
 
 
CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience 
attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a 
contact-lens wearing population in the US, ages 18-65.  Derived CLUE™ scores using Item 
Response Theory (IRT) follow a normal distribution with a population average score of 60 
(SD 20), where higher scores indicate a more favorable/positive response with a range of 0-
120.  A 5-point increase in an average CLUE™ score translates into 10% shift in the 
distribution of scores for population of soft contact lens wearers.6 
2.3. Hypotheses 
 
Primary Hypothesis 
1. The proportion of eyes with corrected distance monocular visual acuity 0.176 logMAR 
or better (ie, Snellen VA 20/30 or better) using the Test lenses under high 
illumination/high contrast is superior to 90%. 
 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Females aged 18 to 29 years (inclusive) who are habitual soft contact lens wearers and current 
wearers of circle/cosmetic contact lenses in the last 6 months will be recruited for this clinical 
study. While patients within the age range will be eligible to enroll, preference should be given 
to patients aged 18-24 years. Subjects must meet all the inclusion and none of the exclusion 
criteria listed in Section 3.2. 
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
  
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form  
2. Females between 18 and 29 (inclusive) years of age at the time of screening 
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3. Appear able and willing to adhere to the instructions set forth in this clinical protocol 
(i.e. willing to wear only the study lenses and not use habitual lenses during the 
dispensing periods) 
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day and 
5 days/week over the last month by self-report 
5. Be a current wearer of cosmetic/circle lenses in the last 6 months, by self-report.  
6. The subject must be willing to be photographed and/or video-taped 
 
Inclusion Criteria after Baseline 
 
7. The subject’s vertex corrected spherical equivalent distance refraction must be in the 
range of -1.00 D to -6.00 D (inclusive) in each eye 
8. The subject’s refractive cylinder must be less than or equal to 0.75 D (inclusive) in each 
eye 
9. Have spherical 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 
2. Any systemic disease (eg, Sjögren’s Syndrome), allergies, infectious disease (eg, hepatitis, 
tuberculosis), contagious immunosuppressive diseases (eg, HIV), autoimmune disease (eg, 
rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with 
contact lens wear and/or participation in the study (at the investigators discretion)  
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with 
contact lens wear (at the investigators discretion)  
4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, PRK, 
LASIK, etc.) 
5. Any previous history or signs of a contact lens-related corneal inflammatory event (eg, past 
peripheral ulcer or round peripheral scar), or any other ocular abnormality that would 
contraindicate contact lens wear (at the investigators discretion).  
6. Participation in any contact lens or lens care product clinical trial within seven (7) days 
prior to study enrollment 
7. Employee or family members of clinical site (eg, Investigator, Coordinator, Technician) 
 
Exclusion Criteria after Baseline 
 
8. 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 (at the investigators discretion) 
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9. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar injection, 
corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the 
cornea which would 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 by a market research company.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a 4-visit, bilateral, dispensing, randomized, double-masked, 2×2 crossover trial. A total 
of approximately 50 subjects will be enrolled with a target of 40 subjects to complete the study. 
 
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
they will be randomized to one of two lens wear sequences (Test/Control or Control/Test) in a 
bilateral fashion.  
 
If the subject is dispensed study lenses at the initial visit, three additional visits will be 
conducted.  Subjects will return for their first follow-up visit (Visit 2) approximately 1-week 
after the initial visit. After Visit 2, subjects will undergo a washout period between 2 to 5 days, 
where subjects will be instructed to wear their habitual contact lenses. After the washout period 
subjects will return for Visit 3, where they will be dispensed their second study lens per the 
randomization schedule. Subjects will return for their first follow-up for visit, their second 
study lens and final evaluation (Visit 4) approximately 1-week after Visit 3.  
 
Subjects will be advised to wear the study lenses at least six (6) hours per day during the 5-7 
day dispensing periods.   
 
4.2. Study Design Rationale 
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×2 bilateral crossover design was considered to 
be the optimal design since the study period is relatively short the design can be cost effective 
and more efficient comparisons between treatments can be made than compared a parallel 
study since fewer subjects are required to achieve the same pre-specified statistical power. 
Each subject will act as their own control to reduce the influence of potential confounding factors 
such as age, gender and vision correction. A 2 to 5-day washout between study lens wear will 
be implemented to help reduce any potential bias.  
 
