Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Protocol Title: Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
Protocol: CR-6286
Version: 3.0
Date: 20 December 2018 
Investigational Products: ACUVUE® 2 DEFINE™ Vivid Style contact lens, LACELLE™ 
Contact Lenses in Sparkling Brown
Key Words: ACUVUE® 2 DEFINE™ Vivid Style contact lens, LACELLE™ Contact 
Lenses, reusable, Etafilcon A, Hefilcon A, dispensing, logMAR visual acuity, subjective 
vision
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, 
or as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc.  Any supplemental information that may be added to this 
document is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and 
must be kept in confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION ............................................................................ 6 
SPONSOR NAME AND ADDRESS ........................................................................................ 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ................................................................................................ 7 
CHANGE HISTORY ................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 8 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS ..................... 13 
1. 
INTRODUCTION AND BACKGROUND .................................................................... 14 
1.1. 
Name and Descriptions of Investigational Products ................................................ 14 
1.2. 
Intended Use of Investigational Products ................................................................ 14 
1.3. 
Summary of Findings from Nonclinical Studies ..................................................... 14 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .................................. 14 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study ..................................................................................................................... 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ....................................... 15 
2.1. 
Objectives ................................................................................................................ 15 
2.2. 
Endpoints ................................................................................................................. 15 
2.3. 
Hypotheses ............................................................................................................... 16 
3. 
TARGETED STUDY POPULATION ............................................................................ 16 
3.1. 
General Characteristics ............................................................................................ 16 
3.2. 
Inclusion Criteria ..................................................................................................... 16 
3.3. 
Exclusion Criteria .................................................................................................... 16 
3.4. 
Enrollment Strategy ................................................................................................. 17 
4. 
STUDY DESIGN AND RATIONALE ........................................................................... 17 
4.1. 
Description of Study Design .................................................................................... 17 
4.2. 
Study Design Rationale ............................................................................................ 18 
4.3. 
Enrollment Target and Study Duration .................................................................... 18 
5. 
TEST ARTICLE ALLOCATION AND MASKING ...................................................... 18 
5.1. 
Test Article Allocation ............................................................................................. 18 
5.2. 
Masking .................................................................................................................... 18 
5.3. 
Procedures for Maintaining and Breaking the Masking .......................................... 19 
6. 
STUDY INTERVENTION ............................................................................................. 19 
6.1. 
Identity of Test Articles ........................................................................................... 19 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 20 
6.3. 
Administration of Test Articles................................................................................ 20 
6.4. 
Packaging and Labeling ........................................................................................... 20 
6.5. 
Storage Conditions ................................................................................................... 20 
6.6. 
Collection and Storage of Samples .......................................................................... 20 
6.7. 
Accountability of Test Articles ................................................................................ 21 
7. 
STUDY EVALUATIONS ............................................................................................... 22 
7.1. 
Time and Event Schedule ........................................................................................ 22 
7.2. 
Detailed Study Procedures ....................................................................................... 23 
VISIT 1 ........................................................................................................................... 23 
VISIT 2 ........................................................................................................................... 28 
VISIT 3 ........................................................................................................................... 30 
VISIT 4 ........................................................................................................................... 34 
FINAL EVALUATION.................................................................................................. 36 
7.3. 
Unscheduled Visits .................................................................................................. 36 
7.4. 
Laboratory Procedures ............................................................................................. 37 
8. 
SUBJECTS COMPLETION/WITHDRAWAL .............................................................. 38 
8.1. 
Completion Criteria ................................................................................................. 38 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 38 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .................. 38 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................... 39 
11. 
STUDY TERMINATION ............................................................................................ 39 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ............... 39 
13. 
ADVERSE EVENTS ................................................................................................... 41 
13.1. 
Definitions and Classifications ............................................................................. 41 
13.2. 
Assessing Adverse Events .................................................................................... 43 
13.2.1. 
Causality Assessment .................................................................................... 43 
13.2.2. 
Severity Assessment ..................................................................................... 44 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................. 44 
13.4. 
