Role of Glare and Spectral Filtering on Contrast Sensitivity: A Pilot Study
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
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JJVC CONFIDENTIAL 
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Protocol Title: Role of glare and spectral filtering on contrast sensitivity: A pilot study 
Protocol CR-6501 
Version: 4.0 
 
Date: 02 November 2022 
 
 
Investigational Products: None. 
 
Keywords: Sphere platform, senofilcon A with a new UV/HEV filter (ACUVUE OASYS 
MAX 1-Day), senofilcon A without the new UV/HEV filter (ACUVUE OASYS 1-Day), daily 
wear, daily disposable, non-dispensing, contrast sensitivity function under photopic and 
mesopic conditions. 
 
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 
......................................16 
1. 
INTRODUCTION AND BACKGROUND .................................................................... 17 
1.1. Name and Descriptions of Investigational Products ................................................... 25 
1.2. Intended Use of Investigational Products ................................................................... 25 
1.3. Summary of Findings from Nonclinical Studies ......................................................... 25 
1.4. Summary of Known Risks and Benefits to Human Subjects ...................................... 25 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study. .............................................................................................................. 26 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ....................................... 27 
2.1. Objectives ................................................................................................................... 27 
2.2. Endpoints .................................................................................................................... 27 
2.3. Hypotheses .................................................................................................................. 27 
3. 
TARGETED STUDY POPULATION ........................................................................... 28 
3.1. General Characteristics ............................................................................................... 28 
3.2. Inclusion Criteria ........................................................................................................ 28 
3.3. Exclusion Criteria ....................................................................................................... 28 
3.4. Enrollment Strategy .................................................................................................... 29 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 30 
4.1. Description of Study Design ....................................................................................... 30 
4.2. Study Design Rationale. .............................................................................................. 30 
4.3. Enrollment Target and Study Duration ....................................................................... 30 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 30 
5.1. Test Article Allocation ................................................................................................ 30 
5.2. Masking....................................................................................................................... 31 
5.3. Procedures for Maintaining and Breaking the Masking .............................................. 32 
6. 
STUDY INTERVENTION ............................................................................................. 32 
6.1. Identity of Test Articles .............................................................................................. 32 
6.2. Ancillary Supplies/Products. ....................................................................................... 33 

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6.3. Administration of Test Articles .................................................................................. 33 
6.4. Packaging and Labeling .............................................................................................. 33 
6.5. Storage Conditions ...................................................................................................... 34 
6.6. Collection and Storage of Samples ............................................................................. 34 
6.7. Accountability of Test Articles ................................................................................... 34 
7. 
STUDY EVALUATIONS .............................................................................................. 35 
7.1. Time and Event Schedule ........................................................................................... 35 
7.2. Detailed Study Procedures .......................................................................................... 36 
VISIT 1 ........................................................................................................................... 36 
FINAL EVALUATION .................................................................................................. 45 
7.3. Unscheduled Visits ..................................................................................................... 45 
7.4. Laboratory Procedures ................................................................................................ 47 
8. 
SUBJECTS COMPLETION/WITHDRAWAL .............................................................. 47 
8.1. Completion Criteria .................................................................................................... 47 
8.2. Withdrawal/Discontinuation from the Study .............................................................. 47 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 48 
9.1. Systemic Medications ................................................................................................. 48 
10. DEVIATIONS FROM THE PROTOCOL ..................................................................... 49 
11. STUDY TERMINATION .............................................................................................. 50 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ................. 51 
13. ADVERSE EVENTS ...................................................................................................... 52 
13.1. Definitions and Classifications. ................................................................................ 52 
13.2. Assessing Adverse Events ........................................................................................ 54 
13.2.1. 
Causality Assessment .................................................................................... 55 
13.2.2. 
Severity Assessment ...................................................................................... 55 
13.3. Documentation and Follow-Up of Adverse Events ................................................. 55 
13.4. Reporting Adverse Events ........................................................................................ 57 
13.4.1. 
Reporting Adverse Events to Sponsor........................................................... 57 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
..............................58 
13.5. Event of Special Interest .......................................................................................... 58 
13.6. Reporting of Pregnancy .............................................................................................. 58 
Johnson & Johnson Vision Care, Inc. 
14. STATISTICAL METHODS ........................................................................................... 59 
14.1. General Considerations ............................................................................................ 59 
14.2. Sample Size Justification .......................................................................................... 59 

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14.3. Analysis Populations ................................................................................................ 59 
14.4. Level of Statistical Significance ............................................................................... 60 
14.5. Primary Analysis ...................................................................................................... 60 
14.6. Secondary Analyses ................................................................................................. 60 
14.7. Other Exploratory Analysis ...................................................................................... 60 
14.8. Interim Analysis ....................................................................................................... 61 
14.9. Procedure for Handling Missing Data and Drop-Outs ............................................. 61 
14.10. Procedure for Reporting Deviations from Statistical Plan ....................................... 61 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................... 61 
15.1. Electronic Case Report Form/Data Collection ......................................................... 61 
15.2. Subject Record ......................................................................................................... 62 
15.3. Trial Registration on ClinicalTrials.gov ................................................................... 62 
16. DATA MANAGEMENT ................................................................................................ 62 
16.1. Access to Source Data/Document ............................................................................ 62 
16.2. Confidentiality of Information ................................................................................. 62 
16.3. Data Quality Assurance ............................................................................................ 63 
16.4. Data Monitoring Committee (DMC) ........................................................................ 63 
17. CLINICAL MONITORING ........................................................................................... 63 
18. ETHICAL AND REGULATORY ASPECTS ................................................................ 64 
18.1. Study-Specific Design Considerations ..................................................................... 64 
18.2. Investigator Responsibility ....................................................................................... 64 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) .............. 64 
18.4. Informed Consent ..................................................................................................... 65 
18.5. Privacy of Personal Data .......................................................................................... 66 
19. STUDY RECORD RETENTION ................................................................................... 67 
20. FINANCIAL CONSIDERATIONS ............................................................................... 68 
21. PUBLICATION .............................................................................................................. 68 
22. REFERENCES ............................................................................................................... 68 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 70 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 71 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 72 
APPENDIX D: ...................................................................................................................... 122 
- 
LENS FITTING CHARACTERISTICS ............................................................. 123 
- 
SUBJECT REPORTED OCULAR SYMPTOMS ............................................. 129 
- 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
............................................................................................................131 

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- 
BIOMICROSCOPY SCALE .............................................................................. 137 
- 
DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ...... 143 
APPENDIX E: - 
GUIDELINES FOR COVID-19 RISK MITIGATION ............. 148 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 160 
 
LIST OF TABLES 
Table 1: Test Atiicles ............................................................................................................... 32 
Table 2: Ancillaiy Supplies ...................................................................................................... 33 
Table 3: Time and Events ........................................................................................................ 35 
Table 4: Disallowed systemic medications .............................................................................. 49 
Table 5: Disallowed systemic antihistamines .......................................................................... 49 
Table 6: Examples of major and minor protocol deviations .................................................... 50 
 
LIST OF FIGURES 
Figure 1: Study Flowchaii ........................................................................................................ 15 
Figure 2: Binocular contrast sensitivity values derived from Figure 2 ofFernandes et al. (black 
line and symbols) compai·ed to data from Scheiber et al (red line and symbols: 20 year-old 
observers).  Note the deviation at the lower frequencies ......................................................... 17 
Figure 3: CSF data from van Nes and Bouman. Note that the peak sensitivity value is near 
around 5 cyc/deg and sensitivity is peaking around 400-500 (about twice the peak from the 
Metropsis sample shown in Fig 2). (also note the similai·ity in the cmves across luminance- 
from 90-900 trolands, analogous to 3 to 300 cd/m2 based on a 2 mm pupil) .......................... 18 
Figure 4: CSF according to Campbell and Robson (1968) ...................................................... 19 
Figure 5: Figure from Elliott et al. (2009); data are from older (red) and younger (black) 
subjects with various abenations con ected. In this study the peak is around 8 cycles per degree 
and contrast sensitivity is about 80 .......................................................................................... 20 
Figure 6: The stimuli used in the CSV-1000 test (right side shows the glare condition) ........ 21 
Figure 7: The glarn source ofthe Metropsis is based on white LEDs mounted ve1iically ..... 22 
Figure 8: University of Georgia CSF Apparatus ...................................................................... 23 
Figure 9: University of Georgia glare system .......................................................................... 25 
Figure 1O: Packaging Labels ................................................................................................... 34 

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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Protocol Title: Role of glare and spectral filtering on contrast sensitivity: A pilot study 
Protocol Nmnber: CR-6501 
Version: 4.0 
Date: 02 November 2022 
 
 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Ine. (JNC) 
7500 Centurion PaJkway 
Jacksonville, FL 32256 
 
 
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hoursofl eaming ofa Serious AdverseEvent. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate. 
 
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File. 

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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessa1y assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulato1y requ irements and applicable U.S. federal regulations,3 ISO 14155:2020,1 and the 
Declaration of Helsinki.2 
 
Author / Study 
Responsible 
Clinician 
See Electronic Signature Report 
  
 
DATE 
 
 
Co -author 
 
 
 
Co -author 
 
 
Clinical Operations 
Manager 
 
 
DATE 
 
 
 
DATE 
 
See Electronic Signature Report 
  
 
DATE 
 
 
Biostatistician 
See Electronic Signature Report 
  
 
DATE 
 
Biostatistical Review 
See Electronic Signature Report 
  
 
DATE 
 
 
Data Management 
 
 
Medical Safety 
Officer 
See Electronic Signature Report 
  
 
DATE 
 
See Electronic Signature Report 
  
 
DATE 
 
 
Reviewer 
See Electronic Signature Report 
  
 
DATE 

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Approver 
 
DATE 
 
 
 
 
 
CHANGE IDSTORY 
 
 
Version Originator Description of Change(s) 
Justification 
Date 
and 
Section 
Affected 
Number(s) for Change 
I.O 
 
 
Original Protocol 
N/A 
21 September 2022 
2.0 
Updated Section 5.1 Test 
Alticle Allocation to 
clarify that there will be 
only one lens assignment 
for the two light sources 
(i.e., without glare and 
with olare 
er sub·  ect 
To align the 
randomization 
plan with 
study 
procedures 
04 October 2022 
3.0 
 
1. Section 7.2 - VI Step 
1.21, 1.22, 1.24 and 1.25, 
changed spatial frequency 
1. Accuracy 
24 October 2022 
2.3 to 3.2 to match lens 
fitting schedule. 
2. Section 1.5 - changed 
"to believe that" to "for 
2. Per Legal 
TeamReview 
why" / changed 
"obtainable" to "of 
interest'' 
4.0 
 
Section 7.2 Steps 1.21, 
1.22, 1.24 and 1.25, 
updated area under the 
contrast sensitivity curve 
range from 100 to 5.00 
Accuracy 
02 November 2022 

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SYNOPSIS 
 
Protocol Title 
Protocol Title: Role of glare and spectral filtering on contrast 
sensitivity: A pilot study 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Clinical trial phase: Feasibility 
Design control phase: Phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s) 
Investigational Products: None. 
Approved Products: 
1. senofilcon A with a new UV/HEV filter (ACUVUE 
OASYS MAX 1-Day). 
2. senofilcon A without a new UV/HEV filter (ACUVUE 
OASYS 1-Day). 
Wear and Replacement 
Schedules 
Wear Schedule:  daily wear 
Replacement Schedule: daily disposable 
Objectives 
The purpose of this study is to evaluate the role of a test lens 
on contrast sensitivity with and without glare. 
Primary Objectives: The primary objective is to evaluate the 
visual performance characteristics of a new UV/HEV filter 
under conditions of an HEV-rich ecologically-valid light 
source. 

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Study Endpoints 
Primary Endpoint(s) 
• Area under the curve of photopic contrast sensitivity 
function under bright light conditions (approx. 120 
cd/m2) with a broadband glare source. 
Secondary Endpoint(s) 
• Area under the curve of mesopic contrast sensitivity 
under dim light conditions (approx. 3 cd/m2) with a 
broadband glare source. 
Other Observations: 
• Area under the curve of photopic contrast sensitivity 
function under bright light conditions (approx. 120 
cd/m2) without a broadband glare source. 
• Area under the curve of mesopic contrast sensitivity 
under dim light conditions (approx. 3 cd/m2) without 
a broadband glare source. 
Study Design 
This is a split-plot design with two parallel arms consisting of 
randomized photopic and mesopic conditions where subjects 
are also randomized contralaterally to the Test and Control 
lenses within each arm. This study will be non-dispensing, 
controlled, and double-masked. Subjects will be assigned 
randomly to the photopic or the mesopic condition arm. Each 
subject will be fitted with a Test lens on one eye and a Control 
lens on the other eye within each condition arm. The 
randomization will be stratified by age with a 1:1 ratio for the 
two age ranges (18-40 years; 41-65 years). 
There will be a total of 1 visit: 
• Visit 1: Screening, baseline evaluation and lens fit #1 
and #2. Evaluation of lens 1 and 2. Final evaluation. 
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 
Approximately 44 subjects will be enrolled with the intent to 
complete approximately 20 in each group (photopic and 
mesopic). 
Study Duration 
This study is non-dispensing and is completed in a single visit. 
The enrollment period is approximately 2 months. 

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Anticipated Study 
Population 
Subjects must be habitual wearers of silicone hydrogel contact 
lenses worn on a daily wear basis. Subjects can be of any 
gender, race, and ethnicity that meet the eligibility criteria. 
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol. 
3. Be between 18 and 65 (inclusive) years of age at the 
time of screening. 
4. By self-report, habitually wear spherical silicone 
hydrogel soft contact lenses in both eyes in a daily 
reusable or daily disposable wear modality (i.e. not 
extended wear modality). Habitual wear is defined as 
a minimum of 6 hours of wear per day, for a minimum 
of 5 days per week during the past 30 days. 
5. Possess a wearable pair of spectacles that provide 
correction for distance vision. 
Inclusion Criteria at Baseline Evaluation 
6. The spherical equivalent of the subject's vertex 
corrected distance refraction must be between -1.00 D 
and -6.00 D (inclusive) in each eye. 
7. The magnitude of the cylindrical component of the 
subject's vertex-corrected distance refraction must be 
between 0.00 D and 1.00 D (inclusive) in each eye. 
8. The best corrected, monocular, distance visual acuity 
must be 20/25 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 currently using any ocular medications or have any 
ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication the 
investigator believes 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, Sjogren's syndrome), or 
history of serious mental illness or seizures. See 
section 9.1 for additional details regarding excluded 
systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) 
lenses, orthokeratology lenses, or hybrid lenses (e.g. 
SynergEyes, SoftPerm) within the past 6 months. 
5. Be currently wearing monovision or multifocal 
contact lenses. 
6. Be currently wearing lenses in an extended wear 
modality. 
7. Have participated in a contact lens or lens care product 
clinical trial within 30 days prior to study enrollment. 
8. 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. 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. 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 the investigator 
believes might contraindicate contact lens wear or may 
otherwise compromise study endpoints (including 

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entropion, ectropion, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions, 
aphakia, moderate or above corneal distortion, 
herpetic keratitis). 
10. Have a history of strabismus or amblyopia. 
11. Have fluctuations in vision due to clinically significant 
dry eye or other ocular conditions. 
12. Have had any ocular or intraocular surgery (e.g., radial 
keratotomy, PRK, LASIK, iridotomy, retinal laser 
photocoagulation, etc.). 
13. Have signs of a contact lens-related corneal 
inflammatory event (e.g., past peripheral ulcer or 
round peripheral scar). 
14. Have a history of eyelid injury, surgery or procedure 
that resulted in abnormal eyelid position or movement. 
Disallowed 
Medications/Interventions 
Subjects taking and ocular medications will not be allowed to 
participate. 
See section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
All measurements will be taken with and without an 
ecologically-valid glare source. Approximately half of the 
subjects will be tested under photopic conditions and the other 
half under mesopic conditions. 
Microbiology or Other 
Laboratory Testing 
None. 
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 
An ecologically-valid broadband glare source that emulates 
natural sunlight in spectral content across the visible spectrum 
will be used. RevitaLens will be used to return any 
problematic lenses to the Sponsor. 

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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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Lens Removal and Ocular Physiology 
► 
T he lenses will be removed and ocular physiology assessoo. 
I 
l 
I 
Johnson & Johnson Vision Care, Ine. 
 
