Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
Phase: NA
Conditions: Visual Performance
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visual performance of senofilcon A with and without a new UV/HEV-filter 
Protocol CR-6463
Version: 3.0
Date: 30 August 2021
Investigational Products: senofilcon A soft contact lens with new UV/HEV-filter
Keywords: Sphere platform, senofilcon A with a new UV/HEV-filter, senofilcon A without a 
new UV/HEV-filter (ACUVUE OASYS 1-Day), daily wear, daily disposable, non-dispensing, 
Cambridge Research Systems Metropsis software, photopic and mesopic contrast sensitivity 
under broadband light conditions, photopic resolution acuity under broadband light conditions.
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 7 
SPONSOR NAME AND ADDRESS....................................................................................... 7 
MEDICAL MONITOR............................................................................................................. 7 
AUTHORIZED SIGNATURES............................................................................................... 8 
CHANGE HISTORY.............................................................................................................. 10 
SYNOPSIS.............................................................................................................................. 13 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 22 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 23 
1.1. 
Name and Descriptions of Investigational Products ................................................ 29 
1.2. 
Intended Use of Investigational Products................................................................. 29 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 29 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 29 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...29 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 32 
2.1. 
Objectives................................................................................................................. 32 
2.2. 
Endpoints.................................................................................................................. 32 
2.3. 
Hypotheses ............................................................................................................... 33 
3. 
TARGETED STUDY POPULATION........................................................................... 34 
3.1. 
General Characteristics ............................................................................................ 34 
3.2. 
Inclusion Criteria...................................................................................................... 34 
3.2.1. 
Phase 1 Inclusion Criteria................................................................................. 34 
3.2.2. 
Phase 2 Inclusion Criteria................................................................................. 34 
3.3. 
Exclusion Criteria..................................................................................................... 35 
3.3.1. 
Phase 1 Exclusion Criteria................................................................................ 35 
3.3.2. 
Phase 2 Exclusion Criteria................................................................................ 36 
3.4. 
Enrollment Strategy.................................................................................................. 37 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 37 
4.1. 
Description of Study Design .................................................................................... 37 
4.2. 
Study Design Rationale............................................................................................ 37 
4.3. 
Enrollment Target and Study Duration.................................................................... 38 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 39 
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5.1. 
Test Article Allocation............................................................................................. 39 
5.2. 
Masking.................................................................................................................... 40 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 40 
6. 
STUDY INTERVENTION............................................................................................. 40 
6.1. 
Ancillary Supplies/Products..................................................................................... 41 
6.2. 
Administration of Test Articles................................................................................ 41 
6.3. 
Packaging and Labeling ........................................................................................... 41 
6.4. 
Storage Conditions................................................................................................... 42 
6.5. 
Collection and Storage of Samples .......................................................................... 42 
6.6. 
Accountability of Test Articles ................................................................................ 42 
7. 
STUDY EVALUATIONS.............................................................................................. 43 
7.1. 
Time and Event Schedule......................................................................................... 43 
7.2. 
Detailed Study Procedures ....................................................................................... 44 
PHASE 1:  VISIT 1......................................................................................................... 44 
PHASE 2:  VISIT 1......................................................................................................... 49 
FINAL EVALUATION.................................................................................................. 56 
7.3. 
Unscheduled Visits................................................................................................... 56 
7.4. 
Laboratory Procedures ............................................................................................. 58 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 58 
8.1. 
Completion Criteria.................................................................................................. 58 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 58 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 59 
9.1. 
Systemic Medications .............................................................................................. 59 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 61 
11. 
STUDY TERMINATION ........................................................................................... 61 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 62 
13. 
ADVERSE EVENTS................................................................................................... 63 
13.1. 
Definitions and Classifications............................................................................. 63 
13.2. 
Assessing Adverse Events.................................................................................... 65 
13.2.1. 
Causality Assessment.................................................................................... 66 
13.2.2. 
Severity Assessment...................................................................................... 66 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 66 
13.4. 
Reporting Adverse Events.................................................................................... 68 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 68 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
………………………………………………………………………………69 
13.5. 
Event of Special Interest....................................................................................... 69 
13.6. 
Reporting of Pregnancy........................................................................................ 69 
14. 
STATISTICAL METHODS........................................................................................ 69 
14.1. 
General Considerations......................................................................................... 69 
14.2. 
Sample Size Justification...................................................................................... 70 
14.3. 
Analysis Populations ............................................................................................ 72 
14.4. 
Level of Statistical Significance........................................................................... 72 
14.5. 
Primary Analyses.................................................................................................. 73 
14.6. 
Secondary Analyses.............................................................................................. 74 
14.7. 
Other Exploratory Analysis.................................................................................. 74 
14.8. 
Interim Analysis ................................................................................................... 75 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 75 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 75 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 75 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 75 
15.2. 
Subject Record...................................................................................................... 76 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 76 
16. 
DATA MANAGEMENT............................................................................................. 77 
16.1. 
Access to Source Data/Document ........................................................................ 77 
16.2. 
Confidentiality of Information.............................................................................. 77 
16.3. 
Data Quality Assurance........................................................................................ 77 
16.4. 
Data Monitoring Committee (DMC).................................................................... 77 
17. 
CLINICAL MONITORING........................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 78 
18.1. 
Study-Specific Design Considerations ................................................................. 78 
18.2. 
Investigator Responsibility................................................................................... 78 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 78 
18.4. 
Informed Consent ................................................................................................. 80 
18.5. 
Privacy of Personal Data ...................................................................................... 80 
19. 
STUDY RECORD RETENTION................................................................................ 81 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION........................................................................................................... 82 
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22. 
REFERENCES ............................................................................................................ 82 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 86 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 87 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 88 
APPENDIX D:
.................................... 117 
 LENS FITTING CHARACTERISTICS............................................................. 118 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS........................ 124 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 126 
 BIOMICROSCOPY SCALE .............................................................................. 132 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION......................... 138 
APPENDIX E: ACCEPTANCE OF THE METROPSIS SYSTEM .................................... 143 
APPENDIX F: DETERMINATION OF EYE DOMINANCE............................................ 148 
APPENDIX G: GUIDANCE FOR INITIAL LENS POWER ............................................. 149 
APPENDIX H: METROPSIS WORK AID ......................................................................... 150 
APPENDIX I: METROPSIS AND GLARE SOURCE SPECIFICS ................................... 168 
APPENDIX J: GUIDELINES FOR COVID-19 RISK MITIGATION ............................... 170 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 182 
 
LIST OF TABLES
Table 1: Anticipated timing of visual performance testing. ................................................... 38 
Table 2: Test Articles for Phase 2........................................................................................... 40 
Table 3: Ancillary Supplies for Phase 2 ................................................................................. 41 
Table 4: Time and Events ....................................................................................................... 43 
Table 5: Disallowed systemic medications............................................................................. 60 
Table 6: Disallowed systemic antihistamines......................................................................... 60 
Table 7: Examples of major and minor protocol deviations................................................... 61 
Table 8:  Descriptive Summary of LogMAR Visual Acuity and AULCSF from qCSF testing 
based on Historical Data – Completed Per Protocol Subjects ................................................ 70 
Table 9:  Power Analysis for the Primary and Secondary Hypotheses (Superiority Testing) 71 
 
LIST OF FIGURES
Figure 1:  Study Flowchart………………………...................................................................20 
Figure 2:  Relevant ocular transmission and absorbance.  ..................................................... 23 
Figure 3:  Scatter and wavelength.  ........................................................................................ 24 
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Figure 4:  Emission spectra various light sources.  ................................................................ 25 
Figure 5: Experimental Set-up................................................................................................ 27 
Figure 6: Broadband light (glare) source.  ............................................................................. 27 
Figure 7:  Example of the Metropsis testing system............................................................... 28 
Figure 8: Disability glare and chromatic contrast measurements........................................... 31 
Figure 9: Two-point light threshold test ................................................................................. 31 
Figure 10: Halo and starburst measurements.......................................................................... 32 
Figure 11: Representative image of the primary and secondary packaging for Phase 2. ....... 42 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Visual performance of senofilcon A with and without a new UV/HEV-filter 
Protocol Number: CR-6463
Version: 3.0
Date: 30 August 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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Reviewer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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SYNOPSIS 
Protocol Title
Visual performance of senofilcon A with and without a new 
UV/HEV-filter 
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: feasibility
Design control phase: confirmatory phase
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products: Test lens: senofilcon A with a new
ultraviolet (UV) and High Energy Visible (HEV) light filter.