Reporting Adverse Events .................................................................................... 45 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 45 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities ...................................................................................................................... 46 
13.4.3. 
Event of Special Interest ............................................................................... 46 
13.5. 
Reporting of Pregnancy ........................................................................................ 47 
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14. 
STATISTICAL METHODS ......................................................................................... 47 
14.1. 
General Considerations ........................................................................................ 47 
14.2. 
Sample Size Justification...................................................................................... 47 
14.3. 
Analysis Populations ............................................................................................ 47 
14.4. 
Level of Statistical Significance ........................................................................... 48 
14.5. 
Primary Analysis .................................................................................................. 48 
14.6. 
Secondary Analysis .............................................................................................. 48 
14.7. 
Other Exploratory Analyses ................................................................................. 48 
14.8. 
Interim Analysis ................................................................................................... 48 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 48 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 48 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................. 48 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 48 
15.2. 
Subject Record ..................................................................................................... 49 
16. 
DATA MANAGEMENT ............................................................................................. 50 
16.1. 
Access to Source Data/Document ........................................................................ 50 
16.2. 
Confidentiality of Information ............................................................................. 50 
16.3. 
Data Quality Assurance ........................................................................................ 50 
17. 
MONITORING............................................................................................................. 50 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................. 51 
18.1. 
Study-Specific Design Considerations ................................................................. 51 
18.2. 
Investigator Responsibility ................................................................................... 51 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 51 
18.4. 
Informed Consent ................................................................................................. 53 
18.5. 
Privacy of Personal Data ...................................................................................... 53 
19. 
STUDY RECORD RETENTION ................................................................................ 54 
20. 
FINANCIAL CONSIDERATIONS ............................................................................. 55 
21. 
PUBLICATION ............................................................................................................ 55 
22. 
REFERENCES ............................................................................................................. 55 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ...... 56 
APPENDIX B: PATIENT INSTRUCTION GUIDE .............................................................. 64 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 65 
APPENDIX D: HULA HOOP AND COSMETIC FIT ASSESSMENT ................................ 68 
APPENDIX E: 
 ........................................ 71 
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 LENS FITTING CHARACTERISTICS ............................................................... 72 
 SUBJECT REPORTED OCULAR SYMPTOMS ................................................ 79 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 81 
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS ...................................................................................................................... 87 
 BIOMICROSCOPY SCALE ................................................................................ 94 
 KERATOMETRY PROCEDURE ...................................................................... 100 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION......................... 102 
 EDTRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE ...... 107 
 PATIENT REPORTED OUTCOMES ............................................................... 111 
 WHITE LIGTH LENS SURFACE WETTABILITY ......................................... 113 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING ............................................................................................................................... 115 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ......................... 121 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 12 
TABLE OF CONTENTS
Table 1: Test Articles.............................................................................................................. 19 
Table 2: Ancillary Supplies .................................................................................................... 20 
Table 3: Time and Events ....................................................................................................... 22 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Clinical Comparison of Two Marketed Reusable Cosmetic Contact Lenses
Protocol Number:  CR-6286 
Version: 3.0 
Date:  20 December 2018 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
Name:  Brian Pall, OD, MS, FAAO
Title: Director, Clinical Sciences
Address: 7500 Centurion Parkway, Suite 100 
Email: bpall@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 signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations,4 ICH 
guidelines,2 ISO 14155,1 and the Declaration of Helsinki.3
Author/Study 
Responsible 
Clinician
See Electronic Signature Page
Brian Pall, OD, MS, FAAO
Director, Clinical Sciences, R&D
DATE
Clinical Operations 
Manager
See Electronic Signature Page
Clinical Operations Manager, Clinical 
Operations
DATE
Biostatistician
See Electronic Signature Page
Biostatistician II, R&D
DATE
Data Management 
See Electronic Signature Page
Clinical Project Manager, Data and Systems, 
R&D
DATE
Reviewer
Fellow review is NOT required
DATE
Approver
Clinical Research Fellow
See Electronic Signature Page
Director, Beauty Platform and External 
Innovation, R&D
DATE
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Visit 3: Reconfirm eligibility, insert treatment #2, logMAR 
vision, post fit questionnaire, lens fit assessment.  Dispense 
treatment #2 for 11-14 days
Visit 4: Follow up on treatment #2: Subjective questionnaire, 
logMAR vision, lens fit, and physiology assessment.  Final 
evaluation. 
