Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title: Evaluation of Comfort for two marketed daily disposable contact lenses 
Protocol Number: CR-6456
Version: 1.0
Date: 11 June 2021
Approved Products: ACUVUE® OASYS Brand Contact Lenses 1-Day with HydraLuxeTM
Technology (O1D), Alcon Precision1™ Soft Contact Lenses (P1)
Keywords: Sphere, senofilcon A (C3), verofilcon A, dispensing, daily disposable, daily wear, 
patient reported outcomes, comfort, digital device. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 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................................................................................................................ 9 
SYNOPSIS .............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 16 
1.
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives ................................................................................................................. 18 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3.
TARGETED STUDY POPULATION ........................................................................... 21 
3.1. 
General Characteristics ............................................................................................ 21 
3.2. 
Inclusion Criteria ...................................................................................................... 21 
3.3. 
Exclusion Criteria ..................................................................................................... 21 
3.4. 
Enrollment Strategy.................................................................................................. 22 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 22 
4.1. 
Description of Study Design .................................................................................... 22 
4.2. 
Study Design Rationale ............................................................................................ 23 
4.3. 
Enrollment Target and Study Duration .................................................................... 23 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 23 
5.1. 
Test Article Allocation ............................................................................................. 23 
5.2. 
Masking .................................................................................................................... 24 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 24 
6.
STUDY INTERVENTION ............................................................................................. 25 
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6.1. 
Identity of Test Articles............................................................................................ 25 
6.2. 
Ancillary Supplies/Products ..................................................................................... 26 
6.3. 
Administration of Test Articles ................................................................................ 26 
6.4. 
Packaging and Labeling ........................................................................................... 26 
6.5. 
Storage Conditions ................................................................................................... 27 
6.6. 
Collection and Storage of Samples .......................................................................... 27 
6.7. 
Accountability of Test Articles ................................................................................ 27 
7.
STUDY EVALUATIONS .............................................................................................. 28 
7.1. 
Time and Event Schedule ......................................................................................... 28 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 34 
VISIT 3 ........................................................................................................................... 36 
VISIT 4 ........................................................................................................................... 40 
FINAL EVALUATION .................................................................................................. 41 
7.3. 
Unscheduled Visits ................................................................................................... 42 
7.4. 
Laboratory Procedures ............................................................................................. 44 
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 44 
8.1. 
Completion Criteria .................................................................................................. 44 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 44 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 45 
9.1. 
Systemic Medications .............................................................................................. 45 
10.
DEVIATIONS FROM THE PROTOCOL .................................................................. 46 
11.
STUDY TERMINATION ........................................................................................... 47 
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 48 
13.
ADVERSE EVENTS ................................................................................................... 49 
13.1. 
Definitions and Classifications ............................................................................. 49 
13.2. 
Assessing Adverse Events .................................................................................... 51 
13.2.1. 
Causality Assessment .................................................................................... 51 
13.2.2. 
Severity Assessment ...................................................................................... 52 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 52 
13.4. 
Reporting Adverse Events .................................................................................... 53 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 54 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
54 
13.5. 
Event of Special Interest ....................................................................................... 55 
13.6. 
Reporting of Pregnancy ........................................................................................ 55 
14.
STATISTICAL METHODS ........................................................................................ 55 
14.1. 
General Considerations ......................................................................................... 55 
14.2. 
Sample Size Justification ...................................................................................... 55 
14.3. 
Analysis Populations ............................................................................................ 56 
14.4. 
Level of Statistical Significance ........................................................................... 56 
14.5. 
Primary Analysis .................................................................................................. 56 
14.6. 
Secondary Analysis .............................................................................................. 58 
14.7. 
Other Exploratory Analysis .................................................................................. 58 
14.8. 
Interim Analysis ................................................................................................... 59 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 59 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 60 
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 60 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 60 
15.2. 
Subject Record ...................................................................................................... 60 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 61 
16.
DATA MANAGEMENT............................................................................................. 61 
16.1. 
Access to Source Data/Document ........................................................................ 61 
16.2. 
Confidentiality of Information.............................................................................. 61 
16.3. 
Data Quality Assurance ........................................................................................ 61 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 62 
17.
CLINICAL MONITORING ........................................................................................ 62 
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 62 
18.1. 
Study-Specific Design Considerations ................................................................. 62 
18.2. 
Investigator Responsibility ................................................................................... 63 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 63 
18.4. 
Informed Consent ................................................................................................. 64 
18.5. 
Privacy of Personal Data ...................................................................................... 64 
19.
STUDY RECORD RETENTION................................................................................ 65 
20.
FINANCIAL CONSIDERATIONS ............................................................................ 66 
21.
PUBLICATION ........................................................................................................... 66 
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Johnson & Johnson Vision Care, Inc.
22. 
REFERENCES ............................................................................................................ 67 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 68 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 73 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 74 
APPENDIX D:
 .................................... 105 
, LENS FITTING CHARACTERISTICS ............................................................ 106 
 SUBJECT REPORTED OCULAR SYMPTOMS .............................................. 112 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 114 
 BIOMICROSCOPY SCALE .............................................................................. 120 
 KERATOMETRY PROCEDURE ...................................................................... 126 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ...... 128 
 PATIENT REPORTED OUTCOMES................................................................ 133 
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 135 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 147 
LIST OF TABLES
Table 1: Test Articles .............................................................................................................. 25 
Table 2: Ancillary Supplies .................................................................................................... 26 
Table 3: Time and Events ....................................................................................................... 28 
Table 4: Disallowed Systemic Medications ............................................................................ 45 
Table 5: Examples of Major and Minor Protocol Deviations ................................................. 46 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 15 
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Johnson & Johnson Vision Care, Inc.
PROTOCOL TITLE, NUMBER, VERSION AND DATE
Title: Evaluation of Comfort for two marketed daily disposable contact lenses
Protocol Number:  CR-6456 
Version: 1.0 
Date: 11 June 2021 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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AUTHORIZED SIGNATURES
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155,1 ICH guidelines,2
and the Declaration of Helsinki.3
Author/Study 
Responsible 
Clinician
See Electronic Signature Report
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Biostatistician 
Reviewer
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety 
Officer
See Electronic Signature Report
DATE
Reviewer
See Electronic Signature Report
DATE
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Approver
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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Johnson & Johnson Vision Care, Inc.
CHANGE HISTORY
Version
Originator
Description of Change(s) and Section 
Number(s) Affected
Date
1.0
Original protocol
11 Jun 2021
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Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Evaluation of Comfort for two marketed daily disposable 
contact lenses
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Post-Market
Design control phase: Post-market (phase 4) marketing claims
Trial Registration
This study will be registered on ClinicalTrials.gov based on 
the following: The test articles are both marketed types of soft 
contact lens.
Test Article(s)
Investigational Products: None
Approved Products: ACUVUE® OASYS Brand Contact 
Lenses 1-Day with HydraLuxeTM Technology (O1D), Alcon 
Precision1™ Soft Contact Lenses (P1)
Wear and Replacement 
Schedules
Wear Schedule: Daily Wear
Replacement Schedule: Daily Disposable
Objectives 
The Primary Objective of this study is to compare the 
performance of O1D relative to P1 with respect to overall 
subjective comfort, as well as subjective comfort and dryness 
at the end of the day. 
The Secondary Objectives of the study are to compare the 
performance of O1D relative to P1 with respect to subjective 
comfort throughout the day, subjective comfort and dryness 
while using digital devices, initial subjective comfort and  lens 
awareness upon insertion, overall ease of handling, ease of 
insertion, and ease of removal.
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Johnson & Johnson Vision Care, Inc.
Study Endpoints
Primary Endpoints: 
Subjective responses to individual items at the 1-week follow-
up evaluation: 
1. Overall comfort 
2. Comfort at the end of the day  
3. Dryness at the end of the day 
Secondary Endpoints:  
Subjective responses to individual items at the 1-week follow-
up evaluation: 
1. Secondary Group 1: Comfort Performance
a.
Comfort throughout the day 
2. Secondary Group 2: Digital Device Performance 
a.
Comfort while using digital devices  
b. Dryness while using digital devices  
3. Secondary Group 3: Performance at lens fitting
a.
Lens awareness upon insertion 
b. Comfort upon insertion
4. Secondary Group 4: Lens Handling Performance
a.
Overall ease of handling  
b. Ease of insertion  
c.
Ease of removal 
Study Design
This study is a 2-phase adaptive approach utilizing a 2×2 
crossover design. The study lenses will be worn in a bilateral 
fashion for a period of approximately 1-week each.
Each phase will have a total of 4 visits:
x Visit 1: Baseline Evaluation.  Fitting of first lens type, 
then dispense for 6 to 8 days 
x Visit 2: Follow-up for first dispensed lens type, then 
commence washout period for 6 to 8 days.   
x Visit 3: Fitting of second lens type, then dispense for 6 to 
8 days. 
x Visit 4: Follow-up for second dispensed lens type.   
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).
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Sample Size
Approximately 65 subjects will be enrolled in Phase I with a
target of completing 60 subjects. An interim analysis based on 
Phase I will determine the number of subjects to be enrolled 
into Phase II, with a maximum of 300 additional subjects. 
Study Duration
The timeframe between anticipated First Subject First Visit 
(FSFV) and anticipated Last Subject Last Visit (LSLV) is 6
months.
Anticipated Study 
Population
Habitual daily disposable soft contact lens wearers in the age 
range of 18 to 40.
Eligibility Criteria -
Inclusion 
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 40 (inclusive) years of age at the
time of screening.
4. By self-report, habitually wear soft spherical contact
lenses in both eyes in a daily disposable wear
modality. Habitual wear is defined as a minimum of 8
hours of wear per day, for a minimum of 4 days per
week during the past 4 weeks.
5. By self-report, typically uses computer screens and
other digital devices (phones, tablets) at least 30 hours
per week.