Approved Products: Control lens: ACUVUE OASYS 1-Day 
(AO1D) (senofilcon A without a new UV/HEV-filter)
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily (non-dispensing study)
Objectives 
The intent of this study is to demonstrate that the Test lens 
provides visual benefits under conditions for which it was 
designed.
Primary Objectives: The primary objective is to evaluate the 
visual performance characteristics of a new HEV-filter under 
conditions of an HEV-rich ecologically-valid light source.
Study Endpoints
Phase 1: 
x
Primary endpoint(s): photopic and mesopic contrast
sensitivity with and without glare.
Phase 2:
x
Primary endpoint(s):  Photopic resolution acuity
x
Secondary endpoint(s): Mesopic contrast sensitivity,
photopic contrast sensitivity
x
All primary and secondary endpoints will be assessed
in the presence of an ecologically-valid broadband
light source that emulates natural sunlight in spectral
content across the visible spectrum.
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Study Design
This study will occur in two non-dispensing phases:
Phase 1: 
o
Approximately 20 subjects will be used to help ensure
that the intensity of the glare source reduces the mean
contrast sensitivity about 0.1 log units at 6 cpd (ANSI
Z80.12 – 2007) under both photopic and mesopic
conditions. 
This phase is a non-dispensing, non-
randomized, controlled evaluation where subjects will
wear their habitual contact lenses during testing.
Subjects will be enrolled for approximately 1 hour.
Phase 2: 
o
Approximately 60 different subjects will be used to
evaluate the primary and secondary hypotheses of the
study.  This phase is a contralateral, non-dispensing,
randomized, controlled, double-masked, study.  Each
subject will be contralaterally fitted with the two study
articles during the single wearing period.  Subjects will
be enrolled for approximately 3 hours.
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
Phase 1: 
o
Up to 24 subjects will be enrolled to help ensure that
20 subjects complete phase 1 as cohort.
Phase 2:  
o
Up to 66 subjects will be enrolled to help ensure that
60 subjects complete phase 2 as cohort.
Study Duration
Phase 1:
o
The enrollment period will last approximately 1 week.
Phase 2:
o
The enrollment period will last approximately 8
weeks.
There will be an approximately one week pause between 
phase 1 and phase 2 for an interim analyses.  Since this is a 
single-visit, non-dispensing study, the entire study duration
(phase 1 + interim analysis + phase 2) will last approximately 
10 weeks.
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Anticipated Study 
Population
Subjects must be habitual wearers of silicone hydrogel contact 
lenses worn on a daily wear basis.  Subjects can be of any 
gender, race, and ethnicity that meet the eligibility criteria.  
Subjects enrolling in phase 1 or phase 2 will largely have the 
same eligibility criteria except where noted.
Subjects who participate in phase 1 of the study will not 
participate in phase 2 of the study.
Eligibility Criteria –
Inclusion – PHASE 1
Phase 1 Inclusion Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF
INFORMED CONSENT and receive a fully executed
copy of the form.
2. Appear able and willing to adhere to the instructions
set forth in this clinical protocol.
3. Be between 18-39 (inclusive) years of age at the time
of screening.
4. By self-report, habitually wear spherical silicone
hydrogel soft contact lenses in both eyes in a daily
reusable or daily disposable wear modality (i.e. not
extended wear modality). Habitual wear is defined as
a minimum of 6 hours of wear per day, for a minimum
of 5 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide
correction for distance vision.
6. Habitual spherical contact lens powers must be
between -1.00 D and -6.00 D (inclusive) in each eye.
Inclusion Criteria following Baseline Evaluation
7. Habitual contact lenses must provide at least 20/20
acuity OD and OS
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Eligibility Criteria –
Inclusion – PHASE 2
Phase 2 Inclusion Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF
INFORMED CONSENT and receive a fully executed
copy of the form.
2. Appear able and willing to adhere to the instructions
set forth in this clinical protocol.
3. Be between 18 and 70 (inclusive) years of age at the
time of screening.
4. By self-report, habitually wear spherical silicone
hydrogel soft contact lenses in both eyes in a daily
reusable or daily disposable wear modality (i.e. not
extended wear modality). Habitual wear is defined as
a minimum of 6 hours of wear per day, for a minimum
of 5 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide
correction for distance vision.
Inclusion Criteria following Baseline Evaluation
6. The spherical equivalent of the subject’s vertex-
corrected distance refraction must be between -1.00 D
and -6.00 D (inclusive) in each eye.
7. The magnitude of the cylindrical component of the
subject’s vertex-corrected distance refraction must be
between 0.00 D and 1.00 D (inclusive) in each eye.
8. The best corrected, monocular, distance visual acuity
must be 20/25 or better in each eye.
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Eligibility Criteria –
Exclusion – PHASE 1
Phase 1 Exclusion Criteria
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any
ocular infection of any type.
3. By self-report, have any ocular or systemic disease,
allergies, infection, or use of medication that might
contraindicate or interfere with contact lens wear, or
otherwise compromise study endpoints, including
infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human
Immunodeficiency Virus [HIV]), autoimmune disease
(e.g. rheumatoid arthritis, Sjögren’s syndrome), or
history of serious mental illness or seizures. See
section 9.1 for additional details regarding excluded
systemic medications.
4. Have habitually worn rigid gas permeable (RGP)
lenses, orthokeratology lenses, or hybrid lenses (e.g.
SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal
contact lenses.
6. Be currently wearing lenses in an extended wear
modality.
7. Have participated in a contact lens or lens care product
clinical trial within 30 days prior to study enrollment.
8. Be an employee (e.g., Investigator, Coordinator,
Technician) or immediate family member of an
employee 
(including 
partner, 
child, 
parent,
grandparent, grandchild or sibling of the employee or
their spouse) of the clinical site.
Exclusion Criteria following Baseline Evaluation
The subject must not:
9. Have clinically significant (grade 3 or higher on the
FDA grading scale) slit lamp findings (e.g., corneal
edema, 
neovascularization 
or 
staining, 
tarsal
abnormalities or bulbar injection) or other corneal or
ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study
endpoints (including entropion, ectropion, chalazia,
recurrent styes, glaucoma, history of recurrent corneal
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erosions, aphakia, moderate or above corneal
distortion, herpetic keratitis).
10. Have a history of strabismus or amblyopia.
11. Have fluctuations in vision due to clinically significant
dry eye or other ocular conditions.
12. Have had any ocular or intraocular surgery (e.g., radial
keratotomy, PRK, LASIK, iridotomy, retinal laser
photocoagulation, etc.).
