Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and Spectacles in Low Astigmats
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and 
Spectacles in Low Astigmats
Protocol CR-6459
Version: 4.0
Date: 11 November 2021
Investigational Products: ACUVUE® Oasys 1-Day contact lenses, ACUVUE® Oasys 1-Day 
for Astigmatism contact lenses
Keywords: Sphere, Astigmatism, senofilcon A, ACUVUE® Oasys 1-Day contact lenses, 
ACUVUE® Oasys 1-Day for Astigmatism contact lenses, daily wear, daily disposable, 
dispensing, CLUE comfort, CLUE vision, CLUE handling, preference, logMAR visual 
acuity, Single use Eye-Cept® Rewetting Drops, LacriPure Saline Solution, ScleralFil 
Preservative Free Saline Solution.
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. 
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, or 
as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc. Any supplemental information that may be added to this document 
is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept 
in confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS 
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 7 
SPONSOR NAME AND ADDRESS....................................................................................... 7 
MEDICAL MONITOR............................................................................................................. 7 
AUTHORIZED SIGNATURES............................................................................................... 8 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS.............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 18 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 19 
1.1. 
Name and Descriptions of Investigational Products ................................................ 19 
1.2. 
Intended Use of Investigational Products................................................................. 19 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 19 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 19 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...20 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 20 
2.1. 
Objectives................................................................................................................. 20 
2.2. 
Endpoints.................................................................................................................. 20 
2.3. 
Hypotheses ............................................................................................................... 21 
3. 
TARGETED STUDY POPULATION........................................................................... 22 
3.1. 
General Characteristics ............................................................................................ 22 
3.2. 
Inclusion Criteria...................................................................................................... 22 
3.3. 
Exclusion Criteria..................................................................................................... 23 
3.4. 
Enrollment Strategy.................................................................................................. 23 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 24 
4.1. 
Description of Study Design .................................................................................... 24 
4.2. 
Study Design Rationale............................................................................................ 24 
4.3. 
Enrollment Target and Study Duration.................................................................... 24 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 25 
5.1. 
Test Article Allocation............................................................................................. 25 
5.2. 
Masking.................................................................................................................... 25 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 26 
6. 
STUDY INTERVENTION............................................................................................. 26 
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6.1. 
Identity of Test Articles............................................................................................ 26 
6.2. 
Ancillary Supplies/Products..................................................................................... 27 
6.3. 
Administration of Test Articles................................................................................ 28 
6.4. 
Packaging and Labeling ........................................................................................... 28 
6.5. 
Storage Conditions................................................................................................... 29 
6.6. 
Collection and Storage of Samples .......................................................................... 29 
6.7. 
Accountability of Test Articles ................................................................................ 29 
7. 
STUDY EVALUATIONS.............................................................................................. 30 
7.1. 
Time and Event Schedule......................................................................................... 30 
7.2. 
Detailed Study Procedures ....................................................................................... 32 
VISIT 1 ........................................................................................................................... 32 
VISIT 2 ........................................................................................................................... 35 
VISIT 3 ........................................................................................................................... 41 
VISIT 4 ........................................................................................................................... 44 
VISIT 5 ........................................................................................................................... 46 
FINAL EVALUATION.................................................................................................. 48 
7.3. 
Unscheduled Visits................................................................................................... 49 
7.4. 
Laboratory Procedures ............................................................................................. 50 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 51 
8.1. 
Completion Criteria.................................................................................................. 51 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 51 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 52 
9.1. 
Systemic Medications .............................................................................................. 52 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 53 
11. 
STUDY TERMINATION ........................................................................................... 54 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 55 
13. 
ADVERSE EVENTS................................................................................................... 56 
13.1. 
Definitions and Classifications............................................................................. 56 
13.2. 
Assessing Adverse Events.................................................................................... 58 
13.2.1. 
Causality Assessment.................................................................................... 59 
13.2.2. 
Severity Assessment...................................................................................... 59 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 59 
13.4. 
Reporting Adverse Events.................................................................................... 61 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 61 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
………………………………………………………………………………62 
13.5. 
Event of Special Interest....................................................................................... 62 
13.6. 
Reporting of Pregnancy........................................................................................ 62 
14. 
STATISTICAL METHODS........................................................................................ 63 
14.1. 
General Considerations......................................................................................... 63 
14.2. 
Sample Size Justification...................................................................................... 63 
14.3. 
Analysis Populations ............................................................................................ 65 
14.4. 
Level of Statistical Significance........................................................................... 65 
14.5. 
Primary Analysis .................................................................................................. 66 
14.6. 
Secondary Analyses.............................................................................................. 67 
14.7. 
Other Exploratory Analysis.................................................................................. 68 
14.8. 
Interim Analysis ................................................................................................... 68 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 68 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 68 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 69 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 69 
15.2. 
Subject Record...................................................................................................... 69 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 70 
16. 
DATA MANAGEMENT............................................................................................. 70 
16.1. 
Access to Source Data/Document ........................................................................ 70 
16.2. 
Confidentiality of Information.............................................................................. 70 
16.3. 
Data Quality Assurance........................................................................................ 70 
16.4. 
Data Monitoring Committee (DMC).................................................................... 71 
17. 
CLINICAL MONITORING........................................................................................ 71 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 71 
18.1. 
Study-Specific Design Considerations ................................................................. 71 
18.2. 
Investigator Responsibility................................................................................... 71 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 72 
18.4. 
Informed Consent ................................................................................................. 73 
18.5. 
Privacy of Personal Data ...................................................................................... 73 
19. 
STUDY RECORD RETENTION................................................................................ 74 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 75 
21. 
PUBLICATION........................................................................................................... 75 
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22. 
REFERENCES ............................................................................................................ 75 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 77 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 109 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)....................................... 110 
APPENDIX D:
.................................... 139 
 LENS FITTING CHARACTERISTICS............................................................ 140 
 SUBJECT REPORTED OCULAR OUTCOMES............................................. 146 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 148 
 BIOMICROSCOPY SCALE ............................................................................. 154 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 160 
 TORIC FIT EVALUATION.............................................................................. 165 
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE .. 170 
 PATIENT REPORTED OUTCOMES .............................................................. 174 
 LENS INSERTION AND REMOVAL ............................................................. 176 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 179 
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 188 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 200 
 
