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-6489  
 
Version: 1.0  
                            
Date: 02 June 2022 
 
 
Investigational Products: etafilcon A with PVP cosmetic lenses 
  
Keywords: Beauty, 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 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (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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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE ....................................................6 
SPONSOR NAME AND ADDRESS ....................................................................................6 
MEDICAL MONITOR .........................................................................................................6 
AUTHORIZED SIGNATURES ............................................................................................7 
CHANGE HISTORY ............................................................................................................8 
SYNOPSIS............................................................................................................................9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
 ............................................................................................................................................ 15 
1. 
INTRODUCTION AND BACKGROUND.................................................................. 16 
1.1. 
Descriptions of Investigational Products ................................................................ 16 
1.2. 
Intended Use of Investigational Products ............................................................... 16 
1.3. 
Summary of Findings from Nonclinical Studies .................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .................................. 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
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............................................................................................... 20 
4. 
STUDY DESIGN AND RATIONALE ........................................................................ 20 
4.1. 
Description of Study Design .................................................................................. 20 
4.2. 
Study Design Rationale ......................................................................................... 21 
4.3. 
Enrollment Target and Study Duration .................................................................. 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING .................................................... 21 
5.1. 
Test Article Allocation .......................................................................................... 21 
5.2. 
Masking ................................................................................................................ 22 
5.3. 
Procedures for Maintaining and Breaking the Masking .......................................... 22 
6. 
STUDY INTERVENTION .......................................................................................... 23 
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6.1. 
Identity of Test Articles ......................................................................................... 23 
6.2. 
Ancillary Supplies/Products .................................................................................. 23 
6.3. 
Administration of Test Articles ............................................................................. 24 
6.4. 
Packaging and Labeling ........................................................................................ 24 
6.5. 
Storage Conditions ................................................................................................ 25 
6.6. 
Collection and Storage of Samples ........................................................................ 25 
6.7. 
Accountability of Test Articles .............................................................................. 25 
7. 
STUDY EVALUATIONS ........................................................................................... 26 
7.1. 
Time and Event Schedule ...................................................................................... 26 
7.2. 
Detailed Study Procedures ..................................................................................... 27 
VISIT 1 ....................................................................................................................... 27 
VISIT 2 ....................................................................................................................... 33 
VISIT 3 ....................................................................................................................... 35 
VISIT 4 ....................................................................................................................... 39 
FINAL EVALUATION ............................................................................................... 40 
7.3. 
Unscheduled Visits ................................................................................................ 41 
7.4. 
Laboratory Procedures .......................................................................................... 42 
8. 
SUBJECTS COMPLETION/WITHDRAWAL ............................................................ 43 
8.1. 
Completion Criteria ............................................................................................... 43 
8.2. 
Withdrawal/Discontinuation from the Study .......................................................... 43 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 44 
9.1. 
Systemic Medications............................................................................................ 44 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................ 45 
11. 
STUDY TERMINATION ......................................................................................... 46 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 47 
13. 
ADVERSE EVENTS ................................................................................................ 48 
13.1. 
Definitions and Classifications ........................................................................... 48 
13.2. 
Assessing Adverse Events ................................................................................. 50 
13.2.1. 
Causality Assessment ................................................................................. 50 
13.2.2. 
Severity Assessment ................................................................................... 51 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................. 51 
13.4. 
Reporting Adverse Events ................................................................................. 53 
13.4.1. 
Reporting Adverse Events to Sponsor ......................................................... 53 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
54 
13.5. 
Event of Special Interest .................................................................................... 54 
13.6. 
Reporting of Pregnancy ..................................................................................... 54 
14. 
STATISTICAL METHODS ..................................................................................... 54 
14.1. 
General Considerations ...................................................................................... 54 
14.2. 
Sample Size Justification ................................................................................... 55 
14.3. 
Analysis Populations ......................................................................................... 56 
14.4. 
Level of Statistical Significance ......................................................................... 56 
14.5. 
Primary Analysis ............................................................................................... 56 
14.6. 
Secondary Analysis ........................................................................................... 58 
14.7. 
Other Exploratory Analysis................................................................................ 58 
14.8. 
Interim Analysis ................................................................................................ 58 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................ 58 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 58 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................... 58 
15.1. 
Electronic Case Report Form/Data Collection .................................................... 58 
15.2. 
Subject Record .................................................................................................. 59 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................. 60 
16. 
DATA MANAGEMENT .......................................................................................... 60 
16.1. 
Access to Source Data/Document ...................................................................... 60 
16.2. 
Confidentiality of Information ........................................................................... 60 
16.3. 
Data Quality Assurance ..................................................................................... 60 
16.4. 
Data Monitoring Committee (DMC) .................................................................. 61 
17. 
CLINICAL MONITORING ..................................................................................... 61 
18. 
ETHICAL AND REGULATORY ASPECTS ........................................................... 61 
18.1. 
Study-Specific Design Considerations ............................................................... 61 
18.2. 
Investigator Responsibility................................................................................. 61 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB)........... 62 
18.4. 
Informed Consent .............................................................................................. 63 
18.5. 
Privacy of Personal Data .................................................................................... 63 
19. 
STUDY RECORD RETENTION ............................................................................. 64 
20. 
FINANCIAL CONSIDERATIONS .......................................................................... 65 
21. 
PUBLICATION ....................................................................................................... 65 
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22. 
REFERENCES ......................................................................................................... 66 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)...... 67 
APPENDIX B: PATIENT INSTRUCTION GUIDE............................................................ 76 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ........................................ 77 
APPENDIX D: ASIAN EYE CRITERIA ASSESSMENT PROCEDURE ........................... 80 
APPENDIX E: HULA HOOP AND COSMETIC LENS FIT ASSESSMENT ..................... 81 
APPENDIX F: 
 ...................................... 84 
, Lens Fitting Characteristics ............................................................................... 85 
, Subject Reported Ocular Symptoms .................................................................. 91 
, Front and Back Surface Lens Deposit Grading Procedure .................................. 93 
, Determination of Distance Spherocylindrical Refractions .................................. 98 
, Biomicroscopy Scale ....................................................................................... 104 
, Keratometry .................................................................................................... 110 
, Distance and Near Visual Acuity Evaluation ................................................... 112 
, Distance LogMAR Visual Acuity Measurement Procedure.............................. 117 
, Patient Reported Outcomes ............................................................................. 121 
, White Light Lens Surface Wettability .............................................................. 123 
, Visual Acuity Chart Luminance and Room Illumination Testing ..................... 125 
Appendix G: COVID-19 Risk Mitigation Guidelines (
) .................................... 134 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 146 
 
