Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing Lines
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-Energy 
Visible Light Produced on Commercial Manufacturing Lines
Protocol CR-6484
Version: 1.0
Date: 14 March 2022
Investigational Products: Test lens: Rotationally stabilized astigmatic contact lens in 
senofilcon A (C3) with a chromophore to block High-Energy Visible Light (HEVL), control 
lens: ACUVUE® OASYS® 1-Day for Astigmatism
Keywords: Astigmatism, toric contact lenses, senofilcon A (C3), RTY-1 chromophore, HEVL,
dispensing, daily wear, daily disposable, visual acuity, CLUE Comfort, CLUE Vision, CLUE 
Handling, logMAR visual acuity, rotation performance, cosmetic acceptability, ACUVUE®
OASYS® 1-Day for Astigmatism, Single use Eye-Cept® Rewetting Drops, LacriPure Saline 
Solution, ScleralFil Preservative Free Saline Solution.
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives................................................................................................................. 17 
2.2. 
Endpoints.................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria...................................................................................................... 18 
3.3. 
Exclusion Criteria..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration.................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 21 
5.1. 
Test Article Allocation............................................................................................. 21 
5.2. 
Masking.................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION............................................................................................. 22 
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6.1. 
Identity of Test Articles............................................................................................ 22 
6.2. 
Ancillary Supplies/Products..................................................................................... 23 
6.3. 
Administration of Test Articles................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS.............................................................................................. 26 
7.1. 
Time and Event Schedule......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 27 
VISIT 1 ........................................................................................................................... 27 
VISIT 2 ........................................................................................................................... 33 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 36 
FINAL EVALUATION.................................................................................................. 37 
7.3. 
Unscheduled Visits................................................................................................... 38 
7.4. 
Laboratory Procedures ............................................................................................. 39 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 39 
8.1. 
Completion Criteria.................................................................................................. 39 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 40 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 40 
9.1. 
Systemic Medications .............................................................................................. 40 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 42 
11. 
STUDY TERMINATION ........................................................................................... 43 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 44 
13. 
ADVERSE EVENTS................................................................................................... 45 
13.1. 
Definitions and Classifications............................................................................. 45 
13.2. 
Assessing Adverse Events.................................................................................... 47 
13.2.1. 
Causality Assessment.................................................................................... 47 
13.2.2. 
Severity Assessment...................................................................................... 48 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 48 
13.4. 
Reporting Adverse Events.................................................................................... 49 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 50 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
50 
13.5. 
Event of Special Interest....................................................................................... 51 
13.6. 
Reporting of Pregnancy........................................................................................ 51 
14. 
STATISTICAL METHODS........................................................................................ 51 
14.1. 
General Considerations......................................................................................... 51 
14.2. 
Sample Size Justification...................................................................................... 51 
14.3. 
Analysis Populations ............................................................................................ 52 
14.4. 
Level of Statistical Significance........................................................................... 53 
14.5. 
Primary Analysis .................................................................................................. 53 
14.6. 
Secondary Analysis .............................................................................................. 53 
14.7. 
Other Exploratory Analysis.................................................................................. 53 
14.8. 
Interim Analysis ................................................................................................... 54 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 54 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 54 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 54 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 54 
15.2. 
Subject Record...................................................................................................... 55 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 55 
16. 
DATA MANAGEMENT............................................................................................. 55 
16.1. 
Access to Source Data/Document ........................................................................ 55 
16.2. 
Confidentiality of Information.............................................................................. 55 
16.3. 
Data Quality Assurance........................................................................................ 56 
16.4. 
Data Monitoring Committee (DMC).................................................................... 56 
17. 
CLINICAL MONITORING........................................................................................ 56 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 57 
18.1. 
Study-Specific Design Considerations ................................................................. 57 
18.2. 
Investigator Responsibility................................................................................... 57 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 57 
18.4. 
Informed Consent ................................................................................................. 58 
18.5. 
Privacy of Personal Data ...................................................................................... 59 
19. 
STUDY RECORD RETENTION................................................................................ 60 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 60 
21. 
PUBLICATION........................................................................................................... 61 
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22. 
REFERENCES ............................................................................................................ 61 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 62 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 78 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 79 
APPENDIX D:
.................................... 108 
 LENS FITTING CHARACTERISTICS............................................................. 109 
 SUBJECT REPORTED OCULAR SYMPTOMS.............................................. 115 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 117 
 BIOMICROSCOPY SCALE .............................................................................. 123 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION......................... 129 
 TORIC FIT EVALUATION............................................................................... 134 
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE...... 139 
 PATIENT REPORTED OUTCOMES................................................................ 143 
 LENS INSERTION AND REMOVAL .............................................................. 145 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 148 
APPENDIX E: IRIS COLOR SCALE ................................................................................. 157 
APPENDIX F: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 158 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 170 
 
LIST OF TABLES
Table 1: Ancillary Supplies .................................................................................................... 24 
Table 2: Time and Events ....................................................................................................... 26 
Table 3: Disallowed systemic medications............................................................................. 41 
Table 4: Disallowed systemic antihistamines......................................................................... 42 
Table 5: Examples of major and minor protocol deviations................................................... 42 
Table 6: Power Calculation for the Primary Hypothesis of CLUE Comfort score (Non-
inferiority of the Test relative to the Control) with Type I error of 0.05................................ 52 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 14 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Evaluation of Toric Soft Contact Lenses Containing a Chromophore to Block High-
Energy Visible Light Produced on Commercial Manufacturing Lines
Protocol Number: CR-6484
Version: 1.0
Date: 14 March 2022
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155:2020,1 ICH 
guidelines,2 and the Declaration of Helsinki.3
Author & Study 
Responsible Clinician
See Electronic Signature Report 
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety 
Officer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
 
