Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population  
Protocol CR-6413
Version: 2.0
Date: 05 October 2020
Investigational Products: JJVC Investigational Multifocal Contact Lenses manufactured in 
senofilcon A C3 material 
Control: Dailies Total 1® Multifocal Contact Lenses manufactured in delefilcon A material
Key Words: Multifocal, Senofilcon A C3, Delefilcon A, Presbyopia, Daily Wear, Daily 
Disposable, Dispensing, Randomized 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
CR-6413, v 2.0
 
 
Page 1 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS .............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives ................................................................................................................. 18 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 20 
3.3. 
Exclusion Criteria ..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale ............................................................................................ 22 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 22 
5.1. 
Test Article Allocation ............................................................................................. 22 
5.2. 
Masking .................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION ............................................................................................. 24 
6.1. 
Identity of Test Articles............................................................................................ 24 
CR-6413, v 2.0
 
 
Page 2 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.2. 
Ancillary Supplies/Products ..................................................................................... 24 
6.3. 
Administration of Test Articles ................................................................................ 25 
6.4. 
Packaging and Labeling ........................................................................................... 25 
6.5. 
Storage Conditions ................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 26 
7. 
STUDY EVALUATIONS .............................................................................................. 27 
7.1. 
Time and Event Schedule ......................................................................................... 27 
7.2. 
Detailed Study Procedures ....................................................................................... 31 
VISIT 1 ........................................................................................................................... 31 
VISIT 2 ........................................................................................................................... 36 
VISIT 3 ........................................................................................................................... 40 
VISIT 4 ........................................................................................................................... 47 
VISIT 5 ........................................................................................................................... 51 
VISIT 6 ........................................................................................................................... 57 
FINAL EVALUATION .................................................................................................. 59 
7.3. 
Unscheduled Visits ................................................................................................... 60 
7.4. 
Laboratory Procedures ............................................................................................. 62 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 62 
8.1. 
Completion Criteria .................................................................................................. 62 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 62 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 63 
9.1. 
Systemic Medications .............................................................................................. 63 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 64 
11. 
STUDY TERMINATION ........................................................................................... 64 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 65 
13. 
ADVERSE EVENTS ................................................................................................... 66 
13.1. 
Definitions and Classifications ............................................................................. 66 
13.2. 
Assessing Adverse Events .................................................................................... 68 
13.2.1. 
Causality Assessment .................................................................................... 68 
13.2.2. 
Severity Assessment ...................................................................................... 69 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 69 
13.4. 
Reporting Adverse Events .................................................................................... 70 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 71 
CR-6413, v 2.0
 
 
Page 3 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
71 
13.4.3. 
Event of Special Interest ............................................................................... 72 
13.5. 
Reporting of Pregnancy ........................................................................................ 72 
14. 
STATISTICAL METHODS ........................................................................................ 72 
14.1. 
General Considerations ......................................................................................... 72 
14.2. 
Sample Size Justification ...................................................................................... 72 
14.3. 
Analysis Populations ............................................................................................ 74 
14.4. 
Level of Statistical Significance ........................................................................... 74 
14.5. 
Primary Analysis .................................................................................................. 74 
14.6. 
Secondary Analysis .............................................................................................. 75 
14.7. 
Other Exploratory Analyses ................................................................................. 76 
14.8. 
Interim Analysis ................................................................................................... 76 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 76 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 77 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 77 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 77 
15.2. 
Subject Record ...................................................................................................... 77 
15.3. 
ClinicalTrials.gov ................................................................................................. 78 
16. 
DATA MANAGEMENT............................................................................................. 78 
16.1. 
Access to Source Data/Document ........................................................................ 78 
16.2. 
Confidentiality of Information.............................................................................. 78 
16.3. 
Data Quality Assurance ........................................................................................ 78 
17. 
CLINICAL MONITORING ........................................................................................ 79 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 79 
18.1. 
Study-Specific Design Considerations ................................................................. 79 
18.2. 
Investigator Responsibility ................................................................................... 79 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 80 
18.4. 
Informed Consent ................................................................................................. 81 
18.5. 
Privacy of Personal Data ...................................................................................... 81 
19. 
STUDY RECORD RETENTION................................................................................ 82 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 83 
21. 
PUBLICATION ........................................................................................................... 83 
22. 
REFERENCES ............................................................................................................ 83 
CR-6413, v 2.0
 
