Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured With an Alternative Hydration Process
Phase: NA
Conditions: Ocular Physiology
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
Feasibility Evaluation of Daily Disposable Toric Soft Contact Lenses Manufactured with an 
Alternative Hydration Process 
Protocol CR-6482  
Version: 2.0   
Date: 27 June 2022 
Investigational Products: Test: ACUVUE® OASYS 1-Day for ASTIGMATISM (AO1DfA) 
manufactured with propylene glycol hydration. Control: currently marketed AO1DfA with 
standard manufacturing process 
Keywords: Astigmatism, ACUVUE® OASYS 1-Day for Astigmatism, senofilcon A, daily 
wear, daily disposable, dispensing, Single use Eye-Cept® Rewetting Drops, LacriPure Saline 
Solution, ScleralFil Preservative Free Saline Solution, CLUE comfort, CLUE vision, CLUE 
handling, logMAR visual acuity, rotation performance. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 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 ..................................................................................................... 18 
3.4. 
Enrollment Strategy.................................................................................................. 19 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION ............................................................................................. 22 
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6.1. 
Identity of Test Articles............................................................................................ 22 
6.2. 
Ancillary Supplies/Products ..................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 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 ........................................................................................................................... 34 
VISIT 3 ........................................................................................................................... 36 
VISIT 4 ........................................................................................................................... 37 
FINAL EVALUATION .................................................................................................. 38 
7.3. 
Unscheduled Visits ................................................................................................... 39 
7.4. 
Laboratory Procedures ............................................................................................. 40 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 41 
8.1. 
Completion Criteria .................................................................................................. 41 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 41 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 42 
9.1. 
Systemic Medications .............................................................................................. 42 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 43 
11. 
STUDY TERMINATION ........................................................................................... 44 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 45 
13. 
ADVERSE EVENTS ................................................................................................... 46 
13.1. 
Definitions and Classifications ............................................................................. 46 
13.2. 
Assessing Adverse Events .................................................................................... 48 
13.2.1. 
Causality Assessment .................................................................................... 49 
13.2.2. 
Severity Assessment ...................................................................................... 49 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 49 
13.4. 
Reporting Adverse Events .................................................................................... 51 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 51 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
52 
13.5. 
Event of Special Interest ....................................................................................... 52 
13.6. 
Reporting of Pregnancy ........................................................................................ 52 
14. 
STATISTICAL METHODS ........................................................................................ 52 
14.1. 
General Considerations ......................................................................................... 52 
14.2. 
Sample Size Justification ...................................................................................... 53 
14.3. 
Analysis Populations ............................................................................................ 53 
14.4. 
Level of Statistical Significance ........................................................................... 53 
14.5. 
Primary Analysis .................................................................................................. 53 
14.6. 
Secondary Analysis .............................................................................................. 53 
14.7. 
Other Exploratory Analysis .................................................................................. 54 
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.............................................................................. 56 
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 ................................................................................................. 59 
18.5. 
Privacy of Personal Data ...................................................................................... 59 
19. 
STUDY RECORD RETENTION................................................................................ 60 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 61 
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21. 
PUBLICATION ........................................................................................................... 61 
22. 
REFERENCES ............................................................................................................ 61 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 63 
APPENDIX B: PATIENT INSTRUCTION GUIDE  ............................................................ 72 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 73 
APPENDIX D: 
 .................................... 102 
LENS FITTING CHARACTERISTICS ............................................................. 103 
SUBJECT REPORTED OCULAR SYMPTOMS .............................................. 109 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 111 
BIOMICROSCOPY SCALE .............................................................................. 117 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION ......................... 123 
TORIC FIT EVALUATION ............................................................................... 128 
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE ...... 133 
PATIENT REPORTED OUTCOMES................................................................ 137 
LENS INSERTION AND REMOVAL .............................................................. 139 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 142 
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 151 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 163 
 
