Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Phase: NA
Conditions: Ocular Physiology
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week of 
Wear
Protocol CR-6478
Version: 1.0
Date: 15 December 2021
Investigational Products: Alcon PRECISION1® for Astigmatism Daily Contact Lenses, 
CooperVision MyDay® Toric Soft Contact Lenses
Keywords: Astigmatism, Alcon PRECISION1® for Astigmatism, CooperVision MyDay®
Toric, verofilcon A, stenfilcon A, daily wear, daily disposable, dispensing, Single use Eye-
Cept® Rewetting Drops, LacriPure Saline Solution, ScleralFil Preservative Free Saline 
Solution, CLUE comfort, CLUE vision, CLUE handling, logMAR visual acuity, rotation 
performance.
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...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives................................................................................................................. 17 
2.2. 
Endpoints.................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria...................................................................................................... 18 
3.3. 
Exclusion Criteria..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 19 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration.................................................................... 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 21 
5.1. 
Test Article Allocation............................................................................................. 21 
5.2. 
Masking.................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION............................................................................................. 22 
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6.1. 
Identity of Test Articles............................................................................................ 22 
6.2. 
Ancillary Supplies/Products..................................................................................... 23 
6.3. 
Administration of Test Articles................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS.............................................................................................. 25 
7.1. 
Time and Event Schedule......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 27 
VISIT 1 ........................................................................................................................... 27 
VISIT 2 ........................................................................................................................... 33 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 36 
FINAL EVALUATION.................................................................................................. 38 
7.3. 
Unscheduled Visits................................................................................................... 38 
7.4. 
Laboratory Procedures ............................................................................................. 40 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 40 
8.1. 
Completion Criteria.................................................................................................. 40 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 40 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 41 
9.1. 
Systemic Medications .............................................................................................. 41 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 42 
11. 
STUDY TERMINATION ........................................................................................... 43 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 44 
13. 
ADVERSE EVENTS................................................................................................... 45 
13.1. 
Definitions and Classifications............................................................................. 45 
13.2. 
Assessing Adverse Events.................................................................................... 47 
13.2.1. 
Causality Assessment.................................................................................... 48 
13.2.2. 
Severity Assessment...................................................................................... 48 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 48 
13.4. 
Reporting Adverse Events.................................................................................... 50 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 50 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
………………………………………………………………………………51 
13.5. 
Event of Special Interest....................................................................................... 51 
13.6. 
Reporting of Pregnancy........................................................................................ 51 
14. 
STATISTICAL METHODS........................................................................................ 51 
14.1. 
General Considerations......................................................................................... 51 
14.2. 
Sample Size Justification...................................................................................... 52 
14.3. 
Analysis Populations ............................................................................................ 52 
14.4. 
Level of Statistical Significance........................................................................... 52 
14.5. 
Primary Analysis .................................................................................................. 52 
14.6. 
Secondary Analysis .............................................................................................. 52 
14.7. 
Exploratory Analysis............................................................................................ 52 
14.8. 
Interim Analysis ................................................................................................... 53 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 53 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 53 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 53 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 53 
15.2. 
Subject Record...................................................................................................... 54 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 54 
16. 
DATA MANAGEMENT............................................................................................. 54 
16.1. 
Access to Source Data/Document ........................................................................ 54 
16.2. 
Confidentiality of Information.............................................................................. 54 
16.3. 
Data Quality Assurance........................................................................................ 55 
16.4. 
Data Monitoring Committee (DMC).................................................................... 55 
17. 
CLINICAL MONITORING........................................................................................ 55 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 56 
18.1. 
Study-Specific Design Considerations ................................................................. 56 
18.2. 
Investigator Responsibility................................................................................... 56 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 56 
18.4. 
Informed Consent ................................................................................................. 57 
18.5. 
Privacy of Personal Data ...................................................................................... 58 
19. 
STUDY RECORD RETENTION................................................................................ 59 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 60 
21. 
PUBLICATION........................................................................................................... 60 
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22. 