13. Have
signs of a contact lens-related corneal
inflammatory event (e.g., past peripheral ulcer or
round peripheral scar).
14. Have a history of eyelid injury, surgery or procedure
that resulted in abnormal eyelid position or movement.
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Eligibility Criteria –
Exclusion – PHASE 2
Phase 2 Exclusion Criteria
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any
ocular infection of any type.
3. By self-report, have any ocular or systemic disease,
allergies, infection, or use of medication that might
contraindicate or interfere with contact lens wear, or
otherwise compromise study endpoints, including
infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human
Immunodeficiency Virus [HIV]), autoimmune disease
(e.g. rheumatoid arthritis, Sjögren’s syndrome), or
history of serious mental illness or seizures. See
section 9.1 for additional details regarding excluded
systemic medications.
4. Have habitually worn rigid gas permeable (RGP)
lenses, orthokeratology lenses, or hybrid lenses (e.g.
SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal
contact lenses.
6. Be currently wearing lenses in an extended wear
modality.
7. Have participated in a contact lens or lens care product
clinical trial within 30 days prior to study enrollment.
8. Be an employee (e.g., Investigator, Coordinator,
Technician) or immediate family member of an
employee 
(including 
partner, 
child, 
parent,
grandparent, grandchild or sibling of the employee or
their spouse) of the clinical site.
Exclusion Criteria following Baseline Evaluation
The subject must not:
9. Have clinically significant (grade 3 or higher on the
FDA grading scale) slit lamp findings (e.g., corneal
edema, 
neovascularization 
or 
staining, 
tarsal
abnormalities or bulbar injection) or other corneal or
ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study
endpoints (including entropion, ectropion, chalazia,
recurrent styes, glaucoma, history of recurrent corneal
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erosions, aphakia, moderate or above corneal 
distortion, herpetic keratitis).
10. Have a history of strabismus or amblyopia.
11. Have fluctuations in vision due to clinically significant
dry eye or other ocular conditions.
12. Have had any ocular or intraocular surgery (e.g., radial
keratotomy, PRK, LASIK, iridotomy, retinal laser
photocoagulation, etc.).
13. Have
signs of a contact lens-related corneal
inflammatory event (e.g., past peripheral ulcer or
round peripheral scar).
14. Have a history of eyelid injury, surgery or procedure
that resulted in abnormal eyelid position or movement.
Disallowed 
Medications/Interventions 
Subjects taking any ocular medication will not be allowed to 
participate.
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
All measurements will be taken with and without an 
ecologically-valid glare source.  The measurements for phase 
1 will include photopic and mesopic contrast sensitivity.  The 
measurements for phase 2 will include photopic and mesopic 
contrast sensitivity and photopic resolution acuity.
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Cambridge Research System Metropsis software will be used 
for clinical measurements.  In addition, an ecologically-valid 
broadband glare source that emulates natural sunlight in 
spectral content across the visible spectrum will be used.  
RevitaLens will be used to return any problematic lenses to
the Sponsor.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
80-90 Subjects
Available powers: -1.00 to -6.00 in 0.25 D steps
Habitual wearers of spherical silicone hydrogel soft contact lenses worn as daily wear
Excludes wearers of toric, monovision, multifocal, extended wear
Age 18-70
PHASE 2 
(60-66 subjects, 18-70 years old)
Informed Consent
Eligibility Criteria
Baseline Information
¾ Habitual lens type, modality
¾ Subjective refraction
¾ Eye dominancy
¾ Ocular physiology
Visual Performance Testing
¾ Photopic resolu ion acuity: Landolt C’s will be presented with and 
without a broadband glare source
¾ Photopic contrast sensitivity: with and without a broadband glare source
¾ Mesopic contrast sensitivity: with and without a broadband glare source
Lens Removal and Ocular Physiology
¾ The lenses will be removed and ocular physiology assessed.
Final Evaluation
PHASE 1 
(20-24 Subjects, 18-39 years old)
Informed Consent
Eligibility Criteria
Baseline Information
¾ Habitual lens type, modality
¾ Visual acuity
¾ Ocular physiology
Visual Performance Testing
Photopic and mesopic contrast sensitivity 
at 6 cpd with and without a broadband 
glare source.
Trial Lens Fitting
¾ Subjects will be randomly assigned a test lens on one eye and a control 
lens on the other eye
¾ Modify lens powers to obtain 0.00 D spherical over-refraction
10-Minute Evaluation
¾ Symptoms
¾ Fitting characteristics, VA
¾ For release, the lenses must provide:
¾ Appropriate fitting characteristics on both eyes
¾ 20/30 or better vision in both eyes
¾ Investigator approval
Interim Analysis
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
AO1D
ACUVUE OASYS 1-Day
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CSF
Contrast Sensitivity Function
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HEV
High Energy Visible light
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICH
The International Council for Harmonization
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LED
Light-Emitting Diode
OD
Right Eye
OS
Left Eye
OU
Both Eyes
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
QA
Quality Assurance
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
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UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
UV
Ultraviolet radiation
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND
Energy from the sun supports almost all of life on planet earth.  Earth exists in a “Goldilocks’ 
zone.” If we were any closer to the sun, we would overheat like Venus and if we were any 
farther from the sun, we would freeze like Mars.  Discussions about global warming that could 
cause ecological collapse revolve around overall atmospheric temperatures that vary by just a 
few degrees.  The biological response to light from the sun is similar.   Light is both essential 
to our biology but in excess drives many deleterious effects especially to our most light
responsive system.  The visual system evolved to respond to light from about 380-780 nm but 
also evolved to carefully manage how those wavebands are processed by the visual system.  
One reason is that these wavelengths are not all equally capable of biological damage.
A wide body of diverse empirical data has shown that light from about 400-500 nm is the most 
damaging to retinal tissue because (1) it reaches the retina  and is not significantly absorbed by 
anterior structures (2) it still retains enough energy to initiate photochemical damage (e.g., 
convert inert oxygen into reactive forms) and (3) fits the action spectrum of retinal 
photosensitizers (like lipofuscin).5-9
Lipofuscin is thought to contribute to retinal 
maculopathies due to generation of singlet oxygen which is abundantly generated by exposure 
to light below 500 nm.10   Collectively, this is shown in Figure 2 as the blue-light hazard 
function (ISO 8980-3).  The terms blue-light hazard function and HEV largely involve the 
same wavelengths.11
Short-wave light is dominant in the atmosphere (e.g., blue skylight ) following Rayleigh’s 
simplified equation (ܵܿܽݐݐ݁ݎ∝
ଵ
ఒర). The danger, however, posed by HEV light to ocular tissue
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specifically is the foundation of many safety standards (e.g., ANSI Z80.3-2015, Z87.1-2015 or 
ISO-8980-3).    Hence, the problem: how does a given species both take advantage of a plentiful 
source of light (e.g., to enhance color vision) while simultaneously obviating the damage from 
such an energetic source of radiation?  A parallel problem exists.  Short-wave light enhances 
visual performance, by for instance, expanding the range of color vision.  HEV, however, 
simultaneously degrades visual performance because lenticular scatter is inversely 
proportional to wavelength (Figure 3)13,14
So how did visual systems adapt to both use HEV light but not have such light excessively 
degrade the visual signal or damage the system?  The adaptive strategy, adopted across an 
extreme variety of species (particularly those that share a similar niche) appears to have been 
a strategic use of filtering.  Such a strategy is not surprising.  Plants have used screening 
pigments to moderate and adapt the effects of light for most of the history of the planet (starting 
with blue-green algae) .15,16 The amount of melanin in the human skin varies by distance from 
the equator and the resultant regular exposure to the sun (balancing protecting folic acid stores 
with the need to synthesize Vitamin D).17   A number of species evolved yellow corneas (e.g., 
Prairie dogs, Perch) or yellow oil droplets (many species of bird) to modulate HEV light 
incident on their photoreceptors.18
One central feature of natural selection is, of course, fecundity.  A trait is selected because it 
increases the probability of reproductive success.  Protection is useful but often is incidental.  
