Design Validation of Toric Contact Lenses in Senofilcon A With a Blue-Blocking Chromophore
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
CR-6521, v 3.0 
JJVC CONFIDENTIAL 
Page 1 of 163 
 
 
 
 
 
 
Design Validation of Toric Contact Lenses in Senofilcon A with a Blue-Blocking Chromophore 
Protocol CR-6521 
Version: 3.0 
 
Date: 01 June 2023 
 
 
Investigational Products: The test product will be rotationally stabilized astigmatic soft contact lenses in 
senofilcon A with a chromophore to block High-Energy Visible Light (HEVL). The control lens will be the 
ACUVUE® OASYS 1 Day for Astigmatism (AO1DfA) contact lenses. 
 
Keywords: Astigmatism, toric contact lenses,  senofilcon A, 
chromophore, High-Energy Visible Light, 
dispensing, daily wear, daily disposable, ocular physiology, lens fit, rotational performance, logMAR visual 
acuity, CLUE Vision, CLUE Comfort, CLUE Handling, situational visual performance, ACUVUE® OASYS 1- 
Day for Astigmatism, Single use Eye-Cept® Rewetting Drops, LacriPure Saline Solution, ScleralFil Preservative 
Free Saline Solution. 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
 
This clinical trial will be conducted in compliance with ISO 14155:2020 Clinical investigation of medical 
devices for human subjects – Good clinical practice,1 and the Declaration of Helsinki.2 
 
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 
………………………………………………………………………………………………..14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 14 
1.1. 
Name and Descriptions of Investigational Products ................................................ 15 
1.2. 
Intended Use of Investigational Products ................................................................. 15 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study… ............................................................................................................................... 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 15 
2.1. 
Objectives ................................................................................................................. 15 
2.2. 
Endpoints .................................................................................................................. 16 
2.3. 
Hypotheses ............................................................................................................... 17 
3. 
TARGETED STUDY POPULATION ........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria ...................................................................................................... 18 
3.3. 
Exclusion Criteria ..................................................................................................... 18 
3.4. 
Enrollment Strategy .................................................................................................. 19 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 19 
4.1. 
Description of Study Design .................................................................................... 19 
4.2. 
Study Design Rationale ............................................................................................ 19 
4.3. 
Enrollment Target and Study Duration .................................................................... 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 20 
5.1. 
Test Article Allocation ............................................................................................. 20 
5.2. 
Masking .................................................................................................................... 20 
5.3. 
Procedures for Maintaining and Breaking the Masking. .......................................... 21 
6. 
STUDY INTERVENTION ............................................................................................. 21 
6.1. 
Identity of Test Articles ............................................................................................ 21 

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6.2. 
Ancillary Supplies/Products ..................................................................................... 22 
6.3. 
Administration of Test Articles ................................................................................ 22 
6.4. 
Packaging and Labeling ........................................................................................... 22 
6.5. 
Storage Conditions ................................................................................................... 22 
6.6. 
Collection and Storage of Samples .......................................................................... 22 
6.7. 
Accountability of Test Articles ................................................................................ 23 
7. 
STUDY EVALUATIONS .............................................................................................. 23 
7.1. 
Time and Event Schedule ......................................................................................... 23 
7.2. 
Detailed Study Procedures ....................................................................................... 24 
VISIT 1 ........................................................................................................................... 24 
VISIT 2 ........................................................................................................................... 30 
VISIT 3 ........................................................................................................................... 32 
VISIT 4 ........................................................................................................................... 32 
FINAL EVALUATION .................................................................................................. 33 
7.3. 
Unscheduled Visits ................................................................................................... 33 
7.4. 
Laboratory Procedures ............................................................................................. 34 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 34 
8.1. 
Completion Criteria .................................................................................................. 34 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 34 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 35 
9.1. 
Systemic Medications .............................................................................................. 35 
10. DEVIATIONS FROM THE PROTOCOL ..................................................................... 36 
11. STUDY TERMINATION .............................................................................................. 37 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ................. 38 
13. ADVERSE EVENTS ...................................................................................................... 39 
13.1. Definitions and Classifications................................................................................. 39 
13.2. Assessing Adverse Events ........................................................................................ 40 
13.2.1. 
Causality Assessment .................................................................................... 40 
13.2.2. 
Severity Assessment ...................................................................................... 41 
13.3. Documentation and Follow-Up of Adverse Events ................................................. 41 
13.4. Reporting Adverse Events ........................................................................................ 42 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 42 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
………………………………………………………………………………43 

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13.5. Event of Special Interest .......................................................................................... 43 
13.6. Reporting of Pregnancy ............................................................................................ 43 
14. STATISTICAL METHODS ........................................................................................... 43 
14.1. General Considerations ............................................................................................ 43 
14.2. Sample Size Justification ......................................................................................... 44 
14.3. Analysis Populations ................................................................................................ 46 
14.4. Level of Statistical Significance ............................................................................... 46 
14.5. Primary Analysis ...................................................................................................... 47 
14.6. Secondary Analysis .................................................................................................. 50 
14.7. Exploratory Analysis ................................................................................................ 50 
14.8. Interim Analysis ....................................................................................................... 51 
14.9. Procedure for Handling Missing Data and Drop-Outs ............................................. 51 
14.10. Procedure for Reporting Deviations from Statistical Plan ....................................... 51 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................... 51 
15.1. Electronic Case Report Form/Data Collection ......................................................... 51 
15.2. Subject Record ......................................................................................................... 52 
15.3. Trial Registration on ClinicalTrials.gov................................................................... 52 
16. DATA MANAGEMENT ................................................................................................ 52 
16.1. Access to Source Data/Document ............................................................................ 52 
16.2. Confidentiality of Information ................................................................................. 52 
16.3. Data Quality Assurance ............................................................................................ 52 
16.4. Data Monitoring Committee (DMC) ........................................................................ 53 
17. CLINICAL MONITORING ........................................................................................... 53 
18. ETHICAL AND REGULATORY ASPECTS ................................................................ 53 
18.1. Study-Specific Design Considerations ..................................................................... 53 
18.2. Investigator Responsibility ....................................................................................... 53 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) .............. 54 
18.4. Informed Consent ..................................................................................................... 54 
18.5. Privacy of Personal Data .......................................................................................... 55 
19. STUDY RECORD RETENTION ................................................................................... 56 
20. FINANCIAL CONSIDERATIONS ............................................................................... 56 
21. PUBLICATION .............................................................................................................. 56 
22. REFERENCES ............................................................................................................... 56 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 58 

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APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 74 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 75 
APPENDIX D: ...................................................................................................................... 104 
LENS FITTING CHARACTERISTICS ............................................................. 105 
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ........................ 111 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE 
ERROR ................................................................................................................................. 113 
BIOMICROSCOPY SCALE .............................................................................. 119 
DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ...... 125 
TORIC FIT EVALUATION ............................................................................... 130 
PATIENT REPORTED OUTCOMES ................................................................ 135 
LENS INSERTION AND REMOVAL .............................................................. 137 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 140 
APPENDIX E: IRIS COLOR SCALE .................................................................................. 149 
APPENDIX F: 
GUIDELINES FOR COVID-19 RISK MITIGATION ............. 151 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 163 
 
LIST OF TABLES 
Table 1: Test Articles .............................................................................................................. 21 
Table 2: Ancillary Supplies..................................................................................................... 22 
Table 3: Time and Events ....................................................................................................... 23 
Table 4: Disallowed systemic medications ............................................................................. 36 
Table 5: Disallowed systemic antihistamines ......................................................................... 36 
Table 6: Examples of major and minor protocol deviations ................................................... 37 
Table 7: Historical Studies Utilized for Sample Size Calculations ........................................ 44 
Table 8: Historical Data by Endpoint – Test Lens .................................................................. 44 
Table 9: Sample Size Estimates for Co-Primary Safety, Efficacy and Secondary Endpoints 
................................................................................................................................................. 46 
 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 13 
 

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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Design Validation of Toric Contact Lenses in Senofilcon A with a Blue-Blocking Chromophore 
Protocol Number: CR-6521 
Version: 3.0 
Date: 01 June 2023 
 
 
 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Ine. (JJVC) 
7500 Centurion Parkway 
Jacksonville, FL 32256 
 
 
 
MEDICAL MONITOR 
The Medica! Monitor must be notified by the clinical institution/site by e-mail or telephone within 24 how-s of 
leaming of a Serious Adverse Event. The Medica! Monitor may be contacted dw-ing business how-s for adverse 
event questions. General study related questions should be directed towards yow- ass igned clinical research 
associate. 
 
The Medica!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 necessa1y 
assmances that this trial will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulato1y requirements and applicable U.S. federa! 
regulations,3 ISO 14155:2020,1 and the Declaration of Helsinki.2 
 
Author & Study 
Responsible Clinician 
 
 
Clinical Operations 
Manager 
 
 
 
Biostatistician 
 
 
 
Biostatistician Review 
 
 
 
Data Management 
 
See Electronic Signature Report 
  
      
 
DATE 
 
 
See Electronic Signature Report 
  
 
DATE 
 
 
See Electronic Signat._u_re_R_epo_,_·t  
_ 
  
 
DATE 
 
 
 
DATE 
 
 
See Electronic -Sign_a_t_.u_re_R_ep_o,_·t  
_ 
  
 
DATE 
 
 
 
Medica! Safety Officer 
See Electronic Sign_a_t_w_·e_Rep_o_,·_t  
_ 
  
 
DATE 
 
 
Approver 
 
See Electronic Signature Report  
_ 
  
 
DATE 

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CHANGE IDSTORY 
 
 
Version 
Originator 
Description of Change(s) and 
Section Numbe s Affected 
Justification for Change 
Date 
1.0 
Original Protocol. 
N/A 
21 December, 
2022 
2.0 
Updated Protocol Management 
lens build protocol numbers in 
section 6.1. 
Test lenses are  being remade 
under 
new 
Protocol 
Management build protocol. 
Additional 
over-labelling 
20 
January, 
2023 
Protocol 
Management 
protocol   was   created   for a 
subset of the control lenses. 
3.0 
Section 7.1 Time and Events 
Table: Removed the 'x' from 
Distance HLHC visual acuity 
using ETDRS charts at Visit 3 as 
this is not applicable. 
Updated biostatistician reviewer
Accmacy 
Accmacy 
01 Jun, 2023 

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SYNOPSIS 
 
Protocol Title 
Design Validation of Toric Contact Lenses in Senofilcon A with a Blue- 
Blocking Chromophore 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Clinical trial phase: Design validation 
Design control phase: Confirmatory phase, phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
Test Article(s) 
Investigational Products: The test product will be rotationally stabilized 
astigmatic soft contact lenses in senofilcon A with a chromophore to block 
High-Energy Visible Light (HEVL). 
Approved Products: The control product will be ACUVUE® OASYS 1-
Day for Astigmatism (AO1DfA) contact lenses. 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily disposable 
Objectives 
The primary objectives of this study are to demonstrate that the 
investigational toric contact lenses in senofilcon A with a blue-blocking 
chromophore meet the design validation requirements related to visual 
acuity, eye health, fit acceptance, and subjective vision. 
The secondary objectives of this study are to demonstrate that the 
investigational toric contact lenses in senofilcon A with a blue-blocking 
chromophore meet the market preference requirements related to 
subjective handling and comfort. 
An exploratory objective of this study is to evaluate the subjective 
response to specific situational visual performance questions regarding 
vision while driving and during digital device use for the test lenses 
compared to the control lenses. 
Study Endpoints 
Primary endpoints: 
• 
Grade 3 or higher biomicroscopy findings related to study lens 
wear (Yes/No) 
• 
Acceptable lens fit (Yes/No) 
• 
Monocular, High-Luminance, High-Contrast (HLHC) distance 
Visual Acuity (VA) (logMAR) 
• 
Absolute lens orientation ≤ 10° (Yes/No) 
• 
Lens rotational stability with blinks ≤ 5° (Yes/No) 
• 
CLUE Vision score 
Secondary endpoints: 
• 
CLUE Handling score 
• 
CLUE Comfort score 
Exploratory endpoints: 
• 
Ability to see comfortably while driving during the day 
 
• 
My vision was clear enough to allow me to drive at night 
 
• 
Reduction in the feeling of tired eyes from using a computer or 
other digital device 

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Study Design 
This will be a 4-visit, randomized, controlled, single-masked, bilateral 
wear, dispensing, 2-treament, 2-sequence, 2-period 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 approximately one week (72 days) in a daily 
disposable modality. Subjective comfort, vision and handling will be 
assessed using the CLUE questionnaire at fitting and follow-up visits for 
each wear period. HLHC monocular VA will be assessed at the follow-up 
evaluation using ETDRS charts. There will be a washout period of 
approximately one week (72 days) between wear periods. 
See the flow chart at the end of the synopsis table for the schematic of the 
study visits and procedures of main observations ( 
Figure 1). 
Sample Size 
This study will have an enrollment target of approximately 180 subjects, 
with a target of at least 165 to complete (assuming a dropout rate of 10%). 
Study Duration 
Total study duration including the enrollment period is anticipated to be 
approximately 10 weeks. 
Anticipated Study Population 
Subjects will be habitual bilateral 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 years of age (inclusive) at the time of screening. 
4. Habitually wear soft contact lenses in both eyes in a daily or daily 
disposable wear modality (i.e., not extended wear modality). Habitual 
wearer is defined as a minimum of 6 hours per day, for a minimum of 
2 days per week during the past four weeks. 
5. Possess a wearable pair of spectacles that provide correction for 
distance vision. 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. In both eyes, have refractive error suitable for correction with the toric 
contact lens powers available in this study: 
a. 
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 
b. Cylinder powers (DC) -0.75 and -1.25 
c. 
Axes () 170, 180, 10, 80, 90, 100 
7. 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 an 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 following 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.). 
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. 

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Measurements and Procedures 
Key procedures associated with the endpoints for this study will include: 
- Measurement of HLHC VA using ETDRS charts 
- Examination of the anterior segment using a slit lamp biomicroscope 
and grading findings using the FDA grading scale 
- Assessment of general lens fitting characteristics (centration, 
movement, push-up test) 
- Assessment of lens orientation and rotational stability using a slit lamp 
biomicroscope 
- Overseeing completion of subjective questionnaires 
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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Washout Period 
A washout period of 72 days duration will 
be observed between wear periods 
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 #2) 
Lens assignment and insertion 
Timed rotation assessments, lens settling 
Toric and general fit assessment 
Spherical over-refraction, modification if required 
CLUE post-fit questionnaire 
Lenses dispensed for 72 days 
Continuance 
Review med history and medications 
Subject reported ocular symptoms 
Entrance VA and biomicroscopy 
Confirm continuing eligibility 
 
Figure 1: Study Flowchart 
 
 
 
 
 
 
Follow-up (#1 through #2) 
CLUE follow-up questionnaire 
ETDRS HLHC visual acuity 
Record lens orientation 
Lens removal 
Biomicroscopy 
Schedule next visit 
After follow-up #1 
After follow-up #2 
 
 
Final Evaluation 
Spherocylindrical refraction 
Completion status 
Biomicroscopy (if discontinued early) 

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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS 
ADE 
Adverse Device Effect 
ADHD 
Attention Deficit Hyperactivity Disorder 
AE 
Adverse Event/Adverse Experience 
AO1DfA 
 ACUVUE 
OASYS® 
1-DAY 
with 
HydraLuxe™ 
TECHNOLOGY 
for 
ASTIGMATISM 
BSCVA 
Best Spectacle Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CLUE 
Contact Lens User Experience 
COVID-19 
Coronavirus Disease 2019 
COM 
Clinical Operations Manager 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
 
 
D 
Diopter 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
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 
OD 
Right Eye 
OS 
Left Eye 
OU 
Both Eyes 
PIG 
Patient Instruction Guide 
PQC 
Product Quality Complaint 
PRK 
Photorefractive Keratectomy 
PRO 
Patient Reported Outcome 
QA 
Quality Assurance 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis System 
SD 
Standard Deviation 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
VA 
Visual Acuity 
 
 
1. 
INTRODUCTION AND BACKGROUND 
High Energy Visible Light (HEVL) may be generally defined as the visible region of the electromagnetic 
spectrum with wavelengths shorter than 500 nm. Due to Rayleigh scattering, light within this range of 

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wavelengths is scattered more than light of longer wavelengths, thus filtering these shorter wavelengths may 
result in increased visual contrast when looking at distant objects. At approximately 435 nm, visible light has 
enough energy to damage the retinal pigment epithelium and has been linked to macular degeneration. 
Additionally, the retinal receptors responsible for photoentrainment (entrainment of the circadian rhythm in 
response to patterns of light and dark) are maximally sensitive to light at approximately 480 nm. 
 
Ophthalmic lenses that block High Energy Visible Light (HEVL) may offer improved vision through enhanced 
chromatic contrast sensitivity. Such lenses may also provide greater retinal protection than regular lenses without 
spectral filtering. This study will evaluate the clinical performance of a daily disposable, toric lens design 
incorporating a HEVL-blocking chromophore 
 
1.1. 
Name and Descriptions of Investigational Products 
The test lens in this study will be a toric contact lens design in senofilcon A containing a HEVL-blocking 
chromophore 
ACUVUE® OASYS 1-Day for Astigmatism (AO1DfA) contact lenses will be evaluated 
as a control lens. 
 
Further details about the test and control articles are given in section 6 of this protocol. 
 
