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

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Evaluation of senofilcon A Contact Lenses Using a Novel Manufacturing Technology
Protocol CR-6417
Version: 3.0
Date: 10 September 2020  
Investigational Products: senofilcon A 
Key Words: sphere, senofilcon A, ACUVUE OASYS® 1-DAY, daily disposable, dispensing, 
sterile rewetting drops, CLUE vision, CLUE comfort 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale ............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 22 
5.1. 
Test Article Allocation ............................................................................................. 22 
5.2. 
Masking .................................................................................................................... 23 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION ............................................................................................. 24 
6.1. 
Identity of Test Articles............................................................................................ 24 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 24 
6.3. 
Administration of Test Articles ................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 25 
6.5. 
Storage Conditions ................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS .............................................................................................. 26 
7.1. 
Time and Event Schedule ......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 28 
VISIT 1 ........................................................................................................................... 28 
VISIT 2 ........................................................................................................................... 32 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 39 
FINAL EVALUATION .................................................................................................. 41 
7.3. 
Unscheduled Visits ................................................................................................... 41 
7.4. 
Laboratory Procedures ............................................................................................. 42 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 42 
8.1. 
Completion Criteria .................................................................................................. 42 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 43 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 43 
9.1. 
Systemic Medications .............................................................................................. 43 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 45 
11. 
STUDY TERMINATION ........................................................................................... 45 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 46 
13. 
ADVERSE EVENTS ................................................................................................... 47 
13.1. 
Definitions and Classifications ............................................................................. 47 
13.2. 
Assessing Adverse Events .................................................................................... 49 
13.2.1. 
Causality Assessment .................................................................................... 50 
13.2.2. 
Severity Assessment ...................................................................................... 50 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 50 
13.4. 
Reporting Adverse Events .................................................................................... 52 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 52 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
53 
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13.4.3. 
Event of Special Interest ............................................................................... 53 
13.5. 
Reporting of Pregnancy ........................................................................................ 53 
14. 
STATISTICAL METHODS ........................................................................................ 53 
14.1. 
General Considerations ......................................................................................... 53 
14.2. 
Sample Size Justification ...................................................................................... 53 
14.3. 
Analysis Populations ............................................................................................ 54 
14.4. 
Level of Statistical Significance ........................................................................... 55 
14.5. 
Primary Analysis .................................................................................................. 55 
14.6. 
Secondary Analysis .............................................................................................. 56 
14.7. 
Other Exploratory Analyses ................................................................................. 56 
14.8. 
Interim Analysis ................................................................................................... 57 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 57 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 57 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 57 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 57 
15.2. 
Subject Record ...................................................................................................... 58 
15.3 
ClinicalTrials.gov ................................................................................................. 58 
16. 
DATA MANAGEMENT............................................................................................. 58 
16.1. 
Access to Source Data/Document ........................................................................ 58 
16.2. 
Confidentiality of Information.............................................................................. 58 
16.3. 
Data Quality Assurance ........................................................................................ 59 
17. 
CLINICAL MONITORING ........................................................................................ 59 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 59 
18.1. 
Study-Specific Design Considerations ................................................................. 59 
18.2. 
Investigator Responsibility ................................................................................... 60 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 60 
18.4. 
Informed Consent ................................................................................................. 61 
18.5. 
Privacy of Personal Data ...................................................................................... 62 
19. 
STUDY RECORD RETENTION................................................................................ 63 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 63 
21. 
PUBLICATION ........................................................................................................... 64 
22. 
