Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses 
Protocol CR-6060 
Version: 2.0 
Date: 21 July 2020 
Investigational Products: etafilcon A with PVP cosmetic lenses, 1-DAY ACUVUE® DEFINE®
Vivid style contact Lenses
Key Words: etafilcon A with PVP cosmetic lenses, 1-DAY ACUVUE® DEFINE® Vivid style,
daily disposable, logMAR visual acuity, objective vision 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 15 
1.1. 
Name and Descriptions of Investigational Products ................................................ 15 
1.2. 
Intended Use of Investigational Products................................................................. 15 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION ............................................................................................. 22 
6.1. 
Identity of Test Articles............................................................................................ 22 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 23 
6.4. 
Packaging and Labeling ........................................................................................... 23 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 24 
7. 
STUDY EVALUATIONS .............................................................................................. 25 
7.1. 
Time and Event Schedule ......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 26 
VISIT 1 ................................................................................................................................... 26 
FINAL EVALUATION .................................................................................................. 32 
7.3. 
Unscheduled Visits ................................................................................................... 33 
7.4. 
Laboratory Procedures ............................................................................................. 34 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 34 
8.1. 
Completion Criteria .................................................................................................. 34 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 34 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 35 
9.1. 
Systemic Medications .............................................................................................. 35 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 35 
11. 
STUDY TERMINATION ........................................................................................... 36 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 37 
13. 
ADVERSE EVENTS ................................................................................................... 38 
13.1. 
Definitions and Classifications ............................................................................. 38 
13.2. 
Assessing Adverse Events .................................................................................... 40 
13.2.1. 
Causality Assessment .................................................................................... 40 
13.2.2. 
Severity Assessment ...................................................................................... 41 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 41 
13.4. 
Reporting Adverse Events .................................................................................... 42 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 42 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
43 
13.4.3. 
Event of Special Interest ............................................................................... 43 
13.5. 
Reporting of Pregnancy ........................................................................................ 44 
14. 
STATISTICAL METHODS ........................................................................................ 44 
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14.1. 
General Considerations ......................................................................................... 44 
14.2. 
Sample Size Justification ...................................................................................... 44 
14.3. 
Analysis Populations ............................................................................................ 45 
14.4. 
Level of Statistical Significance ........................................................................... 46 
14.5. 
Primary Analysis .................................................................................................. 46 
14.6. 
Secondary Analysis .............................................................................................. 47 
14.7. 
Other Exploratory Analyses ................................................................................. 47 
14.8. 
Interim Analysis ................................................................................................... 47 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 47 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 47 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 47 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 47 
15.2. 
Subject Record ...................................................................................................... 48 
15.3 
ClinicalTrials.gov ................................................................................................. 48 
16. 
DATA MANAGEMENT............................................................................................. 49 
16.1. 
Access to Source Data/Document ........................................................................ 49 
16.2. 
Confidentiality of Information.............................................................................. 49 
16.3. 
Data Quality Assurance ........................................................................................ 49 
17. 
CLINICAL MONITORING ........................................................................................ 49 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 50 
18.1. 
Study-Specific Design Considerations ................................................................. 50 
18.2. 
Investigator Responsibility ................................................................................... 50 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 50 
18.4. 
Informed Consent ................................................................................................. 52 
18.5. 
Privacy of Personal Data ...................................................................................... 52 
19. 
STUDY RECORD RETENTION................................................................................ 53 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 54 
21. 
PUBLICATION ........................................................................................................... 54 
22. 