Figure 1: Study Flowchart 
 
 
 
 
 
 
l 
 
 
 
 
 
 
 
 
 
I 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Photopic CSF 
- 20 subjects 
► 
Phot opic contrastsensitivity with and 
withouta broadband glare source 
l 
Mesopic CSF 
- 20 subjects 
► 
Mesopic contrast sensitivity: with and 
without a broadband glare source 
l 
40-44 Subjects 
Available powers: -1.00 to -6.00 in 0.25 Dsteps 
Habitual wearers of spherical silicone hydrogel soficontact lenses wom as daily wear 
Excludeswearers of toric, monovision, multifocal, extended wear 
Age 18-65 
lnformed Consent 
EIigibility Criteria 
Baseline lnformation 
► 
H abitual lens type, modality 
► 
Subject 
ive refraction 
► 
Eye dominancy 
► 
Ocular physiology 
Trial Lens Fitting 
► 
Subjects will berandomly assigned a test lenson one eye and a control lens on the other 
eye 
► 
Modify lens powers to obtain 0.00 D spherical over-refraction 
10-Minute Evaluation 
► 
S ymptoms 
► 
Fitting characteristics, VA 
► 
F or release, the lensesmust provide: 
► 
Apprcpriate frtti ngcharacteristics on both eyes 
► 
20/30or better vision in both e-;es 
► 
ln vesitgator approval 

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C    R    -6    501, 
v     4.0 
- 
 
 
 
 
JJ VC 
C O NFIDENTIAL 

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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 
BSCVA 
Best Spectacle Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CLUE 
Contact Lens User Experience 
COM 
Clinical Operations Manager 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
 
D 
Diopter 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
IB 
Investigator's Brochure 
ICH 
The International Council for Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent-to-Treat 
JJVC 
Johnson & Johnson Vision Care, Inc. 
LASIK 
Laser-Assisted in Situ Keratomileusis 
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 

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1. INTRODUCTION AND BACKGROUND 
Contrast sensitivity functions (CSF) have wide scientific and clinical use (NRC, 1985). Their 
value, however, depends critically on their reliability and their ecological validity. In most 
vision experiments, CSFs are measured with a CRT oscilloscope or computer monitor (or even 
less precisely, with wall charts like the Peli-Robson or the CSV-1000), which allows relatively 
simple electronic control of both spatial frequency and contrast. A common method, for 
example, of measuring CSF is employed by the Metropsis system (Cambridge Research). This 
system presents a series of sine-waves (as Gabor patches) on a highly calibrated monitor with 
computer control over presentations and refined psychophysical procedures (the modern 
version of the original method used on a CRT screen by Campbell and Robson, 1968). The 
Metropsis system has been used to evaluate spatial vision issues in a variety of patient 
populations (e.g. to assess the effects of brain injury, smoking or toxic exposures; Nguyen et 
al,.2017; Costa et al., 2012; Fernandes et al., 2017). 
 
Fernandes et al. (2019) evaluated the Metropsis method on 55 normal subjects. The curves 
provided by Fernandes were unusually flat (e.g., between about 0.2-8.8 cycles/degrees; shown 
in Figure 2) with intraclass correlations of around 0.71 when testing 20 subjects (the authors 
note that this is considerably higher than intraclass correlations generated by the CSV-1000 
(0.19), Pelli-Robson (0.18), Vistech FDT (0.36) or Miller=Nadler (0.36) CSF tests. 
 
Figure 2: Binocular contrast sensitivity values derived from Figure 2 of Fernandes et al. (black 
line and symbols) compared to data from Scheiber et al (red line and symbols: 20 year-old 
observers). Note the deviation at the lower frequencies. 
 
 
 

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Reliability is, of course, critical in a prognostic device. As originally expressed by the National 
Research Council (1985), "The value of the contrast sensitivity function in predicting 
performance on complex visual tasks and in discriminating among individuals in their ability 
on these tasks needs to be further explored."  If the amount of variance explained (r2) is   
only 50% (meaning a measure predicts half of the variance in that same measure taken at a 
different time), then its ability to predict other variables is, perforce, less than 50%. It would 
be optimal to have a system for measuring CSF that has better reliability. 
 
The other major issue with CSF curves measured using monitors is their inconsistency across 
studies (convergent validity). A classic curve in the CSF literature, for example, comes from 
van Nes and Bouman (1967) shown below (Figure 3). 
 
Figure 3: CSF data from van Nes and Bouman. Note that the peak sensitivity value is near 
around 5 cyc/deg and sensitivity is peaking around 400-500 (about twice the peak from the 
Metropsis sample shown in Fig 2). (also note the similarity in the curves across luminance- 
from 90-900 trolands, analogous to 3 to 300 cd/m2 based on a 2 mm pupil). 
 
 
 
The shape of the curve is similar to the classic curve reported by Campbell and Robson (1968). 
The peak is quite different (3 cycles/degree, contrast sensitivity = 700). Shown in Figure 4. 

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Figure 4: CSF according to Campbell and Robson (1968). 
 
 
 
Contrast these peaks with others often reported in the literature. Here, for example, is a sample 
of young and older subjects from Elliott et al. 2009 (Figure 5). 

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-
-- 
Johnson & Johnson Vision Care, Ine. 
 
Figure 5: Figure from Elliott et al. (2009); data are from older (red) and younger (black) 
subjects with various abe1rntions co1Tected. In this study the peak is around 8 cycles per degree 
and contra.st sensitivity is about 80. 
 
 
 
 
 
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Spatial frequencv (c/deQ} 
 
If one does a wide survey of nonnal CSF curves in the literature, you can find wide divergence 
in the shape of CSF curves and in peak sensitivity (a range by at least a factor of ten). One 
reason isa lack of standardizing many of the variables that drive the curves (size, illuminance, 
etc), although even when this is done, convergent validity seems to be poor (Buhren et al., 
2006). Another reason is that the modulation depth of the stimuli are ra.rely directly calibra.ted 
(on monitors, the actual values are derived not actually measured in place). This is a particular 
issue with CRTs (Garcia-Perez and Peli, 2001). The quality of the stimulus display ranges 
from paper wall charts (e.g., Peli-Robson) to cathode-ra.y tubes to various types of monitor 
designs (e.g., Metropsis). The range of procedures also varies from deriving tlu·esholds from 
relatively long psychometric functions (like in Metropsis) to ve1y rough approximations (e.g., 
CSV-1000), see Figure 6). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1O 
1   ..  
. 
 
_..  
_. 
: 

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Figure 6: The stimuli used in the CSV-1000 test (right side shows the glare condition). 
 
 
This lack of standardization is likely why CSF methods often have poor predictability and 
ecological validity. This was originally tested by Owsley and Sloane (1987): 
 
"A major assumption underlying the use of contrast sensitivity testing is that it predicts 
whether a patient has difficulty seeing objects encountered in everyday life. However, there 
has been no large-scale attempt to evaluate whether this putative relationship actually exists." 
 
Owsley and Sloane measured Snellen acuity and the CSF of 93 subjects (aged 20-77 yrs.). 
These measures were then compared with target images (faces, road signs, and other objects) 
that were placed on back-illuminated slides. These slides were placed in an optical system that 
allowed the contrast within the object to be varied. These authors found that Snellen acuity did 
not predict threshold identification of these "real-world targets." CSF did predict real-world 
performance but explained only 25-40% of the variance. This supports the potential utility of 
CSF as a measure of vision in everyday life while also highlighting a potential opportunity to 
develop new methods of measuring CSF to improve its ability to predict vision in everyday 
life. 
 
Fortunately, high quality sine-wave transparencies are available from Applied Image, who can 
custom make the sine-waves and calibrate them precisely. These targets have low harmonic 
distortions (2% or less) and are available cemented between large (100 x100 in) squares of 
glass. They are nearly spectrally flat. These were originally used in a study by Hammond et 
al. (2012) and Fletcher et al. (2014). These foundational studies showed that CSF can be 
measured using real optics and carefully controlled and calibrated conditions. 
 
Another challenge when measuring CSF is to introduce the kind of stressors that actually affect 
spatial vision in the real world. One such stressor is glare. The primary source of glare in the 

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real world is the sun (Mitra, 2014, Sun et al., 2018). A major issue with many of the existing 
glare systems (see Figure 5) is that the glare source that is used does not resemble actual 
sunlight (Tungsten-Halogen is a common source, the Metropsis uses white LEDs). In our 
study we will use white light with xenon as the source and filtered to precisely match specific 
phases of sunlight. Another important consideration is the angle. Often glare sources are made 
to surround the entire display. For example, the CSV-1000 mounts the glare source on the 
sides, Metropsis mounts the glare source vertically as shown in Figure 7. 
 
Figure 7: The glare source of the Metropsis is based on white LEDs mounted vertically. 
 
 
In the real world, the glare source (say the sun) and the visual target (say a stop sign) are 
relatively far away. In some instances, this distance homogenizes the light scatter interfering 
with perception of the stimulus. In a clinic, the stimulus and glare source are only a few feet 
away making the glare less uniform (it is more intense as it gets closer to the source). To 
optimally emulate real world visual conditions, the veiling light should be relatively 
homogenous. 
 
Issues revealed by our previous pilot study: 
In our previous pilot study, we measured CSF (photopic and mesopic) under regular and glare 
conditions. This was done to assess whether CSF with our HEV-absorbing test lens differed 
from a clear control. Although preliminary testing demonstrated a significant reduction in CSF 
with glare, in a second cohort, we found that our glare condition did not reduce CSF (i.e. the 
CSF curves were the same in the glare and non-glare condition). Hence, the HEV test lens did 
not have a reduction to correct. Why did our glare condition not work? 
 
In our previous discussion we argued that the measures of CSF provided by the Metropsis were 
highly variable, likely reducing our ability to discriminate small differences between the two 
test conditions. Another possible methodological limitation might have been the positioning 
of the glare source. One possible reason why the glare condition did not reduce the CSF was 

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Johnson & Johnson Vision Care, Ine. 
 
that it was insufficiently homogeneous and too far from the line of sight. Like in real life, 
people will reflexively try to see around glare (dive1t their eyes to the least glaring portion of 
the image) and this may have been possible with our glare ring a1Tangement (the preliminruy 
testing was sho1t and composed of subjects that were highly compliant). In order to really test 
the effects of glru·e, the glare source needs to be perfectly homogeneous and made such that it 
cannot be avoided. Our current study is designed to address both the reliability issues with 
Metropsis and the homogeneity of the glare source. 
 
University of Georgia contrast sensitivity testing apparatus: 
The simplified design of this system was based on many of the satne principles that were 
worked out on the much more elaborate optical systems used in Hammond et al. (2012) and 
Fletcher et al. (2014). A custom-built apparatus was used to measure contrast sensitivity 
functions at 1.6, 3.2, 8, 16 and 24 cycles/degree (See the schematic in Figure 8). 
 
Figure 8: University of Georgia CSF Apparatus 
 
 
 
 
 
 
The system uses two green (520 nm) lasers (Ll and L2) that are spatially diffused using two 
six-inch circulru· integrating spheres (aluminum hemispheres painted on the interior with highly 
diffusing, 98% reflecting, non-luminescent, white paint, Labsphere, N01th Sutton, NH). To 
measure contrast sensitivity, the intensity of the light source (Ll and L2) is independently 
adjusted using circular neutral density wedges (Wl and W2). The two spheres pass the 
homogeneous green light through two exit poris (~3.5 deg circular). The green laser light 
source is positioned with respect to the surface of the integrating sphere in such a way as to 
create a completely homogeneous light at the plane of the retina, essentially a Lambertian 
 
 

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emitter. This creates a visual stimulus with luminance that is relatively independent of exact 
eye position. 
 
Light from Sphere 1 passes through a 2-inch diameter sine wave grating (1.6, 3.2, 8, 16, or 24 
cyc/deg based on a distance of 36 inches to the plane of the eye). These gratings are placed in 
a mount that can be rotated to the left or right (15 degree cant) in order to provide a forced 
choice procedure. A thin optomechanical shutter (Thor Labs) by L1 allows the intermittent 
exposure (-1 second exposures) of the grating stimulus. Light from Sphere 2 combines with 
Sphere 1 and wedge adjustment allows for constant variation in the modulation of the sine 
waves. A dedicated photodetector (Graseby Optronics United Detection Technology (UDT) 
with a photometric lens Orlando, FL) is used to constantly monitor the luminance output (half 
of the combined beam going to the detector and half going to the eye of the subject to maintain 
a constant luminance of 65 cd/m2). The gratings were calibrated by the manufacturer and 
confirmed within the system by moving a tiny pinhole aperture (-1/2 mm) and photodetector 
(ILT 950, International Light Technologies, Peabody MA) across and very close to the surface 
of the grating while changing the position of the wedges. Optical baffling was used throughout 
(not shown in the schematic) to prevent light noise between the channels. 
 
Subject head position is maintained using a forehead and chin rest assembly (36 inches from 
the grating). Contrast thresholds are calculated based on the Michelson contrast formulation. 
A method of limits is used to obtain threshold (ascending and descending). A method of 
constant stimuli combined with the forced choice procedure (canted left or right) is used to 
refine the threshold determination to approximately 75% correct (based on 10 determinations). 
 
To measure CSF, two ascending and two descending thresholds will be taken for each grating, 
with grating order randomly assigned for each participant. If raw values vary by more than 200 
arbitrary units on the wedge display, the forced choice / constant stimuli method will be used 
to arrive at a more exact threshold. 
 
Glare system 
The glare system is composed of a one-channel optical system with a 1000-watt xenon light 
source. Light exits the housing and is collimated using an achromatic plano-convex lens. This 
collimated light passes through a water baffle (a clear tube with optical flats on either end) that 
removes heat without altering the light spectrum. The collimated light passes through a series 
of achromatic plano-convex lenses that alternately focus and collimate the light. A color 
correcting filter (e.g., Daylight Blue Filter, Edmunds Optics) will be used to achieve a CCT of 
at least 6500K. The collimating light will be approximately three inches in diameter. The 
entire system is orthogonal to the CSF device. At the junction between the exit port of the CSF 
device a large thin glass beam-splitter (analogous to a large cover slip) will be used. This 
creates a large perfectly homogeneous glare source between and co-liner with the grating and 
the eye of the subject. See Figure 9. 

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Figure 9: University of Georgia glare system 
 
 
1.1. Name and Descriptions of Investigational Products 
This study will evaluate two (2) senofilcon A designs with and without a new UV/HEV filter. 
The Test lens is FDA-approved and pending commercial distribution. The Control lens is 
ACUVUE OASYS 1-Day with HydraLuxe™ Technology. Further details about the test 
articles are found in section 6 of this protocol. 
 
1.2. Intended Use of Investigational Products 
The intended use of the investigational products is for correcting myopia (Test and Control) 
and improving visual performance characteristics under applicable conditions (Test). The 
study articles will be worn contralaterally in a daily wear, daily disposable modality for 1-2 
hours. 
 
1.3. Summary of Findings from Nonclinical Studies 
Not Applicable - Marketed product only. 
 
1.4. Summary of Known Risks and Benefits to Human Subjects 
Benefits to the subjects include the correction of their refractive error with the potential of 
improved visual performance in HEV environments. The risks of wearing soft contact lenses 
are well known and are described in the Investigator's Brochure and Informed Consent. The 
material safety testing/lens release criteria was determined based on the Risk Assessment. 