See the flow chart (Figure 1) at the end of the synopsis table 
for the schematic of the study visits and procedures of main 
observations.
Sample Size
Up to 50 female subjects will be enrolled with the aim of 
approximately 40 subjects completing.
Study Duration
The study is expected to last up to 3 months. The enrollment 
period will also be up to 2 months.
Anticipated Study 
Population 
We will aim to recruit up to 50 female subjects, ages 18 to 29
years (inclusive).  Subject must be habitual reusable cosmetic 
contact lens wearers.  
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 (ie, willing to wear 
only the study lenses and not use habitual lenses 
during the study) 
3. Females between 18 and 29 (inclusive) years of age at 
the time of screening
4. The subject’s vertex corrected spherical equivalent 
distance refraction must be in the range of -2.00 D to 
-7.00 D (inclusive) in each eye 
5. The subject’s refractive cylinder must be less than or 
equal to 0.75 D (inclusive) in each eye
6. Have spherical best corrected logMAR visual acuity
(VA) of 0.18 or better in each eye 
7. 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 
8. Must be habitual reusable (2 week, or monthly), 
cosmetic contact lenses wearers. 
9. The subject must be willing to be photographed and/or 
video-taped
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Eligibility Criteria
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
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 VA, PRO questionnaires (comfort, vision, and 
handling), lens fit assessment, and safety parameters (slit 
lamp findings, entrance/exit VA).  
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
EyeCept (Optics Laboratory, Inc.), LacriPure (Menicon), 
Blink Revitalens (Johnson & Johnson Vision), Fluorescein 
(Akorn, Inc.) or other Sponsor-approved supplies
Principal Investigator(s) and 
Study Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required for Near Use
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide 
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PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
1.
INTRODUCTION AND BACKGROUND
Cosmetic contact lenses can have patterns of varying size and opacities.  When designing 
new cosmetic patterns, it is important to test the performance in a clinical study. The 
ACUVUE® 2 DEFINE™ Vivid Style contact lens is a marketed contact lens formulated 
using etafilcon A and the intended use is to correct vision. The ACUVUE® 2 DEFINE™ 
Vivid Style contact lens contains a cosmetic pattern, so it also affects the visual appearance 
of the eye.  Hence, the present study was designed to evaluate the objective vision Objective
Vision Logarithm of Minimal Angle of Resolution (logMAR) high illuminance/high contrast 
of two brands of marketed cosmetic contact lens.
1.1.
Name and Descriptions of Investigational Products  
This study will include two marketed contact lenses. 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 products is to correct vision. During this dispensing 
study, each lens type will be worn for approximately 2 weeks.   
1.3.
Summary of Findings from Nonclinical Studies
Not Applicable - Marketed Product Only 
1.4.
Summary of Known Risks and Benefits to Human Subjects
The following risks/adverse events can be associated with wearing soft contact lenses in 
general:
x
The eyes may burn, sting and/or itch. 
x
There may be a feeling of something in the eye (foreign body, scratched area).
x
There may be the potential for some temporary impairment due to peripheral 
infiltrates, peripheral corneal ulcers and corneal erosion.   
x
There may be the potential for other physiological observations, such as local or 
generalized edema, corneal neovascularization, corneal staining, injection, tarsal 
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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 VA, blurred vision, rainbows or halos around objects, photo-phobia, or dry eyes 
may also occur if the lenses are worn continuously or for too long a time. 
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 contact lenses.  The information from this study will aid if the 
further development and assessment of new potential contact lenses.   