REFERENCES ............................................................................................................ 55 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 56 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 57 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 58 
APPENDIX D: 
 ...................................... 61 
, Lens Fitting Characteristics .................................................................................. 62 
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 Subject Reported Ocular Symptoms/Problems .................................................... 69 
 Determination of Distance Spherocylindrical Refractions ................................... 71 
 Biomicroscopy Scale ............................................................................................ 78 
 Distance and Near Visual Acuity Evaluation ....................................................... 84 
 Distance LogMAR Visual Acuity Measurement Procedure ................................ 89 
 Visual Acuity Chart Luminance and Room Illumination Testing ....................... 93 
APPENDIX E: COSMETIC FIT AND HULA HOOP .......................................................... 99 
APPENDIX F: COVID-19 Risk Mitigation Guidelines ....................................................... 103 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 113 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS
Table 1: Test Articles .............................................................................................................. 22 
Table 2: Ancillary Supplies .................................................................................................... 23 
Table 3: Time and Events ....................................................................................................... 25 
Table 4: 
 Descriptive Summary of Distance Monocular Visual Acuity (logMAR) . 45 
Table 5: Sample Size Calculation to Test for Non-Inferiority – Visual Acuity ..................... 45 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Evaluation of Visual Performance of Two Types of Cosmetic Contact Lenses 
Protocol Number:  CR-6060 
Version: 2.0 
Date:  21 July 2020
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
Name:  Meredith Bishop OD, MS, FAAO
Title: Senior Principal Research Optometrist
Address: 7500 Centurion Parkway, Suite 100 
Email: mbishop4@its.jnj.com 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ICH guidelines,2 ISO 14155,1
and the Declaration of Helsinki.3
Author/Study 
Responsible Clinician
See Electronic Signature Report
Meredith Bishop, OD, MS, FAAO
Senior Principal Research Optometrist,
Clinical Science, R&D
DATE
Clinical Operations 
Manager
See Electronic Signature Report
Clinical Operations Manager, 
Clinical Operations, R&D
DATE
Biostatistician
See Electronic Signature Report
Biostatistician III,  
Clinical Science, R&D
DATE
Data Management 
See Electronic Signature Report
Clinical Project Manager, 
Data and Systems, R&D
DATE
Medical Safety Officer
See Electronic Signature Report
DATE
Reviewer
Global Medical Affairs
See Electronic Signature Report
Research Fellow
DATE
Approver
See Electronic Signature Report
Director, Specialty Growth 
R&D
DATE
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SYNOPSIS 
Protocol Title
Evaluation of Visual Performance of Two Types of Cosmetic 
Contact Lenses
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Confirmatory, 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
Approved Products:  1-DAY ACUVUE® DEFINE® Vivid 
style
Wear and Replacement 
Schedules
Wear Schedule: Daily Wear
Replacement Schedule: Daily Disposable
Objectives 
Primary Objective:
The primary objective of this study is to evaluate the Distance 
Monocular logMAR visual performance of the Investigational
Cosmetic Contact Lenses manufactured in etafilcon A 
material (Test) in comparison to 1-Day Acuvue Define Vivid 
Style (Control), manufactured in etafilcon A material.
Exploratory Objectives:
Additional objectives include lens fit, ocular symptoms, and 
slit-lamp findings
Study Endpoints
Primary endpoint: 
1. Distance Monocular logMAR visual performance 
(high luminance low contrast and low luminance high 
contrast)
Other observations: 
1. Mechanical Lens fit
2. Cosmetic Lens fit/Hula Hoop
3. Ocular Physiology
Study Design
This is a single visit, brand-masked, non-dispensing, 2×2
bilateral crossover study.  Each subject will be bilaterally 
fitted with one of the two test articles in each of the study 
periods in a random order.   
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations.
Sample Size
Up to 40 subjects will be enrolled with the aim of 
approximately 34 subjects completing.
Study Duration
The study is expected to last up to 1 month. The enrollment 
period will also be up to 3 weeks.
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Anticipated Study 
Population
We will aim to recruit up to 40 habitual contact lens wearing 
subjects, ages 18 to 39 (inclusive).  
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol
3. Subjects between 18 and 39 (inclusive) years of age at 
the time of screening
4. Be a current soft contact lens wearer in both eyes with 
a minimum of 6 hours/day and 5 days/week over the 
last month by self-report
5. The subject must be willing to be photographed and/or 
video-taped
Eligibility after Baseline:
6. 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
7. The subject’s refractive cylinder must be less than or 
equal to 0.75 D (inclusive) in each eye
8. Have spherical best corrected visual acuity of 20/25 or 
better in each eye 
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Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
1. Currently pregnant or lactating 
2. Any systemic disease (eg, Sjögren’s Syndrome), 
allergies, 
infectious 
disease 
(eg, 
hepatitis, 
tuberculosis), contagious immunosuppressive diseases 
(eg, HIV), autoimmune disease (eg rheumatoid 
arthritis), or other diseases, by self-report, which are 
known to interfere with contact lens wear and/or 
participation in the study (at the investigators 
discretion)  
3. Use of systemic medications (eg, chronic steroid use) 
that are known to interfere with contact lens wear (at 
the investigators discretion)  
4. Any previous, or planned (during the study) ocular 
surgery (eg, radial keratotomy, PRK, LASIK, etc.) 