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For the most comprehensive risk and benefit information regarding Test and Control lenses, 
refer to the latest version of the package insert. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The new HEV-filter in the Test lens has been evaluated in two previous objective-based 
studies: 
and 
. In both studies, psychophysical evaluations were carried out 
on an optical breadboard system using a broadband light source that emulated sunlight in 
spectral content. These studies demonstrate that benefits of a HEV-filter can be seen when 
tested in an HEV-rich environment such as natural sunlight: 
 
1.  
(n=60 cohort): when compared to a similar contact lens without the new 
UV/HEV filter, the Test lens demonstrated statistical superiority in the following 
metrics: 
o 2-point light threshold 
o Halo diameter 
o Starburst diameter 
o Disability glare 
o Discomfort glare 
o Chromatic contrast 
 
2.  
(n=58 cohort): when compared to a similar contact lens without the new 
UV/HEV  filter  (different  control lens than 
), the Test lens demonstrated 
statistical superiority in the following metrics: 
o 2-point light threshold 
o Halo diameter 
o Discomfort glare 
o Chromatic contrast 
o Photostress recovery 
 
To further, many of the metrics noted above provide a reason for why the specific hypotheses 
of this study are of interest. Mainly: 
 
1. Improved contrast 
o In 
and 
, disability glare was measured by noting the intensity 
of a broadband light source needed to obscure a central grating target. The results 
from this study demonstrate that subjects can see a high contrast central grating 
target under HEV-rich conditions such as sunlight better with an HEV-filter. 
o In 
and 
, heterochromatic contrast was measured by noting the 
intensity of a 460 nm light source needed to obscure a 580 nm central grating 
target. The results demonstrate an improved ability to detect edges while wearing 
an HEV-filter. 
2. Improved low light vision 
o In 
and 
, broadband light that emulated sunlight in spectral 
content was used to generate a point source of light. The halo and starburst 

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diameters of that light were measured using precision calipers. The results 
demonstrate that positive dysphotopsia, which is most prevalent in dim 
illumination, can be improved with an HEV-filter. 4-6 
 
(n=59) was a method development pilot study intended to test contrast sensitivity 
and resolution acuity under various conditions. The learnings from that study are mentioned 
throughout the introduction of this protocol and incorporated into the current study. 
 
Refer to the Package Insert (Appendix C) for additional information about the study lenses. 
 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
 
2.1. Objectives 
The intent of this study is to determine whether or not the Test lens is likely to provide visual 
benefits under conditions for which it was designed. All mentions of broadband glare, or just 
glare, are referring to an ecologically-valid light source that emulates sunlight in spectral 
content. 
 
Primary Objective(s) 
The primary objective is to evaluate the visual performance characteristics of a new UV/HEV 
filter under conditions where an ecologically-valid light source is present. 
 
2.2. Endpoints 
Primary Endpoint(s) 
• Area under the curve of photopic contrast sensitivity function under bright light 
conditions (120 cd/m2) with a broadband glare source. 
 
Secondary Endpoint(s) 
• Area under the curve of mesopic contrast sensitivity under dim light conditions (3 
cd/m2) with a broadband glare source. 
 
Other Observations: 
• Area under the curve of photopic contrast sensitivity function under bright light 
conditions (120 cd/m2) without a broadband glare source. 
• Area under the curve of mesopic contrast sensitivity under dim light conditions (3 
cd/m2) without a broadband glare source. 
 
2.3. Hypotheses 
Primary Hypothesis 
No primary hypothesis will be tested. The primary endpoint will be descriptively summarized. 
 
Secondary Hypothesis 
No secondary hypothesis will be tested. The secondary endpoint will be descriptively 
summarized. 

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Exploratory Hypotheses 
• The Test lens will provide greater photopic contrast sensitivity compared to the Control 
lens under conditions of a broadband glare source. 
• The Test lens will provide greater mesopic contrast sensitivity compared to the Control 
lens under conditions of a broadband glare source. 
 
3. TARGETED STUDY POPULATION 
 
3.1. General Characteristics 
Subjects must be habitual wearers of silicone hydrogel contact lenses worn on a daily wear 
basis. Subjects can be of any gender, race, and ethnicity that meet the eligibility criteria. 
 
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 65 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both 
eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear 
modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a 
minimum of 5 days per week during the past 30 days. 
5. Possess a wearable pair of spectacles that provide correction for distance vision. 
Inclusion Criteria at Baseline Evaluation 
6. The spherical equivalent of the subject's vertex corrected distance refraction must be 
between -1.00 D and -6.00 D (inclusive) in each eye. 
7. The magnitude of the cylindrical component of the subject's vertex-corrected distance 
refraction must be between 0.00 D and 1.00 D (inclusive) in each eye. 
8. The best corrected, monocular, distance visual acuity must be 20/25 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: 

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1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of 
medication the investigator believes 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, 
Sjogren's syndrome), or history of serious mental illness or seizures. See section 9.1 
for additional details regarding excluded systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or 
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 
5. Be currently wearing monovision or multifocal contact lenses. 
6. Be currently wearing lenses in an extended wear modality. 
7. Have participated in a contact lens or lens care product clinical trial within 30 days 
prior to study enrollment. 
8. 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. 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. 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 the investigator 
believes might 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). 
10. Have a history of strabismus or amblyopia. 
11. Have fluctuations in vision due to clinically significant dry eye or other ocular 
conditions. 
12. Have had any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, 
iridotomy, retinal laser photocoagulation, etc.). 
13. Have signs of a contact lens-related corneal inflammatory event (e.g., past peripheral 
ulcer or round peripheral scar). 
14. Have a history of eyelid injury, surgery or procedure that resulted in abnormal eyelid 
position or movement. 
 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site's subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 

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4. STUDY DESIGN AND RATIONALE 
 
4.1. Description of Study Design 
This is a split-plot design with two parallel arms consisting of randomized photopic and 
mesopic conditions where subjects are also randomized contralaterally to the Test and Control 
lenses within each arm. This study will be non-dispensing, controlled, and double-masked. The 
study lenses will be worn in a daily wear modality for 1-2 hours. Subjects will not have access 
to the study lenses at the conclusion of their visit. 
 
4.2. Study Design Rationale 
This is a split-plot design with two parallel arms consisting of randomized photopic and 
mesopic conditions where subjects are also randomized contralaterally to the Test and Control 
lenses within each arm. The photopic and mesopic conditions will be the two-parallel arms so 
that these two conditions can be assessed separately. There are several benefits to the choice 
of the contralateral design within each condition arm. First, a contralateral design will allow 
us to compare performance within the same individual, ostensibly with the same baseline light 
sensitivity by eye. Second, other subject factors that can influence visual performance, such as 
iris color and absorption of test lights via macular pigment, are better controlled using this 
design. Third, in psychophysical testing, which is the gold standard for many of the visual 
functions being tested, participants make judgments about some event threshold, such as when 
an image disappears. Participants may have different criteria for threshold events that are 
internally consistent within subjects but can vary between subjects. A contralateral design 
allows the investigational lens to be compared within subjects, with consistent criteria for 
threshold events. 
 
4.3. Enrollment Target and Study Duration 
This study will have an enrollment target of 44 subjects, with a target of at least 40 to complete 
(approximately 20 subjects [10 subjects from the 18-40 years of age range; 10 subjects from 
the 41-65 years of age range] in each arm). The study will be conducted at a single clinical 
site. A subject will be considered enrolled upon signing of the informed consent form. 
 
There will be 1 visit total per subject; total study duration including the enrollment period is 
expected to be approximately 2 months. If subjects discontinue prior to the final evaluation, 
then additional subjects may be enrolled at the discretion of the study sponsor to maintain the 
sample size plan. 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 
Use of the test articles will be randomized using a lens fitting schedule supplied by the study 
biostatistician. The randomization scheme will be generated by the unmasked biostatistician 
using the PROC PLAN procedure from Statistical Analysis System (SAS) Software Version 
9.4 or higher (SAS Institute, Cary, NC).7 The clinical site will follow the lens fitting schedule 

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provided and will complete enrollment according to the randomization list and will not pre- 
select or pre-assign subjects. 
 
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. Randomization will be stratified into two age groups (18-39 years old and 40-65 years 
old) using a 1:1 allocation ratio. Subjects will be first assigned randomly to the photopic or the 
mesopic condition arm. The order of the light sources within each condition arm is 
predetermined: visual performance will be assessed under the no broadband light source 
(without glare) condition first and then assessed under the broadband light source (with glare) 
condition. Within each condition arm, subjects will be randomized to either wear the Test lens 
in the left eye and the Control lens in the right eye or the Control lens in the left eye and the 
Test lens in the right eye. There will be only one lens assignment for the two light sources (i.e., 
without glare and with glare) per subject. Under each light source condition, the right eye will 
always be tested first. Once a participant's lens assignment has been randomized, the order of 
test stimuli will also be randomly assigned. Five spatial frequencies for contrast sensitivity 
testing (1.6, 3.2, 8, 16, and 24 cycles per degree) will be tested in the no-glare condition, and 
in the glare condition. Spatial frequency order will be randomized for both the no-glare 
condition and the glare condition for each subject eye. 
 
Randomization will be performed at visit 1. 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 
lens fitting schedule. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the "Dispensed" section. 
 
5.2. Masking 
This is a double-masked trial. Masking will be used to reduce potential bias. Subjects will be 
unaware of the identity of the investigational product assigned in the left eye and right eye. 
Investigators involved in the clinical assessment and data collection will be masked as to the 
identity of the investigational product. However, the clinician fitting the lenses may be aware 
of the identity of the investigational product due to the slight color difference between the 

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Test 
Name 
Manufacturer 
- 
AOMAX 
Control 
AOlD 
JNC 
Lens Mate1i al 
senofilcon A C3 
senofilcon A C3 
- 
JNC 
 
study lenses, and the clinician won't be involved in any clinical assessment or data collection 
of the study. 
5.3. Procedures for Maintaining and Breaking the Masking 
Eve1y attempt will be made to keep the clinical trial personnel involved in the study (e.g. data 
management, biostatistician and clinical operations) unaware of the identity of the assigned 
study lenses. The identity of the study lenses will be masked by having the blister packs 
labeled with the study number, lot number, sphere power, expiration date and the 
randomization codes. Only the urunasked biostatistician generating the lens fitting schedule 
will have access to the decode infonnation that allows matching of the randomization codes to 
the test aiiicles. The medical monitor will also have access to the decode info1mation in case 
breaking the mask is necessa1yfor the urgent medical treatment of a subject. 
 
Under no1mal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Othe1wise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject.In such cases, the investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the sponsor must be info1med as soon as possible. The date, time, 
and reason for the unmasking must be documented in the subject record. The investigator is 
also advised not to reveal the study treatment assignment to the clinical site or sponsor 
personnel. 
 
If subjects discontinue prior to the final evaluation, then additional subjects may be emolled at 
the discretion of the study sponsor to maintain the sainple size plan. 
 
6. STUDY INTERVENTION 
 
6.1. Identity of Test Articles 
The following contact lenses will be used in this study: 
Table 1: Test Atiicles 
 
 
 
 
 
 
 
8.5 
8.5 
  Nomina1 Diameter  
14.3 
14.3 
Nominal Distance Powers 
-1.00 throu h -6.00 
-1.00 throuo -6.00 
Water Content (O tional 
38 
38 
Center Thickness 
0.085 
0.085 
Ox oen Pe1meabilit 
Dk 
103 
103 
 
 

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Test 
Control 
Wear Schedule in Cunent Study 
Daily 
Daily 
Replacement Frequency 
Daily 
Daily 
Packaging Fonn (vial, blister, etc.) 
Bhster 
Bhster 
New UV/HEV-blocker 
Yes 
No 
AOMAX = ACUVUE® OASYS MAX 1-Day, AOID = ACUVUE® OASYS 1-Day 
 
Approximately 11 lenses per stock keeping unit (SKU) will be provided based on 44 subjects, 
I-period, contralateral, non-dispensing design, US population n01mahzed far peak SKUs. 
 
6.2. Ancillary Supplies/Products 
The fallowing solutions will be used in this study: 
 
Table 2: Ancillaiy Supphes 
 
Solutions 
Solution 
Name/Description 
Acuvue™ RevitaLens 
Multipurpose Solution 
Single use 
Eye-Cept® 
Rewetting 
Drops 
LacriPure 
Sahne 
Solution 
ScleralFil 
Preservative 
Free Sahne 
Solution 
Manufacturer 
Johnson & Johnson 
Vision 
Optics 
Laborato1y 
Menicon 
Bausch & 
Lomb 
Preservative 
alexidine 
dihydrochloride 
0.00016% and 
polyquatemium-1 
0.0003% 
None 
None 
None 
Lens cases and fluorescein strips (either 0.6 mg or 1.0 mg) will be supplied far use as needed. 
 
6.3. Administration of Test Articles 
Test aiticles will be dispensed to subjects meeting all eligibihty requirements, including any 
dispensing requirements set fa1th in this clinical protocol. Subjects will be dispensed an 
adequate supply of test aiticles to complete the study. Lost or damaged test aiticles may be 
replaced at the discretion of the investigator and/or the sponsor. 
6.4_ 
Pa  c k aging and Labeling 
The study aiticles will be packaged in blisters as the primaiy packaging. The study aiticle will 
be over-labeled to mask the subject and investigators to the identity of the lens. The study 
aiticles will be in plastic bags as the seconda1y packaging fo1m. The samp le study label is 
shown below (Figure 10). 
 
 
 
 
 
 
 

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Figure 10: Packaging Labels 
 
 
Secondary Packaging 
Primary Packaging 
 
 
6.5. Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
 
6.6. Collection and Storage of Samples 
No samples will be collected as part of the study procedures. 
 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
 
6.7. Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes: 
 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits. 
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
 
 
 
 
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3. The number and reason for unplanned replacements. 
 
The Investigator will collect all unused test aiticles from the subjects at the end of the subject's 
paiticipation. Subject retumed unused test aiticles must be sepai·ated from the clinical study 
invent01y of un-dispensed test aiticles and must be labeled with the subject number and date 
of retum. Following final reconciliation of test aiticles by the monitor, the Investigator or 
monitor will retum all unused test articles to JJVC. 
 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
 
7. STUDYEVALUATIONS 
 
7.1. Time and Event Schedule 
 
Table 3: Time and Events 
 
 
Visit Information 
Visit 1 
Screening, Baseline, Fitting / 
Assessment 
Final Evaluation 
Time Point 
DayO 
EstimatedVisit Dmation 
3.0 homs 
Statement of Infonned Consent 
X 
Demographics 
X 
Medica! Hist01y/Concomitan t Medications 
X 
Habitual Contact Lens Info1mation 
X 
Eligibilitv Following Screening 
X 
Entrance Visual Acuity 
X 
Subjective Sphero-Cylindrical Refraction and best- 
co1Tected VA 
X 
Eve Doininancv 
X 
Slit Lamo Bioinicroscoov 
X 
Eligibility Following Baseline Evaluation 
X 
Lens Selection 
X 
Lens Inse1t ion & Settling 
X 
Visual Acuity and Over Refraction 
X 
Lens Power Modification (if applicable) 
X 
Subiect Repo1ied Ocular Symptoms 
X 
Visual Acuitv 
X 
General Fit Assessment 
X 

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Visit Information 
Visit 1 
Screening, Baseline, Fitting / 
Assessment 
Final Evaluation 
Time Point 
DavO 
Estimated Visit Duration 
3.0 hours 
Vision Assessments: photopic and mesopic contrast 
sensitivitv 
X 
Exit Snellen Distance Visual Acuity 
X 
Studv Completion 
X 
 
 
7.2. Detailed Study Procedures 
 
VISIT 1 
The subjects must present to Visit 1 wearing spectacles, not having wom contact lenses on the 
day of the visit. 
 
Visit 1: Screenin 
Step 
Procedure 
Details 
1.1 
Statement of 
Infonned Consent 
Each subject must read, understand, and sign 
the Statement of Infonned Consent before 
being emolled into the study. The Principal 
Investigator or his/her designee conducting 
the info1med consent discussion must also 
sign the consent f01m. 
Note: The subject must be provided a signed 
co 
of this document. 
1.2 
Demographics 
Record the subject's year of bi1th, age, 
oender, race and ethnicit . 
1.3 
Medical Histo1y and 
Concomitant 
Medications 
Record the subject's medical histo1y and 
concomitant medic.ations . 
1.4 
Habitual Lenses 
Record the subjecfs habitual lens type, 
parameters, lens care solution, wear modality, 
dmation of lens wear, and approximate 
rescri tion date. 