1.2. 
Intended Use of Investigational Products 
The intended use of the investigational products is the correction of myopic astigmatism. Study lenses will be 
worn bilaterally in a daily wear, daily disposable modality for at least 8 hours per day and 5 days per week over 
a wear period of 7±2 days. Two wear periods will be completed in total, with a washout period of 7±2 days 
between the wear periods. 
 
1.3. 
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical trials on humans. 
For the most comprehensive nonclinical information regarding the test and control designs refer to the latest 
version of the Investigator's Brochure.4 
 
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. No adverse 
device effects are anticipated. The risks associated with use of the investigational lenses are considered to be the 
same as those for other marketed soft contact lens worn in the same modality (i.e., daily disposable wear). No 
additional risks associated with participation in this investigation are anticipated. 
 
Comprehensive risk and benefit information regarding the test design and the AO1DfA control lens are included 
in the latest versions of the Investigator's Brochure4 and the AO1DfA package insert (Appendix C), respectively. 
 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
Prototype toric lens designs featuring the 
chromophore have previously been evaluated in several JJVC- 
sponsored clinical trials. Safety data from these trials suggest the investigational lenses have a safety profile 
equivalent to currently marketed soft contact lens products; a review of literature references and prior clinical 
data related to the test designs is given in the Investigator’s Brochure.4 
 
For further details regarding the AO1DfA control lens, refer to the AO1DfA package insert (Appendix C). 
 
 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
 
2.1. 
Objectives 
Primary Objective: 

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The objective of this study is to demonstrate that the investigational lens meets the validation requirements related 
to objective and subjective vision, eye health, fit acceptance, toric rotation, and rotational stability. 
 
Secondary Objective: 
The secondary objective of this study is to demonstrate that the investigational lens meets the user needs with 
respect to subjective lens handling and comfort. 
 
Exploratory Objective 
An exploratory objective of this study is to evaluate the subjective response to specific situational visual 
performance questions regarding vision while driving and during digital device use for the test lenses compared 
to the control lenses. 
 
2.2. 
Endpoints 
Primary Safety Endpoints: 
 
Slit Lamp Findings (SLF) 
SLFs (Grade 3 or higher) related to study lens wear will be assessed for each eye at all study visits (scheduled 
and unscheduled). SLFs will be evaluated and graded using the FDA Grading scale from 0 to 4, where Grade 0 
represents the absence of findings and 1 to 4 representing successively worse findings. The percentage of eyes 
with Grade 3 or higher SLF will be analyzed and will include  corneal infiltrates. See 
in Appendix D 
for more details on the collection of SLFs. 
 
Acceptable Lens Fit 
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. 
Acceptable fit is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Lens fit will be deemed 
unacceptable if any one of the following criteria are met: 
• 
limbal exposure at primary gaze or with extreme eye movement; 
• 
edge lift; 
• 
excessive movement in primary up gaze; 
• 
insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test. 
Eyes with multiple unacceptable fitting events will be counted only once. See 
in Appendix H for 
additional details regarding lens fit assessments. 
 
Primary Efficacy Endpoints: 
 
Visual Acuity (logMAR) 
Visual acuity (VA) will be assessed monocularly at the 1-week follow-up evaluation under high-luminance high- 
contrast (HLHC) conditions at a test distance of 4 meters using ETDRS Charts. See 
in Appendix D for 
details regarding the collection of visual acuity. 
 
Toric Lens Orientation 
Toric lens orientation (scribe mark position relative to 6 o’clock) will be assessed for each eye at 1, 3 and at least 
15 minutes after lens insertion at the fitting visit, and at the 1-week follow-up visit. However, lens orientation at 
least 15 minutes after lens insertion at the fitting visit is the primary endpoint. Lens orientation is a binary response 
where Y=1 if the absolute lens orientation is ≤ 10° and Y=0 otherwise. See 
in Appendix D for details 
regarding the collection of absolute toric lens orientation. 
 
Rotational Stability 
Rotational stability will be assessed for each eye at least 15 minutes after lens insertion at the fitting visit, and at 
the 1-week follow-up visit. However, rotational stability assessed at least 15 minutes after lens insertion at the 
fitting visit is the primary endpoint. Rotational stability is a binary response where Y=1 if the lens stability with 
blinks is ≤ 5° and Y=0 otherwise. See 
in Appendix D for details regarding the collection of lens stability 
with blinks. 

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Subjective Vision 
Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) questionnaire after 
approximately 1 week of lens wear. CLUE™ is a validated, patient-reported outcomes questionnaire to assess 
patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a 
contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item Response Theory 
(IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a 
more favorable/positive response with a range of 0-120. A 5-point increase in an average CLUE™ score translates 
into 10% shift in the distribution of scores for population of soft contact lens.5 
 
Secondary Endpoints 
• 
CLUE Handling score at follow-up 
• 
CLUE Comfort score at follow-up 
 
Exploratory Endpoints 
• 
Ability to see comfortably while driving during the day 
• 
My vision was clear enough to allow me to drive at night 
• 
Reduction in the feeling of tired eyes from using a computer or other digital device 
 
2.3. 
Hypotheses 
 
Co-Primary Safety Hypotheses: 
 
1. The percentage of eyes with one or more clinically significant, study-lens related, slit-lamp findings 
(Grade 3 or 4) following wear of the test lenses will be less than 5%. 
 
2. At least 80% of lens fits will be acceptable at the dispensing visit. 
 
Both co-primary safety hypotheses must be met in order to test any co-primary efficacy hypotheses. 
Co-Primary Efficacy Hypotheses: 
1. After approximately 1-week of wear, the mean monocular, high-luminance, high-contrast distance visual 
acuity for the test lens will be lower than 0.00 logMAR (equivalent to 20/20 Snellen visual acuity). 
 
2. Following lens settling (at least 15 minutes) at the dispensing visit, at least 80% of lens fits will have 
absolute rotation less than or equal to 10 degrees. 
 
3. Following lens settling (at least 15 minutes) at the dispensing visit, at least 80% of lens fits will have 
lens rotational stability with blink less than or equal to 5 degrees. 
 
4. 
After approximately 1 week of wear, the mean overall CLUE™ Vision score for the test lens will be 
statistically greater than 62 points. 
 
All safety and efficacy co-primary hypotheses must be satisfied in order to meet the study objectives and to test 
any secondary hypotheses. 
 
Secondary Hypotheses: 
1. After approximately 1 week of wear, the mean overall CLUE™ Handling score for the test lens will be 
greater than 61 points with 95% statistical confidence. 
 
2. After approximately 1 week of wear, the mean overall CLUE™ Comfort score for the test lens will be 
greater than 58 points with 95% statistical confidence. 

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Exploratory Hypotheses: 
 
1. After approximately 1 week of wear, the test lens will be non-inferior to the control lens with respect to 
at least one of the following subjective questionnaire items asked at the follow-up visit: 
a. 
Ability to see comfortably while driving during the day 
b. 
My vision was clear enough to allow me to drive at night 
c. 
Reduction in the feeling of tired eyes from using a computer or other digital device 
A non-inferiority margin of 10% will be used. 
 
 
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 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 years of age (inclusive) at the time of screening. 
4. Habitually wear soft contact lenses in both eyes in a daily or daily disposable wear modality (i.e., not 
extended wear modality). Habitual wearer is defined as a minimum of 6 hours per day, for a minimum 
of 2 days per week during the past four weeks. 
5. Possess a wearable pair of spectacles that provide correction for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in 
this study: 
a. 
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 
b. Cylinder powers (DC) -0.75 and -1.25 
c. 
Axes () 170, 180, 10, 80, 90, 100 
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye. 
 
3.3. 
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be diabetic. 
3. Be currently using any ocular medications or have an 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. 

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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. 
 
 
4. 
STUDY DESIGN AND RATIONALE 
 
4.1. 
Description of Study Design 
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing, 2-treatment, 2-sequence, 
2-period crossover study. 
 
At the initial visit (Visit 1), eligible subjects will be randomized into one of two unique sequences to wear two 
different study lenses one at a time over two wear periods (test/control or control/test). Subjects will wear each 
study lens type in a daily wear, daily disposable modality for approximately 1-week. Subjects will be advised to 
wear the study lenses for a minimum of 8 hours per day for at least 5 days during each 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. Monocular HLHC VA will be assessed at the follow-up evaluation using ETDRS charts. 
There will be a washout period of 72 days duration between wear periods. Subjects will not have access to the 
study lenses following completion of the protocol. 
 
Unscheduled visits may be conducted, if appropriate, and lost or damaged lenses may be replaced when necessary. 
 
4.2. 
Study Design Rationale 
The primary objective of this study is to evaluate the clinical performance of the test lenses against predefined 
targets specified in the Customer Requirements Document, based on historical performance of the ACUVUE® 
OASYS 1-Day for Astigmatism contact lenses.6 While the co-primary, safety, efficacy and secondary hypotheses 
will be tested for the test lenses only, a two-treatment by two-period crossover design was chosen for this study. 
This was considered the optimal design as it will address the primary, secondary and exploratory objectives as 
well as provide clinical data for the control lens. The rationale for collecting data on a marketed product is to the 
monitor the clinical performance, as the lenses for this study will be manufactured from the Flexible 
Manufacturing Platform (FMP), which is not the distributional line utilized for the Control lens (AO1Dfa). 
Moreover, this is only the second study where lenses from the FMP line are being evaluated. 

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Though the primary hypothesis is to test only the investigational study lens, the study design is not anticipated to 
have an impact on subjects’ visual acuity, toric lens orientation, rotational stability, lens fit or SLFs since these 
endpoints are objective in nature, there will be a 1-week washout period between study lenses, and different 
EDTRS charts will be utilized for each eye (left vs. right) to help reduce potential for optotype memorization 
during collection of visual acuity. 
 
However, there is a potential risk of carryover effect in all data collected from this study design, however, this is 
a greater risk for subjective responses than objective ones, i.e., CLUE vision scores. If a sequence effect is 
observed in the statistical model, then the primary hypothesis will be tested on data from the first period only. 
 
 
4.3. 
Enrollment Target and Study Duration 
This study will have an enrollment target of approximately 180 subjects, with a target of at least 165 to complete. 
The study will be conducted at up to 14 clinical sites, where the enrollment target for each site will be 
approximately 10 to 20 subjects. A subject will be considered enrolled upon signing of the informed consent 
form. 
 
At Visit 1, eligible subjects will be randomized to one of two lens wear sequences. There will be 4 visits in total 
per subject; total study duration including the enrollment period is expected to be approximately 10 weeks. 
Subjects who are discontinued prior to the final evaluation may be replaced at the discretion of the study sponsor. 
The investigation will end at the time that the study data is hard locked. 
 
 
5. 
TEST ARTICLE ALLOCATION AND MASKING 
 
5.1. 
Test Article Allocation 
The study lenses will be worn bilaterally in a randomized fashion using a 2x2 crossover design with 2 lens types 
and 2 periods. At Visit 1, eligible subjects will be randomized to one of two unique lens wear sequences using a 
computer-generated randomization scheme provided by the study biostatistician. 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. Each block will contain two different lens trial sequences. The 
randomization scheme will be generated using the PROC PLAN procedure from Statistical Analysis System 
(SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC).7 
 
The study site must follow the randomization scheme provided and complete enrollment per the randomization 
scheme and not pre-select or assign subjects. Randomization will be performed at Visit 1 prior to the first lens 
fitting. The following must have occurred prior to randomization: 
 
• 
Informed consent must have been obtained. 
• 
The subject must have met all eligibility criteria. 
• 
The subject’s screening and baseline information must have been collected. 
 
When dispensing test articles, the following steps should be followed to maintain randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens fitting schedule to 
obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the randomization 
(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 potential for bias, this will be a single-masked trial; subjects will not be aware of the identity of the 
assigned lenses, however, due to the difference in appearance of the test lenses containing the 

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chromophore, it is expected that subjects will be able to visually differentiate between the test and control designs. 
The identity (i.e., brand and type) ofthe studylenses will bemasked by having the blister packs labeled  with  the 
study number, lot number, sphere power, cylinder power, axis, expiration date and randomization code. 
Investigators, site staff and sponsor personnel (including the medical monitor) will be aware of the identity of the 
test and control lenses. 
 
5.3. 
Procedures for Maintaining and Breaking the Masking 
The test aiticles mask shall not be broken unless information conceming the lens type is necessary for 
the urgent medical treatment of a subject. The Sponsor must be notified before the mask is broken. 
 
 
6. 
STUDY INTERVENTION 
 
6.1. 
Identi ty of Te st Articles 
The following contact lenses will be used in this study: 
 
Table 1: Test Articles 
 
Test 
Contrnl 
Test Atticle Fonu 
Sofi contact lens 
Design/ Description 
TRAlOO and TRA200 series toric 
contact lens with HEVL-blocking 
chromo hore 
AOlD fA 
Desi<>   Name 
TRAlXX and TRA2XX 
AOlD fA 
Manufacturer 
Johnson & Johnson Vision Care, Ine. 
-1.50 to -4.00 in 0.25 ste s 
-0.75, -1.25 
10, 80, 90, 100, 170, 180 
Nominal Water Content 
% 
38 
Nominal Base Curve 
mm 
8.5 
Lens Diameter (mm) 
14.3 
Fiducial marks 
6 and 12 o'clock fiducial lines 
Dk (Fatt method, 
boundary coITected , 
edge COITected , x10-11 
[cm2 /sec] [ml Oi/ ml x 
mm H0       at 35°C 
103 
Modality in Ct11Tent 
Stud 
Daily wear 
Replacement Frequency 
Daily disposable 
in CuITe n t Study 
  
 
  
 
 
 
 
 
1n total, both test and control lenses will be available in 132 unique lens powers (11 sphere powers x 2 cylinder 
powers x 6 axes). 

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For each study lens design (test and control), the total number of test lenses to be used in this study (not including 
lenses that are replaced due to droppage, loss or damage) is expected to be approximately 2520 lenses (target 
enrollment of 180 subjects x 2 eyes per subject x 7 days per wear period). 
 
6.2. 
Ancillary Supplies/Products 
The following solutionswill be used in this study: 
 
Table 2: Ancillary Supplies 
Non-Preserved Rewetting Droos 
Solution Name/Description 
Single use Eye-Cept® 
Rewett.ing Drops 
LacriPure Saline 
Solution 
ScleralFil Preservative 
Free Saline Solution 
Manufacturer 
Optics Laboratory 
Menicon 
Bausch & Lomb 
Preservative 
None 
None 
None 
 
Lens cases and fluorescein strips (either 0.6 mg or 1.0 mg) will be supplied for use as needed. 
 
6.3. 
Administration of Test Articles 
Test aiticles will be dispensed to subjects meeting all eligibility requirements, including any dispensing 
requirements set fo1ih in this clinical protocol. Subjects will be dispensed an adequate supply of test a1ticles to 
complete the study. Lost or datnaged test articles may be replaced at the discretion of the investigator and/or the 
sponsor. 
 
6.4. 
Packaging and Labeling 
The test articles will be packaged in blisters as the primaiy packaging. The test aiticle will be over-labeled to 
mask the subject to the identity of the lens. The sample study label is shown below: 
 
Prima1y Packa ggi.'-'--- 
Secondaiy Packaging 
Sponsored By/Parrairre par: 
 
Johnson & Johnsoo V'ision care, Ine. 
7500 Centurion Parkway 
Jacksonvile,FL 32256, USA 
Conten1s/Contenu: 
 
Contact Lenses in Solution 
Lenltlescorneennesdans u esolulion 
 
 
 
 
 
6.5. 
. 
Storage Conditions 
Test a1ticles will be maintained at ambient temperatures at the clinical site. Test a1ticles must be kept under secure 
conditions. 
 
6.6. 
Collection and Storage of Samples 
No samples will be collected as pati of thestudy procedures. 
CAUTOI N: INVESllGAllONALDEVICE 
UMITEDBY U.S. LAW 
TOINVESTIGAllONAL USE 
EXCLUSVIELY FOR 
CUNICALINVESTIGATIONS 
I Cnm:Onecontact nsi1sokitim. 
ISTE   R I  L  E I I [EJ 
LOT ABC123 
SPH -1.00 
CYL-0.75 
AXIS 180 
EXP 2025/12/31 
CR-6521 
RC A 

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When possible, any lens or test aiticle associatedwith an Adverse Event and/or a Product Quality Complaint must 
be retained and stored in a glass vial with moderate solution pending directions from the sponsor for potential 
retum to JN C . 
 
6.7. 
Accountability of Test A11 icles 
JNC will provide the Investigator with sufficient quantitie s of study articles and supplies to complete the 
investigation. The Investigator is asked to retain all lens shipment documentation for the test article accountability 
records. 
 
Test ait icles must be kept in a locked storage cabinet, accessible only to those assigned by the Investigator for 
dispensing. The Investigator may delegate this activity to authorized study site personnel listed on the Site 
Delegation Log. All test articles must be accounted. This includes: 
1. 
What was dispensed for the subject for trial fitting, to wear out of the office, or issued for the subject to 
replace appropriately between visits. 
2. 
What was retumed to the Investigator unused, including expired or malfunctioning product. 
3. 
The number and reason for unplanned replacements. 
 
The Investigator will collect all unused test articles from the subjects at the end of the subject's pa1ticipation. 
Subject retumed unused test articles must be separated from the clinical study invent01y of un-dispensed test 
articles and must be labeled with the subject number and date of retum. Following final reconciliation of test 
articles by the monitor, the Investigator or monitor will retum all unused test a1ticles to JN C . 
 
If there is a discrepancy between the shipment documents and the contents, contact the study monitor 
immediately. 
 