REFERENCES ............................................................................................................ 64 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 65 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 73 
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APPENDIX D: 
 ...................................... 76 
 Limbal and Conjunctival (Bulbar) Redness .......................................................... 77 
 Expanded Sodium Fluorescein Corneal Staining .................................................. 85 
 Lens Fitting Characteristics ................................................................................... 90 
 Subject Reported Ocular Symptoms/Problems ..................................................... 97 
 Front and Back Surface Lens Deposit Grading Procedure ................................... 99 
 Determination of Distance Spherocylindrical Refractions .................................. 105 
 Biomicroscopy Scale ........................................................................................... 112 
 Distance and Near Visual Acuity Evaluation ...................................................... 118 
 Distance LogMAR Visual Acuity Measurement Procedure ............................... 123 
 Patient Reported Outcomes ................................................................................. 127 
 White Light Lens Surface Wettability ................................................................ 129 
 Visual Acuity Chart Luminance and Room Illumination Testing ...................... 131 
Appendix E: Guidelines for COVID-19 Risk Mitigation ..................................................... 137 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 147 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 14 
TABLE OF CONTENTS
Table 1: Target number of subjects by arm and phase ........................................................... 22 
Table 3: Ancillary Supplies .................................................................................................... 24 
Table 4: Time and Events ....................................................................................................... 26 
Table 4: Disallowed systemic medications (less than 6 months of continual use). ................ 44 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Clinical Evaluation of senofilcon A Contact Lenses Using a Novel Manufacturing 
Technology  
Protocol Number:  CR-6417    
Version: 3.0 
Date: 10 September 2020    
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
Name:  Meredith Bishop, OD, MS, FAAO
Address: 7500 Centurion Parkway, Suite 100, Mail W-2A, Jacksonville, FL 32256 
Email: mbishop4@its.jnj.com 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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SYNOPSIS 
Protocol Title
Clinical Evaluation of senofilcon A Contact Lenses Using a 
Novel Manufacturing Technology
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Feasibility Study, Phase 0
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor.   
Test Article(s)
Investigational Products:
x
senofilcon A contact lenses made with a novel 
manufacturing technology (Test) 
x
senofilcon A contact lenses made with the current 
manufacturing technology (Control).
x
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable 
Objectives 
To evaluate the clinical performance of senofilcon A contact 
lenses made with a new manufacturing technology as 
compared to senofilcon A contact lenses made with the 
existing manufacturing technology. 
Study Endpoints
Co-primary endpoint(s):
x
Overall comfort after 1-week of lens wear
x
Overall quality of vision after 1-week of lens wear
Secondary endpoint(s):   
x
Monocular distance visual performance after 1-week 
of lens wear
x
Average daily wear time (in hour) after 1-week of 
lens wear
Additional Endpoints: 
x
Slit lamp findings
x
Subject reported ocular symptoms 
x
Lens fitting characteristics
x
Lens wettability
x
Adverse events
x
Reasons for discontinuation 
x
Lens damage
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Study Design
This study is a feasibility, multi-site, randomized, 
double-masked, 2×2 crossover design, 1-week dispensing 
study.  Subjects will wear bilaterally both Test and Control 
lenses in a random order for 1-week each as a daily 
disposable modality with a wash-out period of 1 week 
between the wearing periods.   
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
Sample Size
Up to 133 eligible subjects will be enrolled and randomized 
into the study to ensure that approximately 120 subjects
complete as cohort. 
Study Duration
The study will last approximately 7 weeks and include an 
enrollment period of 3 weeks. 
Anticipated Study 
Population 
Healthy male and female volunteers (at least 18 and not more 
than 70 years old) who are habitual wearers of daily
disposable contact lenses (we will aim for approximately 
75% habitual silicone hydrogel daily disposable and 
approximately 50% habitual ACUVUE® OASYS 1-DAY
wearers) and have a spectacle astigmatism of 0.75D in both 
eyes.  
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Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:  
Inclusion Criteria after Screening
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Must be at least 18 and not more than 70 years of age 
(including 70) at the time of screening. 
4. The subject must be a habitual and adapted wearer of
daily disposable contact lenses in both eyes (at least 1 
month of daily wear). 
5. The subject must have normal eyes (i.e., no ocular 
medications or infections of any type). 
Inclusion Criteria after Baseline
6. The subject’s required spherical contact lens 
prescription must be in the range of -0.50 to -3.25 and
-3.75 to -6.00 D in each eye.
7. The subject’s refractive cylinder must be 0.75D in 
each eye, if present 
8. The subject must have best corrected visual acuity of 
20/25 or better in each eye.