LIST OF TABLES 
Table 1: Test Article ............................................................................................................ 23 
Table 2: Ancillary Supplies ................................................................................................. 23 
Table 3: Time and Events .................................................................................................... 26 
Table 4: Disallowed systemic medications........................................................................... 44 
Table 5: Disallowed systemic antihistamines ....................................................................... 45 
Table 6: Examples of major and minor protocol deviations .................................................. 45 
Table 7: 
 Distance Monocular High Luminance High Contrast logMAR Visual Acuity 
– Fitting Evaluation – ITT Population ................................................................................. 55 
Table 8: Sample Size Estimate and Statistical Power ........................................................... 56 
 
LIST OF FIGURES 
Figure 1: Study Flowchart ................................................................................................... 14 
 
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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 
Control: Acuvue 1-Day Define Fresh Honey  
Wear and Replacement 
Schedules 
Wear Schedule: Daily Wear 
Replacement Schedule: Daily Disposable 
Objectives  
Primary Objective:  
The primary objective of this study is to evaluate distance 
monocular high luminance, high contrast (HLHC) Visual 
Acuity (Logarithm of Minimal Angle of Resolution 
[logMAR]) of two investigational cosmetic lenses post lens 
fitting.  
 
Secondary Objective:  
The secondary objective of this study is to collect data for the 
control lens in the Asia-Pacific region to further support the 
portfolio of 1-Day Acuvue Define products. 
 