 
7. 
STUDY EVALUATIONS 
 
7.1. 
Time and Event Schedule 
Table 3: Time and Events 
Visit Infonnation 
Visit 1 
Screening, 
Baseline, 
Lens Fitting 
#1 
Visit 2 
Follow-up #1 
Visit 3 
Continuance, 
Lens Fitting 
#2 
Visit 4 
Follow-up #2, 
Final Evaluation 
Time Point 
Day0 
7 ±2 days 
following 
Visit 1 
7 ±2 days 
following 
Visit 2 
7 ± 2 days 
following Visit 
3 
Minimum lens wear time 
immediately prior to visit 
Mustwear 
habitual lenses 
1 hour (study 
lenses) 
No 
reauirement 
1 hour (study 
lenses) 
Estimated Visit Duration 
2.5 hours 
1.5 hours 
1.5 hours 
1.5 hours 
Statement of info1med consent 
X 
Demographic s 
X 
Medica! histo1y/concomitant 
medications 
X 
X 
X 
X 
Habitual contact lens info1mation 
X 
Habitual lens wear time 
X 
Eligibilitv at Screening 
X 
Subiect reoorted ocular svmotolllS 
X 
X 
X 
X 
Baseline PRO ouestionnaire 
X 
Entrance visual acuitv 
X 
X 
X 
X 

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Visit Infon nation 
Visit 1 
Screening, 
Baseline, 
Lens Fitting 
#1 
Visit 2 
Follow-up #1 
Visit 3 
Continuance, 
Lens Fitting 
#2 
Visit 4 
Follow-up #2, 
Final Evaluation 
Time Point 
Day 0 
7 ±2 days 
following 
Visit 1 
7 ±2 days 
following 
Visit 2 
7 ± 2 days 
following Visit 
3 
Minimum lens wear time 
inunediatelv orior to visit 
Mustwear 
habitual lenses 
1 hour (study 
lenses) 
No 
reauirement 
1 hour (study 
lenses) 
Estimated Visit Duration 
2.5 hours 
1.5 hours 
1.5 hours 
1.5 hours 
Remove habitual lenses 
X 
X 
Subjective Sphero-Cylindrical 
Refraction 
X 
X 
Slit Lamp Biomicroscoov 
X 
X 
X 
X 
Eligibility at Baseline 
X 
Iris color 
X 
Lens Selection 
X 
X 
Lens insertion and timed rotation 
assessments 
X 
X 
Lens settling 
X 
X 
Toric fit assessment 
X 
X 
General fit assessment 
X 
X 
Soherical over-refraction 
X 
X 
Lens modification (if necessarv) 
X 
X 
Post-fit PRO auestionnaire 
X 
X 
Additional samples of toric lens 
orientation foerformed tv.•ice) 
X 
X 
X 
X 
Exit visual acuitv 
X 
X 
Disoensiniz criteria 
X 
X 
Disoensiniz instructions 
X 
X 
Schedule next visit 
X 
X 
X 
Wear time and comoliance 
X 
X 
X 
Collect unwom lenses 
X 
X 
X 
Follow-uo PRO auestionnaire 
X 
X 
X 
Distance HLHC visual acuity using 
ETDRS cha1t s 
X 
X 
Toric lens orientation 
X 
X 
X 
Lens removal 
X 
X 
X 
Continuance 
X 
Subiect comoletion status 
X 
 
7.2. 
DetailedStudy Procedures 
 
VISIT l 
Subjects must wear their habitual contact lenses to this visit. 

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Visit 1: Screenimz 
Step 
Procedure 
Details 
1.1 
Statement oflnfo1med 
Consent 
Each subject must read, understand, and sign the 
Statement of Info1med Consent before being enrolled 
into the study. The Principal Investigator or his/her 
designee conducting the info1med consent discussion 
must also sign the consent fonn. 
Note: The subject must be provided a signed copy of 
this document. 
1.2 
Demographics 
Record the subject' s year of birth, age, gender, race, 
and ethnicitv. 
1.3 
Medical Histo1y and 
Concomitant 
Medications 
Record the subject' s medical histo1yand concomitant 
medications. 
1.4 
Habitual Lenses 
Record the subject' s habitual lens type, parameters, 
lens care solution, wear modality, and approximate 
orescriotion date. 
1.5 
Habitual lens wear time. 
Record the average and comfortable wear time for the 
subiect's habitual contact lenses. 
1.6 
Eligibility after 
Screening 
All responses to Screening Inclusion Criteria questions 
must be answered ''y es" and ali responses to Exclusion 
Criteria must be answered " no" for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after screening, 
proceed to Final Evaluation and complete Subject 
Disposition. Refraction and Biomicroscopy fo1ms do 
not need to be comoleted as oait of Final Evaluation. 
 
 
Visit 1: Baseline 
Step 
Procedure 
Details 
1.7 
Subject reported ocular 
s 
toms 
Record any subject reported oculai·symptoms reported 
with re ard to their habitual contact lenses. 
1.8 
Baseline PRO 
questionnaire 
Ask the subject to fill out the baseline questionnaire 
regarding their experience with their habitual contact 
lenses. 
1.9 
Entrance visual acuity 
Record the monoculai·distance Snellen visual acuity 
for each eye (OD, OS) to the nearest letter with the 
subject's habitual contact lens cot1'ection . Subject s 
must continue until at least 50% of the letters on a line 
are read incot1'ectl . 
1.10 
Remove habitual lenses 
The subject' s habitual contact lenses will be removed 
and stored in a lens case, if required. 
 
 
 
 
 
 
 
 
 

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Visit 1: Baseline 
Step 
Procedure 
Details 
1.11 
Subjective sphero- 
cylindrical refraction 
Conduct a full spherocylindrical bare eye subjective 
refraction with binocular balance and record the 
resultant monocular visual acuity for each eye to the 
nearest letter. 
Note: The duo-chrome test should be used for refining 
the monocular and binocular spherical endpoints. This 
test will be considered to have reached the endpoint 
when the targets on red and green backgrounds appear 
to be equally sharp. However, ifthe subject's response 
changse immediately from "red" to "gre.en" with a 
0.25DS change in power, the endpoint will be the most 
plus power (with "red" target clearer) before this 
reversal. 
1.12 
Slit lamp biomicroscopy 
The FDA Slit Lamp Classification Scale will be used 
to grade findings. If any slit lamp finding is graded as 
3 or worse, the visit will be discontinued; however, the 
subject may repeat the baseline evaluation (one time) 
at a later date once the condition lessens. 
Should the clearance of the fluorescein need to be 
expedited, preservative-free rewetting drops or 
artificial tears ma be instilled. 
1.13 
Eligibility at baseline 
All responses to Inclusion Criteria questions must be 
answered " yes" and all responses to Exclusion Criteria 
questions must be answered "no" for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after baseline, 
roceed to Final Evaluation. 
1.14 
Iris color 
The investigator will record the subject' s iris color 
usin<> the sca le  ro vi ded  A endix E. 
AppendixE 

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Visit 1: Lens Fittin #1 
Step 
Procedure 
Details 
1.15 
Lens selection 
Assign the study lens based on the randomization 
scheme. Select the fitting lens powers based on ve1t ex- 
con-ecte d subjecti ve refraction for each eye, with 
consideration of the following guidelines: 
1. Label cylinder axis should be determined by 
rounding the refraction cylinder axis to the 
nearest 1O deg rees. Axis ending in the digit '5' 
should be rounded towards 180 for eyes with 
with-the-mle astigmatism, or towards 90 for 
eyes with against-the-rule astigmatism (e.g., 
175 should be rounded to 180, 105 should be 
rounded to 100). 
2. 
Cylinder power should be chosen based on the 
following table: 

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Visit 1: Lens Fittin #1 
Step 
Procedure 
Details 
3. The fitting lens spherical equivalent  (SE) 
power (label sphere power + 1/2 of the label 
cylinder power) should be as close as possible 
to the SE of the vertex-con ected refraction. If 
the  SE  of  the  vertex-con ected  refraction is 
exactly halfv.•ay betv.•een two label SE powers, 
the least minus label ower should be fit first. 
1.16 
Right eye lens insertion 
Instruct the subject to insert the right-eye lens with 
random orientation. 
If lens is uncornfortable, inspect for datnage and 
remove. reinsert or re lace as necessa . 
1.17 
Timed rotation 
assessments during 
settling period 
Start a stopwatch (or suitable smartphoneor tablet 
tirning app) as soon as the right lens is inse1et d. Record 
lens rotation (direction and magnitude) to the nearest 
degree at one (1) and three (3) minutes following 
insertion. 
Note: All lenses in this study have scribe marks at the 
6 o'clock position and rotation measurements are made 
relative to a ve1tical reference line. 
1.18 
Left eye lens insertion 
Instruct the subject to insert the left-eye lens with 
random orientation. 
If lens is uncornfortable, inspect for datnage and 
remove, reinsert, or re lace as necessa . 
1.19 
Timed rotation 
assessments during 
settling period 
Start a stopwatch (or suitable smartphoneor tablet 
tirning app) as soon as the left lens is inse1et d. Record 
lens rotation (direction and magnitude) to the nearest 
degree at one (1) and three (3) minutes following 
inse1tion. 
Note: All lenses in this study have scribe marks at the 
6 o'clock position and rotation measurements are made 
relative to a ve1tical reference line. 
1.20 
Lens settling 
Allow lenses to settle for a period of at least 
15 minutes followin<> left lens insertion. 
Ve1tex conected 
cylinder power (X) 
within the range: (DC) 
Label cylinder power to 
be fit (DC) 
-0.625 X < -1.125 
-0.75 
-1.125 X < -1.625 
-1.25 

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Visit 1: Lens Fittin #1 
 
Step 
Procedure 
Details 
1.21 
Toric fit assessment 
Record for each eye: 
1. The rotational position to the nearest degree 
2. 
Lens stability with blinks 
3. Toric fit acceptability. The toric lens fit will 
be designated as ' unacceptable' if either: 
a. The lens ABSOLUTE ROTATION is 
greater than 20 degrees 
b. The LENS STABILITY WITH BLINK 
is greater than 5 degrees 
If one or both lenses demonstrate an unacceptable toric 
fit, the subject will be discontinued (proceed to final 
evaluation . 
1.22 
General lens fit 
assessment 
The fitting characteristics of the lens in both eyes will 
be assessed using a slit lamp. Lens position 
(centration, limbal exposure, edge lift) and movement 
(primary and up gaze as well as push-up) will be 
assessed. Fit acceptability is defined as any lens that 
does not display the following general fit 
characteristics: 
• 
Limbal exposure (presence of clear comea) in 
any direction of gaze. 
• 
Edge lift. 
• 
Insufficient movement in ali three movement 
assessments (primary gaze, up-gaze and push- 
up test). 
• 
Excessive movement in prima1y gaze. 
If the general fit is unacceptable for either eye, the 
subject will be discontinued (proceed to exit 
evaluation . 
1.23 
Spherical over-refraction 
Perfonn monocular spherical over-refraction using 
duo-chrome to refme the endpoint as described in step 
1.11 (the final spherical endpoint may be detennined 
binocularly). 
The spherical over-refraction must be plano in both 
eyes to continue. 
If a non-plano over-refractionis found in either eye, 
the lens(es) must be refit with the indicated change in 
sphere power. If the indicated lens power is not 
available for either eye (e.g., outside the available 
SKU range), the subject will be discontinued (proceed 
to fmal evaluation . 

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Visit 1: Lens Fittin #1 
Step 
Procedure 
Details 
1.24 
Lens modification (if 
necessa1y) 
If modification is necessary in one or both eyes, select 
the reason for refitting lenses: 
• 
The settled lens rotation is such that a 
different cylinder axis would be more 
appropriate (use the LARS rule to determine 
the replacement lens cylinder axis) 
• 
The spherical over-refraction is not plano 
• 
Other (specify reason) 
Repeat steps 1.16 through 1.23 for one or both eyes, as 
appropriate. 
A maximum of 2 lens modifications are allowed per 
eye. If , for either eye, the fit is not successful after 2 
modifications, the subject will be discontinued 
roceed to final evaluation . 
1.25 
Post-fit PRO 
questionnaire 
Subjects will complete a PRO questionnaire regarding 
the initial comfo1t, vision and handling of the study 
lenses. 
1.26 
Additional sample of 
toric lens orientation ( I) 
Instruct the subject to leave the consulting room and 
walk around for at least 2 minutes. Upon their retum, 
measure and record the toric lens orientation for each 
e e to the nearest de ree. 
1.27 
Additional sample of 
toric lens orientation 2 
Repeat the previousstep once again. 
1.28 
Exit visual acuity 
Record the exit monocular distance Snellen visual 
acuity for each eye with the subject wearing the study 
lenses. 
1.29 
Dispensing criteria 
Lenses may be dispensed if both following conditions 
are met: 
1. 
The monocular distance visual acuity with the 
study lenses is equal to or better than 20/25 in 
each eye. 
2. The subject indicates that the comfo1t and vision 
with the study lenses is acceptable. 
If either of these conditions is not met, the subject will 
be discontinued roceed to exit evaluation . 
1.30 
Dispensing instructions 
If the study lenses are suitable for dispensing: 
• 
Instruct the subject to wear the study lenses for at 
least 8 hours per day (in a daily wear / daily 
disposable modality) on at least 5 days of the wear 
period. Subjects must not wear their habitual 
lenses at any time dmi ng the dispensing period. 
• 
Provide the subject with a copy of the Patient 
Instruction Guide. 
• 
Preservative-fre.e rewetting drops are pe1mitted, if 
needed. 
• 
Dispense enough lenses  for the subject to 
complete the wear period (i.e., up to and including 
their scheduled follow-up visit). At the 
investigator's discretion, in instances where there 
is a high likelihood of the subject needing 
replacement lenses (e.g., due to subject activities, 
unavailabili of su·b ect or site durin the wear 

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Visit 1: Lens Fittin #1 
Step 
Procedure 
Details 
period, high likelihood ofl ens tears, etc.), one 
additional spare pair may be dispensed. 
1n the event that a subject requires additional 
lenses due to loss or damage, they may retum to the 
clinical site for lens replacement. As much as 
reasonably possible, damaged lenses and packaging 
should be retumed to the clinical site (in solution, if 
possible) for shipping to the Sponsor. If lens datnage is 
present, complete the Product Quality Complaint 
Fonu, store the lens ina labeled vial with sahne and 
retum it to the Sponsor. 
• 
Ensure the subject is aware of the con-ect len s 
power for each eye (label the lenses with R and L 
as appropriate). 
• 
Instruct the subject to bring their habitual 
spectacles or contact lenses to the next visit (to 
wear following removal of the study lenses). 
• 
Instruct the subject to also bring any unwom study 
lenses to the next visit. 
1.31 
Schedule next visit 
Schedule the follow-up visit to occur in 7±2 days 
(counting the day of this visit as day O, the su bject may 
retum on day 5 through 9). Ensure the subject is 
instructed to wear the study lenses for at least 1 hour 
immediatel 
rior to attendin . the follow-u visit. 
 
VISIT 2 
Visit 2 will occur 5 to 9 days following Visit 1. Subjects must present to this visit wearing the study lenses in both 
eyes, and lenses must have been wom for at least 1 hour prior to the visit. 
Subjects should bring their own habitual spectacles or contact lenses to this visit to wear following study lens 
removal. 
 
Visit 2: Follow-U #1 
Step 
Procedure 
Details 
2.1 
Wear time and 
compliance 
Record the subjects wearing time and comfortable 
wearing time. Subjects must have wom lenses for at 
least 8 hours on at least 5 days during the dispensing 
period, and for at least 1 hour prior to attending this 
visit. 
2.2 
Collect unwom lenses 
Collect any unwom study lenses that were dispensed at 
the revious visit. 
2.3 
Review medical history 
and concomitant 
medications 
Record any changes to the subject' s medical history 
(including adverse events) or concomitant medications. 
2.4 
Subject repo1ted ocular 
symptoms 
Record any subject repo1ted ocular symptoms in 
response to a verbal open-ended symptoms 
uestionnaire. 