For the most comprehensive clinical information regarding the marketed contact lenses refer 
to the package inserts (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
For the most comprehensive clinical information regarding the marketed contact lenses refer 
to the package insert (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective: 
The primary objective of this study is to evaluate the logMAR high illuminance/high contrast 
of one brand of marketed contact lens.  
2.2.
Endpoints 
Primary Endpoint: 
LogMAR objective vision (high illumination/high contrast) at lens fit.  
Other Observations: 
Overall quality of vision, overall comfort and handling scores will be assessed using the 
Contact Lens User Experience (CLUE)™ questionnaire.  CLUE is a validated patient-
reported outcomes questionnaire to assess patient-experience attributes of soft, disposable 
contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing 
population in the US, ages 18-65.  Scores follow a normal distribution with a population 
average score of 60 (SD 20), where higher scores indicate a more favorable/positive 
response. 
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LogMAR objective vision (high illumination/low contrast, low illumination/high contrast)
Mechanical Lens Fit
Cosmetic Lens Fit
Hula Hoop Assessment  
Ocular Physiology  
2.3.
Hypotheses
Due to the exploratory nature of this pilot study, there will be no planned hypotheses.  
Instead, descriptive summaries (ie, tables and figures) of study endpoints will be provided for 
each lens type.
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Females aged 18 to 29 years (inclusive) who are habitual reusable (2 week or monthly) soft 
cosmetic 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
(ie, willing to wear only the study lenses and not use habitual lenses during the study) 
3. Females between 18 and 29 (inclusive) years of age at the time of screening
4. The subject’s vertex corrected spherical equivalent distance refraction must be in the 
range of -2.00 D to -7.00 D (inclusive) in each eye 
5. The subject’s refractive cylinder must be less than or equal to 0.75 D (inclusive) in 
each eye
6. Have spherical best corrected logMAR VA of 0.18 or better in each eye 
7. 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
8. Must be habitual reusable (2 week, or monthly), cosmetic contact lenses wearers. 
9. The subject must be willing to be photographed and/or video-taped
3.3.
Exclusion Criteria
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) 
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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
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 Food and Drug Administration [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 will be a 4-visit, multi-site, randomized, brand-masked, bilateral, 2×2 Williams’ 
crossover study.   
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility
criteria, they will be random to one of two lens wear sequences (Test/Control or 
Control/Test).
If the subject is dispensed study lenses at the initial visit, 3 follow-up visits will be 
conducted.  Visit 2 will occur approximately 2 weeks after the initial visit.  At the end of visit 
2, subjects will be instructed to wear their habitual contact lenses or spectacles for 7-10 days. 
Subjects will then return for visit 3 to receive their second study treatment. Visit 4 will occur 
approximately 2 weeks after visit 3.  Unscheduled follow-up visits may occur during the 
study, if needed.  Subjects will be advised to wear the study lenses at least six (6) hours per 
day for a period of 11-14 days each. Lens replacement is scheduled at Visit 3.
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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.  This design was considered since the 
study period is relatively short the design can be cost effective.
4.3.
Enrollment Target and Study Duration
Approximately 50 female subjects ages 18 to 29 years (inclusive) who are habitual reusable 
soft cosmetic contact lens wearers will be enrolled in this 4-visit, two-site clinical study.  The 
study will last approximately 3 months with a 2-month enrollment period.   
Enrollment is defined as execution of the informed consent and/or assent form. 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Use of the test articles will be randomized using a randomization scheme supplied by the 
study biostatistician. 
A block size of two (2) sequences will be utilized.  A computer-generated randomization 
scheme will be used to randomly assign subjects, in blocks of 2, to one of the two possible 
lens wear sequences (TEST/CONTROL or CONTROL/TEST). The randomization scheme 
will be generated by site 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
according to the randomization list and not pre-select or assign subjects. The randomize
assignment of subjects will be performed at the first visit prior to the first fitting. The
following must have occurred prior to randomization: 
• Informed consent has been obtained 
• Subject meets all the inclusion / exclusion criteria
• Subject history and baseline information has been collected.
5.2.