A post hoc meta-analysis including CR-59565 may be performed at the discretion of the study 
responsible clinician and included in the clinical study report of the current study CR-6395.  
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4.3. Enrollment Target and Study Duration 
Approximately 50 female ages 18 to 29 years (inclusive) who are habitual soft contact lens 
wearers and who have purchased and worn circle/cosmetic contact lenses in the last 3 months, 
will be enrolled in this 4-visit, multi-site clinical study.  We will aim to have approximately 
60% of the enrolled subjects of Asian descent and with Asian eye characteristics (Appendix 
C). Additionally, we will aim to enroll subjects who are more frequent beauty contact lens 
wearers (at least once a month for the last 6 months).   
 
Subjects may be screened over the telephone and invited to the site for screening and 
enrollment procedures. Enrollment is defined as execution of the informed consent and/or 
assent form. 
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/Test. 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: 
 
o Informed consent has been obtained 
o Subject meets all the inclusion / exclusion criteria 
o Subject history and baseline information has been collected. 
5.2. Masking 
The subjects and the investigators will be masked.  Both the test and control lens will have the 
same cosmetic pattern.   
 
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 only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken the Sponsor must be informed as soon as possible.  The date, 
time, and reason for the unmasking must be documented in the subject record.  The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
 
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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 
No samples will be collected as part of the study procedures. 
  
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.  
 
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1.28 
Subjective Lens Fit 
Assessment 
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics. 
  
An unacceptable fit is deemed by one of the 
following criteria:  
• Presence of limbal exposure 
(appearance of clear cornea) in any 
gaze; 
• Presence of edge lift; 
• 
Presence of unacceptable movement 
(excessive or insufficient) in all three 
of the following conditions: primary 
gaze, up gaze, and tightness on push 
up. 
 
Note: if lens fit is unacceptable subject will 
be discontinued from the study. 
 
1.29 
Wettability 
Characteristics 
Record the white light lens wettability of both 
lenses. 
 
1.30 
Surface Deposits 
Record any front and back surface lens 
deposits. 
 
1.31 
Continuance 
For the subject to continue in the study, they 
must meet all three of the following criteria: 
• Visual acuity is 20/30 or better OD 
and OS 
• The lens fit is acceptable OD and OS 
• Investigator approval.  If the 
Investigator does not approve the 
dispensing of the first study lens, then 
the study is terminated for that 
subject. 
 
1.32 
Dispense 
The lenses will be dispensed for a 5 to 7 day 
wearing period.  During this time, they are 
required to wear the lenses at least 6 hours 
per day. 
• Dispense enough lenses to last the 
subject to their scheduled follow-up 
visit.  Do not dispense extras*. 
• The lenses will be worn as daily 
wear/daily disposable only. 
• Rewetting drops are permitted if 
needed. 
 
 
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read the smallest line until at least 50% of 
the letters are read incorrectly. 
2.7. Cosmetic Lens Fit 
Assessment 
(without slit-lamp) 
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).   
Appendix 
D 
2.8. Hula Hoop 
Assessment 
(without slit-lamp) 
*If unacceptable 
cosmetic fit in any 
gaze.* 
If there is an unacceptable cosmetic fit in any 
gaze, the Hula Hoop Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).   
Appendix 
D 
2.9. Subjective Lens Fit 
Assessment 
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics. 
  
An unacceptable fit is deemed by one of the 
following criteria:  
• Presence of limbal exposure 
(appearance of clear cornea) in any 
gaze; 
• Presence of edge lift; 
• Presence of unacceptable movement 
(excessive or insufficient) in all three 
of the following conditions: primary 
gaze, up gaze, and tightness on push 
up. 
 
Note: if lens fit is unacceptable subject will 
be discontinued from the study. 
 
2.10 Wettability 
Characteristics 
Record the white light lens wettability of 
both lenses. 
 
2.11 Surface Deposits 
Record any front and back surface lens 
deposits. 
 
2.12 Remove lenses 
The lenses will be removed and discarded. 
 
2.13 Slit Lamp Findings 
 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
Adverse events shall be documented and 
followed for significant slit lamp findings.    
 