Human yellow macular pigments, for example, likely did not evolve in the human eye to 
protect against developing macular degeneration which occurs late in life.  Often evolutionary 
pressures manifest early.  Of course, a very important driver would likely be the ability to see 
when young and fertile.  Consequently, many evolutionary biologists have studied the 
immediate functional significance of intraocular filtering.19
Walls and Judd (1933) first 
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however, which contains very little or no HEV light.  For example, the CSV 1000 uses halogen 
side-mounted bulbs to test contrast sensitivity under glare conditions.  Wall charts like the 
Pelli-Robson, Regan or Bailey-Lovie use ambient illumination most often from fluorescents, 
etc.    
This is the primary reason why classic measures of visual function in the clinic are poor 
predictors of visual performance under real world conditions.24 For example, Owsley et al 
1987 argued that traditional measures of acuity and CSF only explain about a third of the 
variance in real world vision (and that much only when age, a significant covariate, was 
added).25
So, how can we do better?
The key is to measure variables such as CSF and acuity is to measure them under conditions 
that more closely resemble the conditions that we are trying to predict.  Our plan would be to 
measure CSF and acuity with glare (at photopic and low-light, mesopic, levels) under lighting 
conditions designed to closely match the spectrum of everyday life, e.g., real daylight. Natural 
HEV light is also consistently experienced indoors throughout the day since most residential 
windows transmit 56-90% visible light while most commercial windows transmit 13-58% .26
Based on our past studies using a variety of dependent measures, we predict that an HEV-
absorbing contact lens will show a benefit compared to a standard transparent contact lens.
We will achieve this objective through two aims:
1. Use an ecologically-valid light (glare) source with the Metropsis visual function
assessment system (Cambridge Research Systems, Rochester ME2 4BH, United
Kingdom).  The standard glare source of the Metropsis system emits wavelengths
similar to a white LED (Figure 4 top right), and thus is not appropriate for testing the
HEV-filtering properties of the Test lens.  The light source for this study will be an
annular ring placed between the subject and the Metropsis screen (Figure 5, Figure
6).27 The glare source and its approximate intensity at the plane of the eye are
calculated safe for use based on ANSI Z136.1 – 2014 (
.28
Specifically, the glare source can be used up to 350 minutes of photopic contrast
testing and up to 150 minutes of photopic resolution acuity testing during a single
experimental day.
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The light itself will be generated by a xenon source with a neutral density wedge to control 
intensity and chromatic filters to create the spectrum.  The emitted wavelengths will mimic 
mid-day sunlight, while the intensity of the light source will achieve both an approximate 0.1
average log unit reduction in achromatic contrast sensitivity at 6 cpd and be safe for the 
subject during testing.  The Metropsis system is well-accepted in the ophthalmic community 
(Figure 7, Appendix E).  Further information about the Metropsis system and its intended use 
in this study can be found in the Work Aid.  
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1. Within-subject evaluation of the impact of an HEV-absorbing contact lens compared
to a standard transparent contact lens as assessed through CSF and acuity with and
without a broadband glare source (n = 60).
Finally, the statement that “There is no accepted standardized method for glare testing” is 
largely true.29 There are several ISO standards that mention glare (e.g., 9358:1194, 14490-
6:2014, 12646:2008), several CIE documents (e.g., 17-22-098, 17-22-103, 146:2002), several 
IES documents (https://www.ies.org/?s=Glare), and multiple ANSI standards that mention 
glare (https://webstore.ansi.org/Search/Find?in=1&st=glare) and none of them mention how a 
glare source should be consistently incorporated into visual performance testing.  How close 
should the glare source be to the target?  How close should the glare source be to the eye?  
How many glare sources should there be?  How bright should the glare sources be?  What 
should the spectral emission of the glare sources be?  These uncertainties inevitably lead to 
inconsistencies from instruments to instruments, and subsequently, from studies to studies.  
ANSI Z80.12-2007 helps to clarify by stating that a small pilot investigation of young adult 
subjects with normal corneas and normal vision may be necessary to determine the appropriate 
glare level to reduce the mean contrast sensitivity by about 0.1 log units at 6 cpd.  
The number of subjects that constitute “a small pilot” is debatable.  The acceptable standard 
deviation that defines “about” 0.1 log units also unclear. 
Regardless, companies that 
manufacture glare testing instruments (e.g., M&S Technologies (Niles, IL, US), and Metropsis 
by Cambridge Research Systems (Rochester, UK)) have adopted this standard for all glare 
testing and this will be implemented in the study.30-33
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1.1.
Name and Descriptions of Investigational Products  
Phase 1:  Not applicable.  Subjects will wear their habitual contact lenses.
Phase 2: This study will test one (1) Test senofilcon A design prototype containing a new 
UV/HEV-filter  against one (1) Control commercially available marketed product (ACUVUE 
OASYS® 1-Day) which is also made from senofilcon A material but does not contain the new
UV/HEV-filter.  
1.2.
Intended Use of Investigational Products 
Phase 1:  Not applicable.  Subjects will wear their habitual contact lenses.
Phase 2:  The intended use of the investigative product is for correcting myopia and improving 
visual performance characteristics under applicable conditions.  During phase 2 of the 
investigation, the study articles will be worn contralaterally in a daily wear, daily disposable 
modality for 2-3 hours.
1.3.
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding senofilcon A 
with new UV/HEV-filter, refer to the latest version of the Investigator's Brochure.34
1.4.
Summary of Known Risks and Benefits to Human Subjects 
Phase 1:
o
The risk / benefits of the subjects’ habitual lenses are described in their corresponding
patient instruction guide and package insert.
Phase 2:
o
Benefits to the subjects include the correction of their refractive error with the potential
of improved visual performance in HEV environments.  The risks of wearing soft
contact lenses are well known and are described in the Investigator’s Brochure and
Informed Consent. The material safety testing/lens release criteria was determined
based on the Risk Assessment.
For the most comprehensive risk and benefit information regarding senofilcon A with 
new UV/HEV-filter, refer to the latest version of the Investigator's Brochure.34
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The new HEV-filter in the Test lens has been evaluated in two previous objective-based 
studies: 
 and 
  In both studies, psychophysical evaluations were carried out 
on an optical breadboard system using a broadband light source that emulated sunlight in 
spectral content.  These studies demonstrate that benefits of a HEV-filter can be seen when 
tested in an HEV-rich environment such as natural sunlight: 
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1.
 (n=60 cohort): when compared to a similar contact lens without the new
UV/HEV filter, the Test lens demonstrated statistical superiority in the following
metrics:
o
2-point light threshold
o
Halo diameter
o
Starburst diameter
o
Disability glare
o
Discomfort glare
o
Chromatic contrast
2.