 
Page 4 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: 
 (STUDY QUESTIONNAIRES) ..... 85 
APPENDIX B: PATIENT INSTRUCTION GUIDE (To be provided seperatley) .............. 112 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 113 
APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 116 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 117 
APPENDIX F: OCULAR DOMINANCE............................................................................ 118 
APPENDIX G: LENS FITTING GUIDE ............................................................................. 119 
APPENDIX H: Control Lens fitting guide ........................................................................... 121 
APPENDIX I:  C-Quant straylight measurement ................................................................. 154 
APPENDIX J:  VISIONIX CORNEAL TOPOGRAPHY AND WAVEFRONT ................ 161 
APPENDIX K: 
 .................................... 170 
, Determination of Near Addition ........................................................................ 171 
 Near LogMAR Visual Acuity Measurement Procedure .................................... 177 
 Lens Fitting Characteristics ................................................................................ 180 
 Subject Reported Ocular Symptoms/Problems .................................................. 186 
, Determination of Distance Spherocylindrical Refractions ................................. 188 
 Biomicroscopy Scale .......................................................................................... 195 
 Keratometry Procedure ...................................................................................... 201 
 Distance and Near Visual Acuity Evaluation ..................................................... 203 
 Distance LogMAR Visual Acuity Measurement Procedure .............................. 208 
 Patient Reported Outcomes ................................................................................ 212 
 Visual Acuity Chart Luminance and Room Illumination Testing ..................... 214 
APPENDIX L: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 220 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 230 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 14 
TABLE OF CONTENTS 
Table 1: Test Articles .............................................................................................................. 24 
Table 2: Ancillary Supplies .................................................................................................... 25 
Table 3: Time and Events ....................................................................................................... 27 
Table 4: Disallowed systemic medications. ............................................................................ 63 
Table 5:
 Binocular High Luminance High Contrast Visual Performance – 1-Week 
Follow-up ................................................................................................................................ 73 
CR-6413, v 2.0
 
 
Page 5 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL TITLE, NUMBER, VERSION
Title: Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population 
Protocol Number:  CR-6413 
Version: 2.0 
Date: 05 October 2020 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
Name:  Thomas R. Karkkainen, OD, MS, FAAO
Title: Sr. Principal Research Optometrist
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256 
Email: TKarkkai@its.jnj.com
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
CR-6413, v 2.0
 
 
Page 6 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Evaluation of a Daily Disposable Novel Multifocal Contact 
Lens in a Myopic Population 
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 2b
Trial Registration
This study will be registered on ClinicalTrials.gov.
Test Article(s)
Investigational Product:  JJVC Investigational Multifocal 
Contact Lenses manufactured in senofilcon A C3 material 
Control Product: Dailies Total 1® Multifocal Contact Lenses 
manufactured in delefilcon A material
Wear and Replacement 
Schedules
Wear Schedule: The test and control lenses will be used on a 
daily disposable basis.   
Replacement Schedule: The lenses will be replaced after a 
day of wear.
Objectives 
The purpose of this study is to evaluate visual performance
(logMAR) and subjective responses of the JJVC
Investigational Multifocal Contact Lens compared to the 
marketed Dailies Total 1® Multifocal Contact Lens.
Study Endpoints
Primary endpoint
x
Visual Performance (logMAR)
Secondary endpoint 
x
CLUE vision scores
Study Design
This is a single-masked, 2×3 crossover, randomized-
controlled, dispensing clinical trial. Approximately 70 myopic 
eligible subjects will be targeted to complete the study.  
Eligible subjects will be randomized and fit at Visit 1 in a
study lens based on the randomization scheme. Subjects will 
be dispensed lenses at Visit 1 for 3±1 day, then undergo 
optimization (Visit 2). Subjects will wear the optimized pair 
for approximately 1 week (7±1 day). After approximately 
1-week of wear, (Visit 3) the study endpoints will be measured 
and subjects will be fit in the 2nd study lens. The visits will be 
repeated wearing the 2nd study lens (Visit 3 Fit/Visit 4 
Optimization/Visit 5 Follow up). At Visit 5 the subjects will 
be fit in the 3rd study lens that match the same power they were 
dispensed at Visit 4 and wore to Visit 5, and wear the lenses
for 1 week (7±1 day). After approximately 1-week of wear, 
(Visit 6) the study endpoints will be measured and the subject 
will be exited from the study. 
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 80 eligible subjects will be enrolled with the 
target of approximately 70 subjects to complete.
CR-6413, v 2.0
 
 
Page 10 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Study Duration
The study will last approximately 2 to 4 months.
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below.  All volunteers will 
have baseline measurements taken to ensure eligibility.  The 
baseline procedures will occur after informed consent has 
been obtained.  Subjects will have medical and contact lens 
history recorded, baseline questionnaires completed, and 
refractive and anterior segment status determined.  For a 
detailed flowchart of procedures see below.
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol.
3. The subject must be at least 40 years of age and not 
greater than 70 years of age at the time of consent. 
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
5. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 6 hours per wear day, for 1 
month or more duration). 
6. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or 
monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”. 
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction 
must be in the range of -1.25 D to -3.75 D in each 
eye.
8. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQ
each eye.
9. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D.
CR-6413, v 2.0
 
 
Page 11 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
10. The subject must have distance best corrected visual 
acuity of 20/20-3 or better in each eye.
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies 
that may interfere with contact lens wear.  
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere 
with contact lens wear. This may include, but not be 
limited to, diabetes, hyperthyroidism, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases 
or any infectious diseases (e.g. hepatitis, 
tuberculosis). 
4. Any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular 
vision abnormality. 
6. Use of any of the following medications within 2 
weeks prior to enrollment: oral retinoids, oral 
tetracyclines, anticholinergics, systemic/topical
steroids, oral phenothiazines.  See section 9.1 for 
additional details regarding excluded systemic 
medications.
7. Use of any ocular medication, with the exception of 
rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye. 
11. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment.
12.  Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
13. Any known hypersensitivity or allergic reaction to 
non-preserved rewetting drop solutions or sodium 
fluorescein.
Exclusion Criteria after Baseline:
CR-6413, v 2.0
 