Study Endpoints 
Primary endpoint: 
x Distance monocular, high luminance, high contrast 
visual acuity (logMAR) 
 
Other Endpoints: 
x Subjective vision scores     
x Subjective comfort scores 
x Subjective handling scores 
x Monocular high luminance, low contrast (HLLC) 
visual acuity (logMAR) 
x Mechanical Lens fit 
x Cosmetic Lens fit 
x Hula Hoop 
x Ocular Physiology   
 
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Study Design 
This is a multi-site, 4-visit,  brand-masked, bilateral, 2x2 
cross-over dispensing study. Eligible subjects will be 
dispensed the study lenses in a random order for 6 (±1) days. 
A 2-to-5-day washout period between treatments will be 
utilized.   
 
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, 
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, 
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 (Figure 1). 
Sample Size 
Up to 60 subjects will be enrolled with the aim of 
approximately 46 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 60 female subjects, ages 18 to 29 
(inclusive).  Subject must be habitual contact lens wearers 
who have purchased or worn cosmetic/circle contact lenses 
in the last 6 months.   
We will aim for a minimum of 60% of the subjects to be self-
reported as Asian with Asian eye characteristics 
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Eligibility Criteria - 
Inclusion 
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 30 days 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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Eligibility Criteria – 
Exclusion 
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 for details regarding disallowed systemic 
medications. 
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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 an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article 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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Figure 1: Study Flowchart 
40 to complete
Potential Subjects Identified Based on:
-Age: 18-29 year old females
-Habitual soft contact lens wear
-Refraction: Sperical -1.00 D to -6.00 D 
-Cylinder: < -0.75 D
-Worn cosmetic/circle CL within 6 months
Informed consent
Eligibility
Visit 1 Screening/Baseline
-Medical History, Habitual Lens information, Contact lens history, Wear time, Asian eye 
characteristics
-Baseline PRO questionnaires: CLUE
-Ocular Symptoms, Entrance Visual Acuity, Lens Removal, Iris color, Horizontal visible iris 
diameter, Keratometry, Subjective Sphero-cylindrical Refraction, 
-Biomicroscopy
-Eligibility after baseline 
Visit 1 Treatment 1 Lens fitting
-Lens Selection, Lens Insertion, Lens Settling, Subjective best sphere over refraction 
Lens 
Modification
-Lens Fit Assessment: Visual Acuity, Distance ETDRS LogMAR visual acuity, Subject 
reported ocular symptoms, CLUE post-fit questionnaire, Cosmetic lens fit 
assessment, Hula Hoop assessment, Subjective lens fit assessment, wetability 
characteristics, Surface deposits 
Dispensing Criteria, Patient Instructions
-Follow up  6 +1 days 
Visit 2 Treatment 1 Follow-up 1
-Adverse Events, Concomitatnt Medications, Wear Time, Compliance, Subject 
reported ocular Symptoms
-PRO questionnaire: CLUE
- Visual acuity, Cosmetic lens fit assessement, Hula Hoop assessment, Subjective 
lens fit assessment, Wettability characteristics, Surface deposits, Remove lenses
-Slit-lamp biomicroscopy, Washout instructions, Exit visual acuity
-Follow up 2-5 days
After 5 minutes settling
-Subjective best sphere over refraction
Visit 3 Treatment 1 Follow-up 2
-Adverse Events, Concomitant Medications
-Visual acuity, Slit-lamp biomicroscopy, Continuance
-Lens Selection, Lens insertion, Lens settling
Final Evaluation
Yes
No
Lens 
Modification
No
-Visual acuity, Distance ETDRS LogMAR visual acuity, Subject reported ocular 
symptoms
-PRO questionnaire: CLU post fit 
-Cosmetic lens fit assessment, Hula Hoop assessment, Subject lens fit assessment, 
Wettability characteristics, Surface deposits, Continuance
-Dispense
-Follow up  6 +1 days 
Yes
Visit 4 Treatment 2 Follow-up 
-Adverse Events, Concomitant Medications, Wear time, Compliance, Subject 
reported ocular symptoms
-PRO questionnaire: CLUE Follow-up, Preference questions
-Entrance visual acuity, Cosmetic lens fit assessement, Hula Hoop assessment, 
Subjective lens fit assessment, Wettability characteristics, Surface deposits
-Remove lenses
 