LIST OF TABLES
Table 1: Test and Control Article Parameters......................................................................... 27 
Table 2: Ancillary Supplies .................................................................................................... 27 
Table 3: Time and Events ....................................................................................................... 30 
Table 4: Disallowed systemic medications............................................................................. 52 
Table 5: Disallowed systemic antihistamines......................................................................... 53 
Table 6: Examples of major and minor protocol deviations................................................... 54 
Table 7: Historical Data from 
.................................................................................. 63 
Table 8: Power Calculation for the Visual Performance (HLHC logMAR) for the primary 
hypothesis with Type I error of 0.05....................................................................................... 64 
Table 9: Power of the First Secondary Hypothesis of CLUE Vision score for the first secondary 
hypothesis (S1) with Type I error of 0.05............................................................................... 64 
Table 10: Power of the Visual Performance (HLHC logMAR) for the second secondary 
hypothesis (S2)........................................................................................................................ 64 
Table 11: Power Calculation for the Contact Lens Preference (superiority) for the third 
secondary hypothesis (S3). ..................................................................................................... 64 
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LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 17 
Figure 2: Gatekeeping strategy and α-propagation, P1 – Primary hypothesis and S1-3 – the 
first to third secondary hypothesis defined in section 2.3....................................................... 66 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Clinical Evaluation of Spherical Soft Contact Lenses, Toric Soft Contact Lenses and 
Spectacles in Low Astigmats
Protocol Number: CR-6459
Version: 4.0
Date: 11 November 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be 
contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and 
provide the necessary assurances that this trial will be conducted according to all stipulations 
of the protocol, including all statements regarding confidentiality, and according to local 
legal and regulatory requirements and applicable U.S. federal regulations,4 ISO 14155:2020,1
ICH guidelines,2 and the Declaration of Helsinki.3
Author & Study 
Responsible 
Clinician
See Electronic Signature Report 
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Biostatistician
Reviewer
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety 
Officer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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SYNOPSIS 
Protocol Title
Clinical Evaluation of Spherical Soft Contact Lenses, Toric 
Soft Contact Lenses and Spectacles in Low Astigmats
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Post-market
Design control phase: Post-market, phase 4
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor.
Test Article(s)
Approved Products: ACUVUE® Oasys 1-Day contact lenses
(AO1D), ACUVUE® Oasys 1-Day for Astigmatism 
(AO1DfA) contact lenses.
Wear and Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily disposable
Objectives 
Primary Objective
The primary objective of this study is to evaluate the
difference in High-Luminance, High-Contrast (HLHC) 
Visual Acuity (VA) between binocular correction with 
AO1DfA and AO1D contact lenses in habitual contact lens 
wearers with low astigmatism.
Secondary Objectives
The secondary objectives of this study are to assess the 
CLUE subjective vision score and subject overall preference 
for AO1DfA and AO1D contact lenses in habitual contact 
lens wearers with low astigmatism. HLHC VA will also be 
assessed with subjects wearing their own habitual spectacle 
correction and compared to that with the AO1DfA lens.
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Study Endpoints
Primary endpoint:
x
HLHC VA at 1-week follow-up for contact lens wear
periods
Secondary endpoints:
x
CLUE vision score at 1-week follow-up for contact
lens wear periods
x
Subjective preference between sphere and toric
correction at the final study visit
x
HLHC VA with spectacle wear at the end of the
washout period
Other observations (efficacy):
x
High-Luminance, Low-Contrast (HLLC) VA at 1-
week follow-up, and with spectacle wear at the end of
the washout period
x
Number of diagnostic lenses required to achieve fit
success for the contact lens corrections
x
Length of time required to fit the contact lens
corrections
x
CLUE comfort and handling scores at 1-week follow-
up for the contact lens corrections and CLUE vision
with spectacle wear at the end of the washout period
x
MRD and National Eye Institute Refractive Error
Quality of Life Instrument (NEI-RQL) questionnaire
response for the contact lens corrections and with
spectacle wear at the end of the washout period
x
Subjective ranking of corrections (sphere, toric, and
habitual spectacles) in order of preference at the final
visit
x
Average wear time and comfortable wear time for the
contact lens corrections
x
Lens fitting characteristics for the contact lens
corrections
x
Settled lens orientation (for the AO1DfA contact
lenses only)
x
Subject reported ocular symptoms
Other observations (safety):
x
Slit lamp findings
x
Adverse events
Primary Hypothesis: 
1.
After 1 week of wear, monocular HLHC VA for
correction with AO1DfA lenses will be superior to that
for mean sphere correction with AO1D spherical
lenses.
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Secondary Hypotheses:
1.
After 1 week of wear, the mean CLUE vision score for
binocular correction with AO1DfA lenses will be
superior to that for binocular mean sphere correction
with AO1D spherical lenses.
2.
After 1 week of wear, subjects will have greater
overall preference for binocular correction with
AO1DfA lenses over AO1D spherical lenses.
3.
After 1 week of wear HLHC VA for correction with
AO1DfA lenses will be non-inferior to that for
correction with subjects’ habitual spectacles, using a
non-inferiority boundary of -0.05 logMAR.
Study Design
This will be a 5-visit, randomized, partially single-masked, 
bilateral wear, dispensing, 2-treatment × 2-period crossover 
study with spectacle-wear washout and wash-in periods.
Subjects will be randomized into one of two unique 
sequences to wear each contact lens correction one at a time 
(sphere followed by toric or toric followed by sphere sphere).
For each of the two wear periods, lenses will be worn 
bilaterally in a daily wear, daily disposable modality for 
7(±2) days. There will be a 7(±2) day wash-in period prior to 
the first study lens wear period, and a 7(±2) day washout 
period between the first and second wear periods. During the
wash-in and washout periods, subjects will only wear their 
own habitual spectacle correction (i.e., no contact lens wear).
Subjective comfort, vision and handling will be assessed at 
fitting and follow-up visits for each contact lens wear period 
using the CLUE questionnaire, and CLUE vision will also be 
assessed at the end of the washout period. HLHC VA and 
HLLC VA will be assessed with the study contact lenses at 
the 1-week follow-up visits and with spectacle wear at the
end of the washout period. At the final study visit, contact 
lens preference will be assessed (i.e., preference between the 
study contact lenses) as well as overall correction ranking
(i.e., corrections ranked by preference considering both study 
lenses and habitual spectacles). 
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
This study will have an enrollment target of approximately 
170 subjects, with a target of at least 153 to complete
(assuming a dropout rate of approximately 10%).
Study Duration
Total study duration including the enrollment period is 
anticipated to be approximately 11 weeks.
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Anticipated Study 
Population
Subjects will be habitual soft contact lens wearers with
bilateral astigmatism who are between 18 and 39 years of 
age (inclusive).
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Eligibility Criteria -
Inclusion
Potential subjects must satisfy of all the following criteria to 
be enrolled in the study.
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF
INFORMED CONSENT and receive a fully executed
copy of the form.
2. Appear able and willing to adhere to the instructions set
forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time
of screening.
4. By self-report, habitually wear soft contact lenses (sphere
or toric) in both eyes in a daily reusable or daily
disposable wear modality (i.e. not extended wear
modality). Habitual wear is defined as a minimum of 6