5. Participation in any contact lens or lens care product 
clinical trial within seven (7) days prior to study 
enrollment. 
6. Employee or family members of clinical site (eg,
Investigator, Coordinator, Technician) Exclusion 
Criteria after Baseline
Eligibility after Baseline:
7. 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)
8. 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
None
Measurements and 
Procedures
logMAR visual acuity, 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
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Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product. In the event of a 
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled.
Ancillary Supplies/ Study-
Specific Materials
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 
General 
Population 
Potential Subjects Identified based on:  
Age: 18-39 Years
Habitual soft contact lens wear
Sphere: -1.00 to -6.00 D 
&\OLQGHU-0.75 D
Visit 1
Screening
Baseline
Slit-lamp exam
Visit 1- Lens Fits #1 and #2 
With each: 
Lens Insertion
Over-refraction
Modification if needed 
logMAR (distance) 
Cosmetic Fit/Hula Hoop
Lens Fit 
Remove lenses
Final Evaluation
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
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PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
qCSF  
 
Quick Contrast Sensitivity Function 
qVA 
 
 
Quantitative Visual Acuity
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 allow a sufficient clear area in the center of the lens optical 
zone so that the wearer’s vision is not negatively impacted by the pattern. 
In the current study, we will assess the objective visual performance of an investigation 
cosmetic soft contact lens compared to an approved cosmetic soft contact lens.
1.1.
Name and Descriptions of Investigational Products  
This study will include two types of cosmetic contact lenses.  The Control lens, 1-DAY
ACUVUE® DEFINE® Vivid style is an approved product, the Test, Etafilcon A Investigational 
Cosmetic Contact Lenses with PVP, is an investigational 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 
non-dispensing study, each lens type will be worn for approximately 90 minutes.  
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding etafilcon A 
cosmetic contact lenses refer to the latest version of the Investigator’s Brochure (Etafilcon A 
Investigational Limbal Ring Contact Lenses with polyvinylpyrrolidone [PVP]). 
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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 rare potential for some temporary impairment due to peripheral 
infiltrates, peripheral corneal ulcers and corneal erosion.   
x
There may be the rare 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 marketed and 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 and the marketed contact lenses refer to the latest version of the Investigator’s
Brochure (Etafilcon A Investigational Limbal Ring Contact Lenses with PVP) and the package 
insert (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT).
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 report5 for more information on this 
finding. 
For the most comprehensive clinical information regarding etafilcon A cosmetic contact lenses
with PVP and the marketed contact lenses refer to the latest version of the Investigator’s
Brochure (Etafilcon A Investigational Limbal Ring Contact Lenses with PVP) and the package 
insert (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT).
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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 Distance Monocular logMAR visual 
performance of the Investigational Cosmetic Contact Lenses manufactured in etafilcon A 
material (Test) in comparison to 1-Day Acuvue Define Vivid Style (Control), manufactured in 
etafilcon A material.
Exploratory Objectives 
Additional objectives include assessments of mechanical and cosmetic lens fit, subject reported 
ocular symptoms, and slit-lamp findings.     
2.2.
Endpoints 
Primary endpoints 
Distance Monocular Visual Performance (logMAR) 
LogMAR visual acuity will be assessed at distance (4 meters) using ETDRS charts under high 
luminance low contrast and low luminance high contrast lighting conditions. Visual acuity will 
also be measured using high illumination and high contrast charts, while wearing neutral 
density goggles. See 
 in Appendix D for details regarding the 
collection of visual acuity (logMAR). 