REFERENCES ............................................................................................................ 60 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 61 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 72 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 73 
APPENDIX D:
...................................... 79 
, LENS FITTING CHARACTERISTICS.............................................................. 80 
, SUBJECT REPORTED OCULAR SYMPTOMS............................................... 86 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 88 
 BIOMICROSCOPY SCALE ............................................................................... 94 
, DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 100 
 TORIC FIT EVALUATION.............................................................................. 105 
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE .. 110 
 PATIENT REPORTED OUTCOMES .............................................................. 114 
 LENS INSERTION AND REMOVAL ............................................................. 116 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 119 
APPENDIX E:
 GUIDELINES FOR COVID-19 RISK MITIGATION ............ 128 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 140 
 
LIST OF TABLES
Table 1: Test Articles.............................................................................................................. 23 
Table 2: Ancillary Supplies .................................................................................................... 23 
Table 3: Time and Events ....................................................................................................... 25 
Table 4: Disallowed systemic medications............................................................................. 41 
Table 5: Disallowed systemic antihistamines......................................................................... 42 
Table 6: Examples of major and minor protocol deviations................................................... 43 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 14 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Clinical Evaluation of Two Daily Disposable Toric Soft Contact Lenses Over One Week 
of Wear
Protocol Number: CR-6478
Version: 1.0
Date: 15 December 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name: 
Title: 
Address: 
24 Hour Contact Telephone #
Email: 
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
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 Two Daily Disposable Toric Soft 
Contact Lenses Over One Week of Wear
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Descriptive study 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: 
Test: PRECISION1® for Astigmatism Contact Lenses (P1fA)
Control: MyDay® Toric Soft Contact Lenses (MDT)
Wear and Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily disposable
Objectives 
Primary Objective:
To evaluate the incidence of grade 3 or higher biomicroscopy 
findings following a 7(±2) day wear period for PRECISION1®
for Astigmatism Contact Lenses (P1fA) relative to MyDay®
Toric Soft Contact Lenses (MDT) as control.
Exploratory Objectives:
To evaluate the subjective comfort, vision and handling, 
visual acuity, and rotational performance over a 7(±2) day 
wear period for P1fA relative to MDT as control.
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Study Endpoints
Primary endpoint:
x
Incidence of grade 3 or higher biomicroscopy findings 
using the FDA grading scale following a 7(±2) day
wear period
Observational endpoints (efficacy):
x
Subjective comfort, vision and handling at fitting and 
following a 7(±2) day wear period using the CLUE 
questionnaire
x
High-luminance, high-contrast (HLHC) visual acuity
in logMAR measured using ETDRS charts at follow-
up
x
Lens orientation at 1 minute and 3 minutes following 
insertion at fitting
x
Mean and standard deviation of settled lens orientation
calculated from repeated measures of settled lens
orientation at fitting and follow-up visits 
Observational endpoints (safety):
x
Adverse events
All endpoints will be summarized using descriptive statistics 
only; no formal hypothesis testing is planned.
Study Design
This is a bilateral, dispensing, randomized, controlled, double 
masked, 2×2 cross-over study. Each subject will be randomly 
assigned to one of two wear sequences (test followed by 
control or control followed by test). Each wear period will be 
7(±2) days, with a 7(±2) day washout period between wear 
periods. 
There will be a total of 4 visits:
Visit 1: Screening, baseline evaluation and lens fit #1 
Visit 2: Follow-up evaluation for first lens
Visit 3: Continuance, lens fit #2
Visit 4: Follow-up evaluation for second lens
See the flow chart at the end of the synopsis table for a
schematic of the study visits and procedures (Figure 1).
Sample Size
This study will have an enrollment target of approximately 66 
subjects, with a target of at least 60 to complete (assuming a 
dropout rate of 10%).
Study Duration
Total study duration including the enrollment period is 
anticipated to be approximately 8 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).
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 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 month.
5. Possess a wearable pair of spectacles that provide 
correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. Have the spherical component of their vertex-corrected 
distance refraction must be between -0.875 to -4.625 DS 
(inclusive) in each eye.
7. Have the magnitude of the cylindrical component of their 
vertex-corrected distance refraction between 0.625 DC 
and 1.625 DC in both eyes.
8. 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) in each eye.  
9. Have best corrected monocular distance visual acuity of 
20/30 or better in each eye.
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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, 
history of recurrent corneal erosions, aphakia, moderate or 
above corneal distortion, herpetic keratitis). 