Inclusion Criteria at Baseline Evaluation
6. The vertex-corrected best spherical distance refraction
(rounded to nearest 0.25 D) must be between -1.00 and
-4.00 DS (inclusive) in each eye.
7. The magnitude of the cylinder component of the
subject’s distance refraction must be 1.00 DC or less.
8. The subject must have best corrected visual acuity of
20/25 or better in each eye.
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Eligibility Criteria –
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria following Screening
The subject must not: 
1. Be currently pregnant or breastfeeding
2. 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.
3. Have had any previous ocular or intraocular surgery
(e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
4. Habitually wear monovision, multifocal, toric, or
extended wear contact lens correction
5. Have participated in any contact lens or lens care
product clinical trial within 14 days prior to study
enrollment
6. Be an employee or immediate family member of an
employee 
of 
clinical 
site 
(e.g., 
Investigator,
Coordinator, Technician)
7. Have a history of amblyopia or strabismus.
8. Have habitually worn rigid gas permeable (RGP)
lenses, orthokeratology lenses, or hybrid lenses (eg,
SynergEyes) within the past 6 months.
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. Have clinically significant (Grade 3 or higher on the
FDA grading scale) slit lamp findings (e.g., corneal
edema, 
neovascularization 
or 
staining, 
tarsal
abnormalities or bulbar injection) or other corneal or
ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study
endpoints (including entropion, ectropion, chalazia,
recurrent styes, glaucoma, history of recurrent corneal
erosions, aphakia, moderate or above corneal
distortion, herpetic keratitis).
10. Have any ocular infection.
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Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter
(OTC) 
medications that may affect contact lens wear from 24 hours 
prior to the study visit. Habitual medications taken by 
successful soft contact lens wearers are generally considered 
acceptable (see Section 9.1).
Measurements and 
Procedures
Subjective questionnaires will be the primary outcome 
measure.   Slit lamp assessments will be collected as safety 
endpoints.
Microbiology or Other 
Laboratory Testing
None.
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Preservative-free saline and lens vials will be supplied in case 
needed for lenses associated with any adverse events or 
product quality complaints.
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 
60 subjects to complete Phase I, 
then additional subjects (up to a maximum of 300) enrolled in Phase II
Potential Subjects Identified Based On:
x
Age: At least 18 and not greater than 40 at the time of consent
x
Habitual daily disposable contact lens wearers
x
Refraction: Vertex-corrected Best Sphere -1.00D to -4.00D in each eye
x
Cylinder:-1.00 D or less in each eye
x
Visual Acuity: Best corrected 20/25 or better in each eye
x
Typically uses computer screens and other digital devices >30 hrs/week 
Informed Consent 
Eligibility Criteria
Baseline Information
x
Entrance Visual Acuity, Keratometry/SimK, Subjective refraction
x
Biomicroscopy
x
Determine eligibility
Dispensing
x
Exit Visual Acuity
x
Dispensing Criteria, Subject Instructions
x
Schedule Follow-up in 6 to 8 Days
Visit 2: Treatment 1 Follow-up
x
Medical History and Concomitant Medication Review
x
Ocular Symptoms, Wear Time, Digital Device use time, and Compliance
x
Entrance Visual Acuity
x
Follow-up MRD questionnaire
x
Lens Fit Assessment
x
Lens Removal, Biomicroscopy
x
Exit Visual Acuity, Subject Instructions for washout period
x
Schedule next visit in 6 to 8 days
Visit 3: Baseline
x
Medical History and Concomitant Medication Review
x
Ocular Symptoms, Entrance Visual Acuity
x
Patient Reported Outcomes questionnaire
x
Biomicroscopy
Final Evaluation
Visit 1: Treatment 1 Lens Fitting
x
Randomization, Lens Selection and Insertion
x
Lens Fit Assessment, Over-Refraction
x
Lens power modification (if needed)
x
Post-Fit MRD questionnaire
Dispensing
x
Exit Visual Acuity
x
Dispensing Criteria, Subject Instructions
x
Schedule Follow-up in 6 to 8 Days
Treatment 2 Lens Fitting
x
Lens Selection and Insertion
x
Lens Fit Assessment, Over-Refraction
x
Lens power modification (if needed)
x
Post-Fit MRD questionnaire
Visit 4: Treatment 2 Follow-up
x
Medical History and Concomitant Medication Review
x
Ocular Symptoms, Wear Time, Digital Device use time, and Compliance
x
Entrance Visual Acuity
x
Follow-up MRD questionnaire
x
Lens Fit Assessment
x
Lens Removal
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS
ADE
Adverse Device Effect
ADHD  
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience 
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations 
COM
Clinical Operations Manager
COVID-19 
Coronavirus Disease 2019
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
D 
Diopter 
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
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
International Council for Harmonization 
IEC
Independent Ethics Committee 
IRB
Institutional Review Board
ISO
International Organization for Standardization 
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc. 
LASIK 
Laser-Assisted in Situ Keratomileusis
OD
Right Eye 
OS
Left Eye
OU
Both Eyes 
PIG
Patient Instruction Guide 
PQC
Product Quality Complaint 
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome 
QA
Quality Assurance 
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation 
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
The ACUVUE® OASYS 1-Day (O1D) contact lens has been available in the US market since 
early 2016.  In late 2015, a clinical study (
)6 was conducted to compare the clinical 
performance of O1D lenses to an existing marketed lens: Alcon DAILIES TOTAL1®
(DT1)The current study will be similar to 
 but will compare the clinical performance 
of O1D lenses to a newer marketed lens from Alcon called PRECISION1TM (P1).
1.1.
Name and Descriptions of Investigational Products  
ACUVUE® OASYS Brand Contact Lenses 1-Day with HydraLuxeTM Technology (O1D), and 
Alcon PRECISION1™ Soft Contact Lenses (P1) will be used as the Test and Control lens 
types, respectively.  Further details about the test articles are found in Section 6 of this protocol.
1.2.
Intended Use of Investigational Products
ACUVUE® OASYS 1-Day contact lenses 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 1.00 D or less of astigmatism.
PRECISION1™spherical soft contact lenses are indicated for the optical correction of 
refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased 
eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with 
visual acuity. 
In this research study, the test articles will be available in a limited range of minus powers 
suitable for use by participants with certain levels of myopia.  The study population will be 
limited to persons between the ages of 18 to 40 who may have 1.00 D or less of astigmatism.   
The study participants will wear each of the study lens types in random order.  Each study lens 
type will be worn bilaterally in daily wear, daily disposable modality for approximately one 
week (6 to 8 days). 
1.3.
Summary of Findings from Nonclinical Studies
Not applicable – Marketed product only.
1.4.
Summary of Known Risks and Benefits to Human Subjects
A summary of the risks and benefits of the marketed study lenses are contained in the package 
inserts located in Appendix C.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
Both of the study lens types are approved and marketed daily disposable soft contact lenses. 
For more information, refer to the package inserts located in Appendix C.
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2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The Primary Objective of this study is to compare the performance of O1D relative to P1 with 
respect to overall subjective comfort, as well as subjective comfort and dryness at the end of 
the day. 
The Secondary Objectives of the study are to compare the performance of O1D relative to P1 
with respect to subjective comfort throughout the day, subjective comfort and dryness while 
using digital devices, initial subjective comfort and  lens awareness upon insertion, overall ease 
of handling, ease of insertion, and ease of removal. 
2.2.
Endpoints
Primary Endpoints  
1. Overall comfort (Item: How would you rate the study contact lenses on: Overall
Comfort; 
)
2. Comfort at the end of the day (Item: How would you rate the study contact lenses on:
Comfort at the end of the day; 
)
3. Dryness at the end of the day (Item: How would you rate the study contact lenses on:
Keeping your eyes from feeling dry at the end of the day;
)
Each primary endpoint will be assessed at the 1-week follow-up evaluation using individual 
questionnaire items. All primary endpoints utilize an Excellence response set (0: Not 
Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).  
Secondary Endpoints
1. Secondary Group 1: Comfort Performance
a.
Comfort throughout the day (Item: How would you rate the study contact lenses
on: Keeping your eyes feeling comfortable from morning to night; 
)
Response set : Excellence (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
2. Secondary Group 2: Digital Device Performance
a.
Comfort while using digital devices (Item: How would you rate the study
contact lenses on: Remaining comfortable while using computer screens and
other digital devices (phones, tablets); 
)
b. Dryness while using digital devices (Item: How would you rate the study
contact lenses on: Keeping your eyes from feeling dry while using computer
screens and other digital devices (phones, tablets); 
)
Response set: Excellence (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
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3. Secondary Group 3: Performance at lens fitting
a.
Lens awareness upon insertion (Item: I lost awareness of these lenses shortly
after inserting them (within one minute); 
)
b. Comfort upon insertion (Item: These lenses were comfortable shortly after
inserting them (within one minute) ;
)
Response set:  Agreement (1: Strongly disagree, 2: Disagree, 3: Neither agree nor disagree, 4: 
Agree and 5: Strongly agree) 
4. Secondary Group 4: Lens Handling Performance
a.
Overall ease of handling (Item: How would you rate the study contact lenses
on: Overall ease of handling the lenses (putting them on and taking them off);
)
b. Ease of insertion (Item:  How would you rate the study contact lenses on: Ease
of putting the lenses on your eyes;
)
c.
Ease of removal (Item: how would you rate the study contact lenses on: Ease
of taking the lenses off your eyes; 
)
Response set: Excellence (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 
5: Poor). 
Secondary endpoint groups 1,2 and 4 will be assessed at the 1-week follow-up evaluation while 
secondary endpoint group 3 will be assessed at lens fitting. All secondary endpoints are 
assessed using individual questionnaire items.   
Exploratory Endpoints 
Amount of digital device use is collected by self-report at the follow-up visit.  The subject is 
asked their average number of hours of digital device use on the days between visits that they 
wore the study lenses.  
2.3.
Hypotheses
After phase I, the planned interim analysis will only test the primary hypotheses. If the study 
continues to phase II, all hypotheses may be tested. See full details about the strategy for testing 
study hypotheses in Section 14.4.
