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

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Evaluation of senofilcon A Contact Lenses Using a Novel Manufacturing Technology
Protocol CR-6474
Version: 2.0
                           
Date: 19 April 2022
Investigational Products: senofilcon A
Keywords: Sphere, senofilcon A prototype, ACUVUE OASYS Max 1-Day, daily wear, 
daily disposable, dispensing, preservative-free rewetting drops, CLUE comfort, CLUE vision,
logMAR acuity. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
CR-6474, v 2.0
 
 
Page 1 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE ....................................................6 
SPONSOR NAME AND ADDRESS ....................................................................................6 
MEDICAL MONITOR .........................................................................................................6 
AUTHORIZED SIGNATURES............................................................................................7 
CHANGE HISTORY............................................................................................................8 
SYNOPSIS............................................................................................................................9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS .. 15 
1. 
INTRODUCTION AND BACKGROUND.................................................................. 16 
1.1. 
Name and Descriptions of Investigational Products............................................... 16 
1.2. 
Intended Use of Investigational Products............................................................... 16 
1.3. 
Summary of Findings from Nonclinical Studies .................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .................................. 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ..................................... 16 
2.1. 
Objectives ............................................................................................................. 16 
2.2. 
Endpoints .............................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................ 18 
3. 
TARGETED STUDY POPULATION......................................................................... 19 
3.1. 
General Characteristics.......................................................................................... 19 
3.2. 
Inclusion Criteria................................................................................................... 19 
3.3. 
Exclusion Criteria.................................................................................................. 19 
3.4. 
Enrollment Strategy............................................................................................... 20 
4. 
STUDY DESIGN AND RATIONALE........................................................................ 20 
4.1. 
Description of Study Design.................................................................................. 20 
4.2. 
Study Design Rationale......................................................................................... 21 
4.3. 
Enrollment Target and Study Duration .................................................................. 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING.................................................... 21 
5.1. 
Test Article Allocation.......................................................................................... 21 
5.2. 
Masking ................................................................................................................ 22 
5.3. 
Procedures for Maintaining and Breaking the Masking.......................................... 22 
6. 
STUDY INTERVENTION.......................................................................................... 22 
CR-6474, v 2.0
 
 
Page 2 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.1. 
Identity of Test Articles......................................................................................... 22 
6.2. 
Ancillary Supplies/Products .................................................................................. 23 
6.3. 
Administration of Test Articles ............................................................................. 24 
6.4. 
Packaging and Labeling ........................................................................................ 24 
6.5. 
Storage Conditions................................................................................................ 24 
6.6. 
Collection and Storage of Samples ........................................................................ 24 
6.7. 
Accountability of Test Articles.............................................................................. 25 
7. 
STUDY EVALUATIONS........................................................................................... 26 
7.1. 
Time and Event Schedule...................................................................................... 26 
7.2. 
Detailed Study Procedures..................................................................................... 28 
VISIT 1 ....................................................................................................................... 28 
VISIT 2 ....................................................................................................................... 34 
VISIT 3 ....................................................................................................................... 39 
FINAL EVALUATION............................................................................................... 42 
7.3. 
Unscheduled Visits................................................................................................ 43 
7.4. 
Laboratory Procedures .......................................................................................... 45 
8. 
SUBJECTS COMPLETION/WITHDRAWAL............................................................ 45 
8.1. 
Completion Criteria............................................................................................... 45 
8.2. 
Withdrawal/Discontinuation from the Study.......................................................... 46 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 46 
9.1. 
Systemic Medications............................................................................................ 47 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................ 48 
11. 
STUDY TERMINATION......................................................................................... 49 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 50 
13. 
ADVERSE EVENTS................................................................................................ 51 
13.1. 
Definitions and Classifications........................................................................... 51 
13.2. 
Assessing Adverse Events ................................................................................. 53 
13.2.1. 
Causality Assessment ................................................................................. 54 
13.2.2. 
Severity Assessment ................................................................................... 54 
13.3. 
Documentation and Follow-Up of Adverse Events............................................. 55 
13.4. 
Reporting Adverse Events ................................................................................. 56 
13.4.1. 
Reporting Adverse Events to Sponsor......................................................... 56 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 57 
CR-6474, v 2.0
 