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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 procedures associated with the observational 
endpoints for this study will be:
- Grading of ocular physiology by slit lamp biomicroscopy 
using the FDA grading scale
- Completion of the CLUE questionnaire at fitting and 
follow-up
- Measurement of HLHC VA using ETDRS charts at follow-
up
- Measurement of toric lens orientation using a slit lamp 
biomicroscope
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
Statement of Informed Consent
Demographics
Medical History & Concomitant Medications
Habitual Contact Lens Information
Eligibility at Screening
Baseline Evaluation
Subject Reported Ocular Symptoms
Entrance visual acuity
Spherocylindrical refraction and distance visual acuity
Slit lamp biomicroscopy findings
Eligibility after Baseline
Baseline CLUE questionnaire (habitual lenses)
Lens Fitting (#1 through #3)
Lens assignment and insertion
Timed rotation assessments, lens settling
Toric and general fit assessment
Spherical over-refraction, modification if required
CLUE post-fit questionnaire
Additional samples of toric lens orientation
Lenses dispensed for 7r2 days
Follow-up (#1 through #3)
CLUE follow-up questionnaire
HLHC visual acuity using ETDRS charts
Record lens orientation
Additional samples of toric lens orientation
Lens removal
Biomicroscopy
Schedule next visit
Continuance
Review med history and medications
Subject reported ocular symptoms
Entrance VA and biomicroscopy
Confirm continuing eligibility
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 duration 
will be observed between wear periods
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
Add
Near addition; the additional power required for near vision correction 
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
COVID-19
Coronavirus Disease 2019
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
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LogMAR
Logarithm of Minimal Angle of Resolution
MDT
MyDay® Toric Soft Contact Lenses
OD
Right Eye
OS
Left Eye
OU
Both Eyes
P1fA
PRECISION1® for Astigmatism Contact Lenses
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
QA
Quality Assurance
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SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
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 
PRECISION1® (verofilcon A) for Astigmatism Contact Lenses (P1fA) and MyDay®
(stenfilcon A) Toric Soft Contact Lenses (MDT) are daily disposable lenses indicated for the 
correction of astigmatism and associated ametropia in persons with non-diseased eyes. The 
purpose of this study is to evaluate the ocular physiological response following wear of P1fA 
relative to MDT as control. 
1.1.
Name and Descriptions of Investigational Products  
The test lens in this study will be P1fA. P1fA contact lenses are made from a lens material that 
is 51% water and 49% verofilcon A, a silicone containing hydrogel. The color additive 
Reactive Blue 247 is added to the lens material to create a light blue edge-to-edge color to 
make it easier to see when handling. In addition, lenses contain a benzotriazole UV-absorbing 
monomer to block UV radiation. The transmittance characteristics are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 nm for the entire 
power range.
The control lens in this study will be MDT, which is made from stenfilcon A. The stenfilcon 
A material is primarily a random copolymer of polydimethylsiloxane methacrylate and 
vinylmethyl acetamide. The UV blocker used is a benzotriazolyl methacrylate. The lenses have 
a blue tint which is added to make the lens more visible for handling. The lenses also contain 
a UV absorbing monomer which is used to block UV radiation.
Further details about the test articles are found in section 6.1 of this protocol and in the P1fA 
and MDT package inserts (Appendix C).
1.2.
Intended Use of Investigational Products 
The intended use of the investigational products is the correction of astigmatism and associated 
myopic refractive error. Study lenses will be worn bilaterally in a daily wear, daily disposable 
modality for at least 8 hours per day. Each wear period will be 7±2 (i.e., 5 to 9) days in duration, 
and subjects will be instructed to wear lenses for at least 5 days per week during each wear 
period. Two wear periods will be completed, with a washout period of 7±2 days between the 
wear periods.
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable – marketed product only.
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1.4.
Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the investigational lenses will be the correction of refractive 
error. The risks associated with use of the investigational lenses are considered to be equivalent 
to those associated with other marketed soft contact lenses worn in the same modality (i.e., 
daily disposable).  
Comprehensive risk and benefit information regarding the P1fA and MDT lenses are included 
in the P1fA and MDT package inserts (Appendix C).
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Both P1fA and MDT are approved in the US for the correction of astigmatism and associated 
ametropia in persons with non-diseased eyes. 
For further details regarding literature references and prior data relevant to these lenses, refer 
to the P1fA and MDT package inserts (Appendix C).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
Primary Objective:
To evaluate the incidence of grade 3 or higher biomicroscopy findings following a 7(±2) day 
wear period for PRECISION1® for Astigmatism Contact Lenses (P1fA) relative to MyDay®
Toric Soft Contact Lenses (MDT) as control.
Exploratory Objectives:
To evaluate the subjective comfort, vision and handling, visual acuity, and rotational 
performance over a 7(±2) day wear period for P1fA relative to MDT as control.
2.2.
Endpoints  
Primary endpoint:
x
Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period 
Observational endpoints (efficacy):
x
Subjective comfort, vision and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire
x
High-luminance, high-contrast (HLHC) visual acuity in logMAR measured using 
ETDRS charts at follow-up
x
Lens orientation at 1 minute and 3 minutes following insertion at fitting
x
Mean and standard deviation of settled lens orientation calculated from repeated 
measures of settled lens orientation at fitting and follow-up visits 
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Observational endpoints (safety):
x
Adverse events
All endpoints will be summarized using descriptive statistics only; no confirmatory hypothesis
testing is planned.
2.3.
Hypotheses 
Not applicable; no confirmatory hypothesis testing for the primary endpoint is planned with 
respect to data collected in this study. Therefore, any hypothesis testing will be exploratory in 
nature.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
The target population for this study will be healthy adult soft contact lens wearers between 18 
and 39 years of age with binocular myopic astigmatism.  