Primary Hypotheses – Phase I
After approximately one week of wear, O1D will  have non-inferior performance to P1 with 
respect to each of the following endpoints: 
1. Overall comfort
2. Comfort at the end of the day
3. Dryness at the end of the day
A non-inferiority margin of 10% will be used. 
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Primary Hypotheses – Phase II
After approximately one week of wear, O1D will  have superior performance to P1 with respect 
to each of the following endpoints: 
1. Overall comfort
2. Comfort at the end of the day
3. Dryness at the end of the day
All primary hypotheses must be met in order to begin testing any secondary hypotheses. 
Secondary Hypotheses 
Secondary Group 1: Comfort Performance 
After approximately one week of wear, O1D will  have superior performance to P1 with respect 
to the endpoint: Comfort throughout the day.  
Secondary Group 2: Digital Performance 
After approximately one week of wear, O1D will  have superior performance to P1 with respect 
to each of the following endpoints: 
a.
Comfort while using digital devices
b. Dryness while using digital devices
Secondary Group 3: Performance at Lens Fitting
After approximately one week of wear, O1D will  have non-inferior performance to P1 with 
respect to each of the following endpoints: 
a.
Lens awareness upon insertion
b. Comfort upon insertion
A non-inferiority margin of 10% will be used. 
Secondary Group 4: Lens Handling Performance 
After approximately one week of wear, O1D will  have non-inferior performance to P1 with 
respect to each of the following endpoints: 
a.
Overall ease of handling
b. Ease of insertion
c.
Ease of removal
A non-inferiority margin of 10% will be used. 
Exploratory Hypotheses 
All primary and secondary group 2 hypotheses must be met in order to test exploratory 
hypotheses.     
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3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Habitual daily disposable soft contact lens wearers in the age range of 18 to 40 will be enrolled 
in the study.
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria following Screening
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 40 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily
disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear
per day, for a minimum of 4 days per week during the past 4 weeks.
5. By self-report, typically uses computer screens and other digital devices (phones,
tablets) at least 30 hours per week.
Inclusion Criteria at Baseline Evaluation
6. The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D)
must be between -1.00 and -4.00 DS (inclusive) in each eye.
7. The magnitude of the cylinder component of the subject’s distance refraction must be
1.00 DC or less.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
Exclusion Criteria following Screening
The subject must not: 
1. Be currently pregnant or breastfeeding
2. 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.
3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK,
LASIK, cataract, etc.).
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4. Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
5. Have participated in any contact lens or lens care product clinical trial within 14 days
prior to study enrollment
6. Be an employee or immediate family member of an employee of clinical site (e.g.,
Investigator, Coordinator, Technician)
7. Have a history of amblyopia or strabismus.
8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or
hybrid lenses (eg, SynergEyes) within the past 6 months.
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. Have clinically significant (Grade 3 or higher on the FDA grading scale) slit lamp
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate
contact lens wear or may otherwise compromise study endpoints (including entropion,
ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions,
aphakia, moderate or above corneal distortion, herpetic keratitis).
10. Have any ocular infection.
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a two-phase adaptive design. Each phase will be a multi-site 4-visit bilateral 2x2 
dispensing crossover trial. In Phase I, approximately 65 subjects will be enrolled with a target 
of 60 subjects to complete. After Phase I, an interim analysis will be conducted to determine 
the number of subjects that will be enrolled into phase II if the study continues; a maximum of 
up to 300 additional subjects maybe enrolled.
The subjects enrolled in each phase will be randomized separately.  Whenever possible, the 
same clinical sites will be used to enroll subjects throughout the entire course of the study. 
Furthermore, both phases will utilize the same crossover design and will be conducted as 
follows: at Visit 1 (Day 0), eligible subjects will be randomized to one of two lens wear 
sequences (O1D/P1 or P1/O1D). Subjects will be dispensed their first study lens per the 
randomization scheme and will wear the study lenses for 6 to 8 days and return for their follow-
up evaluation (Visit 2). Study measurements will be performed, and subjects will be instructed 
to wear their habitual contact lenses or spectacles for a period of 6 to 8 days. Subjects will then 
return for Visit 3 not having worn their habitual contact lenses the day of the visit and will be 
dispensed their second study lens. Subjects will return for their follow-up evaluation and final 
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visit (visit 4)  6 to 8 days after Visit 3. Study measurements will be performed, and the subject 
will exit from the study. 
Study lenses are to be worn as daily disposable. Unscheduled visits may occur during the 
course of the study. Any unworn lenses are to be collected prior to the subject being exited 
from the study.   
4.2.
Study Design Rationale 
A two-phase adaptative approach utilizing a 2x2 crossover was chosen as the most optimal 
design to achieve the study objectives. An adaptive design was considered since no historical 
data was available for P1 with respect to the primary endpoints. Therefore, incorporating an 
adaptive approach into this study will facilitate the ability to estimate the number of subjects 
needed to demonstrate the primary hypotheses. This approach can help reduce the number of 
subjects and the amount of time to conduct a study to achieve the same results as compared to 
conducting a separate pilot and confirmatory study. Furthermore, a 2x2 crossover was also 
implemented into the study design since this can help reduce the number of subjects required 
to complete a study since participants in a crossover study act as their own Control. Moreover, 
subjects acting as their own control can help reduce the effects of potential confounding factors 
between subjects, such as vision correction, age and race.6  All crossover studies have an 
inherent risk of observing a carryover effect.  To help mitigate the risk of a carryover effect, 
subjects will undergo a washout period for approximately 1-week (6 to 8 days) between study 
lenses. During the washout period subjects will wear either their spectacles or habitual lenses.
4.3.
Enrollment Target and Study Duration
During Phase I, approximately 65 subjects will be enrolled to target 60 subjects completing. 
The number of subjects enrolled in phase II will depend on the interim analysis conducted 
after phase I. A maximum of 300 subjects can be enrolled into phase II. The study duration 
including the enrollment period is expected to be approximately 6 weeks for phase I and 
additional 18 weeks for phase II. Subjects who are discontinued prior to the final evaluation
in each phase may be replaced at the discretion of the study sponsor.  The investigation will 
end at the time that the study data is hard locked.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The randomization scheme will be provided by the study responsible biostatistician for each 
phase separately. In both phases, the study randomization will be stratified by site. Eligible 
subjects will randomly be assigned to one of two unique lens wear sequences (O1D/P1 or 
P1/O1D) using permuted block randomization in block sizes of 2, to avoid bias in the 
assignment of subjects to treatment, and to enhance the validity of statistical comparisons 
between treatment groups. The randomization scheme will be generated using the Statistical 
Analysis System (SAS) software Version 9.4 or higher7 (SAS Institute, Cary, NC). 
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The study site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. Randomization 
will be performed at Visit 1 of each phase. The following must have occurred prior to
randomization: 
•
Informed consent must have been obtained.
•
The subject must have met all eligibility criteria.
•
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens
fitting schedule to obtain the test article assignment for that subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the
lens fitting schedule
3. Investigator or designee will pull the appropriate test articles from the study supply.
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed
outside the clinical site) or not, must be recorded on the Test Article Accountability
Log in the “Dispensed” section.
5.2.
Masking
This will be a double-masked trial to reduce potential bias. Subjects will be unaware of the 
identity of the investigational product. Investigators and clinical site personnel involved in the 
data collection will be masked as to the identity of the investigational product.  
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 are discontinued will not be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking
Every attempt will be made to keep the clinical trial personnel involved in the study (e.g. data 
management, biostatistician and clinical operations) unaware of the identity of the assigned 
study lenses.  The identity of the study lenses will be masked by having the blister packs labeled 
with the study number, lot number, sphere power, expiration date and the randomization codes. 
Only the unmasked biostatistician generating the lens fitting schedule will have access to the 
decode information that allows matching of the randomization codes to the test articles. The 
medical monitor will also have access to the decode information in case breaking the mask is 
necessary for the urgent medical treatment of a subject.
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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 will not be replaced.
6.
STUDY INTERVENTION
6.1.
Identity of Test Articles 
The following contact lenses will be used in this study: 
Table 1: Test Articles
Test
Control
Test Article Form
Soft contact lens
Soft contact lens
Design / Description
Acuvue® Oasys 1-Day
Precision1TM
Manufacturer
Johnson & Johnson Vision 
Care, Inc.
Alcon
Packaging Form
Blister packaging
Blister packaging
Lens Material
senofilcon A (C3)
verofilcon A
Sphere Powers (DS)
-1.00 to -4.00 in 0.25 steps
-1.00 to -4.00 in 0.25 steps
Cylinder Powers (DC) 
none
none
Cylinder Axes (°)
none
none
Add Powers (DS)
none
none
Nominal Base Curve(mm)
8.5
8.3
Nominal Lens Diameter(mm)
14.3
14.2
Nominal Water Content (%)
38
51
Nominal Center Thickness ȝP
at -3.00 DS
85
90
Dk (×10-11 [cm2 /sec] [ml O2/ml
× mm Hg] at 35°C)
103
90
Wear Modality in Current Study 
Daily wear
Daily wear
Replacement Frequency
Daily disposable
Daily disposable
Each subject will wear approximately 14 lenses of each type per eye, so for a total enrollment 
of 124 subjects approximately 1736 lenses will be used.
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6.2.
Ancillary Supplies/Products
The following solutions will be used in this study: 
Table 2: Ancillary Supplies 
Non-Preserved Rewetting Drops / Multipurpose Lens Care 
Solution
Solution 
Name/Description
Single use Eye-Cept®
Rewetting Drops 
LacriPure Saline 
Solution
ScleralFil Preservative 
Free Saline Solution
Manufacturer
Optics Laboratory
Menicon
Bausch & Lomb
Preservative
None
None
None
Preservative-free saline and lens vials will be supplied in case needed for lenses associated 
with any adverse events or product quality complaints. 