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CHANGE HISTORY 
Version
Originator
Description of Change(s) and 
Section Number(s) Affected
Justification 
for 
Change
Date
1.0
Original Protocol
N/A
14 Mar 2022
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SYNOPSIS  
Protocol Title
Evaluation of Toric Soft Contact Lenses Containing a
Chromophore to Block High-Energy Visible Light Produced
on Commercial Manufacturing Lines
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Confirmatory
Design control phase: Development phase, phase 2b
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor.
Test Article(s)
Investigational Products: Test lens: Rotationally stabilized 
astigmatic soft contact lens in senofilcon A (C3) with a
chromophore to block High-Energy Visible Light (HEVL).
Approved Products: Control lens: ACUVUE® OASYS®
1-Day for Astigmatism (AO1DfA)
Wear and Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily disposable
Objectives 
Primary Objective:
The primary objective of this study is to evaluate and compare 
the subjective CLUE Comfort score for the test lens against 
the control lens. The following hypothesis will be tested:
x
The test lens is non-inferior to the control lens with 
respect to overall CLUE Comfort score at follow-up.
A non-inferiority margin of -5 points on the CLUE 
scale will be used.
Exploratory Objectives:
Exploratory objectives of this study will be to evaluate the 
subjective CLUE Vision, subjective CLUE Handling, lens 
fitting characteristics, rotational performance, visual acuity, 
ocular physiological response and cosmetic acceptability for 
the test and control designs. 
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Study Endpoints
Primary endpoints:
x
Responses to the CLUE questionnaire Comfort items
at the follow-up visit
Other observations:
x
HLHC distance VA at the follow-up visit
x
Lens fitting characteristics (centration, movement, and 
push-up test) at dispensing and follow-up visits
x
Settled lens orientation at the dispensing visit and at 
follow-up visits
x
Lens rotational stability with blinks at the dispensing 
visit
x
Subjective response to MRD questionnaire items at the 
follow-up visit
x
Subjective response to the CLUE questionnaire 
Comfort, Vision and Handling items at fitting
x
Subjective response to the CLUE questionnaire Vision 
and Handling items at follow-up
x
Slit lamp findings across all study visits 
x
Adverse events
Study Design
This will be a 4-visit, randomized, controlled, single-masked, 
bilateral wear, dispensing, 2-treament, 2-sequence, 3-period
crossover study. Each subject will be randomized into one of 
two unique sequences to wear two different study lenses one 
at a time over three wear periods (test/control/control or 
control/test/test). During each wear period the lenses will be 
worn bilaterally for approximately 1 week (7r2 days) in a 
daily disposable modality. Subjective CLUE Comfort, Vision 
and Handling will be assessed using the CLUE questionnaire 
at both fitting and follow-up visits for each wear period.
HLHC VA will be assessed at the follow-up evaluation using 
ETDRS charts. There will be no washout period between wear 
periods.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
This study will have an enrollment target of approximately 
140 subjects, with a target of at least 126 to complete
(assuming a dropout rate of 10%).
Study Duration
Total study duration including the enrollment period is 
anticipated to be approximately 10 weeks.
Anticipated Study 
Population
Subjects will be habitual bilateral soft contact lens wearers
with bilateral astigmatism who are between 18 and 39 years 
of age (inclusive).
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Eligibility Criteria -
Inclusion
Potential subjects must satisfy of all the following criteria to 
be enrolled in the study.
Inclusion Criteria following Screening
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed
copy of the form.
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol.
3. Be between 18 and 39 years of age (inclusive) at the time 
of screening.
4. Habitually wear soft contact lenses in both eyes in a daily 
or daily disposable wear modality (i.e., not extended wear 
modality). Habitual wearer is defined as a minimum of 6 
hours per day, for a minimum of 2 days per week during 
the past four weeks.
5. Possess a wearable pair of spectacles that provide 
correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. In both eyes, have refractive error suitable for correction 
with the toric contact lens powers available in this study:
a.
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
b. Cylinder powers (DC) -0.75 and -1.25
c.
Axes (q) 170, 180, 10, 80, 90, 100
7. Have best corrected monocular distance visual acuity of 
20/30 or better in each eye.
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Eligibility Criteria –
Exclusion
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have an 
ocular infection of any type.
4. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication that might 
contraindicate or interfere with contact lens wear, or 
otherwise 
compromise 
study 
endpoints, 
including 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis), 
contagious immunosuppressive disease (e.g., Human 
Immunodeficiency Virus [HIV]), autoimmune disease 
(e.g. rheumatoid arthritis, Sjögren’s syndrome), or history
of serious mental illness or seizures. See section 9.1 for 
additional 
details 
regarding 
excluded 
systemic 
medications. 
5. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, 
SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact 
lenses.
7. Be currently wearing lenses in an extended wear modality.
8. Have a history of strabismus or amblyopia.
9. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an employee 
(including partner, child, parent, grandparent, grandchild 
or sibling of the employee or their spouse) of the clinical 
site.
10. Have participated in a contact lens or lens care product 
clinical trial within 7 days prior to study enrollment.
Exclusion Criteria following Baseline Evaluation
The subject must not:
11. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities that contraindicate contact lens wear or may 
otherwise compromise study endpoints (including 
entropion, ectropion, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, aphakia, moderate or 
above corneal distortion, herpetic keratitis). 
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12. Have fluctuations in vision due to clinically significant dry 
eye or other ocular conditions. 
13. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, 
PRK, LASIK, iridotomy, retinal laser photocoagulation, 
etc.).
Disallowed 
Medications/Interventions 
Subjects will not be eligible to enroll if they are taking any 
ocular medications, or any systemic medications that would 
normally contraindicate contact lens wear or may otherwise 
compromise study endpoints. See section 9.1 for details 
regarding disallowed systemic medications.
Measurements and 
Procedures
Key procedures associated with the endpoints for this study
will include:
- Overseeing completion of subjective questionnaires
- Measurement of HLHC VA using ETDRS charts at follow-
up
- Examination of the anterior segment using a slit lamp 
biomicroscope and grading findings using the FDA 
grading scale
- Assessment of general lens fitting characteristics 
(centration, movement, push-up test)
- Assessment of lens orientation and rotational stability 
using a slit lamp biomicroscope
Microbiology or Other 
Laboratory Testing
Not applicable for this study.
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Lens cases, fluorescein strips and preservative-free rewetting 
drops / artificial tears will be supplied for use as needed.  
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
Visit 1: Screening
Statement of Informed Consent
Demographics
Medical History & Concomitant Medications
Habitual Contact Lens Information
Eligibility at Screening
Baseline Evaluation
Subject Reported Ocular Symptoms
Entrance visual acuity
Spherocylindrical refraction and distance visual acuity
Slit lamp biomicroscopy findings
Eligibility after Baseline
Baseline CLUE questionnaire (habitual lenses)
Lens Fitting (#1 through #3)
Lens assignment and insertion
Timed rotation assessments, lens settling
Toric and general fit assessment
Spherical over-refraction, modification if required
CLUE post-fit questionnaire
Additional samples of toric lens orientation 
Lenses dispensed for 7r2 days
Follow-up (#1 through #3)
Review med history and medications
Subject reported ocular symptoms
Entrance visual acuity
CLUE follow-up questionnaire
ETDRS HLHC visual acuity
Record lens orientation
Additional samples of toric lens orientation 
Lens removal
Biomicroscopy
Confirm continuing eligibility
Final Evaluation
Spherocylindrical refraction
Completion status
Biomicroscopy (if discontinued early)
After follow-up #1 and #2
After follow-up #3
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
AO1DfA
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY for 
ASTIGMATISM
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ESD
Eyelid Stabilized Design
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICH
The International Council for Harmonization
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LogMAR
Logarithm of Minimal Angle of Resolution
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
SAS
Statistical Analysis System
SD
Standard Deviation
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UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND 
High Energy Visible Light (HEVL) may be generally defined as the visible region of the 
electromagnetic spectrum with wavelengths shorter than 500 nm. Due to Rayleigh scattering, 
light within this range of wavelengths is scattered more than light of longer wavelengths, thus 
filtering these shorter wavelengths may result in increased visual contrast when looking at 
distant objects. At approximately 435 nm, visible light has enough energy to damage the retinal 
pigment epithelium and has been linked to macular degeneration. Additionally, the retinal 
receptors responsible for photoentrainment (entrainment of the circadian rhythm in response 
to patterns of light and dark) are maximally sensitive to light at approximately 480 nm. 
Ophthalmic lenses that block High Energy Visible Light (HEVL) may offer improved vision 
through enhanced chromatic contrast sensitivity. Such lenses may also provide greater retinal 
protection than regular lenses without spectral filtering. This study will investigate the 
subjective visual response to a daily disposable, toric lens design incorporating a HEVL-
blocking chromophore (RTY-1) against the ACUVUE® OASYS 1-Day for ASTIGMATISM 
(AO1DfA) design as control. 
1.1.
Name and Descriptions of Investigational Products  
The test lens in this study will be a toric contact lens design with stabilization design and 
geometry similar to AO1DfA in senofilcon A (C3) with the addition of a HEVL-blocking
chromophore (RTY-1). The test lens will be evaluated against the AO1DfA lens in as control. 
Further details about the test and control articles are given in section 6 of this protocol.
1.2.
Intended Use of Investigational Products 
The intended use of the investigational products is the correction of myopic astigmatism. Study 
lenses will be worn bilaterally in a daily wear, daily disposable modality for at least 8 hours 
per day and 5 days per week over a wear period of 7±2 days. Three wear periods will be 
completed in total, with no washout period between the wear periods.
1.3.
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding the test and 
control designs refer to the latest version of the Investigator's Brochure5 and the AO1DfA 
package insert (Appendix C), respectively.
1.4.
Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the investigational lenses will be the correction of refractive 
error. No adverse device effects are anticipated. The risks associated with use of the 
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investigational lenses are considered to be the same as those for other marketed soft contact 
lens worn in the same modality (i.e., daily disposable wear). No additional risks associated 
with participation in this investigation are anticipated. 
Comprehensive risk and benefit information regarding the test design and the AO1DfA control 
lens are included in the latest versions of the Investigator's Brochure5 and the AO1DfA package 
insert (Appendix C), respectively.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Prototype toric lens designs featuring the RTY-1 chromophore were previously evaluated in a 
reusable modality against ACUVUE OASYS 2-week for Astigmatism as control (study 
), and in a daily disposable modality against AO1DfA as control (study 
). 
In study 
, out of the 98 subjects included in the safety population, one ocular adverse 
event (AE) was reported; non-significant meibomianitis was reported in the right eye of one 
subject, and this was considered to have no relation to the investigational articles or study 
procedures. No ocular adverse events were reported in. 
In study 
, 144 subjects were included in the safety population and no ocular adverse 
events were reported throughout the study period. 
For further details regarding literature references and prior clinical data related to the test 
designs and the AO1DfA control lens, refer to the Investigator's Brochure5 and the AO1DfA 
package insert (Appendix C), respectively.  
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
Primary Objective