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening
1. Currently pregnant or lactating (subjects who become 
pregnant during the study will be discontinued).
2. Any systemic disease, autoimmune disease, or use of 
medication that may interfere with contact lens wear.
(at the discretion of the investigator)   
3. Any previous, or planned, ocular or interocular 
surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 
4. Any ocular infection. 
5. Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product 
clinical trial within 7 days prior to study enrollment.
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8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or 
a contagious immunosuppressive disease (e.g., HIV, 
by self-report).
10. Suspicion of or recent history of alcohol or substance 
abuse. 
11. History of serious mental illness.   
12. History of seizures. 
13. Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician)
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal 
distortion  
15. Any Grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the Food and 
Drug Administration (FDA) classification scale 
Disallowed 
Medications/Interventions  
Disallowed medications include any medication that may 
interfere with contact lens wear (at the investigator’s 
discretion).   
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
Subjective assessments, physiological responses, fitting 
characteristics. 
Microbiology or Other 
Laboratory Testing
None
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Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product. In the event of a
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled. 
Ancillary Supplies/ Study-
Specific Materials
Sterile rewetting drops
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
CWT  
 
Comfortable Wear Time
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
HLLC  
 
High Luminance with Low Contrast
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 
LLHC  
 
Low Luminance with High Contrast
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
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1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
See Package Inserts for ACUVUE® OASYS 1-DAY. (APPENDIX C: PACKAGE INSERT 
(APPROVED PRODUCT).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective(s)
To evaluate the clinical performance of senofilcon A contact lenses made with a new 
manufacturing technology as compared to senofilcon A contact lenses made with the existing 
manufacturing technology in the following areas: 
x
Overall comfort after 1-week of lens wear  
x
Overall quality of vision after 1-week of lens wear
Secondary Objective(s)
To evaluate the clinical performance of senofilcon A lenses made with a new manufacturing 
technology by comparison to senofilcon A lenses made with the manufacturing technology in 
the following areas: 
x
Monocular distance visual performance (in logMAR) after 1-week of wear
x
Average daily wear time (in hours) 
2.2.
Endpoints 
Primary Endpoint(s)
CLUE Comfort and Vision Scores:
The co-primary endpoints for this study are subjective assessment of comfort and quality of 
vision after 7±2 days of wearing the study lenses as a daily disposable.  
Subjective assessment of comfort and vision will be performed using the Contact Lens User 
ExperienceTM (CLUE) questionnaire.5 CLUE is a validated patient reported outcomes (PRO) 
questionnaire used to assess patient experience attributes of soft contact lenses (comfort, 
vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 
years of age.  CLUE composite scores are derived using Item Response Theory (IRT) and 
follow a normal distribution with a population average score of 60 (SD 20), where higher 
scores indicate a more favorable/positive response.  A 5-point increase in an average CLUE 
score translates into 10% shift in the distribution of scores for the population of soft disposable 
contact lens wearers.
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Secondary Endpoint(s) 
Average daily wear time (in hours): 
Average daily wear time will be calculated as the number of hours between subjects reported 
time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow 
up evaluation. 
Visual performance
Visual performance will be calculated as monocular contact lens-corrected distance visual 
acuity using a logMAR visual acuity scale.  This will be evaluated under both high 
luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters 
from Early Treatment Diabetic Retinopathy Study (ETDRS) charts at the 1 Week Follow-up 
visit. 
Other Endpoint(s)
Slit Lamp Findings
Frequency and severity by eye of slit lamp findings (SLFs) including conjunctival injection, 
corneal edema, corneal neovascularization, corneal staining, tarsal abnormalities or any other
complications.  SLFs will be evaluated at fitting and post-fitting evaluation visits including
unscheduled visits. 
Subject’s Reported Ocular Symptoms 
Frequency and severity by eye of subject’s reported ocular symptoms and problems with the 
study lens at fitting and post-fitting evaluation visits including unscheduled visits. 