 
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Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for 
each chart read.    
3.12 Subject Reported 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
3.13 CLUE Post-Fit 
Questionnaire 
The subject will respond to the CLUE Post-
Fit Questionnaire 
 
Appendix 
A 
3.14 Cosmetic Lens Fit 
Assessment 
(without slit-lamp) 
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).   
Appendix 
D 
3.15 Hula Hoop 
Assessment 
(without slit-lamp) 
*If unacceptable 
cosmetic fit in any 
gaze.* 
If there is an unacceptable cosmetic fit in any 
gaze, the Hula Hoop Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).   
Appendix 
D 
3.16 Subjective Lens Fit 
Assessment 
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics. 
  
An unacceptable fit is deemed by one of the 
following criteria:  
• Presence of limbal exposure 
(appearance of clear cornea) in any 
gaze; 
• Presence of edge lift; 
• Presence of unacceptable movement 
(excessive or insufficient) in all three of 
the following conditions: primary gaze, 
up gaze, and tightness on push up. 
 
Note: if lens fit is unacceptable subject will 
be discontinued from the study. 
 
3.17 Wettability 
Characteristics 
Record the white light lens wettability of 
both lenses. 
 
3.18 Surface Deposits 
Record any front and back surface lens 
deposits. 
 
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3.19 Continuance 
For the subject to continue in the study, they 
must meet all three of the following criteria: 
• Visual acuity is 20/30 or better OD 
and OS 
• The lens fit is acceptable OD and OS 
• Investigator approval.  If the 
Investigator does not approve the 
dispensing of the first study lens, then 
the study is terminated for that 
subject. 
• Subject is willing to wear the lenses 
for the dispensing period for 6 hours 
per day and will not wear their 
habitual lenses during the dispensing 
period. 
 
3.20 Dispense 
The lenses will be dispensed for a 5 to 7 day 
wearing period.  During this time, they are 
required to wear the lenses at least 6 hours 
per day. 
• Dispense enough lenses to last the 
subject to their scheduled follow-up 
visit.  Do not dispense extras*. 
• The lenses will be worn as daily 
wear/daily disposable only. 
• Rewetting drops are permitted if 
needed. 
• Subjects will be scheduled for their 1-
week follow-up visit, ensuring that 
they wear the study lens at least 6 
hours on the day of the follow-up 
visit. 
 
* Note:  In the event a lens is lost or 
damaged, the subject will return to the 
clinical site for replacement.  As much as 
reasonably possible, a damaged lens and 
packaging should be returned to the clinical 
site (wet, if possible) and then returned to the 
Sponsor.  If lens damage is present, complete 
the Product Quality Complaint Form.  The 
lens will be stored in labeled vial with saline, 
and clearly differentiated from the other 
worn lenses that will be shipped back to the 
Sponsor. 
 
 
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For the dispensing period (following visit 1 and visit 3), if the subject only wears the study 
lenses for 4 or 8 days it would be a minor deviation.  If the subject wears the lenses for 3 or 
less or 9 or more days it would be a major deviation.   
For the washout period (between visit 2 and visits 3), if the duration is 1 or less or 10 or more 
days it would be a major deviation.   
For the study lens wear time on the day of visit 2 and visit 4, if the subject presents having 
worn the study lenses 2-5 hours it would be a minor deviation.  If the subject presents having 
worn the study lenses 1 hour or less it would be a major deviation.   
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: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
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• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• 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:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
• Who received the complaint. 
• Study number. 
• Clinical site information (contact name, site ID, telephone number). 
• Lot number(s). 
• Unique Subject Identifier(s). 
• Indication of who first observed complaint (site personnel or subject). 
• OD/OS indication, along with whether the lens was inserted. 
• Any related AE number if applicable. 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
• Eye Care Provider objective (slit lamp) findings if applicable. 
• Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form 
 
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.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1 
 
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 adverse event that led to any of the following: 
• Death 
• Serious deterioration in the health of the subject that resulted in any of the following: 
• Life-threatening illness or injury 
• Permanent or persistent impairment of a body structure or a body function 
• Hospitalization or prolongation of patient hospitalization 
• Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• Chronic disease 
• Fetal distress, fetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
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• Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• 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. 
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, 
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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: 
• Seriousness/Classifications (see definition in Section 13.1). 
• 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). 
• 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). 
• Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; 
unknown. 
• 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: 
• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
• 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. 
• 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. 
• 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. 
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: 
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• Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities. 
• Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
• 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) begin 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: 
• Adverse event (diagnosis not symptom). 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
• Date the clinical site was notified. 
• Date and time of onset. 
• Date and time of resolution. 
• Adverse event classification, severity, and relationship to test articles, as applicable. 
• Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
• Any referral to another health care provider if needed. 
• Outcome, ocular damage (if any). 
• Likely etiology. 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if related to the visual system. 
 
