Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title: Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact 
Lenses
Protocol Number: CR-6435
Version: 1.0
Date: 12 May 2021
Test Articles: JJVC Investigational Multifocal Toric Contact Lenses manufactured in 
Senofilcon A (C3) material with UV/HEV blocker
Key Words: Presbyopia, Multifocal, Astigmatism, Daily Wear, Daily Disposable, 
Dispensing, senofilcon A, logMAR visual acuity, CLUE questionnaire
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS.............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 16 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 18 
1.1. 
Name and Descriptions of Investigational Products ................................................ 18 
1.2. 
Intended Use of Investigational Products................................................................. 18 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 18 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 18 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...18 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 19 
2.1. 
Objectives................................................................................................................. 19 
2.2. 
Endpoints.................................................................................................................. 19 
2.3. 
Hypotheses ............................................................................................................... 20 
3. 
TARGETED STUDY POPULATION........................................................................... 21 
3.1. 
General Characteristics ............................................................................................ 21 
3.2. 
Inclusion Criteria...................................................................................................... 21 
3.3. 
Exclusion Criteria..................................................................................................... 22 
3.4. 
Enrollment Strategy.................................................................................................. 23 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 23 
4.1. 
Description of Study Design .................................................................................... 23 
4.2. 
Study Design Rationale............................................................................................ 23 
4.3. 
Enrollment Target and Study Duration.................................................................... 24 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 24 
5.1. 
Test Article Allocation............................................................................................. 24 
5.2. 
Masking.................................................................................................................... 24 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 24 
6. 
STUDY INTERVENTION............................................................................................. 25 
6.1. 
Identity of Test Articles............................................................................................ 25 
6.2. 
Ancillary Supplies/Products..................................................................................... 26 
6.3. 
Administration of Test Articles................................................................................ 26 
6.4. 
Packaging and Labeling ........................................................................................... 26 
6.5. 
Storage Conditions................................................................................................... 27 
6.6. 
Collection and Storage of Samples .......................................................................... 27 
6.7. 
Accountability of Test Articles ................................................................................ 27 
7. 
STUDY EVALUATIONS.............................................................................................. 28 
7.1. 
Time and Event Schedule......................................................................................... 28 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
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VISIT 2 ........................................................................................................................... 37 
VISIT 3 ........................................................................................................................... 43 
VISIT 4 ........................................................................................................................... 47 
FINAL EVALUATION.................................................................................................. 49 
7.3. 
Unscheduled Visits................................................................................................... 50 
7.4. 
Laboratory Procedures ............................................................................................. 52 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 52 
8.1. 
Completion Criteria.................................................................................................. 52 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 52 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 53 
9.1. 
Systemic Medications .............................................................................................. 53 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 54 
11. 
STUDY TERMINATION ........................................................................................... 55 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 56 
13. 
ADVERSE EVENTS................................................................................................... 57 
13.1. 
Definitions and Classifications............................................................................. 57 
13.2. 
Assessing Adverse Events.................................................................................... 59 
13.2.1. 
Causality Assessment.................................................................................... 59 
13.2.2. 
Severity Assessment...................................................................................... 60 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 60 
13.4. 
Reporting Adverse Events.................................................................................... 61 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 62 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
………………………………………………………………………………62 
13.5. 
Event of Special Interest....................................................................................... 63 
13.6. 
Reporting of Pregnancy........................................................................................ 63 
14. 
STATISTICAL METHODS........................................................................................ 63 
14.1. 
General Considerations......................................................................................... 63 
14.2. 
Sample Size Justification...................................................................................... 63 
14.3. 
Analysis Populations ............................................................................................ 66 
14.4. 
Level of Statistical Significance........................................................................... 66 
14.5. 
Primary Analysis .................................................................................................. 66 
14.6. 
Secondary Analysis .............................................................................................. 68 
14.7. 
Other Exploratory Analyses ................................................................................. 69 
14.8. 
Interim Analysis ................................................................................................... 69 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 69 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 70 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 70 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 70 
15.2. 
Subject Record...................................................................................................... 70 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 71 
16. 
DATA MANAGEMENT............................................................................................. 71 
16.1. 
Access to Source Data/Document ........................................................................ 71 
16.2. 
Confidentiality of Information.............................................................................. 71 
16.3. 
Data Quality Assurance........................................................................................ 71 
16.4. 
Data Monitoring Committee (DMC).................................................................... 72 
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17. 
CLINICAL MONITORING........................................................................................ 72 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 72 
18.1. 
Study-Specific Design Considerations ................................................................. 72 
18.2. 
Investigator Responsibility................................................................................... 73 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 73 
18.4. 
Informed Consent ................................................................................................. 74 
18.5. 
Privacy of Personal Data ...................................................................................... 75 
19. 
STUDY RECORD RETENTION................................................................................ 76 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 77 
21. 
PUBLICATION........................................................................................................... 77 
22. 
REFERENCES ............................................................................................................ 77 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 79 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 102 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)....................................... 103 
APPENDIX D: LENS FITTING GUIDE............................................................................. 104 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE..................................... 107 
APPENDIX F: OCULAR DOMINANCE............................................................................ 108 
APPENDIX G: BINOCULAR OVER REFRACTION ....................................................... 109 
APPENDIX H: 
.................................... 110 
 DETERMINATION OF NEAR ADDITION .................................................... 111 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE....... 117 
LENS FITTING CHARACTERISTICS............................................................ 120 
 SUBJECT REPORTED OCULAR SYMPTOMS............................................. 126 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 128 
 BIOMICROSCOPY SCALE ............................................................................. 134 
 KERATOMETRY.............................................................................................. 140 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 142 
 TORIC FIT EVALUATION.............................................................................. 147 
 DISTANCE LOGMAR VISUAL ACUITY MESAUREMENT PROCEDURE
............................................................................................................................................... 152 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION     
TESTING.............................................................................................................................. 156 
APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION................................ 165 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 177 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 15 
LIST OF TABLES
Table 1: Test Articles.............................................................................................................. 25 
Table 2: Ancillary Supplies .................................................................................................... 26 
Table 3: Time and Events ....................................................................................................... 28 
Table 4: Disallowed systemic medications............................................................................. 53 
Table 5: Examples of major and minor protocol deviations................................................... 55 
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Table 6:  Historical Binocular High Luminance High Contrast Visual Performance ............ 64 
Table 7: Historical CLUE Scores – 2-Week Follow-up ......................................................... 64 
Table 8: Sample Size Estimates for Primary Endpoints......................................................... 65 
Table 9: Power Analysis for Secondary Endpoints ................................................................ 65 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Protocol Title: Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact 
Lenses
Protocol Number: CR-6435
Version: 1.0
Date: 12 May 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ICH guidelines,2 ISO 14155,1
and the Declaration of Helsinki.3
Author
See Electronic Signature Page
DATE
Clinical Operations 
Manager
See Electronic Signature Page
DATE
Biostatistician
See Electronic Signature Page
DATE
Biostatistics
Reviewer
See Electronic Signature Page
DATE
Data Management 
See Electronic Signature Page
DATE
Medical Safety 
Officer
See Electronic Signature Page
DATE
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Reviewer
See Electronic Signature Page
DATE
Approver
See Electronic Signature Page
DATE
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Johnson & Johnson Vision Care, Inc.
CHANGE HISTORY 
Version
Originator
Description of Change(s) and Section 
Number(s) Affected
Date
1.0
Original Protocol
12 May 2021
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SYNOPSIS 
Protocol Title
Evaluation of Daily Disposable Silicone Hydrogel Multifocal 
Toric Contact Lenses
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256
Clinical Phase
Clinical trial phase: Confirmatory
Design control phase: 2b
Trial Registration
This study will be registered on ClinicalTrials.gov based on 
the following: The purpose of the study is for design 
confirmation, not feasibility.
Test Article
Investigational Products: JJVC Investigational Multifocal
Toric Contact Lenses manufactured in Senofilcon A (C3) 
material with UV/HEV blocker