 
Page 12 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
14. Clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, 
tarsal abnormalities or bulbar injection, or any other 
corneal or ocular abnormalities which would 
contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, glaucoma, history of recurrent corneal 
erosions. 
16. Any current ocular infection or inflammation. 
17. Any current ocular abnormality that may interfere 
with contact lens wear.
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear. 
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
logMAR Visual performance and subjective responses for 
vision using the CLUE™questionnaire. 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any serious adverse event (SAE) 
where relationship to study agent cannot be ruled out, will 
result in stopping further dispensing investigational product. 
In the event of a UADE or SAE, the Sponsor Medical 
Monitor may unmask the treatment regimen of subject(s) and 
may discuss this with the Principal Investigator before any 
further subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Non-Preserved Rewetting drops, lens cases, glass vials, 
saline, ETDRS light cabinet, 4M logMAR charts, and Near 
logMAR charts.
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-6413, v 2.0
 
 
Page 13 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
CR-6413, v 2.0
 
 
Page 15 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
CR-6413, v 2.0
 
 
Page 16 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
CLUE™ score translates into 10% shift in the distribution of scores for population of soft 
contact lens wearers.6
Other Endpoints: 
x
CLUETM Comfort 
x
CLUETM Handling  
x
Lens Optimization Summary 
x
Mechanical Lens Fit
x
Slit Lamp Findings 
2.3.
Hypotheses
All primary and secondary hypotheses must be met in order to satisfy the objective of this 
study. 
Primary Hypotheses 
1. After approximately 1-week of wear in the optimized test lens, the mean distance visual 
acuity score of the Test lens will be statistically lower than 0.00 on logMAR scale.
2. After approximately 1-week of wear in the optimized test lens, the mean intermediate 
visual acuity score of the Test lens will be statistically lower than 0.17 on logMAR
scale.
3. After approximately 1-week of wear in the optimized test lens, the mean near visual 
acuity score of the Test lens will be statistically lower than 0.17 on logMAR scale.
Secondary Hypotheses 
1. After approximately 1-week of wear in the optimized test lens, the mean overall quality 
of vision score of the Test lens will be statistically better than 40 points on CLUE scale. 
2. After approximately 1-week of wear in the optimized lenses, the Test lens will be non-
inferior to the Control lens with respect to the overall quality of vision score. A non-
inferiority margin of 5 points will be used.  
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Healthy male and female subjects who are habitual soft contact lens wearers will be recruited.  
Subjects will be at least 40 years of age and not older than 70 years of age.  They will be 
myopic and have presbyopia.
CR-6413, v 2.0
 
 
Page 19 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
3.2.
Inclusion Criteria
Potential subjects must satisfy all the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. The subject must be at least 40 years of age and not greater than 70 years of age at the 
time of consent. 
4. Subjects must own a wearable pair of spectacles if required for their distance vision. 
5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses 
a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more 
duration). 
6. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or, if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire” (Appendix E). 
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction must be in the range of -1.25 D 
to -3.75 D in each eye. 
8. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQHDFKH\H
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each 
eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.  
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, 
Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious 
diseases (e.g. hepatitis, tuberculosis). 
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 
5. A history of amblyopia, strabismus or binocular vision abnormality. 
CR-6413, v 2.0
 
 
Page 20 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6. Use of any of the following medications within 2 weeks prior to enrollment: oral 
retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids, oral 
phenothiazines.  See section 9.1 for additional details regarding excluded systemic 
medications.
7. Use of any ocular medication, with the exception of rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye. 
11. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment. 
12.  Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop 
solutions or sodium fluorescein. 
Exclusion Criteria after Baseline:
14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions.
16. Any current ocular infection or inflammation. 
17. Any current ocular abnormality that may interfere with contact lens wear.
.
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial. Approximately 80 
subjects will be enrolled with an aim of approximately 70 subjects to complete the study.  
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
they will be randomized to one of two lens wear sequences (Test/Control/Control or 
Control/Test/Test) in a bilateral fashion.  
If the subject is dispensed study lenses at the initial visit, five additional visits will be 
conducted. The first follow-up visit (Visit 2) will occur 3 ± 1 days after the initial visit. At visit 
2, subjects will undergo lens optimization if necessary. Subjects will wear the study lenses for 
7 ± 1 days and then will return for their second follow-up at Visit 3.  At Visit 3, subjects will 
CR-6413, v 2.0
 