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 
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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. 
 
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: 
• Notify the Sponsor immediately. 
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• 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. 
• 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. 
• 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 
Not applicable 
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.  
 
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. 
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14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical analysis will be undertaken by the study biostatistician. A general description of the 
statistical methods to be implemented in this clinical trial is outlined below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 (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.   
 
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 
Approximately 50 eligible subjects will be enrolled to target approximately 40 subjects to 
complete the study. The sample size was calculated to test both the primary hypothesis with a 
2-sided type I error of 5% and a minimum of power of 80%.  
 
Based on historical data from 
 where the same Test lens was utilized, the proportion 
of eye at lens fitting for distance monocular high luminance high contrast was 0.995 and the 
correlation between the left and right eyes was 0.627.  Using this information the total number 
of subjects needed to achieve the primary hypothesis is 34 subjects. To account for subject 
dropout this study will target to enroll approximately 50 subjects with the aim to complete 
approximately 40 subjects. 
 
14.3. The POWER procedure was used to conduct the power analysis for both the 
primary and secondary endpoint.  The total number of subjects needed to test 
both the primary and secondary hypothesis is 39. 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). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file. 
 
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. 
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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  
Visual Acuity (logMAR) 
Distance monocular high luminance high contrast visual acuity data will be dichotomized into 
two groups where Y=1 if subjects VA is below 0.176 logMAR and Y=0 otherwise; Y will be 
analyzed using a generalized linear mixed model with the logit as the link function. Sequence 
of lens wear, study period and lens type will be included in the model as fixed effects. Other 
characteristics such as age may be included as covariates in the model.  Site will be included 
as a random effect (G-side). The covariance between residual errors from the same subject and 
eye across study periods will be modeled using either homogenous compound symmetry (CS) 
or unstructured (UN). The structure that returns the lowest finite-sample corrected Akaike’s 
Information criterion7 will be selected as the structure that best fits the model. The Kenward 
and Roger method,8 will be used for the denominator degrees of freedom. The proportion of 
eye with 0.176 logMAR or better while wearing the Test lens will be estimated using a 95% 
confidence interval for the estimated proportion.  
 
The null and alternative hypothesis to test for superiority of the Test relative to the pre-defined 
threshold 0.176 logMAR is as follows:  
  
𝐻𝐻𝑜𝑜: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇≤ 90% 
𝐻𝐻𝐴𝐴: 𝑃𝑃𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇> 90% 
 
Superiority will be declared if the lower limit of the 95% confidence for the estimated 
proportion of eyes with distance monocular high luminance high contrast VA better than 0.176 
logMAR while wearing the Test lens is above 90%. i.e. P(𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇> 90%) ≥ 0.975.  
 
14.6. Secondary Analysis  
Not applicable.  
 
14.7. Other Exploratory Analyses  
Further statistical exploratory analysis can be undertaken, if necessary, at the discretion of the 
clinical project leader. 
 
Methods for CLUE will follow the analysis described below: 
 
CLUE Scores 
CLUE scores will be analyzed separately by domain using a linear mixed model adjusting for 
baseline values as a covariate. Sequence of lens wear, study period and lens type. Other 
characteristics such as race, gender and age may be included in the model as covariates. Site 
will be included as a random effect (G-side). The covariance between residual errors from the 
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same subject across study periods will be modeled using either homogenous compound 
symmetry (CS) or unstructured (UN). The structure that returns the lowest finite-sample 
corrected Akaike’s Information criterion7 will be selected as the structure that best fits the 
model. The Kenward and Roger method,8 will be used for the denominator degrees of freedom.  
 