Other Endpoints  
Mechanical Lens fit
Lens fitting will be assessed in each eye using a slit-lamp post lens fitting; Lens fitting 
characteristics to be reported are:
x
Lens Centration Grade
x
Decentered Direction
x
Limbal Exposure Grade 
x
Edge Lift (Present or Absent) 
x
Primary Gaze Movement Grade
x
Upgaze Movement Grade
x
Lens Tightness Grade (Push-up Test) 
x
Acceptable Fitting (yes/no)
Cosmetic Lens fit
Cosmetic lens fit assessment will be performed in each eye at post lens fitting by the 
investigator without the use of a slit-lamp at a distance of approximately 3 feet from the subject 
in: 
x
Primary Gaze 
x
Extreme Gaze (left and right) 
x
Extreme Up-gaze
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Hula Hoop 
If an investigator observes an unacceptable cosmetic lens fit in any gaze, a hula hoop 
assessment will be performed post lens fitting by the investigator without the use of a slit-lamp 
at a distance of approximately 3 feet from the subject in: 
x
Primary Gaze 
x
Extreme Gaze (left and right) 
x
Extreme Up-gaze
Ocular Physiology 
Slit lamp findings will be assessed for each subject eye at baseline and the exit evaluation using 
the FDA Grading scale (Grade 0=None, Grade 1=Trace, Grade 2=Mild, Grade 3=Moderate, 
Grade 4=Severe). Slit lamp finding assessments include the following metrics: 
x
Corneal Infiltrates (Yes/No) 
x
Corneal Edema 
x
Corneal Neovascularization 
x
Corneal Neovascularization Location 
x
Corneal Staining
x
Corneal Staining Location  
x
Conjunctival Injection  
x
Tarsal Abnormalities 
x
Other 
2.3.
Hypotheses
Primary Hypotheses 
Both primary hypotheses must be met in order to satisfy the objective of the study.  
1. The Test lens will be non-inferior to the Control lens with respect to high luminance 
low contrast Distance Monocular Visual Acuity (logMAR) post lens fitting. A non-
inferiority margin of 0.05 logMAR will be used.  
2. The Test lens will be non-inferior to the Control lens with respect to low luminance 
high contrast Distance Monocular Visual Acuity (logMAR) post lens fitting. A non-
inferiority margin of 0.05 logMAR will be used.  
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3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Subjects aged 18 to 39 years (inclusive) who are habitual soft contact lens wearers will be 
recruited for this clinical study. Subjects must meet all the inclusion and none of the exclusion 
criteria listed in Section 3.2.      
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form  
2. Appear able and willing to adhere to the instructions set forth in this clinical 
protocol  
3. Subjects between 18 and 39 (inclusive) years of age at the time of screening
4. Be a current soft contact lens wearer in both eyes with a minimum of 6 hours/day 
and 5 days/week over the last month by self-report
5. The subject must be willing to be photographed and/or video-taped. 
Eligibility after Baseline:
6. 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 
7. The subject’s refractive cylinder must be less than or equal to 0.75 D (inclusive) in 
each eye
8. Have spherical best corrected visual acuity of 20/25 or better in each eye. 
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating 
2. Any systemic disease (eg, Sjögren’s Syndrome), allergies, infectious disease (eg,
hepatitis, tuberculosis), contagious immunosuppressive diseases (eg, HIV), 
autoimmune disease (eg rheumatoid arthritis), or other diseases, by self-report, which 
are known to interfere with contact lens wear and/or participation in the study (at the 
investigators discretion)  
3. Use of systemic medications (eg, chronic steroid use) that are known to interfere with 
contact lens wear (at the investigators discretion) 
4. Any previous, or planned (during the study) ocular surgery (eg, radial keratotomy, 
PRK, LASIK, etc.)
5. Participation in any contact lens or lens care product clinical trial within seven (7) days 
prior to study enrollment 
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6. Employee or family members of clinical site (eg, Investigator, Coordinator, 
Technician). 
Exclusion Criteria after Baseline
7. 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) 
8. Clinically significant (Grade 3 or 4 on FDA scale) tarsal abnormalities, bulbar 
injection, corneal edema, corneal vascularization, corneal staining, or any other 
abnormalities of the cornea which would contraindicate contact lens wear. 
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials by a market research company.
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a single-visit, bilateral, randomized, controlled, 2 (lens) × 2 (period) crossover, 
non-dispensing study. Up to 40 subjects will be enrolled with the target of approximately 34
to complete the study.  