(n=58 cohort): when compared to a similar contact lens without the new
UV/HEV filter (different control lens than 
), the Test lens demonstrated
statistical superiority in the following metrics:
o
2-point light threshold
o
Halo diameter
o
Discomfort glare
o
Chromatic contrast
o
Photostress recovery
To further, many of the metrics noted above provide a reason to believe that the specific 
hypotheses of this study are obtainable.  Mainly:
1. Improved contrast
o
In 
 and 
, disability glare (Figure 8, top) was measured by noting
the intensity of a broadband light source needed to obscure a central grating
target.  The results from this study demonstrate that subjects can see a high
contrast central grating target under HEV-rich conditions such as sunlight better
with an HEV-filter.
o
In 
 and 
, heterochromatic contrast (Figure 8, bottom) was
measured by noting the intensity of a 460 nm light source needed to obscure a 580
nm central grating target.  The results demonstrate an improved ability to detect
edges while wearing an HEV-filter.
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2. Improved acuity
o
In 
 and 
, two-point light thresholds were measured by
overlapping two points of broadband light and then slowly pulling them apart
until the subject reports them as being distinctly separate (Figure 9).
o
This is akin to the separation of Airy discs and thus a resolution task.35 The results
demonstrate that subjects can resolve an image under HEV-rich conditions better
with an HEV-filter.
3. Improved low light vision
In 
 and 
, broadband light that emulated sunlight in spectral content was 
used to generate a point source of light.  The halo and starburst diameters of that light were 
measured using precision calipers (Figure 10).  The results demonstrate that positive 
dysphotopsia, which is most prevalent in dim illumination, can be improved with an HEV-
filter. 36-38
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Phase 2:
1. Primary Endpoint(s):
x
Resolution acuity using Landolt C’s under bright light conditions (a120 cd/m2)
with a broadband glare source. The photopic resolution acuity on arcminute scale
will be converted to logMAR scale for the analysis purpose using ݈݋݃ܯܣܴ =
݈݋݃ଵ଴(ܽݎܿ݉݅݊ݑݐ݁), see Statistical Analysis Section for more information (Section
14).
2. Secondary Endpoint(s):
x
Photopic contrast sensitivity under bright light conditions (a120 cd/m2) with a
broadband glare source.
Testing will include 8 reversals with the last 4 being
averaged to provide the contrast threshold.
x
Mesopic contrast sensitivity under dim light conditions (d 3 cd/m2) with a
broadband glare source.
Testing will include 8 reversals with the last 4 being
averaged to provide the contrast threshold.
2.3.
Hypotheses 
Phase 1:
The least-square means (LSM, i.e., adjusted means) of photopic contrast sensitivity and 
mesopic contrast sensitivity at 6 cpd will be estimated with 95% confidence interval separately 
under conditions with glare source and without glare source.  The primary endpoints in phase 
1 will not be statistically tested, and consequentially statistical interferences will not be made. 
Instead, the reduction in the estimated mean for photopic and mesopic contrast sensitivity due 
to the glare source will be compared against the criteria of 0.1 log (per ANSI Z80.12-2007).  
If the reduction in the estimated mean due to the glare source is about 0.1 log units, then it can 
be concluded that the glare light source is effective and the study can move to Phase 2.
Phase 2:
1. Primary Hypothesis:
x
The Test lens will provide improved photopic resolution acuity than the Control
lens under conditions of a broadband glare source.
2. Secondary Hypotheses
x
The Test lens will provide improved photopic contrast sensitivity than the Control
lens under conditions of a broadband glare source.
x
The Test lens will provide improved mesopic contrast sensitivity under conditions
of a broadband glare source.
Phase 2: The primary hypothesis must be met to satisfy the objective of the study. The 
secondary hypotheses will be evaluated only when the primary hypothesis is met. For both 
primary and secondary endpoints, in addition to the statistical testing, the model-based point 
estimate of mean difference will be evaluated against a predetermined clinically meaningful 
margin (0.05 logMAR for visual acuity and 0.06 log for both photopic and mesopic contrast 
sensitivity).
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3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Subjects must be habitual wearers of silicone hydrogel contact lenses worn on a daily wear 
basis.  Subjects can be of any gender, race, and ethnicity that meet the eligibility criteria.  
Subjects enrolling in phase 1 or phase 2 will largely have the same eligibility criteria except 
where noted.
Subject who participate in phase 1 of the study will not participate in phase 2 of the study.
3.2.
Inclusion Criteria 
3.2.1. Phase 1 Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18-39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both
eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear
modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a
minimum of 5 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
6. Habitual spherical contact lens powers must be between -1.00 D and -6.00 D (inclusive)
in each eye.
Inclusion Criteria following Baseline Evaluation
7. Habitual contact lenses must provide at least 20/20 acuity OD and OS
3.2.2. Phase 2 Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 70 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both
eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear
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modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a 
minimum of 5 days per week during the past 30 days.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
Inclusion Criteria following Baseline Evaluation
6. The spherical equivalent of the subject’s vertex-corrected distance refraction must be
between -1.00 D and -6.00 D (inclusive) in each eye.
7. The magnitude of the cylindrical component of the subject’s vertex-corrected distance
refraction must be between 0.00 D and 1.00 D (inclusive) in each eye.
8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each
eye.
3.3.
Exclusion Criteria 
3.3.1. Phase 1 Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any ocular infection of any type.
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of
medication that might contraindicate or interfere with contact lens wear, or otherwise
compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]),
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s syndrome), or history of
serious mental illness or seizures. See section 9.1 for additional details regarding
excluded systemic medications.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing lenses in an extended wear modality.
7. Have participated in a contact lens or lens care product clinical trial within 30 days
prior to study enrollment.
8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family
member of an employee (including partner, child, parent, grandparent, grandchild or
sibling of the employee or their spouse) of the clinical site.
Exclusion Criteria following Baseline Evaluation
The subject must not:
9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study endpoints (including entropion,
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ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, 
aphakia, moderate or above corneal distortion, herpetic keratitis).
10. Have a history of strabismus or amblyopia.
11. Have fluctuations in vision due to clinically significant dry eye or other ocular
conditions.
12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK,
iridotomy, retinal laser photocoagulation, etc.).
13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral
ulcer or round peripheral scar).
14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid
position or movement.
3.3.2. Phase 2 Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be currently using any ocular medications or have any ocular infection of any type.
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of
medication that might contraindicate or interfere with contact lens wear, or otherwise
compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]),
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s syndrome), or history of
serious mental illness or seizures. See section 9.1 for additional details regarding
excluded systemic medications.
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing lenses in an extended wear modality.
7. Have participated in a contact lens or lens care product clinical trial within 30 days
prior to study enrollment.
8. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family
member of an employee (including partner, child, parent, grandparent, grandchild or
sibling of the employee or their spouse) of the clinical site.
Exclusion Criteria following Baseline Evaluation
The subject must not:
9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study endpoints (including entropion,
ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions,
aphakia, moderate or above corneal distortion, herpetic keratitis).
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10. Have a history of strabismus or amblyopia.
11. Have fluctuations in vision due to clinically significant dry eye or other ocular
conditions.
12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK,
iridotomy, retinal laser photocoagulation, etc.).
13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral
ulcer or round peripheral scar).
14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid
position or movement.
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 
Phase 1: This is a non-randomized, non-masked, non-dispensing study where subjects will 
wear their own contact lenses for approximately 1 hour.  
Phase 2: This is a controlled, randomized, double-masked, contralateral (Test/Control or 
Control/Test), non-dispensing study where the study lenses will be worn in a daily wear 
modality for approximately 3 hours.  Subjects will not have access to the study lenses at the 
conclusion of their visit.
4.2.
Study Design Rationale 
Phase1: This study phase is to help ensure that the intensity of the glare source is efficacious
and satisfies ANSI Z80.12-2007.  Subjects will wear their own contact lenses and be tested 
unilaterally.