Comparisons between the Test and Control will be carried out using 2-sided 95% confidence 
intervals constructed for the least-square means (Test minus Control) at the 1-week follow-up 
evaluation. The null and alternative hypothesis for CLUE vision scores to test for non-
inferiority of the Test lens relative to the Control lens is as follows: 
 
𝐻𝐻𝑜𝑜: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇− 𝜇𝜇𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶≤ -5 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇−𝜇𝜇𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶> -5 
 
Non-inferiority will be declared if the lower limit of the 95% confidence interval for the least-
square mean difference is greater than -5. i.e. P(𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇− 𝜇𝜇𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝐶𝑜𝑜𝑙𝑙> -5) ≥ 0.975.  
 
14.8. Interim Analysis 
An interim analysis will be conducted after 20 patients have completed the study, in order to 
monitor the safety and efficacy of the study lenses. Only descriptive statistics will be provided 
to the study responsible clinician and the project lead. No statistical analyses will be performed 
during the interim read. No stopping rules will be applied.   
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-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 15 imputations. 
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. 
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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 (Bioclinica Express 5.5). 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 Data 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. Only specifically delegated staff can enter data on a CRF.  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:  
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
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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. 
15.3 ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: confirmatory study 
meets the requirements for registration.   
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. CLINICAL 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: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
• Ensuring the rights and wellbeing of subjects are protected. 
• Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
• Ensuring that the clinical site has sufficient test article and supplies. 
• Clarifying questions regarding the study. 
• Resolving study issues or problems that may arise. 
• 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): 
• Final protocol. 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information). 
• Sponsor-approved subject recruitment materials. 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
• 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, 
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: 
• Protocol revisions 
• Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
• If applicable, new or revised subject recruitment materials approved by the Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure revisions  
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of 
the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• Any other requirements of the IEC/IRB 
 
For protocol revisions that increase subject risk, the revisions 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 or their representative, 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 contacted 
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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 States9 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: 
• processed fairly and lawfully. 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
• adequate, relevant, and not excessive in relation to said purposes. 
• 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. 
 
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Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
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: 
• Continuing an ineligible subject in the study. 
• 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: 
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• Query resolution. 
• Case Report Form signature. 
• Completion of any follow-up action items. 
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. Bishop, Meredith. 
 Clinical Study Report 
-Clinical 
Report “Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact 
Lenses” published on October 19, 2018. 
6. Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci. 2016;93(8):801-808. 
7. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A comparison of two 
approaches for selecting covariance structures in the analysis of repeated 
measurements. Communications in Statistics-Simulation and Computation. 
1998;27:591–604. 
8. Kenward MG, Roger JH. Small sample inference for fixed effects from restricted 
maximum likelihood. Biometrics. 1997;53:983-997. 
9. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html 
10. EU MDR 2017/745 
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Will be provided separately. 
 
 
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APPENDIX C: ASIAN EYE CRITERIA ASSESSMENT PROCEDURE 
 
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APPENDIX E: CLINICAL TECHNICAL PROCEDURES (CTP) 
 
• 
 LENS FITTING CHARACTERISTICS 
• 
 SUBJECT REPORTED OCULAR SYMPTOMS 
• 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING 
PROCEDURE 
• 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
• 
 BIOMICROSCOPY 
• 
 KERATOMETRY 
• 
 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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 SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
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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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 KERATOMETRY 
 
 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
 
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Title: 
Distance and Near Visual Acuity Evaluation 
Document Type: 
Clinical Test Procedure 
  
 
Revision Number: 3 
 
Page 4 of 4 
 
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
 
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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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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Work Instructions 
  
 
Revision Number: 3 
 
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Title: 
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Document Type: 
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Revision Number: 3 
 
Page 2 of 5 
 
 
 
 
 
 
 
 
 
 
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Title: 
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Document Type: 
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Revision Number: 3 
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Title: 
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Document Type: 
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Revision Number: 3 
 
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APPENDIX F: COVID-19 RISK MITIGATION GUIDELINES (VWI-0081) 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6395 Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic 
Contact Lenses 
 
Version and Date: 3.0 28 July 2020 
 
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. 
 
I have read the suggested guidance from JJVCI pertaining to COVID-19 risk mitigation, (COVID-19 
Work Instruction in the Appendix of this protocol). I agree to conduct the study in compliance with 
local, state and governmental guidelines for COVID-19 risk mitigation.  
 
Principal 
Investigator: 
 
 
  
 
Signature 
 
 
 Date 
 
Name and Professional Position (Printed) 
  
 
Institution/Site: 
 
  
 
Institution/Site Name 
 
 
  
 
Institution/Site Address 
  
 
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