hours of wear per day, for a minimum of 2 days per week
during the 4 weeks.
5. Possess a wearable pair of spectacles that provide
correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. In both eyes, have magnitude of the cylinder component
of their vertex-corrected distance refraction greater than
or equal to 0.625 DC and less than 1.625 DC.
7. In both eyes, have the mean sphere of their vertex-
corrected distance refraction minus half of the indicated
contact lens label cylinder power be between -0.875 to -
4.625 DS (inclusive).
8. For each eye, have the cylinder axis of their distance
refraction between 165° and 15° (i.e., 180±15°, inclusive)
or between 75° and 105° (i.e., 90±15°, inclusive).
9. For both eyes, have the sphere power of their habitual
spectacles within ±0.50 Diopters Sphere (DS) (inclusive)
of the sphere power of their current subjective refraction.
10. For both eyes, have the cylinder power of their habitual
spectacles within ±0.50 Diopters Cylinder (DC)
(inclusive) of the cylinder power of their current
subjective refraction.
11. For both eyes, have the cylinder axis of their habitual
spectacles within ±20° (inclusive) of the cylinder axis of
their current subjective refraction.
12. Achieve monocular VA of 20/30 or better with their
habitual spectacles in both eyes.
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Eligibility Criteria –
Exclusion
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any
ocular infection of any type.
4. By self-report, have any ocular or systemic disease,
allergies, infection, or use of medication that might
contraindicate or interfere with contact lens wear, or
otherwise compromise study endpoints, including
infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human
Immunodeficiency Virus [HIV]), autoimmune disease
(e.g. rheumatoid arthritis, Sjögren’s syndrome), or history
of serious mental illness or seizures. See section 9.1 for
additional details regarding excluded systemic
medications.
5. Have habitually worn rigid gas permeable (RGP) lenses,
orthokeratology lenses, or hybrid lenses (e.g.
SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact
lenses.
7. Be currently wearing lenses in an extended wear
modality.
8. Have a history of strabismus or amblyopia.
9. Be an employee (e.g., Investigator, Coordinator,
Technician) or immediate family member of an employee
(including partner, child, parent, grandparent, grandchild
or sibling of the employee or their spouse) of the clinical
site.
10. Have participated in a contact lens or lens care product
clinical trial within 7 days prior to study enrollment.
Exclusion Criteria at Baseline Evaluation
The subject must not:
11. Have clinically significant (grade 3 or higher on the FDA
grading scale) slit lamp findings (e.g., corneal edema,
neovascularization or staining, tarsal abnormalities or
bulbar injection) or other corneal or ocular disease or
abnormalities that contraindicate contact lens wear or
may otherwise compromise study endpoints (including
entropion, ectropion, chalazia, recurrent styes, glaucoma,
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history of recurrent corneal erosions, aphakia, moderate 
or above corneal distortion, herpetic keratitis).
12. Have fluctuations in vision due to clinically significant
dry eye or other ocular conditions.
13. Have had or have planned (within the study period) any
ocular or intraocular surgery (e.g., radial keratotomy,
PRK, LASIK, iridotomy, retinal laser photocoagulation,
etc.).
Disallowed 
Medications/Interventions 
Subjects will not be eligible to enroll if they are taking any 
ocular medications, or any systemic medications that would 
normally contraindicate contact lens wear or may otherwise 
compromise study endpoints. See section 9.1 for details 
regarding disallowed systemic medications.
Measurements and 
Procedures
The key procedure associated with the endpoints for this 
study will be:
-
Fitting of toric and spherical contact lenses, including 
timing of the fitting process
-
Evaluation of subjective vision, comfort, handling and 
lens preference using PRO questionnaires
-
Measurement of HLHC and HLLC VA using ETDRS 
charts
Microbiology or Other 
Laboratory Testing
Not applicable for this study.
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further 
subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Lens cases, fluorescein strips and preservative-free rewetting 
drops / artificial tears will be supplied for use as needed.  
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
Visit 1: Screening
Habitual contact lenses must be worn to this visit
Statement of Informed Consent
Demographics
Medical History & Concomitant Medications
Habitual Contact Lens Information
Eligibility at Screening
Baseline Evaluation
Baseline PRO questionnaire (habitual lenses)
Entrance visual acuity
Spherocylindrical refraction and distance visual acuity
Measurement of habitual spectacles power
Slit lamp biomicroscopy
Eligibility after Baseline
Continuance & Lens Fitting (#1 through #2)
Review med history and medications
Subject reported ocular symptoms
Entrance VA and biomicroscopy
Lens assignment and insertion
Lens fit assessment, including rotation for toric lenses
Spherical over-refraction, modification if required
PRO post-fit questionnaire
Lenses dispensed for 7r2 days
Follow-up (#1 through #2)
Study lenses must be worn for ≥ 1 hour prior to visit
PRO follow-up questionnaire
ETDRS HLHC and HLLC visual acuity
Lens fit assessment, including rotation for toric lenses
Lens removal
Biomicroscopy
Schedule next visit
Spectacle Evaluation
PRO follow-up questionnaire
ETDRS HLHC and HLLC visual acuity
Final Evaluation
Spherocylindrical refraction
Completion status
Biomicroscopy (if discontinued early)
After follow-up #1
After follow-up #2
Washout Period
A washout period of 7r2 days during 
which subjects will only wear their 
habitual spectacles
Wash-in Period
A wash-in period of 7r2 days during 
which subjects will only wear their 
habitual spectacles
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
AO1D
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY
AO1DfA
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY for 
ASTIGMATISM
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ESD
Eyelid Stabilized Design
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICH
The International Council for Harmonization
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LogMAR
Logarithm of Minimal Angle of Resolution
NEI-RQL
National Eye Institute Refractive Error Quality of Life Instrument
OD
Right Eye
OS
Left Eye
OU
Both Eyes
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
QA
Quality Assurance
SAE
Serious Adverse Event/Serious Adverse Experience
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SAS
Statistical Analysis System
SD
Standard Deviation
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND
Market research data suggests that, particularly in some international markets, patients with 
low astigmatism are often prescribed spherical contact lenses rather than toric lenses.5 A
previous study conducted by JJVC using hydrogel lenses (
) demonstrated that toric 
lenses provide superior high and low contrast visual acuity and better visual comfort 
compared to spherical lenses in a population of low astigmats.4 This study aims to expand on 
the results of the previous research by evaluating CLUE vision scores with sphere and toric 
correction with silicone hydrogel lenses, and also comparing the corrected visual acuity to 
that with subjects’ habitual spectacles. To ensure a valid comparison, subjects’ habitual 
spectacles must be within ±0.50 DS for the sphere component, ±0.50 DC for the cylinder 
component, and ±20 degrees for the axis of their current subjective refraction in both eyes, 
consistent with the 95% limits of agreement for repeatability of these refractive components.6
1.1.
Name and Descriptions of Investigational Products 
Two currently marketed contact lenses will be evaluated in this study; ACUVUE® Oasys 1-
Day (AO1D) spherical lenses and ACUVUE® Oasys 1-Day for Astigmatism (AO1DfA) toric 
lenses. Further details about the test articles are found in section 6 of this protocol.
1.2.
Intended Use of Investigational Products 
The intended use of the study lenses is the correction of myopia and associated astigmatism 
in the case of the AO1DfA lens. Study lenses will be worn bilaterally in a daily wear, daily 
disposable modality for at least 8 hours per day and 5 days per week over a wear period of 
7±2 days. Two wear periods will be completed in total, with a washout period of 7(±2) days
between the wear periods and a wash-in period of 7(±2) days prior to the first wear period. 
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable – marketed product only.
1.4.
Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the study lenses will be the correction of refractive error. 
No adverse device effects are anticipated. The risks associated with use of the study lenses 
are considered to be the same as those for other marketed soft contact lenses worn in the 