Lens Fitting characteristics
Frequency by eye of mechanical lens fitting characteristics including lens centration and lens 
movement and overall lens fitting acceptability at fitting and 1-week follow-up evaluations.  
Lens wettability:
Frequency and Grade by eye of lens wettability at 1-Week Follow-up evaluation. 
The following will be monitored and descriptively evaluated 
x
Adverse events
x
Reasons for discontinuation 
x
Lens damage
2.3.
Hypotheses
This is a feasibility study and all the hypotheses are exploratory in nature. 
Primary Hypotheses: 
There are two co-primary hypotheses in this study. Both of them must be met to satisfy the 
primary objective of the study. 
1. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
comfort score at the follow-up visit.  A non-inferiority margin of -5 points will be used.
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2. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
vision score at the follow-up visit.  A non-inferiority margin of -5 points will be used. 
Secondary Hypotheses: 
1. The Test lens will be non-inferior to the Control lens with respect to logMAR visual 
performance (using ETDRS visual acuity charts) at the follow-up visit.  A non-
inferiority margin of 0.05 logMAR will be used. 
2. The Test lens will be non-inferior to the Control lens with respect to average daily wear 
time at 1-week follow-up visit.  A non-inferiority margin of 1 hour will be used. 
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (we will aim for 
approximately 75% habitual silicone hydrogel daily disposable and approximately 50% 
habitual ACUVUE® OASYS 1-DAY wearers) and have a spectacle astigmatism of 0.75 D 
in both eyes.  Up to 133 subjects will be enrolled to ensure approximately 120 subjects 
successfully complete the study.
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Must be at least 18 and not more than 70 years of age (including 70) at the time of 
screening.
4. The subject must be a habitual and adapted wearer of daily disposable brand contact 
lens in both eyes (at least 1 month of daily wear). 
5. The subject must have normal eyes (i.e., no ocular medications or infections of any 
type).
Inclusion Criteria after Baseline
6. The subject’s required spherical contact lens prescription must be in the range of -0.50 
to -3.25 and -3.75 to -6.00 D in each eye. 
7. The subject’s refractive cylinder must be  0.75 D in each eye, if present. 
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
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3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from 
participating in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating (subjects who become pregnant during the study will 
be discontinued). 
2. Any systemic disease, autoimmune disease, or use of medication that may interfere 
with contact lens wear (at the discretion of the investigator)
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.).
4. Any ocular infection. 
5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens 
wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 7 days prior 
to study enrollment. 
8. History of binocular vision abnormality or strabismus. 
9. Any 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis) 
or 
a 
contagious 
immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse. 
11. History of serious mental illness.   
12. History of seizures. 
13. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician) 
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere 
with contact lens wear and/or participation in the study. This may include, but not be 
limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal distortion. 
15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification 
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. 
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4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week 
dispensing study.  Subjects will wear bilaterally both Test and Control lenses in a random order 
for 1-week each as a daily disposable modality with a wash-out period of 1 week between the 
wearing periods.   
Period 1: 
At study Visit 1, subjects will be consented and screened for inclusion/exclusion criteria.  If a 
subject is found to meet all eligibility criteria (see Section 3.4.), they will be randomly assigned 
to either Test/Control or Control/Test sequence using 1:1 ratio (i.e. 1/2 of subjects on the 
Test/Control sequence and 1/2 on the Control/Test sequence).  Subjects will fit the first pair of 
lenses in both eyes based on the sequence assigned; otherwise, the subject will be deemed 
ineligible for this study.  Subjects will be advised to wear the study lenses at least 8 hours a 
day for a minimum of 5 days. 
Successfully dispensed subjects at the Visit 1 will be scheduled for a follow-up visit (Visit 2).  
The follow-up visit will occur approximately 7±2 days after the Visit 1.  Unscheduled follow-
up visits may occur during the study.  At this visit, CLUE comfort and vision, slit lamp findings 
will be captured.
Wash-out period: 
After completion of Visit 2, there is a 7 to 9 days washout period during which subjects may 
use their habitual products. 