6.3.
Administration of Test Articles
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.  
6.4.
Packaging and Labeling
The test articles will be packaged in blisters as the primary packaging. The test article will be 
over-labeled to mask the subject and investigators to the identity of the lens. The test articles 
will be in investigational cartons sealed with a tamper evident seal as the secondary packaging 
form. The sample study label is shown below: 
Primary Packaging
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Secondary Packaging 
6.5.
Storage Conditions
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures. 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
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If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
.
7.
STUDY EVALUATIONS
7.1.
Time and Event Schedule
Table 3: Time and Events 
Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Fitting
Visit 2
Treatment 1 
Follow-up
Visit 3
Treatment 2 
Fitting
Visit 4
Treatment 2 
Follow-up
Time Point
Day 0
7 ± 1 days after 
Visit 1
7 ± 1 days after 
Visit 2
7 ± 1 days after 
Visit 3
Estimated Visit Duration
1.5 hours
1 hour
1.5 hours
1.5 hours
Statement of Informed 
Consent
X 
Demographics
X
Medical History and 
Concomitant Medications
X 
AE & Con Meds Review
X
X
X
Habitual Contact Lens 
Information
X 
Habitual Contact Lens Wear 
Schedule
X 
Contact lens wear time
X
X
Typical usage of digital 
devices
X 
Digital Device usage
X
X
Compliance
X
X
Eligibility after Screening
X
Subject Reported Ocular 
Symptoms
X 
X 
X 
X 
Entrance Visual Acuity
X
X
X
X
Keratometry/SimK
X
Subjective Sphero-
cylindrical Refraction
X 
Subjective Best Sphere 
Refraction
X 
Vertex-corrected best sphere 
refraction
X 
Slit Lamp Biomicroscopy 
X
X
X
Continuance
X
Eligibility after Baseline
X
Randomization
X
Lens Selection
X
X
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Fitting
Visit 2
Treatment 1 
Follow-up
Visit 3
Treatment 2 
Fitting
Visit 4
Treatment 2 
Follow-up
Time Point
Day 0
7 ± 1 days after 
Visit 1
7 ± 1 days after 
Visit 2
7 ± 1 days after 
Visit 3
Estimated Visit Duration
1.5 hours
1 hour
1.5 hours
1.5 hours
Lens Insertion
X
X
Lens Settling
X
X
Lens Fit Assessment
X
X
X
X
Distance Over-Refraction 
and Visual Acuity 
X 
X 
Lens Power Modification (if 
needed)
X 
X 
PRO questionnaire
X
X
X
X
Lens Removal
X
X
Exit Visual Acuity
X
X
X
Dispensing Criteria
X
X
Schedule next visit
X
X
X
Dispensing
X
X
Subject Instructions
X
X
X
Final Evaluation
X
7.2.
Detailed Study Procedures
VISIT 1
The subjects must present to Visit 1 wearing spectacles, having not worn contact lenses on the 
day of the visit. 
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of Informed 
Consent 
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study. The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form. 
Note: The subject must be provided a signed 
copy of this document.
1.2
Demographics
Record the subject’s year of birth, age, 
gender, race and ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Record the subject’s medical history and 
concomitant medications.
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Visit 1: Screening
Step
Procedure
Details
1.4
Habitual Contact Lens 
Information
Questions regarding the subject’s habitual 
lens type and parameters.
1.5
Habitual Contact Lens 
Wear Schedule
Record the duration of wearing this contact 
lens type and power (number of years and 
months).  
During the past 4 weeks, what is the 
minimum number of days per week that the 
subject has worn their lenses for at least 8 
hours.
1.6
Typical usage of 
digital devices
In a typical week, how many hours does 
the subject use computer screens and other 
digital devices (phones, tablets)?
1.7
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
completed as part of Final Evaluation.
Visit 1: Baseline
Step
Procedure
Details
1.8
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
1.9
Entrance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with their 
habitual spectacle correction in place.
Subjects must read the smallest line until at 
least 50% of the letters are read incorrectly.
1.10
Keratometry/SimK
Record the keratometry or SimK readings 
OD and OS in diopters.
1.11
Subjective Sphero-
cylindrical Refraction
Complete subjective spherocylindrical 
refraction with a phoropter and record the 
resultant distance visual acuity (OD, OS, and 
OU) to the nearest letter.
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Visit 1: Baseline
Step
Procedure
Details
1.12
Subjective Best 
Sphere Refraction
Perform subjective best sphere refraction 
with a phoropter adopting the maximum plus 
to maximum visual acuity (MPMVA) 
approach, and record the resultant distance 
visual acuity (OD, OS, and OU) to the 
nearest letter.
1.13
Vertex-corrected best 
sphere refraction
Record the vertex-corrected best sphere 
refraction for each eye, rounded to the nearest 
0.25 D.
1.14
Slit Lamp 
Biomicroscopy   
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If any of these slit lamp findings are grade 3 
or higher, the subject may not continue at this 
time, but may return up to one additional time 
to determine eligibility. If discontinued a 
final examination must be completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
1.15
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be
answered “no” for the subject to be 
considered eligible.
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
completed as part of Final Evaluation.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.16
Randomization
Record the randomization ID
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.17
Lens Selection
Assign the study lens type based on the 
randomization scheme. Select the contact 
lens powers based on vertex-corrected 
subjective best sphere refraction for each eye.
1.18
Lens Insertion
The subject inserts the study lenses. Record 
the time of last lens insertion. 
If a lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary. 
Damaged lenses will be stored in labeled vial 
with sterile saline for subsequent shipment to 
the Sponsor. Complete the Product Quality 
Complaint form.
1.19
Lens Settling
Allow approximately 10 minutes after last
lens insertion.
1.20
Lens Fit Assessment
Evaluate lens centration, movement on blink, 
and push-up test for each eye. 
An unacceptable fit is defined by one or more 
of the following criteria: 
x
limbal exposure at primary gaze or with
extreme eye movement
x
edge lift
x
excessive movement with blink in
primary gaze
x
insufficient movement with blink in
upgaze
x
insufficient movement in push-up test
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
study.
1.21
Distance Over-
Refraction and Visual 
Acuity
Perform subjective best sphere over-
refraction with a phoropter adopting the 
maximum plus to maximum visual acuity 
(MPMVA) approach, and record the resultant 
distance visual acuity (OD, OS, and OU) to 
the nearest letter.
1.22
Lens Power 
Modification (if 
needed)
One or both lenses may be modified if 
necessary (ie. if the over-refraction result is 
not plano).  Repeat steps 1.17 to 1.21 if 
needed for one or both eyes.
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.23
PRO questionnaire
The subject will respond to the Post-Fit PRO 
(MRD) Questionnaire.
1.24
Exit Visual Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with the 
study contact lenses. Subjects must read the 
smallest line until at least 50% of the letters 
are read incorrectly.
1.25
Dispensing Criteria
For lenses to be dispensed, the following 
criteria must be met:
x
Exit Snellen visual acuity is equal to
or better than 20/30 in each eye
x
Subject indicates that vision and
comfort with the lenses is acceptable
1.26
Schedule next visit
The next scheduled visit is 6 to 8 days after 
Visit 1.
1.27
Dispensing
A quantity of study lenses of the same type 
and power that the subject is currently 
wearing will be dispensed for daily 
disposable wear on days up to and including 
the scheduled follow-up visit.  No spare
lenses will be dispensed.
1.28
Subject Instructions
Instruct the Subject on the following:
x
The lenses will be worn on a daily
disposable wear basis (ie. a new lens will
be opened and worn each day).
x
Subjects will be instructed to wear the
study lenses for a minimum of 6 hours a
day, every day until the next visit. One
missed day of study lens wear between
visits is allowable.
x
The subject is to wear the study lenses to
the next scheduled visit.  It is not required
to have worn the study lenses for at least
6 hours on that day.
x
Instruct the subject to bring back all
unworn study lenses.
x
Instruct the subject no cleaning or
disinfecting solutions will be used for this
lens type.
x
If determined necessary by the
Investigator, sterile non-preserved
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear their
glasses when not wearing the study
lenses.
x
Subjects will be instructed to bring their
habitual spectacles to the next visit as
they will be needed for measuring exit
acuity.
x
A patient instruction booklet will be
provided.
Note: In the event a lens is lost or damaged, 
the subject will return to the investigational 
site for replacement.  As much as reasonably 
possible, a damaged lens should be returned 
to the investigational site and then returned 
to the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline and returned to the 
Sponsor.
VISIT 2 
The subjects must present to Visit 2 wearing study contact lenses. 
Visit 2: Treatment 1 Follow-up
Step
Procedure
Details
2.1
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
2.2
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.3
Contact lens wear 
time
On the days between visits (ie. not including 
the day of fitting and day of follow-up) when 
contact lenses were worn, what was the 
average wearing time and comfortable 
wearing time per day?
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Visit 2: Treatment 1 Follow-up
Step
Procedure
Details
2.4
Digital Device usage
On the days between visits (ie. not including 
the day of fitting and day of follow-up) when 
contact lenses were worn, what was the 
average amount of time per day spent using 
computer screens and other digital devices 
(phones, tablets)?
2.5
Compliance
Confirm compliance with the prescribed wear 
schedule.
2.6
Entrance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with the 
study contact lenses in place. Subjects must 
read the smallest line until at least 50% of the 
letters are read incorrectly.
2.7
PRO questionnaire
The subject will respond to the Follow-Up 
PRO (MRD) Questionnaire.
2.8
Lens Fit Assessment
Evaluate lens centration, movement on blink, 
and push-up test for each eye. 
An unacceptable fit is defined by one or more 
of the following criteria: 
x
limbal exposure at primary gaze or with
extreme eye movement
x
edge lift
x
excessive movement with blink in
primary gaze
x
insufficient movement with blink in
upgaze
x
insufficient movement in push-up test
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
study.
2.9
Lens Removal
Have the subject remove the study lenses.