Phase 2: This study phase will be executed using a contralateral design.  There are several 
benefits to this choice of design.  First, a contralateral design will allow us to compare 
performance within the same individual, ostensibly with the same baseline light sensitivity by 
eye.  Second, other subject factors that can influence visual performance, such as iris color and 
absorption of test lights via macular pigment, are better controlled using this design.  Third, in 
psychophysical testing, which is the gold standard for many of the visual functions being 
tested, participants make judgments about some event threshold, such as when an image 
disappears.  Participants may have different criteria for threshold events that are internally 
consistent within subjects but can vary between subjects.  A contralateral design allows the 
investigational lens to be compared within subjects, with consistent criteria for threshold 
events.  Sufficient time will be taken between measures to reduce any potential bias, as follows:
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4.3.
Enrollment Target and Study Duration 
Phase 1: This phase of the study will enroll up to 24 subjects with the intent of completing 20.  
This will be conducted at 1 clinical site.  A subject will be considered enrolled upon signing 
of the informed consent form.  All subjects will be in the age range 18-39 in accordance with 
ANSI Z80.12-2007.  There will be 1 visit in total per subject lasting approximately one hour.  
Enrollment period is approximately one week.
Phase 2: This phase of the study will have an enrollment target of 66 subjects, with a goal of
at least 60 to complete. The subjects in phase 2 will not include the subjects from phase 1.  
The study will be conducted at 1 clinical site (same site as phase 1).  A subject will be 
considered enrolled upon signing of the informed consent form. Approximately 30 subjects 
(+/- 5) will be in the age range 18-39, with the remainder comprising the 40-70 year old group.  
There will be 1 visit in total per subject.  Total duration of phase 2 is expected to be 
approximately 8 weeks. 
Total study duration (phase 1 + interim analysis + phase 2) is expected to last about 10 weeks.  
Subjects who are discontinued prior to the final evaluation may be replaced at the discretion 
of the study sponsor. The investigation will end at the time that the study data is hard locked.
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5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation  
Phase 1:  Not Applicable.  Subjects are wearing their habitual contact lenses.
Phase 2: Use of the test articles will be randomized using a lens fitting schedule supplied by 
the study biostatistician. The clinical site will follow the lens fitting schedule provided and 
will complete enrollment according to the randomization list and will not pre-select or pre-
assign subjects.
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. Subjects, in blocks of two, will be randomized to either wear the Test lens in the left 
eye and the Control lens in the right eye or the Control lens in the left eye and the Test lens in 
the right eye. The order of the light sources is predetermined: visual performance will be 
assessed under the no broadband light source (without glare) condition first and then assessed 
under the broadband light source (with glare) condition.  The same randomization scheme will 
be used for these two light sources. Under each light source condition, the right eye will always 
be tested first. Subjects will be stratified into one of two age groups (18-39 years old and 40-
70 years old) using a 1:1 allocation ratio. The randomization scheme will be generated using 
the PROC PLAN procedure from Statistical Analysis System (SAS) Software Version 9.4 or 
higher (SAS Institute, Cary, NC).39
Randomization will be performed at phase 2 visit 1.  The following must have occurred prior 
to randomization:
x
Informed consent must have been obtained.
x
The subject must have met all eligibility criteria.
x
The subject’s screening and baseline information must have been collected.
When releasing test articles for vision testing, the following steps should be followed to 
maintain randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens
fitting schedule to obtain the test article assignment for that subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the
lens fitting schedule.
3. Investigator or designee will pull the appropriate test articles from the study supply.
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed
outside the clinical site) or not, must be recorded on the Test Article Accountability
Log in the “Dispensed” section.
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Figure 11: Representative image of the primary and secondary packaging for Phase 2.
Primary Packaging
Secondary Packaging
6.4.
Storage Conditions 
Phase 2: Test articles will be maintained at ambient temperatures at the clinical site. Test 
articles must be kept under secure conditions.
6.5.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures.
When possible for Phase 2, any lens or test article associated with an Adverse Event and/or a 
Product Quality Complaint must be retained and stored in a glass vial with moderate solution 
pending directions from the sponsor for potential return to JJVC.
6.6.
Accountability of Test Articles 
Phase 2:  JJVC will provide the Investigator with sufficient quantities of study articles and 
supplies to complete the investigation. The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning
product.
3. The number and reason for unplanned replacements.
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1.33
Visual Performance 
Testing Without 
Glare
Visual performance testing will be performed 
using the Metropsis system OD and OS in the 
following order.  The eye not being tested 
will be patched.
Without glare OD:
1. Photopic resolution acuity
A. Test distance: 4.0 m
B. Screen luminance approximately 120
cd/m2
C. Ambient luminance must be dark with 
no lights or reflective surfaces within 
the general field of view of the target.  
EDC to record: Arcminute +/- SD.  
Range 0.2 - 60.0 arc minutes.
D. Rest a minimum of 2 minutes before 
next test
2. Photopic contrast sensitivity
A. Test distance: 1.5 m
B. Screen luminance approximately 120
cd/m2
C. Ambient luminance must be dark with 
no lights or reflective surfaces within 
the general field of view of the target
D. Spatial frequencies 3, 6, 9, 12, 18 
using a 2 degree Gabor stimulus.  
EDC to record: contrast threshold 
mean +/- SD for each spatial 
frequency.  Range 0.0000 – 100.0000.
E. Rest a minimum of 5 minutes before 
next test
3. Mesopic contrast sensitivity
A. Test distance: 1.5 m
B. Screen luminance approximately 3
cd/m2.  This will be achieved by 
placing neutral density films over the 
Metropsis monitor.
C. Ambient luminance must be dark with 
no lights or reflective surfaces within 
the general field of view of the target
D. Spatial frequencies 1.5, 3, 6, 9, 12 
using a 2 degree Gabor stimulus.  
EDC to record: contrast threshold 
mean +/- SD for each spatial 
frequency.  Range 0.0000 – 100.0000.
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1.34
Visual Performance 
Testing With Glare
Visual performance testing will be performed 
using the Metropsis system OD and OS in the 
following order.  The eye not being tested 
will be patched. The spectral output and 
intensity of the broadband light source will be 
verified before each test.
With glare OD:
1. Photopic resolution acuity
A. Test distance: 4.0 m
B. Screen luminance approximately 120
cd/m2
C. Ambient luminance must be dark with 
no lights or reflective surfaces within 
the general field of view of the target.  
EDC to record: Arcminute +/- SD.  
Range 0.2 - 60.0 arc minutes.
D. Rest a minimum of 2 minutes before 
next test
2. Photopic contrast sensitivity
A. Test distance: 1.5 m
B. Screen luminance approximately 120
cd/m2
C. Ambient luminance must be dark with 
no lights or reflective surfaces within 
the general field of view of the target.
D. Spatial frequencies 3, 6, 9, 12, 18 
using a 2 degree Gabor stimulus.  
EDC to record: contrast threshold 
mean +/- SD for each spatial 
frequency.  Range 0.0000 – 100.0000.
E. Rest a minimum of 5 minutes before 
next test
3. Mesopic contrast sensitivity
A. Test distance: 1.5 m
B. Screen luminance approximately 3
cd/m2
C. Add a 0.52 log unit ND filter to glare 
source
D. Ambient luminance must be dark with
no lights or reflective surfaces within 
the general field of view of the target
E. Spatial frequencies 1.5, 3, 6, 9, 12
using a 2 degree Gabor stimulus.  
EDC to record: contrast threshold 
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For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled).
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued
from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity.
x
Collect used test article(s) from the subject and discard them, unless otherwise stated
in section 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: any ocular medications.