Masking
Due to visible difference between the lenses, it is difficult to complete mask subject, however 
subjects will be masked to the lens type and brand.  Investigators will not be masked.   
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 
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When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint (PQC) must be retained and stored in a glass vial with moderate solution 
pending directions from the sponsor for potential return back to JJVC. 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records.  
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing.  The Investigator may delegate this activity to authorized study 
site personnel listed on the Site Delegation Log.  All test articles must be accounted.  This 
includes: 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits 
2. What was returned to the Investigator unused 
3. The number and reason for unplanned replacements   
The Investigator will collect all unused test articles from the subjects at the end of the 
subject’s participation. Subject returned unused test articles must be separated from the 
clinical study inventory of un-dispensed test articles, and must be labeled with the subject 
number and date of return.  Following final reconciliation of test articles by the monitor, the 
Investigator or monitor will return all unused test articles to JJVC or a designated third party 
storage depot, or will instruct the site staff to destroy the lenses on site. More detailed 
instructions will be provided prior to the Close-out Visit. 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information.
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1.26
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable/unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit will be any one or more 
of the following criteria: 
x
Presence of limbal exposure 
(appearance of clear cornea) in any 
gaze; 
x
Presence of edge lift;
x
Presence of unacceptable movement 
(excessive or insufficient) in all three
of the following conditions: primary 
gaze, up gaze, and Josephson push 
up.
Note: if lens fit is unacceptable subject will 
be discontinued from the study.
1.27
Wettability 
Characteristics
Record the white light lens wettability of 
both lenses.
1.28
Surface Deposits
Record any front and back surface lens 
deposits.
1.29
LogMAR Visual 
Acuity
Record the logMAR distance visual acuity 
(OD and OS) with the study contact lens 
correction in place.  
1.30
Continuance
For the subject to continue in the study, they 
must meet all three of the following criteria:
x
logMAR VA is 0.18 or better OD and 
OS (high illumination/high contrast)
x
The lens fit is acceptable OD and OS
x
Investigator approval.  If the 
Investigator does not approve the 
dispensing of the first study lens, then 
the subject should be discontinued 
and the final evaluations completed.
1.31
Dispense
The lenses will be dispensed for a 11-14 day 
wearing period.   
x
Subject is willing to wear the lenses 
for the dispensing period for 6 hours 
per day each day, and will not wear 
their habitual lenses during the 
dispensing period. 
x
The lenses will be worn as daily wear 
only. 
x
Subjects will be given Revitalens 
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VCT-0007 (7)
3.14
Hula Hoop 
Assessment (without 
slit-lamp)
The Hula Hoop Assessment will be assessed 
by the investigator (without slit-lamp) in 
primary gaze and extreme gaze (right, left, and 
upgaze) at a normal conversation distance 
(approximately three (3) feet away from the 
subject).  
Appendix D
3.15
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable/unacceptable) based on centration, 
movement and other fitting characteristics.
An unacceptable fit will be any one or more of 
the following criteria: 
x
Presence of limbal exposure 
(appearance of clear cornea) in any 
gaze; 
x
Presence of edge lift;
x
Presence of unacceptable movement 
(excessive or insufficient) in all three of 
the following conditions: primary gaze, 
up gaze, and Josephson push up. 
Note: if lens fit is unacceptable subject will be 
discontinued from the study.
3.16
Wettability 
Characteristics
Record the white light lens wettability of both 
lenses.
3.17
Surface Deposits
Record any front and back surface lens 
deposits.
3.18
LogMAR Visual 
Acuity
Record the logMAR distance visual acuity 
(OD and OS) with the study contact lens 
correction in place.
3.19
Continuance
For the subject to continue in the study, they 
must meet all three of the following criteria:
x
LogMAR VA is 0.18 or better OD and 
OS (high illumination/high contrast)
x
The lens fit is acceptable OD and OS
x
Investigator approval.  If the 
Investigator does not approve the 
dispensing of the first study lens, then 
the study is terminated for that subject.