same modality (i.e., daily disposable wear), and these risks are considered acceptable relative 
to the clinical benefits. Comprehensive risk and benefit information regarding the study 
lenses is included in the AO1D and AO1DfA package inserts (Appendix C).
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1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The AO1D and AO1DfA lenses are FDA-approved and have been marketed commercially 
since 2016 and 2017, respectively. For further details regarding prior clinical data, refer to 
the AO1D and AO1DfA package inserts (Appendix C).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective
The primary objective of this study is to evaluate the difference in High-Luminance, High-
Contrast (HLHC) Visual Acuity (VA) between binocular correction with AO1DfA and 
AO1D contact lenses in habitual contact lens wearers with low astigmatism.
Secondary Objectives
The secondary objectives of this study are to assess the CLUE subjective vision score and 
subject overall preference for AO1DfA and AO1D contact lenses in habitual contact lens 
wearers with low astigmatism. HLHC VA will also be assessed with subjects wearing their 
own habitual spectacle correction and compared to that with the AO1DfA lens.
2.2.
Endpoints  
Primary endpoint
The primary endpoint will be the HLHC VA for the contact lens wear periods.
HLHC VA will be assessed using ETDRS charts under controlled lighting conditions, which 
will be monitored and verified each testing day (room illumination greater than 400 lux, and 
chart luminance between 120 and 200 cd/m2). VA will be scored letter-by-letter in logMAR 
units. 
Secondary Endpoints
Secondary endpoints for this study will be the subject overall preference between sphere 
(AO1D) and toric (AO1DfA) correction at the final study visit, the CLUE vision score at 1-
week follow-up for each contact lens correction (AO1D, AO1DfA) at follow-up, and the 
HLHC VA with spectacle correction.
Subjective quality of vision will be assessed using Contact Lens User Experience (CLUE) 
questionnaire. CLUE is a patient-reported outcomes questionnaire to assess patient-
experience attributes of soft, disposable contact lenses (comfort, vision, handling, and 
packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores 
using Item Response Theory (IRT) follow a normal distribution with a population average 
score of 60 (SD 20), where higher scores indicate a more favorable/positive response.8 A 5-
point increase in an average CLUE score translates into 10% shift in the distribution of 
scores for population of soft disposable contact lens wearers.
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Overall preference between AO1D and AO1DfA correction will be assessed using a 
preference questionnaire at the final visit. The questionnaire will include ‘no overall 
preference’ option. 
Other Exploratory Endpoints
Exploratory endpoints for this study will be:
Other observations (efficacy):
x
High-Luminance, Low-Contrast (HLLC) VA at follow-up, and with spectacle wear at
the end of the washout period
x
Number of diagnostic lenses required to achieve fit success for the contact lens
corrections
x
Length of time required to fit the contact lens corrections
x
CLUE comfort and handling scores at 1-week follow-up for the contact lens
corrections, and CLUE vision with spectacle wear at the end of the washout period
x
MRD and NEI-RQL questionnaire response for the contact lens corrections and with
spectacle wear at the end of the washout period
x
Subjective ranking of corrections (sphere, toric, and habitual spectacles) in order of
preference at the final visit
x
Average wear time and comfortable wear time for the contact lens corrections
x
Lens fitting characteristics for the contact lens corrections
x
Settled lens orientation (for the AO1DfA contact lenses only)
x
Subject reported ocular symptoms
Other observations (safety):
x
Slit lamp findings
x
Adverse events
2.3.
Hypotheses 
Primary Hypothesis
1. After 1 week of wear, monocular HLHC VA for correction with AO1DfA lenses will
be superior to that for mean sphere correction with AO1D spherical lenses.
Secondary Hypotheses
1. After 1 week of wear, the mean CLUE vision score for binocular correction with
AO1DfA lenses will be superior to that for binocular mean sphere correction with
AO1D spherical lenses.
2. After 1 week of wear HLHC VA for correction with AO1DfA lenses will be non-
inferior to that for correction with subjects’ habitual spectacles, using a non-inferiority
boundary of -0.05 logMAR.
3. After 1 week of wear, subjects will have greater overall preference for binocular
correction with AO1DfA lenses over AO1D spherical lenses.
The primary hypothesis must be met for the study to be considered successful. 
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3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The target population for this study will be adult soft contact lens wearers between 18 and 39
years of age (inclusive) with myopia and low astigmatism (suitable for correction with 
either -0.75 or -1.25 cylinder power) in both eyes. Note that the target population may
habitually wear sphere or toric lenses, so long as they meet the refractive eligibility criteria. 
3.2.
Inclusion Criteria 
Potential subjects must satisfy of all the following criteria to be enrolled in the study.
Inclusion Criteria following Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a
fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear soft contact lenses (sphere or toric) in both eyes in a daily
reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual
wear is defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per
week during the past 4 weeks.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. In both eyes, have magnitude of the cylinder component of their vertex-corrected distance
refraction greater than or equal to 0.625 DC and less than 1.625 DC.
7. In both eyes, have the mean sphere of their vertex-corrected distance refraction minus
half of the indicated contact lens label cylinder power be between -0.875 to -4.625 DS
(inclusive).
8. For each eye, have the cylinder axis of their distance refraction between 165° and 15°
(i.e., 180±15°, inclusive) or between 75° and 105° (i.e., 90±15°, inclusive).
9. For both eyes, have the sphere power of their habitual spectacles within ±0.50 Diopters
Sphere (DS) (inclusive) of the sphere power of their current subjective refraction.
10. For both eyes, have the cylinder power of their habitual spectacles within ±0.50 Diopters
Cylinder (DC) (inclusive) of the cylinder power of their current subjective refraction.
11. For both eyes, have the cylinder axis of their habitual spectacles within ±20° (inclusive)
of the cylinder axis of their current subjective refraction.
12. Achieve monocular VA of 20/30 or better with their habitual spectacles in both eyes.
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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 following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have any ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of
medication that might contraindicate or interfere with contact lens wear, or otherwise
compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis),
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]),
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s syndrome), or history of serious
mental illness or seizures. See section 9.1 for additional details regarding excluded
systemic medications.
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact lenses.
7. Be currently wearing lenses in an extended wear modality.
8. Have a history of strabismus or amblyopia.
9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family
member of an employee (including partner, child, parent, grandparent, grandchild or
sibling of the employee or their spouse) of the clinical site.
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to
study enrollment.
Exclusion Criteria at Baseline Evaluation
The subject must not:
11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study endpoints (including entropion,
ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions,
aphakia, moderate or above corneal distortion, herpetic keratitis).
12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
13. Have had or have planned (within the study period) any ocular or intraocular surgery
(e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
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4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design 
This will be a 5-visit, randomized, partially single-masked, bilateral wear, dispensing, 2-
treatment × 2-period crossover study with spectacle-wear washout and wash-in periods.
Subjects will be randomized into one of two unique sequences to wear each contact lens
correction one at a time (sphere followed by toric or toric followed by sphere sphere). For 
each of the two wear periods, lenses will be worn bilaterally in a daily wear, daily disposable 
modality for 7(±2) days. Lenses will be worn for a minimum of 8 hours per day on at least 5 