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria at 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 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 month.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. Have the spherical component of their vertex-corrected distance refraction must be 
between -0.875 to -4.625 DS (inclusive) in each eye.
7. Have the magnitude of the cylindrical component of their vertex-corrected distance 
refraction between 0.625 DC and 1.625 DC in both eyes.
8. 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) in each eye.  
9. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
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3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria 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 4-visit, randomized, controlled, double-masked, bilateral wear, dispensing, 2×2
crossover study. Each subject will be randomized into one of two unique sequences to wear 
two different study lenses one at a time over two wear periods (test followed by control or 
control followed by test). During each wear period the lenses will be worn bilaterally for 1
week (7r2 days) in a daily disposable modality. Study lenses will be worn for a minimum of 
8 hours per day and at least 5 days per week during the wear period. Subjective comfort, vision 
and handling will be assessed using the CLUE questionnaire at both fitting and follow-up visits 
for each wear period. HLHC VA will be assessed at the follow-up evaluation using ETDRS 
charts. Ocular health will be assessed by slit lamp biomicroscopy and graded using the FDA 
grading scale at fitting and follow-up visits. There will be a washout period of 7r2 days 
duration between wear periods. Subjects will not have access to the study lenses following 
completion of the protocol.
4.2.
Study Design Rationale 
A 2×2 crossover study design was chosen to allow each subject to act as their own active 
control. A washout period will be included to mitigate any carryover effects. 
The prescribed wear schedule (7r2 days, minimum of 8 hours per day, minimum of 5 days per 
week) was chosen as this is representative of a typical wear schedule for contact lens wearers.
Slit lamp biomicroscopy was selected as the method for assessing ocular health, on the basis 
that it is the most commonly used instrument for comprehensive examination of the anterior
eye. The FDA slit lamp findings classification scale was selected for grading ocular health on
the basis that it is widely used and is part of the FDA regulatory guidance for contact lenses
(FDA 510(k) guidance). 
The investigational lenses will be fitted by optometrists who are experienced at fitting toric 
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 approximately 66 subjects, with a target of at least 
60 to complete. The study will be conducted at up to 5 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.  
There will be 4 visits in total per subject. The total study duration including the enrollment 
period is expected to be approximately 8 weeks. Subjects who are discontinued prior to the 
final evaluation may be replaced at the discretion of the study sponsor. The investigation will 
end at the time that the study data is hard locked.
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5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
This study will be a randomized, double-masked, 2×2 crossover design. Subjects will be 
randomized into one of 2 unique sequence groups in a 1:1 allocation ratio to wear two different 
study lens designs (test and control designs) one at a time bilaterally over 2 wear periods. 
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 
To reduce the possibility of bias, this will be a double-masked trial. Subjects will not be aware 
of the identity of the assigned lenses. The identity of the study lenses will be masked by having 
the blister packs labeled with the study number, lot number, sphere power, cylinder power, 
axis, expiration date and randomization code. While clinical trial personnel (including
investigators, site technicians, data management, the study biostatistician and clinical 
operations personnel) will be aware of the brand and type of lenses included in the study, every 
attempt will be made to ensure they are not made aware of the corresponding randomization 
codes for the test and control lenses. Only the unmasked Biostatistician generating the 
randomization scheme (lens fitting schedule) will have access to the decode information that
allows matching of the randomization codes to the investigational articles. The medical 
monitor will also have access to the decode information in case breaking the mask is necessary 
for the urgent medical treatment of a subject.
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5.3.
Procedures for Maintaining and Breaking the Masking 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor
personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued may be replaced at the 
discretion of the study sponsor.
6.
STUDY INTERVENTION 
6.1.
Identity of Test Articles  
The following contact lenses will be used in this study:
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NOTE: If the only reason for the unscheduled visit is that the subject requires additional 
test articles, only the dispensing information needs to be recorded.
7.4.
Laboratory Procedures  
Not applicable.
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 4). 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
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JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
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x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form Control No. 
for test article return instructions).
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
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x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
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Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from intentional
misuse of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
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13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely.
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious
adverse events” shall be captured on the appropriate case report form or electronic data system. 
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All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form (
)
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
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date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
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Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None.
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
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14.2. Sample Size Justification 
Approximately 66 subjects will be enrolled in this study to attain a minimum of 60 completed 
subjects.  All endpoints will be summarized using descriptive statistics only; no confirmatory 
hypotheses will be tested.  This is a descriptive study to evaluate the clinical performance of 
the P1fA and MDT lenses. Sample size is not based on the empirical power analysis. The data 
collected for this study may be used for designing future study if applicable.
14.3. Analysis Populations 
Safety Population:
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the Per-Protocol 
Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
No confirmatory hypothesis testing is planned for this study; hence, the level of statistical 
significance is not applicable. If exploratory statistical analysis is conducted after reviewing 
the descriptive summary of an endpoint, a type I error rate will be specified for the analysis.