 
Page 3 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.5. 
Event of Special Interest .................................................................................... 57 
13.6. 
Reporting of Pregnancy ..................................................................................... 57 
14. 
STATISTICAL METHODS..................................................................................... 58 
14.1. 
General Considerations...................................................................................... 58 
14.2. 
Sample Size Justification ................................................................................... 58 
14.3. 
Analysis Populations ......................................................................................... 60 
14.4. 
Level of Statistical Significance......................................................................... 60 
14.5. 
Primary Analysis ............................................................................................... 60 
14.6. 
Secondary Analysis ........................................................................................... 61 
14.7. 
Other Exploratory Analysis................................................................................ 61 
14.8. 
Interim Analysis ................................................................................................ 61 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................ 62 
14.10. 
Procedure for Reporting Deviations from Statistical Plan................................... 62 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................... 62 
15.1. 
Electronic Case Report Form/Data Collection.................................................... 62 
15.2. 
Subject Record .................................................................................................. 63 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................. 63 
16. 
DATA MANAGEMENT.......................................................................................... 63 
16.1. 
Access to Source Data/Document ...................................................................... 63 
16.2. 
Confidentiality of Information ........................................................................... 63 
16.3. 
Data Quality Assurance ..................................................................................... 64 
16.4. 
Data Monitoring Committee (DMC).................................................................. 64 
17. 
CLINICAL MONITORING ..................................................................................... 64 
18. 
ETHICAL AND REGULATORY ASPECTS........................................................... 65 
18.1. 
Study-Specific Design Considerations ............................................................... 65 
18.2. 
Investigator Responsibility................................................................................. 65 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB)........... 65 
18.4. 
Informed Consent .............................................................................................. 66 
18.5. 
Privacy of Personal Data.................................................................................... 67 
19. 
STUDY RECORD RETENTION............................................................................. 68 
20. 
FINANCIAL CONSIDERATIONS.......................................................................... 69 
21. 
PUBLICATION ....................................................................................................... 69 
22. 
REFERENCES......................................................................................................... 69 
CR-6474, v 2.0
 
 
Page 4 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)...... 70 
APPENDIX B: PATIENT INSTRUCTION GUIDE............................................................ 89 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)........................................ 90 
APPENDIX D: 
...................................... 91 
 Expanded Sodium Fluorescein Corneal Staining................................................. 99 
 Lens Fitting Characteristics .............................................................................. 106 
 Subject Reported Ocular Symptoms/Problems.................................................. 112 
 Front and Back Surface Lens Deposit Grading Procedure................................. 114 
 Determination of Distance Spherocylindrical Refractive Error.......................... 119 
 Biomicroscopy Scale........................................................................................ 125 
 Keratometry Procedure..................................................................................... 131 
 Distance and Near Snellen Visual Acuity Evaluation........................................ 133 
 Distance LogMAR Visual Acuity Measurement Procedure .............................. 138 
 Patient Reported Outcomes .............................................................................. 142 
White Light Lens Surface Wettability............................................................... 144 
 Visual Acuity Chart Luminance and Room Illumination Testing...................... 146 
APPENDIX E: Guidelines for COVID-19 Risk Mitigation................................................ 155 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE........................ 167 
LIST OF TABLES
Table 1: Test Articles .......................................................................................................... 23 
Table 2: Ancillary Supplies ................................................................................................. 23 
Table 3: Time and Events.................................................................................................... 26 
Table 4: Disallowed systemic medications........................................................................... 47 
Table 5: Disallowed systemic antihistamines....................................................................... 48 
Table 6: Examples of major and minor protocol deviations.................................................. 49 
Table 7:  Power Calculation for the first primary hypothesis of logMAR visual acuity for either 
HLLC or LLHC at 2-week follow-up with a non-inferiority margin of 0.05......................... 59 
Table 8:  Power Calculation for the second primary hypothesis of average daily wear time at
2-week follow-up with a non-inferiority margin of 1. .......................................................... 59 
LIST OF FIGURES
Figure 1: Study Flowchart ................................................................................................... 14 
CR-6474, v 2.0
 
 
Page 5 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Clinical Evaluation of senofilcon A Contact Lenses Using a 
Novel Manufacturing Technology
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Feasibility
Design control phase: Phase 3
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor.
Test Article(s)
Investigational Products: 
x
senofilcon A contact lenses made with a novel 
manufacturing technology (Test). 
x
senofilcon A contact lenses made with the current 
manufacturing technology (Control).
Approved Products: None
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable
Objectives 
To evaluate the clinical performance of senofilcon A contact 
lenses made with a new manufacturing technology as 
compared to senofilcon A contact lenses made with the 
existing manufacturing technology.
Study Endpoints
Co-primary endpoint(s):
x
Monocular distance visual performance after 1- and 2-
weeks of lens wear
x
Average daily wear time (in hour) after 1- and 2-weeks 
of lens wear
Secondary endpoint(s):
x
Overall comfort after 2-weeks of lens wear
x
Overall quality of vision after 2-week of lens wear
Additional Endpoints:
x
Slit lamp findings
x
Subject reported ocular symptoms
x
Lens fitting characteristics
x
Lens wettability
x
Adverse events
x
Reasons for discontinuation 
x
Lens damage
x
MRD/GSI items
CR-6474, v 2.0
 
 
Page 9 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Study Design
This 
study 
is 
a 
feasibility, multi-site, randomized, 
double-masked, 2-arm parallel group design, 2-week 
dispensing study with weekly visits.  Subjects will wear 
bilaterally either the Test or Control lenses (randomly 
assigned) for 2-weeks in a daily disposable modality.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
Approximately 115 eligible subjects will be enrolled and 
randomized into the study to ensure that approximately 100 
subjects (a50 in the Test group and a50 in the Control group) 
complete as cohort.
Study Duration
There will be a 6-week enrollment window.  The study will 
last approximately 2 weeks per subject.  Therefore, the entire 
study will last approximately 8 weeks per site.
Anticipated Study 
Population 
Healthy male and female adults of any race and ethnicity who 
meet the eligibility criteria can participate.  The study will 
target habitual wearers of daily disposable silicone hydrogel 
contact lenses.
CR-6474, v 2.0
 