days of the wear period. There will be a 7(±2) day wash-in period prior to the first study lens 
wear period, and a 7(±2) day washout period between the first and second wear periods. 
During thew wash-in and washout periods, subjects will only wear their own habitual 
spectacle correction (i.e., no contact lens wear). Subjective comfort, vision, and handling will 
be assessed at fitting and follow-up visits for each contact lens wear period using the CLUE 
questionnaire, and CLUE vision will also be assessed at the end of the washout period. 
HLHC VA and HLLC VA will be assessed with the study contact lenses at the 1-week 
follow-up visits and with spectacle wear at the end of the washout period. At the final study 
visit, contact lens preference will be assessed (i.e., preference between the study contact 
lenses) as well as overall correction ranking (i.e., corrections ranked by preference 
considering both study lenses and habitual spectacles). Subjects will not have access to the 
study lenses following completion of the protocol.  
4.2.
Study Design Rationale 
A crossover design was chosen for efficient comparison of the two study lenses with a
relatively small sample size, as this removes inter-subject variance from the comparison.
Washout and wash-in periods with equal duration to the wear periods are included to reduce 
the potential for carryover effects and to allow comparison with the subject’s habitual 
spectacle correction. 
The AO1D and AO1DfA lenses were chosen as they have the same base material, and both 
have a history of commercial success. The CLUE questionnaire was selected on the basis of 
being the best available validated PRO tool for assessing subjective overall comfort, vision 
and handling among the population of soft contact lens wearers. HLHC VA using ETDRS 
charts was included on the basis of this being the best available method for objectively 
assessing visual acuity. 
The investigational lenses will be fitted by optometrists who are experienced at fitting soft 
contact lenses and will be evaluated by habitual contact lens wearers in their standard 
wearing environment. 
4.3.
Enrollment Target and Study Duration 
This study will have an enrollment target of 170 subjects, with a target of at least 153 to
complete. The study will be conducted at approximately 12 clinical sites, where the 
enrollment target for each site will be approximately 14 subjects. A subject will be 
considered enrolled upon signing of the informed consent form.  
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There will be 5 visits in total per subject; total study duration including the enrollment period 
is expected to be approximately 11 weeks. Subjects who are discontinued prior to the final 
evaluation may be replaced at the discretion of the study sponsor. The investigation will end 
at the time that the study data is hard locked.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
This will be a randomized, partially subject-masked, 2×2 crossover study. Subjects will be 
randomized into one of 2 unique sequence groups in a 1:1 allocation ratio to wear 2 different 
study lenses one at a time bilaterally over 2 wear periods (AO1D followed by AO1DfA, or
AO1DfA followed by AO1D).
Use of the test articles will be randomized using a randomization scheme supplied by the 
study biostatistician.  The randomized assignment of subjects will be performed at the first 
visit prior to the first fitting. Clinical sites will follow the randomization scheme provided 
and will not pre-select or assign subjects. The following must have occurred prior to 
randomization:
x
Informed consent must have been obtained
x
The subject must have met all inclusion and exclusion criteria
x
The subject history and baseline information must have been collected
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups.
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
randomization scheme (lens fitting schedule) to obtain the test article assignment for
that subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of
the randomization scheme (lens fitting schedule).
3. Investigator or designee will pull the appropriate test articles from the study supply.
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed
outside the clinical site) or not, must be recorded on the Test Article Accountability
Log in the “Dispensed” section.
5.2.
Masking 
This will be a partially single-masked trial; subjects will not be aware of the identity (i.e., 
brand) of the assigned lenses, however, they will be able to differentiate between the AO1D 
and AO1DfA lenses due to differences in label powers, lens shape and scribe markings. Due 
to the different fitting procedure requirements for sphere and toric lenses, investigators and 
site staff will not be masked. 
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5.3.
Procedures for Maintaining and Breaking the Masking 
Two randomization codes (alphanumeric characters) will be generated, one for the AO1D 
lens and one for the AO1DfA lens, using the form 
. Study lenses will be supplied 
in blister packs labelled with the study number, lot number, sphere power, expiration date 
and the randomization codes. Sponsor personnel involved in the conduct of the trial will not
be masked to the identity of study lenses.
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 to obtain the test article assignment for that subject prior to
dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of
the lens fitting schedule.
3. Investigator or designee will pull the appropriate test articles from the study supply.
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed
outside the clinical site) or not, must be recorded on the Test Article Accountability
Log in the “Dispensed” section.
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 the subject knowing
their treatment status. 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.
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. If necessary, subjects who are discontinued may be
replaced to reach the subject completion target. 
6.
STUDY INTERVENTION
6.1.
Identity of Test Articles  
Parameters for the test and control designs to be used in this study are shown in the table 
below:
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Lens cases and fluorescein strips (either 0.6 mg or 1.0 mg) will be supplied for use as needed.
6.3.
Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.
6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. Lenses will be over-
labeled to mask subjects to the identity of the lenses. The sample study labels are shown
below:
Sample of Primary Packaging
Secondary Packaging
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6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures. When possible, any lens or test 
article associated with an Adverse Event and/or a Product Quality Complaint must be 
retained and stored in a glass vial with moderate solution pending directions from the sponsor 
for potential return to JJVC.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by 
the Investigator for dispensing. The Investigator may delegate this activity to authorized 
study site personnel listed on the Site Delegation Log. All test articles must be accounted. 
This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the 
subject’s participation. Subject returned unused test articles must be separated from the 
clinical study inventory of un-dispensed test articles and must be labeled with the subject 
number and date of return. Following final reconciliation of test articles by the monitor, the 
Investigator or monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
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1.14
Eligibility at baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible.
Note: If:
x The subject fails to meet baseline criteria
due to the power of their spectacle lenses
not being within the specified tolerance of
their current subjective refraction or their
VA with spectacles being worse than 20/30
in either eye (inclusion criterion 9, 10, 11
or 12), AND
x The subjects best corrected monocular
visual acuity is 20/30 or better in both
eyes, AND
x The subject’s frame is suitable for updating
with new lenses*
Then offer to the subject that they may order 
new single vision distance lenses to be fitted 
in their current spectacle frame*, where the 
study sponsor will cover the cost of the new 
lenses. The subject may then return to repeat 
the baseline evaluation (one time) at a later 
date, after the updated spectacles are 
dispensed. 
*Subjects may choose to purchase a new
spectacle frame (rather than updating the 
lenses in their existing frame), however JJVC 
will only cover the cost of new lenses.
If subject is deemed to be ineligible at
baseline and would not meet eligibility 
criteria after having their spectacle lenses 
updated as described above, proceed to Final 
Evaluation. If the subject would meet the 
eligibility criteria after updating their 
spectacle lenses but chooses not to, mark 
‘No’ on the Lens Fitting Prompt for the 
“eligible to return for another Baseline” and 