Since all analyses for this study will be exploratory in nature, any positive results given by  
significance p-values will be for generating hypotheses for future studies and decisions are
required to make with cautions.
14.5. Primary Analysis 
Descriptive summary tables by Lens Type (P1fA vs. MDT) for the following safety and 
efficacy endpoints will be provided.
x
Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period 
14.6. Secondary Analysis 
Not applicable.  
14.7. Exploratory Analysis 
Descriptive summary tables by Lens Type (P1fA vs. MDT) for the following exploratory
endpoints will be provided
x
Subjective comfort, vision and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire
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x
High luminance, high contrast (HLHC) logMAR visual acuity measured using ETDRS 
acuity charts at 1-Week follow-up
x
Lens orientation at 1 minute and 3 minutes following insertion at fitting
x
Mean and standard deviation of settled lens orientation, as calculated from repeated 
measures of signed lens orientation at fitting and follow-up visits.
Other exploratory analyses will be determined after reviewing the descriptive summary at the 
discretion of the study responsible clinician and project team. They may be performed on study 
endpoints between lens type (P1fA vs. MDT) or on endpoints collected in previous JJVC-
sponsored studies to generate hypotheses for future confirmatory studies.
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.
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 
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confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.
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 
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Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
Not applicable 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.
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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 
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.
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This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
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.
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Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
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Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
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20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION 
There is no plan to externally publish the results of this investigation.
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/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
Page 61 of 140

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10
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A Patient Instruction Guide (PIG) will be provided separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Alcon PRECISION1® (VEROFILCON A) FOR ASTIGMATISM Soft Contact Lenses
COOPERVISION MyDay® (stenfilcon A) Toric SOFT CONTACT LENSES
Page 73 of 140

Part Number: PI01100
Page 1 of 3
Revision: C
Revision Date: June 2021
CooperVision MyDay
Soft (Hydrophilic) Daily Disposable
Contact Lenses
IMPORTANT: Please read carefully and keep this information for future 
use. This package insert is intended for the Eye Care Practitioner but 
should be made available to patients upon request. The Eye Care 
Practitioner should provide the patient with the patient instructions that 
pertain to the patient's prescr bed lens.
SYMBOLS KEY:
The following symbols may appear on the label or carton.
SYMBOL
DEFINITION
REFERENCE
Caution: Federal (USA) law restricts 
this device to sale by or on the order 
of a licensed practitioner
81 FR 38911
Caution / See Instructions for 
Wearers
BS EN ISO 15223-1
Table 1, Symbol 5.4.4
Use by Date (expiration date)
BS EN ISO 15223-1
Table 1, Symbol 5.1.4
Batch Code
BS EN ISO 15223-1
Table 1, Symbol 5.1 5
Sterile using Steam Heat
BS EN ISO 15223-1
Table 1, Symbol 5.2 5
Manufacturer
BS EN ISO 15223-1
Table 1, Symbol 5.1.1
Authorized representative in the 
European Community
BS EN ISO 15223-1
Table 1, Symbol 5.1 2
Do not use if package is damaged
BS EN ISO 15223-1
Table 1, Symbol 5.2 8
Consult instructions for use / consult 
electronic instructions for use
BS EN ISO 15223-1
Table 1, Symbol 5.4 3
Do not re-use
BS EN ISO 15223-1
Table 1, Symbol 5.4 2
Date of manufacture
BS EN ISO 15223-1
Table 1, Symbol 5.1 3
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY 
OR ON THE ORDER OF A LICENSED PRACTITIONER.
DESCRIPTION
MyDay Contact Lenses are available as Asphere, Toric, Multifocal, and 
Multifocal Toric lens designs.
The MyDay material stenfilcon A is primarily a random copolymer of 
polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV 
blocker used is a benzotriazolyl methacrylate. The lenses have a blue 
tint which is added to make the lens more visible for handling. The 
lenses also contain a UV absorbing monomer which is used to block 
UV radiation.
WARNING: UV-absorbing contact lenses are NOT substitutes for 
protective UV-absorbing eyewear such as UV-absorbing goggles 
or sunglasses because they do not completely cover the eye and 
the surrounding area. You should continue to use UV-absorbing 
eyewear as directed.
Long term exposure to the UV radiation is one of the risk factors 
associated with cataracts. Exposure is based on a number of 
factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of the 
outdoor activities). UV-absorbing contact lenses help provide 
protection against harmful UV radiation. However, clinical studies 
have not been done to demonstrate that wearing UV-absorbing 
contact lenses reduces the risk of developing cataracts or other 
eye disorders. Consult your Eye Care Practitioner for more 
information.