LIST OF TABLES 
Table 1: Test Articles .............................................................................................................. 23 
Table 2: Ancillary Supplies .................................................................................................... 24 
Table 3: Time and Events ....................................................................................................... 26 
Table 4: Disallowed systemic medications ............................................................................. 42 
Table 5: Disallowed systemic antihistamines ......................................................................... 43 
Table 6: Examples of major and minor protocol deviations ................................................... 44 
 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 14 
 
 
 
 
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SYNOPSIS  
Protocol Title 
Feasibility Evaluation of Daily Disposable Toric Soft Contact 
Lenses Manufactured with an Alternative Hydration Process 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Clinical trial phase: Feasibility  
Design control phase: Post-launch design change 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s) 
Investigational Products:  
Test: ACUVUE® OASYS 1-Day for ASTIGMATISM 
(AO1DfA) Soft Contact Lenses produced with propylene 
glycol (PG) hydration. 
Approved Products:  
Control: AO1DfA Soft Contact Lenses produced with the 
current commercial manufacturing process.  
Wear and Replacement 
Schedules 
Wear Schedule: daily wear 
Replacement Schedule: daily disposable 
Objectives  
Primary Objective: 
To evaluate the incidence of grade 3 or higher biomicroscopy 
findings following a 7(±2) day wear period for AO1DfA 
contact lenses produced with propylene glycol (PG) hydration 
relative to the same design produced using the current 
commercial manufacturing process. 
 
Exploratory Objectives: 
To evaluate the subjective comfort, vision and handling, 
visual acuity, and rotational performance over a 7(±2) day 
wear period for AO1DfA contact lenses produced with 
propylene glycol (PG) hydration relative to the same design 
produced using the current commercial manufacturing 
process. 
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Study Endpoints 
Primary endpoint: 
x Incidence of grade 3 or higher biomicroscopy findings 
using the FDA grading scale following a 7(±2) day 
wear period  
 
Observational endpoints (efficacy): 
x Subjective comfort, vision and handling at fitting and 
following a 7(±2) day wear period using the CLUE 
questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity 
in logMAR measured using ETDRS charts at follow-
up 
x Lens orientation at 1 minute and 3 minutes following 
insertion at fitting 
x Mean and standard deviation of settled lens orientation 
calculated from repeated measures of settled lens 
orientation at fitting and follow-up visits  
 
Observational endpoints (safety): 
x Adverse events 
 
All endpoints will be summarized using descriptive statistics 
only; no formal hypothesis testing is planned. 
Study Design 
This is a bilateral, dispensing, randomized, controlled, double 
masked, 2×2 cross-over study. Each subject will be randomly 
assigned to one of two wear sequences (test followed by 
control or control followed by test). Each wear period will be 
7(±2) days, with a 7(±2) day washout period between wear 
periods.  
 