 
Page 10 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Eligibility Criteria -
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form.
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time 
of screening.
4. By self-report, habitually wear spherical soft silicone 
hydrogel contact lenses in both eyes in a daily reusable or 
daily disposable wear modality (i.e. not extended wear 
modality). Habitual wear is defined as a minimum of 6 
hours of wear per day, for a minimum of 5 days per week 
during the past 30 days.
5. Possess a wearable pair of spectacles that provide 
correction for distance vision.
Inclusion Criteria at Baseline Evaluation
6. The spherical equivalent of the subject’s vertex-corrected 
distance refraction must be between -1.00 and -6.00 DS 
(inclusive) in each eye.
7. The magnitude of the cylindrical component of the 
subject’s vertex-corrected distance refraction must be 
between 0.00 and 1.00 DC (inclusive) in each eye.
8. The best corrected, monocular, distance visual acuity must 
be 20/25 or better in each eye.
CR-6474, v 2.0
 
 
Page 11 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Eligibility Criteria –
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any 
ocular infection of any type.
3. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication that the 
investigator believes might contraindicate or interfere 
with contact lens wear, or otherwise compromise study 
endpoints, including infectious disease (e.g., hepatitis, 
tuberculosis), contagious immunosuppressive disease 
(e.g., 
Human 
Immunodeficiency 
Virus 
[HIV]), 
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s 
syndrome), or history of serious mental illness or seizures. 
See section 9.1 for additional details regarding excluded 
systemic medications. 
4. Be currently wearing monovision or multifocal contact 
lenses.
5. Be currently wearing lenses in an extended wear modality.
6. Have participated in a contact lens or lens care product 
clinical trial within 7 days prior to study enrollment.
7. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an employee 
(including partner, child, parent, grandparent, grandchild 
or sibling of the employee or their spouse) of the clinical 
site.
Exclusion Criteria at Baseline Evaluation 
The subject must not:
8. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities 
that 
the 
investigator 
believes 
will 
contraindicate contact lens wear or may otherwise 
compromise study endpoints (including entropion, 
ectropion, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, aphakia, moderate or above 
corneal distortion, herpetic keratitis). (Specify method of 
determination if needed).
9. Have fluctuations in vision due to clinically significant dry 
eye or other ocular conditions. 
CR-6474, v 2.0
 
 
Page 12 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
10. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, 
PRK, LASIK, iridotomy, retinal laser photocoagulation, 
etc.).
Disallowed 
Medications/Interventions
Disallowed medications include any medication that may 
interfere with contact lens wear (at the investigator’s 
discretion).  
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
Subjective assessments, physiological responses, fitting 
characteristics.
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Sterile rewetting drops, ACUVUE Revitalens
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.
CR-6474, v 2.0
 
 
Page 13 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
ADE 
 
 
Adverse Device Effect
ADHD  
 
Attention Deficit Hyperactivity Disorder
AE 
 
 
Adverse Event/Adverse Experience 
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COM  
 
Clinical Operations Manager 
CRA 
 
 
Clinical Research Associate
CRF 
 
 
Case Report Form 
CRO 
 
 
Contract Research Organization
 
 
 
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 
HEV 
 
 
High Energy Visible 
HIPAA 
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICH 
 
 
The International Council for Harmonization 
IEC 
 
 
Independent Ethics Committee
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LASIK  
 
Laser-Assisted in Situ Keratomileusis
OD 
 
 
Right Eye 
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PIG 
 
 
Patient Instruction Guide 
PQC 
 
 
Product Quality Complaint 
PRK 
 
 
Photorefractive Keratectomy 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect 
UV 
 
 
Ultraviolet
VA 
 
 
Visual Acuity
CR-6474, v 2.0
 
 
Page 15 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
1.
INTRODUCTION AND BACKGROUND
In the spirit of continuous improvement, JJVC has identified a new manufacturing technology
for senofilcon A.  The purpose of this clinical trial is to demonstrate whether this new 
manufacturing technology has any clinically relevant impact on the clinical performance of the 
contact lens.
1.1.
Name and Descriptions of Investigational Products 
This study will test two (2) senofilcon A design prototypes against each other.  The Test lens 
will utilize a new manufacturing technology, while the Control lens will be made with the 
current manufacturing technology.  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 investigative products is for correcting refractive error.  During the 
study, the study article will be worn bilaterally in daily wear, daily disposable modality for at 
least 6 hours per day, 5 days per week, for approximately 2 weeks. Only one study article will 
be worn by each subject.  
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.  For the most comprehensive nonclinical information regarding senofilcon 
A refer to the latest version of the Investigator’s Brochure (IB).
1.4.
Summary of Known Risks and Benefits to Human Subjects
For the most comprehensive risk and benefit information regarding the senofilcon A 
prototypes, refer to the latest version of the Investigator’s Brochure (IB).5
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
Neither the Test nor the Control are marketed products, and therefore no relevant literature 
exists.  Refer to the Investigator Brochure for additional information of the study articles. 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective(s)
To evaluate the clinical performance of senofilcon A contact lenses made with a new 
manufacturing technology as compared to senofilcon A contact lenses made with the existing 
manufacturing technology in the following areas:
x
Monocular distance visual performance (in logMAR) after 2-weeks of wear
x
Average daily wear time (in hours)
CR-6474, v 2.0
 