proceed to final evaluation. 
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8.
SUBJECTS COMPLETION/WITHDRAWAL
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
x
provided informed consent.
x
they are eligible.
x
have not withdrawn/discontinued from the study for any reason described in section
8.2.
x
completed all visits through the final visit (visit 5).
x
If all visits were completed but an additional visit is considered necessary for subject
care, follow the requirements for unscheduled visits in section 7.3.
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent.
x
Subject not compliant to protocol.
x
Subject lost to follow-up.
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of
study lens wear.
x
Subjects who have experienced a Corneal Infiltrative Event (CIE).
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the
best interest of the subject to stop treatment).
x
Subject 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 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal. The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
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the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
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.  
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Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms,
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
x
Confirmation of product availability for return (and tracking information, if
available), or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented.
13. ADVERSE EVENTS
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of
the study.
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2. Was present prior to the study but worsened during the study. This would include any
condition resulting from concomitant illnesses, reactions to concomitant medications,
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the 
following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth
defect.
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)
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x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually 
asymptomatic and usually do not warrant discontinuation of contact lens wear but may cause 
a reduction in wear time.  However, the Investigator may choose to prescribe treatment as a 
precautionary measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event,
which necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
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x
Causality or Relatedness – i.e. the relationship between the test article, study treatment
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of
intensity of the adverse event (mild, moderate, or severe - see definition in
section 13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time
suggests that a causal relationship is not likely.
x
Possibly Related – An adverse event that might be due to the use of the test article, or
to the study treatment or study procedures. An alternative explanation, e.g.
concomitant treatment, concomitant disease(s), is inconclusive. The relationship in
time is reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or
adverse reaction (drug) and cannot be reasonably explained by an alternative
explanation, e.g. concomitant treatment of concomitant disease(s). The relationship in
time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject. The assessment 
of severity is made irrespective of test article, study treatment or study procedure relationship 
or seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy
and interferes with the subject’s daily activities.
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 
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reported before the use of test article, start of study treatment, or study procedures will be
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements. Such documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate 
Assessment eCRF. Where necessary, a culture of the corneal lesion will be collected to 
determine if the 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 
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intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. 
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study 
visit date, should be followed to resolution of the adverse event or until referral to an 
appropriate health care provider, as recommended by the Investigator. Non-ocular adverse 
events that are not related to the test article, study treatment, or study procedures may be 
recorded as “ongoing” without further follow-up.
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or 
telephone as soon as possible and no later than 24 hours from discovery for any serious 
/significant adverse events, and 2 days from discovery for any non-significant adverse event. 
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements (section 13.4.2). The report will comment whether the
adverse event was considered to be related to the test article, study treatment or study 
procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
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.
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x
Provide the Sponsor with a complete case history which includes a statement as to
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect. This report is in addition to 
the immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
forth by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines 
set forth by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None.
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur 
secondary to systemic hormonal changes, and not due to unforeseen health risks to the 
mother or fetus.
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14. STATISTICAL METHODS
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. 
A general description of the statistical methods to be implemented in this clinical trial is 
outlined below.
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC). 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 170 subjects with a target of at least 153 subjects to complete. No
historical 2 by 2 crossover study was available to estimate the treatment difference of the 
primary and secondary endpoints between the Test (AO1DfA) and the Control (AO1D) on 
the study population. The Visual Performance HLHC logMAR and Contact Lens Preference 
from 
 between 1-Day ACUVUE® Moist Astigmatism and 1-Day ACUVUE® Moist 
were summarized in Table 7. These estimates are used as references to estimate the power for 
the primary hypothesis in Table 8 and for the third secondary hypothesis (S3) in Table 11.
Due to the lack of historical data, several scenarios are enumerated to estimate the power for 
the first secondary hypothesis (S1) in Table 9 and similarly for second secondary hypothesis 
(S2) in Table 10. Scenarios with above 80% power is highlighted in blue. The power 
calculations were conducted with paired t test for the primary, first and second secondary 
hypotheses; and with Pearson’s chi-square test for the third hypothesis using the POWER 
procedure in SAS 9.4.
Table 7: Historical Data from 
Endpoint
N Subjects
1-Day
ACUVUE® Moist
for Astigmatism
1-Day
ACUVUE®
Moist 
Intraclass 
Correlation
Visual Performance 
(HLHC logMAR)
72
Mean (SD)
-0.09 (0.08)
Mean (SD)
-0.02 (0.09)
0.399
Contact Lens 
Preference
72
N (%)
49 (68.1%)
N (%)
17 (23.6%)
-
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14.6. Secondary Analyses 
The secondary analyses will be conducted on Intent-to-Treat populations to establish 
superiority and Per-protocol populations for non-inferiority.
CLUE Vision score – (S1)
CLUE vision scores at 1-week follow-up will be analyzed using a linear mixed effect model. 
This model will include the experimental design factors: sequence of lens wear, lens wearing 
period, lens type and the interaction between lens type and lens wearing period as fixed 
effects. Baseline characteristics known of importance such as age and gender will be 
included as fixed covariates. Site will be included as random effects (G-side). The covariance 
of residuals between of the same subject (R-side) across period will be modeled using either 
homogenous compound symmetry (CS) or unstructured (UN) covariance structure. The 
structure that returns the lowest finite sample corrected Akaike’s Information criterion10 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 freedom11.
The null and alternative hypotheses for superiority of CLUE Vision for the Test (AO1DfA) 
minus Control (AO1D) is as follows:
ܪ0: Δ ≤0.0
ܪܣ: Δ > 0.0
where Δ is the least-square means (LSM) difference between the Test and Control lens (Test 
minus Control). Superiority for the Test to the Control lens will be established on ITT 
population if the lower bound of the 95% two-sided confidence interval (CI) for least squares
mean (LSM) difference (Test - Control) of CLUE Vision score is greater than 0.
Visual Performance (HLHC logMAR) – (S2)