There will be a total of 4 visits: 
Visit 1: Screening, baseline evaluation and lens fit #1  
Visit 2: Follow-up evaluation for first lens 
Visit 3: Continuance, lens fit #2 
Visit 4: Follow-up evaluation for second lens 
 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
Sample Size 
This study will have an enrollment target of approximately 66 
subjects, with a target of at least 60 to complete (assuming a 
dropout rate of 10%). 
Study Duration 
Total study duration including the enrollment period is 
anticipated to be approximately 8 weeks. 
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Anticipated Study 
Population 
Subjects will be habitual soft contact lens wearers with 
bilateral astigmatism who are between 18 and 39 years of age 
(inclusive). 
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy of all the following criteria to 
be enrolled in the study. 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form.  
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol. 
3. Be between 18 and 39 (inclusive) years of age at the time 
of screening. 
4. By self-report, habitually wear soft contact lenses in both 
eyes in a daily reusable or daily disposable wear modality 
(i.e. not extended wear modality). Habitual wear is defined 
as a minimum of 6 hours of wear per day, for a minimum 
of 2 days per week during the past month. 
5. Possess a wearable pair of spectacles that provide 
correction for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. In both eyes, have astigmatic refractive error suitable for 
correction with the toric contact lens powers available in 
this study: 
a. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 
0.25 steps 
b. Cylinder powers (DC) -0.75 and -1.25 
c. Axes (°) 170, 180, 10, 80, 90, 100 
7. Have best corrected monocular distance visual acuity of 
20/30 or better in each eye. 
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Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be diabetic. 
3. Be currently using any ocular medications or have an 
ocular infection of any type. 
4. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication that might 
contraindicate or interfere with contact lens wear, or 
otherwise 
compromise 
study 
endpoints, 
including 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis), 
contagious immunosuppressive disease (e.g., Human 
Immunodeficiency Virus [HIV]), autoimmune disease 
(e.g. rheumatoid arthritis, Sjögren’s syndrome), or history 
of serious mental illness or seizures. See section 9.1 for 
additional 
details 
regarding 
excluded 
systemic 
medications.  
5. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, 
SoftPerm) within the past 6 months. 
6. Be currently wearing monovision or multifocal contact 
lenses. 
7. Be currently wearing lenses in an extended wear modality. 
8. Have a history of strabismus or amblyopia. 
9. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an employee 
(including partner, child, parent, grandparent, grandchild 
or sibling of the employee or their spouse) of the clinical 
site. 
10. Have participated in a contact lens or lens care product 
clinical trial within 7 days prior to study enrollment. 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
11. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities that contraindicate contact lens wear or may 
otherwise compromise study endpoints (including 
entropion, ectropion, chalazia, recurrent styes, glaucoma, 
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history of recurrent corneal erosions, aphakia, moderate or 
above corneal distortion, herpetic keratitis).  
12. Have fluctuations in vision due to clinically significant dry 
eye or other ocular conditions.  
13. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, 
PRK, LASIK, iridotomy, retinal laser photocoagulation, 
etc.). 
Disallowed 
Medications/Interventions  
Subjects will not be eligible to enroll if they are taking any 
ocular medications, or any systemic medications that would 
normally contraindicate contact lens wear or may otherwise 
compromise study endpoints. See section 9.1 for details 
regarding disallowed systemic medications. 
Measurements and 
Procedures 
Key procedures associated with the endpoints for this study 
will include: 
- Examination of the anterior segment using a slit lamp 
biomicroscope and grading findings using the FDA 
grading scale 
- Completion of the CLUE questionnaire at fitting and 
follow-up 
- Measurement of HLHC VA using ETDRS charts at follow-
up 
- Measurement of lens orientation at 1 minute and 3 minutes 
following insertion, and following lens settling 
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 #2) 
Lens assignment and insertion
Timed rotation assessments, lens settling 
Toric and general fit assessment 
Spherical over-refraction, modification if required 
CLUE post-fit questionnaire 
Additional samples of toric lens orientation  
Lenses dispensed for 7r2 days 
Follow-up (#1 through #2) 
CLUE follow-up questionnaire 
ETDRS HLHC visual acuity 
Record lens orientation 
Additional samples of toric lens orientation  
Lens removal 
Biomicroscopy 
Schedule next visit 
Continuance 
Review med history and medications 
Subject reported ocular symptoms 
Entrance VA and biomicroscopy 
Confirm continuing eligibility 
Final Evaluation 
Spherocylindrical refraction 
Completion status 
Biomicroscopy (if discontinued early) 
After follow-up #1 
al Evaluation
After follow-up #2
Washout Period 
A washout period of 7r2 days duration 
will be observed between wear periods 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
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 
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 
The AO1DfA lens is a daily wear, daily disposable toric soft contact lens manufactured in 
senofilcon A. This lens is currently produced with isopropyl alcohol (IPA) hydration, whereas 
the spherical counterpart to this lens (ACUVUE® OASYS 1-Day Contact Lenses) is 
manufactured with propylene glycol (PG) hydration.  
 