 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
 
Add 
 
 
Near addition; the additional power required for near vision correction  
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 
COVID-19 
 
Coronavirus Disease 2019 
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 
 
 
The International Council for 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 
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PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
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 
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, objective and subjective performance measures of an investigational 
cosmetic soft contact lens will be collected and compared to a marketed cosmetic soft contact 
lens 
1.1. Descriptions of Investigational Products  
This study will include two types of cosmetic contact lenses.  The Test lens is an investigational 
product and the Control lens is a marketed product.  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 Brochure (Etafilcon A 
Investigational Limbal Ring Contact Lenses with polyvinylpyrrolidone [PVP]). 
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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: 
x The eyes may burn, sting and/or itch. 
x There may be a feeling of something in the eye (foreign body, scratched area). 
x There may be the potential for some temporary impairment due to peripheral 
infiltrates, peripheral corneal ulcers and corneal erosion.   
x 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. 
x There may be excessive watering, unusual eye secretions, or redness of the eye. 
x Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or 
dry eyes may also occur if the lenses are worn continuously or for too long a time. 
x 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. 
 
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 previous 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.  See 
 Clinical Study report4 for more information on this 
finding. 
 
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). 
 
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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. 
 
Secondary Objective:  
The secondary objective of this study is to collect data for the control lens in the Asia-Pacific 
region to further support the portfolio of 1-Day Acuvue Define products. 
2.2. Endpoints  
Primary Endpoint: 
Visual Acuity (logMAR) 
Monocular visual acuity (OD and OS) measured post-lens fitting using ETDRS Charts under 
high contrast letters in bright illuminance conditions at distance (4 meters) will be the primary 
endpoint. Additional measurements of visual acuity will be collected 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). 
 
Other Exploratory Endpoints: 
x Subjective vision scores     
x Subjective comfort scores 
x Subjective handling scores 
x Distance monocular HLLC visual acuity (logMAR) 
x Mechanical Lens fit 
x Cosmetic Lens fit 
x Hula Hoop 
x Ocular Physiology   
 
Subjective vision, comfort, and handling will be assessed using the CLUE™ questionnaire. 
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.5  
 
 
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2.3. Hypotheses 
 
Primary Hypothesis 
1. While wearing the Test lenses, the proportion of eyes with high luminance high contrast 
distance (4 meters) logMAR visual acuity less than 0.176 logMAR (i.e., 20/30 Snellen 
VA) will be superior to 0.90. 
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 and Section 3.3. 
 
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
 
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 30 days 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 at 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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3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
 
Exclusion Criteria following 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 at 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. 
 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a 4-visit, bilateral, dispensing, brand-masked, randomized, 2×2 crossover trial. Up to 
60 subjects will be enrolled with a target of 46 subjects to complete the study. 
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At Visit 1 (Day 0), eligible subjects will be randomized to one of two lens wear sequences 
(Test/Control or Control/Test) in a bilateral fashion. Subjects will be fit into their first study 
lenses per the randomization scheme.  Subjects will be scheduled to return after 6 ± 1 days for 
their follow-up evaluation (Visit 2). After Visit 2, a washout period of 2 to 5 days will occur 
in between Visit 2 and Visit 3. During the washout period subjects will be instructed to wear 
their habitual contact lenses. At Visit 3, subjects will be fit into their second study lenses per 
the randomization scheme and will be dispensed for 6 ± 1 days. Subjects will return for their 
follow-up evaluation and then will be exited from study (Visit 4). Unscheduled visits may 
occur during the course of this study. Subjects will be advised to wear the study lenses at least 
six (6) hours per day during each dispensing period (5 to 7 days).  
4.2. Study Design Rationale 
While the primary objective of this study is to assess logMAR visual acuity post-lens fitting 
for the investigational study lens, a controlled, bilateral, 2x2 crossover with a dispensing period 
of 6 ± 1 days was chosen as the design for this study. This was considered as the optimal design 
as it will address both the primary objective as well as provide clinical data for the control lens 
in the Asia-Pacific region. The intent for collecting data on a marketed product is to further 
support the portfolio of 1-Day Acuvue Define products. Though the primary hypothesis is to 
test only the investigational study lens, the study design is not anticipated to have an impact 
on subjects’ visual acuity since this endpoint is objective in nature, there will be 2 to 5 days 
washout period between study lenses, and different EDTRS charts will be utilized for each eye 
(left vs. right) to help reduce potential for any memorization of the eye chart during collection 
of visual acuity.   
4.3. Enrollment Target and Study Duration 
Approximately 60 female ages 18 to 29 years (inclusive) who are habitual soft contact lens 
wearers and who have purchased or worn circle/cosmetic contact lenses in the last 6 months, 
will be enrolled in this 4-visit, multi-site clinical study.  A minimum of 60% of the enrolled 
subjects will be of Asian descent and with Asian eye characteristics (Appendix C). 
Additionally, subjects who are more frequent beauty contact lens wearers (at least once a 
month for the last 6 months) will also be enrolled.   
 