Temporarily store the worn lenses until 
Biomicroscopy has been completed.  If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded.
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Visit 2: Treatment 1 Follow-up
Step
Procedure
Details
2.10
Slit Lamp 
Biomicroscopy   
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
2.11
Exit Visual Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with their 
habitual spectacle correction in place.
Subjects must read the smallest line until at 
least 50% of the letters are read incorrectly.
2.12
Schedule next visit
The next scheduled visit is 6 to 8 days after 
Visit 2.
2.13
Subject Instructions
Instruct the Subject on the following:
x
Subjects may wear their habitual
spectacles or contact lenses during the
washout period.
x
The subject must wear their spectacles to
the next scheduled visit, having not worn
their contact lenses on the day of the visit.
VISIT 3 
The subjects must present to Visit 3 wearing spectacles, having not worn contact lenses on the 
day of the visit. 
Visit 3: Baseline
Step
Procedure
Details
3.1
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
3.2
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
3.3
Entrance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with their 
habitual spectacle correction in place.
Subjects must read the smallest line until at 
least 50% of the letters are read incorrectly.
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Visit 3: Baseline
Step
Procedure
Details
3.4
Slit Lamp 
Biomicroscopy   
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
3.5
Continuance
Determine whether the visit can continue
based on the biomicroscopy findings.
Visit 3: Treatment 2 Fitting
Step
Procedure
Details
3.6
Lens Selection
Assign the study lens type based on the 
randomization scheme. Select the contact 
lens powers based on vertex-corrected 
subjective best sphere refraction for each eye.
3.7
Lens Insertion
The subject inserts the study lenses. Record 
the time of last lens insertion. 
If a lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline for subsequent shipment to 
the Sponsor. Complete the Product Quality 
Complaint form.
3.8
Lens Settling
Allow approximately 10 minutes after last 
lens insertion.
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Visit 3: Treatment 2 Fitting
Step
Procedure
Details
3.9
Lens Fit Assessment
Evaluate lens centration, movement on blink, 
and push-up test for each eye. 
An unacceptable fit is defined by one or more 
of the following criteria: 
x
limbal exposure at primary gaze or with
extreme eye movement
x
edge lift
x
excessive movement with blink in
primary gaze
x
insufficient movement with blink in
upgaze
x
insufficient movement in push-up test
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
study.
3.10
Distance Over-
Refraction and Visual 
Acuity
Perform subjective best sphere over-
refraction with a phoropter adopting the 
maximum plus to maximum visual acuity 
(MPMVA) approach, and record the resultant 
distance visual acuity (OD, OS, and OU) to 
the nearest letter.
3.11
Lens Power 
Modification (if 
needed)
One or both lenses may be modified if 
necessary (ie. if the over-refraction result is 
not plano).  Repeat steps 3.6 to 3.10 if needed 
for one or both eyes.
3.12
PRO questionnaire
The subject will respond to the Post-Fit PRO 
(MRD) Questionnaire.
3.13
Exit Visual Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with the 
study contact lenses. Subjects must read the 
smallest line until at least 50% of the letters 
are read incorrectly.
3.14
Dispensing Criteria
For lenses to be dispensed, the following 
criteria must be met:
x
Exit Snellen visual acuity is equal to
or better than 20/30 in each eye
x
Subject indicates that vision and
comfort with the lenses is acceptable
3.15
Schedule next visit
The next scheduled visit is 6 to 8 days after 
Visit 3.
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Visit 3: Treatment 2 Fitting
Step
Procedure
Details
3.16
Dispensing
A quantity of study lenses of the same type 
and power that the subject is currently 
wearing will be dispensed for daily 
disposable wear on days up to and including 
the scheduled follow-up visit.  No spare
lenses will be dispensed.
3.17
Subject Instructions
Instruct the Subject on the following:
x
The lenses will be worn on a daily
disposable wear basis (ie. a new lens will
be opened and worn each day).
x
Subjects will be instructed to wear the
study lenses for a minimum of 6 hours a
day, every day until the next visit. One
missed day of study lens wear between
visits is allowable.
x
The subject is to wear the study lenses to
the next scheduled visit.  It is not required
to have worn the study lenses for at least
6 hours on that day.
x
Instruct the subject to bring back all
unworn study lenses.
x
Instruct the subject no cleaning or
disinfecting solutions will be used for this
lens type.
x
If determined necessary by the
Investigator, sterile non-preserved
rewetting drops may be dispensed to be
used as needed for dryness.
x
Subjects will be instructed to wear their
glasses when not wearing the study
lenses.
x
Subjects will be instructed to bring their
habitual spectacles to the next visit as
they will be needed for measuring exit
acuity.
Note: In the event a lens is lost or damaged, 
the subject will return to the investigational 
site for replacement.  As much as reasonably 
possible, a damaged lens should be returned 
to the investigational site and then returned 
to the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
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Visit 3: Treatment 2 Fitting
Step
Procedure
Details
Form. The lens will be stored in labeled vial 
with sterile saline and returned to the 
Sponsor.
VISIT 4 
The subjects must present to Visit 4 wearing study contact lenses.
Visit 4: Treatment 2 Follow-up
Step
Procedure
Details
4.1
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
4.2
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
4.3
Contact lens wear 
time
On the days between visits (ie. not including 
the day of fitting and day of follow-up) when 
contact lenses were worn, what was the 
average wearing time and comfortable 
wearing time per day?
4.4
Digital Device usage
On the days between visits (ie. not including 
the day of fitting and day of follow-up) when 
contact lenses were worn, what was the 
average amount of time per day spent using 
computer screens and other digital devices 
(phones, tablets)?
4.5
Compliance
Confirm compliance with the prescribed wear 
schedule.
4.6
Entrance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with the 
study contact lenses in place. Subjects must 
read the smallest line until at least 50% of the 
letters are read incorrectly.
4.7
PRO questionnaire
The subject will respond to the Follow-Up 
PRO (MRD) Questionnaire.
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Visit 4: Treatment 2 Follow-up
Step
Procedure
Details
4.8
Lens Fit Assessment
Evaluate lens centration, movement on blink, 
and push-up test for each eye. 
An unacceptable fit is defined by one or more 
of the following criteria: 
x
limbal exposure at primary gaze or with
extreme eye movement
x
edge lift
x
excessive movement with blink in
primary gaze
x
insufficient movement with blink in
upgaze
x
insufficient movement in push-up test
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
study.
4.9
Lens Removal
Have the subject remove the study lenses.
Temporarily store the worn lenses until 
Biomicroscopy has been completed.  If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded.
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study. 
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason.
F.2
Exit Refraction 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter and record the 
best-corrected distance visual acuity (OD and
OS, OU) to the nearest letter. 
Note: This step is not necessary if the subject 
exited due to screen failure.
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Final Evaluation
Step
Procedure
Details
F.3
Exit Slit Lamp 
Biomicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled.
Note: This step is not necessary if the subject 
exited due to screen failure.
F.4
Exit Visual Acuity
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter with their 
habitual spectacle correction in place.
Subjects must read the smallest line until at 
least 50% of the letters are read incorrectly.
7.3.
Unscheduled Visits
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected, as appropriate: 
x
Chief complaint prompting the visit. If the reason is an adverse event, the applicable
eCRF for the adverse event must be completed and subject record completed as
appropriate.
x
Date and time of the visit and all procedures completed at the unscheduled visit.
x
Review of adverse event and concomitant medications.
x
Documentation of any test article dispensed or collected from the subject, if applicable.
x
Slit lamp findings (using the Slit Lamp Classification Scale).
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified. 
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider.  
The following information will be collected during an unscheduled visit. 
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Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit 
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for 
reasons for the unscheduled visit.
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
U.4
Entrance VA (if 
applicable)
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided).
U.5
Subjective Sphero-
cylindrical 
Refraction (if 
applicable)
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS, OU). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.  If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled.
U.7
Dispensing (if 
applicable)
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the 
dispensing instructions given in the detailed 
study procedures.
U.8
Exit Visual Acuity 
(if applicable)
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided).
Note: If the only reason for the unscheduled visit is that the subject requires additional test 
articles, only the dispensing information needs to be recorded. 
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7.4.
Laboratory Procedures 
Not applicable.
8.
SUBJECTS COMPLETION/WITHDRAWAL
8.1.
Completion Criteria
Completion criteria will be assessed for each phase separately. Subjects are considered to have 
completed a study phase 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 scheduled 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 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 will not be enrolled if a subject discontinues from the study prematurely. 
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In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: Table 4
Concomitant therapies that are disallowed include: Table 4
9.1.
Systemic Medications
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. A summary of disallowed medications is shown 
in Table 4.  Subjects with a history of taking these medications will be allowed to enroll only 
if:
x
The medications have been taken on a continual or routine basis for at least 6 months
and the subject has demonstrated successful contact lens wear during this time.
Or
x
The subject previously used these medications on a temporary basis and has ceased that
medication at least 1 week prior to signing the informed consent.
Table 4: Disallowed Systemic Medications
Class of Drug
Common Indication(s)
Common Examples
Anticholinergics
Irritable bowel syndrome, 
Parkinson’s disease, peptic 
ulcer, cystitis, nasal 
congestion, cold symptoms, 
overactive bladder, COPD 
Bentyl, Spiriva, Atrovent, 
Hyosyne, Levsin, Symax 
Fastab, Symax SL, Homax 
SL, Cogentin, Transderm 
Scop, etc.
Oral Phenothiazines
Antipsychotic disorders 
(schizophrenia, mania) 
Compazine, Mellarill, 
Thorazine, Phenagran, etc. 
Oral/Inhaled Corticosteroids
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions  
Cortisone, Prednisone, 
Hydrocortisone, Medrol, 
Kenalog, Flonase etc. 
Oral Retinoids 
Seborrhea, acne 
Isotretinoin, Acitretin, 
Alitretinoin, etc. 