The comparison of Monocular distance visual performance of HLHC in logMAR scale
between the Test (AO1DfA) to the Control (Spectacles) will be analyzed using a similar 
linear mixed effect model described in the primary analysis above. Since this endpoint for the 
Test lens (AO1DfA) will be collected before or after the Control (Spectacles) and no 
carryover effect is expected in objective visual performance, the lens wearing period can be 
defined accordingly.    
The null and alternative hypotheses for non-inferiority of Test lens (AO1DfA) relative to 
Control (Spectacles) are as follows:
ܪ0: Δ > 0.05
ܪܣ: Δ ≤ 0.05
where Δ is the mean difference in logMAR between Test lens and Control lens (Test minus 
Control).  Non-inferiority will be declared on Per-protocol population if the upper bound of 
the (1- α) two-sided confidence interval of the mean difference between Test and Control is 
less than 0.05. The α is the Type I error derived from Gatekeeping strategy and α-
propagation in Section 14.4.  If the non-inferiority is established, superiority will be declared 
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if the upper bound of the confidence interval of the mean difference between Test and 
Control is less than 0.0.
Contact Lens Preference – (S3)
Contact lens preference question will be analyzed using a baseline-category logistic model,
where the response of the Control lens preference is the baseline category. This model will 
include the experimental design factors: sequence of lens wear, lens wearing period, lens 
type and the interaction between lens type and lens wearing period as fixed effects. Baseline 
characteristics known of importance such as age and gender will be included as fixed 
covariates.
The null and alternative hypotheses for superiority of Test (AO1DfA) lens relative to Control
(AO1D) are as follows:
ܪ0: Δ ≤1.0
ܪܣ: Δ > 1.0
where Δ is the odds of the preference for the Test to the preference for the Control (Test 
divided by Control). Superiority for the Test to the Control lens will be established on ITT 
population if the lower bound of the (1- α) % two-sided confidence interval (CI) for least 
squares mean (LSM) odds (Test divided by Control) of the contact lens preference is greater
than 1.0. The α is the Type I error derived from Gatekeeping strategy and α-propagation in 
Section 14.4.
14.7. Other Exploratory Analysis 
Not applicable.
14.8. Interim Analysis 
Not applicable.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change.
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15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis. 
No external data sources will be included in this study.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit. Only specifically delegated staff can enter data on a CRF.  
Once completed, the eCRFs will be reviewed for accuracy and completeness and signed by 
the Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to 
the subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate 
and complete data collection. Data will be transmitted from the clinical site to a secure 
central database as forms are completed or updated, ensuring information accuracy, security, 
and confidentiality. After the final database lock, the Investigator will be provided with 
Individual Patient Profiles (IPP) including the full audit trail on electronic media in PDF 
format for all of the study data. The IPP must be retained in the study files as a certified copy 
of the source data for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if
applicable
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The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.
16. DATA MANAGEMENT
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, 
scientific data or other pertinent information is confidential and remains the property of 
JJVC. The Investigator may use this information for the purposes of the study only. It is 
understood by the Investigator that JJVC will use information developed in this clinical study 
in connection with the development of the investigational product and therefore may disclose 
it as required to other clinical investigators and to regulatory agencies. In order to allow the 
use of the information derived from this clinical study, the Investigator understands that 
he/she has an obligation to provide complete test results and all data developed during this 
study to the Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the 
conduct of clinical trials. The clinical sites will provide direct access to study-related source 
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data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
Not applicable for this study. 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any
subsequent versions, and regulatory requirements are maintained.
x
Ensuring the rights and wellbeing of subjects are protected.
x
Ensuring adequate resources, including facilities, laboratories, equipment, and
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as
applicable.
x
Ensuring that the clinical site has sufficient test article and supplies.
x
Clarifying questions regarding the study.
x
Resolving study issues or problems that may arise.
x
Reviewing of study records and source documentation verification in accordance with
the monitoring plan.
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, 
during the study, subjects will be given any new information that may affect their decision to 
continue participation. Subjects will be told that their consent to participate in the study is 
voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled. Subjects will only be enrolled if 
the fully able to understand the risks, benefits, and potential adverse events of the study and
provide their consent voluntarily.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good 
Clinical Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless
not required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval 
letter must be dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided
to subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
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For protocol revisions that increase subject risk, the revisions and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local 
requirements after the nature of the study has been fully explained. The consent form must be 
signed before performance of any study-related activity. The consent form that is used must 
be approved by both the Sponsor and by the reviewing IEC/IRB. The informed consent is in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH GCP2
and ISO 14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA)4 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 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents.
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 
CR-6459, v4.0
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical 
Research Agreement. The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol 
violations such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION
Outcomes of this study may be published, at the discretion of the study Sponsor. 
22. REFERENCES
.
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html
2. International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP).
Available at: https://www.ich.org/page/efficacy-guidelines
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
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Johnson & Johnson Vision Care, Inc.
4. United States (US) Code of Federal Regulations (CFR). Available at:
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Morgan, P. B., Woods, C. A., Tranoudis, I. O., Efron, N., Jones, L., Aighamdi, W., et
al. (2019). International Contact Lens Prescribing in 2018. Contact Lens Spectrum,
34(1), 26–32.
6. Taneri, S., Arba-Mosquera, S., Rost, A., Kießler, S., & Dick, H. B. (2020).
Repeatability and reproducibility of manifest refraction. Journal of Cataract &
Refractive Surgery, 46(12), 1659-1666.
7. Osborn Lorenz, K. Clinical Report #(
) Toric Eye Strain and
Stability (TESS). February 1, 2016.
8. Wirth RJ, Edwards MC, Henderson M, et al. Development of the contact lens user
experience: CLUE scales. Optometry and Vision Science. 2016;93.8:801.
9. Health Information Portability and Accountability Act (HIPAA). Available at:
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
10. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A comparison of two
approaches for selecting covariance structures in the analysis of repeated
measurements. Communications in Statistics - Simulation and Computation.
1998;27(3):591-604.
11. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted
Maximum Likelihood. Biometrics. 1997;53(3):983.
12. Bretz, F., Posch, M., Glimm, E., Klinglmueller, F., Maurer, W., & Rohmeyer, K.
(2011). Graphical approaches for multiple comparison procedures using weighted
Bonferroni, Simes, or parametric tests. Biometrical Journal, 53(6), 894-913.
CR-6459, v4.0
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A Patient Instruction Guide (PIG) will be provided separately.
Page 109 of 200