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Visit 2: Follow-U #1 
Step 
Procedure 
Details 
2.5 
Follow-up PRO 
questionnaire 
Subjects will complete a PRO questionnaire to assess 
their experience with the study lenses. 
Note: at the end oj the second wear pel'iod (Visit 4: 
Follo w-Up #2) the PRO questionnaire ,vi/1 a/so 
ine/ude questions regarding lens preference 
bet, veen the lenses worn in thefirst and second 
wear eriods. 
2.6 
Entrance visual acuity 
Record the entrance Snellen VA for each eye while 
wearin . the stud lenses. 
2.7 
Distance ETDRS visual 
acuity 
Measure monocular distance high luminance high 
contrast (HLHC) visual acuity using ETDRS charts at 4 
meters. 
Measure each eye using the cha1t s shown in the table 
below· 
Recorded letter-b -letter results into EDC. 
2.8 
Toric lens orientation 
Record the toric lens orientation for each eye to the 
nearest de0   -·ee. 
2.9 
Additional sample of 
toric lens orientation (1) 
Instrnct the subject to leave the consulting room and 
walk around for at least 2 minutes. Upon their retum, 
measure and record the toric lens orientation to the 
nearest de0   -·ee in each e  e. 
2.10 
Additional sample of 
toric lens orientation 2 
Repeat the previous step once again. 
2.11 
Lens removal 
Remove and place both lenses into a lens case with 
saline solution. 
Do not discard the lenses until after biomicroscopy has 
been com leted. 
2.12 
Biomicroscopy 
The FDA Slit Lamp Classification Scale will be used to 
grade findings. If any slit lamp finding is graded as 3 or 
worse, the subject must be discontinued, an adverse 
event will be recorded, and the subject will be 
monitored as per the guidelines given in section 13. 
Should the clearance of the fluorescein need to be 
expedited, preservative-free rewetting drops or a1tificial 
tears may be instilled. 
Study lenses may be discarded if there is no reason to 
store them followin<> biomicrosco 
2.13 
Exit visual acuity 
Record the exit monocular distance Snellen visual acuity 
for each eye with the subject wearing their habitual 
co!1'ection . 
Condition 
HLHC 
Room illumination 
> 400 lux 
Cha1t luminance 
120 - 200 cd/m2 
Eye 
OD 
os 
Cha1ts 
HC-1 
HC-2 
HC-3 
HC-4 

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Verify that the subject is eligible to continue in the 
stud . 
Continuance 
3.6 
The FDA Slit Lamp Classification Scale will be used 
to grade findings. If any slit lamp finding is graded as 
3 or worse, the subject must be discontinued, an 
adverse event will be recorded, and the subject will be 
monitored as per the guidelines given in section 13. 
Should the clearance of the fluorescein need to be 
expedited, preservative free rewetting drops or 
a1tificial tears ma be instilled. 
Biomicroscopy 
3.5 
3.4 
3.3 
3.2 
Ste 
3.1 
 
 
Visit 2: Follow-U #1 
Step 
Procedure 
Details 
2.14 
Schedule next visit 
Schedule the next visit (Visit 3) to occur following a 
washout period of 7±2 days (counting the day of this 
visit as day O, the su bjec t may retum on day 5 through 
9). Subjects may wear their habitual lenses during the 
washout eriod. 
 
VISIT 3 
Visit 3 will occur 5 to 9 days following Visit 2. Subjects may wear their habitual contact lenses to this visit. 
 
 
Procedure 
Review medical histo1y 
and concomitant 
medications 
Subject reported ocular 
symptoms 
 
Entrance visual acuity 
 
 
Remove habitual lenses (if 
wom) 
Visit 3: Continuance 
Details 
Record any changes to the subject's medical history 
or concomitant medications. 
 
Record any subject repo1ted ocular symptoms in 
response to a verbal open-ended symptoms 
uestionnaire. 
Record the entrance distance Snellen visual acuity for 
OD and OS with the subject wearing their habitual 
con-ection . 
If wom, the subjec t's habitual contact lenses will be 
removed. Lenses may be stored in a lens case, if 
re uired. 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
Visit 3: Lens Fitting #2 
 
The steps followed will be the same as those listed under Visit 1: Lens Fitting #1. 
VISIT 4 
Visit 4 will occur 5 to 9 days following Visit 3. Subjects must present to this visit wearing the study lenses in 
both eyes, and lenses must have been wom for at least 1 hour prior to the visit. 
Subjects should bring their own habitual spectacles or contact lenses to this visit to wear following study lens 
removal. 
 
  
Visit 4: Follow-Up #2 
 
 
The steps followed will be the same as those listed under Visit 2: Follow-Up #1, up to and including step 2.12 
'Biomicroscopy' (' Exit visual acuity' and 'Schedule next visit' will not be completed here). Additionally, a 
Preference Questionnairewill be completed as pati ofthe Follow-UpPRO questionnaire (step 2.5). 

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FINAL EVALUATION 
The final evaluation will ordinarily take place immediately following the last scheduled follow-up visit per the 
study protocol. It may also take place at any point the subject discontinues the study or is terminated from the 
study. 
 
Final Evaluation 
Ste 
Procedure 
Details 
F.l 
Subject Disposition 
Indicate ifthe subjectcompleted the study  successfully. 
If the subject is discontinued from the study, indicate the 
reason. 
F.2 
Exit Refraction 
Perfo1m 
bare-eye 
subjective 
spherocylindrical 
refraction with a phoropter and record the best-coITected 
distance visual acuity (OD and OS) to the nearest letter. 
Note: Thisstep is notnecessaiy if the subject was exited 
due to scre.en failure. 
F.3 
Exit Slit Latnp 
Biomicroscopy (for 
subjects that are 
discontinued eai·ly) 
FDA Slit Lamp Classification Scale will be used to 
grade the findings. 
If the cleai·ance of the fluore sc ein needs to be expedited, 
preservative-free rewetting drops or saline may be 
instilled. This step is not necessaiy if the subject was 
exited due to screen failure. 
Note: Thisstep is notnecessa1y if the subject was exited 
due to screen failure, or if biomicroscopy was 
perfo1med as patiof the final follow-up visit procedures 
i.e„ immediatel rior to the final evaluation . 
 
 
 
7.3. 
Unscheduled Visits 
If , during the investigation, a subject requires an unscheduled visit to the clinical site, the following information 
will be collected, as appropriate: 
• 
Chief complaint prompting the visit. If the reason is an adverse event, the applicable eCRF for the 
adverse event must be completed and subject record completed as appropriate. 
• 
Date and time of the visit and all procedures completed at the unscheduled visit. 
• 
Review of adverse event and concomitant medications. 
• 
Documentation of any test a1ticle dispensed or collected from the subject, if applicable. 
• 
Slit lainp findings (using the Slit Lamp Classification Scale). 
 
If the Investigator withdraws a subject from the study, the final study visit case repo1t fonns must be completed 
indicating the reason(s) why the subject was withdrawn. The subject record must be completed documenting the 
date and primary reason for withdrawal and the study CRA notified. 
 
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will be followed by the 
Investigator, within licensure, until they have resolved, retumed to pre-treatment status, stabilized, or been 
satisfactorily explained. If futther treatment i.e., beyond licensure is required, the subject will be refeITed to the 
appropriate health cai·e pro vider . 
 
The follo wing info1mation will be collec ted during an unscheduled visit. 

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Unscheduled Visit 
Ste 
Procedure 
Details 
U.I 
Reason for unscheduled 
visit 
Indicate if the only reason for the visit is that the 
subject requires additional test articles. If the reason is 
other than resupply of previously dispensed lenses, 
s  ec 
the reason for the visit. 
U.2 
Chief Complaints (if 
a 
licable 
Record the subject' s chief complaints for reasons for 
the unscheduled visit. 
U.3 
Adverse Events and 
Concomitant 
Medications Review (if 
a 
licable 
Review any changes to the subject' s medical history or 
concomitant medications from the previous study visit. 
Record any changes, and any adverse events. 
U.4 
Entrance VA (if 
a licable 
Record the entrance distance visual acuity (OD, OS) to 
the nearest letter. 
U.5 
Subjective Sphero- 
cylindrical Refraction (if 
applicable) 
Perfo1m bare-eye sub jective spherocylindrica l 
refraction with a phoropter (adopt the maximum plus 
to maximum visual acuity (MPMVA) approach and 
use the duo-chrome test for binocular balancing) and 
record the best cot1'ected distance visual acuity to the 
nearest letter OD, OS . 
U.6 
SlitLamp 
Biomicroscopy (if 
applicable) 
FDA Slit Lamp Classification Scale will be used to 
grade the findings. If the clearance of the fluorescein 
needs to be expedited, preservative-free rewetting 
dro s ma be instilled. 
U.7 
Dispensing (if 
applicable) 
If the subject requires additional lenses to complete the 
wear period and is eligible to do so, provide additional 
lenses per the dispensing instmctions given in the 
detailed stud rocedures. 
u.s 
Exit Visual Acuity (if 
a 
licable 
Record the subject' s exit distance visual acuity (OD, 
OS to the nearest letter. 
 
NOTE: If the onl y rea son fo1· 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: 
• 
provided infonned consent. 
• 
they are eligible. 
• 
have not withdrawn/discontinued from the study for any reason described in section 8.2. 
• 
completed ali visits through the final visit (visit 4). 
• 
If ali 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: 
• 
Subject withdrawal of consent. 
• 
Subject not compliant to protocol. 

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Johnson & Johnson Vision Care, Inc. 
 
• 
Subject lost to follow-up. 
• 
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
• 
Subject develops significant or serious adverse events necessitating discontinuation of study lens wear. 
• 
Subjects who have experienced a Corneal Infiltrative Event (CIE). 
• 
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the best interest of the 
subject to stop treatment). 
• 
Subject missed any study visits 
• 
Subject not compliant with study lens wear schedule. 
• 
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: 
• 
Complete the current visit (scheduled or unscheduled). 
• 
Complete the Final Evaluation, indicating the reason that the subject was discontinued from the study. 
• 
Record the spherocylindrical refraction with best corrected distance visual acuity. 
• 
Collect used test article(s) (worn or brought to the visit) from the subject and discard them, unless 
otherwise stated in section 7.2. 
• 
Collect all unused test article(s) from the subject. 
• 
Make arrangements for subject care, if needed, due to their study participation 
Additional subjects may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the subject and 
determine the reason for discontinuation/withdrawal. The measures taken to follow up must be documented 
including two written attempts and a certified letter (or equivalent) as the final attempt. 
 
 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. Disallowed 
concomitant interventions for this study include ocular medications of any kind, or any systemic medications that 
would normally contraindicate contact lens wear or may otherwise compromise study endpoints. 
 
9.1. 
Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact lens wear, chiefly 
by disrupting the tear film. 
 
A summary of disallowed systemic medications is shown in Table 4. Subjects with a history of taking these 
medications will be allowed to enroll only if: 
• 
The medications have been taken on a continual, routine basis for at least 6 months, and 
• 
The subject has demonstrated successful contact lens wear during this time. 
Or:  
• 
The subject was taking the medication on a temporary basis and ceased taking that medication at least 2 
weeks prior to signing the informed consent (this is considered sufficient time for the medication to have 
left the body prior to enrollment). 
 
Subjects with a history of taking medications listed in Table 4 on a long-term, routine basis for less than 6 months 
will not be allowed to participate in the study. 
 
 
 
 
 
 
 
 
 
 
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Table 4: Disallowed systemic medications 
 
Class of Drug 
Common Indication(s) 
Common Examples 
Estrogens (not 
including 
contraceptive 
medication) 
Menopause, osteoporosis, vaginitis 
Vagifem, Estrace, Climara, Vivelle-Dot, 
Premarin, Minivelle, etc. 
Anticholinergics 
In-itable bowel syndrome, Parkinson ' s 
disease, peptic ulcer, cystitis, nasal 
congestion, cold symptoms, overactive 
bladder, COPD 
Bentyl, Spiriva , Atrovent, Hyosyne, 
Levsin, Symax Fastab, Symax SL, 
Homax SL, Cogentin, Transdenn Scop, 
etc. 
Beta-blockers 
Hype1tension,     angina,     heart     attack, 
migraine, atrial fibrillation, andrenal 
cancer, essential tumor, glaucoma 
Toprol 
XL, 
Lopressor, 
Tenonnin, 
Propranolol, Timoptic, Trandate, Inderal 
LA, etc. 
Psychotropics 
Antipsychotic (schizophrenia, mania), 
antidepression, antiobsessive, antianxiety, 
mood stabilizer, stimulants (ADHD) 
Zoloft, 
Celexa, 
Prozac, 
 
Lexapro, 
Effexor, 
Cymbalta, 
Ativan, 
Xanax, 
Desyrel, Wellbutrin, etc. 
Vitamin A analogs 
Cystic acne 
Isotretinoin 
Analgesics 
Urinruy tract infection 
Phenazopyridine HCL 
 
Examples of disallowed systemic antihistamines are given in Table S. Subjec ts wi th a hist01y oftaking systemic 
antihistamines will be allowed to enroll only if: 
• 
They have taken antihistamines continuously for at least 2 weeks, and 
• 
They have demonstrated successful wear while taking the medication 
Or: 
• 
They stopped taking the medication for at least 2 weeks prior to enrollment. 
 
 
Table 5: Disallowed systemic antihistamines 
 
Class of Drug 
Common Indication(s) 
Common Examples 
Antihistamines 
Allergic rhinitis, sedation, hives, allergic 
conjunctivitis, skin allergy, itching, motion 
sickness 
Hydroxyzine, Promethagan, Phenadoz, 
Vistaril, 
Claritin, 
Zyitec, 
Astepro, 
Astelin, Optivar, Allegra, Benadryl, etc. 
 
 
 
10. DEVIATIONSFROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol deviations must be 
repo1ted to the sponsor within 24 hours after discove1y of the protocol deviation. The Investigator will report 
deviations per IRB/IEC requirements. All deviations will be tracked, and con-ective actions implemen ted as 
appropr iate. 
 
If it become s necessa1y for the Investigator to implement a deviation in order to eliminate an immediate hazru·d 
to the trial subject, the Investigator may implement the deviation immediately without notification to the sponsor. 
Within 24 hours after the implemented deviation, the Investigator must notify and provide the rationale to the 
Sponsor and as required, the IEC/IRB. 
 
If the deviation potentially impacts the safety of patient or changes the technical integrity of the  study,  then  it  
must be repo1t ed to IEC/IRB. This is a "Major Deviation". Deviations that contradict the info1mation contained  
in the Infon ned Consent/Assent fonn s will be considered Major Deviations. 

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Minor deviations have no substantive effect on patient safety or technical integrity of the study. They are often 
logistical in nature. 
 
Protocol waivers are prohibited. 
 
Table 6 lists examples of deviations that will constitute major and minor protocol deviations for this study. 
Table 6: Examples of major and minor protocol deviations 
Deviation catego1y 
Maio r deviation 
Minor deviation 
Out-of-window visit 
Visit attended > 3 days out of visit 
window 
defined 
in 
study 
procedures 
Visit attended 
3 days out of visit 
window 
defined 
lll 
study 
procedures 
Unanswered PRO questions 
If  questionnaire is not completed 
(i.e., all questions are unanswered) 
for any visit questionnaire, or more 
than 2 questions are unanswered 
for   the   follow-up   visit  CLUE 
auestionnaire. 
Any individua! or multiple PRO 
questions 
(2 
or 
less) 
are 
unanswered (i.e., left blank). 
Insufficient wear of study lenses 
Subject does not wear study lenses 
for at least 8 hours on at least 5 
days of a study lens wear period. 
Subject wears their habitual lenses 
during any of the study lens wear 
periods. 
Subject does not wear study lenses 
for at least 1 hour prior to attending 
a follow-up visit. 
 
1n the case of a major protocol deviation, the decision of whether or not the subject will be excluded from the 
Per-Protocol analysis population will be made at the time of coho1t review. 
 
 
11. STUDY TERMINATION 
The occm1·ence of one or more Unanticipated Serious Adverse Device Effect (USADE), or any SAE where the 
relationship to study agent cannot be rnled out, may result in stopping further dispensing of test article. 1n the 
event of a USADE or SAE, the Sponsor may unmask the treatment regimen for the subject(s) and will discuss 
this with the Investigator before any fmiher subjects are enrolled. 
 
The Sponsor will detennine when a study will be stopped. The Principal Investigator always has the discretion to 
initiate stoppingthe study based on patient safety or if infonnation indicates the study's results are compromised. 
 
JNC reserves the right to te1minate the study at any time for any reason. Additionally, the IEC/IRB reserves the 
right to tenninate the study if an unreasonable risk is dete1mined. The study can be tenninated by the Principal 
Investigator at the individua! clinical site due to specific clinical observations, if in their opinion, after a discussion 
with JN C, it is detennined that it would be unwise to continue at the clinical site. 
 
JNC (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 pa1t of the investigation presenting the risk, will be 
te1minated as soon as possible. 
 
Should the study be te1minated (either prematm·ely or as scheduled), the Investigator will notify the IEC/IRB and 
Regulato1yAuthority as required by local regulato1yrequirements. 

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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: 
• 
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient Reported Outcomes 
(PRO).” 
• 
Clinical test articles that are stored improperly or damaged after receipt at the investigational site. 
• 
Lens replacements that occur due to drops/fall-outs. 
• 
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: 
• 
Date the complaint was received/recorded in the EDC System (Date of Sponsor Awareness). 
• 
Who received the complaint. 
• 
Study number. 
• 
Clinical site information (contact name, site ID, telephone number). 
• 
Lot number(s). 
• 
Unique Subject Identifier(s). 
• 
Indication of who first observed complaint (site personnel or subject). 
• 
OD/OS indication, along with whether the lens was inserted. 
• 
Any related AE number if applicable. 
• 
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, resolution of 
symptoms, etc.). 
• 
Eye Care Provider objective (slit lamp) findings if applicable. 
• 
Confirmation of product availability for return (and tracking information, if available), or rationale if 
product is not available for return 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel to determine if it is 
an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint results in an AE/SAE, the COM/CRA, or 
trained site personnel will follow section 13 of this protocol. If the AE/SAE was potentially the result of a product 
quality related deficiency, these procedures also apply 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. 