 
Page 21 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
be dispensed their second study lens per the randomization schedule. Subjects will return for 
their first follow-up visit (Visit 4) 3 ± 1 days after Visit 3, for lens optimization. Subjects will 
return for their second follow-up visit 7 ± 1 days after Visit 4. At Visit 5, subjects will be 
dispensed their 3rd study lens per the randomization schedule and wear the lens for (7±1 days). 
At the follow-up (Visit 6) the endpoints will again be measured and the subject will be exited 
from the study. 
4.2.
Study Design Rationale 
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×3 bilateral crossover design was considered to 
be the optimal design since the study period is relatively short the design can be cost effective 
and more efficient comparisons between treatments can be made than compared to a parallel 
study since fewer subjects are required to achieve the same pre-specified statistical power. 
Each subject will act as their own control to reduce the influence of potential confounding factors 
such as age, gender and vision correction.
4.3.
Enrollment Target and Study Duration
Approximately 80 eligible subjects will be enrolled with the aim of approximately 70 to 
complete the study. The study will last approximately 2-4 months. 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The study lenses will be worn in a bilateral and random fashion using a 2×3 crossover design. 
A computer-generated randomization scheme will be used to randomly assign subjects, in 
blocks of 4, to one of the two possible lens wear sequences: Test/Control/Control or 
Control/Test/Test. The random scheme will be generated using the PROC PLAN procedure 
from Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, 
NC).
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization: 
o
Informed consent has been obtained 
o
Subject meets all the inclusion / exclusion criteria
o
Subject history and baseline information has been collected.
5.2.
Masking
This is a single-masked study with the subjects being masked.  The term partial masking is 
being used as subjects will not be told any information regarding the optical designs of the 
lenses beyond that they are intended to correct for their refractive error and presbyopia, 
CR-6413, v 2.0
 
 
Page 22 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
however there are slight differences in the tint of the lenses which is impossible to mask from 
the 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 may be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before 
the mask is broken. 
When dispensing test articles, the following steps should be followed to maintain
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme 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 
randomization scheme if applicable
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. 
CR-6413, v 2.0
 
 
Page 23 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
lenses if any of the following is observed:
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
1.30
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
1.31
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
1.32
Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
CR-6413, v 2.0
 
 
Page 35 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
1.33
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 3±1 day. 
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 2
The subjects must present to Visit 2 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit. 
CR-6413, v 2.0
 
 
Page 36 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
same power to last the subject until their next
visit.
2.12
Lens Removal
The study lenses will be removed and 
discarded.
2.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
2.14
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.12 above.  
2.15
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
2.16
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued.  
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
2.17
Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
CR-6413, v 2.0
 
 
Page 39 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#4, 
HC#5, HC#6 
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
3.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.   
Note: No lens changes are allowed based on 
the over-refraction.  
3.10
C-Quant Straylight 
Meter Testing (Site 
1036 only)
Ocular straylight will be measured using the 
C-Quant OD and OS and record the log (s), 
Esd and Q values to two decimal places. 
3.11
Corneal Topography 
and Wavefront 
measurement (Site 
1036 only)
Using the VISIONIX corneal topography and 
wavefront will be measured over the contact 
lens OD and OS.  The simulated Ks will be 
recorded.
3.12
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
CR-6413, v 2.0
 
 
Page 42 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
centration, movement and other fitting 
characteristics.
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
3.27
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
3.28
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
3.29
Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
CR-6413, v 2.0
 
 
Page 45 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
3.30
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days. 
CR-6413, v 2.0
 
 
Page 46 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
the lenses, and complete the Final 
Evaluation forms.
4.11
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the subject 
when lens power has been optimized. 
If lens power was not changed allow the
subject to use the unworn lenses dispensed at
Visit 3 and dispense enough lenses of the
same power to last the subject until their next
visit.
4.12
Lens Removal
The study lenses will be removed and 
discarded.
4.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
4.14
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 4.12 above.  
4.15
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
4.16
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
CR-6413, v 2.0
 
 
Page 49 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Lenses must have an acceptable general 
lens fit.
4.17
Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
CR-6413, v 2.0
 
 
Page 50 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
5.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.   
Note: No lens changes are allowed based on 
the over-refraction.   
5.10
C-Quant Straylight 
Meter Testing (Site 
1036 only)
Ocular straylight will be measured using the 
C-Quant OD and OS and record the log (s), 
Esd and Q values to two decimal places. 
5.11
Corneal Topography 
and Wavefront 
measurement (Site 
1036 only)
Using the VISIONIX corneal topography and 
wavefront will be measured over the contact 
lens OD and OS.  The simulated Ks will be 
recorded.
5.12
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
5.13
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
5.14
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
5.15
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
CR-6413, v 2.0
 
 
Page 53 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement; 
x
edge lift;
x
excessive movement in primary and 
up gaze; or  
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up. 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
5.26
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
5.27
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
5.28
Patient Instructions
Instruct the Subject the following:
CR-6413, v 2.0
 
 
Page 55 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
x
Subjects will be instructed to bring their 
habitual contacts or glasses to the next 
visit.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
CR-6413, v 2.0
 