The purpose of this study is to evaluate the feasibility of manufacturing AO1DfA lenses using 
PG hydration with comparable clinical performance to those made with the current IPA 
hydration process.  
1.1. Name and Descriptions of Investigational Products  
This study will evaluate the AO1DfA lens design produced using PG hydration against 
AO1DfA lenses produced using the standard IPA hydration process as control. Further details 
about the test articles are found in section 6.1 of this protocol. 
1.2. Intended Use of Investigational Products 
The intended use of the investigational product is the correction of astigmatism and associated 
myopic refractive error. Study lenses will be worn bilaterally in a daily wear, daily disposable 
modality for at least 8 hours per day. Each wear period will be 7±2 (i.e., 5 to 9) days in duration, 
and subjects will wear lenses for at least 5 days per week during each wear period. Two wear 
periods will be completed, with a washout period of 7±2 days between the wear periods. 
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding AO1DfA 
lenses manufactured with PG hydration refer to the latest version of the Investigator's 
Brochure.5 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the investigational lenses will be the correction of refractive 
error. The risks associated with use of the investigational lenses are considered to be equivalent 
to those associated with other commercial soft contact lenses worn in the same modality (i.e. 
daily disposable).   
 
For the most comprehensive risk and benefit information regarding AO1DfA lenses 
manufactured with PG hydration refer to the latest version of the Investigator's Brochure.5 
Comprehensive risk and benefit information regarding AO1DfA lenses produced using the 
current manufacturing process is included in the AO1DfA package insert (Appendix C).   
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1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The AO1DfA lens (manufactured with IPA hydration) has an extensive safety history and has 
been marketed in the US and Europe since 2017 with no incidence of recalls. The spherical 
counterpart to this lens, ACUVUE® OASYS 1-Day (AO1D) manufactured with PG hydration, 
has been marketed commercially since 2016 and also has no history of recalls.  
 
AO1DfA lenses manufactured with PG hydration were previously evaluated in 
 over 
a 5- to 7-day dispensing period.6 Out of the 121 subjects that were randomized, two ocular and 
two non-ocular adverse events were reported, all of which were considered unrelated or 
doubted to be related to the investigational lenses.  
 
Further information regarding literature references and prior data relevant to the test and 
control lenses can be found in the Investigator's Brochure5 and AO1DfA package insert 
(Appendix C), respectively. 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Primary Objective: 
To evaluate the incidence of grade 3 or higher biomicroscopy findings following a 7(±2) day 
wear period for AO1DfA contact lenses produced with propylene glycol (PG) hydration 
relative to the same design produced using the current commercial manufacturing process. 
 
Exploratory Objectives: 
To evaluate the subjective comfort, vision and handling, visual acuity, and rotational 
performance over a 7(±2) day wear period for AO1DfA contact lenses produced with 
propylene glycol (PG) hydration relative to the same design produced using the current 
commercial manufacturing process. 
2.2. Endpoints  
Primary endpoint: 
x Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period  
 
Observational endpoints (efficacy): 
x Subjective comfort, vision and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity in logMAR measured using 
ETDRS charts at follow-up 
x Lens orientation at 1 minute and 3 minutes following insertion at fitting 
x Mean and standard deviation of settled lens orientation calculated from repeated 
measures of settled lens orientation at fitting and follow-up visits  
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Observational endpoints (safety): 
x Adverse events 
2.3. Hypotheses 
All endpoints will be summarized using descriptive statistics only; no formal hypothesis testing 
will be conducted. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
The target population for this study will be healthy adult soft contact lens wearers between 18 
and 39 years of age with binocular myopic astigmatism.   
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria at Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.  
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between 18 and 39 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or 
daily disposable wear modality (i.e. not extended wear modality). Habitual wear is 
defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week 
during the past month. 
5. Possess a wearable pair of spectacles that provide correction for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. In both eyes, have astigmatic refractive error suitable for correction with the toric 
contact lens powers available in this study: 
a. Sphere powers (DS) -1.50 through -4.00 (inclusive) in 0.25 steps 
b. Cylinder powers (DC) -0.75 and -1.25 
c. Axes (°) 170, 180, 10, 80, 90, 100 
7. Have best corrected monocular distance visual acuity of 20/30 or better in each eye. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
Exclusion Criteria following Screening 
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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 at Baseline Evaluation 
The subject must not: 
11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp 
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate 
contact lens wear or may otherwise compromise study endpoints (including entropion, 
ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, 
aphakia, moderate or above corneal distortion, herpetic keratitis).  
12. Have fluctuations in vision due to clinically significant dry eye or other ocular 
conditions.  
13. Have had or have planned (within the study period) any ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
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4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This will be a 4-visit, randomized, controlled, double-masked, bilateral wear, dispensing, 2×2 
crossover study. Each subject will be randomized into one of two unique sequences to wear 
two different study lenses one at a time over two wear periods (test followed by control or 
control followed by test). During each wear period the lenses will be worn bilaterally for 1 
week (7r2 days) in a daily disposable modality. Study lenses will be worn for a minimum of 
8 hours per day and at least 5 days per week during the wear period. Subjective comfort, vision 
and handling will be assessed using the CLUE questionnaire at both fitting and follow-up visits 
for each wear period. HLHC VA will be assessed at the follow-up evaluation using ETDRS 
charts. There will be a washout period of 7r2 days duration between wear periods. Subjects 
will not have access to the study lenses following completion of the protocol. 
4.2. Study Design Rationale 
A 2×2 crossover study design was chosen to allow efficient comparison of the test articles by 
allowing each subject to act as their own control. A washout period will be included to mitigate 
any carryover effects.  
 