The MyDay (stenfilcon A) Soft (Hydrophilic) Contact Lens (-6.00 D) 
blocks 86% of UVA radiation and 97% UVB radiation average 
across the spectrum. The radiation blockage of the MyDay 
(stenfilcon A) lens will increase for thicker lenses (please refer to 
accompanying transmittance curve graph).
1.
Leman, S., Radiant Energy and the Eye, MacMillan, New York, 1980,
p. 58, figure 2-21. Transmittance profile of the human cornea of a 24-
year-old person.
2.
Waxler M., and V. M. Hitchins, Optical Radiation and Visual Health,
CRC Press, Boca Raton, Florida, 1986, p. 19, figure 5. Transmittance 
profile for the human crystalline lens of a 25-year-old person.
MyDay (stenfilcon A) contact lens parameters:
o Chord Diameter: 
13.0 mm to 15.5mm
o Base Curve: 
8.4 ± 0.5 mm and 8.7 ± 0.5 mm
o Center Thickness: 
0.08 mm @ -3.00D (varies with power)
o Powers:
-20.00D to +20.00D
o Cylinder Powers:
-0.25D to -10.00D
o Axis:
0
o to 180
o in 10
o increments
o Add Power Range:
+0.50D to +4.00D
o Multifocal Add Power Range:
LOW = (+0.75D to +1.25D)
MED = (+1.50D to +1.75D)
HIGH = (+2.00D to +2.50D)
The physical/optical properties of the lens are:
o Specific Gravity:
1.033
o Refractive Index:
1.401
o Light Transmittance:
96%
o Surface Character:
Hydrophilic
o Water Content:
54%
o Oxygen Permeability:
80x10
-11
[(cm
2/sec)x(ml O2)/(ml x mm Hg)]
Call our Customer Service Department at (800) 341-2020
for current availability.
ACTIONS
When placed on the cornea in its hydrated state, the MyDaySoft 
(Hydrophilic) Contact Lens acts as a refracting medium to focus light 
rays on the retina. 
INDICATIONS FOR USE
Aspherical:
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for 
the correction of ametropia (myopia and hyperopia) in aphakic and 
non-aphakic persons with non-diseased eyes in powers from -20.00D 
to +20.00D diopters. The lenses may be worn by persons who exhibit 
astigmatism of -2.00 diopters or less that does not interfere with visual 
acuity.
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Part Number: PI01100
Page 2 of 3
Revision: C
Revision Date: June 2021
Toric:
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the 
correction of ametropia (myopia or hyperopia with astigmatism) in 
aphakic and non-aphakic persons with non-diseased eyes in powers 
from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to 
-10.00 diopters.
Multifocal:
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated 
for the correction of refractive ametropia (myopia and hyperopia) and 
emmetropia with presbyopia in aphakic and non-aphakic persons with 
non-diseased eyes. The lenses may be worn by persons who exh bit 
astigmatism of -2.00 diopters or less that does not interfere with visual 
acuity.
Multifocal Toric:
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are 
indicated for the optical correction of distance and near vision in 
presbyopic phakic or aphakic persons with non-dieseased eyes who 
may have -10.00 diopters of astigmatism or less.
CONTRAINDICATIONS (REASONS NOT TO USE):
Do not use the MyDay lens when any of the following conditions exist:
o Acute and subacute inflammation or infection of the anterior 
chamber of the eye.
o Any eye disease, injury, or abnormality that affects the cornea, 
conjunctiva, or eyelids.
o Severe insufficiency of lacrimal secretion (dry eyes).
o Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
o Any systemic disease that may affect the eye or be exaggerated 
by wearing contact lenses.
o Allergic reactions of ocular surfaces or adnexa that may be 
induced or exaggerated by wearing contact lenses.
o Any active corneal infection (bacterial, fungal, or viral).
o If eyes become red or irritated.
o The patient is unable to follow lens care regimen or unable to 
obtain assistance to do so.
WARNINGS
Patients should be advised of the following warnings 
pertaining to contact lens wear:
o PROBLEMS WITH CONTACT LENSES AND LENS CARE 
PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE 
EYE. It is essential that patients follow their Eye Care 
Practitioner’s directions and all labeling instructions for proper 
use of lenses. Eye problems, including corneal ulcers, can 
develop rapidly and lead to loss of vision. Daily wear lenses 
are not indicated for overnight wear, and patients should be 
instructed not to wear lenses while sleeping. Clinical studies 
have shown that the risk of serious adverse reactions is 
increased when these lenses are worn overnight. Studies have 
shown that contact lens wearers who are smokers have a 
higher incidence of adverse reactions than nonsmokers. If a 
patient experiences eye discomfort, excessive tearing, vision 
changes, or redness of the eye, the patient should be 
instructed to immediately remove lenses and promptly contact 
his or her Eye Care Practitioner.