 
Page 56 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.10
C-Quant Straylight 
Meter Testing (Site 
1036 only)
Ocular straylight will be measured using the 
C-Quant OD and OS and record the log (s), 
Esd and Q values to two decimal places. 
6.11
Corneal Topography 
and Wavefront 
measurement (Site 
1036 only)
Using the VISIONIX corneal topography and 
wavefront will be measured over the contact 
lens OD and OS.  The simulated Ks will be 
recorded.
6.12
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
6.13
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
6.14
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
6.15
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study. 
CR-6413, v 2.0
 
 
Page 59 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
CR-6413, v 2.0
 
 
Page 65 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form Control No. VWI-0028
for test article return instructions).
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury 
x
Permanent or persistent impairment of a body structure or a body function 
x
Hospitalization or prolongation of patient hospitalization 
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x
Chronic disease 
x
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
CR-6413, v 2.0
 
 
Page 66 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA 
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
CR-6413, v 2.0
 
 
Page 67 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
NOTE 1: to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x
Seriousness/Classifications (see definition in Section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 0). 
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown. 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
CR-6413, v 2.0
 
 
Page 68 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g.
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
CR-6413, v 2.0
 
 
Page 69 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements.
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. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
CR-6413, v 2.0
 
 
Page 70 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
CR-6413, v 2.0
 
 
Page 71 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.4.3. Event of Special Interest
None 
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
 
Summaries will be presented by study lens type (Test and Control) and will be performed 
separately by completion status (Safety Population, Per-Protocol Population or Intent-to-Treat 
Population). 
14.2. Sample Size Justification
This study was designed and powered to demonstrate that the binocular high luminance high 
contrast, visual performance (logMAR) of the Test lens at distance (4 meters) is statistically 
lower than 0.00 logMAR and statistically lower than 0.17 logMAR at intermediate (64 cm) 
and near (40 cm) after1-week of lens wear. Historical data for the Test lens with respect to 
visual acuity is presented in the Table below. 
CR-6413, v 2.0
 
 
Page 72 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Table 5:
 Binocular High Luminance High Contrast Visual Performance – 1-Week 
Follow-up 
Position
Mean
SD*
Minimum
Maximum
Distance (4 m)
-0.057
0.1125
-0.300
0.140
Intermediate (64 cm)
-0.038
0.0946
-0.200
0.180
Near (40 cm)
0.091
0.1267
-0.120
0.360
*SD: Standard Deviation 
Visual Performance (logMAR)
Sample size calculation for Visual performance (logMAR) was carried out using Monte Carlo 
simulation methods using PROC IML. One-thousand boot strap samples were simulated based 
on the historical data in Table 5 above for each Position separately. An interclass correlation 
of 0.5 was assumed for the correlation between period 1 and period 2 and period 2 and period 3. 
An intraclass correlation of 0.3 was assumed for the correlation between period 1 and period 3. 
For this sample size calculation, we assumed that there was no period or sequence effect since 
the Test and Control have not be evaluated together in the same clinical study. For each 
replicated sample a linear mixed model was used; lens was included as the only fixed effect.  
A variance component (VC) covariance structure was used to model measurements from the 
same subject across study periods. Seventy subjects to complete provides at least 90% power 
to meet all primary hypotheses (Distance, Intermediate and Near) associated with visual 
performance.
CLUE Vision Scores
This study Historical CLUE vision scores for the Control lens (Dailies Total 1® Multifocal 
Contact Lenses manufactured in delefilcon A material) from 
 at the 1-week follow-
up for the hyperopic population only, was utilized in the power analysis. The mean and 
standard deviation for the Control was 54.35 and 16.52, respectively. However, a conservative 
estimate of 20 points for the standard deviation was considered for the power calculation.
Assuming the Test and Control will have similar performance with respect to subjective vision 
scores (CLUE), the table below provide the power for different scenarios of effect size and 
intra-class correlation.
Table 4: Statistical Power Analysis for Non-inferiority of the Test relative to the Control at the 
1-Week Follow-up Evaluation  
Effect Size
Intra-class 
correlation
Power
0
0.3
0.542
0
0.6
0.749
0
0.8
0.984
1
0.3
0.676
1
0.6
0.872
1
0.8
0.989
2
0.3
0.790
2
0.6
0.945
CR-6413, v 2.0
 
 
Page 73 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
The plan is to enroll 80 eligible subjects with a target completion of 70 subjects. During the 
enrollment period, the subject drop-out rate with be closely monitored, if an unexpectedly high 
dropout rate is observed, then the targeted total enrollment number maybe be increased 
accordingly to ensure that a minimum of 70 subjects complete the study.
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file. 
Intent-to-Treat (ITT) Population:
All subjects regardless of actual treatment and subsequent withdrawal from study or deviation 
from protocol.  At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
All primary analysis will be conducted on the Intent-to-Treat Population. A sensitivity analysis 
will be conducted on the Per-Protocol population.  
Visual Performance (logMAR)
Binocular, high luminance, high contrast visual performance (logMAR) will be analyzed using 
a linear mixed model. Sequence of lens wear, study period, lens type, distance (4 m, 64 cm and 
40 cm) and the lens by distance interaction as fixed effects. Other characteristics including, 
age, gender and race and ADD power may be included when appropriate. Site will be included 
as a random effect (G-side). The covariance between residual errors from the same subject and 
distance across study periods will be modeled using either homogenous compound symmetry 
(CS) or unstructured (UN) covariance structure. The structure that returns the lowest finite-
sample corrected Akaike’s Information criterion7 will be selected as the structure that best fits 
the model. The Kenward and Roger method8 will be used for the denominator degrees of 
freedom.
2
0.8
0.998
3
0.3
0.876
3
0.6
0.980
3
0.8
>.999
CR-6413, v 2.0
 