Wear and Replacement 
Schedules
Wear Schedule: The lenses will be used on a daily disposable 
basis.
Replacement Schedule: The lenses will be replaced each day  
of wear or if lost or damaged.
Objectives 
The purpose of the study is to confirm the performance of the 
study lens relative to previously established safety and 
efficacy criteria.  Study results may also be compared to the 
results obtained in other studies through aggregation of results 
in graphs and tables.
Primary Objective
The primary objectives of this study are to assess the clinical 
performance of investigational multifocal toric contact lenses 
with respect to subjective vision measured via CLUE™ 
questionnaire, 
and 
visual 
acuity 
(logMAR) 
after 
approximately two weeks of lens wear.
Secondary Objective
The secondary objectives of this study are to compare the
clinical performance of investigational multifocal toric 
contact lenses with the subjects’ habitual correction with 
respect to subjective vision, comfort and lens handling 
measured via the CLUE™ questionnaire after approximately 
two weeks of lens wear.
Exploratory Objectives
Additional exploratory objectives are to evaluate the lens fit
acceptance and toric fit of the investigational multifocal toric
lenses, and the ocular health via slit lamp findings.
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Study Endpoints
All secondary and primary endpoints are considered at the 2-
week follow-up in the optimized lenses (Visit 4). 
Primary endpoints: 
x
Binocular high luminance, high contrast logMAR
visual acuity at distance (4 m), intermediate (64 cm),
and near (40 cm) at 2-week follow-up
x
Subjective vision via CLUE™ questionnaire at 2-
week follow-up
Secondary endpoints: 
x
Subjective vision score via CLUE™ questionnaire:
change from baseline to 2-week follow-up
x
Subjective comfort score via CLUE™ questionnaire:
change from baseline to 2-week follow-up
x
Subjective handling score via CLUE™ questionnaire:
change from baseline to 2-week follow-up
Exploratory endpoints: 
x
Percentage of eyes with an unacceptable lens fit during
the study
x
Percentage of lens fits with rotation stability within 5
degrees at 15 minutes after insertion at the fitting visit
x
Percentage of lens fits with absolute rotation error
within 10 degrees at 15 minutes after insertion at the
fitting visit
x
Percentage of eyes with Grade 3 or 4 findings during
the post-fit period.
Study Design
The study is a bilateral, single-masked, single-arm, 4-visit 
dispensing study.  There will be one study treatment, with the 
subject being dispensed lenses for 6 to 8 days, then will return 
for lens optimization (if needed).  Following the optimization 
visit, the study lenses will be worn for approximately two
weeks, including a follow-up visit after 6 to 8 days.
The 
primary endpoints will be logMAR visual acuity at distance, 
intermediate and near and subjective vision scores. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations.
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Sample Size
Approximately 50 myopic subjects with against-the-rule 
astigmatism will be enrolled, with the aim that at least 45 will 
complete the study.  Approximately 40 hyperopic subjects 
with against-the-rule astigmatism will be enrolled, with the 
aim that at least 35 will complete the study.  The study lenses 
for the hyperopic subjects are likely to be available before the 
lenses for the myopic subjects, therefore, the study may enroll 
and complete all hyperopes before myopes are enrolled.   
Study Duration
Lenses in minus powers and plus powers will be evaluated in 
two separate phases of the study which may run at  different 
times depending on when lenses become available.  Each 
phase of the study will last approximately 3 months. Each 
individual subject is expected to be in the study for 
approximately 3 weeks. 
Anticipated Study 
Population
Healthy male and female volunteers with presbyopia,
ametropia (hyperopia or myopia) and astigmatism will be 
screened as per criteria outlined below.  All volunteers will 
have baseline measurements taken to ensure eligibility.  The 
baseline procedures will occur after informed consent has 
been obtained.  
For a detailed list of procedures see the time and events 
schedule listed below.
Eligibility Criteria -
Inclusion
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF
INFORMED CONSENT and receive a fully executed
copy of the form.
2. Appear able and willing to adhere to the instructions
set forth in this clinical protocol.
3. Be at least 40 and not more than 70 years of age at
the time of screening.
4. Own a wearable pair of spectacles if required for
their distance vision.
5. Be an adapted soft contact lens wearer in both eyes
(i.e. worn lenses for at least 8 hours per day at least
two days per week for the past 4 weeks).
6. Be already wearing a presbyopic contact lens
correction (e.g., reading spectacles over contact
lenses, multifocal or monovision contact lenses, etc.)
or if not respond positively to at least one symptom
on the “Presbyopic Symptoms Questionnaire”.
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Inclusion Criteria at Baseline Evaluation:
7. The subject’s distance spherical component of their
refraction must be in the range of either -1.25 D to -
3.75 D, or +1.25 D to +3.75 D.
8. The subject’s refractive cylinder must be -1.00 D to -
1.50 D in each eye, with the cylinder axes in the
range of 90°±30°.
9. The subject’s ADD power must be in the range of
+0.75 D to +2.50 D in each eye.
10. The subject must have best corrected distance visual
acuity of 20/20-3 or better in each eye.
Eligibility Criteria -
Exclusion
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. By self-report, have any systemic disease (e.g. Sjögren’s
Syndrome), allergies, infectious disease (e.g., hepatitis,
tuberculosis), contagious immunosuppressive diseases
(e.g., HIV), autoimmune disease (e.g. rheumatoid
arthritis), or other diseases, by self-report, which are
known to interfere with contact lens wear and/or
participation in the study.
3. Use systemic medications that may interfere with contact
lens wear or cause blurred vision. See Section 9.1 for
additional 
details 
regarding 
excluded 
systemic
medications.
4. Currently use ocular medication (with the exception of
rewetting drops).
5. Have any known hypersensitivity or allergic reaction to
single use preservative free rewetting drops or sodium
fluorescein.
6. Have had any previous, or have any planned, ocular or
intraocular surgery (e.g. radial keratotomy, PRK, LASIK,
cataract surgery, retinal surgery, etc.).
7. Have had previous eyelid injuries, surgeries or procedures
which are known to have caused abnormal eyelid position
or movement, by self-report.
8. Have participated in any contact lens or lens care product
clinical trial within 7 days prior to study enrollment.
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9. Be an employee or immediate family member of an
employee of clinical site (e.g., Investigator, Coordinator,
Technician).
10. Have a history of amblyopia or strabismus, by self-report.
11. Have a history of herpetic keratitis, by self-report.
Exclusion Criteria at Baseline Evaluation
The subject must not:
12. Have
ocular allergies, infections or other ocular
abnormalities that are known to interfere with contact lens
wear and/or participation in the study. This may include,
but not be limited to entropion, ectropion, chalazia,
recurrent styes, glaucoma, history of recurrent corneal
erosions, aphakia, or corneal distortion
13. Have any Grade 3 or greater slit lamp findings (e.g.,
edema, corneal neovascularization, corneal staining, tarsal
abnormalities, conjunctival injection) on the FDA scale.
Disallowed 
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.  
See Section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
logMAR visual acuity and subjective responses for vision,
comfort and lens handling using the CLUE questionnaire.
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, may result in stopping the further 
dispensing of 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
Rewetting drops and saline for storing worn lenses. Lens vials 
and caps and materials for returning worn contact lenses will 
be supplied to sites.
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 Subjects to Complete (45 myopes, 35 hyperopes)
Potential Subjects Identified Based On:
x
Age: At least 40 and not greater than 70 at the time of consent
x
Habitual contact lens wearers with Presbyopic correction or symptoms
x
Refractive Spherical Component either -1.25D to -3.75D or +1.25D to +3.75D
x
Refractive Cylinder:-1.00D to -1.50D with a cylinder axis of 90° ± 30°
x
Near Add: +0.75D to +2.50D
x
Visual Acuity: Best corrected 20/20-3 or better in each eye
Informed Consent (Visit 1)
Eligibility Criteria
Baseline Information
x
Habitual lens type, modality, and contact lens history. Wear Time
x
Baseline CLUE, MRD and CLDEQ-8 Questionnaire, Ocular symptoms, and Entrance Visual Acuity
x
Lens Removal, Keratometry, Subjective refraction, Add Determination, Ocular Dominance, Add Refinement, and 
Near Visual Acuity
x
Biomicroscopy
Modifications
(up to 2 attempts, 
if necessary)
Yes
No
Dispensing
x
Exit Visual Acuity
x
Dispensing Criteria, Subject Instructions
x
Schedule Follow-up in 6 to 8 Days
Trial Fitting (Visit 1)
x
Lens Selection
x
Right Eye Lens Insertion and Lens Damage
x
Measure Rotation at 1 Minute and 3 Minutes
x
Left Eye Lens Insertion and Lens Damage
x
Measure Rotation at 1 Minute and 3 Minutes
x
Lens Settling, then Toric Fit Evaluation and Lens Fit Assessment
x
Visual Satisfaction, Visual Acuity, Over-Refraction
Follow-up 1 (Visit 2)
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
CLUE and MRD Questionnaire
x
Ocular Symptoms, Subjective Acceptance, Entrance Visual Acuity, and Over-Refraction
x
Toric Fit Evaluation and Lens Fit Assessment
Modifications
(if necessary)
Dispensing
x
Lens Removal and Biomicroscopy
x
Insertion of a New Pair of Study Lenses
x
Exit Visual Acuity, Dispensing Criteria, and Subject Instructions
x
Schedule Follow-up in 6 to 8 Days
No
Follow-up 2 (Visit 3)
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
CLUE, MRD and CLDEQ-8 Questionnaires
x
Ocular Symptoms, Subjective Acceptance, Entrance VA, Over-Refraction
x
Toric Fitting Evaluation and Lens Fit Assessment
x
logMAR Visual Performance
x
Lens Removal, Biomicroscopy
x
Insertion of a New Pair of Study Lenses, Exit Visual Acuity, Dispensing Criteria, and Subject Instructions
x
Schedule follow-up in 6 to 8 days
Final Evaluation
Lens Optimization (up to 2 attempts allowed)
x
Lens Selection (Right, Left or Both)
x
Right Eye Lens Insertion and Lens Damage (if applicable)
x
Measure Rotation at 1 Minute and 3 Minutes (if applicable)
x
Left Eye Lens Insertion and Lens Damage (if applicable)
x
Measure Rotation at 1 Minute and 3 Minutes (if applicable)
x
Lens Settling, then Toric Fit Evaluation and Lens Fit Assessment
x
Visual Satisfaction, Visual Acuity, Over-Refraction
Yes
Follow-up 3  (Visit 4)
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
CLUE, MRD and CLDEQ-8 Questionnaires
x
Ocular Symptoms, Subjective Acceptance, Entrance VA, Over-Refraction
x
Toric Fitting Evaluation and Lens Fit Assessment
x
logMAR Visual Performance
x
Lens Removal
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADD
Plus Power Required For Near Use
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COAS
Complete Ophthalmic Analysis System
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CT
Center Thickness
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
logMAR
Logarithm of Minimal Angle of Resolution
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
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OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
Johnson & Johnson Vision launched their most recent multifocal contact lens called
ACUVUE® OASYS MULTIFOCAL in March, 2021.  The lens is recommended for 
presbyopes who have up to -0.75 D of refractive cylinder.  There is a considerable population 
of presbyopic patients who have greater than -0.75 D of cylinder, in one or both eyes.  Currently 
there are a limited number of soft toric multifocal lenses available. This study will evaluate 
the performance of prototype daily disposable multifocal toric lenses with a similar optical 
design to ACUVUE® OASYS MULTIFOCAL which are manufactured in senofilcon A (C3) 
material with an added high energy visible (HEV) light blocker.
1.1.
Name and Descriptions of Investigational Products 
Test Article:  JJVC Investigational Multifocal Toric Contact Lenses manufactured in 
Senofilcon A (C3) material with UV/HEV blocker
Refer to Table 1 in Section 6.1 the protocol.   
1.2.
Intended Use of Investigational Products 
The Investigational Test lens is indicated for daily wear for the optical correction of refractive 
ametropia (myopia, hyperopia) and presbyopia in phakic or aphakic persons with non-diseased 
eyes who may need up to +2.50 D of ADD power and have astigmatism in the range of  -1.00 
D to -1.50 D.   In this study, the lenses will be used in a population of presbyopes who require
+1.25 D to +3.75 D or -1.25 D to -3.75 D of spherical correction, -1.00 D to -1.50 D of cylinder, 
cylinder axis within 90°±30° and add powers of +0.75 D to +2.50 D (see Section 3.2).
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 JJVC 
Multifocal Toric Contact Lenses manufactured in senofilcon A material refer to the latest 
version of the CR-6435 Investigator's Brochure.
1.4.
Summary of Known Risks and Benefits to Human Subjects 
For the most comprehensive risk and benefit information regarding JJVC Multifocal Toric 
Contact Lenses manufactured in senofilcon A material refer to the latest version of the CR-
6435 Investigator’s Brochure and Informed Consent.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Investigational multifocal toric lenses with the same design and similar materials have been 
evaluated in two feasibility clinical studies prior to this study. A summary of these studies is 
shown below, and relevant safety information for these studies is included in the CR-6435 
Investigator’s Brochure.
was a single-arm dispensing evaluation of multifocal toric investigational lenses in a 
myopic population with against-the-rule astigmatism. Lenses used in this study had a slightly 
different material formulation than the lenses being used in the current CR-6435 study.  The 
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study lenses were worn for approximately 2 weeks (with a first follow-up visit after 6-8 days, 
and second follow-up visit after a further 6-8 days). Forty subjects were enrolled in the study 
and thirty-seven completed it.    No adverse events were reported.
is an ongoing single-arm dispensing evaluation of multifocal toric investigational 