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Visit 1: Baseline 
Step 
Procedure 
Details 
1.6 
Entrance Visual 
Acuity 
Record the distance Sne11en visual acuity 
(OD, OS, and OU) to the nearest letter with 
their habitual spectacle. Subjects must read 
the sma11est line until at least 50% of the 
letters are read incon ectl . 
1.7 
Subjective Sphero- 
cylindrical 
Refraction 
Complete subjective spherocylindrical 
refraction and record the resultant distance 
visual acuity (OD, OS, and OU) to the nearest 
letter. 
1.8 
Eye Dominancy 
The investigator wi11 detennine eye 
dominancy of the subject by first using the 
+1.00 blur test. If this fails to detennine 
dominancy, then the sighting test wi11 be 
used. 
1.9 
Slit Lamp 
Biomicroscopy 
FDA Slit Lamp Classification Scale wi11 be 
used to grade the findings. 
If any of these slit lamp findings are grade 3 
or higher, the subject may not continue at this 
time, but may retum up to one additional time 
to detennine eligibility. If  discontinued a 
final examination must be completed. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline ma be insti1led . 
Visit 1: Screenin 
Details 
AH responses to Screening Inclusion Criteria 
questions must be answered "yes" and al1 
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 Fina! Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
com leted as art o Fina! Evaluation. 
Eligibility after 
Screening 
1.5 
Procedure 
Step 

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Visit 1: Treatment 1 Lens Fittin 
Step 
Procedure 
Details 
1.11 
Lens Selection 
Assign the study lens based on the 
randomization scheme provided by the 
biostatistician. 
Select the contact lens power based on 
ve1texed spherical equivalent from the 
refraction. 
1.12 
Lens Inse1tio11 
The Investigator or the subject inse1ts the 
study lenses. Record the time of lens 
inse1t io11. 
Check for lens damage under the slit lamp 
before proceeding with lens settling. 
Re  lace dama  ed lenses if a 
licable. 
1.13 
Lens Settling 
Allow the study lenses to settle for a 
minimum of 5 minutes. 
1.14 
Subjective Best 
Sphere Over 
Refraction 
Perfo1m subjective best sphere refraction 
over the study lenses (adopt the maximum 
plus to maximum visual acuity (MPMVA) 
a roach. 
1.15 
Lens Power 
Modification (if 
applicable) 
Adjust the lens power if the subject's best 
sphere over-refractionis not plano. 
For each power modification, select the 
adjusted fitting lens power as appropriate and 
repeat steps 1.12 through 1.14. 
Up to two power modifications are allowed 
ere e. 
Visit 1: Baseline 
Details 
AH re sponses to Inclusion Criteria questions 
must be answered "yes" and al1responses to 
Exclusion Criteria questions must be 
answered "no" for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after 
baseline, proceed to Fina! Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
com leted as art o Fina! Evaluation. 
Eligib i lity afte r 
B ase l ine 
1.1O 
Procedure 
Step 

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Visit I: Treatment I Lens Fittin 
Step 
Procedure 
Details 
1.16 
Subject Reported 
Ocular S m toms 
Subjects will respond to a verbal open-ended 
s m toms uestionnaire. 
1.17 
Visual Acuity 
Record the best conected Snellen distance 
visual acuity to the nearest letter (OD, OS 
and OU). Subjects must read the smallest 
line until at least 50% of the letters are read 
incon ectly. Visual acuity with the study 
contact lenses must be 20/30 or better OD 
and OS. 
1.18 
General Lens Fit 
Assessment 
Evaluate lens centration, movement on blink, 
a.ud push -up tes t for each eye. 
An unacceptable fit is deemed by one of the 
following criteria: 
• 
limba! exposure at prima1ygaze or 
with extreme eye movement. 
• 
edge lift. 
• 
excessive movement in primaiy and 
up gaze. 
• 
insufficient movement in all three of 
the following conditions: primaiy 
gaze, up gaze, and push-up test. 
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
stud . 
1.19 
Continuance 
For the subject to continue in the study, they 
must meet all three of the following criteria: 
1. Visual acuity is 20/30 or better OD 
andOS. 
2. The lens fit is acceptable OD and OS. 
3. Investigator approval. 
If the Investigator does not approve the study 
lens, then the study is terminated for that 
subject. 

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Visit I: Photo 
Details 
Contrast sensitivity testing will be perfo1med 
using the University of Georgia system OD 
and OS in the following order. The eye not 
being tested will be patched. The following 
spatial frequencies will be randomized: 1.6, 
3.2, 8, 16 and 24 cpd. 
Photopic contrast sensitivity without glare 
1. Participant is seated in front of the 
optical device with their chin in the 
chin rest assembly and asked to patch 
OS. 
2. To practice, the paiticipant is shown the 
0.5 cycles per mm grating (which 
yields a threshold at 8 cycles per degree 
of visual angle). The procedure is 
demonstrated, and the paiticipant 
confinns that they can view the grating 
easil . 
Photopic Contrast 
Sensitivity Testing 
Without Glare 
1.21 
Procedure 
Step 
 
 
Visit I : Treatment I Lens Fittin 
Step 
Procedure 
Details 
1.20 
Lenses Wom in 
Clinic 
The lenses will be released for approximately 
two hours. 
1. The subjects must wear both study 
lenses the entire time. 
2. The lenses will be wom as daily wear 
only. 
3. Rewetting drops   are   pennitted if 
needed. 
Note: In the event a lens is lost or damaged, it 
will be replaced immediately. 
A clinic-only-wear Patient Instmction 
Guide will be provided. 
 
 
Based on the randomization scheme, subjects are either in the photopic testing group or the 
mesopic testing group. Proceed to the coITect test: 
 
 

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Visit 1: Photo 
Step 
Procedme 
Details 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Photopic Contrast 
Sensitivity Testing 
With Glai·e 
3. The paiiicipant rests for a period of two 
minutes while the researcher replaces 
the 0.5 cycles per mm filter with the 
first spatial frequency grating dictated 
by the randomization scheme. Three 
ascending and three descending 
thresholds are obtained for the first 
spatial frequency dictated by the 
randomization scheme. EDC to record 
contrast sensitivity to 2 decimal places 
(range 0.01 - 10,000). 
4. The paiiicipant rests for two minutes 
while the researcher changes the spatial 
frequency grating. 
5. The procedure is repeated until all 5 
spatial frequencies have been tested, 
with two-minute breaks between trials. 
EDC to record contrast sensitivity to 2 
decimal places (range 0.01 - 10,000). 
Area tmder the contrast sensitivity 
curve will be computed (range 5.00 - 
20,000) and entered. 
6. The participant will then be given a 5- 
minute break and asked to change the 
patch to OD, in order to test OS. 
7. The procedure above will be repeated 
OS. 
Contrast sensitivity testing will be perfo1med 
using the University of Georgia system OD 
and OS in the following order. The eye not 
being tested will be patched. The following 
spatial frequencies will be randomized: 1.6, 
3.2, 8, 16 and 24 cpd. 
 
1. The paiiicipant will be given a 5 
minute break to change the patch back 
to OS while the researcher confinns 
alignment with the glare stimulus. 
2. The paiiicipai1t will be instrncted to 
keep eyes closed, and to position their 
chin in the chin rest assembl . 

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Visit 1: Photo 
Step 
Procedure 
Details 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.23 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Lens Removal 
3. With the glare  stimulus  on, paiiicipants 
will complete three ascending and three 
descending trials for the first spatial 
frequency dictated by the 
rai1domization scheme for the glare 
condition. Note that the first spatial 
frequency tested in the glai·e condit ion 
will likely be different from the first 
spatial frequency tested in the 110-gl 
are condition. 
EDC to record 
contrast sensitivity  to  2  decimal 
places (range 0.01 - 10,000). 
4. The paiiicipant will be given a four 
minute break and will be instrncted to 
keep eyes closed during the break. 
5. The procedure is repeated until all 5 
spatial frequencies have been tested, 
with four-minute breaks between 
trials. EDC to record contrast 
sensitivity to 2 decimal places (range 
0.01 - 10,000). Area under the 
contrast sensitivity curve will be 
computed (range 5.00 - 20,000) and 
entered. 
6. The paiiicipant will then be given a 5- 
minute break and asked to change the 
patch to OD, in order to test OS. 
7. The procedure above will be repeated 
OS. 
The wom study lenses will be removed and 
discarded. Proceed to the Final Evaluation. 
 
 
Visit 1: Meso 
Details 
1.24 
 Mesopic Contrast 
Sensitivity Testing 
Without Glare 
Mesopic contrast sensitivity testing will be 
perfo1med using the University of Georgia 
system OD and OS in the following order. 
The eye not being tested will be patched. The 
following spatial frequencies will be 
randomized: 1.6, 3.2, 8, 16 and 24 cpd. 
Procedure 
Step 

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Step 
Procedme 
Details 
 
Mesopic contrast sensitivi ty without glare 
1. Prior to seating the participant, the 
resea1·cher confams that the wedge 
controlling the background luminance 
is dimmed to the appropriate position 
for mesopic testing. 
2. Paiticipant is seated in front of the 
optical device with their chin in the 
chin rest assembly and asked to patch 
OS. 
3. To practice, the participa11t is shown 
the 0.5 cycles per mm grating (which 
yields a threshold at 8 cycles per 
degree of visual angle). The procedure 
is demonstrnted, and the pa1t icipant 
confums that they can view the 
grating easily. 
4. The pait icipant rests fora periodof 
two minutes while the reseai·cher 
replaces the 0.5 cycles per mm filter 
with the first spatial frequency grating 
dictated by the randomization scheme. 
Three ascending and three descending 
thresholds are obtained for the first 
spatial frequency dictated by the 
randomization scheme.  EDC to 
record contrast sensitivity to 2 
decimal places (range 0.01 - 10,000). 
5. The pait icipant rests for two minutes 
while the reseai·cher changes the 
spatial frequency grating. 
6. The procedure is repeated until all 5 
spatial frequencies have been tested, 
with two-minute breaks between trials 
EDC to record contrast sensitivity to 2 
decimal places (range 0.01 - 10,000). 
Area under the contrast sensitivity 
cmve will be computed (range 5.00 - 
20,000) and entered. 
7. The participant will then be given a 5- 
minute break and asked to change the 
atch to OD, in order to test OS. 

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Step 
 
 
 
1.25 
Procedure 
 
 
 
Mesopic Contrast 
Sensitivity Testing 
With Glai-e 
Details 
 
The procedure above will be repeated 
OS. 
Mesopic contrast sensitivity testing will be 
perfo1med using the University of Georgia 
system OD and OS in the following order. 
The eye not being tested will be patched. The 
following spatial frequencies will be 
randomized: 1.6, 3.2, 8, 16 and 24 cpd. 
 
Mesopic contrast sensitivity with glare 
1. Prior to seating the pariicip ant, the 
researcher confirms that the wedge 
controlling the background luminance 
is dimmed to the appropriate position 
for mesopic testing. 
2. The pariicipant will be given a 5 
minute break to change the patch back 
to OS while the researcher confinns 
alignment with the glare stimulus. 
3. The pariicipant will be instmcted to 
keep eyes closed, and to position their 
chin in the chin rest assembly. 
4. With the glar·e stimulu s on, 
pariicipants will complete three 
ascending and three descending trials 
for the first spatial frequency dictated 
by the randomization scheme for the 
glare condition. Note that the first 
spatial frequency tested in the glare 
condition will likely be different from 
the first spatial frequency tested in the 
no-glare condition. EDC to record 
contrast sensitivity to 2 decimal 
places (range 0.01 - 10,000). 
5. The pariicipant will be given a four 
minute break and will be instrncted to 
keep eyes closed during the break. 
6. The procedure is repeated until all 5 
spatial frequencies have been tested, 
with four-minute breaks between 
trials. EDC to record contrast 
sensitivity to 2 decimal laces range 

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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 tenninated from the study. 
 
Final Evaluation 
Ste 
Procedure 
Details 
F.1 
Final Exam Fo1m 
fudic ate if the subject completed the study 
successfully. If subject discontinued from the 
stud 
indicate the reason. 
F.2 
Exit Slit Lamp 
Bioinicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. This step is not 
necessa1y if the subject was exited due to 
screen failure. 
F.3 
Exit Visual Acuity 
Record the distance Snellen visual acuity 
(OD, OS, and OU) to the nearest letter with 
their habitual con ection in place. Subjects 
must read the smallest line until at least 50% 
of the letters are read inconectl . 
 
7.3. UnscheduledVisits 
If , during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following info1mation will be collected , as appropriate: 
Details 
The wom study lenses will be removed and 
discarded. Proceed to the Final Evaluation. 
Lens Removal 
1.26 
0.01 - 10,000). Area under the 
contrast sensitivity curve will be 
computed (range 5.00 - 20,000) and 
entered. 
7. The participant will then be given a 5- 
minute break and asked to change the 
patch to OD, in order to test OS. 
8. The procedure above will be repeated 
OS. 
Procedure 
Step 

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• 
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 aiticle dispensed or collected from the subject, if applicable. 
• 
Slit lamp findings (using the Slit Lamp Classification Scale). 
 
If the Investigator withdraws a subject from the study, the final study visit case report fo1ms 
must be completed indicating the reason(s) why the subject was withdrawn.The subject record 
must be completed documenting the date and primaiy reason for withdrawal and the study 
CRA notified. 
 
Any ocular and non-ocular Adverse Events that ai-e ongo ing at th e time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre- 
treatment status, stabilized, or been satisfactorily explained. If fmther treatment i.e., beyond 
licensure is required, the subject will be refened to the appropriate health cai·e provide r. 
 
The following info1m ation will be collected dming an unscheduled visit. 
 
Unscheduled Visit 
Ste 
Procedme 
Details 
U.I 
Reason for 
unscheduled visit 
Indicate if the only reason for the visit is that 
the subject requires additional test aiticles.If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit. 
U.2 
Chief Complaints (if 
a lic.able 
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 medica! 
histo1y or concomitant medications from the 
previous study visit. Record any changes, and 
an adverse events. 
U.4 
Entrance VA (if 
a licable 
Record the entrance distance visual acuity 
OD, OS, and OU to the nearest letter. 
U.5 
Subjective Sphero- 
cylindrical 
Refraction (if 
applicable) 
Perfo1m bare-eye subjective spherocylindrical 
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 conected distance visual acuity to the 
nearest letter OD OS, and O 

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Unscheduled Visit 
Ste 
Procedure 
Details 
U.6 
Slit Lamp 
Biomicroscopy (if 
applic.able) 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled. 
U.7 
Dispensing(if 
applicable) 
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, previde additional lenses per the 
dispensing instmctions given in the detailed 
stud 
rocedures. 
U.8 
Exit Visual Acuity 
if a 
licable 
Record the subject's exit distance visual 
acm 
OD, OS, and O 
to the nearest letter. 
 
NOTE: If the only reason for the unscheduled visit is that the subject requires additional test 
aiticles, only the dispensing infonnation needs to be recorded. 
 
7.4. Laboratory Procedures 
None 
 
8. 
SUBJECTS COMPLETION/WITHDRAWAL 
 
8.1. Completion Criteria 
Subjects are considered to bave completed the study if they: 
 
• 
provided info1med consent. 
• 
they ai·e eligible . 
• 
Complete d a ll sc hedu led tests 
 
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the sh1dy for any of the following reasons: 
 
• 
Subject withdrawal of consent. 
• 
Subject not compliant to protocol (e.g., subject does not complete all scheduled tests). 
• 
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear. 
• 
Subjects who have experienced a Comeal 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 not successfully released with lenses due to lack of efficacy and safety 
including poor vision, poor comfo1t or unacceptable fit. 

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Johnson & Johnson Vision Care, Inc. 
 
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) 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 will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: any ocular medications. 
Concomitant therapies that are disallowed include: see section 9.1. 
 
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 
Menopause, osteoporosis, vaginitis Vagifem, 
Estrace, 
Climara, 
Vivelle-Dot, Premarin, Minivelle, 
contrnceptive 
medication) 
etc. 
Anticholinergics 
IITitable 
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 
Hypertension , angina, heait attack, 
migraine, atrial fibrillation, adrenal 
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 
 
Examples of disallowed systemic antihistamines are given in Table 5. Subjects with a histo1y 
of taking systemic antihistamines will be allowed to emoll only if: 
 
 
 
Or: 
• 
They have taken antihistamines continuously for at least 2 weeks, and 
• 
They have demonstrnted successful weai· while taking the medication 
 
• 
They stopped taking the medication for at least 2 weeks prior to emollment. 
 
Table 5: Disallowed systemic antihistamines 
 
Class of Drug 
Common Indication(s) 
Common Examples 
Antihistamines 
Allergic rhinitis, sedation, hives, 
allergic conjm1ctivitis, skin allergy, 
itching, motion sickness 
Hydroxyzine,  
Promethagan, 
Phenadoz, 
Vistaril, 
Claritin, 
Zyitec, Astepro, Astelin, Optivar, 
Allegra, Benadiyl, etc. 
 
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discove1y of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
 

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If it becomes necessaiy for the Investigatorto implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigatormust notify and provide the rationale to the Sponsor and as required, 
the IEC/IRB. 
 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations 
that contradict the info1mation contained in the Info1med Consen/tAssent fo1ms will be 
considered Major Deviations. 
 