If a subject meets all eligibility criteria, they will be randomized to one of two lens wear 
sequences (Test/Control or Control/Test) in a bilateral fashion; otherwise they will be screen 
failed. Subjects will not be masked to the variant/pattern of the lenses due to visible differences
in the study lenses; however, subjects will be masked to the lens brands.  There will be a 
5-minute washout period between study lenses.
4.2.
Study Design Rationale 
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×2 bilateral crossover design was considered to 
be the optimal design since the study period is short the design can be cost effective and more 
efficient comparisons between treatments can be made than compared a parallel study since 
fewer subjects are required to achieve the same pre-specified statistical power. Each subject 
will act as their own control to reduce the influence of potential confounding factors such as 
age, gender and vision correction. Only a 5-minute washout between study lens wear will be
implemented to help reduce any potential bias, since this is a non-dispensing study. 
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4.3.
Enrollment Target and Study Duration
Approximately 40 subjects ages 18 to 39 years (inclusive) who are habitual soft contact lens 
wearers will be enrolled in this single-visit clinical study with the goal of 34 subjects to 
complete. While both male and female patients are eligible to participate, we will aim to enroll 
female subjects ages 18-29 years.   
Enrollment is defined as execution of the informed consent form.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover design. 
A computer-generated randomization scheme will be used to randomly assign subjects, in 
block of 4, to one of the two possible lens wear sequences: Test/Control or Control/Test. The 
random scheme will be generated using the PROC PLAN procedure from Statistical Analysis 
System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC).
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization: 
o
Informed consent has been obtained 
o
Subject meets all the inclusion / exclusion criteria
o
Subject history and baseline information has been collected.
5.2.
Masking
Due to visible print differences, subjects and investigators will be aware of the different 
patterns/variants of the investigational product.  However, subjects will be masked to the lens 
brand to prevent bias during the lens discussions. 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized.  Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken the Sponsor must be informed as soon as possible.  The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
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6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures. 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC. 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
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1. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS high contrast visual acuity OD 
(HC1), OS (HC2) and OU (HC3).
2. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS low contrast visual acuity OD 
(LC1), OS (LC2), and OU (LC3).
3. With the goggles on, under high 
illumination and chart luminance, 
record the distance (4 meter) ETDRS 
high contrast visual acuity OD (HC1), 
OS (HC2) and OU (HC3).  Allow 
subject to adjust to dim condition for 3 
minutes
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each 
chart read.  
1.19
Cosmetic Lens Fit 
Assessment (without 
slit-lamp)
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
Appendix 
E 
1.20
Hula Hoop 
Assessment (without 
slit-lamp)
*if unacceptable 
cosmetic lens fit in 
any gaze*
If there is an unacceptable cosmetic fit in any 
gaze, the Hula Hoop Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
Appendix 
E 
1.21
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
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x
Subject lost to follow-up  
x
Subject no longer meets eligibility criteria (eg the subject becomes pregnant)
x
Subject develops significant or serious adverse events causing discontinuation of study 
lens wear 
x
Subjects who have experienced a Corneal Infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
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, as 
appropriate  
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the subject
An additional subject may be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: None  
Concomitant therapies that are disallowed include: None 
9.1.
Systemic Medications
Due to the non-dispensing, single visit nature of the study and endpoints being assessed, 
systemic medications will be allowed provided they did not interfere with contact lens wear, 
which will be at the discretion of the investigator.   
Disallowed systemic medications - Not applicable 
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
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deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study then it must be reported to IEC/IRB. This is a "Major Deviation".
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation. 
Protocol waivers are prohibited 
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
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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. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to 
for test article return instructions).
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
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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.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
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 
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
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
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
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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)
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.
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NOTE 1: to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
NOTE 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x
Seriousness/Classifications (see definition in Section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 0). 
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown. 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
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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. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements.
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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 related to the visual system. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
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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
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest
Not applicable
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13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  
Pregnant participants are not discontinued from contact lens or solution related studies for 
safety concerns, but due to general concerns relating to pregnancy and contact lens use. 
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or 
visual acuity that occur secondary to systemic hormonal changes, and not due to unforeseen 
health risks to the mother or fetus. 
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). Throughout the analysis of data, the results 
for each subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
14.2. Sample Size Justification
This study was designed and powered to test for non-inferiority of the Test relative to the 
Control with respect to Distance Monocular Visual Acuity (logMAR) post lens fitting under 
the lighting conditions, low luminance high contrast and high luminance low contrast. 