Oral Tetracycline 
Urinary Tract Infection, 
acne, chlamydia, gonorrhea 
Sumycin, Achromycin V, 
etc. 
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10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB.   This is a "Major Deviation". Deviations 
that contradict the information contained in the Informed Consent/Assent forms will be 
considered Major Deviations. 
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. 
Protocol waivers are prohibited. 
Table 5 lists examples of deviations that will constitute major and minor protocol deviations 
for this study.  
Table 5: Examples of Major and Minor Protocol Deviations 
Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended more than 2 days 
out of visit window defined in 
study procedures 
Visit attended 2 or fewer
days out of visit window 
defined in study procedures 
Unanswered PRO questions
For questionnaires where data 
is related to a primary or 
secondary endpoint, more than
2
PRO 
questions 
are 
unanswered (i.e., left blank). 
For questionnaires where 
data is related to a primary or 
secondary endpoint, 2 or 
fewer PRO questions are 
unanswered (i.e., left blank). 
Insufficient wear of study 
lenses 
Subject does not wear study 
lenses for 3 or more days
between fitting and follow-up 
visits.
Subject does not wear study 
lenses for 2 days between 
fitting and follow-up visits. 
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In the case of a major protocol deviation, the decision of whether or not the subject will be 
excluded from the Per-Protocol analysis population will be made at the time of cohort 
review.
11. STUDY TERMINATION
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC Safety Review 
committee, the study may be terminated. This potential stopping rule is established based on 
our trial involving approximately 200 subjects wearing the investigational soft contact lens for 
up to 3 years with an assumed MK rate that is below 0.2% per patient-year. The rate of 0.2% 
per patient year is the established rate for extended wear lenses in adults, which was requested 
by the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA response to 
a pre-IDE submission. To be conservative, 200 independent patient years were used in the 
calculation. The probability of observing 2 cases or more incidents of MK is 0.061, and 3 cases 
or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient year).  
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
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. 
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12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use. 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user,
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms,
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
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 
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results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also apply and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of
the study.
2. Was present prior to the study but worsened during the study. This would include any
condition resulting from concomitant illnesses, reactions to concomitant medications,
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function.
x
Chronic disease
x
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)
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x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which
necessitates temporary lens discontinuation < 2 weeks
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Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x
Seriousness/Classifications (see definition in Section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in Section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of
intensity of the adverse event (mild, moderate, or severe - see definition in Section
13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time
suggests that a causal relationship is not likely.
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.
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x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g.
concomitant treatment of concomitant disease(s). The relationship in time is very
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.   
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.).
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.
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x
Treatment regimen instituted (where appropriate), including concomitant medications
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
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. 
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13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and
medical judgment for colleagues who assisted in the treatment and follow-up of the
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
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 the 
written guidelines, including reporting timelines.  
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13.5. Event of Special Interest
None 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock.
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher7 (SAS Institute, Cary, NC). Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
Summaries will be presented by separately for each phase and lens type (O1D (Test) and P1 
(Control)) and will be performed separately by completion status (Safety Population, Per-
Protocol Population and Intent-to-Treat Population, when appropriate). 
The interim analysis will be performed on the Per-Protocol population while the primary and 
secondary analyses for phase II will be performed on the Intent-to-Treat Population (see 
Section 14.3 for additional details).
14.2. Sample Size Justification
Phase I of this study was not powered to test non-inferiority of O1D relative to P1 with respect 
to the primary endpoints. However, data collected during Phase I of the study will be used to
power Phase II to test for superiority of the O1D relative to P1 with respect to Overall comfort,
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Comfort at the End of the Day and Dryness at the End of the Day. Based on these results from 
testing for non-inferiority for each primary endpoint from the interim analysis (Phase I 
analysis), the sample size will be calculated to test all three primary hypotheses for superiority 
with at least 80% power. This will be calculated using an approximation of the power of an F-
test derived from the non-centrality parameter calculated from the observed F-statistic from 
the generalized linear model described in Section 14.5 for Phase I.9  If the sample size 
calculation for Phase II exceeds 300 then then the Sponsor reserves the right to terminate the 
study. Alpha will be adjusted as described in Section 14.4. Complete details of the sample size 
calculation for Phase II are described in Section 14.5.
14.3. Analysis Populations 
Safety Population: 
All subjects who were 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 have successfully completed all study visits and did not substantially deviate 
from the protocol as determined by the trial cohort review committee prior to database hard 
lock (Per-Protocol Population). Justification of excluding subjects with protocol deviations in 
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 or deviation from protocol. At least one 
observation should be recorded. 
14.4. Level of Statistical Significance
All type I error adjustments utilized in this study were calculated using a Bonferroni10
correction.  
Primary hypotheses in Phase I will be tested using a familywise type I error rate of 5%; each 
hypothesis with be tested using an individual type I error rate of 1.67%.  
Hypotheses in Phase II will be tested using the following strategy:  
Primary hypotheses will be tested using a familywise type I error rate of 5%; each hypothesis 
with be tested using an individual type I error rate of 1.67%.  All primary hypotheses must be 
met in order to test any secondary hypotheses. Secondary hypotheses were grouped according 
to item sematic similarities. Each secondary hypothesis group will be tested using an overall 
type I error rate of 5% and in a sequential order. Each preceding secondary hypothesis group 
must be fully met in order to continue testing the remaining secondary hypotheses. Exploratory 
hypotheses will only be tested if all primary and secondary group 2 hypotheses are met.  
14.5. Primary Analysis 
Phase I (Interim Analysis)
Overall comfort, Comfort at the end of the day, and Dryness at the end of the day 
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Subjective responses to each primary endpoint will be grouped as: aval=1 is a subject responds’ 
‘Excellent’ or ‘Very Good’, aval=2 is a subject responds’ ‘Good’ and aval=3 if a subject 
responds’ ‘Fair’ or ‘Poor’.  Aval will be analyzed separately for each primary endpoint using 
a generalized linear model with a multinomial distribution and the general logit as the link 
function. In each model, sequence of lens wear, period, lens type and site id will be included 
as fixed effects. Prior to fitting the final models for the primary endpoints, allocation of 
subjects’ completion between sites will be evaluated. If a difference of more than 30% is 
observed between sites, a likelihood ratio test for homogeneous variance will be conducted 
using a generalized linear mixed model with a multinomial distribution and the general logit 
as the link function. Comparisons between O1D and P1 will be carried out under the final 
model using 1-sided 97.5% confidence intervals (CIs) constructed for the odds ratio (O1D over 
P1).  
The Model:
Let ܽݒ݈ܽ௜௝௞௟= (ܽݒ݈ܽ1௜௝௞௟௠, ܽݒ݈ܽ2௜௝௞௟௠, ܽݒ݈ܽ3௜௝௞௟௠) denote the rating for ݈௧௛subject at the ݉௧௛
site assigned to the ݇௧௛sequence for the ݅௧௛study lens during the ݆௧௛ study period (i=1, 2; j=1, 
2; k=1,2; l=1….݊௠; m=1,…,10). Possible values of  ܽݒ݈ܽ௜௝௞௟௠are ܽݒ݈ܽ௜௝௞௟௠=1 if a subject 
responds: ‘Excellent’ or ‘Very Good’, ܽݒ݈ܽ௜௝௞௟௠=2 if a subject responds: ‘Good’ and 
ܽݒ݈ܽ௜௝௞௟௠=3 if a subject responds: ‘Fair’ or ‘Poor’. The Likelihood will be constructed as 
follows: 
ܽݒ݈ܽ௜௝௞௟௠~ Multinomial (݌1௜௝௞௟௠, ݌2௜௝௞௟௠, ݌3௜௝௞௟௠)
݌1௜௝௞௟௠= ܽݒ݈ܽ1௜௝௞௟௠
݌2௜௝௞௟௠= ܽݒ݈ܽ2௜௝௞௟௠െܽݒ݈ܽ1௜௝௞௟௠
݌3௜௝௞௟௠= 1 - σ
݌ܺ௜௝௞௟௠
௑ୀଵ,ଶ
Logit (ܽݒ݈ܽܺ௜௝௞௟௠) = ߚ௢+ ߚଵכ ݏ݁ݍݑ݁݊ܿ݁௞+ ߚଶכ ݌݁ݎ݅݋݀௝+ ߚଷכ ݈݁݊ݏ௜[௝,௞] + ߚସכ ܵ݅ݐ݁௠ 
Where, ߚ௢ is the intercept for X=1,2,3; ݏ݁ݍݑ݁݊ܿ݁௞=1 if O1D/P1 and ݏ݁ݍݑ݁݊ܿ݁௞= 0 if 
P1/O1D; ݌݁ݎ݅݋݀௝=1 if first period and ݌݁ݎ݅݋݀௝= 0 if second period; ݈݁݊ݏ௜[௝,௞]=1 if O1D 
and ݈݁݊ݏ௜[௝,௞] = 0 if P1.  
Hypothesis Testing 
Hypothesis testing will be conducted separately for each primary endpoint as follows: 
+R25
Ha: OR > 0.67 
Where, the OR represents the odds of having a more positive experience (Excellent or Very 
Good) while wearing O1D compared to P1. Non-inferiority of O1D relative to P1 will be 
concluded if the lower limit of the 97.5% CI  is above 0.67 (using 10% as non-inferiority 
margin and assuming a reference proportion of 0.5) . 