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They ai·e 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 category 
Major deviation 
Minor deviation 
Incomplete tests 
Subject does not complete all 
scheduled 
psychophysical 
tests. 
NA 
 
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 occunence of one or more Unanticipated Serious Adverse Device  Effect  (USADE),  or 
any SAE where the relationship to study agent cannot be mled out, may result in stopping 
fmther dispensing of test a1ticle. 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 
fmther subjects are enrolled. 
 
The Sponsor will detennine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if info1mation 
indica tes the study's results are compromised. 
 
JJVC reserves the right to te1minate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to te1minate the study if an unreasonable risk is dete1mined. The 
study can be te1minated by the Principal Investigator at the individua! clinical site due to 
 
 
 
 
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specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use. 
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
 
• 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). 

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• 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. 
 
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: 

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• 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) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 

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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). 

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• 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. 
• 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 

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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. 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed 'possibly related' or 'related' to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 

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intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
"ongoing" without further follow-up. 
 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
 
• 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. 

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• 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. 
• 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. 

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14. STATISTICAL METHODS 
 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. 
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (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. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
 
14.2. Sample Size Justification 
The plan is to enroll approximately 44 subjects with approximately 40 subjects to compete the 
study. Given that no historical data is available for the primary and secondary endpoints using 
the same glare system, the sample size was not determined based on any empirical sample size 
calculation. Targeting 40 subjects to complete the study (20 subjects for each condition arm) 
is considered appropriate to assess descriptive summaries of the primary and secondary 
endpoints. The data collected for this study may be used to design future clinical trials. 
 
14.3. Analysis Populations 
The following analysis populations will be defined and used in the analysis and presentation 
of the data. 
All Enrolled: 
All Enrolled Population includes all subjects with recorded data in the electronic Case Report 
Form (eCRF) database. 
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. Subjects will be 
analyzed as per treatment received. 
 
Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 

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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. Subjects 
will be analyzed as per randomized treatment. 
 
14.4. Level of Statistical Significance 
No primary or secondary hypothesis will be tested. Each exploratory hypothesis will be tested 
at the 2-sided Type I error rate of 0.05. 
 
14.5. Primary Analysis 
No primary hypothesis will be tested. The primary endpoint will be summarized descriptively, 
as discussed in 14.1. 
 
14.6. Secondary Analyses 
No secondary hypothesis will be tested. The secondary endpoint will be summarized 
descriptively, as discussed in 14.1. 
 
14.7. Other Exploratory Analysis 
Exploratory analyses of the primary and secondary endpoints will be conducted using the ITT 
population. With a broadband glare source, the AUC of the photopic and mesopic contrast 
sensitivity function will be analyzed separately using a linear mixed effects model. Lens type, 
dominant eye, and the interaction of lens type by dominant eye will be included in the model 
as fixed effects adjusting for age and gender. The covariance of residuals of within-subject 
repeated measurements (R-side) will be modeled using Unstructured (UN) covariance 
structure. If the model does not converge, then a compound Symmetry (CS) covariance 
structure will be considered. The Kenward and Roger method will be used for the denominator 
degrees of freedom.8 
 
Hypothesis Testing 
The null and alternative hypotheses for testing superiority of the Test Lens compared to the 
Control lens from the previously described model are presented below: 
 
HO    µT - µC ೦ O 
HA  µT - µC > O  
 
Where, µT and µc represent the mean AUC of photopic or mesopic contrast sensitivity function 
with a glare source for the Test lens and the Control lens, respectively. Statistical superiority 
will be declared if the lower bound of the 2-sided 95% confidence interval of the mean 
difference (Test - Control) is larger than 0. A model-based point estimate of the mean 
difference being 0.06 log or more (2'0.06 log) will be considered clinically meaningful. 

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If the proposed mixed effect model fails to converge, the hypothesis will be tested using a 
paired sample t-test or equivalent non-parametric method. 
 
Other study endpoints and observations will be summarized descriptively. Further exploratory 
and/or post-hoc analyses may be conducted at the discretion of the study responsible clinician. 
 
14.8. Interim Analysis 
Not applicable. 
 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
 
15.1. Electronic Case Report Form/Data Collection 
The vision assessments (photopic and mesopic contrast sensitivity with and without glare) will 
be collected using the previously validated optical device described above. The data from the 
device will be recorded on a paper case report form (CRF) stored at the study site. Paper forms 
will be used to record the raw values that are used to compute the final sensitivity values, which 
are then entered into 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. 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF. Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor's representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 

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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 

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the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub- 
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
 
16.4. Data Monitoring Committee (DMC) 
Not applicable 
 
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. 

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• Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
 
18. ETHICAL AND REGULATORY ASPECTS 
 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study, and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is 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 applicable 
regulatory requirements. 
 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
 
• 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. 

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This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
 
• 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 subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States and other applicable personal data protection and security laws and regulations.9 
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. 

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Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
 
19. STUDY RECORD RETENTION 
In compliance with the ISO 14155:2020,1 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 14155:20201 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 

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20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
 
• 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 
This is a single site study. The participating institution and Principal Investigators for this 
study agree that, should the study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint publication of the study 
results with the investigators contributing data, analyses and comments. 
 
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 
4. 
Buch J. The Effects of Contact Lenses With HEV-Blocker on Visual FunctionAugust 
21, 2019. 
5. 
Buch J. The Effects of Contact Lenses With UV/HEV-Blocker on Visual FunctionJune 
22, 2021. 
6. 
Kojima T HA, Hara S, et al. Quantitative evaluation of night vision and correlation of 
refractive and topographical parameters with glare after orthokeratology. Graefe's 
Archive for Clinical and Experimental Ophthalmology. 2011;249(10):1519-1526. 
7. 
SAS/STAT® 14.3 User's Guide. . Cary, NC: SAS Institute Inc; 2016. 

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8. 
Kenward MG, Roger JH. An Improved Approximation to the Precision of Fixed Effects 
from Restricted Maximum Likelihood. Computational Statistics and Data Analysis. 
2009(53):2583-2595. 
9. 
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) 
Not Applicable for this study. 

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APPENDIX B: PATIENT INSTRUCTION GUIDE 
Not Applicable for this study. 

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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 

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IMPORTANT: Please read carefully and keep this information for future use. 
This Package Insert and Fitting Guide is intended for the Eye Care Professional, but should be 
made available to patients upon request. 
The Eye Care Professional should provide the patient with the appropriate instructions that 
pertain to the patient's prescribed lenses. Copies are available for download at www.acuvue.com. 
 
 
 
PACKAGE INSERT & FITTING INSTRUCTION GUIDE 
 
 
 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses 
ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses 
senofilcon A Soft (hydrophilic) Contact Lenses 
for Daily Disposable Wear 
 
 
 
 
 
 
 
 
 
 
CAUTION: U.S. Federal law restricts this device to sale by or 
on the order of a licensed practitioner. 

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Johnson & Johnson Vision Care, Ine. 
 
SYMBOLS KEY 
The fo ll ow ing symbols may appear on the la be l or carton: 
 
 
.. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SYMBOL 
DESCRIPTION 
&CDJ 
Caution, Consult lnst ructio ns for Use 
d 
Date of Manufacture 
Manufacturer 
Use-By Date (expiration date) 
Batch Code 
'IIJILII11 
o 
Sterilized Using Steam Heat 
lndicates a Single Sterile Barrier System 
DIA 
Diameter 
BC 
Base Curve 
D 
Diopter (lens power) 
CE: 2191 
CE Mark and lde nti fication number of Notified 
Body 
UV BLOCKIN G 
UV Blocking 
e) 
Fee Paid for Waste Management 
 I 
Oriy I 
CAUTION: US Federal law restricts this device to 
sale by or on the order of a licensed practitioner 
Lens Orientation Correct 
X 
Lens Orientation lnco rrect 
(Lens lnside Out) 
I EC j R EP I 
Authorized Representative in the European 
Community 
Contains Hazardous Substances 
® 
Do Not Re -Use (Single 
Use) 
Do Not Use if Package is Damaged 
Medical Device Symbol 
.. / 
Package Opening lcon (Blister) 
G 
Package Opening lcon (Carton) 
L 
"Low" near ADD 
M 
"Medium" near ADD 
H 
"High" near ADD 
MAXADD 
Near ADD 

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LOW 
"Low" near ADD 
MID 
"Medium" near ADD 
HGH 
"High" near ADD 
Visit www.acuvue.com/guides for additional information about symbols. 
 
 
 
 
 
 
 
  
DESCRIPTION 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses are soft (hydrophilic) contact lenses available as spherical 
and multifocal lenses. 
 
These lenses are made of a silicone hydrogel material (senofilcon A) containing an internal wetting agent 
and are tinted using Reactive Blue Dye #247 to make lenses more visible for handling. 
 
A benzotriazole ultraviolet (UV) absorbing monomer is used to block UV radiation (280 nm - 380 nm) in 
combination with a novel fused tricyclic chromophore that also blocks UV radiation and partially filters 
high energy visible radiation (HEV)* in the range of 380 nm to 450 nm. The light transmittance 
characteristics for these lenses are less than 1% in the UVB range of 280 nm to 315 nm and 10% in the 
UVA range of 315 nm to 380 nm. The thinnest lenses transmit ೦ 45% of the radiation in the range from 
380 nm to 450 nm. Please see HEV filtering NOTE in the ACTIONS section below. 
 
Lens Properties: 
The physical/optical properties of the lens are: 
 
• 
Specific Gravity (calculated): 
0.98 - 1.12 
• 
Refractive Index: 
1.42 
• 
Visible Light Transmittance: 
;?78% 
• 
HEV Light Transmittance*: 
೦ 45% 
• 
Surface Character: 
Hydrophilic 
• 
Water Content: 
38% 
• 
Oxygen Permeability (Dk): 
VALUE 
METHOD 
103 x 10-11 (cm2/sec) 
(ml O2/mL x mm Hg) @ 35°C 
Fatt (boundary corrected, edge 
corrected) 
 
Lens Parameter Ranges: 
• 
Diameter (DIA): 
12.0 mm to 15.0 mm 
• 
Center Thickness: 
varies with power 

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• 
Base Curve (BC): 
7.85 mm to 10.00 mm 
• 
Spherical Power (D): 
-20.00D to +20.00D 
• 
Multifocal ADD Power: 
+0.25D to +4.00D 
Each lens is supplied in a foil-sealed plastic package containing borate buffered saline solution with 
methyl ether cellulose. 
 
 
 
 
 
 
 
  
AVAILABLE LENS PARAMETERS 
 
 
The ACUVUE® OASYS MAX 1-Day Contact Lenses (senofilcon A) are hemispherical shells of the 
following dimensions: 
Diameter (DIA): 
14.3 mm 
Center Thickness: 
0.085 mm to 0.221 mm (varies with power) 
Base Curve (BC): 
8.5 mm, 9.0 mm 
Powers (D): 
-12.00D to +8.00D 
 
 
The ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses (senofilcon A) are hemispherical 
shells of the following dimensions: 
Diameter (DIA): 
14.3 mm 
Center Thickness: 
0.070 mm to 0.191 mm (varies with power) 
Base Curve (BC): 
8.4 mm 
Powers (D): 
-9.00D to +6.00D 
ADD Powers (D): 
+1.25D (LOW), +1.75D (MID), +2.50D (HGH) 
 
 
  
TRANSMITTANCE CURVE 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses (senofilcon A) vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 

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V)
Johnson & Johnson Vision Care, Ine. 
 
 
 
 
100 
 
90 
 
80 
uv 
--------...  , ,---------- 
 
z 
70 
o 
vi 
V) 
ε 
z 
so 
o:: 
I- 
40 
 
30 
 
20 
 
10 
 
o 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
200 
300 
 
 
 
 
 
 
 
 
I 
I 
I 
I 
I 
I 
 
 
 
 
 
 
 
 
400 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
500 
WAVELENGTH 
(NANOMETERS) 
 
 
 
- 
24 Yr Old Human Cornea1 
 
- 
- - 25 Yr Old Crystalline Lens2 
 
----•-0.500 ACUVUE® OASYS MAX 1- 
Day3 
- 
Crystalline lens with -0.50D 
ACUVUE® OASYS MAX 1-Day 3 
 
 
 
600 
700 
800 
 
1 Le r man, S., Rad ia nt Energy and the Eye , MacMillan, Ne w York, 1980, p. 58, figure 2-21 
2Waxler, M. Hitchins, V.M., Optica l Radiation and Vis ua l Health, CRC Press, Boca Raton, Flo r ida, 1986, p. 19, figure 
s 
3The  data  wasobtained from  measurements taken through  the  centra I 6  mm  portion  for  the  thinne st  sing le   vision 
le ns (-0.500 lens, 0.085mm center thickness ). 
 
ACTIONS 
 
ln its hydrated state, the contact lens, when placed on the cornea, acts as a refracting medium to focus 
light rays on the retina. 
 
These len ses cont ain UV and HEV* light absorbing monomers to help protect against transmission of 
harmful UV radiation to the cornea and into the eye and reduce transmittance of HEV* light. The light 
transmittance characteristics for these lenses are less than 1% in the UVB range of 280 nm to 315 nm 
and less than 10% in the UVA range of 315 nm to 380 nm for the entire power range. The thinnest 
lenses transmit $ 45% of the radiation across the high energy visible* light wavelength in the range from 
380 nm to 450 nm. The visible light transmittance in the range from 380 nm to 780 nm is greater than or 
equal to 78% depending on the lens thickness. 
 
WARNING: UV absorbing contact lenses are NOT substitutes for protective UV absorbing eyewear, 
such as UV absorbing goggles or sunglasses because they do not completely cover the eye and 
surrounding area. You should continue to use UV absorbing eyewear as directed. 
 
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, 
 
60 

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cloud cover) and personal factors (extent and nature of outdoor activities). UV Blocking contact 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. 
 
*NOTE: Filtering of HEV light by contact lenses has not been demonstrated to confer any health 
benefit to the user, including but not limited to retinal protection, protection from cataract 
progression, reduced eye strain, improved contrast, improved acuity, reduced glare, improved low 
light vision, or improved circadian rhythm/sleep cycle. The Eye Care Professional should be consulted 
for more information. 
 
  
INDICATIONS (USES) 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses (senofilcon A) are indicated for daily disposable wear for the 
correction of vision in people with non-diseased eyes who are nearsighted (myopic) or farsighted 
(hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity. 
ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily 
disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and 
may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that 
does not interfere with visual acuity. 
The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is 
required. Lenses should be discarded upon removal. 
 
 
  
CONTRAINDICATIONS (REASONS NOT TO USE) 
 
DO NOT USE these lenses when any of the following conditions exist: 
 
• 
Acute or subacute inflammation or 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) 
• 
Corneal hypoesthesia (reduced corneal sensitivity) 
• 
Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses 
• 
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 or 
Thimerosal, etc.) to which some people may develop an allergic response 
• 
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by 
wearing contact lenses 
• 
Any active corneal infection (bacterial, fungal, protozoal, or viral) 
• 
If eyes become red or irritated 

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WARNINGS 
 
Patients should be advised of the following warnings pertaining to contact lens wear: 
 
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF 
VISION. IF THE PATIENT EXPERIENCES: 
 
• 
Eye Discomfort, 
• 
Excessive Tearing, 
• 
Vision Changes, 
• 
Loss of Vision, 
• 
Eye Redness, or 
• 
Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY 
CONTACT THE EYE CARE PROFESSIONAL. 
 
• 
Patients should be instructed not to wear their 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 extended wear contact lens 
users than for daily wear users.4 
• 
Studies have shown that contact lens wearers who are smokers have a higher incidence of 
adverse reactions than nonsmokers. 
• 
Problems with contact lenses or lens care products could result in serious injury to the eye. 
Patients should be cautioned that proper use and care of contact lenses and lens care 
products are essential for the safe use of these products. 
• 
The overall risk of ulcerative keratitis may be reduced by carefully following directions for 
lens care. 
4New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783 
 
Specific Instructions for Use and Warnings: 
• 
Water Activity 
lnstruction for Use 
Do not expose contact lenses to water while wearing them. 
WARNING: 
 
Water can harbor microorganisms that can lead to severe infection, vision loss, or 
blindness. If lenses have been submersed in water when participating in water sports or 
swimming in pools, hot tubs, lakes, or oceans, the patient should be instructed to discard 
them and replace them with a new pair. The Eye Care Professional should be consulted for 
recommendations regarding wearing lenses during any activity involving water. 