 
Page 74 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Comparisons between the Test and Control lenses will be carried out at each distance (4 m, 64
cm and 40 cm) using 2-sided 95% confidence intervals constructed of least square means 
(LSM) differences (Test minus Control) at the 1-week follow-up evaluation.
Secondary hypothesis 1:  
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0.0 logMAR is as 
follows: 
ܪ௢: ߤ்௘௦௧൒ 0 logMAR 
ܪ஺: ߤ்௘௦௧< 0 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0 logMAR. i.e. P(ߤ்௘௦௧
Secondary hypothesis 2:  
The null and alternative hypothesis for binocular near HLHC visual performance to test for 
superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as follows: 
ܪ௢: ߤ்௘௦௧൒ 0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧
Secondary hypothesis 3:  
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as 
follows: 
ܪ௢: ߤ்௘௦௧൒ 0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧
14.6. Secondary Analysis  
CLUE Vision
CLUE vision scores at the 1-week follow-up will be analyzed using a linear mixed model 
adjusting for baseline values as a covariate. Sequence of lens wear, study period, lens type will 
be included as fixed effects. Other factors such as, race, gender or ADD power may be included 
in the model as covariates when appropriate. Site will be included as a random effect (G-side). 
The covariance between residual errors from the same subject across study periods will be 
CR-6413, v 2.0
 
 
Page 75 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
modeled using either homogenous compound symmetry (CS) or unstructured (UN). The 
structure that returns the lowest finite-sample corrected Akaike’s Information criterion7 will 
be selected as the structure that best fits the model. The Kenward and Roger method, (Kenward 
and Roger, 1997)8 will be used for the denominator degrees of freedom.  
Comparisons between the Test and Control lenses at the 1-week follow-up evaluation will be 
carried out using two-sided 95% confidence intervals constructed for the least-square mean 
difference (Test minus Control).      
Primary hypothesis 1:  
The null and alternative hypothesis for CLUE vision to test for superiority of the Test lens 
relative to the pre-defined threshold of 40 is as follows: 
ܪ௢: ߤ்௘௦௧൑ 40 
ܪ஺: ߤ்௘௦௧> 40 
Superiority will be declared if the lower limit of the 95% confidence interval of the adjusted 
mean for the Test lens is greater than 32. i.e. P(ߤ்௘௦௧!
Primary Hypothesis 2: 
The null and alternative hypothesis for CLUE vision to test for non-inferiority of the Test lens 
relative the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟൑ -5 
ܪ஺: ߤ்௘௦௧െߤ஼௢௡௧௥௢௟> -5 
Non-inferiority will be declared if the lower limit of the 95% confidence interval for the least-
square mean difference is greater than -5. i.e. P(ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟>-
14.7. Other Exploratory Analyses 
CLUETMcomfort and handling scores will be descriptively summarized for each timepoint and 
lens type.  
Further exploratory analysis may be undertaken at the discretion of the study responsible 
clinician.  
14.8. Interim Analysis
There will not be an interim analysis performed on this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
CR-6413, v 2.0
 
 
Page 76 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 15 imputations.
14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). 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 Date Sources for this study include:
Not Applicable 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
CR-6413, v 2.0
 
 
Page 77 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. ClinicalTrials.gov  
This study will be registered on ClincalTrials.gov. 
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
CR-6413, v 2.0
 
 
Page 78 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
CR-6413, v 2.0
 
 
Page 79 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
CR-6413, v 2.0
 
 
Page 80 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 ICH2 and ISO 141551
guidelines, applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
CR-6413, v 2.0
 
 
Page 81 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
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.
CR-6413, v 2.0
 
 
Page 82 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
CR-6413, v 2.0
 
 
Page 83 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci. 2016;93(8):801-808. 
7. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation.
1998;27:591-604. 
8. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983–997. 
CR-6413, v 2.0
 
 
Page 84 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: 
 (STUDY QUESTIONNAIRES)
CR-6413, v 2.0
 