Period 2: 
Following the washout period, the subject returns for Visit 3 and post-washout baseline 
evaluation will take place prior to lens fitting.  After baseline evaluation, subject will be fitted 
and dispensed with the second pair of lenses in the assigned sequence.  Subjects will be advised 
to wear the study lenses at least 8 hours a day for a minimum of 5 days. 
Visit 4 takes place 7±2 days after Visit 3, at which CLUE comfort and vision, slit lamp 
findings, final evaluation will take place.
Both study lenses will be worn as a daily disposable modality.  JJVC will provide the 
investigational sites with sufficient quantities of study lenses and supplies to complete the 
study.
4.2.
Study Design Rationale 
The crossover study design will allow each subject to evaluate both the Test and Control lenses 
and will help to reduce potential intra-subject variation.  To reduce any potential carryover 
effect, a 7 to 9 days washout period was considered between the wearing periods.  
Both lenses will be worn as daily disposable modality, therefore 1-week wearing period was 
considered sufficiently longer to assess the primary and secondary objectives of the study.
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4.3.
Enrollment Target and Study Duration
Up to 133 subjects will be initially enrolled and approximately 120 are targeted to complete 
the study.   
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (we will aim for 
approximately 75% habitual silicone hydrogel daily disposable and approximately 50% 
habitual ACUVUE® OASYS 1-DAY wearers) and have a spectacle astigmatism of 0.75 D
in both eyes.   
The Investigator is responsible for ensuring that all subjects entering the study conform to 
subject selection criteria.  The number of subjects targeted for randomization and completion 
are as follows: 
Table 1: Target number of subjects by arm and phase 
Test/Control
Control/Test
Total
Randomization
65
65
130
Completion
60
60
120
Number of sites
7
7
7
Subjects/site (Min-
Max)
8-12 
8-12 
16-24 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover design.  
A computer-generated randomization scheme will be used to randomly assign subjects, in 
block of 2, to one of the two possible lens wear sequences: Test/Control or Control/Lens.  The 
random scheme will be generated using the PROC PLAN procedure from Statistical Analysis 
System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC).6
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization: 
x
Informed consent has been obtained 
x
Subject meets all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected. 
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5.2.
Masking
This is a double-masked study where subjects, investigators are masked to the identity of the 
study lenses during the study period.  Every attempt will be made to keep the other clinical 
trial personnel involved in the study (e.g. data management, biostatistician) unaware of the 
identity of the study lenses. 
The identity of the study lenses will be masked by over-labeling the blister packs with a label 
containing the study number, lot number, sphere power, expiration date and the randomization 
codes.  Only the personnel involved in the over labeling and the statistician generating the
randomization scheme will have access to the decode information translating the 
randomization codes into Test and Control groups.  The Biostatistician performing the interim 
analysis will have access to the decode information to run the interim analysis.  The medical 
monitor will also have access to the decode information in case breaking the mask is necessary 
for the urgent medical treatment of a subject.
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized.  Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject.  In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible.  The date, 
time, and reason for the unmasking must be documented in the subject record.  The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued will not 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.  The Biostatistician performing the interim analysis should keep the decode 
information in a secure location and should not share it with the personnel involved in the study 
until the all subjects have completed the study and the database is finalized.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply.  
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
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6.4.
Packaging and Labeling
The test articles will be packaged in blisters as the primary packaging.  The test article will be 
over-labeled to mask the subject/Investigators to the identity of the lens.  The test articles will 
be in investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic 
bags as the secondary packaging form.  The sample study label is shown below:       
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 
Lenses that are being collected will be stored wet (using saline solution) in separate glass vials 
with labels that minimally contain study number, date, subject number, and eye from which 
the lens was removed.
When possible, any lens or test article associated with an Adverse Events 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 back to JJVC 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test 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:
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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 misses any study visits  
x
Subject not compliant with study lens wear schedule 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort, or unacceptable fit. 
For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled) 
x
Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard
them, unless otherwise stated in Section 0
x
Collect all unused test article(s) from the subject.