lenses in a hyperopic population with against-the-rule astigmatism. This study is testing lenses 
with an older formulation (same as the one used in 
) in comparison with a newer 
formulation (same as the one to be used in the current CR-6435 study).  In the 2x3 crossover 
study design involving 6 visits, subjects wear one of the study lens types for approximately 2 
weeks, and the other study lens type for approximately 3 weeks.   As of May 5, 2021, 30
subjects had been enrolled, with 3 screen failures, 2 discontinuations, 23 completed and 2
ongoing.    One non-significant ocular adverse has been reported to date, which was determined 
to be not related to the study lens.
In addition to these two multifocal toric studies, a series of studies have been performed on a 
non-toric multifocal version of the study lens.  Further details of the safety profile of these 
related lens types are included in the Investigator’s Brochure.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The main purpose of the study is to confirm the performance of the study lens relative to 
previously established safety and efficacy criteria.  Study results may also be compared to the 
results obtained in other studies through aggregation of results in graphs and tables.
Primary Objective
The primary objective of this study is to assess the clinical performance of investigational 
multifocal toric contact lenses with respect to subjective vision measured via CLUE™ 
questionnaire, and visual acuity (logMAR) after approximately two weeks of lens wear.
Secondary Objective
The secondary objectives of this study are to compare the clinical performance of 
investigational multifocal toric contact lenses with the subjects’ habitual correction with 
respect to subjective vision, comfort and lens handling measured via the CLUE™ 
questionnaire after approximately two weeks of lens wear.
Exploratory Objectives
Additional exploratory objectives are to evaluate the lens fit acceptance and toric fit of the 
investigational multifocal toric lenses, and the ocular health via slit lamp findings.
2.2.
Endpoints  
Primary Endpoints
Visual Acuity (logMAR)
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Multiple assessments of binocular and monocular visual acuity will be made during the study, 
but the binocular measurements made at the 2-week follow-up evaluation using high contrast 
letters in bright illuminance conditions will be the primary endpoint. At distance (4 meters), 
VA is assessed using ETDRS Charts; while near (40 cm) and intermediate (64 cm) assessments 
will be made using reduced Guillon-Poling charts. Visual acuity will be measured using high
and low contrast charts in bright illuminance conditions.   Visual acuity will also be measured 
using high contrast charts in dim illuminance conditions created by the use of goggles. See 
 in Appendix H for details regarding the collection of 
visual acuity (logMAR). 
CLUE Vision Score
Subjective quality of vision will be assessed using the Contact Lens User Experience 
(CLUE™) questionnaire after approximately 2-weeks of wear.  CLUE is a validated patient-
reported outcomes questionnaire to assess patient-experience attributes of soft, disposable 
contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 
in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory (IRT) follow a 
normal distribution with a population average score of 60 (SD 20), where higher scores indicate 
a more favorable/positive response with a range of 0-120. A 5-point increase in an average 
CLUE™ score translates into 10% shift in the distribution of scores for population of soft 
contact lens wearers.5
Secondary Endpoints
x
CLUE Vision Scores, change from baseline to 2-week follow-up
x
CLUE Comfort Scores, change from baseline to 2-week follow-up
x
CLUE Handling Scores, change from baseline to 2-week follow-up
Other Exploratory endpoints: 
x
Percentage of eyes with an unacceptable lens fit during the study
x
Percentage of lens fits with rotation stability within 5 degrees at 15 minutes after
insertion at the fitting visit
x
Percentage of lens fits with absolute rotation error within 10 degrees at 15 minutes after
insertion at the fitting visit
x
Percentage of eyes with Grade 3 or 4 findings during the post-fit period.
2.3.
Hypotheses 
All primary hypotheses must be met in order to satisfy the study objective.
Primary Hypotheses
1. After approximately 2 weeks of wear in the optimized lenses, the mean overall quality
of vision score with the Test lens will be statistically better than 40 points on CLUE
scale for myopic subjects.
2. After approximately 2 weeks of wear in the optimized lenses, the mean overall quality
of vision score with the Test lens will be statistically better than 32 points on CLUE
scale for hyperopic subjects.
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3. After approximately 2 weeks of wear in the optimized lenses, the binocular, high-
luminance, high-contrast distance (4 M) logMAR visual acuity of the test lens will be
statistically better than 0.00 logMAR. This will be determined using ETDRS LogMAR
acuity testing charts.
4. After approximately 2 weeks of wear in the optimized lenses, the binocular, high-
luminance, high-contrast intermediate (64 cm) logMAR visual acuity of the test lens
will be statistically better than +0.17 logMAR. This will be determined using
Guillon/Poling LogMAR acuity testing charts.
5. After approximately 2 weeks of wear in the optimized lenses, the binocular, high-
luminance, high-contrast near (40 cm) logMAR visual acuity of the test lens will be
statistically better than +0.17 logMAR. This will be determined using Guillon/Poling
LogMAR acuity testing charts.
Secondary Hypotheses
Secondary hypotheses will be tested for the hyperopes and the myopes separately. 
1. After approximately 2 weeks of wear in the optimized lenses, the mean overall quality
of vision CLUE score for Test lens will be non-inferior to the baseline score measured
for habitual correction.  A non-inferiority margin of -5 will be used.
2. After approximately 2 weeks of wear in the optimized lenses, the mean comfort CLUE
score with the Test lens will be non-inferior to the baseline score measured for habitual
correction.  A non-inferiority margin of -5 will be used.
3. After approximately 2 weeks of wear in the optimized lenses, the mean lens handling
CLUE score with the Test lens will be non-inferior to the baseline score measured for
habitual correction.  A non-inferiority margin of -5 will be used.
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics  
The population to be studied will consist of adapted contact lens wearers with presbyopia,
ametropia (hyperopia or myopia) and astigmatism.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a
fully executed copy of the form.
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2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be at least 40 and not more than 70 years of age at the time of screening.
4. Own a wearable pair of spectacles if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses for at least 8 hours
per day at least two days per week for the past 4 weeks).
6. Be already wearing a presbyopic contact lens correction (e.g., reading spectacles over
contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively
to at least one symptom on the “Presbyopic Symptoms Questionnaire”.
Inclusion Criteria at Baseline Evaluation
7. The subject’s distance spherical component of their refraction must be in the range of
either -1.25 D to -3.75 D, or +1.25 D to +3.75 D.
8. The subject’s refractive cylinder must be -1.00 D to -1.50 D in each eye, with the
cylinder axes in the range of 90°±30°.
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each
eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. By self-report, have any systemic disease (e.g. Sjögren’s Syndrome), allergies, infectious
disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV),
autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are
known to interfere with contact lens wear and/or participation in the study.
3. Use systemic medications that may interfere with contact lens wear or cause blurred vision.
See Section 9.1 for additional details regarding excluded systemic medications.
4. Currently use ocular medication (with the exception of rewetting drops).
5. Have any known hypersensitivity or allergic reaction to single use preservative free
rewetting drops or sodium fluorescein.
6. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial
keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
7. Have had previous eyelid injuries, surgeries or procedures which are known to have caused
abnormal eyelid position or movement, by self-report.
8. Have participated in any contact lens or lens care product clinical trial within 7 days prior
to study enrollment.
9. Be an employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician).
10. Have a history of amblyopia or strabismus, by self-report.
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11. Have a history of herpetic keratitis, by self-report.
Exclusion Criteria at Baseline Evaluation
The subject must not:
12. Have ocular allergies, infections or other ocular abnormalities that are known to interfere
with contact lens wear and/or participation in the study. This may include, but not be
limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent
corneal erosions, aphakia, or corneal distortion
13. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization,
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
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 
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. Approximately 
90 (50 myopes and 40 hyperopes) subjects will be enrolled into this study with the target of 
completing approximately 80 (45 myopes and 35 hyperopes) subjects. 
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
the subject will be dispensed the study lens in a bilateral fashion. If the subject is dispensed 
study lenses at the initial visit, then three follow-up visits will occur. The first follow-up visit 
will occur approximately one week after the initial visit. If necessary, the lens power may be 
modified at Visit 2, then a new pair of lenses with the final lens power will be dispensed. The 
second follow-up (Visit 3) will occur approximately 1-week after Visit 2. The 3rd and final 
follow-up evaluation (Visit 4) will occur approximately 1-week after Visit 3. 
4.2.
Study Design Rationale 
A single-arm study was chosen to confirm the performance of the study lens relative to 
previously established safety and efficacy criteria. These criteria have been defined based on 
data from previous studies of 1-DAY ACUVUE® MOIST Multifocal (1DAMM) that have 
been successfully marketed since 2015.5
Additionally, results from this study may be 
compared to data from a similar single-arm study on a marketed multifocal toric lens.7 Data 
from these studies will be compared by creating tables and graphs of aggregate data after the
study databases are all hard-locked. 
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4.3.
Enrollment Target and Study Duration 
Approximately 50 myopic subjects with against-the-rule astigmatism will be enrolled, with the 
aim that at least 45 will complete the study.  Approximately 40 hyperopic subjects with against-
the-rule astigmatism will be enrolled, with the aim that at least 35 will complete the study.  
Subjects to be enrolled will have -1.00 D to -1.50 D of astigmatism in both eyes with 90°±30°
axis.
Lenses in minus powers and plus powers will be evaluated in two separate phases of the study 
which may run at  different times depending on when lenses become available.  Each phase of 
the study will last approximately 3 months. Each individual subject is expected to be in the 
study for approximately 3 weeks. Lens will be worn as daily disposable and will be replaced 
daily. 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
This is a single-arm study. All subjects will be dispensed the study lens in a bilateral fashion. 
5.2.
Masking 
Subjects will be masked to the study lens to help reduce potential bias. Subjects will be 
unaware of the identity of the investigational product. Investigators and clinical site personnel 
involved in the data collection will not be masked as to the identity of the investigational 
product. 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued may be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before 
the mask is broken.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
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1. Investigator or designee (documented on the Delegation Log) will consult the lens
fitting schedule/randomization scheme to obtain the test article assignment for that
subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the
randomization scheme
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.
6.
STUDY INTERVENTION
6.1.
Identity of Test Articles 
The following contact lenses will be used in this study:
Table 1: Test Articles
Test Lens
Name
JJVC Investigational Multifocal Toric
Contact Lenses manufactured in 
Senofilcon A (C3) material with
UV/HEV blocker
Manufacturer
JJVC
Lens Material
senofilcon A(C3) with chromophore
Nominal Base Curve 
8.5
Nominal Diameter 
14.3
Nominal Distance Powers (D)
-1.00 to -4.00 in 0.25D steps,
+1.00 to +4.00 in 0.25D steps
Nominal Cylinder Powers (D)
-1.00
Cylinder axes (º)
70, 90, 110
Nominal ADD Power (D)
Low, Mid, High
Water Content
38%
Oxygen Permeability (Dk)
122.0
Wear Schedule in Current Study 
Daily Disposable
Replacement Frequency
Daily
Packaging Form (vial, blister, etc.)
Blister
Each subject will wear approximately 42 lenses for the average 21 day dispensing period, plus 
any additional lenses needed for modifications and replacements. 
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6.2.
Ancillary Supplies/Products 
The following solutions will be used in this study:
Table 2: Ancillary Supplies
Single-Use Preservative-Free Rewetting Solutions 
(any of these three options may be supplied)
Solution 
Name/Description
Eye-Cept®
Rewetting 
Drops
ScleralFil®
Preservative 
Free Saline 
Solution
LacriPure
Saline Solution
Manufacturer
Optics
Laboratory
Bausch + 
Lomb
Menicon
Preservative
Non-
Preserved
Non-
Preserved
Non-Preserved
Stopwatches will be provided to research sites to help with managing the timing of toric fit 
assessments and lens settling.
6.3.
Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Test articles which are lost or damaged 
may be replaced at the discretion of the Investigator.
6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging with an investigational 
lens label. The test articles will be in plastic bags as the secondary packaging form. The sample 
study label is shown below:
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6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
 