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 to one 
of the two possible lens wear sequences: Test/Control or Control/Test. The random scheme 
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will be generated using the PROC PLAN procedure from Statistical Analysis System (SAS) 
Software Version 9.4 or higher (SAS Institute, Cary, NC).6 
 
Randomization will be performed at the first visit prior to the first fitting.  The following 
must have occurred prior to randomization: 
• Informed consent must have been obtained.  
• The subject must have met all eligibility criteria. 
• The subject’s screening and baseline information must have been collected. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule to obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2. Masking 
Due to differences in cosmetic pattern between the Test and Control lenses, subjects in this 
study cannot be double-masked. However, subjects, investigators, and clinical site personnel 
will be unaware of the identity (brand) of both study lenses.  
 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database are finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the identity of the 
treatment. In such cases, the Investigator may, in an emergency, must 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.   
 
5.3. Procedures for Maintaining and Breaking the Masking 
The identity of the test article shall not be broken unless information concerning the identity 
of the study lenses is necessary for the urgent medical treatment of a subject. The Sponsor 
must be notified as soon as possible if mask is broken. 
 
If the masked need to be broken, the site investigatory or clinical site personnel designee will 
pull the appropriate test articles from the study supply. All test articles opened, whether 
dispensed (placed/fit on eye or dispensed outside the clinical site) or not, must be record on 
the Test Article Accountability Log in the “Dispensed” section.  
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8. SUBJECTS COMPLETION/WITHDRAWAL  
8.1. Completion Criteria 
Subjects are considered to have completed the study if they:  
x provided informed consent. 
x they are eligible. 
x have not withdrawn/discontinued from the study for any reason described in section 
8.2. 
x completed all visits through the final visit four (4).    
. 
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
x Subject death during the study period 
x Subject withdrawal of consent and/or assent. 
x Subject not compliant to protocol.  
x Subject lost to follow-up. 
x Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear for four or more days  
x Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x Subject missed any scheduled study visits  
x Subject not compliant with study lens wear schedule  
x Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
 
For discontinued subjects, the Investigator will: 
x Complete the current visit (scheduled or unscheduled). 
x Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x Record the spherocylindrical refraction with best corrected distance visual acuity. 
x Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x Collect all unused test article(s) from the subject. 
x Make arrangements for subject care, if needed, due to their study participation 
 
Additional subjects will be enrolled if a subject discontinues from the study prematurely.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt.  
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specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x Lens replacements that occur due to drops/fall-outs. 
x Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x Who received the complaint. 
x Study number. 
x Clinical site information (contact name, site ID, telephone number). 
x Lot number(s). 
x Unique Subject Identifier(s). 
x Indication of who first observed complaint (site personnel or subject). 
x OD/OS indication, along with whether the lens was inserted. 
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x Any related AE number if applicable. 
x Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x Eye Care Provider objective (slit lamp) findings if applicable. 
x Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
 
 
 