An additional subject will be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: See Section 3.3   
Concomitant therapies that are disallowed include: See Section 3.3
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 taking these medications on a continual, routine basis that have 
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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".
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation. 
Protocol waivers are prohibited 
Subjects will be dispensed study lenses at visit 1 and visit 3 for 5-9 days of wear.  If the subject 
wears the lenses for 4 days or 10 days this will be a minor deviation.  If the subject wears the 
lenses for 3 or less days or 11 or more days this will be a major deviation and the subject will 
be removed from cohort.   
The washout between visit 2 and visit 3 is 7-9 days.  If the washout is instead 4-6 days or 10-
15 days, this will be a minor deviation.  If the washout is 3 or less days and 16 or more days,
this will be a major deviation and the subject will be removed from cohort.   
While dispensed, the study lenses are to be worn 8 hours a day.  If the average wear time is 7 
hours a day this will be a minor deviation.  If the average wear time is 6 hours or less a day 
this will be a major deviation and the subject will be removed from cohort. 
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
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JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
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x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury 
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x
Permanent or persistent impairment of a body structure or a body function 
x
Hospitalization or prolongation of patient hospitalization 
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x
Chronic disease 
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA 
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
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Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
NOTE 1: to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x
Seriousness/Classifications (see definition in Section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 0). 
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown. 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
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13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
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All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
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13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
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. 
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13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest
None 
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor.  A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.   
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum).  Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
14.2. Sample Size Justification
The plan is to enroll 130 subjects with a target completion of 120 subjects. This is a feasibility
study and the sample size is chosen by the study responsible clinician and was not based on 
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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 analysis for this study will be conducted with an overall type I error rate of 5%.  
No adjustment for multiple comparisons will be conducted unless specified otherwise.
14.5. Primary Analysis  
The co-primary endpoints for this study are the CLUE comfort and the CLUE vision scores 
evaluated after 7±2 days of lens wear.  The primary analysis will be conducted on per-protocol 
and ITT populations.   
CLUE Comfort and Vision scores 
CLUE comfort and vision scores after 7±2 days of lens wear will be analyzed separately using 
a linear mixed effect model to compare between Test and Control lenses. Each regression 
model will include the baseline score, lens type, lens wearing sequence and lens wearing period 
as fixed effects and investigational site as a random effect (G-side). Other subject 
characteristics such as habitual lens, age, gender and will also be included as fixed effects when 
appropriate. The habitual lens will be categorized as ACUVUE OASYS 1-DAY, silicone 
hydrogel daily disposable – non-ACUVUE OASYS 1-DAY and non-silicone hydrogel daily
disposable. The covariance of residual errors between different periods for the same subject 
will be modeled using either homogenous compound symmetry (CS), First-Order Ante-
dependence (ANTE) or unstructured (UN) covariance structure. The structure that returns the 
lowest finite sample corrected Akaike’s Information criterion7 will be selected as the structure 
that best fits the model. The Kenward and Roger method will be used for the calculation of the 
denominator degree of freedom.8  
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪǻ-5 
ܪܣǻ-5 
ZKHUHǻLVWKH&/8(VFRUHPHDQGLIIHUHQFH after 7±2 days of lens wear between Test lens and 
Control lens (Test minus Control). The hypothesis will be tested via the corresponding two-
sided 95% confidence interval (CI) for least squares mean (LSM) difference (Test - Control) 
in CLUE scores. Non-inferiority will be declared if the lower bound of the confidence interval 
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of the mean difference between Test and Control is greater than -5. If non-inferiority is 
demonstrated, superiority will be tested and concluded if the lower bound of the 95% CI is 
greater than 0.