 
 
 
 
 
 
 
 
 
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7.
STUDY EVALUATIONS
7.1.
Time and Event Schedule 
Table 3: Time and Events
Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1
Visit 2
Treatment 1 
Follow-up 1
Visit 3
Treatment 1 
Follow-up 2
Visit 4
Treatment 1 
Follow-up 3
Time Point
Day 0
7 ± 1 days after 
Visit 1
7 ± 1 days after
Visit 2
7 ± 1 days after
Visit 3
Estimated Visit Duration
2.5 hours
1.0 hours
1.0 hours
1.5 hours
Statement of Informed 
Consent
X
Demographics
X
Medical History/Concomitant 
Medications/Review
X
AE/Concomitant Med Review
X
X
X
Habitual Contact Lens 
Information & Wear Schedule
X
Contact Lens History
X
Habitual Lens Wear Time
X
Study Lens Wear Time
X
X
X
Compliance
X
X
X
Presbyopic Symptoms
Questionnaire
X
Screening 
Inclusion/Exclusion Criteria
X
Patient Reported Outcomes
X
X
X
X
Ocular Symptoms
X
X
X
X
Subjective Acceptance
X
X
X
Entrance distance and near 
Visual Acuity
X
X
X
X
Lens Removal
X
X
X
X
Keratometry
X
Subjective Sphero-Cylindrical 
Refraction
X
Near ADD Determination
X
Ocular Dominance
X
ADD Refinement
X
Near Visual Acuity
X
Slit Lamp Biomicroscopy
X
X
X
Baseline Inclusion/ Exclusion
X
Lens Selection
X O O
O O
Right Lens Insertion
X O O
O O
Right Lens 1 Minute and 3 
Minute Rotation
X O O
O O
Left Lens Insertion
X O O
O O
Left Lens 1 Minute and 3 
Minute Rotation
X O O
O O
Lens Settling
X O O
O O
Toric Fit Assessment
X O O
X O O
X
X
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1
Visit 2
Treatment 1 
Follow-up 1
Visit 3
Treatment 1 
Follow-up 2
Visit 4
Treatment 1 
Follow-up 3
Time Point
Day 0
7 ± 1 days after 
Visit 1
7 ± 1 days after
Visit 2
7 ± 1 days after
Visit 3
Estimated Visit Duration
2.5 hours
1.0 hours
1.0 hours
1.5 hours
Subjective Lens Fit 
Assessment
X O O
X O O
X
X
Visual Satisfaction
X O O
O O
Study Lens Distance and Near 
Visual Acuity
X O O
O O
Over Refraction and Visual 
Acuity
X O O
X O O
X
X
Lens Power Modification (if 
required)
X
X
Additional Lens Power 
Modification (if required)
X
Collect unworn lenses (if 
required)
O
Visual Performance
X
X
Insert new pair of lenses
X
X
Exit Snellen Distance and 
Near Visual Acuity
X
X
X
Dispensing Criteria
X
X
X
Dispensing
X
X
Subject Instructions
X
X
X
Schedule Follow-Up
X
X
X
Final Evaluation
X
Note: O denotes Optional items performed if required based on results
7.2.
Detailed Study Procedures 
VISIT 1
Subjects must report to the visit wearing their habitual contact lenses to accurately assess 
baseline PRO (CLUE and MRD) performance.  If the subject is not wearing their lenses they 
must be rescheduled.  
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of 
Informed Consent
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study.  The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form.
Note:  The subject must be provided a signed
copy of this document.
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Visit 1: Screening
Step
Procedure
Details
1.2
Demographics
Record the subject’s year of birth, age, 
gender, race and ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Questions regarding the subject’s medical 
history and concomitant medications.
1.4
Habitual Contact 
Lens Information
Questions regarding the subject’s habitual 
lens type and parameters.
1.5
Habitual Contact 
Lens Wear Schedule
Record the duration of wearing this contact 
lens type and power (number of years and 
months).
During the past four weeks, what is the 
minimum number of days per week that the 
subject has worn their lenses for at least 8 
hours.
1.6
Contact Lens History Record the subject’s correction type (i.e. 
monovision, multifocal, sphere with readers, 
etc.).
1.7
Wear time and 
Comfortable Wear 
time with Habitual 
lenses 
Record the subject’s wear time and 
comfortable wear time with their habitual 
contact lenses.  
1.8
Presbyopic 
Symptoms 
Questionnaire
Subjects will be asked if they are wearing a 
presbyopic correction and whether they are 
experiencing any of five common symptoms 
of presbyopia.
Appendix 
E
1.9
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms are not required.
Visit 1: Baseline
Step
Procedure
Details
1.10
Baseline PRO 
(CLUE and MRD) 
and CLDEQ-8
Questionnaires
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
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Visit 1: Baseline
Step
Procedure
Details
of their habitual lenses using the PRO (CLUE 
and MRD) and CLDEQ-8 questions.  
1.11
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
1.12
Entrance Distance 
and Near Visual 
Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the subject’s habitual contact lenses in place.
For near measurements use the ETDRS 2000
Series Chart 1 or 2. If the subject habitually 
wears reading glasses over their contact 
lenses, these may be worn for near acuity.
1.13
Lens Removal 
Have the subject remove their habitual lenses 
and store in an approved storage solution.
1.14
Keratometry / SimK
Keratometry/SimK will be performed OD 
and OS and the steep and flat dioptric power 
and corresponding meridians recorded.
1.15
Subjective Sphero-
cylindrical 
Refraction
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and 
distance visual acuity (OD, OS, OU) to the 
nearest letter.
Note:  Best distance visual acuity with 
sphero-cylindrical refraction must be at least 
20/20-3 in each eye for the subject to be 
eligible in the study.
1.16
Near ADD 
Determination
The near reading addition will be determined 
using the binocular crossed cylinder 
technique (BCC) at 40 cm
1.17
Ocular Dominance
Determine the distance ocular dominance 
with the best distance correction in place 
using a +1.00-blur test. If the results are 
equivocal use the sighting dominance test to 
determine the dominant eye used for the 
study.
Appendix 
F
1.18
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses 
(or flippers) under binocular conditions. 
1.19
Near Visual Acuity
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm.  Record the near 
visual acuity (OD, OS, OU).
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Baseline
Step
Procedure
Details
1.20
Biomicroscopy  
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
1.21
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible.
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete all forms.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.22
Lens Selection
Select the lens power and axis based on the 
refraction and fitting guide for each eye.  
Record the test lens parameters (power and 
lot number).  
Appendix 
D
1.23
Right Lens Insertion
Subjects will insert the right lens themselves.  
If the lens is uncomfortable, inspect for 
damage and remove, reinsert or replace as 
necessary.
Damaged lenses will be stored in a labeled 
vial with saline for shipment back to the 
Sponsor.  Complete the Quality Product 
Complaint form.
1.24
Timed Settling for 
Right Lens
The investigator will start a stopwatch as
soon as the right lens is inserted.
Note:  All lenses in this study have toric 
orientation marks at the 6 and 12 o’clock 
CR-6435, v1.0
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
positions.  Rotation measurements are 
made relative to a vertical reference line.
Record base nasal or base temporal rotation 
to the nearest degree.
At one (1) minute after insertion: Record:
1. The rotational position to the nearest
degree
At three (3) minutes after insertion: Record:
The rotational position to the nearest degree
1.25
Left Lens Insertion
Subjects will insert the left lens themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in a labeled 
vial with saline for shipment back to the 
Sponsor.  Complete the Quality Product 
Complaint form.
1.26
Timed Settling for 
Left Lens
The investigator will start a stopwatch as
soon as the left lens is inserted.
Note:   All lenses in this study have toric 
orientation marks at the 6 and 12 o’clock 
positions.  Rotation measurements are 
made relative to a vertical reference line.
Record base nasal or base temporal rotation 
to the nearest degree.
At one (1) minute after insertion: Record:
1.
The rotational position to the nearest
degree
At three (3) minutes after insertion: Record:
The rotational position to the nearest degree
1.27
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes.
1.28
Toric Fit Evaluation
Record:
• The rotational position to the nearest
degree
• Lens stability with blink
• Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
with blink. If toric fit is unacceptable,
remove, store, and label the lenses, and
proceed to Final Evaluation.
1.29
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear
the lenses if any of the following is
observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
1.30
Determine Visual 
Satisfaction
Determine if the subject’s vision is acceptable 
with the lenses.  Allow the subject to look 
down a hallway or out of a window for 
distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision.  
1.31
Study Lens Distance 
and Near Visual 
Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS 2000
Series Chart 1 or 2.
1.32
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  
Record the results.  The results of the 
distance over-refraction may also be checked 
for the impact on near vision under 
monocular and/or binocular conditions.   
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.33
Lens Power 
Modification (if 
applicable)
If the subject reports unsatisfactory vision,
or is unable to obtain 20/30 distance visual 
acuity OU with the lenses than a modification 
must be attempted. If the subject reports 
satisfactory vision with the lenses a 
modification is not required however may be 
made at the Investigators discretion based 
upon their findings on the measured visual 
acuity and/or over- refraction.
Note: switching to a non-multifocal lens per 
Step 3 of the Fitting Guide is not an available 
option in this study.
Select the reason(s) for lens change (select
all that apply):
• The settled lens rotation is such that one of
the other available lens cylinder axis would 
be   better (use LARS rule to determine the 
replacement lens cylinder axis)
• Power Modification needed
• Unsatisfactory Vision
• Other (specify reason)
If one or both lenses are modified, repeat 
steps 1.22 through 1.32 for one or both eyes 
as appropriate.
A maximum of two lens modifications are 
allowed.
Appendix 
D
1.34
Exit Distance and
Near Visual Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS 2000
Series Chart 1 or 2.
1.35
Dispensing
Criteria
The lenses may be dispensed for 6-8 days, if 
the following criteria are met:
x
Distance Snellen acuity equal to or better
than 20/30 OU
x
Subject must indicate that the vision is
acceptable.
x
Subject
must
indicate that the
comfort of the lenses is acceptable.
Lenses must have an acceptable toric and 
general lens fit.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.36
Dispensing
Only enough lenses will be dispensed to the 
subject to wear for the required number of 
days until their follow-up visit. No additional 
lenses will be dispensed.
1.37
Subject Instructions
Instruct the Subject on the following:
x
The lenses will be worn on a daily
disposable wear basis.
x
Instruct the subject to bring back all
unworn study lenses.
x
Instruct the subject no cleaning or
disinfecting solutions will be used for this
lens type.
x
If determined necessary by the
Investigator sterile non-preserved
rewetting drops may be dispensed to be
used as needed for dryness.
x
Subjects will be instructed to wear lenses
for a minimum of 6 hours a day, every
day between visits. One missed day of
lens wear between visits is acceptable.
x
Subjects will be instructed to wear study
lenses to the next visit.  It is not required
that they have worn lenses for 6 hours on
the day of the visit.
x
Subjects will be instructed to wear their
glasses when not wearing the study
lenses.
x
A patient instruction booklet will be
provided.
Note: In the event a lens is lost or damaged, 
the subject may return to the investigator site 
for a replacement. As much as reasonably 
possible, a damaged lens should be returned 
to the investigational site and then returned 
to the Sponsor. If lens damage is present, 
complete the Product Quality Complaint 
Form. The lens will be stored in a labeled 
vial with saline solution and returned to the 
Sponsor.
1.38
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
VISIT 2
The subjects must present to Visit 2 wearing the study lenses.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
2.1
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit.  Record any changes, 
and any adverse events.
2.2
Wear time and 
Comfortable Wear 
time (Study Lenses)
Record the average wearing time and 
comfortable wearing time with the study 
lenses.
2.3
Compliance
Confirm compliance with the prescribed 
wear schedule.
2.4
PRO (CLUE and 
MRD) Questionnaires
The subject will respond to the Follow-Up
PRO (CLUE and MRD) Questionnaires.
2.5
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.6
Subjective Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
2.7
Entrance Distance and 
Near Visual Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS
2000 Series Chart 1 or 2.
2.8
Distance Over-
Refraction and 
Distance Visual Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  
Record the results.  The results of the 
distance over-refraction may also be checked 
for the impact on near vision under 
monocular and/or binocular conditions.   
2.9
Toric Fit Evaluation
Record:
•
The rotational position to the nearest
degree
•
Lens stability with blink