 
Page 16 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Secondary Objective(s)
To evaluate the clinical performance of senofilcon A lenses made with a new manufacturing 
technology by comparison to senofilcon A lenses made with the manufacturing technology in 
the following areas:
x
Overall comfort after 2-weeks of lens wear 
x
Overall quality of vision after 2-weeks of lens wear
2.2.
Endpoints 
Primary Endpoint(s)
Average daily wear time (in hours):
Average daily wear time will be calculated as the number of hours between subjects reported 
time of insertion and time of removal of the study lenses, on an average day, at 2-Week Follow 
up evaluation.
Visual performance
Visual performance will be calculated as monocular contact lens-corrected distance visual 
acuity using a logMAR visual acuity scale.  This will be evaluated under both high 
luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters 
from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 2 Week Follow-up 
visit.
Secondary Endpoint(s) 
CLUE Comfort and Vision Scores:
The co-primary endpoints for this study are subjective assessment of comfort and quality of 
vision after 14±4 days of wearing the study lenses as a daily disposable.  
Subjective assessment of comfort and vision will be performed using the Contact Lens User 
ExperienceTM (CLUE) questionnaire.5 CLUE is a validated patient reported outcomes (PRO) 
questionnaire used to assess patient experience attributes of soft contact lenses (comfort, 
vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 
years of age.  CLUE composite scores are derived using Item Response Theory (IRT) and 
follow a normal distribution with a population average score of 60 (SD 20), where higher 
scores indicate a more favorable/positive response.  A 5-point increase in an average CLUE 
score translates into 10% shift in the distribution of scores for the population of soft disposable 
contact lens wearers.
Other Endpoint(s)  
Slit Lamp Findings
Frequency and severity by eye of slit lamp findings (SLFs) including conjunctival injection,
corneal edema, corneal neovascularization, corneal staining, tarsal abnormalities or any other
complications.  SLFs will be evaluated at fitting and post-fitting evaluation visits including
unscheduled visits.
CR-6474, v 2.0
 
 
Page 17 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Subject’s Reported Ocular Symptoms
Frequency and severity by eye of subject’s reported ocular symptoms and problems with the
study lens at fitting and post-fitting evaluation visits including unscheduled visits.
Lens Fitting characteristics
Frequency by eye of mechanical lens fitting characteristics including lens centration and lens
movement and overall lens fitting acceptability at fitting and 2-week follow-up evaluations. 
Lens wettability:
Frequency and Grade by eye of lens wettability at 2-Week Follow-up evaluation. 
MRD/GSI items:
The individual MRD/GSI items will be descriptively summarized
The following will be monitored and descriptively evaluated: 
x
Adverse events
x
Reasons for discontinuation
x
Lens damage
2.3.
Hypotheses
This is a feasibility study and all the hypotheses are exploratory in nature.
Primary Hypotheses:
There are two co-primary hypotheses in this study. Both of them must be met to satisfy the 
primary objective of the study.
1. The Test lens will be non-inferior to the Control lens with respect to logMAR visual 
performance (using ETDRS visual acuity charts) at the 2-week follow-up visit.  A non-
inferiority margin of 0.05 logMAR will be used.
2. The Test lens will be non-inferior to the Control lens with respect to average daily wear 
time at 2-week follow-up visit.  A non-inferiority margin of 1 hour will be used.
Secondary Hypotheses:
1. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
comfort score at the follow-up visit.  A non-inferiority margin of -5 points will be used.
2. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
vision score at the follow-up visit.  A non-inferiority margin of -5 points will be used.
All primary hypotheses of this study have to be met for study success.
CR-6474, v 2.0
 
 
Page 18 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 39 years old) who are habitual wearers of daily disposable silicone hydrogel contact
lenses, DQGKDYHDVSHFWDFOHDVWLJPDWLVPRI1.00 D in both eyes.  Approximately 115 subjects 
will be enrolled to ensure approximately 100 subjects successfully complete the study.
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between 18 and 39 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both 
eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear 
modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a 
minimum of 5 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
Inclusion Criteria at Baseline Evaluation 
6. The spherical equivalent of the subject’s vertex-corrected distance refraction must be 
between -1.00 and -6.00 DS (inclusive) in each eye. 
7. The magnitude of the cylindrical component of the subject’s vertex-corrected distance 
refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each 
eye. 
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any ocular infection of any type.
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of 
medication that the investigator believes might contraindicate or interfere with contact 
lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human 
Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis,
CR-6474, v 2.0
 