3.20
Dispense
The lenses will be dispensed for a 11-14 day 
wearing period.   
x
Subject is willing to wear the lenses for 
the dispensing period for 6 hours per 
day each day, and will not wear their 
habitual lenses during the dispensing 
period.
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1. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS high contrast VA twice OD 
(HC1-HC2) and twice OS (HC3-HC4).
2. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS low contrast VA twice OD (LC1-
LC2) and twice OS (LC3-LC4).
3. With the goggles on, under normal 
illumination and chart luminance, record 
the distance (4 meter) ETDRS high 
contrast VA twice OD (HC5-HC26 and 
twice OS (HC7-HC8).  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.  
4.7.
Cosmetic Lens Fit 
Assessment 
(without slit-lamp)
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-lamp) 
in primary gaze and extreme gaze (right, left, 
and upgaze) at a normal conversation distance 
(approximately three (3) feet away from the 
subject).  
Appendix D
4.8.
Hula Hoop 
Assessment 
(without slit-lamp)
The Hula Hoop Assessment will be assessed by 
the investigator (without slit-lamp) in primary 
gaze and extreme gaze (right, left, and upgaze) 
at a normal conversation distance 
(approximately three (3) feet away from the 
subject).  
Appendix D
4.9.
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance (acceptable 
or unacceptable) based on centration, 
movement and other fitting characteristics.
An unacceptable fit will be any one or more of 
the following criteria: 
x
Presence of limbal exposure (appearance 
of clear cornea) in any gaze; 
x
Presence of edge lift;
x
Presence of unacceptable movement 
(excessive or insufficient) in all three of 
the following conditions: primary gaze, 
up gaze, and Josephson push up. 
Note: if lens fit is unacceptable subject will be 
discontinued from the study.
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8.
SUBJECTS COMPLETION/WITHDRAWAL 
8.1.
Completion Criteria
Subjects are considered to have completed the study if they:  
x
provided informed consent and/or assent;
x
they are eligible;
x
Completed all three phases of testing;
x
Have not withdrawn/discontinued from the study for any reason described in Section 
8.2.
8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons: 
x
Subject death during the study period 
x
Subject withdrawal of consent  
x
Subject not compliant to protocol 
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 VA  
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: Not applicable.
Concomitant therapies that are disallowed include: Not applicable. 
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10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.   
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint 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 PQCs:
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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 (ie, 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 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented. 
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13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include 
any condition resulting from concomitant illnesses, reactions to concomitant 
medications, or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening 
event, a significant persistent or permanent change, impairment, damage, or 
disruption to the subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article 
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected VA equivalent to 2 acuity lines or 
greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
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x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other Grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  
However, the Investigator may choose to treat as a precautionary measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following: 
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, 
which necessitates temporary lens discontinuation < 2 weeks 
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Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure (IB) 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 – ie, the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1) 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and 
the test article. The test article relationship for each adverse event should be determined by 
the investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded
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x
Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship 
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject.  The 
assessment of severity is made irrespective of test article, study treatment or study procedure 
relationship or seriousness of the event and should be evaluated according to the following 
scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following: 
x
Adverse event (diagnosis not symptom) 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
x
Date the clinical site was notified  
x
Date and time of onset
x
Date and time of resolution
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x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected VA at the discovery of the event and upon conclusion of the event 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate 
Assessment eCRF.  Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature.  If cultures are collected, the date of culture 
collection and laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study 
visit date, should be followed to resolution of the adverse event or until referral to an 
appropriate health care provider, as recommended by the Investigator. Non-ocular adverse 
events that are not related to the test article, study treatment, or study procedures may be 
recorded as “ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or 
telephone as soon as possible and no later than 24 hours from discovery for any serious 
/significant adverse events, and 2 days from discovery for any non-significant adverse event.  
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements (Section 13.4.2).  The report will comment whether the 
adverse event was considered to be related to the test article, study treatment or study 
procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
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hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received.  The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect.  This report is in addition to 
the immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
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.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
will not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or VA 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 study biostatistician. A general description of 
the statistical methods to be implemented in this clinical trial is outlined below.