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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 and whether anticipated or unanticipated.” 
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: 
• 
Death 
• 
Serious deterioration in the health of the subject that resulted in any of the following: 
• 
Life-threatening illness or injury 
• 
Permanent or persistent impairment of a body structure or a body function 
• 
Hospitalization or prolongation of patient hospitalization 
• 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 
a body structure or a body function. 
• 
Chronic disease 
• 
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: 
• 
Microbial Keratitis (MK) 
• 
Iritis (including cells in the anterior chamber) 
• 
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or greater 
• 
Central Corneal Opacity 
• 
Central Corneal Neovascularization 
• 
Uveitis 
• 
Endophthalmitis 
• 
Hypopyon 
• 
Hyphemia 
• 
Penetration of Bowman’s Membrane 
• 
Persistent Epithelial Defect 
• 
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: 
• 
Contact Lens Induced Peripheral Ulcer (CLPU) 
• 
Significant Infiltrative Events (SIE) 
• 
Superior Epithelial Arcuate Lesions (SEALs) 
• 
Any Temporary Loss of > 2 Lines of BSCVA 
• 
Other grade 3 or higher corneal findings, such as abrasions or edema 
• 
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 

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• 
Asymptomatic Corneal Scar 
• 
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic and usually do not 
warrant discontinuation of contact lens wear but may cause a reduction in wear time. However, the Investigator 
may choose to prescribe treatment as a precautionary measure. 
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, but not limited to 
the following: 
• 
Non-significant Infiltrative Event (NSIE) 
• 
Contact Lens Papillary Conjunctivitis (CLPC) 
• 
Superficial Punctate Keratitis (SPK) 
• 
Conjunctivitis: Bacterial, Viral, Allergic 
• 
Blepharitis 
• 
Meibomianitis 
• 
Contact Dermatitis 
• 
Localized Allergic Reactions 
• 
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: 
• 
Seriousness/Classifications (see definition in section 13.1). 
• 
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). 
• 
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). 
• 
Outcome – not recovered or not resolved, recovering or resolving, recovered or resolved with sequelae, 
recovered or resolved, death related to adverse event, or unknown. 
• 
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the test article. The 
test article relationship for each adverse event should be determined by the investigator using these explanations: 
• 
Not Related- An adverse event that is not related to the use of the test article, study treatment or study 
procedures. 

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• 
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. 
• 
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. 
• 
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: 
• 
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere with the subject’s 
daily activities. 
• 
Moderate – Event is bothersome, possible requiring additional therapy, and may interfere with the 
subject’s daily activities. 
• 
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy and interferes with 
the subject’s daily activities. 
 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the subjects are exposed 
to the test article, study treatment or study procedure. Adverse events reported before the use of test article, start 
of study treatment, or study procedures will be recorded as medical history. However, if the condition deteriorates 
at any time during the study, it will be recorded and reported as an AE. Untoward medical events reported after 
the subject’s exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the subject record and 
in the eCRFs and complete the Adverse Event eCRF. 
 
Complete descriptions of all adverse events must be available in the subject record. All Adverse Events including 
local and systemic reactions not meeting the criteria for “serious adverse events” shall be captured on the 
appropriate case report form or electronic data system. All adverse events occurring while the subject is enrolled 
in the study must be documented appropriately regardless of relationship. 
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. All adverse events 
will be followed in accordance with applicable licensing requirements. Such documentation will include the 
following: 
• 
Adverse event (diagnosis not symptom). 
• 
Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, and depth, etc.). 
• 
Date the clinical site was notified. 
• 
Date and time of onset. 
• 
Date and time of resolution. 
• 
Adverse event classification, severity, and relationship to test articles, as applicable. 
• 
Treatment regimen instituted (where appropriate), including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
• 
Any referral to another health care provider if needed. 
• 
Outcome, ocular damage (if any). 
• 
Likely etiology. 

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• 
Best corrected visual acuity at the discovery of the event and upon conclusion of the event, if the AE is 
related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or study procedures 
(whether related to the visual system or not), an AE review form 
must be completed. Additional 
dated and initialed entries should be made at follow-up evaluations. Separate forms must be completed for each 
eye if the AE is bilateral. 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment eCRF. Where 
necessary, a culture of the corneal lesion will be collected to determine if the infection is microbial in nature. If 
cultures are collected, the date of culture collection and laboratory utilized will be recorded. 
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration of the event at each 
level of intensity to be performed. Adverse events characterized as intermittent require documentation of the onset 
and duration of each episode. Changes in the assessment of relationship to the test article shall also be clearly 
documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within licensure, until all signs 
and symptoms have returned to pre-treatment status, stabilized, or been satisfactorily resolved. If further treatment 
beyond licensure is required, the patient will be referred to the appropriate health care provider. The Investigator 
will use his/her clinical judgment as to whether a subject reporting with an adverse event will continue in the 
study. If a subject is discontinued from the study, it will be the responsibility of the Investigator to record the 
reason for discontinuation. The Investigator will also document the adverse event appropriately and complete the 
Adverse Event eCRF. Any subjects with ongoing adverse events related to the test article, study treatment or 
study procedures, as of the final study visit date, should be followed to resolution of the adverse event or until 
referral to an appropriate health care provider, as recommended by the Investigator. Non-ocular adverse events 
that are not related to the test article, study treatment, or study procedures may be recorded as “ongoing” without 
further follow-up. 
 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone as soon as possible 
and no later than 24 hours from discovery for any serious /significant adverse events, and 2 days from discovery 
for any non-significant adverse event. In addition, 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: 
• 
Notify the Sponsor immediately. 
• 
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. 
• 
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. 

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• 
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator will submit a report 
of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later than 24 hours after the Investigator 
first learns of the effect. This report is in addition to the immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the evaluation to FDA, the 
IEC/IRB and participating Investigators within 10 working days after the Sponsor first receives notification of 
the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported to the sponsor by 
the Investigator no later than 2 days from discovery. 
 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the IEC/IRB’s written 
guidelines. Each clinical site will refer to and follow any guidelines set forth by their Approving IEC/IRB. Each 
clinical site will refer to and follow any guidelines set forth by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according 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. More details will be included 
in the stand-alone Statistical Analysis Plan (SAP). The SAP will be developed and finalized prior to database 
lock. 
 
All data summaries and statistical analyses will be performed using the SAS software Version 9.4 SAS Institute, 
Cary, NC)7. Throughout the analysis of data, the results for each subject/eye will be used when available for 
summarization and statistical analysis. For the analysis of co-primary safety endpoints, unscheduled visits will 
be summarized separately and will not be excluded from the statistical analysis. However, for the analysis of co- 
primary efficacy endpoints and secondary endpoints, unscheduled visits will be summarized separately and 
excluded from the statistical analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline variables, efficacy 
variables and safety variables as appropriate. Continuous variables will be summarized with descriptive statistics 

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Johnson & Johnson Vision Care, Ine. 
 
(n, mean, standard deviation(SD), median, minimum and maximum). Frequency count and percentage of subject.s 
or eyes within each catego1ywill be provided for categorical data. 
 
Summaries will be presented by separately for each time point (baseline, fitting and 1-week follow-up) and will 
be perfo1med separately by completion status (Safety Population, Per-Protocol Population or Intent-to-treat, when 
appropriate). 
 
14.2. Sample Size Justification 
This study was designed and powered to test for superiority of the test lens after 1-week of lens wear with respect 
to the following: distance monocular HLHC visual acuity (logMAR), subjective vision scores, toric lens 
orientation, and rotational stability. This study was also powered to test superiority of the test lenses with respect 
to grade 3 or higher slit lamp findings and percentage of eyes with acceptable lens fit. Additionally, this  study 
was also powered to test for superiority with respect to CLUE Comfo1t and Handling scores after 1-week of lens 
wear. The described alpha adjustment is also factored into these estimations of sample size and power. 
 
The sample size for co-prima1y efficacy endpoints was estimated to achieve a minimum statistical power of 90% 
for distance monocular visual acuity (logMAR), toric lens orientation, rotational stability, and CLUE Vision 
scores using a 2-sided type I eITor rate of 5%. Co-prima1y safety endpoints (grade 3 or higher SLFs and acceptable 
lens fitting) were estimated to achieve a minimum statistical power of 99% with 95% central posterior credible 
interval. 
 
A summa1y of historical studies utilized in the sample size calculation are summarized in Table 7 below, while 
Table 8 summarizes the historical data for the test lens by endpoint. 
Table 7: Historical Studies Utilized for Sample Size Calculations 
 
Study Nu=m=:b:.e.::r:-4 -=D
;.,e;:..s;:.i:.;..:=---
2x3 
---=S.t;u;;;;d::.1:P.....:h::a;;;s;:..e;:;     -
Feasibility 
Number 
Number in Safety 
Number in PP 
-_  -=E==nr ol:::el.d.:;    --11--- 
..:.-=Po=  =ul a:.t.i;:.o.;:.n::;  
  ,1.-_  ..i:;.o;:;.i:;.;u:;;::a:;l;t;i:::.o.;:.n::;  ---- 
145 
144 
133 
2x3 
Confomation 
126 
26 
119 
PP: Per-Protocol 
 
Table 8: Historical Data by Endpoint - Test Lens 
 
Endpoint Tvue 
Endpoint 
Data 
Tvue 
Value 
*Primary Safety 
Grade 3 + SLFs (Adverse Event) 
Rate 
0% 
Acceptable Lens Fitting 
100% 
**Prima1y 
Efficacy 
Distance Monocular Visual Acuity (logMAR) 
Mean 
(SD) 
-0.115 (0.0769) 
Absolute Toric Rotation 
10° 
97.5% 
Lens Stability with Blinks 5° 
100% 
CLUE Vision Scores 
67.4 (19.67) 
**Secondary 
CLUE Handling Scores 
Mean 
(SD) 
65.4 (21.50) 
CLUE Comfort Scores 
67.9 (21.50) 
SD=Standard Deviation 
*Summaries for the primaiy safety endpoints were provided for the safety population; all available data was 
included 
**Summaries for primary efficacy and seconda1y endpoints were provided for the per-protocol population at the 
1-week follow-up evaluation. 
 
 
 

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Co-Primary Safety Endpoint Sample Size Calculations: 
 
Grade 3 or Higher Slit Lamp Findings (SLFs) 
Grade 3 or Higher SLFs related to study lens wear will be converted to a binary response as 𝑌𝑌 = 1 , if a subject 
eye has a clinically significant SLF, and 𝑌𝑌 = 0 otherwise, for analysis purposes. From the historical data there 
was none or an extremely low rate (< 1%) for clinically significant SLFs (Grade 3 or higher) for the test lens. 
Assuming a correlation of 0.70 between left and right eyes within the same subject, a total of 5000 replicating 
trials were simulated with a reference rate of 2% (worse-case scenario). Given the rare event binary outcome of 
slit lamp findings, each replicated sample was analyzed using a Bayesian beta-binomial model with correlated 
binary data (Diniz et al; 2010).8 For each simulated trial, the upper bound of the 95% central posterior credible 
interval constructed for the percentage of grade 3 or higher SLFs for the test lens was compared to a margin of 
5%. With the proposed sample size, at least 99% of the estimated 95% credible intervals had the upper bound 
below 5%. 
 
Acceptable Lens Fitting 
Acceptable lens fitting will be converted to a binary response as 𝑌𝑌 = 1 , if a subject eye has acceptable lens fitting, 
and 𝑌𝑌 = 0 otherwise, for analysis purposes. As indicated in the historical data of these lenses there was an 
extremely high rate (> 99%) acceptable lens fitting for the test lens. Assuming a correlation of 0.70 between left 
and right eyes within the same subject, a total of 5000 replicating trials were simulated with a reference rate of 
99% (worse-case scenario). Given the rare event binary outcome of Y=0 (unacceptable lens fitting), each 
replicated sample was analyzed using a Bayesian beta-binomial model with correlated binary data (Diniz et al; 
2010).8 For each simulated trial, the upper bound of the 95% central posterior credible interval constructed for 
the percentage of acceptable lens fittings for the test lens was compared to a margin of 80%. With the proposed 
sample size, at least 99% of the estimated 95% credible intervals had the lower bound above 80%. 
 
Co-Primary Efficacy Endpoint Sample Size Calculations: 
 
Distance Monocular Visual Acuity (logMAR) and CLUE Vision Scores 
Sample size calculations for visual acuity and vision scores were carried out separately using one-sided, one- 
sample mean t-test, with a type I error rate of 5% for each hypothesis. The hypothesis regarding visual acuity was 
powered to 99%, while the hypothesis for CLUE Vision scores was powered to 91%. Sample size calculations 
were performed using the One-Sample T-Tests for Superiority by a Margin procedure in Power Analysis & 
Sample Size (PASS2021) software Version 21.0.6 (NCSS LLC, Kaysville UT).9 Table 9 below, displays sample 
size estimates by endpoint. 
 
Toric lens orientation and rotational stability 
Sample size estimates for toric lens orientation and rotational stability were calculated using the same technique. 
Both endpoints are testing against an 80% threshold and have an event rate greater than 97%. A reference rate of 
97.5% was used for toric lens orientation, while a worst-case scenario of 98% was used for rotational stability. 
 
Toric lens orientation and rotational stability will be converted to a binary response as 𝑌𝑌 = 1 if a subject eye has 
absolute toric lens orientation ≤ 10° (rotational stability: Y=1 if a subject eye has lens stability with blinks ≤ 5°) 
and 𝑌𝑌 = 0 otherwise, for analysis purposes. As indicated historical data of these products there was an extremely 
high rate (> 97%) for both toric lens orientation and rotational stability for the test lens. Assuming a correlation 
of 0.70 between left and right eyes within the same subject, a total of 5000 replicating trials were simulated with 
a reference rate of 97.5% for toric rotation and 98% for rotation stability (worse-case scenario). Given the rare 
event binary outcome of Y=0, each replicated sample was analyzed using a Bayesian beta-binomial model with 
correlated binary data (Diniz et al; 2010).8 For each simulated trial, the upper bound of the 95% central posterior 
credible interval constructed for the percentage of acceptable lens fittings for the test lens was compared to a 
margin of 80%. With the proposed sample size, at least 99% of the estimated 95% credible intervals had the lower 
bound above 80%. 
 
Secondary Endpoint Sample Size Calculations: 
 
 
 
 
 
 
 
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CLUE Handling and Comfo1t Scores 
Sample size calculations for handling and comfo1t scores were caITied sepa rate ly ou t using one-sided, one-sample 
mean t-test, with a type I eITor rate of 2.5% for each hypothesis. To  preserve  the  overall  study  power,  each 
endpoint was powered to 99%. Sample size calculations were perfo1med  using  the  One-Sample  T-Tests  for 
SuperiOl'i ty b y a Margin procedure in Power Analysis & Sample  Size (PASS2021)  software  Version  21.0.6 
(NCSS LLC, Kaysville UT).9 
 
Table 9 below, displays sample size estimates by endpoint. As indicated below, co-primary safety endpoints were 
powered ~99% individually yielding a combined power of ~98%. With respect to co-prima1y efficacy, each 
hypothesis, except for CLUE Vision (powered to 91%) was powered to ~99%, which provided a combine power 
of ~88%. Therefore, the overall combined study power for co-primary safety and co-primaiy efficacy hypotheses 
is ~86% and is considered reasonable to suppo1t  any conclusions from these analyses. Furthe1more, seconda1y 
endpoints were powered to achieve at least 99% statistical power. This was considered to have a minimal impact 
on overall study power because of the multibranch gate keeping approach being implemented. 
 
Table 9: Samole Size Estimates for Co-PrimarvSafetv. Efficacv and Secondarv End)oints 
Endpoint 
Tvoe 
Endpoint 
Test Tvoe 
Sample 
Size 
Power (% ) 
Prima1y 
Safety 
Grade 3 or Hillher SLFs (5%) 
Statisticallv less then (5%) 
100 
99 
Acceptable Lens Fitting (%) 
Statistically greater then 
(80%) 
100 
99 
Prima1y 
Efficacy 
Distance (4m) Monocular Visual 
Acuitv (lollMAR) 
Superiority (0.00) 
9 
99 
Absolute Toric Rotation 
< 100 
Statistically greater then 
( 80   % ) 
40 
99 
Lens Stability with Blinks 
5° 
Statistically greater then 
(80%) 
100 
99 
CLUE Visions Scores 
Suoerioritv (62) 
144 
91 
Seconda1y 
CLUE Handling Scores 
Suoerioritv (61) 
135 
97 
CLUE Comfo1t Scores 
Suoerioritv (58) 
135 
97 
 
While only a total of 144 subjects are required to complete the study based on the sample size calculations, the 
target enrollment is approximately 180 subjects with a target completion of at least 165 subjects. Data collected 
from this study may be utilized to pe1fonn a meta-analysis at a later date, therefore, the target completion for this 
study was increased to 165 subjects to accommodate this possibility. 
 
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 detennined 
by the trial coho1t review collllllittee 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 
All co-prima1ysafety, co-primary efficacy, and secondaty hypotheses will be tested using a multibranch gate 
keeping strntegy. Study hypotheses will be evaluated sequentially as follows: 
 

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೦
𝑍𝑍 = 
 
First, co-primary safety hypotheses will be evaluated using 95% central posterior credible intervals for the 
probability of grade 3 or higher SLFs and acceptable lens fitting. Both hypotheses must be met in order to test co- 
primary efficacy hypotheses. Each co-primary efficacy hypothesis will be tested with a type I error rate of 5%. 
All co-primary safety and co-primary efficacy hypotheses must be met to test any secondary hypotheses. 
Secondary hypotheses will be tested utilizing a Bonferroni adjustment10 with an overall two-sided family-wise 
type I error rate of 5% (2.5% individually). 
 
14.5. Primary Analysis 
Methodology regarding the plan for testing and/or handling statistical associations between co-primary safety 
and/or efficacy endpoints will be documented in the SAP. 
 
Co-Primary Safety Analyses: 
All primary safety analysis will be conducted on the safety population. 
 