Concomitant therapies that are disallowed include: see section 9.1.
9.1.
Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. 
A summary of disallowed systemic medications is shown in Table 5: Disallowed systemic 
medications. Subjects with a history of taking these medications will be allowed to enroll 
only if:
x
The medications have been taken on a continual, routine basis for at least 6 months,
and
x
The subject has demonstrated successful contact lens wear during this time.
Or:
x
The subject was taking the medication on a temporary basis and ceased taking that
medication at least 2 weeks prior to signing the informed consent (this is considered
sufficient time for the medication to have left the body prior to enrollment).
Subjects with a history of taking medications listed in Table 5: Disallowed systemic 
medications on a long-term, routine basis for less than 6 months will not be allowed to 
participate in the study.
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The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (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).
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x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms,
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
x
Confirmation of product availability for return (and tracking information, if available),
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of
the study.
2. Was present prior to the study but worsened during the study. This would include any
condition resulting from concomitant illnesses, reactions to concomitant medications,
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
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Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
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 
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wear time. However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of
intensity of the adverse event (mild, moderate, or severe - see definition in section 0).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
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13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time
suggests that a causal relationship is not likely.
x
Possibly Related – An adverse event that might be due to the use of the test article, or
to the study treatment or study procedures. An alternative explanation, e.g. concomitant
treatment, concomitant disease(s), is inconclusive. The relationship in time is
reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g.
concomitant treatment of concomitant disease(s). The relationship in time is very
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
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All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
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 
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date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
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.
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Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None.
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
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).39 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.
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14.5. Primary Analyses 
Phase I (interim analysis):
For photopic and mesopic contrast sensitivity, the logarithm of contrast sensitivity will be 
calculated as ݈݋݃ܥܵ= ݈݋݃ଵ଴(1/(ܿ݋݊ݐݎܽݏݐ ݐℎݎ݁ݏℎ݋݈݀/100)) and the logCS will be used for 
the analysis purpose. Note that ܿ݋݊ݐݎܽݏݐ ݐℎݎ݁ݏℎ݋݈݀ is reported in percentage (%) in the 
Electronic Data Capture system. Photopic and mesopic logCS will be analyzed separately 
using linear mixed effects models with a normal distribution. The dependent variable will be 
the logCS and light source condition (i.e., without glare and with glare) will be the fixed effect 
in both models. A subject-specific random intercept will be included to account for repeated 
measurement on the same individuals. The least-square means (LSM, i.e., adjusted means) of 
photopic and mesopic logCS at 6 cpd will be estimated with 95% confidence interval under 
each light source condition. The reduction in the estimated means due to the glare source will 
be compared against the criteria of 0.1 log. If the reduction in the estimated mean due to the 
glare source is about 0.1 log units, it can be concluded that the glare light source is verified 
and the study can move to Phase 2.  
Phase 2:
Superiority testing with respect to the primary endpoint in phase 2 will be assessed on the 
Intent-to-Treat (ITT) population.
Photopic Resolution Acuity using Landolt C’s with a Glare Source
The photopic resolution acuity using Landolt C’s (converted to logMAR unit using 
݈݋݃ܯܣܴ =  ݈݋݃ଵ଴(ܽݎܿ݉݅݊ݑݐ݁)) will be analyzed under bright light conditions with a 
broadband light source (glare) using a linear mixed model with a normal distribution. Lens 
type, dominant eye, and the interaction of lens type by dominant eye will be included in the 
model as fixed effects and age as a covariate. The covariance of residuals between eyes within 
the same subject (R-side) will be modeled using Unstructured (UN) covariance structure. If 
the model does not converge, then a compound Symmetry (CS) covariance structure will be 
considered. The Kenward and Roger method (Kenward and Roger, 1997) will be used for the 
denominator degrees of freedom.
Hypothesis Testing
The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens with respect to photopic resolution acuity with a glare source are as follows: 
ܪ଴: ߤ்− ߤ஼≥0
ܪ஺: ߤ்− ߤ஼ < 0
Where, ߤ்represents the mean photopic resolution acuity (logMAR) for the Test lens and ߤ௖
represents the mean photopic resolution acuity (logMAR) for the Control lens. Statistical 
superiority will be declared if the upper bound of the adjusted 2-sided 95% confidence interval 
of the mean difference (Test – Control) is less than 0. A model-based point estimate of mean 
difference being -0.05 logMAR or more (≤-0.05 logMAR) will be considered clinically 
meaningful.
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14.6. Secondary Analyses  
Superiority testing with respect to the secondary endpoints in phase 2 will be assessed on the 
Intent-to-Treat (ITT) population.
Photopic Contrast Sensitivity with a Glare Source
For photopic and mesopic contrast sensitivity, first the logarithm of contrast sensitivity will be 
calculated as ݈݋݃ܥܵ= ݈݋݃ଵ଴(1/(ܿ݋݊ݐݎܽݏݐ ݐℎݎ݁ݏℎ݋݈݀/100)), and then the area under the log
contrast sensitivity function (AULCSF) will be calculated using logCS and the log (base 10) 
of each spatial frequency based on the trapezoidal rule per eye per subject for the analysis 
purpose.42
The AULCSF for photopic contrast sensitivity will be analyzed under bright light conditions 
with a broadband light source (glare) using a linear mixed model with a normal distribution. 
Lens type, dominant eye, and the interaction of lens type by dominant eye will be included in 
the model as fixed effects and age as a covariate. The covariance of residuals between eyes 
within the same subject (R-side) will be modeled using Unstructured (UN) covariance 
structure. If the model does not converge, then a compound Symmetry (CS) covariance 
structure will be considered. The Kenward and Roger method will be used for the denominator 
degrees of freedom.43
Hypothesis Testing
The null and alternative hypotheses for testing superiority of the Test Lens compared to the 
Control lens with respect to AULCSF for photopic contrast sensitivity with a broadband light 
source are presented below:
ܪ଴: ߤ்− ߤ஼≤0
ܪ஺: ߤ்− ߤ஼ > 0
Where, ߤ்represents the mean AULCSF for the Test lens and ߤ௖represents the mean AULCSF
for the Control lens. Statistical superiority will be declared if the lower bound of the 2-sided
95% confidence interval of the mean difference (Test – Control) is larger than 0. A model-
based point estimate of the mean difference being 0.06 log or more (≥0.06 log) will be 
considered clinically meaningful.44
Mesopic Contrast Sensitivity with a Glare Source
The AULCSF for mesopic contrast sensitivity testing under dim light conditions with a 
broadband light source (glare) will be analyzed, tested, and interpreted in the same manner as 
the analysis of the AULCSF for photopic contrast sensitivity.
14.7. Other Exploratory Analysis  
Other exploratory analysis may be conducted at the discretion of the study responsible 
clinician.
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14.8. Interim Analysis 
This is a two-phase study and approximately 24 subjects will be enrolled in phase 1 with a 
target of 20 to complete. An interim analysis will be performed after all subjects completed 
phase 1 on the primary endpoints (see Section 14.5 for the details of the planned interim 
analysis). Other endpoints in phase 1 may be descriptive summarized. The interim analysis on 
the primary endpoints in phase 1 will be used to verify the glare light source. If the glare light 
source is found effective (e.g., the reduction in the estimated mean of contrast sensitivity due 
to the glare source is about 0.1 log units), the study can move to Phase 2. If the glare source 
has no effect, or obliterates the target, then phase 2 will not begin and the study will be 
terminated.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection 
The Vision Assessments (photopic and mesopic contrast sensitivity, photopic resolution 
acuity) will be collected using the Cambridge Research Systems Metropsis system. This data 
will be generated as PDF files. The data from the Metropsis and all other study data will be 
captured on electronic case report forms (eCRFs) using the Bioclinica EDC system. An
authorized data originator will enter study data into the eCRFs using the EDC system. Data 
collected on equipment that is not captured in EDC will be formatted to the specification of 
the JJVC database manager and sent to JJVC for analysis. 