All data summaries and statistical analyses will be performed using the SAS software 
Version 9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization.  Unscheduled visits will be 
summarized separately.  
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. 
Further exploratory analysis can be undertaken, if necessary, at the discretion of the clinical 
project leader.
14.2. Sample Size Justification
This pilot study is not powered to test for any planned hypotheses. Hence, the sample size 
was chosen based on availability of time and resources. Targeting 20 subjects to complete 
the study will be sufficient to evaluate descriptive summaries of study endpoints.
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 
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(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from 
study or deviation from protocol.  At least one observation should be recorded. 
14.4. Level of Statistical Significance
Not applicable.  
14.5. Primary Analysis  
The primary endpoint will be descriptively summarized by lens type.
14.6. Secondary Analysis  
Not applicable.
14.7. Other Exploratory Analyses  
All observations will be descriptively summarized by lens type.
14.8. Interim Analysis
Not applicable.  
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be 
included in the summary tables and listings.
14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using 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. 
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External Date Sources for this study include: Not Applicable  
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy 
and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
will be authorized to gain access to the subject recordation for the purposes of monitoring 
and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate 
and complete data collection. Data will be transmitted from the clinical site to a secure 
central database as forms are completed or updated, ensuring information accuracy, security, 
and confidentiality. After the final database lock, the Investigator will be provided with 
Individual Patient Profiles (IPP) including the full audit trail on electronic media in PDF 
format for all of the study data. The IPP must be retained in the study files as a certified copy 
of the source data for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
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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. MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x
Ensuring the rights and wellbeing of subjects are protected 
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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 and, if applicable, amendments 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information) and amendments 
x
Sponsor-approved subject recruitment materials 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
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x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless 
not required, as documented by IEC/IRB) 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), the informed consent form, applicable recruiting materials, 
and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved. 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments 
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects 
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s) 
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
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 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. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be:
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x
processed fairly and lawfully 
x
collected for specified, explicit, and legitimate purposes and not further processed in 
a way incompatible with these purposes 
x
adequate, relevant, and not excessive in relation to said purposes 
x
accurate and, where necessary, kept current 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform 
the Investigator/Institution as to when these documents no longer need to be retained. 
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.
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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. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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PRO SPECIFICATION Version 2 Final  2018-05-17
Protocol 6286                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATION Version 2 Final  2018-05-17
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2
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PRO SPECIFICATION Version 2 Final  2018-05-17
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3
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PRO SPECIFICATION Version 2 Final  2018-05-17
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PRO SPECIFICATION Version 2 Final  2018-05-17
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5
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PRO SPECIFICATION Version 2 Final  2018-05-17
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PRO SPECIFICATION Version 2 Final  2018-05-17
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide (PIG) will be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
ACUVUE® 2 DEFINE™ Vivid Style & LACELLE™ Sparkling Brown
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APPENDIX E: 
 
 
x
LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS
x
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING 
PROCEDURE
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
x
 BIOMICROSCOPY SCALE
x
 KERATOMETRY PROCEDURE
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
 PATIENT REPORTED OUTCOMES
x
 WHITE LIGHT LENS SURFACE WETTABILITY CHARACTERISTICS
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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SUBJECT REPORTED OCULAR SYMPTOMS
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FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE
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Page 5 of 5 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
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BIOMICROSCOPY SCALE
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KERATOMETRY PROCEDURE
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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EDTRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
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PATIENT REPORTED OUTCOMES
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Page 1 of 1
Patient Reported Outcomes 
  
The training requirement for this document is “Read Only.”
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WHITE LIGTH LENS SURFACE WETTABILITY
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number/Title: CR-6286 Clinical Comparison of Two Marketed Reusable Cosmetic 
Contact Lenses  
Version and Date: 3.0, 20 December 2018 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and 
GCP guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
All clinical site personnel involved in the conduct of this study have completed Human
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization.
Principal Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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