 
Page 19 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Sjögren’s syndrome), or history of serious mental illness or seizures. See section 9.1
for additional details regarding excluded systemic medications. 
4. Be currently wearing monovision or multifocal contact lenses. 
5. Be currently wearing lenses in an extended wear modality.
6. Have participated in a contact lens or lens care product clinical trial within 7 days prior 
to study enrollment. 
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family 
member of an employee (including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site. 
Exclusion Criteria at Baseline Evaluation 
The subject must not:
8. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp 
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or abnormalities that the investigator 
believes will contraindicate contact lens wear or may otherwise compromise study 
endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic 
keratitis). (Specify method of determination if needed). 
9. Have fluctuations in vision due to clinically significant dry eye or other ocular 
conditions.  
10. Have had or have planned (within the study period) any ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This study is a controlled, randomized, double-masked, 2-arm parallel group, 2-treatment, 1-
period, 2-week dispensing (minimum of 6 hours/day, 5 days/week), bilateral, daily wear, daily 
disposable study.  Subjects will not have access to the study articles after study closure.  
There are three scheduled visits:
1. Visit 1:  Subjects will be consented and screened for inclusion/exclusion criteria.  If a 
subject is found to meet all eligibility criteria, they will be randomly assigned to either 
Test lenses on both eyes or Control lenses on both eyes at 1:1 ratio.  Subjects will fit 
their assigned lenses in both eyes and advised to wear the study lenses at least 6 hours 
CR-6474, v 2.0
 
 
Page 20 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
a day for a minimum of 5 days per week during the subsequent 2 weeks.  Follow-up 1 
will be scheduled for approximately one week.
2. Visit 2:  The follow-up visit will occur approximately 7±2 days after Visit 1.  
Unscheduled follow-up visits may occur during the study.  At this visit, CLUE comfort 
and vision, slit lamp findings will be captured.  The same lens type will be dispensed 
again, and the procedures repeated for an additional week.
3. Visit 3:  The follow-up visit will occur approximately 7±2 days after Visit 2.  
Unscheduled follow-up visits may occur during the study.  At this visit, CLUE comfort 
and vision, slit lamp findings will be captured.  Complete the Final Evaluation forms.
4.2.
Study Design Rationale
The purpose of this study is to evaluate the performance of a new manufacturing method in a 
2-arm parallel design. In this parallel design, subjects are randomized to one of the two study 
arms and after randomization each participant will stay in their assigned treatment arm for the 
duration of the study. Randomization eliminates the selection bias and balances both the known 
and unknown confounding factors that may affect the study outcomes.
4.3.
Enrollment Target and Study Duration
Approximately 115 subjects will be initially enrolled and approximately 100 are targeted to 
complete the study. Subjects will be in the study for approximately 2 weeks.  The enrollment 
period is approximately 6 weeks, making the entire study approximately 8 weeks in duration.  
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Use of the test articles will be randomized using a lens fitting schedule supplied by the study 
biostatistician. The clinical site will follow the lens fitting schedule provided and will complete 
enrollment according to the randomization list and will not pre-select or pre-assign subjects.
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. 
Randomization will be performed at visit 1. The following must have occurred prior to
randomization: 
•
Informed consent must have been obtained.  
•
The subject must have met all eligibility criteria. 
•
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
CR-6474, v 2.0
 
 
Page 21 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule to obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2.
Masking
This is a double-masked study where neither the subjects nor investigators or clinical team 
interacting with subjects or data during the trial are aware of the identity of the assigned 
treatment.  Masking will be used to reduce potential bias.
5.3.
Procedures for Maintaining and Breaking the Masking
Every attempt will be made to keep the clinical trial personnel involved in the study (e.g. data 
management, biostatistician and clinical operations) unaware of the identity of the assigned 
study lenses.  The identity of the study lenses will be masked by having the blister packs 
labeled with the study number, lot number, sphere power, expiration date and the 
randomization codes. Only the unmasked biostatistician generating the lens fitting schedule
will have access to the decode information that allows matching of the randomization codes to 
the test articles. The medical monitor will also have access to the decode information in case 
breaking the mask is necessary for the urgent medical treatment of a subject.
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the sponsor must be informed as soon as possible. The date, time, 
and reason for the unmasking must be documented in the subject record. The investigator is 
also advised not to reveal the study treatment assignment to the clinical site or sponsor 
personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued will be replaced.
6.
STUDY INTERVENTION
6.1.
Identity of Test Articles 
The following contact lenses will be used in this study:
CR-6474, v 2.0
 
 
Page 22 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.3.
Administration of Test Articles
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.  
6.4.
Packaging and Labeling
The study articles will be packaged in blisters as the primary packaging. The study articles 
will be over-labeled to mask the subject and investigators to the identity of the lens. The study  
articles will be in plastic bags as the secondary packaging form.  The sample study label is 
shown below. The information represented on the label below is sample information only and 
is not representative of the actual study lens information.
Primary Packaging
Secondary Packaging
6.5.
Storage Conditions
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples
The study articles worn into the follow-up visits will be collected. The OD and OS lenses will 
be stored wet (using RevitaLens solution) in separate glass vials with labels that minimally 
contain study number, date, subject number, and eye from which the lens was removed in a 
study specific refrigerator. (Temperature monitoring of refrigerator not required).  The lenses 
will be shipped back to the Sponsor ambiently once the study has completed.
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC.
CR-6474, v 2.0
 