The primary objective of this study is to evaluate and compare the subjective CLUE Comfort 
of the HEVL-blocking test design against AO1DfA as control.
Exploratory Objectives
Exploratory objectives of this study will be to evaluate the subjective CLUE Vision, subjective 
CLUE Handling, lens fitting characteristics, rotation performance, visual acuity, ocular 
physiological response and cosmetic acceptability for the test and control designs.
2.2.
Endpoints  
Primary Endpoint
The primary endpoint will be the responses to the CLUE questionnaire Comfort items at the 
follow-up evaluation.
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Subjective comfort will be assessed using Contact Lens User Experience (CLUE) 
questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-
experience attributes of soft, disposable contact lenses (Comfort, Vision, Handling, and 
Packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal 
distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response.6 A 5-point increase in an average CLUE score translates into 10% 
shift in the distribution of scores for population of soft disposable contact lens wearers.
The CLUE questionnaire was selected for the primary endpoint since this is thought to be the 
best psychometric method available for evaluating and quantifying subjective lens comfort. 
The follow-up CLUE questionnaire was selected since this allows the ample time for subjects 
to subjectively assess lens performance over a variety of wear conditions.
Other Exploratory Endpoints
x
HLHC distance VA at the follow-up visit
x
Lens fitting characteristics (centration, movement, and push-up test) at dispensing and 
follow-up visits
x
Settled lens orientation at the dispensing visit and at follow-up visits
x
Lens rotational stability with blinks at the dispensing visit
x
Subjective response to MRD questionnaire items at the follow-up visit
x
Subjective response to the CLUE questionnaire Comfort, Vision, and Handling items 
at fitting
x
Subjective response to the CLUE questionnaire Vision and Handling items at follow-
up
x
Slit lamp findings across all study visits 
x
Adverse events
2.3.
Hypotheses 
Primary Hypothesis
The following hypothesis will be tested:
x
The test lens is non-inferior to the control with regard to the CLUE Comfort score at 
the follow-up evaluation. A non-inferiority margin of -5 CLUE points will be used. 
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
The target population for this study will be healthy adult soft contact lens wearers between 18
and 39 years of age with binocular myopic astigmatism.  
3.2.
Inclusion Criteria 
Potential subjects must satisfy of all the following criteria to be enrolled in the study.
Inclusion Criteria following Screening
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The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 years of age (inclusive) at the time of screening.
4. By self-report, habitually wear soft contact lenses in both eyes in a daily or daily disposable 
wear modality (i.e. not extended wear modality). Habitual wearer is defined as a minimum 
of 6 hours per day, for a minimum of 2 days per week during the past four weeks.
5. Possess a wearable pair of spectacles that provide correction for distance vision.
Inclusion Criteria at Baseline Evaluation
The subject must:
6. In both eyes, have refractive error suitable for correction with the toric contact lens powers 
available in this study:
a.
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps
b. Cylinder powers (DC) -0.75 and -1.25
c.
Axes (q) 170, 180, 10, 80, 90, 100
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria following Screening
The subject must not:
1. Be currently pregnant or lactating.
2. Be diabetic.
3. Be currently using any ocular medications or have an ocular infection of any type.
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of 
medication that might contraindicate or interfere with contact lens wear, or otherwise 
compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), 
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), 
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s syndrome), or history of serious 
mental illness or seizures. See section 9.1 for additional details regarding excluded 
systemic medications. 
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid 
lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
6. Be currently wearing monovision or multifocal contact lenses.
7. Be currently wearing lenses in an extended wear modality.
8. Have a history of strabismus or amblyopia.
9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member 
of an employee (including partner, child, parent, grandparent, grandchild or sibling of the 
employee or their spouse) of the clinical site.
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior to 
study enrollment.
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Exclusion Criteria at Baseline Evaluation
The subject must not:
11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings 
(e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar 
injection) or other corneal or ocular disease or abnormalities that contraindicate contact 
lens wear or may otherwise compromise study endpoints (including entropion, ectropion, 
chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, 
moderate or above corneal distortion, herpetic keratitis). 
12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions. 
13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., 
radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This will be a 4-visit, randomized, controlled, single-masked, bilateral wear, dispensing,
2-treatment, 2-sequence, 3-period crossover study. Each subject will be randomized into one 
of two unique sequences to wear two different study lenses one at a time over three wear 
periods (test/control/control or control/test/test). During each wear period, study lenses will be 
worn bilaterally for approximately 1 week (7r2 days) in a daily disposable modality. Study 
lenses will be worn for a minimum of 8 hours per day and at least 5 days per week during each
wear period. Subjective CLUE Comfort, Vision and Handling will be assessed using the CLUE 
questionnaire at both fitting and follow-up visits for each wear period. HLHC VA will be 
assessed at the follow-up evaluation using ETDRS charts. There will be no washout period
between wear periods. Subjects will not have access to the study lenses following completion 
of the protocol.  
4.2.
Study Design Rationale 
A crossover study design was chosen to allow each subject to act as their own active control. 
A 3-period design was chosen to allow estimation of first-order carryover effects. 
The AO1DfA lens was chosen as control since this is thought to be the best performing 
currently marketed ACUVUE® toric lens in terms of comfort. The prescribed wear schedule 
(lenses to be worn for a minimum of 8 hours per day and a minimum of 5 days per week) was 
chosen as this is representative of a typical wear schedule for contact lens wearers.
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For the primary study endpoint, the CLUE questionnaire was selected on the basis of being the 
best available validated PRO tool for assessing the subjective comfort of soft contact lens 
wearers.
The investigational lenses will be fitted by optometrists who are experienced at fitting toric 
soft contact lenses and will be evaluated by habitual contact lens wearers in their standard 
wearing environment.
4.3.
Enrollment Target and Study Duration 
This study will have an enrollment target of 140 subjects, with a target of at least 126 to 
complete. The study will be conducted at up to 12 clinical sites, where the enrollment target 
for each site will be approximately 10 to 20 subjects. A subject will be considered enrolled 
upon signing of the informed consent form.  
There will be 4 visits in total per subject; total study duration including the enrollment period 
is expected to be approximately 10 weeks. The investigation will end with completion of the 
final subject’s last visit. Subjects who are discontinued prior to the final evaluation may be 
replaced at the discretion of the study sponsor. The investigation will end at the time that the
study data is hard locked.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
This study will be a randomized, single-masked, crossover design. Subjects will be randomized 
into one of two unique sequence groups in a 1:1 allocation ratio to wear two different study 
lens designs (test and control designs) one at a time bilaterally over three wear periods. 
Use of the test articles will be randomized using a randomization scheme supplied by the study 
biostatistician.  The randomized assignment of subjects will be performed at the first visit prior 
to the first fitting. Clinical sites will follow the randomization scheme provided and will not 
pre-select or assign subjects. The following must have occurred prior to randomization:
x
Informed consent must have been obtained
x
The subject must have met all inclusion and exclusion criteria
x
The subject history and baseline information must have been collected
Randomly permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme (lens fitting schedule) to obtain the test article assignment for 
that subject prior to dispensing.
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2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme (lens fitting schedule).
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section.
5.2.
Masking 
To reduce the potential for bias, this will be a single-masked trial; subjects will not be aware 
of the identity of the assigned lenses, however, due to the difference in appearance of the test 
lenses containing the RTY-1 chromophore, it is expected that subjects will be able to visually 
differentiate between the test and control designs. The identity (i.e., brand and type) of the 
study lenses will be masked by having the blister packs labeled with the study number, lot 
number, sphere power, cylinder power, axis, expiration date and randomization code. 
Investigators, site staff and sponsor personnel (including the medical monitor) will be aware 
of the identity of the test and control lenses. 
5.3.
Procedures for Maintaining and Breaking the Masking 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by the subject knowing their treatment 
status. In such cases, the Investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued may be replaced at the 
discretion of the study sponsor.
6.
STUDY INTERVENTION 
6.1.
Identity of Test Articles  
The following contact lenses will be used in this study:
Test
Control
Test Article Form
Soft contact lens
Design / Description
TRA100 and TRA200 series
toric contact lens with HEVL-
blocking chromophore
AO1DfA
Design Name
AO1DfA
Manufacturer
Johnson & Johnson Vision Care, Inc.
Packaging Form
Blister packaging in sterile packing solution
Packaging Solution
Optimized Borate Buffer (OBB) solution
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In total, both test and control lenses will be available in 132 unique lens powers (11 sphere
powers × 2 cylinder powers × 6 axes).
For each study lens design (test and control), the total number of test lenses to be used in this 
study (not including lenses that are replaced due to droppage, loss or damage) is expected to 
be approximately 2940 lenses (target enrollment of 70 subjects × 2 eyes per subject × 7 days
per wear period × 2 wear periods for the first sequence, plus 70 subjects × 2 eyes per subject 
× 7 days per wear period × 1 wear period for the second sequence).
6.2.
Ancillary Supplies/Products 
The following solutions will be used in this study:
Lens Material
senofilcon A (C3) with RTY-1
chromophore
senofilcon A (C3)
Sphere Powers (DS)
-1.50 to -4.00 in 0.25 steps
Cylinder Powers 
(DC)
-0.75, -1.25
Cylinder Axes (°)
10, 80, 90, 100, 170, 180
Nominal Water 
Content (%)
41
Nominal Base 
Curve (mm)
8.5
Lens Diameter 
(mm)
14.3
Fiducial marks
6 and 12 o’clock fiducial lines
Dk (Fatt method, 
boundary corrected, 
edge corrected, ×10-
11 [cm2 /sec] [ml 
O2/ml × mm Hg] at 
35°C)
103
Modality in Current 
Study
Daily wear
Replacement 
Frequency in 
Current Study
Daily disposable
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Table 1: Ancillary Supplies
Non-Preserved Rewetting Drops 
Solution Name/Description
Single use Eye-
Cept® Rewetting 
Drops 
LacriPure Saline 
Solution
ScleralFil 
Preservative Free 
Saline Solution
Manufacturer
Optics Laboratory
Menicon
Bausch & Lomb
Preservative
None
None
None
Lens cases and fluorescein strips (either 0.6 mg or 1.0 mg) will be supplied for use as needed.
6.3.
Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.
6.4.
Packaging and Labeling 
The test articles will be supplied in blister packages as the primary packaging and placed into 
plastic bags as secondary packaging. Test and control blister packages will be physically over-
labeled with permanent labels. Representative sample labels for the primary and secondary 
packaging are shown below: 
Primary Packaging
Secondary 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.
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6.6.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures. When possible, any lens or test 
article associated with an Adverse Event and/or a Product Quality Complaint must be retained 
and stored in a glass vial with moderate solution pending directions from the sponsor for 
potential return to JJVC.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning 
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
 