14.6. Secondary Analysis  
Visual Performance
Monocular distance visual performance in logMAR scale will be analyzed using a linear mixed 
effect model to compare between Test and Control lenses. The regression model will include 
baseline scores, lens type, lens wearing sequence and lens wearing period as fixed effects; and 
investigational site and patient as random effects. Other subject characteristics such as habitual 
lens as defined in the primary analysis, age, gender and will also be included as fixed effects 
when appropriate. The covariance of residual errors between different periods for the same eye 
and subject across wearing periods will be modeled using either homogenous compound 
symmetry (CS) , First-Order Ante-dependence (ANTE), or unstructured (UN) covariance 
structure. The structure that returns the lowest finite sample corrected Akaike’s Information 
criterion7
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪǻ!
ܪܣǻ
ZKHUHǻLVWKHPHDQGLIIHUHQFHLQORJ0$5EHWZHHQ7HVWOHQVDQG&RQWUROOHQV7HVWPLQXV
Control).  Non-inferiority will be declared if the upper bound of the confidence interval of the 
mean difference between Test and Control is less than 0.05.
Average Daily Wearing Time
Average daily wear time will be analyzed using the same linear mixed effect model described 
in the primary analysis. 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪǻ-1 
ܪܣǻ-1 
ZKHUHǻLVWKHPHDQGLIIHUHQFHLQDYHUDJHGDLO\ZHDULQJWLPHEHWZHHQ7HVWOHQVDQG&RQWURO
lens (Test minus Control). Non-inferiority will be declared if the lower bound of the confidence
interval of the mean difference between Test and Control is greater than -1. 
14.7. Other Exploratory Analyses  
A subgroup analysis will be conducted by considering only subjects who are habitual users of 
ACUVUE OASYS 1-DAY.
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14.8. Interim Analysis
No interim analysis is planned.
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 15 imputations. 
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system Bioclinica. An authorized data originator will enter study data into the eCRFs using the 
EDC system. Data collected on equipment that is not captured in EDC will be formatted to the 
specification of the JJVC database manager and sent to JJVC for analysis. 
External Data Sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
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The content and structure of the eCRFs are compliant with ISO14155:2011.1 
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.  
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
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obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. 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 
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participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol. 
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
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x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current 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. 
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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 States9 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
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. 
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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.
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. 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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6
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APPENDIX B: PATIENT INSTRUCTION GUIDE 
To be provided separately
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
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 Limbal and Conjunctival (Bulbar) Redness
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:       Work Instructions
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:       Work Instructions
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:       Work Instructions
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:       Work Instructions
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 Expanded Sodium Fluorescein Corneal Staining
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:       Work Instructions
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:       Work Instructions
Document Number: CTP-2003 
Revision Number:  5 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:       Work Instructions
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 Lens Fitting Characteristics 
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 Subject Reported Ocular Symptoms/Problems 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 Front and Back Surface Lens Deposit Grading Procedure
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Johnson & Johnson Vision Care, Inc.
 Determination of Distance Spherocylindrical Refractions 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 Biomicroscopy Scale 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 Distance and Near Visual Acuity Evaluation 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:       Work Instructions
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 WHITE LIGHT LENS SURFACE WETTABILITY
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 2
 
1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.  
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as 
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
doctors of optometry (O.D.), optometric professionals, and optometry students. Doctors of optometry take a 
leading role in patient care with respect to eye and vision care, as well as general health and well-being. As 
primary health care providers, doctors of optometry have extensive, ongoing training to examine, diagnose, 
treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the eye. The 
American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).  
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.  
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
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Document Number:
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Revision Number: 2
Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures. 
x
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.   
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:  
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
VWI-0081
Revision Number: 2
 
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  
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html
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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Guidelines for COVID-19 Risk Mitigation
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Revision Number: 2
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 (Form Control No. VCT-
0063) per Study Site Initiation (Form Control No. VCCL-0002).  
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):  
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.). 
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan (Form Control No. VCT-0026).
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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Document Type:
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Document Number:
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Revision Number: 2
 
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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Document Type:
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Document Number:
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Revision Number: 2
 
Attachment A: Study Site Correspondence 
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principle Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principle Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
  
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.   
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6417 Clinical Evaluation of senofilcon A Contact Lenses Using a
Novel Manufacturing Technology
Version and Date: 3.0 10 September 2020
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed 
about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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