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. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: 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 devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
Note: 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: 
x Death 
x Serious deterioration in the health of the subject that resulted in any of the following: 
x Life-threatening illness or injury 
x Permanent or persistent impairment of a body structure or a body function 
x Hospitalization or prolongation of patient hospitalization 
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x Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x Chronic disease 
x Foetal distress, foetal 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: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – 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: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of > 2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
x Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x Asymptomatic Corneal Scar 
x Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – 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: 
x Non-significant Infiltrative Event (NSIE) 
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x Contact Lens Papillary Conjunctivitis (CLPC) 
x Superficial Punctate Keratitis (SPK) 
x Conjunctivitis: Bacterial, Viral, Allergic 
x Blepharitis 
x Meibomianitis 
x Contact Dermatitis 
x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
NOTE 1: 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: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.7  
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x Seriousness/Classifications (see definition in section 13.1). 
x Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in section 0). 
x Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
x Actions Taken – none, temporarily discontinued, permanently discontinued, or 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: 
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x Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) 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 and 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.   
 
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It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x Adverse event (diagnosis not symptom). 
x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
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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 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: 
x Notify the Sponsor immediately. 
x Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
x Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
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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 to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
Not applicable 
13.6. 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. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).6 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided by lens type 
(Test and Control (1-Day Acuvue Define Fresh Honey), timepoint (Baseline, Fitting 
Evaluation, Lens Dispensing, 1-Week Follow-up), and analysis population (ITT, PP or safety), 
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. 
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that moment of data collection. Therefore, this method treated the Test and Control lenses 
independently.  
 
Given the rare event binary outcome, Y=0 a Bayesian beta-binomial model with correlated 
binary data (Diniza et al; 2010)9 was chosen for the sample size estimation. A total of 2000 
trial were simulated using the reference rate and correlations specified above. For each 
simulated trial, the lower bound of the 95% central posterior credible interval constructed for 
the proportion of eye with logMAR VA less than 0.176 was compared to a margin of 0.90. 
Based on the historical information and success criteria described above, a total of 46 subjects 
are required to complete the study in order to test the primary hypothesis with at least 80% 
statistical power (Table 8). To account for subject drop and/or screen failures up to 60 subjects 
will be enrolled with the target of 46 subjects to complete the study.  
 
Table 8: Sample Size Estimate and Statistical Power  
Endpoint 
Number of Subjects to Complete 
Statistical Power (%) 
Proportion of eyes with 
logMAR VA < 0.176 
46 (33 per arm) 
82.0 
 
14.3. Analysis Populations 
 
Safety Population: 
All subjects who are 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 successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from 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 the 
study or deviation from the protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
The planned primary analysis for this study will be conducted with an overall type I error rate 
of 5%.  
14.5. Primary Analysis  
The primary analysis will be conducted on the ITT population. 
 
Visual Acuity (logMAR) 
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Distance monocular high luminance high contrast logMAR VA scores post-fitting will be 
converted into a binary response for the purposes of analysis. YY=1 if an eye has logMAR VA 
less than 0.176 and YY=0 otherwise. The dichotomized variable YY will be analyzed using a 
Bayesian beta-binomial model for correlated binary data9. 
 
The Model: 
Let ܻଵ and ܻଶ denote the binary outcomes of logMAR VA less than 0.176 (Yes/No) in left and 
right eyes, respectively, post-fitting for the Test lens. Considering the correlation, ߩ, between 
ܻଵ and ܻଶ, the distribution of the sum ܻ = ܻଵ + ܻଶ is obtained by the mixture of two variables. 
One of them follow a binomial distribution ܤ݅݊(2, ݌) with mixing probability (1 െ ߩ) and the 
other one follows a modified Bernoulli distribution, ܯܤ݁ݎ݊(݌), taking value 0 and 2 rather 
than conventional 0 and 1, with mixing probability ߩ:  
 
ܲ(ܻ =  ݕ| ݌, ߩ) = (1 െ ߩ)ܤ݅݊(2, ݌)ܫ஺ଵ +   ߩܯܤ݁ݎ݊(݌)ܫ஺ଶ , 
 
where ܫ஺ଵ = {0, 1, 2}, ܫ஺ଶ= {0, 2} and ݌ is the probability of success (i.e., acceptable lens 
fitting).   
 