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PRECAUTIONS 
 
 
Special Precautions for Eye Care Professionals: 
• 
Due to the small number of patients enrolled in clinical investigation of lenses, all refractive 
powers, design configurations, or lens parameters available in the lens material are not 
evaluated in significant numbers. Consequently, when selecting an appropriate lens design 
and parameters, the Eye Care 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. 
The potential impact of these factors on the patient's ocular health should be carefully 
weighed against the patient's need for refractive correction; therefore, the continuing 
ocular health of the patient and lens performance on the eye should be carefully monitored 
by the prescribing Eye Care Professional. 
• 
Patients who wear these lenses to correct presbyopia using monovision or multifocal 
correction may not achieve the best corrected visual acuity for either far or near vision. 
Visual requirements vary with the individual and should be considered when selecting the 
most appropriate type of lens for each patient. 
• 
Fluorescein, a yellow dye, should not be used while the lenses are on the eyes unless 
otherwise indicated. The lenses absorb this dye and become discolored. Whenever 
fluorescein is used in eyes, the eyes should be flushed with a sterile saline solution that is 
recommended for in-eye use. 
• 
Eye Care Professionals should instruct the patient to remove lenses immediately if the eyes 
become red or irritated. 
Eye Care Professionals should carefully instruct patients about the following care regimen 
and safety precautions: 
 
Handling Precautions: 
• 
Before leaving the Eye Care Professional's office, the patient should be able to promptly 
remove lenses or should have someone else available who can remove the lenses for him or 
her. 
• 
DO NOT use if the sterile blister package is opened or damaged. 
• 
Always wash, rinse, and dry hands before handling lenses. It is best to put on lenses before 
putting on makeup. 
• 
DO NOT touch contact lenses with fingers or hands if the hands are not free of foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
• 
Carefully follow the handling, insertion, removal, and wearing instructions in the "Patient 
Instruction Guide" for ACUVUE® OASYS MAX 1-Day Contact Lenses and those prescribed by 
the Eye Care Professional. 
• 
Always handle lenses carefully and avoid dropping them. 

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• 
Never use tweezers or other tools to remove lenses from the lens container. Slide the lens 
up the side of the bowl until it is free of the container. 
 
Lens Wearing Precautions: 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions in "Care for 
a Sticking (Non-Moving) Lens". The lens should move freely on the eye for the continued 
health of the eye. If non-movement of the lens continues, the patient should be instructed 
to immediately consult his or her Eye Care Professional. 
• 
Never wear lenses beyond the period recommended by the Eye Care Professional. 
• 
The patient should be advised to never allow anyone else to wear their lenses. Sharing 
lenses greatly increases the chance of eye infections. 
• 
If aerosol products, such as hair spray, are used while wearing lenses, exercise caution and 
keep eyes closed until the spray has settled. 
• 
Avoid all harmful or irritating vapors and fumes while wearing lenses. 
• 
Ask the Eye Care Professional about wearing lenses during sporting activities. 
• 
The patient should be advised to never rinse the lenses in water from the tap. Tap water 
contains many impurities that can contaminate or damage the lenses and may lead to eye 
infection or injury. 
 
Lens Care Precautions: 
• 
The patient should be informed that no cleaning or disinfection is needed when lenses are 
worn for daily disposable wear. Patients should always dispose of lenses when removed and 
have spare lenses or spectacles available. 
 
Other Topics to Discuss with Patients: 
• 
Always contact the Eye Care Professional before using any medicine in the eyes. 
• 
Certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, 
tranquilizers, and those for motion sickness may cause dryness of the eye, increased lens 
awareness, or blurred vision. Should such conditions exist, proper remedial measures should 
be prescribed. Depending on the severity, this could include the use of lubricating drops that 
are indicated for use with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• 
Oral contraceptive users could develop visual changes or changes in lens tolerance when 
using contact lenses. Patients should be cautioned accordingly. 
• 
Do not change lens type (e.g. brand name, etc.) or parameters (e.g. diameter, base curve, 
lens power, etc.) without consulting the Eye Care Professional. 
• 
Instruct patients to always confirm the lens parameters printed on the multi-pack and on 
the individual lens package match their prescription. If there is a mismatch the patient 
should not use the product. 

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• 
As with any contact lens, follow-up visits are necessary to assure the continuing health of 
the patient's eyes. The patient should be instructed as to a recommended follow-up 
schedule. 
 
Who Should Know That the Patient is Wearing Contact Lenses? 
• 
Patients should inform all doctors (Health Care Professionals) about being a contact lens 
wearer. 
• 
Patients should always inform their employer of being a contact lens wearer. Some jobs may 
require use of eye protection equipment or may require that the patient not wear contact 
lenses. 
  
ADVERSE REACTIONS 
 
The patient should be informed that the following problems may occur when wearing contact lenses: 
 
• 
The eye may burn, sting and/or itch. 
• 
There may be less comfort than when the lens was first placed on the eye. 
• 
There may be a feeling of something in the eye (foreign body, scratched area). 
• 
There may be the potential for some temporary impairment due to peripheral infiltrates, 
peripheral corneal ulcers, or corneal erosion. There may be the potential for other 
physiological observations, such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjunctivitis; some of which are 
clinically acceptable in low amounts. 
• 
There may be excessive watering, unusual eye secretions or redness of the eye. 
• 
Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or dry 
eyes may also occur if the lenses are worn continuously or for too long a time. 
The patient should be instructed to conduct a simple 3-part self-examination at least once a day. They 
should ask themselves: 
 
• 
How do the lenses feel on my eyes? 
• 
How do my eyes look? 
• 
Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to IMMEDIATELY REMOVE THE LENS. 
If the problem or discomfort stops, the patient should discard the lens and place a new fresh lens on the 
eye. 
 
If after inserting the new lens, the problem continues, the patient should be directed to IMMEDIATELY 
REMOVE THE LENS AND CONTACT HIS OR HER EYE CARE PROFESSIONAL. 
 
The patient should be advised that when any of the above symptoms occur, a serious condition such as 
infection, corneal ulcer, neovascularization, or iritis may be present. He or she should be instructed to 

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

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Example 2: 
 
For the Spherical or Multifocal ACUVUE® OASYS MAX 1-Day Contact Lenses, the initial lens should be 
selected from the currently available base curves. 
 
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 Properly Fit Lens 
 
A properly fit lens will center and completely cover the cornea (i.e., no limbal exposure), have 
sufficient movement to provide tear exchange under the contact lens with 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 characteristics: decentration, 
incomplete corneal coverage (i.e., limbal exposure), excessive movement with the blink, and/or 
edge standoff. If 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 characteristics: insufficient 
movement with the blink, conjunctival indentation, and resistance when pushing the lens up 
digitally with the lower lid. If the lens is judged to be steep fitting, it should not be dispensed to 
the patient. 
 
If the initial 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 lower lid, and then return to a properly centered position when released. If 
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 
 
A spherical over-refraction should be performed to determine the final lens power after the lens fit is 
judged acceptable. The spherical over-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 unless there is excessive residual astigmatism. 
 
Example 1: 
Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
-0.25D 
Final lens power: 
-2.25D 
 

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Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
+0.25D 
Final lens power: 
-1.75D 
If vision is acceptable, perform a slit lamp examination to assess adequate fit (centration and 
movement). If fit is acceptable, dispense the lenses instructing the patient to return in one week for 
reassessment (see dispensing and follow up information in PATIENT MANAGEMENT). 
 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download from www.acuvue.com. 
 
  
MULTIFOCAL FITTING GUIDELINES 
 
 
A. Presbyopic Needs Assessment & Patient Education 
Multifocal contact lenses may produce compromise to vision under certain circumstances and the 
patient should understand that they might not find their vision acceptable in specific situations (i.e., 
reading a menu in a dim restaurant, driving at night in rainy/foggy conditions, etc.). 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 visually challenging environments. Occupational and 
environmental visual demands should be considered. If the patient requires critical visual acuity and 
stereopsis, it should be determined by trial whether this patient can function adequately with the 
ACUVUE® OASYS MAX 1-Day Multifocal Contact Lenses. Wear may not be optimal for such activities 
as: 
1. Visually demanding situations such as operating potentially dangerous machinery or performing 
other potentially hazardous activities; and 
2. Driving automobiles (e.g., driving at night). Patients who cannot pass their state driver's license 
requirements with these lenses should be advised to not drive with this correction, OR may 
require that additional over-correction be prescribed. 
These lenses are not recommended for patients who have -1.00D or greater of refractive cylinder as 
this level of uncorrected cylinder may lead to additional visual compromise. 
These lenses are available in the following ADD powers: 
• 
Lens "LOW" ="low" near ADD lens (Max +1.25 ADD) 
• 
Lens "MID" = "medium" near ADD lens (Max +1.75 ADD) 
• 
Lens "HGH" = "high" near ADD lens (Max +2.50 ADD) 
 
B. Initial Power Determination 
A spectacle refraction should be performed to establish the patient's baseline refractive status and 
to guide in the selection of the appropriate lens power. Remember to compensate for vertex 
distance if the refraction is ;? ±4.00D. Determine the spherical equivalent distance prescription for a 
multifocal patient. Determine the eye dominance using one of the methods below: 
Method 1: Determine which eye is the "sighting eye." Have the patient point to an object at the 
far end of the room. Cover one eye. If the patient is still pointing directly at the object, the eye 
being used is the dominant (sighting) eye. 

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Method 2 (preferred): Determine which eye will accept the added power with the least 
reduction in vision while both eyes are open. Place a hand-held trial lens equal to +1.00D 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 +1.00D lens over the right or 
left eye, which is the non-dominant eye. 
 
C. Select the Initial Trial Lens 
1. 
For each eye, select the trial lens distance power that is closest to the patient's distance 
spherical equivalent. Remember to compensate for vertex distance if the refraction is ;? ±4.00D. 
2. 
Select the near power of the lens based on the patients ADD range as follows: 
• 
ADD: +0.75 to +1.25 use a "LOW" near ADD lens on each eye 
• 
ADD: +1.50 to +1.75 use a "MID" near ADD lens on each eye 
• 
ADD: +2.00 to +2.50 use a "MID" near ADD on the dominant eye and a "HGH" near ADD 
lens on the non-dominant eye 
3. 
Allow the lenses to settle for a minimum 10 minutes. 
4. 
Assess distance and near vision binocularly and monocularly. 
5. 
Demonstrate the vision under various lighting conditions (normal and decreased illumination) 
and at distance, intermediate and near. 
6. 
Make adjustments in power as necessary based on the distance over-refraction. The use of 
hand held trial lenses is recommended. Check the impact on distance and near vision. 
7. 
If vision is still unacceptable, make adjustments in power as necessary (see "Multifocal 
Troubleshooting" below). If distance and near vision are acceptable, perform a slit lamp 
examination to assess adequate fit (centration and movement). If fit is acceptable, dispense the 
lenses instructing the patient to return in one week for reassessment (see PATIENT 
MANAGEMENT section). 
D. Multifocal Troubleshooting 
Unacceptable Near Vision: 
If it has been determined that no change is required based on the over-refraction then add +0.25 D 
to the spherical power of the non-dominant eye. 
 
Unacceptable Distance Vision: 
If it has been determined that no change is required based on the over-refraction then make the 
changes as listed below: 
• 
If the patient is wearing two "LOW" ADD lenses, change the dominant eye to an 
ACUVUE® OASYS MAX 1-Day Contact Lens sphere lens with a power equal to the spherical 
equivalent distance prescription. 
• 
If the patient is wearing two "MID" ADD lenses, change the ADD power in the dominant eye 
to the "LOW" ADD power. 

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• 
If the patient is wearing a "MID" ADD lens in the dominant eye and a "HGH" ADD lens in the 
non-dominant eye, change the non-dominant eye to a "MID" ADD lens and add +0.25D to 
the distance power. 
 
Once the changes have been made for the troubleshooting repeat steps 3-6 in section C above 
("Select the Initial Trial Lens") to assess if the vision is acceptable. 
 
E. Adaptation 
Visually demanding situations should be avoided during the initial wearing period. A patient may at 
first experience some mild blurred vision, dizziness, headaches and a feeling of slight imbalance. You 
should explain the adaptational symptoms to the patient. These symptoms may last for a brief 
minute or for several weeks. The longer these symptoms persist, the poorer the prognosis for 
successful adaptation. 
To help in the adaptation process, the patient can be advised to first use the lenses in a comfortable 
familiar environment such as in the home. 
Some patients feel that automobile driving performance may not be optimal during the adaptation 
process. This is particularly true when driving at night. Before driving a motor vehicle, it may be 
recommended that the patient be a passenger first to make sure that their vision is satisfactory for 
operating an automobile. During the first several weeks of wear (when adaptation is occurring), it 
may be advisable for the patient to only drive during optimal driving conditions. After adaptation 
and success with these activities, the patient should be able to drive under other conditions with 
caution. 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download from www.acuvue.com. 
 
  
MONOVISION FITTING GUIDELINES 
 
 
A. Patient Selection 
Monovision Needs Assessment 
For a good prognosis the patient should have adequately corrected distance and near visual acuity in 
each eye. The amblyopic patient with significant amounts of uncorrected astigmatism (greater than 
1.00D) in one eye may not be a good candidate for monovision correction with these lenses. 
 
Occupational and environmental visual demands should be considered. If the patient requires critical 
vision (visual acuity and stereopsis), it should be determined by trial whether this patient can function 
adequately with monovision correction. Monovision contact lens wear may not be optimal for activities 
such as: 
 
(1) visually demanding situations such as operating potentially dangerous machinery or 
performing other potentially hazardous activities; and 

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(2) driving automobiles (e.g., driving at night). Patients who cannot pass their state driver's 
license requirements with monovision correction should be advised to not drive with this 
correction, OR may require that additional over-correction be prescribed. 
 
Patient Education 
 
All patients do not function equally well with monovision correction. 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. 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. 
 
B. Eye Selection 
 
Generally, the non-dominant eye is corrected for near vision. The following two methods for eye 
dominance can be used. 
 
1. Ocular Preference Determination Methods 
 
Method 1: 
Determine which eye is the "sighting eye." Have the patient point to an object at 
the far end of the room. Cover one eye. If the patient is still pointing directly at 
the object, the eye being used is the dominant (sighting) eye. 
 
Method 2: 
Determine which eye will accept the added power with the least reduction in 
vision. Place a hand-held trial lens equal to the spectacle near ADD in front of 
one eye and then the other while the distance refractive error correction is in 
place for both eyes. Determine whether the patient functions best with the near 
ADD lens over the right or left eye 
 
Other methods include the "Refractive Error Method" and the "Visual Demands Method." 
 
2. Refractive Error Method 
 
For anisometropic correction, it is generally best to fit the more hyperopic (less myopic) eye for 
distance and the more myopic (less hyperopic) eye for near. 
 
3. Visual Demands Method 
 
Consider the patient's occupation during the eye selection process to determine the critical 
vision requirements. If a patient's gaze for near tasks is usually in one direction, correct the eye 
on that side for near. 
 
Example: 

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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 Requirement 
 
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 both eyes. 
 
Example: 
 
A presbyopic emmetropic patient who requires a +1.75D ADD would have a +1.75D lens on the 
near eye and the other eye left without correction. 
 
A presbyopic patient requiring a +1.50D ADD who is -2.50D myopic in the right eye and -1.50D 
myopic in the left eye may have the right eye corrected for distance and the left uncorrected for 
near. 
 
2. Near ADD Determination 
 
Always prescribe the lens power for the near eye that provides optimal near acuity at the 
midpoint of the patient's habitual reading distance. However, when more than one power 
provides optimal reading performance, prescribe the least plus (most minus) of the powers. 
 
3. Trial Lens Fitting 
 
A trial fitting is performed in the office to allow the patient to experience monovision correction. 
Lenses are fit according to the "General Fitting Guidelines" for base curve selection described in 
this guide. 
 
Case history and standard clinical evaluation procedure should be used to determine the 
prognosis. Determine the distance correction and the near correction. Next determine the near 
ADD. With trial lenses of the proper power in place, observe the reaction to this mode of 
correction. 
 
Allow the lenses to settle for about 20 minutes with the correct power lenses in place. Walk 
across the room and have the patient look at you. Assess the patient's reaction to distance 
vision under these circumstances. Then have the patient look at familiar near objects such as a 
watch face or fingernails. Again assess the reaction. As the patient continues to look around the 
room at both near and distance objects, observe the reactions. Only after these vision tests are 
completed should the patient be asked to read print. Evaluate the patient's reaction to large 
print (e.g., typewritten copy) at first and then graduate to news print and finally smaller type 
sizes. 