Historical data from 
 was utilized for the sample size calculation since this study used 
the same control lens (1-Day Acuvue Define Vivid Style). 
11 was a dispensing, 4-
visit, 2×2 crossover where, 313 subjects were enrolled with 282 completing the study. 
However, visual acuity was only collected post lens fitting. Table 4 below contains the 
summary of visual acuity (logMAR) by lighting condition and lens type.     
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Table 4:
 Descriptive Summary of Distance Monocular Visual Acuity (logMAR)   
Lens Type
High Luminance Low Contrast
Low Luminance High Contrast
Control -Mean 
(SD1)
0.0474 (0.09041)
0.0851 (0.09454)
1SD: Standard Deviation
Since the Test and Control lenses have not been utilized in the same study, it was assumed for 
the sample size calculation that there was no difference between the Test and Control lenses 
and that both study lenses have similar variation with respect to visual acuity for both lighting 
conditions and that there was a perfect correlation between the left and right eyes. Furthermore, 
a conservative estimate of 0.30 was used for the intraclass correlation between periods,
providing a sample size estimate based on the “worst-case” scenario. The sample size was 
calculated using a two-sided type I error rate of 5% to achieve a minimum power of 80%. The 
calculation was performed using the POWER Procedure in SAS Version 5.1. Table 5 below 
contains the sample size to test for non-inferiority of the Test relative to the Control for each 
lighting condition.   
Table 5: Sample Size Calculation to Test for Non-Inferiority – Visual Acuity 
Lighting Condition
Minimum Number of 
Subjects to Complete
Power (%)
High Luminance Low 
Contrast 
30
80.4
Low Luminance High 
Contrast
33
80.7
As shown in the table above, to meet both primary hypotheses a minimum of 33 subjects are 
required to complete the study. Since this is 2×2 crossover we will aim to complete 34 subjects 
with equal allocation between the 2 lens wear sequences. To adjust to subject dropout, 
approximately 40 subjects will be enrolled to ensure that at least 34 subjects complete the 
study.
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file. 
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Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%.
Both adjusted and unadjusted confidence intervals will be reported. For the adjustment of 
multiple comparisons, a Bonferroni10 approach will be used.  
14.5. Primary Analysis  
The primary analysis will be conducted on the Per-Protocol Population.  If subject dropout rate 
exceeds 15%, a sensitivity analysis will be conducted on the Safety Population.   
Distance Monocular Visual Acuity (logMAR)  
Distance monocular visual acuity will be analyzed using a linear mixed model post lens fitting. 
Sequence of lens wear, lens, period, lighting condition and the interaction between lens by 
lighting condition will be included in the model as fixed effects. Other baseline characteristics 
such as age, gender and race may be included in the model when necessary. Subject and eye 
nested within subject will be included as random effects. Residual errors from measurements 
between lighting conditions within the same period will be model using one of the following 
covariance structures:  
x
Unstructured (UN)  
x
Compound Symmetry (CS) 
x
Heterogenous Compound Symmetry (CSH) 
The structure that returns the lowest finite sample corrected Akaike’s Information criterion8
will be selected as the structure that best fits the model. The Kenward and Roger method9 will 
be used for the denominator degrees of freedom. 
Comparisons between the Test and Control post lens fitting will be carried out separately for 
each lighting condition using 2-sided 95% confidence intervals for the least-square mean 
(LSM) difference (Test minus Control). Adjustments for multiple comparisons will be 
conducted using a Bonferroni10 approach.  
Hypothesis: 
The null and alternative hypothesis for visual acuity to test for non-inferiority of the Test lens 
relative to the Control lens is as follows:
ܪ௢: ߤ்െߤ஼
ܪ஺: ߤ்െߤ஼ < 0.05 
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Where  ߤ் and  ߤ஼represent the populations means for distance monocular visual acuity for 
the Test and Control lenses, respectively. Non-inferiority will be tested separately for each 
lighting condition.  Non-inferiority will be declared if the upper limit of each 95% confidence 
interval for the LSM difference between the Test and Control is below 0.05. i.e. P(  ߤ்െߤ஼<

14.6. Secondary Analysis  
Not applicable.  