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Page 110 of 200

DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
.25D to -10.00D
• Axis Range:
2.5° to 180°
Page 113 of 200

AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
Page 114 of 200

• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious advers
 is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
Page 

extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products.
• The overall risk of ulcerative keratitis may be reduced by carefully 
following directions for lens care.
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783
Speciﬁ c Instructions for Use and Warnings:
• Water Activity
Instructions for Use
Do not expose contact lenses to water while wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, 
vision loss or blindness. If lenses have been submersed in water 
when participating in water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient should be instructed to discard them 
and replace them with a new pair. The Eye Care Professional should 
be consulted for recommendations regarding wearing lenses during 
any activity involving water.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investiga-
tion of lenses, all refractive powers, design conﬁ gurations, or lens 
parameters available in the lens material are not evaluated in signif-
icant numbers. Consequently, when selecting an appropriate lens 
design and parameters, the Eye Care Professional should consider 
all characteristics of the lens that can affect lens performance and 
ocular health, including oxygen permeability, wettability, central and 
peripheral thickness, and
 diameter.
P
1 8
0

• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handli
r
n, removal, and wearing 
instructions in the “Patient Instruction Guide” for the prescribed 
Page 119 of 200

wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
Page 120 of 200

Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potential for some temporary impairment due to 
Page 121 of 200

peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
Page 122 of 200

GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be selected for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
 
Page 123 of 200

Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll 
ﬁ nd two primary marks approximately 1 mm from the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, 
either mark can represent the vertical position – there is no “top” 
and “bottom” as in a prism-ballasted lens. You don’t need to view 
both marks to assess orientation; simply look for the 6 o’clock 
mark as you would with 
-
llasted lens.
Page 125 of 200

Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
Page 126 of 200

B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
Page 127 of 200

Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
Page 128 of 200

MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately 
corrected distance and near visual acuity in each eye. The 
amblyopic patient or the patient with signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
Page 129 of 200

B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an 
 
 would only require a near 
lens, whereas a bilateral myope would require corrective lenses on 
CR-6459, v4.0
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JJVC CONFIDENTIAL

both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s perform
u
er the above conditions 
is completed, tests of vis
ac it and reading ability under 
CR-6459, v4.0
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JJVC CONFIDENTIAL

Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
CR-6459, v4.0
 
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JJVC CONFIDENTIAL

the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
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JJVC CONFIDENTIAL

The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day 
MATISM: base curve, power, 
diameter, cylinder, axis, lot
and expiration date
CR-6459, v4.0
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JJVC CONFIDENTIAL

REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 
x
LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL
REFRACTIONS
x
 BIOMICROSCOPY SCALE
x
DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
TORIC FIT EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
 PATIENT REPORTED OUTCOMES
x
 LENS INSERTION AND REMOVAL
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION
TESTING
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 LENS FITTING CHARACTERISTICS 
 
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 SUBJECT REPORTED OCULAR OUTCOMES 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
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BIOMICROSCOPY SCALE 
 
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Title:
Biomicroscopy Scale
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Title:
Biomicroscopy Scale
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Biomicroscopy Scale
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Title:
Biomicroscopy Scale
Document Type:
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Revision Number:  10
  
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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TORIC FIT EVALUATION 
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ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
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Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 5 
 
 
 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 5 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
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Title:
Patient Reported Outcomes
Document Type:
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3
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 LENS INSERTION AND REMOVAL 
 
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Lens Insertion and Removal
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
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APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
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Title:
Guidelines for COVID-19 Risk Mitigation
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1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures.
x
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
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STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
4.1.3
Protocol Compliance Investigator(s) Signature Page:
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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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
per Study Site Initiation 
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.).
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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6.1.3
Study Site Closure:  
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).  
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Attachment A: Study Site Correspondence
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principal Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.   
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
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RESOURCE LINKS
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist   
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf
OUS Resource Links 
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings html
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x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health:
https://www health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
 
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6459 Clinical Evaluation of Spherical Soft Contact Lenses, Toric 
Soft Contact Lenses and Spectacles in Low Astigmats
Version and Date: 4.0 11 November 2021
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to 
all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion.
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed 
about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in the Appendix E of this protocol). I agree to conduct 
this study in compliance with local, state, governmental guidance for COVID-19 risks.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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