To overcome the complexity of the mixture likelihood a latent variable ܼ௜, i = 1, 2 is introduced 
in the model to indicate in which component of the model the observation ݕ௜, i=1, 2, belongs 
to, that is, 
ܼ௜= ൜1, if the observation belong to the MBern(p),
0, if the observation belong to the Bin(2,p)   
 
The joint distribution of the augmented data (ܻ௜, ܼ௜), ݅= 1, 2, is given by 
P(Y = y୧, Z = z୧| p, ɏ)
=  ɏ୸౟p୷౟୸౟/ଶ(1 െp)(ଶି୷౟)୸౟/ଶ(1 െɏ)ଵି୸౟൬2
y୧൰p୷౟(ଵି୸౟)(1 െp)(ଶି୷౟)(ଵି୸౟) 
The probability p links to the regression variables through a logit transformation as follow: 
 
logit (p) =  Ⱦ଴+ Ⱦଵlens 
It is assumed that Ⱦ଴, Ⱦଵ and ߩ to be independent with a non-informative prior N(0, 1000) for 
Ⱦ଴ and Ⱦଵ, and beta(0.5, 0.5) for ߩ. The Metropolis sampler algorithm as implemented in the 
SAS/STAT MCMC procedure will be used to estimate the posterior distributions of the 
parameters (Ⱦ଴, Ⱦଵ, ߩ). Inferences will be made based on a posterior credible interval for the 
relevant parameters.  
 
Bayesian Estimation and Statistical Evaluation of Hypothesis: 
Superiority of the Test lens relative to the pre-defined threshold with respect to the proportion 
of eyes with logMAR VA less than 0.176 will be evaluated using Bayesian statistics. 
 
Primary Hypothesis 
The null and alternative hypothesis to test for superiority are as follows:  
  
ܪ௢: ்ܲ൑ 0.90 
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ܪ஺: ்ܲ> 0.90 
 
Where ்ܲ is the probability of the event (i.e., the probability of having logMAR VA < 0.176 
in on eye while wearing the Test lens). Based on the central posterior probability distribution 
of the proportion ݌், superiority is interpreted as 95% probability of the Test lens being 
statistically higher than the pre-specified threshold of 0.90 (i.e., ்ܲ> 0.90 ). If the lower bound 
of the 95% central posterior credible interval is above 0.90, it can be concluded that there is a 
95% probability that the ்ܲ is superior to 0.90 (statistically higher) based on the observed 
sample (i.e., P(݌்௘௦௧! 
 
In the case of all eyes have a logMAR VA less than 0.176 (i.e., zero events of logMAR VA 
0.176 or higher), a Bayesian hierarchical model accounting for zero event problem will be 
considered10. 
14.6. Secondary Analysis  
Not applicable.  
 
14.7. Other Exploratory Analysis 
 Not applicable. 
 
14.8. Interim Analysis  
No interim read will be conducted. 
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.  
 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. 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.  
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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 ISO14155:2020.7  
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x subject identification 
x eligibility 
x study identification 
x study discussion 
x provision of and date of informed consent 
x visit dates 
x results of safety and efficacy parameters as required by the protocol 
x a record of all adverse events 
x follow-up of adverse events 
x medical history and concomitant medication 
x test article receipt/dispensing/return records 
x date of study completion 
x reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
 
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15.3. Trial Registration on 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 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
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16.4. Data Monitoring Committee (DMC) 
Not required. 
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: 
x Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x Ensuring the rights and wellbeing of subjects are protected. 
x Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test article and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide 
their consent voluntarily. 
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(R2) 
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(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
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18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x Final protocol. 
x Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x Investigator’s Brochure (or equivalent information). 
x Sponsor-approved subject recruitment materials. 
x Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x Protocol revisions 
x Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x If applicable, new or revised subject recruitment materials approved by the Sponsor 
x Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x Investigator’s Brochure revisions  
x Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x Major protocol deviations as required by the IEC/IRB 
x Report of deaths of subjects under the Investigator's care 
x Notification if a new Investigator is responsible for the study at the clinical site 
x Any other requirements of the IEC/IRB 
 
For protocol 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 ICH GCP2 and ISO 
14155:20207 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. 
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 State12  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. 
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x processed fairly and lawfully. 
x collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x adequate, relevant, and not excessive in relation to said purposes. 
x accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
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. 
 