The prescribed wear schedule (7r2 days, minimum of 8 hours per day, minimum of 5 days per 
week) was chosen as this is representative of a typical wear schedule for contact lens wearers.  
 
The control lens will be AO1DfA manufactured on commercial production lines using the 
standard IPA hydration process, thus the only difference between the test and control lenses in 
this study will be the hydration process.  
 
The CLUE questionnaire was selected on the basis of being the best available validated PRO 
tool for assessing subjective overall comfort, vision and handling of soft contact lens wearers. 
 
ETDRS charts will be used to measure visual acuity in logMAR units under high-luminance 
conditions using high-contrast charts. ETRDS charts were chosen on the basis of being 
considered the gold standard for logMAR visual acuity measurements in clinical trials.  
 
The investigational lenses will be fitted by optometrists who are experienced at fitting soft 
contact lenses and will be evaluated by habitual contact lens wearers in their standard wearing 
environment. 
4.3. Enrollment Target and Study Duration 
This study will have an enrollment target of approximately 66 subjects, with a target of at least 
60 to complete. The study will be conducted at up to approximately 6 clinical sites, where the 
enrollment target for each site will be approximately 11 subjects. A subject will be considered 
enrolled upon signing of the informed consent form.   
 
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There will be 4 visits in total per subject; total study duration including the enrollment period 
is expected to be approximately 8 weeks. Subjects who are discontinued prior to the final 
evaluation may be replaced at the discretion of the study sponsor. The investigation will end 
at the time that the study data is hard locked. 
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
This study will be a randomized, double-masked, 2×2 crossover design. Subjects will be 
randomized into one of 2 unique sequence groups (test/control or control/test) in a 1:1 
allocation ratio to wear two different study lens designs (test and control designs) one at a time 
bilaterally over 2 wear periods.  
 
Use of the test articles will be randomized using a randomization scheme supplied by the study 
biostatistician.  The randomized assignment of subjects will be performed at the first visit prior 
to the first fitting. Clinical sites will follow the randomization scheme provided and will not 
pre-select or assign subjects. The following must have occurred prior to randomization: 
x Informed consent must have been obtained 
x The subject must have met all inclusion and exclusion criteria 
x The subject history and baseline information must have been collected 
 
Randomly permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme (lens fitting schedule) to obtain the test article assignment for 
that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme (lens fitting schedule).  
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2. Masking 
To reduce the possibility of bias, this will be a double-masked trial. Subjects will not be aware 
of the identity of the assigned lenses. The identity of the study lenses will be masked by having 
the blister packs labeled with the study number, lot number, sphere power, cylinder power, 
axis, expiration date and randomization code. While clinical trial personnel (including 
investigators, site technicians, data management, the study biostatistician and clinical 
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operations personnel) will be aware of the parameters of the test and control lenses (material, 
design, etc. including brand and type of the control lenses), every attempt will be made to 
ensure they are not made aware of the corresponding randomization codes for the test and 
control articles. Only the unmasked Biostatistician generating the randomization scheme (lens 
fitting schedule) will have access to the decode information that allows matching of the 
randomization codes to the investigational designs. The medical monitor will also have access 
to the decode information in case breaking the mask is necessary for the urgent medical 
treatment of a subject. 
5.3. Procedures for Maintaining and Breaking the Masking 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued may be replaced at the 
discretion of the study sponsor.  
6. STUDY INTERVENTION 
6.1. Identity of Test Articles  
The following contact lenses will be used in this study: 
 