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After the patient's performance under the above conditions is completed, tests of visual acuity 
and reading ability under conditions of moderately dim illumination should be attempted. 
 
An initial unfavorable response in the office, while indicative of a guarded prognosis, should not 
immediately rule out a more extensive trial under the usual conditions in which a patient 
functions. 
 
4. Adaptation 
 
Visually demanding situations should be avoided during the initial wearing period. A patient may 
at first experience some mild blurred vision, dizziness, headaches and a feeling of slight 
imbalance. You should explain the adaptation symptoms to the patient. These symptoms may 
last for a brief minute or for several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation. 
 
To help in the adaptation process, the patient can be advised to first use the lenses in a 
comfortable familiar environment such as in the home. 
 
Some patients feel that automobile driving performance may not be optimal during the 
adaptation process. This is particularly true when driving at night. Before driving a motor 
vehicle, it may be recommended that the patient be a passenger first to make sure that their 
vision is satisfactory for operating an automobile. During the first several weeks of wear (when 
adaptation is occurring), it may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the patient should be able to 
drive under other conditions with caution. 
 
S. Other Suggestions 
 
The success of the monovision technique may be further improved by having your patient follow 
the suggestions below: 
◼ 
Have a third contact lens (distance power) to use when critical distance viewing is needed. 
◼ 
Have a third contact lens (near power) to use when critical near viewing is needed. 
◼ 
Having supplemental spectacles to wear over the monovision contact lenses for specific 
visual tasks may improve the success of monovision correction. This is particularly applicable 
for those patients who cannot meet their state driver's license requirements with a 
monovision correction. 
◼ 
Make use of proper illumination when carrying out visual tasks. 
Monovision fitting success can be improved with 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 for 
presbyopic patients. 

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◼ 
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. 
 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download from www.acuvue.com. 
 
  
PATIENT MANAGEMENT 
 
 
• 
Follow the accepted standard of care in fitting and following up with your patient. 
• 
Schedule the appropriate follow-up examination. 
• 
Preferably, at the follow-up visits, lenses should have been worn for at least six hours. 
• 
Provide the patient with a copy of the PATIENT INSTRUCTION GUIDE for these lenses, which 
can be found at www.acuvue.com. REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT 
HE OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING AND REPLACEMENT 
SCHEDULE (DAILY DISPOSABLE). 
 
  
WEARING SCHEDULE 
 
 
The wearing schedule should be determined by the Eye Care Professional. Regular checkups, as 
determined by the Eye Care Professional, are also extremely important. 
 
Patients tend to over wear the lenses initially. The Eye Care Professional should emphasize the 
importance of adhering to the initial maximum wearing schedule. Maximum wearing time should be 
determined by the Eye Care Professional based upon the patient's physiological eye condition, because 
individual response to contact lenses varies. 
 
The maximum suggested wearing time for these lenses is: 
 
Day 
Hours 
 
1 
6-8 
 
2 
8-10 
 
3 
10-12 
 
4 
12-14 
 
5 and after 
all waking hours 
 
 
 
  
REPLACEMENT SCHEDULE 
 
 
These lenses are indicated for daily disposable wear and should be discarded upon removal. 

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LENS CARE DIRECTIONS 
 
 
When lenses are dispensed, the Eye Care Professional should provide the patient with appropriate and 
adequate warnings and instructions for daily disposable lens wear. 
 
The Eye Care Professional should review with patients that no cleaning or disinfection is needed with 
disposable lenses. Patients should always dispose of lenses when they are removed and have spare 
lenses or spectacles available. 
 
Basic Instructions: 
• 
Always wash, rinse, and dry hands before handling contact lenses. 
• 
Do not use saliva or anything other than the recommended solutions for lubricating or rewetting 
lenses. Do not put lenses in the mouth. 
• 
Eye Care Professionals may recommend a lubricating/rewetting solution which can be used to 
wet (lubricate) lenses while they are being worn to make them more comfortable. 
 
Care for a Sticking (Non-Moving) Lens 
During removal, if the lens sticks to the eye, the patient should be instructed to apply a few drops of the 
recommended lubricating or rewetting solution directly to the eye and wait until the lens begins to 
move freely on the eye before removing it. If non-movement of the lens continues after a few minutes, 
the patient should immediately consult the Eye Care Professional. 
 
 
 
 
 
 
 
  
EMERGENCIES 
 
 
The patient should be informed that if chemicals of any kind (household products, gardening solutions, 
laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY 
WITH TAP WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A HOSPITAL 
EMERGENCY ROOM WITHOUT DELAY. 
 
  
REPORTING OF ADVERSE REACTIONS 
 
 
All serious adverse experiences and adverse reactions observed in patients wearing these lenses or 
experienced with the lenses should be reported to: 
 
Johnson & Johnson Vision Care, Inc. 
7500 Centurion Parkway 
Jacksonville, FL 32256 
USA 

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Tel: 1-800-843-2020 
www.acuvue.com 
 
Revision Date: 02/2022 
Revision Number: AO-01-22-03 

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Qg ys 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ACUVUE8 
H;draluxe™ 
ACUWE OASYS• Brand Contact lenses1-Day 
wltllHydraLuxeTM Technology 
ACUWE OASYS• Brand Contact lenses1-Day 
wlthHydraluxe"' Teclinology for ASTIGMATISM 
senofilcon A Soft (hydrophilic) Contact Lenses 
Visibility Tinted withUV Blocker 
for Daily Disposable Wear 
rii':n.i:7 CAUTION: U.S. Feđerallawrestricts this device to 
sale by or on the order of a licensed practitioner. 
IMPORTANT:  Please read carefully and keep this 
lnformatlon flN' future use. 
This Package Insert andFrtting Guide isintended for the 
Eye Care Professlonal, but should be made available to 
patlents upon request. 
The EyeCare Professional should provide the patient 
wittl the appropriate instructions thatpertain tothe 
patient's prescribed lenses. Copies are available for 
download at www.acuvu.ecom. 

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SYMBOLS KEY 
 
The following symbols may appear on the label or carton: 
 
SYMBOL 
DEFINITION 
lliJ 
Consult lnstructions for Use 
Manufactured by or in 
d 
Date of Manufacture 
Use By Date (expiration date) 
I LOTI Batch Code 
ISTERILEIiI 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 
I!) 
UV Blockin9 
UV-Blocking 
(e) 
Fee Paid for Waste Management 
i lJt0nly I 
CAUTION: U.S. Federa! law restricts this device 
to sale by or on the order of a licensed practitioner 
'lW e 
Lens Orientation Correct 
'qD7 
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 ASTIGMATIMS are soft (hydrophilic) 
contact lenses made with HydraluxeTM TechnologyT. hey are available as 
spherical or toric lensesrespective.ly 
These lenses are made of a siliconehydrogel material containingan interna! 
wetting agent, visibility tint, and UV absorbingmonomer and are tinted blue 
using Reactive Blue Dye #4 to make the lensesmore visiblefor handling. 
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lensesare lessthan 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range. 
lens Properties: 
The physical/optical properties of the lens are: 
• 
Specific Gravity (calculated): 
0.98  - 1.12 
• 
Refractivelndex: 
• 
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: 
• 
Diameter 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 
-20.00D to +20.00D 
-0.25D to -10.00D 
2.5° to 180° 

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AVAILABLE LENS PARAMETERS 
 
ACUVUE OASYS® Brand 1-Day 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 
-0.50D to -6.00D (in 0.25D increments) 
-6.50D to -12.00D (in 0.50D increments) 
+0.50D to +6.00D (in 0.25D increments) 
+6.50D to +8.00D (in 0.50D increments) 
 
 
 
ACUVUE OASYS® Brand 1-Day with HydraluxeTM Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions: 
Diameter: 
14.3 mm 
Center Thickness: 
0.075 mm to 0.172 mm (varies with power) 
Base Curve: 
Powers: 
8.5 mm 
+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 
*-2.25Dcylinder 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 (senofilcon A) 
Visibility Tint ed with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
 
 
100 
90 
z 
ACUVUE 0ASYS® 
1-Daywith 
Hydraluxe™ 
o 
80 
či5 
CI) 
70 
Technology 
(senofilconA)* 
CI) 
60 
50 
24 YR. OLD HUMAN 
I- 
40 
30 
20 
10 
0 
 
 
 
 
 
200 
 
 
 
 
 
300 400 500 600 
WAVELENGTH 
(NANOMETERS) 
 
 
 
 
 
700 800 
CORNEA1 
25 YR. OLD HUMAN 
CRYSTALLINE LENS
2 
 
 
* The data was obtained from measurements taken through the centra! 3-5 mm portion for 
thethinnest marketed lens(-9.00D lens, 0.075mm center thickness). 
1Lerman,S., Radiant Energyand the Eye, MacMillan, New York, 1980, p. 58, figure 2-21 
2Waxler; M ., Hi tchins, V.M ., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, figure5 
 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
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 lenses are less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire power range. 
- 
_J_I 
---·····----... 
,,. ... . ...... .. . 
- - - --
r 
r 
I 
I 
I 
r 
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-Blocking contact 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 HydraluxeTM 
Technology are indicated tor daily disposablewear tor the optical 
correction ot retracitveametropia (myopia and hyperopia)in phakic or 
aphakic persons with non-diseasedeyes who may have 1.00D or less ot 
astigmatism. 
 
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraluxeT M   Tech- 
nology tor ASTIGMATISMare indicated tor daily disposable wear tor the 
optical correction ot refractive ametropia (myopia and hyperopia)in phakic 
or aphakic persons with non-diseasedeyes who may have 0.50Dto 3.00D 
ot astigmatism. 
These lenses contain a UV Blocker to help protect againsttransmission ot 
harmtul UV radiationto 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 subacuteintlammationor intection ot the anterior chamber 
ot the eye. 
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids. 
• Severe insufficiencyot 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 wearingcontact lenses or use of contact lens 
solutions. 
• Ocular irritationdue to allergic reactions which may be caused by 
use of contact lenssolutions (i.e., rewetitng drops) that contain 
chemicalsor preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response. 
• Any active corneal infection (bacterial, fungal, protozoal, or viral). 
• 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 
RAPIDLV 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 ulcerativekeratitis is greater for 

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extended wear contact lens users than for daily wear users3. 
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers. 
• Problemswith contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products. 
• The overall risk of ulcerativekeratitismay be reduced by carefully 
following directions for lens care. 
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783 
 
Specific lnstructions 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 lossor blindness. lf lenses have been submersedin water 
when participatingin water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient shouldbe 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- 
tionof lenses, ali refractive powers, design configuration, sor lens 
parameters available in the lens material are not evaluated in signif- 
icant numbers. Consequenlyt, 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, includingoxygen permeability,wettability, centra! and 
peripheral thickness, and optic zone diameter. 

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Johnson & Johnson Vision Care, Ine. 
 
Other Topics to Discuss with Patients: 
• Always contact the Eye Care Professional before using any medi- 
cine in the eyes. 
• Certain medication,ssuch as antihistamine,sdecongestants, 
diuretics, muscle relaxants, tranquilizer,sand those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurredvision. Should such conditions exist, proper remedial 
measures should be prescribed.Depending on the severity,this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lenswear 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 contactlens, follow-up visits are necessary to assure 
the continuing health of the patient'seyes. The patient should be 
instructedas to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses? 
• Patients should inform all doctors (Health Care Professionals)about 
being a contact lens wearer. 
• Patients should alwaysinformtheiremployerof 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 bum, sting,and/or itch. 
• There may be lesscomfort than when the lens was first placed on 
the eye. 
• There may be a feeling of something in the eye (foreign body, 
scratched area). 
• There may be the potential for some temporary impairment due to 
 

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GENERAL FITTING GUIDELINES 
 
A. Patient Selection 
Patients selectedto wear these lenses should be chosen based on: 
• Motivation to wearlenses 
• Ability to tollow instructions regarding lens wear care 
• General health 
• Abiilty to adequately handle andcare for thelenses 
• Ability to understand therisk and benefits of lens wear 
Pa tients who do not meet the above crtteria shouldnot beprovidedwith 
oontact lenses. 
B. Pre-fitting Examination 
lnitial evaluation of thepatientshould begin wlth a thorough casehistory 
to determinelf lhere are anycontraindications to oontactlenswear. Durlng 
the casehistory,thepatient'svisual needs andexpectationsshould be 
determinedas well as anassessment of their overall ocular,physical, and 
mental health. 
Preoedng theinltial selection of trialoontact lenses, a comprehensive 
ooular evaluation shouldbe performed that includes, but is not limltedto, 
lhemeasurement of distanoe andnear vlsual aculty, distanceandnear 
refractive prescription (includng determining thepreferred reacfng distanoe 
tor presbyopes,)keratometry,and biomicroscopic evaluation. 
Based on this evaluatlon, ff lt isdeterminedthat the patient1s eligible to 
wear these lenses, the Eye CareProfessional should prooeed to thelens 
fittinginstructions asoutlned below. 
C. lnltial Power Detennlnation 
Aspectacle refraction should be perlormed to establish thepatient's 
baseline refractive status and to guidein the selection of theappropriate 
lens powe.r Remember to co m pensate for vertex distanoe  therefraction 
is greaterthan :t4.000. 
 
D. Base Curve Selection (Trial Lens Fitting) 
The following triallenses should be selected for patientsregardless of kera• 
tometryreadings. However.oorneal curvature measurements shouldbe 
performed to establish the patient'sbasellneocular status. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm 
• ACUVUE OASYS® 1-Day tor 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 Properly Fit Lens 
A properly fit lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufficient movement to provide tear exchange 
under the contact lens with 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: decentration, incomplete corneal coverage (i.e., limbal 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 initial trial 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 lens fit is judged acceptable. The spherical over-refraction 
should be combinedwith the trial lens power to determine the final lens 
prescription. The patient should experience good visual acuity with the 
correct lens power unless there is excessive residual astigmatism. 

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Example 1 
Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
-0.250 
Fina! lens power: 
-2.25D 
 
Example 2 
Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
+0.25D 
Final lens power: 
-1.750 
 
lf vision is acceptable, 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, 
repeatab ility, 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 trom the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o'clock (Fig. 1). Because of the lens' ballasting system, 
either mark can represent the vertical position - there is no "top" 
and "bottom" as ina prism-ballastedlens. 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: 
O.O. -3.00D I -1.00D x 90° 20/20 
O.S. -4.75D I -2 .00D x 90° 20/20 
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. lf the lens has 
not yet stabilized, recheck until stable. 
 
Right Eye 
The orientation mark on the right lens rotates left from the 6 
o'clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis. 
Here is the Rx Prescribed: 
O.O. -3.00D I -0.75D x 100° 
 
Left Eye 
The orientation mark on the left lens rotates right from the 6 
o'clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D I -1.75D 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 MANAGEMENT). 
 
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. 

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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 1.000) 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 
Ali patients do not function equally well with monovision correc- 
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the first 
time until they are familiar with the vision provided in visually chal- 
lenging environments (e.g., reading a menu ina dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the fitting 
process, it is necessary tor 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-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used. 
Method 1: Determine which eye is the "sighting eye." Havethe 
patientpoint to an object at the far end of the room. 
Cover one eye. lf the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting)eye. 
Method 2: Determine which eye will accept the added power with 
the leastreduction 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 
correcitonis 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 includethe "RefractiveError Method" and the 
"Visual Demands Method." 
Refractive Error Method 
For anisometropic correciton,it is generally best to fit the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperop ic) eye for near. 
 
Visual Demands Method 
Consider the patient's occupationduring 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 
Thereare circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateralmyope would require correcitve 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. 
• Reftne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients. 
• Emphasize the benefits of clearnear vision and straight ahead 
and upward gaze with monovision. 
The decision to fit a patient with monovision correction is most 
appropriatelyleft to the Eye Care Professional in conjunction with the 
patient after carefully consideirng the patient's needs. 
Ali patients should be supplied with a copy ot the PATIENT 
INSTRUCTION GUIDE tor these lenses. Copies are available tor 
download at www.acuvue.com. 
 