 
 
 
 
 
 
 
 
 
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7.
STUDY EVALUATIONS  
7.1.
Time and Event Schedule 
Table 2: Time and Events
Visit Information
Visit 1
Screening, 
Baseline, 
Lens Fitting 
#1
Visit 2
Follow-up
#1, Lens
Fitting #2
Visit 3
Follow-up
#2, Lens 
Fitting #3
Visit 4
Follow-up
#3, Final 
Evaluation
Time Point
Day 0
7 ± 2 days 
following 
Visit 2
7 ± 2 days 
following 
Visit 3
7 ± 2 days 
following 
Visit 4
Minimum lens wear time 
immediately prior to visit
Must wear 
habitual 
lenses
1 hour (study 
lenses)
1 hour (study 
lenses)
1 hour (study 
lenses)
Estimated Visit Duration
2.5 hours
2.5 hours
2.5 hours
1.5 hours
Statement of informed consent
x
Demographics
x
Medical history/concomitant 
medications
x
x
x
x
Habitual contact lens information
x
Habitual lens wear time
x
Eligibility at Screening
x
Subject reported ocular 
symptoms
x
x
x
x
Baseline PRO questionnaire
x
Entrance visual acuity
x
x
x
x
Remove habitual lenses
x
Subjective Sphero-Cylindrical 
Refraction
x
x
Slit Lamp Biomicroscopy
x
x
x
x
Eligibility at Baseline
x
Iris color
x
Lens Selection
x
x
x
Lens insertion and timed rotation 
assessments
x
x
x
Lens settling
x
x
x
Toric fit assessment
x
x
x
General fit assessment
x
x
x
Spherical over-refraction
x
x
x
Lens modification (if necessary)
x
x
x
Post-fit PRO questionnaire
x
x
x
Additional samples of toric lens 
orientation (performed twice)
x
x
x
x
Exit visual acuity
x
x
x
Dispensing criteria
x
x
x
Dispensing instructions
x
x
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Lens Fitting 
#1
Visit 2
Follow-up
#1, Lens
Fitting #2
Visit 3
Follow-up
#2, Lens 
Fitting #3
Visit 4
Follow-up
#3, Final 
Evaluation
Time Point
Day 0
7 ± 2 days 
following 
Visit 2
7 ± 2 days 
following 
Visit 3
7 ± 2 days 
following 
Visit 4
Minimum lens wear time 
immediately prior to visit
Must wear 
habitual 
lenses
1 hour (study 
lenses)
1 hour (study 
lenses)
1 hour (study 
lenses)
Estimated Visit Duration
2.5 hours
2.5 hours
2.5 hours
1.5 hours
Schedule next visit
x
x
x
Wear time and compliance
x
x
x
Collect unworn lenses
x
x
x
Follow-up PRO questionnaire
x
x
x
Distance HLHC visual acuity 
using ETDRS charts
x
x
x
Toric lens orientation
x
x
x
Lens removal
x
x
x
Continuance
x
x
Subject completion status
x
7.2.
Detailed Study Procedures 
VISIT 1
Subjects must wear their habitual contact lenses to this visit.
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of Informed 
Consent
Each subject must read, understand, and sign the 
Statement of Informed Consent before being 
enrolled into the study. The Principal Investigator 
or his/her designee conducting the informed 
consent discussion must also sign the consent 
form.
Note: The subject must be provided a signed 
copy of this document.
1.2
Demographics
Record the subject’s year of birth, age, gender, 
race and ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Record the subject’s medical history and 
concomitant medications.
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Visit 1: Screening
Step
Procedure
Details
1.4
Habitual Lenses
Record the subject’s habitual lens type, 
parameters, lens care solution, wear modality and 
approximate prescription date.
1.5
Habitual lens wear 
time.
Record the average and comfortable wear time 
for the subject’s habitual contact lenses. 
1.6
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be answered 
“no” for the subject to be considered eligible. 
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be completed 
as part of Final Evaluation.
Visit 1: Baseline
Step
Procedure
Details
1.7
Subject reported ocular 
symptoms
Record any subject reported ocular symptoms 
reported with regard to their habitual contact 
lenses.  
1.8
Baseline PRO 
questionnaire 
Ask the subject to fill out the baseline 
questionnaire regarding their experience with 
their habitual contact lenses.
1.9
Entrance visual acuity
Record the monocular distance Snellen visual 
acuity for each eye (OD, OS) to the nearest letter 
with the subject’s habitual contact lens correction.  
Subjects must continue until at least 50% of the 
letters on a line are read incorrectly.
1.10
Remove habitual 
lenses
The subject’s habitual contact lenses will be 
removed and stored in a lens case, if required. 
1.11
Subjective sphero-
cylindrical refraction
Conduct a full spherocylindrical bare eye 
subjective refraction with binocular balance and 
record the resultant monocular visual acuity for 
each eye to the nearest letter.
Note: The duo-chrome test should be used for 
refining the monocular and binocular spherical 
endpoints. This test will be considered to have 
reached the endpoint when the targets on red and 
green backgrounds appear to be equally sharp. 
However, if the subject’s response changes 
immediately from “red” to “green” with a 
0.25DS change in power, the endpoint will be the 
most plus power (with “red” target clearer) 
before this reversal.  
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Visit 1: Baseline
Step
Procedure
Details
1.12
Slit lamp 
biomicroscopy
The FDA Slit Lamp Classification Scale will be 
used to grade findings.  If any slit lamp finding is 
graded as 3 or worse, the visit will be discontinued; 
however, the subject may repeat the baseline 
evaluation (one time) at a later date once the 
condition lessens.  
Should the clearance of the fluorescein need to be 
expedited, preservative free rewetting drops or 
artificial tears may be instilled.
1.13
Eligibility at baseline
All responses to Inclusion Criteria questions must 
be answered “yes” and all responses to Exclusion 
Criteria questions must be answered “no” for the 
subject to be considered eligible.
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation.
1.14
Iris color
The investigator will record the subject’s iris color 
using the scale provided (Appendix E).
Visit 1: Lens Fitting #1
Step
Procedure
Details
1.15
Lens selection
Assign the study lens based on the randomization 
scheme. Select the fitting lens powers based on 
vertex-corrected subjective refraction for each 
eye, with consideration of the following 
guidelines:
1. Label cylinder axis should be determined by 
rounding the refraction cylinder axis to the 
nearest 10 degrees.  Axis ending in the digit ‘5’ 
should be rounded towards 180 for eyes with 
with-the-rule astigmatism, or towards 90 for 
eyes with against-the-rule astigmatism (e.g. 175 
should be rounded to 180, 105 should be 
rounded to 100).  
2. Cylinder power should be chosen based on the 
following table:
3. The fitting lens spherical equivalent (SE) 
power (label sphere power + 1/2 of the label 
Vertex corrected 
cylinder power (X) 
within the range: 
(DC)
Label cylinder power 
to be fit (DC)
-0.625 ≤ X < -1.125
-0.75
-1.125 ≤ X < -1.625
-1.25
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Visit 1: Lens Fitting #1
Step
Procedure
Details
cylinder power) should be as close as possible 
to the SE of the vertex-corrected refraction.  If 
the SE of the vertex-corrected refraction is 
exactly halfway between two label SE powers, 
the least minus label power should be fit first.
1.16
Right eye lens 
insertion 
Instruct the subject to insert the right-eye lens 
with random orientation.    
If lens is uncomfortable, inspect for damage and 
remove, reinsert or replace as necessary.  
1.17
Timed rotation 
assessments during 
settling period
Start a stopwatch (or suitable smartphone or 
tablet timing app) as soon as the right lens is 
inserted. Record lens rotation (direction and 
magnitude) to the nearest degree at one (1) and 
three (3) minutes following insertion.  
Note:  All lenses in this study have scribe marks 
at 6 o’clock and 12 o’clock positions and rotation 
measurements are made relative to a vertical 
reference line.  
1.18
Left eye lens insertion 
Instruct the subject to insert the left-eye lens with 
random orientation.    
If lens is uncomfortable, inspect for damage and 
remove, reinsert or replace as necessary.  
1.19
Timed rotation 
assessments during 
settling period
Start a stopwatch (or suitable smartphone or 
tablet timing app) as soon as the left lens is 
inserted. Record lens rotation (direction and 
magnitude) to the nearest degree at one (1) and 
three (3) minutes following insertion.  
Note:  All lenses in this study have scribe marks 
at 6 o’clock and 12 o’clock positions and rotation 
measurements are made relative to a vertical 
reference line.  
1.20
Lens settling
Allow lenses to settle for a period of at least 
10 minutes following left lens insertion.  
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Visit 1: Lens Fitting #1
Step
Procedure
Details
1.21
Toric fit assessment
Record for each eye:
1.
The rotational position to the nearest 
degree
2.
Lens stability with blinks
3.
Toric fit acceptability. The toric lens fit 
will be designated as ‘unacceptable’ if 
either:
a.
The lens ABSOLUTE ROTATION is 
greater than 20 degrees 
b.
The 
LENS 
STABILITY 
WITH 
BLINK is greater than 5 degrees
If one or both lenses demonstrate an unacceptable 
toric fit, the subject will be discontinued (proceed 
to final evaluation).  
1.22
General lens fit 
assessment
The fitting characteristics of the lens in both eyes 
will be assessed using a slit lamp.  Lens position 
(centration, limbal exposure, edge lift) and 
movement (primary and up gaze as well as push-
up) will be assessed. Fit acceptability is defined as 
any lens that does not display the following 
general fit characteristics:
x
Limbal exposure (presence of clear cornea) 
in any direction of gaze.
x
Edge lift
x
Insufficient movement in all three 
movement assessments (primary gaze, up-
gaze and push-up test).  
x
Excessive movement in primary gaze
If the general fit is unacceptable for either eye, 
the subject will be discontinued (proceed to exit 
evaluation).  
1.23
Spherical over-
refraction
Perform monocular spherical over-refraction 
using duo-chrome to refine the endpoint as 
described in step 1.11 (the final spherical 
endpoint may be determined binocularly).  
The spherical over-refraction must be plano in 
both eyes to continue.
If a non-plano over-refraction is found in either 
eye, the lens(es) must be refit with the 
indicated change in sphere power.  If the 
indicated lens power is not available for either 
eye (e.g., outside the available SKU range), the 
subject will be discontinued (proceed to final 
evaluation).  
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Visit 1: Lens Fitting #1
Step
Procedure
Details
1.24
Lens modification (if 
necessary)
If modification is necessary in one or both eyes, 
select the reason for refitting lenses:
x
The settled lens rotation is such that a 
different cylinder axis would be more 
appropriate (use the LARS rule to 
determine the replacement lens cylinder 
axis)
x
The spherical over-refraction is not plano
x
Other (specify reason)
Repeat steps 1.16 through 1.23 for one or both 
eyes, as appropriate.  
A maximum of 2 lens modifications are allowed 
per eye. If, for either eye, the fit is not successful 
after 2 modifications, the subject will be 
discontinued (proceed to final evaluation).  