PRECAUTIONS
Special Precautions for Eye Care Practitioners
o
Due to the small numbers of patients enrolled in clinical 
investigation of lenses, all refractive powers, design 
configurations, or lens parameters available in the lens material 
are not evaluated in significant numbers. Consequently, when 
selecting an appropriate lens design and parameters, the Eye 
Care Practitioner should consider all characteristics of the lens 
that can affect lens performance and ocular health, including 
oxygen permeability, wettability, central and peripheral thickness, 
and optic zone diameter.
o
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 prescr bing Eye Care Practitioner.
o
Patients who wear aspheric contact lenses to correct presbyopia 
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.
o
Aphakic patients should not be fitted with any MyDay contact 
lenses until the determination is made that the eye has healed 
completely.
o
Fluorescein, a yellow dye, should not be used while the lenses 
are on the eyes. The lenses absorb the dye and become 
discolored. Whenever fluorescein is used in the eyes, the eyes 
should be flushed with a sterile saline solution that is 
recommended for in-eye use.
o
Before leaving the Eye Care Practitioner’s office, 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. Eye Care Practitioners should instruct the patient to remove 
the lenses immediately if the eye becomes red or irritated.
Eye Care Practitioners should carefully instruct patients about the 
following safety precautions:
o
Always discard disposable lenses after the recommended 
wearing schedule prescr bed by the Eye Care Practitioner.
o
The compatibility of the lens with lens care regimens has not been
evaluated. 
o
Do not use saliva or any solutions for lubricating or wetting 
lenses.
o
If the lens sticks (stops moving) on the eye, follow the 
recommended directions on Care for a Sticking 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 
Practitioner.
o
Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorant, 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.
o
Do not touch the contact lenses with the finger or hands if the 
hands are not free of foreign materials, as lens damage may 
occur.
o
Carefully follow the handling, insertion, removal, and wearing 
instructions in the Patient Instructions for MyDay contact lenses 
and those prescr bed by the Eye Care Practitioner.
o
Never wear lenses beyond the period recommended by the Eye 
Care Practitioner.
o
If aerosol products such as hairspray are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
o
Always handle lenses gently and avoid dropping them.
o
Avoid all harmful or irritating vapors and fumes while wearing 
lenses.
o
Ask the Eye Care Practitioner about wearing the lenses during 
sporting activities.
o
Inform the doctor (health care practitioner) about being a contact 
lens wearer.
o
Never use tweezers or other tools to remove lenses from the lens 
container unless specifically indicated for that use. Pour the lens 
into your hand.
o
Do not touch the lens with fingernails.
o
Always contact the Eye Care Practitioner before using any 
medicine in the eyes.
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Part Number: PI01100
Page 3 of 3
Revision: C
Revision Date: June 2021
o
Always inform the employer of being a contact lens wearer. Some 
jobs may require use of eye protection equipment or may require 
that the patient not wear contact lenses.
o
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.
ADVERSE REACTIONS
The patient should be informed that the following problems may occur:
o
Eyes stinging, burning, or itching (irritation), or other eye pain.
o
Comfort is less than when the lens was first placed on the eye.
o
Feeling that something is in the eye such as a foreign body or a 
scratched area.
o
Excessive watering (tearing) of the eyes.
o
Unusual eye secretions.
o
Redness of the eyes.
o
Reduced sharpness of vision (poor visual acuity).
o
Blurred vision, rainbows, or halos around objects.
o
Sensitivity to light (photophobia).
o
Dry eyes.
If the patient notices any of the above, he or she should be instructed 
to:
o
Immediately remove the lenses.
o
If the discomfort or the problem stops, then look closely at the 
lens. If the lens is in some way damaged, do not put the lens back 
on the eye. Place the lens in a storage case and contact the Eye 
Care Practitioner. Daily disposible lenses should not be 
reinserted. If the problem continues, the patient should 
immediately remove the lenses and consult the Eye Care 
Practitioner.
When any of the above problems occur, a serious condition such as 
infection, corneal ulcer, neovascularization, or iritis may be present. 
The patient should be instructed to keep the lens off the eye and 
seek immediate professional identification of the problem and prompt 
treatment to avoid serious eye damage.
FITTING
Conventional methods of fitting contact lenses apply to all MyDay 
contact lenses. For a detailed description of the fitting techniques, refer 
to the MyDay Professional Fitting and Information Guide, copies of 
which are available from:
CooperVision, Inc.
711 North Road
Scottsville, New York 14546
(800) 341-2020
www.coopervision.com
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care 
Practitioner. Patients tend to over-wear the lenses initially. The Eye 
Care Practitioner should emphasize the importance of adhering to the 
initial maximum wearing schedule. Regular checkups, as determined 
by the Eye Care Practitioner are also extremely important.