Grade 3 or Higher SLF 
Grade 3 of Higher SLFs will be analyzed using a Bayesian beta-binomial model with correlated binary data.8 
 
The Model: 
Let 𝑌𝑌1   and 𝑌𝑌2   denote the binary outcomes of lens fit acceptance (Yes/No) in left and right eyes, respectively, 
across dispensing and follow-up visits when wearing the test lens. Considering the correlation, 𝜌𝜌, between 𝑌𝑌1  and 
𝑌𝑌2, the distribution of the sum 𝑌𝑌  =  𝑌𝑌1   +  𝑌𝑌2  is obtained by the mixture of two variables. One of them follow a 
binomial distribution 𝐵𝐵𝐵𝐵𝐵𝐵(2, 𝑝𝑝) with mixing probability (1 −  𝜌𝜌) and the other one follows a modified Bernoulli 
distribution, 𝑀𝑀𝐵𝐵𝑀𝑀𝑀𝑀𝐵𝐵(𝑝𝑝), taking value 0 and 2 rather than conventional 0 and 1, with mixing probability 𝜌𝜌: 
 
𝑃𝑃(𝑌𝑌  =  𝑦𝑦| 𝑝𝑝, 𝜌𝜌)  =  (1 −  𝜌𝜌)𝐵𝐵𝐵𝐵𝐵𝐵(2, 𝑝𝑝)𝐼𝐼𝐴𝐴1   +   𝜌𝜌𝑀𝑀𝐵𝐵𝑀𝑀𝑀𝑀𝐵𝐵(𝑝𝑝)𝐼𝐼𝐴𝐴2  , 
 
where 𝐼𝐼𝐴𝐴1    =  {0, 1, 2}, 𝐼𝐼𝐴𝐴2  =  {0, 2} and 𝑝𝑝 is the probability of success (i.e., acceptable lens fitting). 
 
To overcome the complexity of the mixture likelihood a latent variable 𝑍𝑍𝑖𝑖 , i = 1, 2 is introduced in the model to 
indicate in which component of the model the observation 𝑦𝑦𝑖𝑖 , i=1, 2, belongs to, that is, 
1, if the observation belong to the MBern(p), 
𝑖𝑖 
೦ 0, if the observation belong to the Bin(2, p) 
The joint distribution of the augmented data (𝑌𝑌𝑖𝑖 , 𝑍𝑍𝑖𝑖 ), 𝐵𝐵 = 1, 2, is given by 
P(Y = y , Z = z | p, ρ) = ρzipyizi/2(1 − p)(2−yi)zi/2(1 − ρ)1−zi 2 ೦ p 
i 
i 
yi 
yi(1−zi)(1 − p)(2−yi)(1−zi) 
The probability p links to the regression variables through a logit transformation as follow: 
 
logit (p) =   β0  +  β1lens 
 
It is assumed that β0, β1 and 𝜌𝜌 to be independent with a non-informative prior N(0, 1000) for β0 and β1, and 
beta(0.5, 0.5) for 𝜌𝜌. The Metropolis sampler algorithm as implemented in the SAS/STAT MCMC Procedure7 will 
be used to estimate the posterior distributions of the parameters (β0, β1, 𝜌𝜌). Inferences will be made based on a 
posterior credible interval for the relevant parameters. 
 
Bayesian Estimation and Statistical Evaluation of Hypothesis: 
Superiority of the test lens relative to the pre-defined threshold with respect to grade 3 or higher will be evaluated 
using Bayesian statistics. 
 
Primary Safety Hypothesis 1: 
The null and alternative hypotheses for evaluating superiority of the test lens relative to 5% are as follows: 
 
 
𝐻𝐻0: 𝑝𝑝T  ≥ 5% 
𝐻𝐻𝐴𝐴: 𝑝𝑝T  < 5%, 

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where 𝑝𝑝T  is the probability of a grade 3 or higher SLF across all study visits for test lens. Based on Bayesian 
posterior probability distribution of the proportion 𝑝𝑝𝑇𝑇 , superiority is interpreted as 95% probability of test being 
statistically lower than the threshold of 5% (i.e., 𝑝𝑝T  < 0.05). If the upper bound of the 95% central posterior 
credible interval is below 0.05, it can be concluded that there is 95% probability that the test lens is superior to 
5% (statistically less than) based on the observed sample. 
 
In the case of zero clinically significant SLF, a Bayesian hierarchical model accounting for zero-event problem 
will be considered.8 
 
Acceptable Lens Fitting 
Lens fit acceptance will be analyzed using a Bayesian beta-binomial model with correlated binary data.8 
 
Bayesian Estimation and Statistical Evaluation of Hypothesis: 
Superiority of the test lens relative to the pre-defined threshold with respect to acceptable lens fitting will be 
evaluated using Bayesian statistics. 
 
Primary Safety Hypothesis 2: 
The null and alternative hypotheses for evaluating superiority of the test lens relative to 80% are as follows: 
 
𝐻𝐻0: 𝑝𝑝T  ≤ 80% 
𝐻𝐻𝐴𝐴: 𝑝𝑝T  > 80%, 
where 𝑝𝑝T  is the probability of event (i.e., probability of acceptable lens fitting while wearing the test lens). Based 
on Bayesian posterior probability distribution of the proportion 𝑝𝑝𝑇𝑇 , superiority is interpreted as 95% probability 
of the test lens being statistically larger than the pre-defined threshold of 80% (i.e., 𝑝𝑝T  > 80) with respect to 
acceptable lens fitting rate. If the lower bound of the 95% central posterior credible interval is above 80%, it can 
be concluded that there is 95% probability that the test lens is superior to the 80% threshold (statistically greater) 
based on the observed sample. 
 
In the case of all eyes have an acceptable lens fit (i.e., zero unacceptable lens fits), a Bayesian hierarchical model 
accounting for zero-event problem will be considered.8 Details of this model will be provided in the stand-alone 
SAP. 
 
Co-Primary Efficacy Analyses 
 
Visual Acuity (VA) 
Distance, monocular, high-luminance, high-contrast (HLHC), VA after 1 week of lens wear will be analyzed 
using a linear mixed model. Sequence of lens wear, lens type and period will be included in the model as fixed 
effects. Subject characteristics such as, gender, age and/or cylinder power may be included in the model if 
appropriate. Site ID and subject nested within site will be included in the model as random effects (G-side). The 
residual error between measurements within the same subject across study period will be modeled using an 
unstructured (UN) covariance structure. If the model fails to converge with a UN covariance, then a compound 
systemic (CS) covariance structure will be used. The Kenward and Roger Method will be used for the denominator 
degrees of freedom.11 Visual Acuity scores will be estimated using 95% confidence intervals (CI) constructed for 
the least-square means (LSM). 
 
 
Primary Efficacy Hypothesis 1: 
The null and alternative hypothesis for distance monocular HLHC VA to test for superiority of test relative to the 
threshold 0.0 logMAR are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 ≥ 0 logMAR 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  < 0 logMAR 

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Where 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population mean for test lens after 1-week of lens wear with respect to distance 
monocular HLHC VA. Superiority will be declared if the upper limit of the 95% CI is below 0.0. 
 
 
Toric Lens Orientation and Rotational Stability at Least 15- Minutes Following Lens Settling 
Absolute toric lens orientation (degrees) will be dichotomized as Y=1 if the absolute lens orientation (degrees) ≤ 
10° and Y=0, otherwise. Rotational stability will be quantified by lens stability with blinks (degrees). Lens 
stability will be dichotomized as Z=1 if the lens stability with blinks (degrees) ≤ 5° and Z=0, otherwise. 
 
Y and Z will be analyzed separately using a generalized linear mixed model with a binary distribution and the 
logit as the link function. Sequence of lens wear, lens type and period will be included in the model as fixed 
effects. Subject characteristics such as, gender, age and/or cylinder power may be included in the model if 
appropriate. Site ID and subject nested within site will be included in the model as random effects (G-side). The 
residual error between measurements within the same subject across study period will be modeled using an 
unstructured (UN) covariance structure. If the model fails to converge with a UN covariance, then a compound 
systemic (CS) covariance structure will be used. The Kenward and Roger Method will be used for the denominator 
degrees of freedom.11 
 
 
Primary Efficacy Hypothesis 2: 
The null and alternative hypothesis to test for superiority of absolute lens orientation ≤ 10° for the test lens 
relative to the threshold 80% are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇   ≤ 80% 
𝐻𝐻𝐴𝐴: 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  > 80% 
 
Where 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population percentage for the percentage of eyes wearing the test lens with absolute 
lens orientation ≤ 10°. Superiority will be declared if the lower limit of the 95% CI is above 80. 
 
Depending on the observed response rates for the percentage of subjects’ eyes with absolute lens orientation ≤ 
10° and the percentage of subjects’ eyes with lens stability with blinks ≤ 5°, a Bayesian hierarchical model 
accounting for zero event problem may be considered (i.e., 0% of eyes with toric rotation >10° [or lens stability 
>5°]) . Details of this model will be provided in the stand-alone SAP. 
 
Primary Efficacy Hypothesis 3: 
The null and alternative hypothesis to test for superiority of lens stability with blinks ≤ 5° for the test lens relative 
to the threshold 80% are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇   ≤ 80% 
𝐻𝐻𝐴𝐴: 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  > 80% 
Where 𝑝𝑝𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population percentage for the percentage of eyes wearing the test lens with lens 
stability with blinks ≤ 5°. Superiority will be declared if the lower limit of the 95% CI is above 80. 
 
CLUE Vision Scores 
CLUE vision scores after 1 week of lens wear will be analyzed using a linear mixed model adjusting for baseline 
scores as a covariate. Sequence of lens wear, lens type and period will be included in the model as fixed effects. 
Subject characteristics such as, gender, age and/or cylinder power may be included in the model if appropriate. 
Site ID will be included in the model as a random effect (G-side). The residual error between measurements 
within the same subject will be modeled using an unstructured (UN) covariance structure. If the model fails to 
converge with a UN covariance, then a compound systemic (CS) covariance structure will be used. The Kenward 
and Roger Method will be used for the denominator degrees of freedom.11 CLUE Vision Scores estimates for each 
study lens will be estimated using 95% confidence intervals (CI) constructed for the least-square means (LSM). 

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Primary Efficacy Hypothesis 4: 
The null and alternative hypothesis to test for superiority of CLUE vision score for the test lens relative to the 
threshold 62 are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 ≤ 62 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  > 62 
 
Where 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population mean for test lens after 1 week of lens wear with respect to CLUE vision 
scores. Superiority will be declared if the lower limit of the 95% CI is above 62. 
 
14.6. Secondary Analysis 
CLUE Handling and Comfort Scores 
CLUE Handling and Comfort scores after 1-week of lens wear will be analyzed separately using a linear mixed 
model adjusting for baseline scores as a covariate. Sequence of lens wear, lens type and period will be included 
in the model as fixed effects. Subject characteristics such as, gender, age and/or cylinder power made be included 
in the model if appropriate. Site ID will be included in the model as a random effect (G-side). The residual error 
between measurements within the same subject will be modeled using an unstructured (UN) covariance structure. 
If the model fails to converge with a UN covariance, then a compound systemic (CS) covariance structure will be 
used. The Kenward and Roger Method will be used for the denominator degrees of freedom.11 CLUE Handling 
and Comfort scores for each study lens will be estimated using 97.5% confidence intervals (CI) constructed for 
the least-square means (LSM). 
 
Secondary Hypothesis 1: 
The null and alternative hypothesis to test for superiority of CLUE Handling score for the test lens relative to the 
threshold 61 are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 ≤ 61 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  > 61 
 
Where 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population mean for test lens after 1 week of lens wear with respect to CLUE 
Handling scores. Superiority will be declared if the lower limit of the 97.5% CI is above 61. 
 
Secondary Hypothesis 2: 
The null and alternative hypothesis to test for superiority of CLUE Comfort score for the test lens relative to the 
threshold 58 are as follows: 
 
𝐻𝐻𝑜𝑜 : 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 ≤ 58 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇  > 58 
 
Where 𝜇𝜇𝑇𝑇𝑇𝑇𝑇𝑇𝑇𝑇 , represents the population mean for test lens after 1 week of lens wear with respect to CLUE 
comfort scores. Superiority will be declared if the lower limit of the 97.5% CI is above 58. 
 
 
14.7. Exploratory Analysis 
 
Ability to see comfortably while driving during the day or Reduction in the feeling of tired eyes from using a 
computer or other digital device 
Subjective responses for exploratory endpoints will be the outcome (aval) defined as category one if a subject’s 
response is ‘Excellent’, ‘Very Good’, ‘Fair’, or ‘Poor’. 
 
 
My vision was clear enough to allow me to drive at night 
Subjective responses for exploratory endpoints will be the outcome (aval) defined as category one if a subject’s 
response is ‘Strongly Agree’ or ‘Agree’, the outcome is defined as category two if a subject’s response is ‘Not 
Applicable’, ‘Strongly Disagree’, ‘Disagree’, or ‘Neither Agree nor Disagree’. 

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Statistical Model: 
The outcome for each item will be analyzed separately using a generalized linear mixed model with a binary 
distribution and the logit as the link function. In each model, sequence of lens wear, period, lens type will be 
included as fixed effects. Site will be included as a random effect. Residual errors between measurements within 
the same subject will be modeled using an unstructured covariance (UN) structure. Comparisons between the test 
and control will be carried out using 2-sided 95% confidence intervals (CIs) constructed for the odds ratio (test 
over control). Non-inferiority will be concluded if a lower limit of a 95% CI is above 0.67. 
 
 
Hypothesis Testing 
The null and alternative hypothesis to test for non-inferiority of the test lens compared to the control lens will be 
conducted separately for each item as follows: 
 
Ho: OR ≤ 0.67 
Ha: OR > 0.67 
 
 
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. 
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. Past clinical trials 
don’t provide the evidence that subject dropout is systematic or not-at-random. To evaluate the impact of missing 
data, sensitivity analysis will be conducted using multiple imputation methods if the proportion of subject dropout 
is greater than the 15%. The SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a 
parametric regression method used to make at least 50 imputations. 
 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no known reasons for 
which it is planned to deviate from these analysis methods. If for any reason a change is made, the change will be 
documented in the study report along with a justification for the change. 
 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using 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 

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updated, ensuring information accuracy, security, and confidentiality. After the final database lock, the 
Investigator will be provided with Individual Patient Profiles (IPP) including the full audit trail on electronic 
media in PDF format for all of the study data. The IPP must be retained in the study files as a certified copy of 
the source data for the study. 
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
 
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
• 
subject identification 
• 
eligibility 
• 
study identification 
• 
study discussion 
• 
provision of and date of informed consent 
• 
visit dates 
• 
results of safety and efficacy parameters as required by the protocol 
• 
a record of all adverse events 
• 
follow-up of adverse events 
• 
medical history and concomitant medication 
• 
test article receipt/dispensing/return records 
• 
date of study completion 
• 
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 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, including the selection of qualified investigators 
and appropriate clinical sites and review of protocol procedures with the Principal Investigator. The Principal 

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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. 
 
 
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: 
• 
Ensuring that the investigation is being conducted according to the protocol, any subsequent versions, 
and regulatory requirements are maintained. 
• 
Ensuring the rights and wellbeing of subjects are protected. 
• 
Ensuring adequate resources, including facilities, laboratories, equipment, and qualified clinical site 
personnel. 
• 
Ensuring that protocol deviations are documented with corrective action plans, as applicable. 
• 
Ensuring that the clinical site has sufficient test article and supplies. 
• 
Clarifying questions regarding the study. 
• 
Resolving study issues or problems that may arise. 
• 
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 they are 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, according to ISO 14155:2020,1 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 20132 and that the clinical study data are 
credible. The Investigator must maintain clinical study files in accordance with applicable regulatory 
requirements. 

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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): 
• 
Final protocol. 
• 
Sponsor-approved informed consent form (and any other written materials to be provided to the subjects) 
• 
Investigator’s Brochure (or equivalent information). 
• 
Sponsor-approved subject recruitment materials. 
• 
Information on compensation for study-related injuries or payment to subjects for participation in the 
study. 
• 
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not required, as 
documented by IEC/IRB). 
• 
Information regarding funding, name of the Sponsor, institutional affiliations, other potential conflicts 
of interest, and incentives for subjects. 
• 
Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, the informed 
consent form, applicable recruiting materials, and subject compensation programs, and the Sponsor has received 
a copy of this approval. This approval letter must be dated and must clearly identify the documents being 
approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following documents to the IEC/IRB 
for their review and approval, where appropriate: 
• 
Protocol revisions 
• 
Revision(s) to informed consent form and any other written materials to be provided to subjects 
• 
If applicable, new or revised subject recruitment materials approved by the Sponsor 
• 
Revisions to compensation for study-related injuries or payment to subjects for participation in the study 
• 
Investigator’s Brochure revisions 
• 
Summaries of the status of the study (at least annually or at intervals stipulated in guidelines of the 
IEC/IRB) 
• 
Reports of adverse events that are serious, unanticipated, and associated with the test articles, according 
to the IRB’s requirements 
• 
New information that may adversely affect the safety of the subjects or the conduct of the study 
• 
Major protocol deviations as required by the IEC/IRB 
• 
Report of deaths of subjects under the Investigator's care 
• 
Notification if a new Investigator is responsible for the study at the clinical site 
• 
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,2 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 subjects 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 their 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)12 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: 
• 
processed fairly and lawfully. 
• 
collected for specified, explicit, and legitimate purposes and not further processed in a way incompatible 
with these purposes. 
• 
adequate, relevant, and not excessive in relation to said purposes. 
• 
accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating subject before 
collection of data. Such consent should also address the transfer of the data to other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the right to request 
rectification of any data that are not correct or complete. Reasonable steps should be taken to respond to such a 
request, taking into consideration the nature of the request, the conditions of the study, and the applicable laws 
and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against unauthorized disclosures 
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place. Sponsor 
personnel whose responsibilities require access to personal data agree to keep the identity of study subjects 
confidential. 