PATIENT MANAGEMENT 
Dispensing Visit 
Each sterile lensis supplied in a foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
from 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. 
• Previde the patient with a copy ot 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 speciftc 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. 
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear- 
ing schedule. Maximum wearing time should be determined by the Eye 
Care Professionlabased upon the patient's physiological eye 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 after 
all waking hours 
 
 
REPLACEMENTSCHEDULE 
These lenses are indicated for daily disposable wear and should be 
discarded upon removal. 
 
LENS CARE DIRECTIONS 
When lenses are prescribedfor daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposablelens 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. 
Bas ic lnstruct ions 
• Always wash, rinse, and dry hands before handling contact lenses. 
• Do not use saliva or anything other than the recommended solutions 
tor lubricating or rewetting lenses. Do not put lensesin the mouth. 
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens 
lf the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. lf non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional. 
 
EMERGENCIES 
 
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
 
HOW SUPPLIED 
 
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1 -Day:base curve, power, diameter, lot number, 
and expiration date 
• 
ACUVUE OASYS® 1 -Dayfor ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, lot number, and expiraitondate 

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REPORTING OF ADVERSE REACTIONS 
 
Ali serious adverse experiences and adversereactionsobserved in 
patients wearing theselenses or experiencedwith these lensesshould be 
reported to: 
 
 
Johnson& Johnson Vision Care, Ine. 
7500 CenturionParkway 
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/PROBLEMS 
• 
 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
• 
BIOMICROSCOPY SCALE 
• 
DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 

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APPENDIX E: 
GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1.0 
PURPOSE 
 
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Ine. (JJVCI) clinical studies during the COVID-19 
pandemic. 
 
2.0 
SCOPE 
 
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as 
appropriate. 
 
NOTE: Re-opening of sites outside of the US will be evaluated  on a  country by country basis subject 
to local health authority guidance. 
 
3.0 
DEFINITIONS 
 
American Academy of Optometry (AAO): The American Academy of Optometiy is an organization of 
optometrists based in Orlando, Florida. Its goal isto maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific joumal, gives credentials to optometi·ists through the fellowship 
process and publishes position statements. 
 
American Optometric Association (AOA): The American OptometI'ic Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors ofOptometry (O.D.), optometric professionals, and optometiy students. Doctor ofOptometry take 
a leading role in patient care with respect to eye and visi011care , as w ell as general health and well-being. 
As primary health care providers, Doctor of Optometiy have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association isa fe.deration of state, student, and anned forces optometi·ic 
associations. Through these affiliations, the AOA serves members consisting of optometi'ists, students of 
optometry, paraoptometi·icassistants and technicians. The AOA and its affiliates work to provide the public 
with quality visi011and eye care. 
Centers fo1· Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federa! agency, under the 
Department ofHealth and Human Services, and is headquartered in Atlanta, Georgia. 
COVID-19: CtuTent outbreak of respiratory disease caused by a nove! coronavirus. The virus has been 
named "S ARS-CoV-2" and the disease it causes has been named " Coronavirus Disease 2019" (COVID- 
19). 
Clinical Study: Volw1taiyresearch studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
ti·eatinenst. May also be calle.d clinical trials, studies, reseai·ch, ti·iasl, or protocols. 
Clinical Study Site: Location where a clinica l study is conducted, such as a doctor's office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator. 
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individua! 
responsible for the overall management of a clinical trial. 
 
 
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Monitor: An individua! designated to oversee the progress of a clinicaI 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 regulat01y requirements. 
 
Medical Safety Office1· (MSO): Physician who has prima1y accountability in their product po1tfolio for 
product health and safety, and who serves as an independent medica! voice for patient safety. 
 
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaiuation of medica! safety data arising from any source throughout the product life cycle. 
 
4.0 
GUIDANCE FOR STUDY DOCUMENTS 
 
In alignment with recent health authority guidance, JNCI is providing recommendations for study-related 
management in the event of dismption to the conduct of the clinical study. This guidance does not supersede 
any locaI or govemment requirements or the clinical judgement of the investigator to protect the health, safety 
and well-being of pa1ticipants and site staff. If , at any time, a pa1ticipant's safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol. 
 
During the COVID-19 pandemic, the additional risks listed below need to be considered for study pa1ticipants 
and study personnel: 
 
4. I 
AdditionaI Risks Related to the COVID-19 Pandemic: 
• 
The possible transmission of the Coronavims 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 heaith care professionals dw·ing the procedures and assessments (since the investigator 
must make the measw·ements close to the subject's face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the vims, even if they do not have symptoms. 
• 
Potential dismptions to the study may be necessa1y due to cun-ent or future pandemic-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, all assessments that can be conducted virtuaUy will be 
completed by the investigator  to detennine  the best course oftreatment 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 pa1ticipation ina study , he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution. 
 
To help minimize the above potential risks, JNCI recommend reviewing/complying with locaI, state, 
and govemmental guidance for COVID-19 risks. 
 
JNCI will provide the following studyspecific documents with language pe1taining to COVID-19 risks: 
 
4.1.1 
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 Infonned 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 pa1i, during the COVID·19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is pa1ticularly 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-tenn serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on ctment knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe ilh1ess from COVID-19 include 
older adults and people with underlying medica! conditions. 
 
During this study, all appropriate measures will be taken to minimize risks including the use of personalprotective 
equipment such as masks and gloves, as well as proper sanitization. This is in conf01mance to guidance from the 
CDC, local health deprut ments, 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. 
 
Ifyou ru·e found to have contrncted 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 and/or study staff. 
 
4.1.2 
COVID-19 Risk Control Checklist (Attaclunen-tB): 
 
Will include COVID-19 risk contrnl 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 Investigato(rs) Signature Page: 
 
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and govenunental guidance' s for COVID-19 risk mitigation. 
 
I have read the suggested guidanceprovided by JNCI pertaining to the COVID-19 risk mitigation, 
(COVID-19Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, govenunental 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 
GUIDANCE 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 exrunple 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: 
 
 

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Procedure 
Details 
Subject Repo1ted Ocular 
Symptoms 
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test article when applicable and feasible. 
Change ofMedical 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 a:verage wearing time (including number ofhow-s per day 
during weekdays and weekends, and number of days per week). 
Confinn compliance with the prescribed wear schedule. 
• 
Re.cord and discuss the lens wear compliance based on the 
subject's self-repo1t. For example, the subjects will be a.sked 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 mllllber of consecutive days the subject 
didn' t wear the study lenses, etc. 
 
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If during the telephone c.onsultation, a subject states he/she wishes to discontinue participating 
in the study, instruct the subject to stop wearing the study lenses and schedule the subject to retum to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should retum all wmsed lenses to the 
clinic at the la.st 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 DURINGPANDEMIC 
 
It is recognized that the Coronavims 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; 
trave! rest1·ictions/lin1ited access to public places, including Optometly 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 pe1fo1m ed to the extent possible remotely/vit1ually or delayed w1til such time that on-site 
visits can be resumed it1 order to continue pruticipant monitoring in a.ccordat1ce with the protocol where 
possible. At each contact, pru·ticipants will be it1terviewed to collect safety data. Key effica.cy endpoit1t 
assessments should be perfo1med if required ru1d as feasibl e . 
 
Modifica.tions to protocol-required assessments may be pennitted via COVID-19 Appendix after consultation 
with the prut icipant , itiv estigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol devia.tions. Inten uptions of test ruticle wear or discontinuations of 
study it1terventions and withdrawal from the study should be documented with the prefix "COVID-19- 
related" it1 the ca.se report f01m (CRF). 
 

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The sponsor will continue to monitor the conduct and progress ofthe clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance. 
 
If a patticipant 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 repo1ted "COVI D-19 ", "Asymptomatic 
COVID -19", or "S uspec ted COVID-19" adverse events within 24 hours of the notification. 
 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study repo1t. 
 
COVID -19 scr eening procedures that may be mandated by local healthcare systems do not need to be 
repo1ted as an amendment to the protocol even if đone during clinical study visits. 
 
6.1 
Monitoring Visits 
 
When on-site monitoring by the sponsor is not feasible, the sponsor's site monitor will contact the study 
site to schedule remote visits. 1n such cases, on-site monitoring visits will resume when feasible, with 
increased frequency to address the source data verification backlog. 
 
Even with staffing liniitations during this COVID-19 pandemic, aU routine operations related to clinical 
trials should be well-documentedand at·chived as part of standard process. When conditions permit, all 
pruties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently info1med. 
 
6.1.1 
Study Site Initiation: 
 
During the period that this Work Instmction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable. 
Study site training will be documented utilizing Site Initiation Repo1t 
 
per Study Site Initiation 
 
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow aU local, stat e, and 
govemmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site. 
 
6.1.2 
Interim Monitoring Visits (if applicable): 
 
During the period that this Work Instmction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot pe1fo rm remotely (e.g., source 
document verification, test a1ticle reconci liation, etc.). 
 
To ensur e data 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 govemmental policies for COVID-19 Risk 
Mitigation, including social distancing, weati·ng of PPE, etc. as applicable for the location of fue 
study site. 
 
 
 
 

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6.1.3 
Study Site Closure: 
 
During the period that this Work Instn1ction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perfonn remotely (e.g., sow·ce document verification, 
test article final reconciliation and retw1,1etc.). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title: 
   Document Ty  e: 
Guidelines for CO_VI_D_r-u_·s_1_9k    M
·t·tgi_at_i_o_n 
 

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Clinical Study Protocol 
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Document Ty e: 
-T-itl-e  ----------------------------- Guidelines for COVID-19Risk Mitigation 
   Document Number: 
 
  
Revision Number: 5  
 
 
XXXX xx, 2020 
At tachment A: Stud y Site Col'l'espondence 
 
 
 
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>> 
 
 
Dear <<Principal Investigator>> and Study Team, 
 
Coronavirns (COVID·19) has impacted several conununities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our conunitment continues to be the safety of 
patients, healthcare professionals, and to om conununities. 
 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Visi011Care 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 sta.tement indica ting the Principa.I Investigator agrees to conduct the study in compliance 
with all local, state, and govenunental 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 the Infonned consent document. 
 
COVID-19 Risk Control Checklist fot· Clinical Studies: 
 
• 
Will include COVID-19 risk control mea.sme s that are required to ensme the safety and health of subjects, 
site staff and monitors during the pandemic. 
 
We want to encourage the need for open lines of communication a.bout poten tial challenge s you ma y fore s ee as the 
result of the cun-ent COVID-19 situation . Therefore , we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers). 
 
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
 
 
Please file this letter in your site file study con-es pondence . 
 
 
 
 
 
 
 

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Document Ty e: 
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le  ------------------------------ Guidelines for COVID-19Risk Mitigation 
   Document Number: 
 
  
Revision Number: 5  
 
 
Attachment B: COVID-19 Risk Control Checklist 
 
 
 
Study Number 
Site Number 
Principal Investigator (PI) Name 
 
 
The followi.ng COVID -19 ri sk co .ntrol methods ru·e required to co.nduct John so.n & Joh.nso.n Vison Cru·e cli.nical 
studies . Plea se review the follo wi.ng requiremen ts a.nd I.nitial each requirement. 
 
PI Initials 
General Site Safetv PlannirnzMeasures 
Si1maize w ith i.n s ite de s cribin iz Ri s k Control methods 
Social Distanci.niz oractices throucrhout site (waiti.niz room s lobbv, exam rooms, etc.) 
Non-contact thermometer available to assess temoeratures of staff ru1d oa tient s 
Trai.niniz on oatient flow and ohvsical distanci.niz i.n waiti.niz room 
Establish lonizer time frame between oatient annointments to reduce oersons i.n the s ite 
Staff should receive job-specific traini.ng on PPE and demon strate compe tency with selec tion a.nd 
proper use of PPE ru1d w ea r at ali tirnes during i.nterac tion s with subjects (e.g., putting on and 
removing without self-contami.nation ) 
 
 
P I Initials 
Site Staff Dailv Safetv Measures 
As part of routine practic.e, si te staff should regularly monitor themselves for fever and symptoms 
of COVID-19 i.ncludi.ng temperature checks 
A.ny staff member (including 11011s- tudy clinic staff and Investigators) showi.ng s igns  ofbei.ng sick 
or testing positive for COVID-19 must not be pennitted to work on activity  that may  expose  study 
related staff ru1d subjec t and the Sponsor shall be i.nformed 
NOTE: Inform JJVC in 24 how·s of any COVID-19 cases and all potentfal exposure dw'ing 
the dinical study. 
Ensure that all staff wear a mask 
Gloves should be reauired when working directlv with oatients ru1d changed between each oatient 
Have staff thoroughly wash hands for at least 20 seconds or use ru1 a lcohol-ba s ed hru1d s anitizer 
when thev ruri ve. before and after each oatient before eati.ng and aBer using the bathroom. 
Cleru1i.ng ru1d disi.nfection procedure s for exrun rooms and instruments or equipment between 
oatients with izlo v e s . 
Cleru1i.ng ru1d disinfection procedures for collllllonly touched surfaces (doors, chairs, computers, 
phones, etc ...) with gloves. 
 
 
PI Initials 
Before a Patient or Study Visit: 
Patients should be asked prior to enteri.ng the site about fever and respiratory illness and whether 
they or a frunily membe r have had conta ct with another person with confinned COVID-19 i.n the 
past 14 days. Patients exhibiting signs ofbei.ng sick should be rescheduled when their symptoms 
resolve. 
Instmct patients that companions should remain outside of the facility ru1d not accompany the 
patient i.nto the facility unless they are a parent/guardianof the patient or if they ru·e a trne 
c ru·egiv er and need to assist the oatient 
Request the patient to call or text the office upon all'ival so entrance to and movement through 
facility can be coordi.nated by site staff 
 
 
 
 

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PI Initials 
Patients Entering the site: 
Temperatme checks utilizing a non-contact thennometer for ali patients and companions entering 
the site. 
Alpi atien ts and companions must wear cloth or disposable mask at ali 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 re larly. 
 
 
 
I certify that I have read and agree to implement ali the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Visi011Care studies. 
 
 
 
 
 
 
 
Principal Investigator Signature and Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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 
 
• 
I&R Training 
ACUVUE® Len sA ss ist: http s://www.acuvue.com/lensassist 
 
• 
Clinic Preparedness Guides 
CDC: https://www.cdc.gov/coronavinis/2019-ncov/hcp/clinic-preparedness html 
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4= 
American Optometric Association: https://www.aoa.org/optometzy-practice -reactivation -prw aredness- 
imide 
 
• 
lu-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.govhk/eng/index.html 
 
• 
Resumption of optical services in England: Letter from Matt Neligan and Poonam Shanna 
https://www.england nhs.uk/coronavims/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical- 
services-Ietter-17-june-2020.pdf 
 
• 
NHS Optical Letter 
https://www.englandnhs.uk/coronavims/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april- 
2020.pdf 
 
• 
The College of Optometrists primacy eye care COVID-19 guidance: Red phase 
https://www.college-optometrists.org/the-college/media-hub/news-listgi/ncoronavims-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.). Ret,rieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_gnidelines_2016.pdf 
 
• 
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulato1y care 
settings. (2020, May 23 May). Retrieved from Govemment of Canada: https://www.canada.ca/en/public- 
health/services/diseases/2019-novel -coronavims-infectio n/guidance-documents/interim-guidance- 
outpatient-ambulato1y-care-settings html 
 
 
 
 
 
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   Document Number: 
 
  
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-
 
• 
Info1mation for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of 
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/info1mation_for_members_on_coronavims.pdf 
 
• 
Coronavirns (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Govenunent 
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/enviromnental-cleaning-and-disinfection- 
principles-for-covid-19.pdf 
 
• 
Infection control guidelines and advice. (11.d .). Re trie v ed from Optometiy Australia : 
https://www.optometiy.org.au/practice-professional-suppo11/coronavims-covid-l 9-what-optometrists-need- 
to-know/covid-19-clinical-advice/infect.ion - con  ti·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-6501 Protocol Title: Role of glare and spectral filtering on 
contrast sensitivity: A pilot study 
 
Version and Date: 4.0 02 November 2022 
 
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. The Principal Investigator is responsible for ensuring that all clinical site 
personnel, including Sub-Investigators adhere to all 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 E of this protocol). I agree to 
conduct this study in compliance with local, state, governmental guidance for COVID-19 
risks. 
 
Principal 
Investigator: 
 
  
 
Signature 
Date 
Name and Professional Position (Printed) 
 
Institution/Site:    
 
Institution/Site Name 
 
Institution/Site Address 
 
 
 
 
 
 
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