 
Page 24 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
If all visits were completed but an additional visit is considered necessary for subject 
care, follow the requirements for unscheduled visits in section 7.3. 
8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent. 
x
Subject not compliant to protocol (e.g., out of window more than 2 days). 
x
Subject lost to follow-up. 
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear. 
x
Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x
Subject missed any study visits. 
x
Subject not compliant with study lens wear schedule. 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
x
Disallowed medications for this study include: any ocular medication.
x
Concomitant therapies that are disallowed include: See section 9.1. 
CR-6474, v 2.0
 
 
Page 46 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
CR-6474, v 2.0
 
 
Page 50 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
CR-6474, v 2.0
 
 
Page 51 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
CR-6474, v 2.0
 
 
Page 52 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
x
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
x
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1). 
CR-6474, v 2.0
 
 
Page 53 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 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, or
unknown. 
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
CR-6474, v 2.0
 
 
Page 54 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified. 
x
Date and time of onset. 
x
Date and time of resolution. 
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x
Any referral to another health care provider if needed. 
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
CR-6474, v 2.0
 
 
Page 55 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
CR-6474, v 2.0
 
 
Page 56 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 to
the written guidelines, including reporting timelines. 
13.5. Event of Special Interest
None
13.6. Reporting of Pregnancy
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
CR-6474, v 2.0
 
 
Page 57 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor.  A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum).  Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
14.2. Sample Size Justification
The plan is to enroll 115 subjects with a target completion of 100 subjects with approximately 
50 subjects in the Test group and approximately 50 in the Control group. This is a feasibility
study, and the sample size is chosen not based on estimates from historical studies with the 
product characteristics. The data collected for this study will be used to design future clinical 
trials. Thus, power calculations were conducted under different scenarios for the primary 
hypotheses to provide estimates on power with 2-sided type I error of 0.05 given the parallel 
design and 1:1 randomization ratio for average daily wear time and LogMAR visual acuity test 
at a 4-meter distance under high luminance/low contrast (HLLC) and low luminance/high 
contrast (LLHC) conditions. 
Table 7 provides a summary of power based on the hypothesis of non-inferiority for logMAR 
visual acuity test at a 4-meter distance under either HLLC or LLHC at 1 Week Follow-up visit
with a non-inferiority margin of 0.05 logMAR. Table 8 provides a summary of power based 
on the hypothesis of non-inferiority for average daily wear time at 1-week follow-up visit with 
a non-inferiority margin of 1 hour. The power calculation based on two sample t-test is
conducted using the POWER procedure in SAS 9.4.
CR-6474, v 2.0
 
 
Page 58 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Table 7: Power Calculation for the first primary hypothesis of logMAR visual acuity for either 
HLLC or LLHC at 2-week follow-up with a non-inferiority margin of 0.05.
Mean 
Difference
(Test - 
Control)
Type I error
Standard 
Deviation
Total Sample 
Size
(n/2 per arm)
Power
-0.01
0.05
0.08
100
0.981
-0.01
0.05
0.09
100
0.952
-0.01
0.05
0.10
100
0.909
0.00
0.05
0.08
100
0.928
0.00
0.05
0.09
100
0.867
0.00
0.05
0.10
100
0.799
As shown in the Table 7, the power is 0.8 or higher to show non-inferiority of the Test  relative 
to the Control with respect to logMAR VA test at a 4-meter distance under either HLLC or 
LLHC when the Test - Control  0 and the standard deviation for both Test and Control < 
0.10.
Table 8: Power Calculation for the second primary hypothesis of average daily wear time at 
2-week follow-up with a non-inferiority margin of 1. 
Mean 
Difference
(Test - 
Control)
Type I error
Standard 
Deviation
Total Sample 
Size
(n/2 per arm)
Power
-0.05
0.05
1.90
100
0.799
-0.05
0.05
1.93
100
0.788
0.00
0.05
1.90
100
0.834
0.00
0.05
1.93
100
0.823
0.05
0.05
1.90
100
0.864
0.05
0.05
1.93
100
0.855
As shown in the Table 8, the power is 0.8 or higher to show non-inferiority of the Test  relative 
to the Control with respect to when the Test - &RQWURO 0 and the standard deviation for both 
Test and Control  1.93.
CR-6474, v 2.0
 