CooperVision recommends that all MyDay lenses be discarded and 
replaced with a new lens on a daily basis. 
DAILY DISPOSABLE WEAR: (less than 24 hours, while awake). 
The maximum suggested wearing time is 12 hours:
LENS CARE DIRECTIONS
The MyDay (stenfilcon A) Soft (Hydrophilic) Contact Lenses are 
indicated for daily wear single use only. The lenses are to be discarded 
upon removal; therefore, no cleaning or disinfection is required.
For MyDay contact lenses prescribed for daily wear single use only:
The Eye Care Professional should review with patients that no 
cleaning or disinfection is needed. Patients should always dispose of 
lenses when they are removed and have replacement lenses or 
spectacles available.
Eye Care Practitioners should review with the patient lens care 
directions, including basic lens care information in accordance with 
patients lens type and wearing schedule.
o
Always wash, rinse, and dry hands before handling contact 
lenses.
o
Do not use saliva or any solutions for lubricating or rewetting. Do 
not put lenses in the mouth.
o
The patient should always have a spare pair of lenses at all times.
o
Eye Care Practitioners may recommend a lubrication/rewetting 
solution, which can be used to wet (lubricate) the lenses while 
they are being worn to make them more comfortable.
CARE FOR A DRIED OUT (DEHYDRATED) LENS
If any MyDay lens is exposed to air while off the eye, it may become 
dry and brittle. In this event, simply dispose of the lens and replace 
with a fresh one.
CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving or cannot be removed), the patient 
should be instructed to apply 2 to 3 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 more than 5 minutes, the patient 
should immediately consult the Eye Care Practitioner.
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 THE EYES 
IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT 
THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL 
EMERGENCY ROOM WITHOUT DELAY.
HOW SUPPLIED
Each lens is supplied sterile in a blister containing buffered saline 
solution. The blister is labeled with the base curve, diameter, dioptric 
power, cylinder and axis for toric lenses, multifocal add for multifocal 
lenses, manufacturing lot number, and expiration date of the lens, and 
the presence of a UV-blocker is noted.
DO NOT USE IF THE BLISTER IS BROKEN OR 
THE SEAL HAS BEEN DAMAGED
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing any MyDay contact lens or experienced with the 
lenses should be reported to:
CooperVision, Inc.
Attn: Product Services
711 North Road
Scottsville, New York 14546
(800) 341-2020
www.coopervision.com
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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
CR-6478, v1.0 
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 LENS FITTING CHARACTERISTICS 
CR-6478, v1.0 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
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Title:                          Lens Fitting Characteristics
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
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Johnson & Johnson Vision Care, Inc.
SUBJECT REPORTED OCULAR SYMPTOMS 
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Title:                         Subject Reported Ocular Symptoms/Problems
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 2 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:  
Revision Number:  5
Page 3 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE 
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  10
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  10
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  10
CR-6478, v1.0 
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  10
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Title:
Biomicroscopy Scale
Document Type:
Document Number:
Revision Number:  10
CR-6478, v1.0 
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Johnson & Johnson Vision Care, Inc.
DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
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Johnson & Johnson Vision Care, Inc.
TORIC FIT EVALUATION 
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Title:                          Toric Fit Evaluation
Document Type:  
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Title:                          Toric Fit Evaluation
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Title:                          Toric Fit Evaluation
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
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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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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES 
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Title:
Patient Reported Outcomes
Document Type:
Document Number:
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3
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
LENS INSERTION AND REMOVAL 
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Title:   
Lens Insertion and Removal
Document Type:
Document Number:
Revision Number:  3
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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Title:                        Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:  
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Revision Number:  4
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Title:                        Visual Acuity Chart Luminance and Room Illumination Testing
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Title:                        Visual Acuity Chart Luminance and Room Illumination Testing
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Title:                        Visual Acuity Chart Luminance and Room Illumination Testing
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Title:                        Visual Acuity Chart Luminance and Room Illumination Testing
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Revision Number:  4
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
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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:
CR-6478, v1.0 
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
4.1.3
Protocol Compliance Investigator(s) Signature Page:
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.
 
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable.  
Study site training will be documented utilizing Site Initiation Report (Form Control No. 
) per Study Site Initiation (Form Control No. 
).
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.).
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan (Form Control No.
).
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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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
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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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
 
RESOURCE LINKS
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist   
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf
OUS Resource Links 
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings html
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Document Number:
Revision Number: 5
 
x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health:
https://www health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
 
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6478 Clinical Evaluation of Two Daily Disposable Toric Soft 
Contact Lenses Over One Week of Wear
Version and Date: 1.0 15 December 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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