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Sample size Estimation for Phase II
If non-inferiority is demonstrated for the primary endpoints, the sample size required to test 
superiority for each primary endpoint will be estimated. The odds ratio and the cumulative log-
odds from the model described above for each endpoint will be used to create a new dataset 
with the same structure and design as Phase I. This new dataset will then be analyzed using the 
same model. The statistical power of each endpoint will be calculated using the F-statistics as 
Power=P(F[Fcrit, v, ncp] > Fcrit); where Fcrit is the critical value of the central F distribution
(Fcrit=ܨ[௡௨௠ௗ௙,ௗ௠ௗ௙,଴,௔௟௣௛௔]) under Ho (Ho: centrality param = 0), v is the magnitude of the 
departure from Ho and ncp is the non-centrality parameter (Stroup).9
Phase II
Overall comfort, Comfort at the end of the day, and Dryness at the end of the day 
Subjective responses to each primary endpoint will be grouped as: aval=1 is a subject responds’ 
‘Excellent’ or ‘Very Good’, aval=2 is a subject responds’ ‘Good’ and aval=3 if a subject 
responds’ ‘Fair’ or ‘Poor’.  Aval will be analyzed separately for each primary endpoint using 
a generalized linear mixed model with a multinomial distribution and the cumulative logit as 
the link function. In each model, sequence of lens wear, period and lens type will be included 
as fixed effects. Site and subject nested within site will be included as a random effect. Errors 
between measurements within the same subject across study periods will be modeled using an 
unstructured covariance (UN) structure. Comparisons between O1D and P1 will be carried out 
using 1-sided 97.5% confidence intervals (CIs) constructed for the odds ratio (O1D over P1). 
Superiority of O1D relative to P1 will be concluded if the lower limit of the 97.5% CI is above 
1.
14.6. Secondary Analysis 
All secondary items will be analyzed individually regardless of grouping and will model using 
the same model as described for the primary endpoints in Phase II above. Comparisons 
between O1D and P1 will be carried out using 1-sided 97.5% confidence intervals (CIs) 
constructed for the odds ratio (O1D over P1). For Secondary Group 1 – Comfort Performance 
and Secondary Group 2- Digital Device Performance, superiority of O1D relative to P1 will 
be concluded if the lower limit of the 97.5% CI is above 1.  For Secondary Group 3 – 
Performance at Lens Fitting and Secondary Group 4- Lens Handling Performance, non-
inferiority of O1D relative to P1 will be concluded if the lower limit of the 97.5% CI  is above 
0.67 (using 10% as non-inferiority margin and assuming a reference proportion of 0.5) . 
Note. Aval will be derived as follows for Secondary Group 3 – Performance at Lens Fitting; 
aval=1 if a subject responds’ ‘Strongly Agree’ or ‘Agree’, aval=2 if a subject responds’ 
‘Neither Agree Nor Disagree’ and aval=3 if a subject responds’ ‘Strongly Disagree’ or 
‘Disagree’)  
14.7. Other Exploratory Analysis 
Digital Device Performance by amount of digital device use 
Subjective responses to digital device items will be grouped as: aval=1 is a subject responds’ 
‘Excellent’ or ‘Very Good’, aval=2 is a subject responds’ ‘Good’ and aval=3 if a subject 
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responds’ ‘Fair’ or ‘Poor’.  Amount of digital device use is collected by self-report at the 
follow-up visit: the subject is asked their average number of hours of digital device use on the 
days between visits that they wore the study lenses. Subjects with digital device use below the 
50th percentile of the distribution of digital device use for all subjects in the study will be 
classified as grp1 (lower digital device usage), and subjects with digital device use above the 
50th percentile will be classified as grp2 (higher digital device usage). Digital device items will 
be analyzed separately using a generalized linear mixed model with a multinomial distribution 
and the cumulative logit as the link function. Sequence of lens wear, period, lens type, group 
(grp 1 and grp 2) and the interaction between lens type and group will be included in each 
model as fixed effects. Site and subject nested within site will be included as a random effect. 
Errors between measurements within the same subject across study periods will be modeled 
using an unstructured covariance (UN) structure. Comparisons between O1D and P1 will be 
carried for each group separately (grp 1 and grp 2) out using 1-sided 97.5% confidence 
intervals (CIs) constructed for the odds ratio (O1D over P1). Non-inferiority of O1D relative 
to P1 will be concluded if the lower limit of the 97.5% CI  is above 0.67 (using 10% as non-
inferiority margin and assuming a reference proportion of 0.5) .  
14.8. Interim Analysis 
This is a two-phase adaptive approach utilizing stopping rules. Approximately 65 subject swill 
be enrolled in Phase with a target of 60 to complete. An interim analysis will be performed 
after all subjects have completed Phase I on primary endpoints only.  Data from Phase I will 
be utilized to calculate the number of subjects required to complete Phase II to achieve all 
primary hypotheses with at least 80% power. However, maximum enrollment for Phase II can 
be no more than 300 subjects (based on resources and study timing). After reviewing the results 
from the interim analysis, the study may be stopped prior to beginning enrollment for Phase II 
for one of the following reasons:  
1. Lack of efficacy with respect to primary endpoints (results are inconclusive)
2. Required sample size too large to achieve primary endpoints
Full details regarding the planned interim analysis are located in Section 14.5 above. 
Information about how the sample size calculations for Phase II will be conducted is located 
in Section 14.2. Addition safety endpoints such as adverse events, slit lamp findings and lens 
fitting characteristics may also be descriptive summarized and provided.  
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 10%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations.
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14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in this protocol and the stand-alone 
statistical analysis plan. 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.  
External data sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
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
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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 based on the following: The test articles are 
both marketed types of soft contact lens.   
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, 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 
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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.
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 subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide
their consent voluntarily.
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18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
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)
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x
Reports of adverse events that are serious, unanticipated, and associated with the test
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 141551
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 Health Information Portability and Accountability Act (HIPAA)11 and 
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other applicable personal data protection and security laws and regulations. Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the 
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
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 
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study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION
There is no plan to publish this outcome of this investigation.
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22. REFERENCES
.
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.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. Wang T, Malone J, Fu H, Heilmann C, Qu Y, Huster WJ.  Crossover design and its
application in late-phase diabetes studies.  J Diabetes 2016;8:610-618.
6. Young G.  
 Clinical Study Report v1.0: Clinical evaluation of two Silicone
Hydrogel Daily Disposable Contact Lenses.  29 February 2016.
7. SAS Institute Inc: SAS® 9.4 Statements: Reference TEC, NC: SAS Institute Inc;
2014.
8. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary NC: SAS Institute Inc.
9. Mixed Model Procedures To Assess Power, Precision, And Sample Size In The
Design Of Experiments. Walter W. Stroup, University of Nebraska
10. Bonferroni C. Calculation of the insurance groups of heads. Studies in Honour of
Professor Salvatore Ortu Carboni. 1935;Rome: Italy:13-60
11. 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 
To be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
1.) ACUVUE OASYS®
Brand Contact Lenses 1-Day
with HydraLuxeTM 
Technology 
2.) Alcon PRECISION1™ and PRECISION1™ for Astigmatism (verofilcon A) soft 
contact lenses for Daily Disposable Wear 
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IMPORTANT:  Please read carefully and keep this 
information for future use.
This Package Insert and Fitting Guide is intended for the 
Eye Care Professional, but should be made available to 
patients upon request. 
The Eye Care Professional should provide the patient 
with the appropriate instructions that pertain to the 
patient’s prescribed lenses. Copies are available for 
download at www.acuvue.com.
senoﬁ lcon A Soft (hydrophilic) Contact Lenses
Visibility Tinted with UV Blocker
for Daily Disposable Wear
CAUTION: U.S. Federal law restricts this device to 
sale by o
practitioner.
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology for ASTIGMATISM
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SYMBOLS KEY
The following symbols may appear on the label or carton:
Date of Manufacture
Manufactured by or in
Consult Instructions for Use
CAUTION: U.S. Federal law restricts this device 
to sale by or on the order of a licensed practitioner
Use By Date (expiration date)
Diameter
DIA
Base Curve
BC
Diopter (lens power)
D
Batch Code
LOT
Sterile Using Steam or Dry Heat
STERILE
UV-Blocking
Fee Paid for Waste Management
Quality System Certification Symbol
123
Lens Orientation Correct
123
Lens Orientation Incorrect (Lens Inside Out)
CYL
AXIS
Cylinder
Axis
Single-Use
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
•
Speciﬁ c Gravity (calculated):
0.98 - 1.12
•
Refractive Index:
1.42
•
Light Transmission:
85% minimum
•
Surface Character:
Hydrophilic
•
Water Content:
38%
•
Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
•
Diameter Range:
12.0 mm to 15.0 mm
•
Center Thickness:
varies with power
•
Base Curve Range:
7.85 mm to 10.00 mm
•
Spherical Power Range:
-20.00D to +20.00D
•
Cylinder Power Range:
-0.25D to -10.00D
•
Axis Range:
5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°,
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®
1-Day with
HydraLuxe™
Technology
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area. The patient should continue to use UV absorbing 
eyewear as directed.
ACTIONS
In its hydrated state, the contact lens, when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina.
The transmittance characteristics for these lenses are less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire 
ge.
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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
lcerative 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 “Patien
 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 potent l
 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
re measurements should be 
performed to establish the 
lar 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
e residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability,
repeatability, and drift angle of the lens axis so that you can prescribe the
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll
ﬁ nd two primary marks approximately 1 mm from the lens edge
representing the vertical position on opposite ends of the lens at
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system,
either mark can represent the vertical position – there is no “top”
and “bottom” as in a prism-ballasted lens. You don’t need to view
both marks to assess orientation; simply look for the 6 o’clock
mark as you would with a prism-ballasted lens.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually
stabilizes at the 6 o’clock position. If it does, calculation of the
lens power will be straightforward. The 6 o’clock position is not a
“must”; however, the absolute requirement is that the axis position
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical
meridian and still enable you to ﬁ t a toric lens for that eye, as
long as the lens always returns to the same “drift axis” position
after settling. The deviation can be compensated for in the ﬁ nal
prescription. Your objective is to ensure that whatever position the
initial lens assumes near 6 o’clock, this position must be stable
and repeatable. With full eye movement or heavy blink, you may
see the marks swing away, but they must return quickly to the
original stable position. If the lens does not return quickly, you may
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a
30° interval. If the orientation mark of the initial lens stabilizes
somewhat left or right of the vertical position, the ﬁ nal lens will
orient on the eye with the same deviation. You can use an axis
reticule in the slit lamp or use a line-scribed lens in a spectacle trial
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then
add or subtract it from the refractive axis to determine the correct
cylinder axis. Use the LARS (Left Add, Right Subtract) method to
determine which direction to compensate.