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
with blink. If toric fit is unacceptable,
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
remove, store, and label the lenses, and
proceed to final evaluation.
2.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
The subject should not proceed to wear the 
lenses if any of the following is observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
2.11
Lens Power 
Modification (if 
required)
If the subject’s vision is unacceptable for at
least one distance or the Investigator 
determines that the visual acuity or over-
refraction are not acceptable then a lens 
modification must be made. If modifications 
are not needed, proceed to step 2.23.
Up to two attempts at changes are permitted 
if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject.
Select the reason(s) for lens change (select
all that apply):
• The settled lens rotation is such that one of
the other available lens cylinder axis would 
be   better (use LARS rule to determine the 
replacement lens cylinder axis)
• Power Modification needed
• Unsatisfactory Vision
• Other (specify reason)
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
Follow the fitting guide allowing for at least
10 minutes of settling time between lens 
changes. Note: switching to a non-multifocal 
lens per Step 3 of the Fitting Guide is not an 
available option in this study.
2.12
Lens Selection (if 
required)
Select the lens power, based on the Fitting
Guide for each eye needing optimization.
Record the test lens parameters (power and
lot number).
Appendix
D
2.13
Lens Insertion (if 
required)
Subjects will insert the lens themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with saline solution, and clearly 
differentiated from the other worn lenses that 
will be shipped back to the Sponsor. 
Complete the Quality Product Complaint 
form.
2.14
Timed Settling for 
Lens (if required)
The investigator will start a stopwatch as
soon as the lens is inserted.
Note:  All lenses in this study have toric 
orientation marks at the 6 and 12 o’clock 
position.  Rotation measurements are 
made relative to a vertical reference line.
Record base nasal or base temporal rotation 
to the nearest degree.
At one (1) minute after insertion: Record:
a.
The rotational position to the
nearest degree
At three (3) minutes after insertion: Record:
a.
The rotational position to the
nearest degree
2.15
Lens Settling (if 
required)
Allow the study lenses to settle for a 
minimum of 15 minutes.
2.16
Toric Fit Evaluation (if 
required)
Record:
•
The rotational position to the nearest
degree
•
Lens stability with blink
•
Lens stability with eye versions
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
with blink. If toric fit is unacceptable,
remove, store, and label the lenses, and
proceed to final evaluation.
2.17
Lens Fit Assessment (if 
required)
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
The subject should not proceed to wear the 
lenses if any of the following is observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
2.18
Determine Visual 
Satisfaction (if 
required)
Determine if the subject’s vision is 
acceptable with the lenses.  Allow the subject 
to look down a hallway or out of a window 
for distance vision assessments, and for them 
to read a book, magazine or similar for near 
vision.  
2.19
Study Lens Distance 
and Near Visual 
Acuity (if required)
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS 2000
Series Chart 1 or 2.
2.20
Distance Over-
Refraction and 
Distance Visual Acuity
(if required)
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
Record the results.  The results of the 
distance over-refraction may also be checked 
for the impact on near vision under 
monocular and/or binocular conditions.   
2.21
Additional Lens Power 
Optimization (if 
required)
If the subject reports unsatisfactory vision,
or is unable to obtain 20/30 distance visual 
acuity OU with the lenses than a 
modification must be attempted. If the 
subject reports satisfactory vision with the 
lenses a modification is not required however 
may at the Investigators discretion based 
upon their findings on the measured visual 
acuity and/or over- refraction. Note: 
switching to a non-multifocal lens per Step 3
of the Fitting Guide is not an available 
option in this study.
Select the reason(s) for lens change (select
all that apply):
• The settled lens rotation is such that one of
the other available lens cylinder axis would 
be   better (use LARS rule to determine the 
replacement lens cylinder axis)
• Power Modification needed
• Unsatisfactory Vision
• Other (specify reason)
If one or both lenses are modified, repeat 
steps 2.13 through 2.21 for one or both eyes 
as appropriate.
Appendix 
D
2.22
Collect unworn study 
lenses (if applicable)
If the lens power for either eye has been 
modified at this visit, collect any unworn 
lenses for that eye.
If the subject is being discontinued for any 
reason, collect any unworn lenses.
2.23
Lens Removal
Have the subject remove the study lenses.
Temporarily store the worn lenses until 
Biomicroscopy has been completed.  If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded.
2.24
Biomicroscopy  
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled.  
2.25
Insertion of Study
Lenses
Provide the subject with a NEW PAIR of
lenses that match the power of the lenses that
were removed in step 2.23 above.
2.26
Exit Distance and
Near Visual Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS
2000 Series Chart 1 or 2.
2.27
Dispensing
Criteria
The lenses may be dispensed for 6-8 days, if 
the following criteria are met:
x
Distance Snellen acuity equal to or better
than 20/30 OU
x
Subject must indicate that the vision is
acceptable.
x
Subject
must
indicate that the
comfort of the lenses is acceptable.
x
Lenses must have an acceptable toric and
general lens fit.
2.28
Dispensing
Only enough lenses will be dispensed to the 
subject to wear for the required number of 
days until their follow-up visit. No additional 
lenses will be dispensed.
2.29
Subject Instructions
Instruct the Subject on the following:
x
The lenses will be worn on a daily
disposable wear basis.
x
Instruct the subject to bring back all
unworn study lenses.
x
Instruct the subject no cleaning or
disinfecting solutions will be used for this
lens type.
x
If determined necessary by the
Investigator sterile non-preserved
rewetting drops may be dispensed to be
used as needed for dryness.
x
Subjects will be instructed to wear lenses
for a minimum of 6 hours a day, every
day between visits. One missed day of
lens wear between visits is acceptable.
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
x
Subjects will be instructed to wear study
lenses to the next visit.  It is not required
that they have worn lenses for 6 hours on
the day of the visit.
x
Subjects will be instructed to wear their
glasses when not wearing the study
lenses.
2.30
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
VISIT 3
The subjects must present to Visit 3 wearing the study lenses.
Visit 3: Treatment 1 Follow-Up 2
Step
Procedure
Details
3.1.
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
3.2.
Wear time and 
Comfortable Wear 
time (Study Lenses)
Record the average wearing time and 
comfortable wearing time with the study 
lenses.
3.3.
Compliance
Confirm compliance with the prescribed wear 
schedule.
3.4.
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires
The subject will respond to the Follow-Up
PRO (CLUE and MRD) and Dry Eye 
Questionnaires.
3.5.
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
3.6.
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
3.7.
Entrance Distance 
and Near Visual 
Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS
2000 Series Chart 1 or 2.
3.8.
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.  
Appendix 
G
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-Up 2
Step
Procedure
Details
3.9.
Toric Fit Evaluation
Record:
•
The rotational position to the nearest
degree
•
Lens stability with blink
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
with blink. If toric fit is unacceptable,
remove, store, and label the lenses, and
proceed to final evaluation.
3.10.
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear
the lenses if any of the following is
observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
3.11.
Visual Performance
Distance (4 M) 
Intermediate (64 cm)
Near (40 cm)
Visual performance will be recorded OD, OS,
and OU for the following:
Distance, Bright Illuminance
ETDRS Charts 4 M-HC#1, HC#2, HC#3 and
LC#1, LC#2 and LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts High Contrast
and Low Contrast Intermediate (64 cm) and
Near (40 cm).
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-Up 2
Step
Procedure
Details
Distance, Dim Illuminance (with Distance
goggles)
ETDRS Charts 4 M-HC#4, HC#5, HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast
Intermediate (64 cm) and Near (40 cm).
Note:
x
The room illuminance must be between
7.3 and 7.9 EV.
x
Distance, HC-1 Chart luminance
Acceptable EV Range 10.5-10.7.
x
Guillon-Poling, Near Chart Luminance
Acceptable EV Range 10.8-11.1.
x
Do not use the Mesopic filter for Dim
luminance (Dim luminance will be
simulated by using the goggles).
3.12.
Lens Removal
Have the subject remove the study lenses.
Temporarily store the worn lenses until 
Biomicroscopy has been completed.  If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded.
3.13.
Biomicroscopy  
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled.  
3.14.
Insertion of Study
Lenses
Provide the subject with a NEW PAIR of
lenses that match the power of the lenses that
were discarded in step 3.12 above.
3.15.
Exit Distance and
Near Visual Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS
2000 Series Chart 1 or 2.
3.16.
Dispensing
Criteria
The lenses may be dispensed for 6-8 days, if 
the following criteria are met:
x
Distance Snellen acuity equal to or better
than 20/30 OU
CR-6435, v1.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-Up 2
Step
Procedure
Details
x
Subject must indicate that the vision is
acceptable.
x
Subject
must
indicate that the
comfort of the lenses is acceptable.
x
Lenses must have an acceptable toric and
general lens fit.
3.17.
Dispensing
Only enough lenses will be dispensed to the 
subject to wear for the required number of 
days until their follow-up visit. No additional 
lenses will be dispensed.
3.18.
Subject Instructions
Instruct the Subject on the following:
x
The lenses will be worn on a daily
disposable wear basis.
x
Instruct the subject to bring back all
unworn study lenses.
x
Instruct the subject no cleaning or
disinfecting solutions will be used for this
lens type.
x
If determined necessary by the
Investigator sterile non-preserved
rewetting drops may be dispensed to be
used as needed for dryness.
x
Subjects will be instructed to wear lenses
for a minimum of 6 hours a day, every
day between visits. One missed day of
lens wear between visits is acceptable.
x
Subjects will be instructed to wear study
lenses to the next visit.  It is not required
that they have worn lenses for 6 hours on
the day of the visit.
x
Subjects will be instructed to wear their
glasses when not wearing the study lenses.
x
Subjects will be instructed to bring their
spectacles with distance vision correction,
or their habitual contact lenses to the final
visit.
3.19.
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
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VISIT 4
The subjects must present to Visit 4 wearing the study lenses.
Visit 4: Treatment 1 Follow-Up 3
Step
Procedure
Details
4.1.
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
4.2.
Wear time and 
Comfortable Wear 
time (Study Lenses)
Record the average wearing time and 
comfortable wearing time with the study 
lenses.
4.3.
Compliance
Confirm compliance with the prescribed wear 
schedule.
4.4.
Collect unworn 
lenses (if applicable)
The subject will return any unworn lenses.
4.5.
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires
The subject will respond to the Follow-Up
PRO (CLUE and MRD) and Dry Eye 
Questionnaires.
4.6.
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
4.7.
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
4.8.
Entrance Distance 
and Near Visual 
Acuity
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with
the study contact lenses in place.
For near measurements use the ETDRS
2000 Series Chart 1 or 2.
4.9.
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.  
Appendix 
G
4.10.
Toric Fit Evaluation
Record:
•
The rotational position to the nearest
degree
•
Lens stability with blink
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
with blink. If toric fit is unacceptable,
remove, store, and label the lenses, and
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Visit 4: Treatment 1 Follow-Up 3
Step
Procedure
Details
proceed to final evaluation.
4.11.
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear
the lenses if any of the following is
observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
4.12.
Visual Performance
Distance (4M) 
Intermediate (64 cm)
Near (40 cm)
Visual performance will be recorded OD, OS,
and OU for the following:
Distance, Bright Illuminance
ETDRS Charts 4M-HC#1, HC#2, HC#3 and
LC#1, LC#2 and LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts High Contrast
and Low Contrast Intermediate (64 cm) and
Near (40 cm).
Distance, Dim Illuminance (with Distance
goggles)
ETDRS Charts 4M-HC#4, HC#5, HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast
Intermediate (64 cm) and Near (40 cm).
Note:
x
The room illuminance must be between
7.3 and 7.9 EV.
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Visit 4: Treatment 1 Follow-Up 3
Step
Procedure
Details
x
Distance, HC-1 Chart luminance
Acceptable EV Range 10.5-10.7.
x
Guillon-Poling, Near Chart Luminance
Acceptable EV Range 10.8-11.1.
x
Do not use the Mesopic filter for Dim
luminance (Dim luminance will be
simulated by using the goggles).
4.13.
Lens Removal
Have the subject remove the study lenses.
Temporarily store the worn lenses until 
Biomicroscopy has been completed.  If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded.
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol.  It may also take place at any point the subject 
discontinues the study or is terminated from the study.
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
Indicate if the subject completed the study 
successfully.  If subject discontinued from the 
study, indicate the reason.
F.2
Biomicroscopy  
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled.  
F.3
Subjective 
spherocylindrical 
Refraction
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and 
distance visual acuity (OD, OS, OU) to the 
nearest letter.
F.4
Exit Distance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (habitual 
lenses, distance spectacles or unaided).
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7.3.
 Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected at a minimum:
x
Chief complaint prompting the visit.  If the reason is an adverse event, the applicable
eCRF for the adverse event must be completed and subject record completed as
appropriate
x
Date and time of the visit and all procedures completed at the unscheduled visit
x
Review of adverse event and concomitant medications
x
Documentation of any test article dispensed or collected from the subject, if applicable
x
Slit lamp findings (using the Slit Lamp Classification Scale)
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified.
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained.  If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider. 
The following information will be collected during an unscheduled visit.
Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for 
reasons for the unscheduled visit.
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
U.4
Entrance VA (if 
applicable)
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided).
U.5
Subjective Sphero-
cylindrical 
Refraction (if 
applicable)
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
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Unscheduled Visit
Step
Procedure
Details
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.  If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled.
U.7
Dispensing (if 
applicable)
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the
dispensing instructions given in the detailed 
study procedures.
U.8
Toric Fit 
Evaluation (if 
applicable)
After lens settling, record:
•
The rotational position to the nearest
degree
•
Lens stability with blink
•
Lens stability with eye versions
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses
rotated more than 30 degrees, or lens
stability is worse than 5 degrees movement
with blink. If toric fit is unacceptable,
remove, store, and label the lenses, and
proceed to final evaluation.
U.9
Lens Fit
Assessment (if 
applicable)
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear
the lenses if any of the following is
observed:
x
presence of limbal exposure (appearance
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement
(excessive or insufficient) in all three
movement categories (primary gaze,
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
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Unscheduled Visit
Step
Procedure
Details
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final 
Evaluation form.
U.10
Exit Visual Acuity 
(if applicable)
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided).
7.4.
Laboratory Procedures 
None
8.
SUBJECTS COMPLETION/WITHDRAWAL
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
x
provided informed consent.
x
are eligible.
x
completed all visits
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject death during the study period.
x
Subject withdrawal of consent.
x
Subject not compliant to protocol
x
Subject lost to follow-up.
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events causing discontinuation of study
lens wear.
x
Subjects who have experienced a Corneal Infiltrative Event (CIE).
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the
best interest of the subject to stop treatment).
x
Subject missed any study visit.
x
Subject not compliant with study lens wear schedule.
x
Subject not successfully dispensed due to lack of efficacy and safety including poor
vision, poor comfort or unacceptable fit.
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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) (worn or brought to the visit) from the subject and discard
them, unless otherwise stated in Section 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
An additional subject may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear.  See the Exclusion criteria for specific details. 
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 medications is shown 
in Table 4. Subjects with a history of taking these medications will be allowed to enroll only 
if:
x
The medications have been taken on a continual or routine basis for at least 6 months
and the subject has demonstrated successful contact lens wear during this time.
Or
x
The subject previously used these medications on a temporary basis and has ceased that
medication at least 1 week prior to signing the informed consent.
Table 4: Disallowed systemic medications
Class of Drug
Common Indication(s)
Common Examples
Anticholinergics
Irritable bowel syndrome, 
Parkinson’s disease, peptic ulcer, 
cystitis, nasal congestion, cold 
symptoms, overactive bladder, 
COPD
Bentyl, Spiriva, Atrovent, 
Hyosyne, Levsin, Symax 
Fastab, Symax SL, Homax SL, 
Cogentin, Transderm Scop, etc.
Oral Phenothiazines
Antipsychotic disorders 
(schizophrenia, mania)
Compazine, Mellaril, 
Thorazine, Phenergan, etc.
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Class of Drug
Common Indication(s)
Common Examples
Oral/Inhaled 
Corticosteroids
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions
Cortisone, Prednisone, 
Hydrocortisone, Medrol, 
Kenalog, Flonase etc.
Oral Retinoids 
Seborrhea, acne
Isotretinoin, Acitretin, 
Alitretinoin, etc. 
Oral Tetracycline 
Urinary Tract Infection, acne, 
chlamydia, gonorrhea
Sumycin, Achromycin V, etc.
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations
that contradict the information contained in the Informed Consent/Assent forms will be
considered Major Deviations.
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. 
Protocol waivers are prohibited.
Table 5 lists examples of deviations that will constitute major and minor protocol deviations 
for this study. 
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Table 5: Examples of major and minor protocol deviations
Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended 3 or more days
out of visit window defined 
in study procedures
Visit attended 2 or fewer 
days out of visit window 
defined in study procedures
Insufficient wear of study 
lenses 
Subject does not wear study 
lenses for at least 6 hours per 
day for 3 or more days 
between scheduled visits.
Subject does not wear study 
lenses for at least 6 hours per 
day for 2 days between 
scheduled visits.
11. STUDY TERMINATION
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC Safety Review 
committee, the study may be terminated. This potential stopping rule is established based on 
our trial involving approximately 200 subjects wearing the investigational soft contact lens for 
up to 3 years with an assumed MK rate that is below 0.2% per patient-year. The rate of 0.2% 
per patient year is the established rate for extended wear lenses in adults, which was requested 
by the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA response to 
a pre-IDE submission. To be conservative, 200 independent patient years were used in the 
calculation. The probability of observing 2 cases or more incidents of MK is 0.061, and 3 cases 
or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient year). 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
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Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user,
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms,
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
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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.
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.
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Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
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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 13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time
suggests that a causal relationship is not likely.
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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. 
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.).
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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 
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, 
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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.
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 
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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 Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC).8 Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
14.2. Sample Size Justification 
This study was designed and powered to demonstrate that the binocular high luminance high 
contrast, visual performance (logMAR) of the Test lens at distance (4 meters), intermediate 
(64 cm) and near (40 cm) after 2-week of lens wear in the optimized lenses is superior to 0.00, 
+0.17 and +0.17 logMAR, respectively. Additionally, this study was also powered to show 
that CLUE vision scores for the Test lens for the hyperopic population is greater than 32 points
and greater than 40 points for the myopic population. The sample size calculation included 
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two historical studies, 
 and 
Previous hyperopic data was not available 
for the Test lens, therefore, data from 
was used because it evaluated lenses with a
similar lens design on a hyperopic population.  Data from
 was used for the myopic 
population since this study evaluated lenses with the same lens design and similar material as 
the current Test lens on a population of myopic subjects. 
Table 6: Historical Binocular High Luminance High Contrast Visual Performance – 2-Week 
Follow-up
Chart Position
Mean
SD*
Minimum
Maximum
Distance (4 M)
-0.048
0.0943
-0.220
0.280
Intermediate (64 cm)
-0.015
0.1183
-0.240
0.320
Near (40 cm)
0.097
0.1318
-0.200
0.500
*SD: Standard Deviation 
**This summary included data from both 
Table 7: Historical CLUE Scores – 2-Week Follow-up
CLUE Domain 
Strata 
Baseline 
Mean (SD*)
2-Week Follow-up
Mean (SD*)
Vision 
Hyperope
45.5(14.71)
47.3(18.65)
Myope
42.9(15.43)
55.1(20.73)
Comfort 
Hyperope
50.7(19.70)
60.9(22.38)
Myope
54.5(20.39)
62.7(21.95)
Handling 
Hyperope
50.9(17.26)
56.6(21.12)
Myope
56.9(16.49)
70.6(18.02)
*SD: Standard Deviation 
Sample size calculations for each primary endpoint were carried out using a 2-sided one 
sample mean t-test, with a family wise error rate of 5%. The calculation was performed using 
the POWER11 procedure in SAS Version 9.48. The Bonferroni12 method was used to adjust 
the type I error for multiple primary hypotheses α = 
଴Ǥ଴ହ
ହൌͲǤͲͳ. A power analysis was also 
performed for each secondary hypothesis to test for non-inferiority of the 2-week follow-up
relative to the baseline assessment with respect to CLUE vision, comfort and handling 
scores. The power analysis was performed for each secondary hypothesis separately using 
the POWER procedure and 2-sided t-test for paired means with alpha=0.05. The power 
Analysis was performed for different scenarios of intraclass correlation and effect sizes. The 
sample size required for all primary endpoints is displayed in Table 8, while the power 
analysis for the secondary endpoints is located in Table 9.
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Table 8: Sample Size Estimates for Primary Endpoints 
Endpoint
Power 
Sample Size 
Visual Acuity - Distance (4 M)
80.6%
42
Visual Acuity - Intermediate (64 cm)
80.1%
7
Visual Acuity - Near (40 cm)
80.7%
36
CLUE Vision Scores – Hyperopes 
80.1%
18
CLUE Vision Scores – Myopes 
80.9%
22
Table 9: Power Analysis for Secondary Endpoints
Endpoint
Strata
correlation
Effect size
Power 
Vision – CFB* 
Hyperope
N=35
0.3
1
42.3%
3
75.0%
0.5
1
65.5%
3
86.0%
Myope
N=45
0.3
3
78.1%
5
91.7%
0.5
3
88.2%
5
97.1%
Comfort – CFB* 
Hyperope
N=35
0.3
3
58.4%
5
75.0%
0.5
3
70.8%
5
86.3%
Myope
N=45
0.3
3
67.8%
5
83.9%
0.5
3
80.1%
5
92.9%
Handling – CFB*
Hyperope
N=35
0.3
3
64.8%
5
81.2%
0.5
3
76.9%
5
90.8%
Myope
N=45
0.3
3
82.6%
5
94.3%
0.5
3
92.0%
5
98.5%
*CFB = Change from baseline (calculated as 2-week follow-up minus baseline)
Represents conservative power estimate based on the most conservative effect size and intraclass correlation.