1.25
Post-fit PRO 
questionnaire
Subjects will complete a PRO questionnaire 
regarding the initial comfort, vision and handling 
of the study lenses.  
1.26
Additional sample of 
toric lens orientation 
(1)
Instruct the subject to leave the consulting room 
and walk around for at least 2 minutes. Upon their 
return, measure and record the toric lens 
orientation for each eye to the nearest degree.
1.27
Additional sample of 
toric lens orientation 
(2)
Repeat the previous step once again.    
1.28
Exit visual acuity
Record the exit monocular distance Snellen visual 
acuity for each eye with the subject wearing the 
study lenses.  
1.29
Dispensing criteria
Lenses may be dispensed if both following 
conditions are met:
1.
The monocular distance visual acuity with the 
study lenses is equal to or better than 20/25 in 
each eye.
2.
The subject indicates that the comfort and 
vision with the study lenses is acceptable.
If either of these conditions is not met, the subject 
will be discontinued (proceed to exit evaluation).  
1.30
Dispensing 
instructions
If the study lenses are suitable for dispensing: 
x
Instruct the subject to wear the study lenses 
for at least 8 hours per day (in a daily wear / 
daily disposable modality) on at least 5 days 
of the wear period. Subjects must not wear
their habitual lenses at any time during the 
dispensing period.
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Visit 1: Lens Fitting #1
Step
Procedure
Details
x
Provide the subject with a copy of the Patient 
Instruction Guide.
x
Preservative-free rewetting drops are 
permitted, if needed.
x
Dispense enough lenses for the subject to 
complete the wear period (i.e. up to and 
including their scheduled follow-up visit). At 
the investigator’s discretion, in instances 
where there is a high likelihood of the subject 
needing replacement lenses (e.g., due to 
subject activities, unavailability of subject or 
site during the wear period, high likelihood of 
lens tears, etc.), one additional spare pair may 
be dispensed.
Note: In the event that a subject requires 
additional lenses due to loss or damage, they may 
return to the clinical site for lens replacement. As 
much as reasonably possible, damaged lenses and 
packaging should be returned to the clinical site 
(in solution, if possible) for shipping to the 
Sponsor. If lens damage is present, complete the 
Product Quality Complaint Form, store the lens in 
a labeled vial with saline and return it to the 
Sponsor.
x
Ensure the subject is aware of the correct lens 
power for each eye (label the lenses with R 
and L as appropriate). 
1.31
Schedule next visit
Schedule the follow-up visit to occur in 7 ± 2
days (counting the day of this visit as day 0, the 
subject may return on day 5 through 9). Ensure 
the subject is instructed to wear the study lenses 
for at least 1 hour immediately prior to attending 
the follow-up visit.  
VISIT 2
Visit 2 will occur 5 to 9 days following Visit 1. Subjects must present to this visit wearing the 
study lenses in both eyes, and lenses must have been worn for at least 1 hour prior to the visit. 
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Visit 2: Follow-Up #1
Step
Procedure
Details
2.1
Wear time and 
compliance
Record the subjects wearing time and comfortable 
wearing time. Subjects must have worn lenses for 
at least five 8-hour (continuous) periods during 
the dispensing period, and for at least 1 hour prior 
to attending this visit.  
2.2
Collect unworn lenses
Collect any unworn study lenses that were 
dispensed at the previous visit. 
2.3
Review medical 
history and 
concomitant 
medications
Record any changes to the subject’s medical 
history (including adverse events) or concomitant 
medications.  
2.4
Subject reported ocular 
symptoms
Record any subject reported ocular symptoms in 
response to a verbal open-ended symptoms 
questionnaire.  
2.5
Follow-up PRO 
questionnaire
Subjects will complete a PRO questionnaire to 
assess their experience with the study lenses. 
Note: at the end of the second wear period (Visit 
3: Follow-Up #2) the PRO questionnaire will also 
include questions regarding lens preference
between the lenses worn in the first and second 
wear periods.
2.6
Entrance visual acuity
Record the entrance Snellen VA for each eye 
while wearing the study lenses.  
2.7
Distance ETDRS 
visual acuity
Measure monocular distance high luminance high 
contrast (HLHC) visual acuity using ETDRS charts 
at 4 meters. 
Measure each eye using the charts shown in the 
table below:
Condition
HLHC
Room 
illumination
> 400 lux
Chart luminance
120 - 200 cd/m2
Eye
OD
OS
Charts
HC-1
HC-2
HC-3
HC-4
Recorded letter-by-letter results into EDC.
2.8
Toric lens orientation
Record the toric lens orientation for each eye to 
the nearest degree.  
2.9
Additional sample of 
toric lens orientation 
(1)
Instruct the subject to leave the consulting room 
and walk around for at least 2 minutes. Upon their 
return, measure and record the toric lens 
orientation to the nearest degree in each eye.  
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Visit 2: Follow-Up #1
Step
Procedure
Details
2.10
Additional sample of 
toric lens orientation 
(2)
Repeat the previous step once again.    
2.11
Lens removal
Remove and place both lenses into a lens case 
with saline solution.
Do not discard the lenses until after 
biomicroscopy has been completed.  
2.12
Biomicroscopy
The FDA Slit Lamp Classification Scale will be 
used to grade findings.  If any slit lamp finding is 
graded as 3 or worse, the subject must be 
discontinued, an adverse event will be recorded,
and the subject will be monitored as per the 
guidelines given in section 13.
Should the clearance of the fluorescein need to be 
expedited, preservative free rewetting drops or 
artificial tears may be instilled.
Study lenses may be discarded if there is no 
reason to store them following biomicroscopy.  
2.13
Continuance
Verify that the subject is eligible to continue with 
the study.
Visit 2: Lens Fitting #2
The steps followed will be the same as those listed under Visit 1: Lens Fitting #1.
VISIT 3
Visit 3 will occur 5 to 9 days following Visit 2. Subjects must present to this visit wearing the 
study lenses in both eyes, and lenses must have been worn for at least 1 hour prior to the visit.
Visit 3: Follow-Up #2
The steps followed will be the same as those listed under Visit 2: Follow-Up #1, with the 
addition of a Preference Questionnaire as part of the Follow-Up PRO questionnaire step.
Visit 3: Lens Fitting #3
The steps followed will be the same as those listed under Visit 1: Lens Fitting #1.
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VISIT 4
Visit 4 will occur 5 to 9 days following Visit 3. Subjects must present to this visit wearing the 
study lenses in both eyes, and lenses must have been worn for at least 1 hour prior to the visit.  
Subjects should bring their own habitual spectacles or contact lenses to this visit to wear 
following study lens removal.
Visit 4: Follow-Up #3
Step
Procedure
Details
4.1
Wear time and 
compliance
Record the subjects wearing time and comfortable 
wearing time.  Subjects must have worn lenses for 
at least five 8-hour (continuous) periods during the 
dispensing period, and for at least 1 hour prior to 
attending this visit.  
4.2
Collect unworn lenses
Collect any unworn study lenses that were 
dispensed at the previous visit. 
4.3
Review medical 
history and 
concomitant 
medications
Record any changes to the subject’s medical 
history (including adverse events) or concomitant 
medications.  
4.4
Subject reported 
ocular symptoms
Record any subject reported ocular symptoms in 
response to a verbal open-ended symptoms 
questionnaire.  
4.5
Follow-up PRO 
questionnaire
Subjects will complete a PRO questionnaire to 
assess their experience with the study lenses. 
4.6
Entrance visual acuity
Record the entrance Snellen VA for each eye while 
wearing the study lenses.  
4.7
Distance ETDRS 
visual acuity
Measure monocular distance high luminance high 
contrast (HLHC) visual acuity using ETDRS charts 
at 4 meters. 
Measure each eye using the charts shown in the table 
below:
Condition
HLHC
Room 
illumination
> 400 lux
Chart luminance
120 - 200 cd/m2
Eye
OD
OS
Charts
HC-1
HC-2
HC-3
HC-4
Recorded letter-by-letter results into EDC.
4.8
Toric lens orientation
Record the toric lens orientation for each eye to the 
nearest degree.  
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Visit 4: Follow-Up #3
Step
Procedure
Details
4.9
Additional sample of 
toric lens orientation 
(1)
Instruct the subject to leave the consulting room 
and walk around for at least 2 minutes. Upon their 
return, measure and record the toric lens 
orientation to the nearest degree in each eye.  
4.10
Additional sample of 
toric lens orientation 
(2)
Repeat the previous step once again.    
4.11
Lens removal
Remove and place both lenses into a lens case with 
saline solution.
Do not discard the lenses until after biomicroscopy 
has been completed.  
4.12
Biomicroscopy
The FDA Slit Lamp Classification Scale will be 
used to grade findings.  If any slit lamp finding is 
graded as 3 or worse, an adverse event will be 
recorded, and the subject will be monitored as per 
the guidelines given in section 13.
Should the clearance of the fluorescein need to be 
expedited, preservative free rewetting drops or 
artificial tears may be instilled.
Study lenses may be discarded if there is no reason
to store them following biomicroscopy.  
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study.
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
(subject completion 
status)
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason.
F.2
Exit Refraction 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter and record the best-
corrected distance visual acuity (OD and OS) to 
the nearest letter. 
Note: This step is not necessary if the subject was 
exited due to screen failure.
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Final Evaluation
Step
Procedure
Details
F.3
Exit Slit Lamp 
Biomicroscopy (for 
subjects that are 
discontinued early)
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 necessary 
if the subject was exited due to screen failure.
Note: This step is not necessary if the subject was 
exited due to screen failure, or if biomicroscopy 
was performed as part of the final follow-up visit 
procedures (i.e., immediately prior to the final 
evaluation).
7.3.
Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected, as appropriate:
x
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.
x
Date and time of the visit and all procedures completed at the unscheduled visit.
x
Review of adverse event and concomitant medications.
x
Documentation of any test article dispensed or collected from the subject, if applicable.
x
Slit lamp findings (using the Slit Lamp Classification Scale).
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified.
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider. 
The following information will be collected during an unscheduled visit.
Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit
Indicate if the only reason for the visit is that the 
subject requires additional test articles. If the 
reason is other than resupply of previously 
dispensed lenses, specify the reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for reasons 
for the unscheduled visit.
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Unscheduled Visit
Step
Procedure
Details
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and any
adverse events.
U.4
Entrance VA (if 
applicable)
Record the entrance distance visual acuity (OD, 
OS) to the nearest letter. 
U.5
Subjective Sphero-
cylindrical Refraction
(if applicable)
Perform 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 corrected 
distance visual acuity to the nearest letter (OD, 
OS). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be used 
to grade the findings.  If the clearance of the 
fluorescein needs to be expedited, preservative-
free rewetting 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, 
provide additional lenses per the dispensing 
instructions given in the detailed study 
procedures.  
U.8
Exit Visual Acuity (if 
applicable)
Record the subject’s exit distance visual acuity 
(OD, OS) to the nearest letter. 
NOTE: If the only reason for the unscheduled visit is that the subject requires additional 
test articles, only the dispensing information needs to be recorded.
7.4.
Laboratory Procedures  
Not applicable.
8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
x
provided informed consent.
x
they are eligible.
x
have not withdrawn/discontinued from the study for any reason described in 
section 8.2.
x
completed all visits through the final visit (visit 4). If all visits were completed but an 
additional visit is considered necessary for subject care, follow the requirements for 
unscheduled visits in section 7.3.
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8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent.
x
Subject not compliant to protocol.
x
Subject lost to follow-up.
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear.
x
Subjects who have experienced a Corneal Infiltrative Event (CIE).
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment).
x
Subject misses any study visits.
x
Subject not compliant with study lens wear schedule.
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort, or unacceptable fit.
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled).
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity.
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. 
Disallowed concomitant interventions for this study include ocular medications of any kind, 
or any systemic medications that would normally contraindicate contact lens wear or may
otherwise compromise study endpoints.
9.1.
Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. 
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A summary of disallowed systemic medications is shown in Table 3. Subjects with a history 
of taking these medications will be allowed to enroll only if:
x
The medications have been taken on a continual, routine basis for at least 6 months,
and
x
The subject has demonstrated successful contact lens wear during this time.
Or:
x
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 3 on a long-term, routine basis for 
less than 6 months will not be allowed to participate in the study.
Table 3: Disallowed systemic medications
Class of Drug
Common Indication(s)
Common Examples
Estrogens (not
including
contraceptive 
medication)
Menopause, osteoporosis, vaginitis
Vagifem, 
Estrace, 
Climara, 
Vivelle-Dot, Premarin, Minivelle, 
etc.
Anticholinergics
Irritable 
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, 
Transderm Scop, etc.
Beta-blockers
Hypertension, angina, heart attack, 
migraine, 
artrial 
fibrillation, 
andrenal cancer, essential tumor, 
glaucoma
Toprol XL, Lopressor, Tenormin, 
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 4. Subjects with a history 
of taking systemic antihistamines will be allowed to enroll only if:
x
They have taken antihistamines continuously for at least 2 weeks, and 
x
They have demonstrated successful wear while taking the medication
Or:
x
They stopped taking the medication for at least 2 weeks prior to enrollment.
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Table 4: Disallowed systemic antihistamines
Class of Drug
Common Indication(s)
Common Examples
Antihistamines
Allergic rhinitis, sedation, hives, 
allergic conjunctivitis, skin allergy, 
itching, motion sickness
Hydroxyzine, 
Promethagan, 
Phenadoz, 
Vistaril, 
Claritin, 
Zyrtec, Astepro, Astelin, Optivar, 
Allegra, Benedryl, 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 discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations
that contradict the information contained in the Informed Consent/Assent forms will be
considered Major Deviations.
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. 
Protocol waivers are prohibited.
Table 5 lists examples of deviations that will constitute major and minor protocol deviations
for this study. 
Table 5: Examples of major and minor protocol deviations
Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended > 2 days out of 
visit window defined in 
study procedures.
Visit attended ≤ 2 days out of 
visit window defined in 
study procedures.
Unanswered PRO questions
For questionnaires where 
data is related to a primary 
endpoint, more than 2 PRO 
For questionnaires where 
data is related to a primary or
secondary endpoint,
2
or
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Deviation category
Major deviation
Minor deviation
questions are unanswered 
(i.e., left blank).
For 
questionnaires 
not 
related 
to 
the 
primary 
endpoint, the questionnaire 
is not completed (i.e., all 
questions are unanswered).
fewer PRO questions are 
unanswered (i.e., left blank).
For questionnaires where 
data where data is not related 
to the primary endpoint, any 
individual PRO questions are 
unanswered (i.e., left blank).
Insufficient wear of study 
lenses 
Subject does not wear study 
lenses for at least 8 hours on 
at least 5 days of a study lens 
wear period.
Subject wears their habitual 
lenses during any of the 
study lens wear periods.
Subject does not wear study 
lenses for at least 1 hour prior 
to attending a follow-up 
visit.
In 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 cohort 
review.
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
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Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
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x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
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Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
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x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely.
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x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study, it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.).
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x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the
event if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
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, 
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a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
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 
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by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according to
the written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None.
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using Statistical Analysis
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC). Throughout the
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will / will not be summarized separately and will /
will not 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 140 subjects with a target of at least 126 subjects to complete. The power 
calculation is based on 2-sequence and 3-period (Test/Control/Control or Control/Test/Test) 
crossover study design and study results from 
 where prototype toric lens designs with 
the RTY-1 chromophore evaluated in a daily disposable modality against AO1DfA as control 
to demonstrate non-inferiority of the Test relative to the Control.
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Table 6 provides a summary of power based on the primary hypothesis of non-inferiority for 
CLUE Comfort with 126 subjects to complete the study and two-sided Type I error of 0.05
with the assumptions for treatment effect (Test minus Control), standard deviation and 
intraclass correlation. The power calculation is conducted using 1000 simulations with linear 
mixed models using the GLIMMIX procedure in SAS 9.4.
Table 6: Power Calculation for the Primary Hypothesis of CLUE Comfort score (Non-
inferiority of the Test relative to the Control) with Type I error of 0.05.
Mean 
Difference
(Test-Control)
Standard 
Deviation
Number of 
Subjects
(n/2 per 
sequence)
Within Subject Correlation
0.4
0.5
-0.8
23
126
0.710
0.727
-0.8
25
126
0.618
0.633
0
23
126
0.870
0.887
0
25
126
0.804
0.814
0.8
23
126
0.965
0.974
0.8
25
126
0.909
0.931
As shown in the Table 6, the study will be powered (power of 0.8 or higher) to show non-
inferiority of the Test relative to the Control lens with respect to CLUE Comfort score when 
the mean difference ≥ 0, the standard deviation ≤ 25 and an intraclass correlation ≥ 0.4.
14.3. Analysis Populations 
Safety Population:
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the Per-Protocol 
Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded.
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14.4. Level of Statistical Significance 
The primary analysis for this study will be conducted with an overall type I error rate of 5%. 
If any post-hoc statistical analysis after reviewing data is conducted, a type I error rate of 5% 
will be used for exploratory purposes.
14.5. Primary Analysis  
CLUE Comfort score
CLUE Comfort scores at 1-week follow-up will be analyzed using a linear mixed effect model 
to compare between the Test and Control lenses. The model will include the baseline score,
sequence, lens type, lens wearing period, and first order carryover effect as fixed effects.
Additional fixed effects will include subject characteristics such as age and gender. 
Investigational site will be included as a random intercept. The covariance of residual errors 
between different periods for the same subject will be modeled using either homogenous 
compound symmetry (CS), heterogeneous compound-symmetry (HCS) or unstructured (UN) 
covariance structure. The structure that returns the lowest finite sample corrected Akaike’s 
Information criterion will be selected as the structure that best fits the model.8 The Kenward 
and Roger method will be used for the calculation of the denominator degree of freedom.9
The null and alternative hypotheses for non-inferiority of the Test - Control is as follows:
 