 
Page 59 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
14.3. Analysis Populations
Safety Population:
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance
Since this is a feasibility study, the primary and secondary endpoints will be each tested under 
a Type I error rate of 5%. If exploratory statistical analysis is conducted after reviewing the 
descriptive summary of an endpoint, a type I error rate of 5% will be used with no multiplicity 
adjustments.
14.5. Primary Analysis
The co-primary endpoints for this study are the logMAR VA test at a 4-meter distance under 
either HLLC or LLHC and the average daily wear time at 2-week follow-up evaluated after 
14±4 days of lens wear.  The primary analysis will be conducted on per-protocol populations.  
Visual Performance
Monocular distance visual performance in logMAR scale at follow-up visits will be analyzed 
using a mixed model of repeated measurement (MMRM) for HLLC and LLHC respectively to 
compare between Test and Control lenses at 2-week follow-up. The model will include 
baseline logMAR, lens type, visit, and the interaction of lens type and visit as the fixed effect,
and investigational site and patient as random effects. Baseline demographics such as age and 
gender have historically limited influence on objective visual performance; thus, in accordance 
with the principle of parsimony, will not be included in the model. The covariance of residual 
errors between two follow-up visits across periods for the same eye and subject across wearing 
periods will be modeled using an unstructured (UN) covariance structure. 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows:
ܪ0ǻ!
ܪܣǻ
CR-6474, v 2.0
 
 
Page 60 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
ZKHUHǻLVWKHPHDQGLIIHUHQFHLQORJ0$5EHWZHHQ7HVWOHQVDQG&RQWUROOHQV7HVWPLQXV
Control) at 2-week follow-up.  Non-inferiority will be declared if the upper bound of the 
confidence interval of the mean difference between Test and Control is less than 0.05.  
Average Daily Wearing Time
Average daily wear time will be analyzed using a similar MMRM model with fixed and 
random effects described in the primary analysis. Age and gender will also be included as fixed 
effects.
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪ0ǻ-1 
ܪܣǻ-1 
wherHǻLVWKHPHDQGLIIHUHQFHLQDYHUDJHGDLO\ZHDULQJWLPHEHWZHHQ7HVWOHQVDQG&RQWURO
lens (Test minus Control) at 2-week follow-up. Non-inferiority will be declared if the lower 
bound of the confidence interval of the mean difference between Test and Control is greater 
than -1.
14.6. Secondary Analysis
CLUE Comfort and Vision scores
CLUE scores at follow-up visits will be analyzed using a MMRM model for comfort and vision
respectively to compare between Test and Control lenses at 2-week follow-up. Each regression 
model will include the baseline score, lens type, visit, and the interaction of lens type and visit
as fixed effects and investigational site as a random effect (G-side). Age and gender will also 
be included as fixed effects. The covariance of residual errors between different periods for the 
same subject will be modeled using an unstructured (UN) covariance structure. The Kenward 
and Roger method will be used for the calculation of the denominator degree of freedom.8  
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
       ܪ0ǻ-5 
ܪܣǻ-5 
ZKHUHǻis the CLUE score mean difference between Test lens and Control lens (Test minus 
Control) at 2-week follow-up. The hypothesis will be tested via the corresponding two-sided 
95% confidence interval (CI) for least squares mean (LSM) difference (Test - Control) in 
CLUE scores. Non-inferiority will be declared if the lower bound of the confidence interval 
of the mean difference between Test and Control is greater than -5. 
14.7. Other Exploratory Analysis 
Not applicable.
14.8. Interim Analysis
Not applicable.
CR-6474, v 2.0
 
 
Page 61 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout due to reasons other than Adverse Event is expected to be the main reason of 
missing data in this study and is expected to be no larger than 10 percent. Prior studies don’t 
provide the evidence that subject dropout or major protocol deviation is systematic or not-at-
random. Therefore, the primary and secondary analyses based on mixed model which is robust 
under missing-at-random (MAR) would be sufficient for this study9. If the percentage of 
missing data for primary or secondary endpoints is greater than 15 percent, further sensitivity 
analyses will be conducted to confirm the validity of the missing data assumptions.    
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis. 
External data sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
CR-6474, v 2.0
 
 
Page 62 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
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 
CR-6474, v 2.0
 
 
Page 63 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.
16.4. Data Monitoring Committee (DMC)
 Not applicable 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
CR-6474, v 2.0
 
 
Page 64 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully
able to understand the risks, benefits, and potential adverse events of the study and provide
their consent voluntarily.
18.2. Investigator Responsibility
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
CR-6474, v 2.0
 
 
Page 65 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy.
 
 
Page 66 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 States4 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
 
 
Page 67 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.
 
 
Page 68 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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
There is no plan to publish this outcome of this investigation.
22. REFERENCES
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html 
2. International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). 
Available at: https://www.ich.org/page/efficacy-guidelines 
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. 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  
6. General Data Protection Regulation. Available at:
https://eur-lex.europa.eu/eli/reg/2016/679/oj 
7. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at: 
http://data.europa.eu/eli/reg/2017/745/2017-05-05
8. Little, Roderick JA, and Donald B. Rubin. Statistical analysis with missing data. Vol. 
793. John Wiley & Sons, 2019.
9. Little, Roderick JA, and Donald B. Rubin. Statistical analysis with missing data. Vol. 
793. John Wiley & Sons, 2019.
 