The source data from the Metropsis will be transferred by the site staff to JJVC in regular 
intervals to be reviewed by JJVC. The data will be uploaded to a cloud-based system, such as 
MBox, by the site staff. The uploaded data will be remotely source verified by the monitors in 
accordance to the timelines in the Clinical Monitoring Plan. The Metropsis source data will be 
stored at the site in accordance with Section 19 of this protocol. The Metropsis source data 
stored at the site will be stored confidentially and will only be accessible by study site staff. 
The source data stored at the site may be stored on an external protected drive or a protected 
shared drive. 
External data sources for this study include: Not Applicable
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The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.
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16. DATA MANAGEMENT
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
Not applicable
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17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any
subsequent versions, and regulatory requirements are maintained.
x
Ensuring the rights and wellbeing of subjects are protected.
x
Ensuring adequate resources, including facilities, laboratories, equipment, and
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as
applicable.
x
Ensuring that the clinical site has sufficient test article and supplies.
x
Clarifying questions regarding the study.
x
Resolving study issues or problems that may arise.
x
Reviewing of study records and source documentation verification in accordance with
the monitoring plan.
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully
able to understand the risks, benefits, and potential adverse events of the study and provide 
their consent voluntarily.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
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.
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x
Sponsor-approved informed consent form (and any other written materials to be
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
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At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy.
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) and other 
applicable personal data protection and security laws and regulations.45,46 Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the 
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
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These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
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.
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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 is a single site study.  The participating institution and Principal Investigators for this 
study agree that, should the study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint publication of the study 
results with the investigators contributing data, analyses and comments.
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45.
Health Information Portability and Accountability Act (HIPAA). Available at
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
46.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April
2017 on medical devices. Available at http://data.europa.eu/eli/reg/2017/745/2017-05-
05
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
Not Applicable
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-Day ACUVUE OASYS® with HydraLuxe™
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
0.25D to -10 00D
• Axis Range:
2.5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®  
1-Day with 
HydraLuxe™ 
Technology 
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area. The patient should continue to use UV absorbing 
eyewear as directed.
ACTIONS
In its hydrated state, the contact lens, when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina.
The transmittance characteristics for these lenses are less than 1% in the 
UVB range of 280 nm to 315 nm
han 10% in the UVA range of 
316 nm to 380 nm for the entire power range.
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NOTE:  Long-term exposure to UV radiation is one of the risk 
factors associated with cataracts.  Exposure is based on a number 
of factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of outdoor 
activities).  UV-Blocking contact lenses help provide protection 
against harmful UV radiation. However, clinical studies have not 
been done to demonstrate that wearing UV-Blocking contact 
lenses reduces the risk of developing cataracts or other eye 
disorders. The Eye Care Professional should be consulted for more 
information.
INDICATIONS (USES)
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism.
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ Tech-
nology for ASTIGMATISM are indicated for daily disposable wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism.
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these contact lenses when any of the following 
conditions exist:
• Acute or subacute inﬂ ammation or infection of the anterior chamber 
of the eye.
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids.
• Severe insufﬁ ciency of lacrimal secretion (dry eye)
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• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious 
 is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
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• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handli
n, removal, and wearing 
instructions in the “Patient Instruction Guide” for the prescribed 
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wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
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Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potential for some temporary impairment due to 
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peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
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GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be e ec ed for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses.  
1. Criteria of a Properly Fit Lens 
A properly ﬁ t lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufﬁ cient movement to provide tear exchange 
under the contact lens with the blink, and be comfortable. The lens 
should move freely when manipulated digitally with the lower lid, and 
then return to its properly centered position when released.
2. Criteria of a Flat Fitting Lens 
A ﬂ at ﬁ tting lens may exhibit one or more of the following characteris-
tics: decentration, incomplete corneal coverage (i.e., limbal exposure), 
excessive movement with the blink, and/or edge standoff. If the lens is 
judged to be ﬂ at ﬁ tting, it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens 
A steep ﬁ tting lens may exhibit one or more of the following charac-
teristics: insufﬁ cient movement with the blink, conjunctival indentation, 
and resistance when pushing the lens up digitally with the lower lid. 
If the lens is judged to be steep ﬁ tting, it should not be dispensed to 
the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t and evaluated after the patient 
has adjusted to the lens. The lens should move freely when manipulated 
digitally with the lower lid, and then return to a properly centered position 
when released. If resistance is encountered when pushing the lens up, the 
lens is ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should
e good visual acuity with the 
correct lens power unless there is excessive residual astigmatism.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
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B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately 
corrected distance and near visual acuity in each eye. The 
amblyopic patient or the patient with signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an 
ent would only require a near 
lens, whereas a bilateral myope would require corrective lenses on 
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s perform
er the above conditions 
is completed, tests of vis
and reading ability under 
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Monovision ﬁ tting success can be improved by the following 
suggestions:
• Reverse the distance and near eyes if a patient is having trouble 
adapting.
• Reﬁ ne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients.
• Emphasize the beneﬁ ts of clear near vision and straight ahead 
and upward gaze with monovision.
The decision to ﬁ t a patient with monovision correction is most 
appropriately left to the Eye Care Professional in conjunction with the 
patient after carefully considering the patient’s needs.
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
PATIENT MANAGEMENT
Dispensing Visit
Each sterile lens is supplied in a foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
from the container, peel back the foil seal, place a ﬁ nger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of 
the container.
• Evaluate the physical ﬁ t and visual acuity of the lens on each eye.
• Teach the patient how to apply and remove his or her lenses.
• Explain daily disposable lens wear and schedule a follow-up 
examination.
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com.
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES.
Follow-Up Examinations
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of speciﬁ c problems, if any, and a
th the patient of the wear 
schedule, daily disposable modality, and proper lens handling procedures. 
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Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
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the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
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The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day 
MATISM: base curve, power, 
diameter, cylinder, axis, lot
and expiration date
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 
 
 Lens Fitting Characteristics
 Subject Reported Ocular Symptoms/Problems
Determination of Distance Spherocylindrical Refractions
 Biomicroscopy Scale
Distance and Near Visual Acuity Evaluation
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 1 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 2 of 5
            
       
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 3 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 4 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
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Title:                         Subject Reported Ocular Symptoms/Problems
Document Type:  
Document Number:  
Revision Number:  3
Page 1 of 1
  
  
            
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 1 of 5
  
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 2 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 3 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 4 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 5 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE 
 
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  9
  
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
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Title:  
Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 3 of 4
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: ACCEPTANCE OF THE METROPSIS SYSTEM  
 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: GUIDANCE FOR INITIAL LENS POWER 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX H: METROPSIS WORK AID 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX I: METROPSIS AND GLARE SOURCE SPECIFICS 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX J: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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. Doctor 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, Doctor 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.
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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:
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
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.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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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
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
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.
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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.).  
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Attachment A: Study Site Correspondence
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principal 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 Principal 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. 
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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
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings html
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x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health:
https://www health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
 
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6463 Visual performance of senofilcon A with and without a new 
UV/HEV-filter 
Version and Date: 3.0 30 August 2021
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155:2020,1 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 J of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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