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19. STUDY RECORD RETENTION 
In compliance with the ISO 14155:2020 guidelines,1 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 
ISO 14155:2020,1 and all study documents as specified by the applicable regulatory requirement(s). The 
Investigator/Institution will take measures to prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a marketing application 
in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or until 
at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational 
product. These documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the responsibility of keeping 
the study records, custody must be transferred to a person who will accept the responsibility. The Sponsor must 
be notified in writing of the name and address of the new custodian. Under no circumstance shall the Investigator 
relocate or dispose of any study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any documentation 
relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact JJVC. 
 
 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research Agreement. The 
Research Agreement will be signed by the Principal Investigator and a JJVC management representative prior to 
study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations such as: 
• 
Continuing an ineligible subject in the study. 
• 
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: 
• 
Query resolution. 
• 
Case Report Form signature. 
• 
Completion of any follow-up action items. 
 
21. PUBLICATION 
There is no plan to publish this outcome 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. 
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/ 
3. 
United      States      (US)      Code      of      Federal      Regulations      (CFR). 
Available 
at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 

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4. 
Straker B.Investigator’s Brochure CR-6521 Toric lens design in senofilcon A with HEV-blocking 
chromophore 
). December, 2022. 
5. 
Wirth RJ EM, Henderson M, et al. Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci. 2016(93(8)):801-808. 
6. 
Straker  B.Customer  Requirements  Document   (CRD)  ( 
) Project TRIUMPH for 
Astigmatism. November 23, 2022. 
7. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC SAS Institute Inc; 2014. 
8. 
CAR Diniz, MH Tutia, Leite L. Bayesian analysis of a correlated binomial model. Brazilian Journal of 
Probability and Statistics. 2010;24(1). 
9. 
PASS. Power Analysis and Sample Size Software. Kaysville, Utah, USA: NCSS, LLC; 2021. 
10. 
C B. Calculation of the insurance groups of heads. Studies in Honour of Professor Salvatore Ortu 
Carboni. 1935:13-60. 
11. 
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted Maximum 
Likelihood. Biometrics. 1997;53(3):983. 
12. 
Health 
Information 
Portability 
and 
Accountability 
Act 
(HIPAA), 
Available 
at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html 

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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 

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A patient instruction guide (PIG) will be provided separately 

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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
CR-6521, v 3.0 
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Page 79 of 163 
 
 
 

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Page 80 of 163 
 
ACUVUE'8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Q_q ys H; draluxe™ 
 
ACUVUE OASYS• Brand Contact Lenses 1-Day 
withHydraluxe™ Technology 
ACUVUE OASYS•Brand Contact Lenses 1-Day 
wlthHydraluxe"' Technology tor ASTIGMATISM 
senofilcon ASofi (hydrophilic) Contact Lenses 
Vlslblllty Tlnted wlthUV Blocker 
tor Daily Disposable Wear 
f""D""iw.7 CAUTION: U.S.Federa!law restricts this d8\lice to 
sale by or on the order ofa licensed practtiioner. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMPORTANT: Please read carefully and keep thls 
infonnation tor future use. 
This Package Insert and Frtting Guide is intended tor the 
EyeCareProfesslona,lbut shoukl be made avallable to 
patients upon request 
The Eye Care Professional should provide the patient 
wlthtlle appropriate lnstructions thatpertaln to the 
patient's prescribed lenses. Copies are available tor 
download at www.acuvue.com. 

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CR-6521, v 3.0 
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SYMBOLS KEY 
 
The following symbols may appear on the label or carton: 
 
SYMBOL 
ffi] 
Consult lnstructions for Use 
.I 
Manufactured by or in 
d 
Date of Manufacture 
Use By Date (expiration date) 
I LOTI 
Batch Code 
1   STERILEI    a 1 
Sterile Using Steam or Dry Heat 
® 
Single-Use 
DIA 
Diameter 
BC 
Base Curve 
D 
Diopter (lens power) 
CYL 
Cylinder 
AXIS 
Axis 
CE 
0086 
Quality System Certification Symbol 
@ 
UV Blocklng 
UV-Blocking 
e) 
Fee Paid for Waste Management 
I IJcOnfy I 
CAUTION: U.S. Federa! law restricts this device 
to sale by or on the order of a licensed practitioner 
e 
Lens Orientation Correct 
X 
X 
Lens Orientation lncorrect (Lens lnside Out) 

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DESCRIPTION 
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lensesmade with HydraluxeTM  Technology.They are availableas 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an interna! 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling. 
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittancecharacteristics for these lenses are less than 1% in the UVB 
rangeof 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range. 
Lens Properties: 
The physical/opticalproperties of the lens are: 
• 
Specific Gravity (calculated): 
0.98 - 1.12 
• 
Refractive lndex: 
• 
Light Transmission: 
• 
Surface Character: 
• 
Water Content: 
• 
Oxygen Permeability: 
 
VALUE 
122 x 10·11 (cm2/sec) 
(mi O/ mi x mm Hg) at 35°C 
103 x 10·11 (cm2/sec) 
(mi O/ mi x mm Hg) at 35°C 
Lens Parameters: 
• 
Oiameter Range: 
• 
Center Thickness: 
• 
Base Curve Range: 
• 
Spherical Power Range: 
• 
Cylinder Power Range: 
• 
Axis Range: 
1.42 
85% minimum 
Hydrophilic 
38% 
 
 
METHOD 
Fatt (boundary corrected, non- 
edge corrected) 
Fatt (boundary corrected, edge 
corrected) 
 
 
12.0 mm to 15.0 mm 
varies with power 
7.85 mm to 10.00 mm 
-20.000 to +20.000 
-0.250 to -10.000 
2.5° to 180° 

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AVAILABLE LENS PARAMETERS 
 
ACUVUE OASYS® Brand 1-0ay with HydraluxeTM Technology are 
hemispherical shells of the following dimensions: 
Diameter: 
14.3 mm 
Center Thickness: 0.085 mm to 0.221 mm (varies with power) 
Base Curve: 
Powers: 
8.5 mm, 9.0 mm 
-0.500 to -6.000 (in 0.250 increments) 
-6 .50 0  to  -12.000 (in 0.500 increments) 
+0.500 to +6.000 (in 0.250 increments) 
+6.500 to +8.000 (in 0.50D increments) 
 
 
 
ACUVUE OASYS® Brand 1-0ay with HydraluxeTM Technology tor 
ASTIGMATISM are hemitoric shells of the following dimensions: 
Diameter: 
14.3 mm 
Center Thickness: 
0.075 mm to 0.172 mm (varies with power) 
Base Curve: 
8.5 mm 
Powers: 
+0.00D to -6.00D (in 0.25D increments) 
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D* 
Axis: 10° to 180° in 10° increments 
*-2.250 cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only. 
 
 
+0.25D to +4.00D (in 0.25D increments) 
-6.50D to -9.00D (in 0.50D increments) 
Cylinders: -0.75D, -1.25D, -1.75D 
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180° 

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z
 
 
TRANSMITTANCE CURVES 
ACUVUE OASYS® 1-Day with HydraluxeTM Technology (senoflicon A) 
Visibility Tinted with UV Blocker vs. 24 yr. o ld human cornea and 25 yr. old 
human crystalline lens. 
 
 
oz 
ci5 
CI) 
 
CI) 
 
a: 
 
 
100 
90 
80 
70 
60 
50 
ACUVUE OASYS® 
1-Day with 
HydraluxeTM 
Technology 
(senofilcon A)* 
24 YR. OLD HUMAN 
t- 
40 
30 
20 
10 
: , 
; I 
CORNEA1 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2 
0 200· 300 -\oo 
500 600 700 800 
WAVELENGHT 
(NANOMETERS) 
 
 
 
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens(-9.00D lens, 0.075 mm center thickness). 
1 Le rman, S., Radiant Energy and the Eye, MacMillan,NewYork, 1980, p. 58, figure 2-21 
 
2Waxler, M., Hitchins, V.M ., Op tical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, figure 5 
 
WARNING: UV absorbing contact lenses are NOT substitutes tor 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area . The patient should continue to use UV absorbing 
eyewear as directed. 
 
ACTIONS 
ln its hydrated state, the contact lens,when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina. 
The transmittance characteristics for these lensesare less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire power range. 
I 
I 

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NOTE: Long-term exposure to UV radiation is one of the risk 
factors associated with cataracts. Exposure is based on a number 
of factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of outdoor 
activities). UV-Blockingcontact lenses help provide protection 
against harmful UV radiation. However, clinical studies have not 
been done to demonstrate that wearing UV-Blocking contact 
lenses reduces the risk of developing cataracts or other eye 
disorders.The Eye Care Professional should be consulted for more 
information. 
 
INDICATIONS (USES) 
ACUVUE OASYS® Brand Contact Lenses 1-Day with Hydral uxeTM 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism. 
 
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraluxerM Tech- 
nology for ASTIGMATISMare indicated for daily disposable wear for the 
optical correction of refractiveametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism. 
 
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye. 
 
CONTRAINDICATIONS (REASONS NOT TO USE) 
 
DO NOT USE these contact lenses when any of the following 
conditions exist: 
• Acute or subacute inflammationor infection of the anterior chamber 
of the eye. 
• Any eye disease,injury or abnormality that affects the cornea, 
conjunctiva, or eyelids. 
• Severe insufficiency of lacrimal secretion(dry eye). 

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

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

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

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GENERAL FITTING GUIDELINES 
 
A. Patient Selection 
Patlents selected to wear these lenses should be chosen basedon: 
• Motivation to wear lenses 
• Ability to follow instructionsregarding lenswear care 
• General health 
• Ability to adequatety hande andcare tor the tenses 
• Ability to understandtherisk andbenefits of tenswear 
Patlents v.i1o do not meet theabove criteria should not be pro\/lded wlth 
oontact tenses. 
B. Pre-fitting Examination 
lnitial evalualton of the patlent shoold begln witha thorough case history 
to determinen the reare any oontraindicationsto contact lenswear. During 
the case lis tory, thepatient'sllislJal needs and expectations shOuld be 
determined as well asanassessment of their overall ocular, physical, and 
mental health. 
Preceding theinijiaJselection of trialoontact lenses, a comprehensive 
ocular evalualion should be pertormed that includes, but isnot li ed to, 
themeasurement of distance and near visual acuity, distanceand near 
refractille prescription CTncluding determiningthepreferred read  ngdistance 
torpresbyopes), keratometry,and biomicroscopicevaluation. 
Basedon thls evaluatlon,ii lt isdetermined thal thepatient is eigible to 
wear these lenses, the Eye CareProfessional shouldproceed to the tens 
fitting instl\Jctions asoutlined below. 
C . lnitial Power Deterrnination 
Aspectacteretraction should be per1ormed to establishthe palient's 
baseline relractlve status andto g1.1de in th e selectlon of theappropriate 
lenspower. Remember to compensate tor vertexdistance ntherefraction 
is greater than:t4.00D. 
 
D. Base Curve Selection (Trial LensFrtting) 
The followingtlial lenses should be selectedtor patients regardless o! kera- 
tometryreadings. However, comealcurvatll'8 measurements shoudl  be 
pertormed to establish thepatient's baseline ocular status. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• ACUVUE OASYS® 1- Day: 8.5 mm/14.3 mm 
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm 
 
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses. 
 
1. Criteria of a Propelry Fit Lens 
A properly fit lens will center and completely cover the cornea (i.e., no 
limba! exposure), have sufficient movement to provide tear exchange 
under the contact lenswith the blink, and be comfortable. The lens 
should move freely when manipulated digitally with the lower lid, and 
then return to its properly centered position when released. 
 
2. Criteria of a Flat Fitting Lens 
A flat fitting lens may exhibit one or more of the following characteris- 
tics: decentratio,nincomplete corneal coverage (i.e., limba! exposure,) 
excessive movement with the blink, and/or edge standoff. lf the lens is 
judged to be flat fitting, it should not be dispensed to the patient. 
3. Criteria of a Steep Fitting Lens 
A steep fitting lens may exhibit one or more of the following charac- 
teristics: insufficient movement with the blink, conjunctival indentation, 
and resistance when pushing the lens up digitally with the lower lid. 
lf the lens is judged to be steep fitting, it should not be dispensed to 
the patient. 
 
lf the initialtrial base curve is judged to be flat or steep fitting, the alternate 
base curve, if available, should be trial fit and evaluated after the patient 
has adjusted to the lens. The lens should move freely when manipulated 
digitally with the lower lid, and then return to a properly centered position 
when released. lf resistance is encountered when pushing the lens up, the 
lens is fitting tightly and should not be dispensed to the patient. 
 
E. Final Lens Power (Spherical) 
A spherical over-refraction should be performed to determine the final lens 
power after the lensfit is judged acceptable. The sphericalover-refraction 
should be combined with the trial lens power to determine the final lens 
prescription. The patient should experience good visual acuity with the 
correct lens power unlessthere is excessive residual astigmatism. 

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Example 1 
Oiagnostic lens: 
-2.000 
Spherical over-refraction: 
-0.250 
Final lens power : 
-2.250 
 
Example 2 
Oiagnostic lens: 
-2.000 
Spherical over-refraction: 
+0.250 
Final lens power: 
-1.750 
 
lf vision is accep table, perform a slit lamp examination to assess adequate 
fit (centration and movement). lf the fit is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT M ANAGEMENT). 
AII patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com. 
 
TORIC FITTING GUIDELINES 
 
Although most aspects of the fitting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper fit of toric lenses. 
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient. 
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks 
To help determine the proper orientation of the toric lens, you'II 
find two primary marks approximately 1 mm from the lens edge 
representing the vertical position on oppos ite ends of the lens at 
6 and 12 o'clock (Fig. 1). Because of the lens' ballasting system, 
either mark can represent the vertical position - there is no "top " 
and "bottom " as in a prism-ballasted lens. You don't need to view 
both marks to assess orientation; simply look for the 6 o'clock 
mark as you would with a prism-ballasted lens. 

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Example 2 
Manifest (spectacle) refraction : 
0 .0 . -3.000 / -1.000 X 90° 20/20 
O.S. -4.75 0  I - 2.00 0  X  90° 20/20 
Choose diagnostic lenses of  -3.000 /  -0.750 x 90° for the  right 
eye and -4.500 / -1.750 x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.750, 
compensating for vertex distance the sphere is reduced by 0.250 
to -4.500. The cylinder power will be -1.750 . Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. lf the lens has 
not yet stabilized, recheck until stable. 
 
Right Eye 
The orientation mark on the right lens rotates left trom the 6 
o'clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis. 
Here is the Rx Prescribed: 
0 .0. -3.000 / -0.750 X 100° 
 
Left Eye 
The orientation mark on the left lens rotates right trom the 6 
o'clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.500 I - 1 .75 0 x 80° 
lf vision is acceptable, perform a slit lamp examination to assess 
adequate fit (centration and movement). lf fit is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT M ANAGEMENT). 
 
Ali patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com. 

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

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B. Eye Selection 
1. Ocular Preference Determination Methods 
Generally, the non-dom inant eye is corrected for near vision. The 
following two methods for eye dominance can be used. 
Method 1: Determine which eye is the "sighting eye." Have the 
patient point to an object at the far end of the room. 
Cover one eye. lf the patient is stil! pointing directly at the 
object, the eye being used is the dominant (sighting) eye. 
Method 2: Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye. 
 
2. Other Eye Selection Methods 
Other methods include the "Refractive Error Method " and the 
"Visual Demands Method." 
Refractive Error Method 
For anisometropic correction, it is generally best to fit the more 
hyperopic (less myop ic) eye for distance and the more myopic 
(less hyperopic) eye for near. 
 
Visual Demands Method 
Consider the patient's occupation during the eye selection process 
to determine the critical vision requirements. lf a patient's gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near. 
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye. 
 
C. Special Fitting Characteristics 
 
1. Unilateral Vision Correction 
There are circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateral myope would require corrective lenses on 

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Monovision fitting success can be improved by the following 
suggestions: 
• 
Reverse the distance and near eyes if a patient is having trouble 
adapting. 
• 
Refine the lens powers if there is trouble with adaptation. 
Accurate lens power is critical tor presbyopic patients. 
• Emphasize the benefits of clear near vision and straight ahead 
and upward gaze with monovision. 
The decision to fit a patient with monovision correction is most 
appropriately left to the Eye Care Professional in conjunction with the 
patient after carefully considering the patient's needs. 
AII patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com. 
 
PATIENT MANAGEMENT 
Dispensing Visit 
Each sterile lens is supplied ina foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
trom the container, peel back the foil seal, place a finger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of 
the container. 
• 
Evaluate the physical fit and visual acuity of the lens on each eye. 
• Teach the patient how to apply and remove his or her lenses. 
• Explain daily disposable lens wear and schedule a follow-up 
examination. 
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com. 
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES. 
Follow-Up Examinations 
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of specific problems, if any, and a review with the patient of the wear 
schedule, daily disposable modality, and proper lens handling procedures. 
 

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the criteria for successful fit are not satisfied during any follow-up 
examinations, repeat the patient's trial fitting procedure and refit 
the patient. 
 