 
Page 69 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
 
 
Page 70 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
1
 
 
Page 71 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
2
 
 
Page 72 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
4
 
 
Page 74 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
5
 
 
Page 75 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
6
 
 
Page 76 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
7
 
 
Page 77 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
8
 
 
Page 78 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
9
 
 
Page 79 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
10
 
 
Page 80 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
11
 
 
Page 81 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
12
 
 
Page 82 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
13
 
 
Page 83 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
14
 
 
Page 84 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
15
 
 
Page 85 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
16
 
 
Page 86 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
17
 
 
Page 87 of 167

35263(&,),&$7,219HUVLRQ)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
18
 
 
Page 88 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately.
 
 
Page 89 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
Not Applicable for Investigational Products
 
 
Page 90 of 167

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
 
 
Page 92 of 167

Title:                        Limbal & Conjunctival (Bulbar) Redness
Document Type:       
Document Number:
Revision Number:  6 
Page 3 of 6 
CR-6474, v 2.0
 
 
Page 95 of 167
JJVC CONFIDENTIAL

Title:                        Limbal & Conjunctival (Bulbar) Redness
Document Type:       
Document Number:
Revision Number:  6 
Page 4 of 6 
CR-6474, v 2.0
 
 
Page 96 of 167
JJVC CONFIDENTIAL

Title:                        Limbal & Conjunctival (Bulbar) Redness
Document Type:       
Document Number:
Revision Number:  6 
Page 5 of 6 
  
CR-6474, v 2.0
 
 
Page 97 of 167
JJVC CONFIDENTIAL

Title:                        Limbal & Conjunctival (Bulbar) Redness
Document Type:       
Document Number:
Revision Number:  6 
Page 6 of 6 
CR-6474, v 2.0
 
 
Page 98 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
CR-6474, v 2.0
 
 
Page 99 of 167
JJVC CONFIDENTIAL

Title:                        Expanded Sodium Fluorescein Corneal Staining
Document Type:       
Document Number:
Revision Number:  6 
Page 3 of 6 
CR-6474, v 2.0
 
 
Page 102 of 167
JJVC CONFIDENTIAL

Title:                        Expanded Sodium Fluorescein Corneal Staining
Document Type:       
Document Number:
Revision Number:  6 
Page 4 of 6 
CR-6474, v 2.0
 
 
Page 103 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS
CR-6474, v 2.0
 
 
Page 106 of 167
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 1 of 5
CR-6474, v 2.0
 
 
Page 107 of 167
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 2 of 5
            
       
CR-6474, v 2.0
 
 
Page 108 of 167
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 3 of 5
CR-6474, v 2.0
 
 
Page 109 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS  
CR-6474, v 2.0
 
 
Page 112 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE  
CR-6474, v 2.0
 
 
Page 114 of 167
JJVC CONFIDENTIAL

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
CR-6474, v 2.0
 
 
Page 115 of 167
JJVC CONFIDENTIAL

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
CR-6474, v 2.0
 
 
Page 116 of 167
JJVC CONFIDENTIAL

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
CR-6474, v 2.0
 
 
Page 118 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
CR-6474, v 2.0
 
 
Page 119 of 167
JJVC CONFIDENTIAL

Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 5 
  
CR-6474, v 2.0
 
 
Page 121 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
BIOMICROSCOPY SCALE  
CR-6474, v 2.0
 
 
Page 125 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
KERATOMETRY PROCEDURE  
CR-6474, v 2.0
 
 
Page 131 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION  
CR-6474, v 2.0
 
 
Page 133 of 167
JJVC CONFIDENTIAL

Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 4 
CR-6474, v 2.0
 
 
Page 135 of 167
JJVC CONFIDENTIAL

Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 4 
CR-6474, v 2.0
 
 
Page 137 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE  
CR-6474, v 2.0
 
 
Page 138 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PATIENT REPORTED OUTCOMES 
CR-6474, v 2.0
 
 
Page 142 of 167
JJVC CONFIDENTIAL

Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
3
Page 1 of 1
                      
CR-6474, v 2.0
 
 
Page 143 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
WHITE LIGHT LENS SURFACE WETTABILITY  
CR-6474, v 2.0
 
 
Page 144 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING  
CR-6474, v 2.0
 
 
Page 146 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 2 of 8 
CR-6474, v 2.0
 
 
Page 148 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 3 of 8 
CR-6474, v 2.0
 
 
Page 149 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 4 of 8 
CR-6474, v 2.0
 
 
Page 150 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 5 of 8 
CR-6474, v 2.0
 
 
Page 151 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 6 of 8 
CR-6474, v 2.0
 
 
Page 152 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 7 of 8 
CR-6474, v 2.0
 
 
Page 153 of 167
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
Page 8 of 8 
CR-6474, v 2.0
 
 
Page 154 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION
CR-6474, v 2.0
 
 
Page 155 of 167
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6474 Clinical Evaluation of senofilcon A Contact Lenses Using a 
Novel Manufacturing Technology 
Version and Date: 2.0 19 April 2022 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent 
individual country laws/regulations and to comply with its obligations, subject to ethical and safety 
considerations. The Principal Investigator is responsible for ensuring that all clinical site personnel, 
including Sub-Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical 
trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to 
all ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion.
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed 
about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix E of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
CR-6474, v 2.0
 
 
Page 167 of 167
JJVC CONFIDENTIAL