14.7. Other Exploratory Analyses  
Further statistical exploratory analysis can be undertaken, if necessary, at the discretion of the 
clinical project leader.
14.8. Interim Analysis
An interim analysis will not be conducted on this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at 
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric
regression method used to make at least 15 imputations.  
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica Express 5.5). An authorized data originator will enter study data into the 
eCRFs using the EDC system. Data collected on equipment that is not captured in EDC will 
be formatted to the specification of the JJVC database manager and sent to JJVC for analysis.
External Data Sources for this study include: Not Applicable  
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The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
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. 
15.3 ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: confirmatory study 
meets the requirements for registration.   
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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. 
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. 
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x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
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. 
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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). 
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. 
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18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551
guidelines, applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has been 
fully explained. The assent and consent forms must be signed before performance of any study-
related activity. The assent and consent forms that are used must be approved by both the 
Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms should be in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH2 and 
GCP guidelines, applicable regulatory requirements, and Sponsor policy. Before entry into the 
study or pre-screening, the Investigator or an authorized member of the clinical site personnel 
must explain to the potential subject and parent and/or legal guardian the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study or pre-screening, and any 
discomfort it may entail. Subjects and parent and/or legal guardian will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. They 
will be informed that choosing not to participate will not affect the care the subject will receive. 
Finally, they will be told that the Investigator will maintain a subject identification register for 
the purposes of long-term follow-up if needed and that their records may be accessed by health 
authorities and authorized Sponsor personnel without violating the confidentiality of the 
subject, to the extent permitted by the applicable law(s) or regulations. By signing the assent 
and informed consent form, the subject is authorizing such access and agrees to be contacted 
after study completion by health authorities and authorized Sponsor personnel for the purpose 
of obtaining consent for additional safety evaluations if needed. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
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United States7 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential.
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
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 
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study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
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22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Bishop, Meredith. 
 Clinical Study Report VIS-CSRP-005768/1 Clinical 
Evaluation of Daily Disposable Etafilcon A Cosmetic Contact Lenses. October 19,
2018.
6. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
7. EU MDR 2017/745 
8. Keselman HJ et al. A Comparison of Two Approaches for Selecting Covariance 
Structures in the Analysis of Repeated Measures. Communications in Statistics—
Simulation and Computation. 1998;27:591-604. 
9. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted
Maximum Likelihood. Biometrics. 1997;53:983–997. 
10. Dunn OJ. Multiple Comparisons among Means. Journal of the American Statistical 
Association. 1961;56(293):52-64.
11. Bishop, Meredith. 
 Clinical Study Protocol VIS-CR-005598 Evaluation of 
New Limbal Ring Prototypes. May 1, 2014. 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
Not applicable.
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Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
This will be provided separately.  
CR-6060, v2.0
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
1-DAY ACUVUE® DEFINE™ Brand Contact Lenses 
CR-6060, v2.0
 
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Johnson & Johnson Vision Care, Inc.
APPENDIX D: CLINICAL TECHNICAL PROCEDURES (CTP) 
 
x
Lens Fitting Characteristics  
x
 Subject Reported Ocular Symptoms/Problems  
x
Determination Of Distance Spherocylindrical Refractions 
x
 Biomicroscopy Scale  
x
Distance And Near Visual Acuity Evaluation   
x
Distance LogMAR Visual Acuity Measurement Procedure 
x
 Visual Acuity Chart Luminance And Room Illumination Testing 
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LENS FITTING CHARACTERISTICS
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Page 6 of 6 
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Clinical Study Protocol
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SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
CR-6060, v2.0
 
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 BIOMICROSCOPY SCALE 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
CR-6060, v2.0
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
Page 2 of 5 
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
Page 4 of 5 
 
CR-6060, v2.0
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
Page 5 of 5 
 
CR-6060, v2.0
 
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Clinical Study Protocol
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APPENDIX E: COSMETIC FIT AND HULA HOOP 
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Johnson & Johnson Vision Care, Inc.
APPENDIX F: COVID-19 RISK MITIGATION GUIDELINES
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6060 Evaluation of Visual Performance of Two Types of Cosmetic 
Contact Lenses
Version and Date: 2.0 21 July 2020 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct the study in 
compliance with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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