 
Page 85 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
1
CR-6413, v 2.0
 
 
Page 86 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
2
CR-6413, v 2.0
 
 
Page 87 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
3
CR-6413, v 2.0
 
 
Page 88 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
4
CR-6413, v 2.0
 
 
Page 89 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
5
CR-6413, v 2.0
 
 
Page 90 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
6
CR-6413, v 2.0
 
 
Page 91 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
7
CR-6413, v 2.0
 
 
Page 92 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
8
CR-6413, v 2.0
 
 
Page 93 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
9
CR-6413, v 2.0
 
 
Page 94 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
10
CR-6413, v 2.0
 
 
Page 95 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
11
CR-6413, v 2.0
 
 
Page 96 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
12
CR-6413, v 2.0
 
 
Page 97 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
13
CR-6413, v 2.0
 
 
Page 98 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
14
CR-6413, v 2.0
 
 
Page 99 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
15
CR-6413, v 2.0
 
 
Page 100 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
16
CR-6413, v 2.0
 
 
Page 101 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
17
CR-6413, v 2.0
 
 
Page 102 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
18
CR-6413, v 2.0
 
 
Page 103 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
19
CR-6413, v 2.0
 
 
Page 104 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
20
CR-6413, v 2.0
 
 
Page 105 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
21
CR-6413, v 2.0
 
 
Page 106 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
22
CR-6413, v 2.0
 
 
Page 107 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
23
CR-6413, v 2.0
) 
 
Page 108 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
24
CR-6413, v 2.0
 
 
Page 109 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
25
CR-6413, v 2.0
 
 
Page 110 of 230
JJVC CONFIDENTIAL

35263(&,),&$7,2
'UDIW
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
26
CR-6413, v 2.0
 
 
Page 111 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE (TO BE PROVIDED 
SEPERATLEY) 
 
CR-6413, v 2.0
 
 
Page 112 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
CR-6413, v 2.0
 
 
Page 113 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: BINOCULAR OVER REFRACTION
Binocular Over-refraction Technique
1. Place trial frame on subject
2. Add +1.00 D sphere to OS
3. Add + 0.50DS OD and check VA
- 
if VA remained unchanged or improved, repeat step 3 
-
if VA decreased, add minus until best VA first achieved *note: add minus for 0.5 
seconds to avoid reflex accommodation. 
4. Record VA
5. Change +1.00 D sphere to OD
6. Repeat steps 3 and 4
CR-6413, v 2.0
 
 
Page 116 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE
Presbyopic Symptoms Questionnaire
1. Do you notice that you often have to hold things farther away so that you can read 
them?
2. Do you notice that you often have difficulty focusing on near objects (i.e., 
experiencing blurry vision when looking at things close-up)? 
3. Do you often have headaches or eyestrain, or feel fatigued, when reading or 
conducting other near activities?
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc.?
5. Do you often have difficulty reading under dim or low light? 
CR-6413, v 2.0
 
 
Page 117 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: LENS FITTING GUIDE
Step 1.
Choose the first lens based on the best spherical equivalent refraction and ADD power for both eyes.   
Select the first lens per Table 1 below.  
Table 1.  Initial Lens Selection   
ADD
+0.75
+1.00
+1.25
+1.50
+1.75
+2.00
+2.25
+2.50
Dominant Eye
LOW
LOW
LOW
MID
MID
MID
MID
MID
Non Dominant 
Eye
LOW
LOW
LOW
MID
MID
HGH
HGH
HGH
Assess the subject’s vision at distance and near after the lens has settled (10 minutes).  If the vision is 
acceptable continue with the fit assessment and dispensing as per the protocol.  
If the vision is not acceptable, ensure that the proper initial lens power was selected by performing a 
distance over-refraction with +/- 0.25D trial lenses (or flippers) to determine if a change in the initial 
lens power is required (note:  the over-refraction should be performed outside of the phoropter in 
normal room illumination).  Recheck both distance and near vision with the over-refraction in place.  
If a change in the initial lens power is not required refer to the fitting steps listed below in step 2 
(table 2).  
Step 2.
Table 2.  Lens change if required.*
Distance 
Complaint
ADD
+0.75
+1.00
+1.25
+1.50
+1.75
+2.00
+2.25
+2.50
Dominant Eye
N/A
N/A
N/A
LOW
LOW
MID
MID
MID
Non Dominant 
Eye
N/A
N/A
N/A
MID
MID
MID+
MID+
MID+
Near 
Complaint
ADD
+0.75
+1.00
+1.25
+1.50
+1.75
+2.00
+2.25
+2.50
Dominant Eye
LOW
LOW
LOW
MID
MID
MID
MID
MID
Non Dominant 
Eye
LOW+
LOW+
LOW+
MID+
MID+
HGH+
HGH+
HGH+
CR-6413, v 2.0
 
 
Page 119 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
*Note:  a + following the contact lens design indicates to add +0.25 D to the distance contact lens power 
on the non-dominant eye (see example below).   
Example:  The subject is a +1.75 ADD and has a near complaint and it is determined a change in 
lens pairs is needed.  Referring to table 2 near complaint section, under the +1.75 ADD it 
states to keep the dominant eye the same (i.e. MID) and add +0.25D to the non-dominant eye 
(i.e. MID+).        
Subjects spherical equivalent distance refraction  
OD: +2.50 
OS:  +3.00 (OS non-dominant eye) 
The new lens chosen should be as follows:
OD: +2.50 MID ADD (i.e. no change)  
OS:  +3.25 MID ADD
Repeat step 3 above.  
If after the above lens modifications have been attempted and the subject’s vision is still not satisfactory, 
and additional optimizations are allowed by the protocol, lens changes may be attempted by the 
Investigator to determine if acceptable vision can be achieved.   
CR-6413, v 2.0
 