ܪ0: Δ < -5
ܪA: Δ ≥ -5
where Δ is the least square mean (LSM) difference of CLUE Comfort score at 1-week follow-
up between the Test and Control lens (Test minus Control). Non-inferiority will be declared if 
the corresponding lower bound of the 95% two-sided confidence interval (CI) of the least 
squares mean (LSM) difference (Test - Control) for CLUE Comfort score at 1-week follow-
up based on the per-protocol population is greater than -5.
14.6. Secondary Analysis 
Not applicable.
14.7. Other Exploratory Analysis  
Descriptive summary of the following efficacy endpoints by treatment arm will be provided 
on the per-protocol population.
x
HLHC distance VA at the follow-up visit
x
Settled lens orientation at the dispensing visit and at follow-up visits
x
Lens rotational stability with blinks at the dispensing visit
x
Subjective response to MRD questionnaire items at the follow-up visit
x
Subjective response to the CLUE questionnaire Comfort, Vision, and Handling items 
at fitting
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x
Subjective response to the CLUE questionnaire Vision and Handling items at follow-
up
14.8. Interim Analysis 
Not applicable.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis. 
No external data sources will be included in this study.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
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15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
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obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
Not applicable for this study. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained.
x
Ensuring the rights and wellbeing of subjects are protected.
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable.
x
Ensuring that the clinical site has sufficient test article and supplies.
x
Clarifying questions regarding the study.
x
Resolving study issues or problems that may arise.
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan.
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18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the fully able to 
understand the risks, benefits, and potential adverse events of the study and provide their 
consent voluntarily.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
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.
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Johnson & Johnson Vision Care, Inc.
During the study, the Investigator (or Sponsor when applicable) will send the following
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy.
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. 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 States7 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential.
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
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Johnson & Johnson Vision Care, Inc.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION 
There is no plan to externally publish this outcome of this investigation.
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html
2. International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). 
Available at: https://www.ich.org/page/efficacy-guidelines
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Straker B. Investigator’s Brochure: Toric lens design in senofilcon A with HEV-
blocking chromophore (RTY-1). 2022.
6. Wirth RJ, et al. Development of the contact lens user experience: CLUE 
scales. Optometry and Vision Science. 2016;93.8:801.
7. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
8. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A comparison of two 
approaches for selecting covariance structures in the analysis of repeated 
measurements. Communications in Statistics - Simulation and Computation.
1998;27(3):591-604.
9. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted
Maximum Likelihood. Biometrics. 1997;53(3):983.
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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1
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Will be provided separately. 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
ACUVUE Oasys 1-Day for Astigmatism
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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.
senoﬁ lcon A Soft (hydrophilic) Contact Lenses
Visibility Tinted with UV Blocker
for Daily Disposable Wear
CAUTION: U.S. Federal law restricts this device to 
sale by or on the order of a licensed practitioner.
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology for ASTIGMATISM
CR-6484, v 1.0
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SYMBOLS KEY
The following symbols may appear on the label or carton:
Date of Manufacture
Manufactured by or in
Consult Instructions for Use
CAUTION: U.S. Federal law restricts this device 
to sale by or on the order of a licensed practitioner
Use By Date (expiration date)
Diameter
DIA
Base Curve
BC
Diopter (lens power)
D
Batch Code
LOT
Sterile Using Steam or Dry Heat
STERILE
UV-Blocking
Fee Paid for Waste Management
Quality System Certification Symbol
123
Lens Orientation Correct
123
Lens Orientation Incorrect (Lens Inside Out)
 