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8. SUBJECTS COMPLETION/WITHDRAWAL  
8.1. Completion Criteria 
Subjects are considered to have completed the study if they:  
x provided informed consent. 
x they are eligible. 
x have not withdrawn/discontinued from the study for any reason described in 
section 8.2. 
x completed all visits through the final visit (visit 4). If all visits were completed but an 
additional visit is considered necessary for subject care, follow the requirements for 
unscheduled visits in section 7.3. 
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
x Subject withdrawal of consent. 
x Subject not compliant to protocol. 
x Subject lost to follow-up. 
x Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear. 
x Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x Subject misses any study visits. 
x Subject not compliant with study lens wear schedule. 
x Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
 
For discontinued subjects, the Investigator will: 
x Complete the current visit (scheduled or unscheduled). 
x Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x Record the spherocylindrical refraction with best corrected distance visual acuity. 
x Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x Collect all unused test article(s) from the subject. 
x Make arrangements for subject care, if needed, due to their study participation 
 
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 
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JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x Lens replacements that occur due to drops/fall-outs. 
x Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x Who received the complaint. 
x Study number. 
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x Clinical site information (contact name, site ID, telephone number). 
x Lot number(s). 
x Unique Subject Identifier(s). 
x Indication of who first observed complaint (site personnel or subject). 
x OD/OS indication, along with whether the lens was inserted. 
x Any related AE number if applicable. 
x Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x Eye Care Provider objective (slit lamp) findings if applicable. 
x Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
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x Death 
x Serious deterioration in the health of the subject that resulted in any of the following: 
x Life-threatening illness or injury 
x Permanent or persistent impairment of a body structure or a body function 
x Hospitalization or prolongation of patient hospitalization 
x Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x Chronic disease 
x Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
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 
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wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x Non-significant Infiltrative Event (NSIE) 
x Contact Lens Papillary Conjunctivitis (CLPC) 
x Superficial Punctate Keratitis (SPK) 
x Conjunctivitis: Bacterial, Viral, Allergic 
x Blepharitis 
x Meibomianitis 
x Contact Dermatitis 
x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lenVGLVFRQWLQXDWLRQZHHNV 
 
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. 
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x Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
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.   
 
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Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x Adverse event (diagnosis not symptom). 
x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
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 
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a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
x Notify the Sponsor immediately. 
x Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
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 
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than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
 
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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 
Approximately 66 subjects will be enrolled in this study to attain a minimum of 60 completed 
subjects. All endpoints will be summarized using descriptive statistics describe in section 14.1; 
no hypothesis is planned to be tested. Sample size is selected to limit the exposure to the new 
hydration process, and to evaluate the clinical performance of AO1DfA produced with PG vs. 
IPA hydration. 
14.3. Analysis Populations 
Safety Population: 
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the Per-Protocol 
Population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
No inferential statistics are planned to be performed in this study; hence, the level of statistical 
significance is not a concern.  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 
Descriptive summary of the primary endpoint by treatment arm will be provided for safety 
population. 
x Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period  
14.6. Secondary Analysis 
Not applicable.   
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14.7. Other Exploratory Analysis 
Descriptive summary of the following efficacy endpoints by treatment arm  will be provided 
for both intent-to-treat and per-protocol population. 
x Subjective comfort, vision and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity in logMAR measured using 
ETDRS charts at follow-up 
x Lens orientation at 1 minute and 3 minutes following insertion at fitting 
x Mean and standard deviation of settled lens orientation calculated from repeated 
measures of settled lens orientation at fitting and follow-up visits  
   
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.  
 