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If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
x Continuing an ineligible subject in the study. 
x Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x Query resolution. 
x Case Report Form signature. 
x Completion of any follow-up action items. 
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
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22. REFERENCES 
 
1. 
ISO 14155:2020: Clinical investigation of medical devices for human subjects — Good 
clinical practice,  Available at: 
https://www.iso.org/standard/71690.html 
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),  
Available at: https://www.ich.org/page/efficacy-guidelines 
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. 
Bishop M. 
 Clinical Study Report 
 Clinical Report: 
""Clinical Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses"" 
published on  October 19, 2018. 
5. 
Wirth R, al e. Development of the Contact Lens User Experience: CLUE Scales. Optom 
Vis Sci. 2016;93(8):801-808. 
6. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC SAS 
Institute Inc; 2014. 
7. 
ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good 
clinical practice.,  Available at: https://www.iso.org/standard/71690.html 
8. 
Bishop M. 
 Protocol.  
 Clinical Report: "Clinical Evaluation 
of Daily Disposable Etafilcon A Cosmetic Contact Lenses" published on. 
9. 
Product Health & Safety Clinical Risk Assessment 
 
Product Health & Safety Clinical Risk Assessment. June 1, 2020. 
10. 
Record 
 Rev 10 1•DAY ACUVUE® DEFINE® Brand Contact Lenses with 
LACREON® (etafilcon A) Device Master Record.  
11. 
Procedure 
 1-DAY ACUVUE® DEFINE® Brand Contact Lenses with 
LACREON® (etafilcon A).  
12. 
Health Information Portability and Accountability Act (HIPAA),  Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
13. 
United States (US) Code of Federal Regulations (CFR).  Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
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5
CR-6489, v 1.0
 
 
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CR-6489, v 1.0
 
 
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CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately. 
 
CR-6489, v 1.0
 
 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX F: 
 
 
x 
 LENS FITTING CHARACTERISTICS 
x 
 SUBJECT REPORTED OCULAR SYMPTOMS 
x 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING 
PROCEDURE 
x 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
x 
 BIOMICROSCOPY 
x 
 KERATOMETRY 
x 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
x 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
x 
 PATIENT REPORTED OUTCOMES 
x 
 WHITE LIGHT LENS SURFACE WETTABILITY 
x 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 LENS FITTING CHARACTERISTICS 
 
 
 
 
CR-6489, v 1.0
 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 1 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 2 of 5
     
       
CR-6489, v 1.0
 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6
Page 3 of 5
CR-6489, v 1.0
 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6
Page 4 of 5
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE 
 
 
 
 
CR-6489, v 1.0
 
 
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
CR-6489, v 1.0
 
 
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
CR-6489, v 1.0
 
 
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 5 
  
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 BIOMICROSCOPY SCALE 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
KERATOMETRY 
 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
 
 
CR-6489, v 1.0
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 4 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 PATIENT REPORTED OUTCOMES 
 
 
 
CR-6489, v 1.0
 
 
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Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
3
Page 1 of 1
                      
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 WHITE LIGHT LENS SURFACE WETTABILITY 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
CR-6489, v 1.0
 
 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 2 of 8 
CR-6489, v 1.0
 
 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 3 of 8 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 5 of 8 
CR-6489, v 1.0
 
 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 6 of 8 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 8 of 8 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX G: COVID-19 RISK MITIGATION GUIDELINES 
 
 
 
 
CR-6489, v 1.0
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6489 Clinical Evaluation of Daily Disposable etafilcon A 
Cosmetic Contact Lenses 
 
Version and Date: 1.0 02 June 2022 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155:2020,7 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),13 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 provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix G of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
Principal 
Investigator: 
 
 
 
 
Signature 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
Institution/Site:  
 
 
 
Institution/Site Name 
 
 
 
 
 
Institution/Site Address 
 
 
 
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