CYL
AXIS
Cylinder
Axis
Single-Use
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
-0.25D to -10.00D
• Axis Range:
5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®  
1-Day with 
HydraLuxe™ 
Technology 
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
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
In 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
range.
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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 HydraLuxe™ 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism.
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ Tech-
nology for ASTIGMATISM are indicated for daily disposable wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism.
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these contact lenses when any of the following 
conditions exist:
• Acute or subacute inﬂ ammation or infection of the anterior chamber 
of the eye.
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids.
• Severe insufﬁ ciency of lacrimal secretion (dry eye).
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• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious advers
actions is increased when lenses are 
worn overnight, and that 
 
 of ulcerative keratitis is greater for 
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extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products.
• The overall risk of ulcerative keratitis may be reduced by carefully 
following directions for lens care.
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783
Speciﬁ c Instructions for Use and Warnings:
• Water Activity
Instructions for Use
Do not expose contact lenses to water while wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, 
vision loss or blindness. If lenses have been submersed in water 
when participating in water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient should be instructed to discard them 
and replace them with a new pair. The Eye Care Professional should 
be consulted for recommendations regarding wearing lenses during 
any activity involving water.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investiga-
tion of lenses, all refractive powers, design conﬁ gurations, or lens 
parameters available in the lens material are not evaluated in signif-
icant numbers. Consequently, when selecting an appropriate lens 
design and parameters, the Eye Care Professional should consider 
all characteristics of the lens that can affect lens performance and 
ocular health, including oxygen permeability, wettability, central and 
peripheral thickness, and optic zone diameter.
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• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handlin
in
rt n, removal, and wearing 
instructions in the “Patient
t
ct n Guide” for the prescribed 
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wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
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Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potenti
e temporary impairment due to 
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peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
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GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be selected for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses.  
1. Criteria of a Properly Fit Lens 
A properly ﬁ t lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufﬁ cient 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 ﬂ at ﬁ tting 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. If the lens is 
judged to be ﬂ at ﬁ tting, it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens 
A steep ﬁ tting lens may exhibit one or more of the following charac-
teristics: insufﬁ cient 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 ﬁ tting, it should not be dispensed to 
the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t 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. If resistance is encountered when pushing the lens up, the 
lens is ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should 
p
n e good visual acuity with the 
correct lens power unless there 
x
ss ve residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll 
ﬁ nd two primary marks approximately 1 mm from the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, 
either mark can represent the vertical position – there is no “top” 
and “bottom” as in a prism-ballasted lens. You don’t need to view 
both marks to assess orientation; simply look for the 6 o’clock 
mark as you would with a prism-ballasted lens.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
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B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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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 signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
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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.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateral 
uld require corrective lenses on 
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s performance under the above conditions 
is completed, tests of 
 
t and reading ability under 
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conditions of moderately dim illumination should be attempted.
An initial unfavorable response in the ofﬁ ce, 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 ﬁ rst 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 
ﬁ rst 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 ﬁ rst to make sure 
that their vision is satisfactory for operating an automobile. During 
the ﬁ rst 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.
D. Other Suggestions
The success of the monovision technique may be further improved by 
having the 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 speciﬁ c visual tasks may improve the success 
of monovision correction. This is particularly applicable for those 
patients who cannot meet state driver's licensing requirements 
with monovision correction.
• Make use of proper 
when carrying out visual tasks.
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Monovision ﬁ tting success can be improved by the following 
suggestions:
• Reverse the distance and near eyes if a patient is having trouble 
adapting.
• Reﬁ ne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients.
• Emphasize the beneﬁ ts of clear near vision and straight ahead 
and upward gaze with monovision.
The decision to ﬁ t 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 at www.acuvue.com.
PATIENT MANAGEMENT
Dispensing Visit
Each sterile lens is 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 ﬁ nger 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 ﬁ t and visual acuity of the lens on each eye.
• Teach the patient how to apply and remove his or her lenses.
• Explain daily disposable lens wear and schedule a follow-up 
examination.
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com.
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES.
Follow-Up Examinations
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of speciﬁ c problems, if any, and a
v
 
th the patient of the wear 
schedule, daily disposable modal
a
 p oper lens handling procedures. 
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Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
CR-6484, v 1.0
VCT-0007 (13) 
 
Page 103 of 170
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the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
CR-6484, v 1.0
 
 
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The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day for ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, 
r, and expiration date
CR-6484, v 1.0
13) 
 
Page 105 of 170
JJVC CONFIDENTIAL

REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
CR-6484, v 1.0
 
 
Page 106 of 170
JJVC CONFIDENTIAL

Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
©Johnson & Johnson Vision Care Companies 2016
In Canada: Johnson & Johnson Vision Care, division of Johnson & Johnson, Inc. 
In USA: Johnson & Johnson Vision Care, Inc.
Printed in USA.
Revision date: 09/16
Revision number: AO-03-16-13
ACUVUE OASYS® and HydraLuxe™ are Trademarks of 
the Johnson & Joh
is n Care Companies
20401080
CR-6484, v 1.0
-
 (
 
 
Page 107 of 170
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 
 
x
LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
x
 BIOMICROSCOPY SCALE 
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
x
TORIC FIT EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
PATIENT REPORTED OUTCOMES
x
 LENS INSERTION AND REMOVAL
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
 
 
CR-6484, v 1.0
 
 
Page 108 of 170
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS 
 
CR-6484, v 1.0
 
 
Page 109 of 170
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 1 of 5
CR-6484, v 1.0
 
 
Page 110 of 170
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 2 of 5
              
       
CR-6484, v 1.0
 
 
Page 111 of 170
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 3 of 5
CR-6484, v 1.0
 
 
Page 112 of 170
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 4 of 5
CR-6484, v 1.0
 
 
Page 113 of 170
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 5 of 5
CR-6484, v 1.0
 
 
Page 114 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS 
 
CR-6484, v 1.0
 
 
Page 115 of 170
JJVC CONFIDENTIAL

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CR-6484, v 1.0
 
 
Page 116 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS  
 
CR-6484, v 1.0
 
 
Page 117 of 170
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 1 of 5
       
  
       
       
       
        
CR-6484, v 1.0
 
 
Page 118 of 170
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 2 of 5
CR-6484, v 1.0
 
 
Page 119 of 170
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 3 of 5
CR-6484, v 1.0
 
 
Page 120 of 170
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 4 of 5
       
       
       
       
       
CR-6484, v 1.0
 
 
Page 121 of 170
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 5 of 5
CR-6484, v 1.0
 
 
Page 122 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE  
 
CR-6484, v 1.0
 
 
Page 123 of 170
JJVC CONFIDENTIAL

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Page 127 of 170
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CR-6484, v 1.0
 
 
Page 128 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
 
CR-6484, v 1.0
 
 
Page 129 of 170
JJVC CONFIDENTIAL

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CR-6484, v 1.0
 
 
Page 130 of 170
JJVC CONFIDENTIAL

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Page 131 of 170
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CR-6484, v 1.0
 
 
Page 132 of 170
JJVC CONFIDENTIAL

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CR-6484, v 1.0
 
 
Page 133 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 TORIC FIT EVALUATION 
 
CR-6484, v 1.0
 
 
Page 134 of 170
JJVC CONFIDENTIAL

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CR-6484, v 1.0
 
 
Page 135 of 170
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CR-6484, v 1.0
 
 
Page 136 of 170
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Page 137 of 170
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CR-6484, v 1.0
 
 
Page 138 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
 
CR-6484, v 1.0
 
 
Page 139 of 170
JJVC CONFIDENTIAL

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CR-6484, v 1.0
 
 
Page 140 of 170
JJVC CONFIDENTIAL

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Page 141 of 170
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dŝƚůĞ͗
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CR-6484, v 1.0
 
 
Page 142 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES 
 
CR-6484, v 1.0
 
 
Page 143 of 170
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Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
3
Page 1 of 1
                      
CR-6484, v 1.0
 
 
Page 144 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS INSERTION AND REMOVAL 
 
CR-6484, v 1.0
 
 
Page 145 of 170
JJVC CONFIDENTIAL

Title:   
Lens Insertion and Removal
Document Type:
Document Number:
Revision Number:  3
Page 1 of 2
CR-6484, v 1.0
 
 
Page 146 of 170
JJVC CONFIDENTIAL

Title:   
Lens Insertion and Removal
Document Type:
Document Number:
Revision Number:  3
Page 2 of 2
CR-6484, v 1.0
 
 
Page 147 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
CR-6484, v 1.0
 
 
Page 148 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 149 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 150 of 170
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 151 of 170
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 152 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 153 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 154 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 155 of 170
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6484, v 1.0
 
 
Page 156 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
CR-6484, v 1.0
 
 
Page 157 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
CR-6484, v 1.0
 
 
Page 158 of 170
JJVC CONFIDENTIAL

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Page 168 of 170
JJVC CONFIDENTIAL

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Page 169 of 170
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6484 Evaluation of Toric Soft Contact Lenses Containing a 
Chromophore to Block High-Energy Visible Light Produced on Commercial Manufacturing 
Lines
Version and Date: 1.0 14 March 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 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion.
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in Appendix F of this protocol). I agree to conduct 
this study in compliance with local, state, governmental guidance for COVID-19 risks.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
CR-6484, v 1.0
 
 
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