While only 42 subjects are required to complete the study based on the sample size calculation, 
the plan is to compare the data from this study to another study which is similar in design and 
sample size and is assessing a marketed multifocal toric lens. Therefore, the sample size was 
increased in order to perform a meta-analysis at a later date. Moreover, as shown in Table 9, a
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target completion of 80 subjects demonstrates a reasonable statistical power for the secondary 
endpoints under most of the assessed scenarios.
The plan is to enroll 90 eligible subjects with a target completion of 80 subjects (45 myopes 
and 35 hyperopes). During the enrollment period, the subject drop-out rate will be closely 
monitored, if an unexpectedly high dropout rate is observed, then the targeted total enrollment
number maybe be increased accordingly to ensure that the target numbers of 45 myopes and 
35 hyperopes subjects complete the study. 
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned primary analyses for this study will be conducted with a 2-sided type I family wise 
error rate of 5%. The Bonferroni12 method will be used to adjust for the number of primary 
hypotheses tested. Secondary hypotheses will be tested separately with a 2-sided type I error 
rate of 5% individually. 
14.5. Primary Analysis 
CLUE Vision Scores
Vision scores after approximately 2-weeks in the optimized lenses will be analyzed using a
linear mixed model. Baseline vision scores, event (visit 1: baseline, visit 2: 1-wk non-
optimized, visit 3: 1-wk optimized and visit 4: 2-wk optimized), strata (hyperope and myope) 
and the interaction between event and strata will be included in the model as fixed effects. 
Other covariates such as age, gender and add power may be included when appropriate. Site 
will be included as a random effect (G-side).  Residual errors between measurements within 
the same subject across event will be model using one of the following:
x
Unstructured (UN)
x
Compound Symmetric (CS)
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x
Heterogenous Compound Symmetric (CSH)
The structure that returns the lowest corrected Akaike’s Information Criterion (Keselman et al. 
1998)13 will be selected as the structure that best fits the data. The Kenward and Roger method 
will be used for the calculation of the denominator of degrees of freedom.14
Primary hypothesis 1: 
The null and alternative hypothesis for CLUE vision to test for superiority of the Test lens 
relative to the pre-defined threshold of 40 for myopes is as follows: 
ܪ௢: ߤ்௘௦௧൑40
ܪ஺: ߤ்௘௦௧൐40
Superiority will be declared if the lower limit of the 95% confidence interval of the adjusted 
mean for the Test lens is greater than 40. i.e. P(ߤ்௘௦௧> 40) ≥ 0.975. 
Primary hypothesis 2: 
The null and alternative hypothesis for CLUE vision to test for superiority of the Test lens 
relative to the pre-defined threshold of 32 hyperopes is as follows: 
ܪ௢: ߤ்௘௦௧൑32
ܪ஺: ߤ்௘௦௧൐32
Superiority will be declared if the lower limit of the 95% confidence interval of the adjusted 
mean for the Test lens is greater than 32. i.e. P(ߤ்௘௦௧> 32) ≥ 0.975. 
LogMAR Visual Acuity
Binocular, high luminance, high contrast visual acuity on logMAR scale after approximately 
2-weeks in the optimized lenses will be analyzed using a linear mixed model. 
Position(distance/intermediate/near) will be included as the only fixed effect. Site will be 
included as random effect (G-side). Other baseline characteristics known of importance such 
as age, gender and add power may be included as covariates when appropriate. The covariance 
between residual errors from the same subject across different positions will be selected based 
on the finite-sample corrected Akaike’s Information Criterion (Keselman et al. 1998).13
Covariance structures considered may include: Homogenous compound symmetry (CS) and 
Unstructured covariance structure (UN). 
The structure that returns the lowest Akaike 
Information Criteria Corrected (AICC) will be selected as the structure that best fit the data.
The Kenward and Roger method will be used for the calculation of the denominator of degrees 
of freedom.14
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Primary hypothesis 3: 
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0 logMAR is as follows: 
ܪ௢: ߤ்௘௦௧൒0 logMAR
ܪ஺: ߤ்௘௦௧൏0 logMAR
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0 logMAR. i.e. P(ߤ்௘௦௧< 0) ≥ 0.975. 
Primary hypothesis 4: 
The null and alternative hypothesis for binocular near HLHC visual performance to test for 
superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as follows: 
ܪ௢: ߤ்௘௦௧൒0.17 logMAR
ܪ஺: ߤ்௘௦௧൏0.17 logMAR
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧< 0.17) ≥ 0.975. 
Primary hypothesis 5: 
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as 
follows:
ܪ௢: ߤ்௘௦௧൒0.17 logMAR
ܪ஺: ߤ்௘௦௧൏0.17 logMAR
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧< 0.17) ≥ 0.975. 
14.6. Secondary Analysis 
CLUE Vision, Comfort and Handling Scores
Vision, Comfort and Handling scores after approximately 2-weeks in the optimized lenses will 
be analyzed separately using a linear mixed model. event (visit 1: baseline, visit 2: 1-wk non-
optimized, visit 3: 1-wk optimized and visit 4: 2-wk optimized), strata (hyperope and myope) 
and the interaction between event and strata will be included in the model as fixed effects. 
Other covariates such as age, gender and add power may be included when appropriate. Site 
will be included as a random effect (G-side).  Residual errors between measurements within 
the same subject across event will be model using one of the following:
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x
Unstructured (UN)
x
Compound Symmetric (CS)
x
Heterogenous Compound Symmetric (CSH)
x
Spatial Power (SP(POW))
The structure that returns the lowest corrected Akaike’s Information Criterion (Keselman et al. 
1998)13 will be selected as the structure that best fits the data. The Kenward and Roger method 
will be used for the calculation of the denominator of degrees of freedom.14
Hypothesis Testing
The null and alternative hypotheses for non-inferiority are as follows and will be conducted 
separately for each strata (hyperopes and myopes) and CLUE vision, comfort and handling : 
ܪைǣο൑െͷ
ܪைǣο൐െͷ
Where ο is the change from baseline to 2-week follow-up (2-week follow up minus baseline). 
Non-inferiority of the 2-week follow-up CLUE score relative to the baseline CLUE scores of 
subjects’ habitual lens was concluded if the lower limit of the 95% CI was above -5 (Pr: ʹ െ
ݓ݇݉݅݊ݑݏܾܽݏ݈݁݅݊݁> -5, ) > 0.975. 
14.7. Other Exploratory Analyses 
Unacceptable lens fitting, Grade 3 + SLFs, absolute rotation and stability will be descriptively 
summarized by event (baseline, 1-wk follow-up non-optimized, 1-wk follow-up optimized and 
2-wk follow-up optimized), when applicable.  If unacceptable lens fitting, Grade 3 + SLFs,  
rotation stability > 5 degrees and absolution rotation > 10 degrees are observed during the 
study, then an analysis maybe conducted at the discretion of the study responsible clinician. 
14.8. Interim Analysis 
Lenses in minus powers and plus powers will be evaluated in two separate phases of the 
study which may run at  different times depending on when lenses become available. The 
study lenses for hyperopic subjects are likely to be available before the lenses for the myopic 
subjects. Therefore, a planned interim read will be performed once all hyperopic subjects 
have completed the study.  The interim read will include descriptive summaries of all 
primary and secondary endpoints. Additionally, summaries for adverse events, lens fitting, 
lens rotation and stability will also be provided.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial.
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Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric
regression method used to make at least 15 imputations.
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). 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 clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
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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 based on the following: The purpose of the 
study is for design confirmation, not feasibility.
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-
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Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
Not applicable.
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any
subsequent versions, and regulatory requirements are maintained.
x
Ensuring the rights and wellbeing of subjects are protected.
x
Ensuring adequate resources, including facilities, laboratories, equipment, and
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as
applicable.
x
Ensuring that the clinical site has sufficient test article and supplies.
x
Clarifying questions regarding the study.
x
Resolving study issues or problems that may arise.
x
Reviewing of study records and source documentation verification in accordance with
the monitoring plan.
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
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risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
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
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x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551
guidelines, applicable regulatory requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has been 
fully explained. The assent and consent forms must be signed before performance of any study-
related activity. The assent and consent forms that are used must be approved by both the 
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Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms should be in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH2 and 
GCP guidelines, applicable regulatory requirements, and Sponsor policy. Before entry into the 
study or pre-screening, the Investigator or an authorized member of the clinical site personnel 
must explain to the potential subject and parent and/or legal guardian the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study or pre-screening, and any 
discomfort it may entail. Subjects and parent and/or legal guardian will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. They 
will be informed that choosing not to participate will not affect the care the subject will receive. 
Finally, they will be told that the Investigator will maintain a subject identification register for 
the purposes of long-term follow-up if needed and that their records may be accessed by health 
authorities and authorized Sponsor personnel without violating the confidentiality of the 
subject, to the extent permitted by the applicable law(s) or regulations. By signing the assent 
and informed consent form, the subject is authorizing such access and agrees to be contacted 
after study completion by health authorities and authorized Sponsor personnel for the purpose 
of obtaining consent for additional safety evaluations if needed.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States15 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
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x
collected for specified, explicit, and legitimate purposes and not further processed in a
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
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20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION
There is no plan to publish the outcome of this investigation.
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP).
Available 
at: 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human
Subjects. 
Available 
at: 
https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at:
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales.
Optom Vis Sci. 2016;93(8):801-808
6. Karkkainen T.  
Clinical Study Report v3.0. An Evaluation of the Performance
of the Vistakon Investigational Multifocal Contact Lens. 31 March, 2015.
7. Franklin R.  
Clinical Study Protocol v2.0. Evaluation of Visual Acuity with
a Reusable Toric Multifocal Contact Lens. 10 February 2021.
8. SAS Institute Inc: SAS® 9.4 Statements: Reference TEC, NC: SAS Institute Inc; 2014.
9. Karkkainen T.  
 Clinical Study Report, v2.0.  Evaluation of a Novel Toric
Multifocal Contact Lens in Hyperopic Presbyopes.  27 December, 2017.
10. Franklin R.  
 Clinical Study Report, v1.0.  Pilot Evaluation of a Silicone
Hydrogel Daily Disposable Toric Multifocal Contact Lens.  15 March, 2021.
11. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary NC: SAS Institute Inc.
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12. Bonferroni C. Calculation of the insurance groups of heads. Studies in Honour of
Professor Salvatore Ortu Carboni. 1935;Rome: Italy:13-60.
13. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two
Approaches for Selecting Covariance Structures in the Analysis of Repeated Measures.
Communications in Statistics—Simulation and Computation. 1998;27(3):591-604.
14. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted
Maximum Likelihood. Biometrics. 1997;53:983-997.
15. Health Information Portability and Accountability Act (HIPAA). Available at:
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
Will be provided separately.
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APPENDIX A: PACKAGE INSERT (APPROVED PRODUCT) 
Not Applicable, as this study uses Investigational Products.
 