WEARING SCHEDULE 
The wearing schedule should be determined by the Eye Care Professional. 
Regular checkups, as determined by the Eye Care Professional,are also 
extremely important. 
Patientstend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importanceof adhering to the initial maximum wear- 
ing schedule. Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient's physiologicaleye condition, 
because individua! response to contact lenses varies. 
 
The maximum suggested wearing time for these lenses is: 
Day 
Hours 
1 
6-8 
2 
8-10 
3 
10-12 
4 
12-14 
5 and atter 
all waking hours 
 
 
REPLACEMENT SCHEDULE 
These lenses are indicated for daily disposable wear and should be 
discarded upon removal. 
 
LENS CARE DIRECTIONS 
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should previde the patient with appropriate and adequate 
warnings and instructions for daily dispo sable lens wear at the time they 
are dispensed. 

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

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REPORTING OF ADVERSE REACTIONS 
 
AII seriousadverse experiences and adverse reactionsobserved in 
patients wearing these lenses or experienced with these lensesshould be 
reported to: 
 
 
Johnson & Johnson Vision Care, Ine. 
7500 Centurion Parkway 
Jacksonville, FL 32256 
USA 
Tel: 1 - 800 -843 -2020 
www.acuvue.com 

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APPENDIX D: 
• 
LENS FITTING CHARACTERISTICS 
• 
SUBJECT REPORTED OCULAR SYMPTOMS 
• 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
• 
BIOMICROSCOPY SCALE 
• 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
• 
TORIC FIT EVALUATION 
• 
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
• 
PATIENT REPORTED OUTCOMES 
• 
LENS INSERTION AND REMOVAL 
• 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION TESTING 

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APPENDIX F: 
GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1.0 
PURPOSE 
 
The pmpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, fuc. (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 fustrnction 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 countr y by countr y basis subject 
to local health authot·ity guidance. 
 
3.0 
DEFINITIONS 
 
American Academy of Optometry (AAO): The American Academy of Optometiy is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometi-ic 
practice, by both promoting research and the dissemination of knowledge.The AAO holds an annual 
meeting, publishes a monthly scientific jown al, gives credentials to optometi-ists through the fellowship 
process and publishes position statements. 
 
American Optometric Association (AOA): The Ame1-ican Op tometi-ic Ass ocia tion , 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 Optometiy (O.D.), optometi-ic profe ss iona ls, and optometiy students. Doctor of Optometiy 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 Optometiy have extensive, ongoing ti·aining to examine , 
diagnose , treat and manage ocular disorders, diseases and injw-ies and systemic diseases that manifest in the 
eye. The American Optometi-ic Association is a federation of state, student, and anned forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometi-ists, stu dents of 
op tometiy , paraop tome ti·ic assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care. 
Centers fot· Disease Control and Prevention (CDC): The Centers for Disease Conti·ol and Prevention is a 
national public health institute in the United States. It isa United States federa! agency, under the 
Department of Health and Human Services, and is headqua1tered in Atlanta, Georgia. 
COVID-19: CwTent outbreak of respirato1ydisease caused by a novel coronavirns. The virns has be.en 
named "S ARS-CoV-2" and the disease it causes has been named " Coronavirns Disease 2019" (COVID- 
19). 
Clinical Study: Volunta1y research stu dies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drngs, vaccines, other therapies, or new ways of using existing 
ti·eatinents. May also be called clinical trials, studies, research, ti·ials, or protocols. 
Clinical Study Site: Location where a clinical study is conducted, such as a doctor's office, university, or 
laborato1y. 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 
fuvestigator is the responsible leader of the team and may be called the P1-incipal fu vestigat or. 
C linical Op era tion s Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individua! 
responsible for the overall management of a clinical ti-ial. 
 
 
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and repo1ted in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements. 
 
Medica! 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 evaluationof medica! safety data arising from any source throughout the product life cycle. 
 
4.0 
GUIDANCE FOR STUDY DOCUMENTS 
 
1n alignment with recent health authority guidance, JJVCI is providing recollllllendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or govemment 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 paiticipant'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 pande1nic, the additional risks listed below need to be considered for study paiticipants 
and study personnel: 
 
4.I 
I 
Additional Risks Related to the COVID-19 Pandernic: 
• 
The possible transrnission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures. 
• 
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health cai·e profes sional s 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 healthcai·e 
professionals who 1night be transmi tting the virus, even if they do not have symptoms. 
• 
Potential disruptions to the study may be necessaiy due to current or future pandernic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits. 
• 
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. 1n this event, ali assessments that can be conducted virtually will be 
completed by the investigator to deterrnine 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 paiticipation ina study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution. 
 
To help minirnize the above potential risks, JJVCI recollllllend reviewing/complying with local, state, 
and govemmental guidance for COVID-19 risks. 
 
JJVCI will provide the following study specific documents with language pe1taining to COVID-19 risks: 
 
4.1. I 
Info1med Consent: 
 
Will include info1mation conceming the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document: 
 
 
 

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STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC 
 
It is important to note that this study will be conducted, at least in pa1t , during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is pa1t iculady 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-te1mserious health 
consequences. In severe cases, this may result in hospitalization ancl/or dea th. Based on cun-ent 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 undedying medica! 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 confo1mance to guidance from the 
CDC, local health depa1tments, 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 pe1mitted to continue in-office study follow-up visits, but you will receive instmctions and your 
condition will be monitored by the doctor ancl/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 JNCI 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 govemmental guidance's for COVID-19 risk mitigation. 
 
I have read the suggested guidance provided by JNCI 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, govemmental 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. 
 
S.O 
G UIDANCE FOR REMOTE SUBJECT VISITS 
 
Potential dismptions to the study may be necessary due to cmTent 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 concems 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: 
 
 

Clinical Study Protocol 
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Procedure 
Details 
Subject Repo1ted Ocular 
Symptoms 
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test a1ticle when applicable and feasible. 
Change of Medical History 
(Adverse Events) and 
Concomitant Medications / 
Therapies Review 
Record any adverse events or medical history changes from the 
previous study visit with the subject/parents. 
Review the subject' s concomitant medications/therapies and record 
any changes from the previous study visit. 
Wearing Time and 
Compliance 
Record the average wearing time (including number ofhow-s per day 
dw-ing weekdays and weekends, and number of days per week). 
Confinn compliance with the prescribed wear schedule. 
• 
Record and discuss the lens wear compliance based on the 
subject's self-report. For example, the subjects will be asked the 
time of the day the subject typically puts on the study lenses in the 
moming and takes off in the evening, the number of days per week 
lenses were wom, and the number of consecutive days the subject 
didn' t wear the study lenses, etc. 
 
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If dw-ing the telephone consultation, a subject states he/she wishes to discontinue participating 
in the study, instrnct the subject to stop wearing the study lenses and schedule the subject to retum to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should retum all unused lenses to the 
clinic at the last visit. 
 
Changes in study visit schedules, missed visits, or participant discontinuations may lead to missing data, 
including   data  related  to   protocol-specified  procedures.  Case  repo1t   fonns   should   capture  specific 
info1mation regarding the basis of missing data, including the relationship to the COVID-19 pandemic. 
 
6.0 
STUDY CONDUCT DURING PANDEMIC 
 
It is recognized that the Coronavirns Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantineby participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometty Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge. 
 
Eve1y effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be perfo1med to the extent possible remotely/vittually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, pait icipants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be perfo1med if required and as feasible. 
 
Modifications to protocol-required assessments may bepennitted via COVID-19 Appendix after consultation 
with the paiticipant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
tt·ial management system for protocol deviations. Intenuptions of test a1t icle wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix "COVID-19- 
related" in the case repo1t  f01m (CRF). 
 

Clinical Study Protocol 
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   Title: 
Guidelines for COVID-19 Risk Miti ation 
   Document T, 
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The spon s or w ill con tinue 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 "SuspectedCOVID-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 repo1t. 
 
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
repo1ted as an amendmen t to the protocol even if đone during clinical study visits. 
 
6.1 
Monitorin g Vi sit s 
 
When on-site monitoring by the sponsor is not feasible, the sponsor' s site monitor will contact the study 
site to schedule remote visits. 1n 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 prut of standard process. When conditions pennit, all 
parties involved in this clinical trial should communicate relevant infonnation in a timely manner so that 
all relevant pa1ties remain sufficiently infon ned. 
 
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 Teains orsimilarsoftwai·eas well as utilize online traini 
tud site training will be documented utilizin . Site  Initiation  Report ---- 
per Study Site Initiation 
 
- On-site visits may be consideredwhen, 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 
governnientalpolicies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the locationof the study site. 
 
6.1.2 
Interim Monitoring Visits (if applicable): 
 
During the period that this Work Instrnction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot pe1fonn remotely (e.g., source 
document verification, test a1ticle reconciliation , etc.). 
 
To ensure da.ta integrity during the conduct of ali JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan 
 
While on site, the CRA will follow all local, state, and governniental policies for COVID-19 Risk 
Mitigation, including social distancing, weai·ingof PPE, etc. as applicable for the location of the 
study site. 
 
 
 
 

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6.1.3 
Study Site Closure: 
 
Duringthe period that this Work Instrnction is in effect, the dura.tion ofthe Study Site Closure Visit 
will be limited to ta.sks tha t the CRA cannot perfonn remotely (e.g., source document verifica.tion, 
test article final reconcilia.tion and retum, etc.). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: 
   Document T,  e: 
Guidelines for COVID-19 Risk Miti ation 
 

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A t ta c hm e nt A: S tud y S ite Co rr es pond e n ce 
 
XXXX XX, 2020 
 
 
 
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>> 
 
 
Dear <<Principal Investigator>> and Study Team, 
 
Coronavirns (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 ctmently working on or considering pa1ticipation 
within. 
 
Protocol: 
 
• 
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section. 
 
Protocol Signature Page: 
 
• 
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and govemmental guidelines for COVID-19 risk mitigation. 
 
Informed Consent: 
 
• 
Will include infonnation conceming the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of tlie Info1med consent document. 
 
COVID-19 Risk Control Checklist for Clinical Studies: 
 
• 
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during tlie pandemic. 
 
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the cun-ent C OVID- 19 situa tion . 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 con-es pondenc e. 
 
 
 
 
 
 
 

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Att achment B: COVID-19 Risk Control Checklist 
 
 
 
Study Number 
SiteNumber 
Principal Investigator (PI) Name 
 
 
The following COVID-19 risk control methods are required to conduct Johnson & Johnson Vison Care clinical 
studies. Please review the following requirements and Initial each requirement. 
 
PI Initials 
General Site Safetv Plannin2 Measures 
Si<ma2e within site describin2 Risk Control methods 
Social Distancin2 oractices thro,w: hout site (waitin2 rooms lobbv. exam rooms. etc.) 
Non-contact thermometer available to assess temoeratures of staff and oatients 
Trainin2 on oatient flow and ohvsical distancin2 in waitin2 room 
Establish lon2er time frame betwe.en oatien t annoin tments to reduce oersons in the site 
Staff should receive job-specific training on PPE and demonstrate competency with selection and 
proper use of PPE and wear at all tirnes during interactions with subjects (e.g., putting on and 
removing without self-contamination) 
 
 
PI Initials 
Site StaffDailv Safetv Measures 
As pati of routine practice, site staff should regulai·ly monitor themselves for fever and symptoms 
of COVID-19 including temperature checks 
Any staff member (including non-study clinic staff and Investigators) showing signs ofbeing sick 
or testing positive for COVID-19 must not be pennitted to work on activity that may expose study 
related staff and subject and the Sponsor shall be informed 
NOTE: Inform JJVC in 24 hours of any COVID-19 cases and all potential exposure during 
the clinical study. 
Ensure that all staff wear a mask 
Gloves should be reauired when working directlv with oatients and changed between each oatient 
Have staff thoroughly wash hands for at least 20 seconds or use an alcohol-based hand sanitizer 
when thev airive before and after each oatient before eating and after using the bathroom. 
Cleaning and disinfection procedures for exam rooms and instnunents or equipment between 
oatients with 2loves. 
Cleaning and disinfection procedures for commonly touched surfaces (doors, chairs, computers, 
phones, etc.) with gloves. 
 
 
PI Initials 
Before a Patient or Study Visit: 
Patients should be asked prior to entering the site about fever and respiratory illness and whether 
they or a fainily member have had contact with another person with confumed COVID-19 in the 
past 14 days. Patients exhibiting signs ofbeing sick shouldbe rescheduled when their symptoms 
resolve. 
Instrnct patients that companions should remain outside of the facility and not accompany the 
patient into the facility unless they are a parent/guardianof the patient or if they are a trne 
cai·egvi er and need to assist the oatient 
Request the patient to call or text the office upon an ival so entrance to and movement through 
facility can be coordinated by site staff 
 
 
 
 

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   Title: 
Guidelines for COVID-19 Risk Miti ation 
   Document T, 
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   Do cum ent N umb er: 
 
  
 
  
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Ine. 
   Title: 
Guidelines for COVID-19 Risk Miti ation 
   Document T, 
 e: 
 
   Do cum ent N umb er: 
 
  
 
  
R evis ion N umb er: 5  
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PI Initials 
Patienst Entering the site: 
T em pera ture checks utilizing a non-contact thennometer for all patients and companions entering 
the site. 
All oatients and comoanions must wear cloth or disoosable mask at all times in the site 
Maintain social distancing. Waiting rooms or lobbies should be as empty as possible. Advise 
seated patients to remain at least 6 feet from one another. 
Communal obiects in (e.g. toys, reading materials, etc.) should be removed or cleaned regulady. 
 
 
 
I ce1tify that I have read and agree to implement all the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Vision Care studies. 
 
 
 
 
 
 
 
Principal Investigator Signature and Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Clinical Study Protocol 
Johnson & Johnson Vision Care, Ine. 
   Title: 
Guidelines for COVID-19 Risk Miti ation 
   Document T, 
 e: 
 
   Do cum ent N umb er: 
 
  
 
  
R evis ion N umb er: 5  
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Ine. 
   Title: 
Guidelines for COVID-19Risk Miti ation 
   Document T, 
 e: 
 
   Docum ent N umb er: 
 
  
 
  
R e vis ion N umb er: 5  
Page 161 of 163 
 
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RESOURCE LINKS 
 
US Resource Links 
 
• 
OSHA Training 
https://www.osha.gov/SLTC/covid-19/controlprevention.html 
 
Personal Protective Equipment (PPE) Training 
CDC: https://www.cdc.gov/coronavims/2019-ncov/hcp/using-ppe.html 
 
• 
l&R Training 
ACUVUE® Len sAssis t: https: // www.acuvue.com/lensassist 
 
• 
Clinic Preparedness Guides 
CDC: https://www.cdc.gov/coronavims/2019-ncov/hcp/clinic-preparedness html 
AOA: https://aoa.uberflip.com/i/1240437-aoa-w idance-for-re-opening-practices-covid·19/1?m4= 
American Optometric Association: https://v.rww.aoa.org/optome try-practice-reactivation-preparedness- 
guide 
 
• 
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 
 
• 
Updates on local regulations in Hong Kong 
https://www.coronavims.gov hk/eng/index.html 
 
• 
Resumption of optical services in England: Letter from Matt Neligan and Poonam Shruma 
https://www.england nhs.uk/coronavims/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical- 
services-letter-17- june-2020.pdf 
 
• 
NHS Optical Letter 
https://www.england nhs.uk/coronavims/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-l -april- 
2020.pdf 
 
• 
The College of Optometrists primary eye care COVID-19 guidance: Red phase 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavims-covid-19-guidance- 
for-optometrists.html 
 
• 
The College of Optometrists COVID-19: College updates 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavims-2019-advice-for- 
optometrists.html#CollegeGuidelines 
 
• 
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf 
 
• 
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulato1y cru·e 
s etting s . (2020 , May 23 May). Retrieved from Govemment of Canada: https://www.canada.ca/en/public- 
health/services/diseases/2019-novel-coronavims-infection/guidance-documents/interim-guidance- outpatient-
ambulato1y-care-settings html 
 
 
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Ine. 
   Title: 
Guidelines for COVID-19Risk Miti ation 
   Document T, 
 e: 
 
   Docum ent N umb er: 
 
  
 
  
R e vis ion N umb er: 5  
Page162of163 
 
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• 
Info1mation for Members On Coronavims (COVID-19). (n.d.). Retrieved from Canadian Association Of 
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/info1mation_for_members_on_coronavims.pdf 
 
• 
Coronavims (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Govemment 
Department of Health: 
https://www health.gov.au/resources/collections/coronavims-covid-19-resources-for-health-professionals- 
including-aged-care-providers-pathology-providers-and-health-care-managers 
 
• 
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Govemment Depa11ment of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection- 
principles-for-covid-19.pdf 
 
• 
Infection control guidelines and advice. (n.d.). Retrieved from Optometiy Austi·alia: 
https://www.optometiy.org.au/practice-professional-support/coronavims-covid-19-what-optometrists-need- to-
know/covid-19-clinical-advice/infection-conti·ol-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-6521 Design Validation of Toric Contact Lenses in Senofilcon A with a Blue- 
Blocking Chromophore 
 
Version and Date: 3.0 01 June 2023 
 
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 the Declaration of Helsinki,2 United States (US) 
Code of Federal Regulations (CFR),3 and the pertinent individual country laws/regulations and to comply with 
its obligations, subject to ethical and safety considerations. I, as the Principal Investigator, am responsible for 
ensuring that all clinical site personnel, including Sub-Investigators, adhere to all 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. 
 
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 F 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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6521, v 3.0 
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