 
Page 120 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX H: CONTROL LENS FITTING GUIDE
CR-6413, v 2.0
 
 
Page 121 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX I:  C-QUANT STRAYLIGHT MEASUREMENT
CR-6413, v 2.0
 
 
Page 154 of 230
JJVC CONFIDENTIAL

Page 1 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
CR-6413, v 2.0
 
 
Page 155 of 230
JJVC CONFIDENTIAL

Page 2 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
CR-6413, v 2.0
 
 
Page 156 of 230
JJVC CONFIDENTIAL

Page 3 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
CR-6413, v 2.0
 
 
Page 157 of 230
JJVC CONFIDENTIAL

Page 4 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
CR-6413, v 2.0
 
 
Page 158 of 230
JJVC CONFIDENTIAL

Page 5 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
CR-6413, v 2.0
 
 
Page 159 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX J:  VISIONIX CORNEAL TOPOGRAPHY AND WAVEFRONT
CR-6413, v 2.0
 
 
Page 161 of 230
JJVC CONFIDENTIAL

Page 1 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
  
CR-6413, v 2.0
 
 
Page 162 of 230
JJVC CONFIDENTIAL

Page 2 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 163 of 230
JJVC CONFIDENTIAL

Page 3 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 164 of 230
JJVC CONFIDENTIAL

Page 4 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 165 of 230
JJVC CONFIDENTIAL

Page 5 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 166 of 230
JJVC CONFIDENTIAL

Page 6 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 167 of 230
JJVC CONFIDENTIAL

Page 7 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 168 of 230
JJVC CONFIDENTIAL

Page 8 of 8
Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument    
CR-6413, v 2.0
 
 
Page 169 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DETERMINATION OF NEAR ADDITION
CR-6413, v 2.0
 
 
Page 171 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
CR-6413, v 2.0
 
 
Page 177 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS
CR-6413, v 2.0
 
 
Page 180 of 230
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
CR-6413, v 2.0
 
 
Page 184 of 230
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
CR-6413, v 2.0
 
 
Page 185 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
CR-6413, v 2.0
 
 
Page 186 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
CR-6413, v 2.0
 
 
Page 188 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE  
CR-6413, v 2.0
 
 
Page 195 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 KERATOMETRY PROCEDURE
CR-6413, v 2.0
 
 
Page 201 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
CR-6413, v 2.0
 
 
Page 203 of 230
JJVC CONFIDENTIAL

Title:                          Distance and Near Snellen Visual Acuity Evaluation
CR-6413, v 2.0
 
 
Page 207 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE
CR-6413, v 2.0
 
 
Page 208 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES
CR-6413, v 2.0
 
 
Page 212 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
CR-6413, v 2.0
 
 
Page 214 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX L: GUIDELINES FOR COVID-19 RISK MITIGATION
CR-6413, v 2.0
 
 
Page 220 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
 
Page 1 of 9 
1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.  
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as 
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
doctors of optometry (O.D.), optometric professionals, and optometry students. Doctors of optometry take a 
leading role in patient care with respect to eye and vision care, as well as general health and well-being. As 
primary health care providers, doctors of optometry have extensive, ongoing training to examine, diagnose, 
treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the eye. The 
American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).  
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.  
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
CR-6413, v 2.0
 
 
Page 221 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
Page 2 of 9 
Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures. 
x
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.   
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:  
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
CR-6413, v 2.0
 
Page 222 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
 
Page 5 of 9 
RESOURCE LINKS
  
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist   
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=  
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf  
OUS Resource Links 
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html  
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
4.1.3
Protocol Compliance Investigator(s) Signature Page:  
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
CR-6413, v 2.0
 
 
Page 225 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
Page 7 of 9 
6.0
STUDY CONDUCT DURING PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometry Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge.
Every effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be performed to the extent possible remotely/virtually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, participants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be performed if required and as feasible.
Modifications to protocol-required assessments may be permitted via COVID-19 Appendix after consultation 
with the participant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol deviations. Interruptions of test article wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix “COVID-19-
related” in the case report form (CRF).
The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.  
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable.  
Study site training will be documented utilizing Site Initiation Report
  
CR-6413, v 2.0
 
Page 227 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
 
Page 8 of 9 
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):  
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.). 
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan (Form Control No. VCT-0026).
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
6.1.3
Study Site Closure:  
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).  
CR-6413, v 2.0
 
 
Page 228 of 230
JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 3
 
Page 9 of 9 
Attachment A: Study Site Correspondence 
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principle Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principle Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
  
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.   
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
CR-6413, v 2.0
 
 
Page 229 of 230
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6413 Evaluation of a Daily Disposable Novel Multifocal Contact Lens 
in a Myopic Population  
Version and Date: 2.0 05 October 2020 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct 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-6413, v 2.0
 
 
Page 230 of 230
JJVC CONFIDENTIAL