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B. Final Lens Power
When the diagnostic lens has its axis aligned in the same meridian
as the patient’s refractive axis, a spherocylindrical over-refraction may
be performed and visual acuity determined. However, in the case
of crossed axes, such as when the diagnostic lens axis is different
from the spectacle cylinder axis, it is not advisable to perform a full
spherocylindrical over-refraction because of the difﬁ culty in computing
the resultant power. A spherical over-refraction without cylinder
refraction may be performed.
If the required cylinder correction falls between two available cylinder
powers, it is recommended to prescribe the lower cylinder power
lens. See below for instructions on how to determine the ﬁ nal lens
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D,
compensate for vertex distance. If sphere alone or combined
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately
corrected distance and near visual acuity in each eye. The
amblyopic patient or the patient with signiﬁ cant astigmatism
(greater than 1.00D) in one eye may not be a good candidate for
monovision correction with these lenses.
Occupational and environmental visual demands should be
considered. If the patient requires critical vision (visual acuity and
stereopsis), it should be determined by trial whether this patient
can function adequately with monovision correction. Monovision
contact lens wear may not be optimal for activities such as:
•
visually demanding situations such as operating potentially
dangerous machinery or performing other potentially hazardous
activities; and
•
driving automobiles (e.g., driving at night). Patients who cannot
meet state driver's licensing requirements with monovision
correction should be advised to not drive with this correction,
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this
correction as they have with spectacles (multifocal, bifocal, trifocal,
readers, progressives). Each patient should understand that
monovision, as well as other presbyopic alternatives, can create
a vision compromise that may reduce visual acuity and depth
perception for distance and near tasks. Therefore, caution should
be exercised when the patient is wearing the correction for the ﬁ rst
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant,
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting
process, it is necessary for the patient to realize the disadvantages
as well as the advantages of clear near vision and straight ahead
and upward gaze that monovision contact lenses provide.
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more
hyperopic (less myopic) eye for distance and the more myopic
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required.
As an example, an emmetropic patient would only require a near
lens, whereas a bilateral 
uld require corrective lenses on
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides
optimal near acuity at the midpoint of the patient’s habitual reading
distance. However, when more than one power provides optimal
reading performance, prescribe the least plus (most minus) of the
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to
experience monovision correction. Lenses are ﬁ t according to
the GENERAL FITTING GUIDELINES for base curve selection
described in this Package Insert.
Case history and standard clinical evaluation procedure should
be used to determine the prognosis. Determine the distance
correction and the near correction. Next determine the near ADD.
With trial lenses of the proper power in place, observe the reaction
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct
power lenses in place. Walk across the room and have the patient
look at you. Assess the patient’s reaction to distance vision under
these circumstances. Then have the patient look at familiar near
objects such as a watch face or ﬁ ngernails. Again assess the
reaction. As the patient continues to look around the room at both
near and distance objects, observe the reactions. Only after these
vision tests are completed should the patient be asked to read
print. Evaluate the patient’s reaction to large print (e.g., typewritten
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller
type sizes.
After the patient’s performance under the above conditions
is completed, tests of vis
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 moda
per 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 ab
sional judgment to 
alleviate the problem and
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, lo
nd 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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Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
©Johnson & Johnson Vision Care Companies 2016
In Canada: Johnson & Johnson Vision Care, division of Johnson & Johnson, Inc. 
In USA: Johnson & Johnson Vision Care, Inc.
Printed in USA.
Revision date: 09/16
Revision number: AO-03-16-13
ACUVUE OASYS® and HydraLuxe™ are Trademarks of 
the Johnson & Joh
n Care Companies
20401080
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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
KERATOMETRY PROCEDURE
x
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION
x
 PATIENT REPORTED OUTCOMES
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LENS FITTING CHARACTERISTICS
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Title:  
Lens Fitting Characteristics
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Title:  
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Title:  
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Title:  
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Lens Fitting Characteristics
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 SUBJECT REPORTED OCULAR SYMPTOMS
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Title:  
Subject Reported Ocular Symptoms/Problems
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL
REFRACTIONS 
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Title:  
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Title:  
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Title:  
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Clinical Study Protocol
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APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION
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Title:
Guidelines for COVID-19 Risk Mitigation
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1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the
risk of adverse events due to the investigational device and/or procedures.
x
The risk may be higher in an optometric clinical study because of the close contact the subject will
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple
follow-up visits/exams which may expose the subject to other patients and/or healthcare
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
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STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
4.1.3
Protocol Compliance Investigator(s) Signature Page:
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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Procedure
Details
Subject Reported Ocular 
Symptoms
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test article when applicable and feasible. 
Change of Medical History 
(Adverse Events) and 
Concomitant Medications / 
Therapies Review
Record any adverse events or medical history changes from the 
previous study visit with the subject/parents.
Review the subject’s concomitant medications/therapies and record 
any changes from the previous study visit.
Wearing Time and 
Compliance
Record the average wearing time (including number of hours per day 
during weekdays and weekends, and number of days per week).
Confirm compliance with the prescribed wear schedule.
x
Record and discuss the lens wear compliance based on the
subject’s self-report. For example, the subjects will be asked the
time of the day the subject typically puts on the study lenses in the
morning and takes off in the evening, the number of days per week
lenses were worn, and the number of consecutive days the subject
didn’t wear the study lenses, etc.
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If during the telephone consultation, a subject states he/she wishes to discontinue participating 
in the study, instruct the subject to stop wearing the study lenses and schedule the subject to return to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should return all unused lenses to the 
clinic at the last visit.
Changes in study visit schedules, missed visits, or participant discontinuations may lead to missing data, 
including data related to protocol-specified procedures. Case report forms should capture specific 
information regarding the basis of missing data, including the relationship to the COVID-19 pandemic.
6.0
STUDY CONDUCT DURING PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometry Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge.
Every effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be performed to the extent possible remotely/virtually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, participants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be performed if required and as feasible.
Modifications to protocol-required assessments may be permitted via COVID-19 Appendix after consultation 
with the participant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol deviations. Interruptions of test article wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix “COVID-19-
related” in the case report form (CRF).
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The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable. 
Study site training will be documented utilizing Site Initiation Report
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.).
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 6 of 11 
6.1.3
Study Site Closure: 
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).  
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 7 of 11 
Attachment A: Study Site Correspondence
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principal Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects,
site staff and monitors during the pandemic.
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 8 of 11 
COVID-19 Risk Control Checklist (Attachment-B):
Study Number
Site Number
Principal Investigator (PI) Name
The following COVID-19 risk control methods are required to conduct Johnson & Johnson Vison Care clinical 
studies. Please review the following requirements and Initial each requirement.
PI Initials
General Site Safety Planning Measures
Signage within site describing Risk Control methods
Social Distancing practices throughout site (waiting rooms, lobby, exam rooms, etc.)
Non-contact thermometer available to assess temperatures of staff and patients
Training on patient flow and physical distancing in waiting room
Establish longer time frame between patient appointments to reduce persons in the site
Staff should receive job-specific training on PPE and demonstrate competency with selection and 
proper use of PPE and wear at all times during interactions with subjects (e.g., putting on and 
removing without self-contamination)
PI Initials
Site Staff Daily Safety Measures
As part of routine practice, site staff should regularly monitor themselves for fever and symptoms 
of COVID-19, including temperature checks 
Any staff member (including non-study clinic staff and Investigators) showing signs of being sick 
or testing positive for COVID-19 must not be permitted to work on activity that may  expose study 
related staff  and subject and the Sponsor shall be informed
NOTE: Inform JJVC in 24 hours of any COVID-19 cases and all potential exposure during
the clinical study.
Ensure that all staff wear a mask
Gloves should be required when working directly with patients and changed between each patient
Have staff thoroughly wash hands for at least 20 seconds or use an alcohol-based hand sanitizer 
when they arrive, before and after each patient, before eating and after using the bathroom.
Cleaning and disinfection procedures for exam rooms and instruments or equipment between 
patients with gloves.
Cleaning and disinfection procedures for commonly touched surfaces (doors, chairs, computers, 
phones, etc.) with gloves.
PI Initials
Before a Patient or Study Visit:
Patients should be asked prior to entering the site about fever and respiratory illness and whether 
they or a family member have had contact with another person with confirmed COVID-19 in the 
past 14 days. Patients exhibiting signs of being sick should be rescheduled when their symptoms 
resolve.
Instruct patients that companions should remain outside of the facility and not accompany the 
patient into the facility unless they are a parent/guardian of the patient or if they are a true 
caregiver and need to assist the patient
Request the patient to call or text the office upon arrival so entrance to and movement through 
facility can be coordinated by site staff
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 9 of 11 
PI Initials
Patients Entering the site:
Temperature checks utilizing a non-contact thermometer for all patients and companions entering 
the site.
All patients and companions must wear cloth or disposable mask at all times in the site
Maintain social distancing. Waiting rooms or lobbies should be as empty as possible. Advise 
seated patients to remain at least 6 feet from one another. 
Communal objects in (e.g. toys, reading materials, etc.) should be removed or cleaned regularly.
I certify that I have read and agree to implement all the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Vision Care studies. 
Principal Investigator Signature and Date
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 10 of 11 
RESOURCE LINKS
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness.html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf
OUS Resource Links
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov.hk/eng/index.html
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists:
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings.html
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Document Number:
Revision Number: 5
Page 11 of 11 
x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists:
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology
providers and health care managers. (2020, September 24). Retrieved from Australian Government
Department of Health:
https://www.health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian
Government Department of Health:
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia :
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6456 Evaluation of Comfort for two marketed daily disposable contact 
lenses
Version and Date: 1.0 11 June 2021 
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in Appendix 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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