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APPENDIX D: LENS FITTING GUIDE 
CR-6435, v1.0
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
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APPENDIX F: OCULAR DOMINANCE 
SCALE
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APPENDIX G: BINOCULAR OVER REFRACTION 
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APPENDIX H: 
 
 
x
DETERMINATION OF NEAR ADDITION
x
NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE
x
 LENS FITTING CHARACTERISTICS
x
SUBJECT REPORTED OCULAR SYMPTOMS
x
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
x
 BIOMICROSCOPY SCALE
x
KERATOMETRY
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
 TORIC FIT EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
CR-6435, v1.0
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Document Type:  
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
, SUBJECT REPORTED OCULAR SYMPTOMS 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
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Johnson & Johnson Vision Care, Inc.
, BIOMICROSCOPY SCALE 
 
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Title:
Biomicroscopy Scale
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Title:
Biomicroscopy Scale
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Title:
Biomicroscopy Scale
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Title:
Biomicroscopy Scale
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Title:
Biomicroscopy Scale
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Johnson & Johnson Vision Care, Inc.
KERATOMETRY 
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GRADING  
 
 
SCALE  
 
 
x
Diopters (0.125 steps) and/or Millimeters
x
Quality:  
Clear 
 
 
 
 
Mild distortion 
 
 
 
 
Moderate distortion 
 
 
 
 
Severe distortion  
 
 
 
 
 
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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
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Johnson & Johnson Vision Care, Inc.
TORIC FIT EVALUATION 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MESAUREMENT 
PROCEDURE  
 
 
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Title: 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
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Page 2 of 3 
 
 
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Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION     
TESTING 
 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION 
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Title:
Guidelines for COVID-19 Risk Mitigation
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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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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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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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Procedure
Details
Subject Reported Ocular 
Symptoms
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test article when applicable and feasible. 
Change of Medical History 
(Adverse Events) and 
Concomitant Medications / 
Therapies Review
Record any adverse events or medical history changes from the 
previous study visit with the subject/parents.
Review the subject’s concomitant medications/therapies and record 
any changes from the previous study visit.
Wearing Time and 
Compliance
Record the average wearing time (including number of hours per day 
during weekdays and weekends, and number of days per week).
Confirm compliance with the prescribed wear schedule.
x
Record and discuss the lens wear compliance based on the 
subject’s self-report. For example, the subjects will be asked the 
time of the day the subject typically puts on the study lenses in the 
morning and takes off in the evening, the number of days per week 
lenses were worn, and the number of consecutive days the subject 
didn’t wear the study lenses, etc.
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If during the telephone consultation, a subject states he/she wishes to discontinue participating 
in the study, instruct the subject to stop wearing the study lenses and schedule the subject to return to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should return all unused lenses to the 
clinic at the last visit.
Changes in study visit schedules, missed visits, or participant discontinuations may lead to missing data, 
including data related to protocol-specified procedures. Case report forms should capture specific 
information regarding the basis of missing data, including the relationship to the COVID-19 pandemic.
6.0
STUDY CONDUCT DURING PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometry Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge.
Every effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be performed to the extent possible remotely/virtually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, participants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be performed if required and as feasible.
Modifications to protocol-required assessments may be permitted via COVID-19 Appendix after consultation 
with the participant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol deviations. Interruptions of test article wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix “COVID-19-
related” in the case report form (CRF).
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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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COVID-19 Risk Control Checklist (Attachment-B):
Study Number
Site Number
Principal Investigator (PI) Name
The following COVID-19 risk control methods are required to conduct Johnson & Johnson Vison Care clinical 
studies. Please review the following requirements and Initial each requirement.
PI Initials
General Site Safety Planning Measures
Signage within site describing Risk Control methods
Social Distancing practices throughout site (waiting rooms, lobby, exam rooms, etc.)
Non-contact thermometer available to assess temperatures of staff and patients
Training on patient flow and physical distancing in waiting room
Establish longer time frame between patient appointments to reduce persons in the site
Staff should receive job-specific training on PPE and demonstrate competency with selection and 
proper use of PPE and wear at all times during interactions with subjects (e.g., putting on and 
removing without self-contamination)
PI Initials
Site Staff Daily Safety Measures
As part of routine practice, site staff should regularly monitor themselves for fever and symptoms 
of COVID-19, including temperature checks 
Any staff member (including non-study clinic staff and Investigators) showing signs of being sick 
or testing positive for COVID-19 must not be permitted to work on activity that may  expose study 
related staff  and subject and the Sponsor shall be informed
NOTE: Inform JJVC in 24 hours of any COVID-19 cases and all potential exposure during
the clinical study.
Ensure that all staff wear a mask
Gloves should be required when working directly with patients and changed between each patient
Have staff thoroughly wash hands for at least 20 seconds or use an alcohol-based hand sanitizer 
when they arrive, before and after each patient, before eating and after using the bathroom.
Cleaning and disinfection procedures for exam rooms and instruments or equipment between 
patients with gloves.
Cleaning and disinfection procedures for commonly touched surfaces (doors, chairs, computers, 
phones, etc.) with gloves.
PI Initials
Before a Patient or Study Visit:
Patients should be asked prior to entering the site about fever and respiratory illness and whether 
they or a family member have had contact with another person with confirmed COVID-19 in the 
past 14 days. Patients exhibiting signs of being sick should be rescheduled when their symptoms 
resolve.
Instruct patients that companions should remain outside of the facility and not accompany the 
patient into the facility unless they are a parent/guardian of the patient or if they are a true 
caregiver and need to assist the patient
Request the patient to call or text the office upon arrival so entrance to and movement through 
facility can be coordinated by site staff
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PI Initials
Patients Entering the site:
Temperature checks utilizing a non-contact thermometer for all patients and companions entering 
the site.
All patients and companions must wear cloth or disposable mask at all times in the site
Maintain social distancing. Waiting rooms or lobbies should be as empty as possible. Advise 
seated patients to remain at least 6 feet from one another. 
Communal objects in (e.g. toys, reading materials, etc.) should be removed or cleaned regularly.
I certify that I have read and agree to implement all the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Vision Care studies. 
Principal Investigator Signature and Date
CR-6435, v1.0
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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
CR-6435, v1.0
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JJVC CONFIDENTIAL

Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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/
 
CR-6435, v1.0
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6435 Evaluation of Daily Disposable Silicone Hydrogel Multifocal 
Toric Contact Lenses
Version and Date: 1.0, 12 May 2021
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion.
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix I 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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