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Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x subject identification 
x eligibility 
x study identification 
x study discussion 
x provision of and date of informed consent 
x visit dates 
x results of safety and efficacy parameters as required by the protocol 
x a record of all adverse events 
x follow-up of adverse events 
x medical history and concomitant medication 
x test article receipt/dispensing/return records 
x date of study completion 
x reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
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. 
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16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
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. 
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x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test article and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the fully able to 
understand the risks, benefits, and potential adverse events of the study and provide their 
consent voluntarily. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2) 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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. 
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x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x Protocol revisions 
x Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x If applicable, new or revised subject recruitment materials approved by the Sponsor 
x Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x Investigator’s Brochure revisions  
x Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x Major protocol deviations as required by the IEC/IRB 
x Report of deaths of subjects under the Investigator's care 
x Notification if a new Investigator is responsible for the study at the clinical site 
x Any other requirements of the IEC/IRB 
 
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. 
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18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the 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. 
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The Sponsor ensures that the personal data will be: 
x processed fairly and lawfully. 
x collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x adequate, relevant, and not excessive in relation to said purposes. 
x accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
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. 
 
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If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
x Continuing an ineligible subject in the study. 
x Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x Query resolution. 
x Case Report Form signature. 
x Completion of any follow-up action items. 
21. PUBLICATION 
There is no plan to externally publish the results of this investigation. 
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html 
2. International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). 
Available at: https://www.ich.org/page/efficacy-guidelines 
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Straker B. Investigator’s Brochure: ACUVUE® OASYS 1-Day for ASTIGMATISM 
Toric Soft Contact Lens Manufactured with Propylene Glycol Hydration. 2022.   
6. Hamada, W. Clinical Study Report 
 Three-way Cross-over 
Evaluation of Senofilcon-based Prototype C2 Acuvue® Oasys® for Astigmatism Toric 
Lens Design using an Alternative Manufacturing Process and Acuvue® Oasys® Brand 
for Astigmatism. May 29, 2014. 
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7. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The patient instruction guide (PIG) will be provided separately.  
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
 
 
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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:
2.5° 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 power 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 adverse reactions is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
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extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the 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 handling, insertion, removal, and wearing 
instructions in the “Patient Instruction 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 potential for some 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 experience good visual acuity with the 
correct lens power unless there is excessive residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
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 myope would 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 visual acuity 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 illumination 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 review with the patient of the wear 
schedule, daily disposable modality, and proper 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 
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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. 
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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, lot number, and expiration date
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX D: 
 
 
x 
LENS FITTING CHARACTERISTICS 
x 
SUBJECT REPORTED OCULAR SYMPTOMS 
x 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS  
x 
BIOMICROSCOPY SCALE  
x 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
x 
TORIC FIT EVALUATION 
x 
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
x 
PATIENT REPORTED OUTCOMES 
x 
LENS INSERTION AND REMOVAL 
x 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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 LENS FITTING CHARACTERISTICS 
 
 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
  
 
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 BIOMICROSCOPY SCALE  
 
 
 
 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
 
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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 TORIC FIT EVALUATION 
 
 
 
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Title:                          Toric Fit Evaluation
Document Type:  
Document Number:
Revision Number:  7 
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Title:                          Toric Fit Evaluation
Document Type:  
Document Number:
Revision Number:  7 
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 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
 
 
 
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PATIENT REPORTED OUTCOMES 
 
 
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 LENS INSERTION AND REMOVAL 
 
 
 
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Title:    
 
Lens Insertion and Removal
Document Type:
Document Number: 
Revision Number:  3 
 
 
 
 
 
 
 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Clinical Study Protocol 
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APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION  
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6482 Feasibility Evaluation of Daily Disposable Toric Soft Contact 
Lenses Manufactured with an Alternative Hydration Process 
 
Version and Date: 2.0 27 June 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 the Appendix E of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
Principal 
Investigator: 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
 
Institution/Site: 
 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
 
Institution/Site Address 
 
 
 
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