Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2
Phase: NA
Conditions: Myopia
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol 
Protocol Title: Clinical Evaluation of etafilcon A Contact Lenses Using a Novel Molding 
Process
Protocol CR-6307 
Version: 2.0 
Date: September 6, 2018 
Investigational Products: etafilcon A
Key Words: Words: etafilcon A, mold process, daily disposable 
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 
Conference on Harmonization Good Clinical Practice E6 (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 ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products ................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed
Clinical Study...................................................................................................................... 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 20 
3.4. 
Enrollment Strategy .................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale ............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 23 
5.1. 
Test Article Allocation ............................................................................................. 23 
5.2. 
Masking .................................................................................................................... 23 
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 ..................................................................................... 25 
6.3. 
Administration of Test Articles ................................................................................ 25 
6.4. 
Packaging and Labeling ........................................................................................... 26 
6.5. 
Storage Conditions ................................................................................................... 26 
6.6. 
Collection and Storage of Samples .......................................................................... 26 
6.7. 
Accountability of Test Articles ................................................................................ 26 
7. 
STUDY EVALUATIONS .............................................................................................. 27 
7.1. 
Time and Event Schedule ......................................................................................... 27 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 34 
VISIT 3 ........................................................................................................................... 36 
VISIT 4 ........................................................................................................................... 40 
FINAL EVALUATION .................................................................................................. 42 
7.3. 
Unscheduled Visits ................................................................................................... 42 
7.4. 
Laboratory Procedures ............................................................................................. 43 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 43 
8.1. 
Completion Criteria .................................................................................................. 43 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 44 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 44 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 44 
11. 
STUDY TERMINATION ........................................................................................... 45 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 45 
13. 
ADVERSE EVENTS ................................................................................................... 47 
13.1. 
Definitions and Classifications ............................................................................. 47 
13.2. 
Assessing Adverse Events .................................................................................... 49 
13.2.1. 
Causality Assessment .................................................................................... 49 
13.2.2. 
Severity Assessment ...................................................................................... 50 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 50 
13.4. 
Reporting Adverse Events .................................................................................... 51 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 52 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 52 
13.4.3. 
Event of Special Interest ............................................................................... 53 
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13.5. 
Reporting of Pregnancy ........................................................................................ 53 
14. 
STATISTICAL METHODS ........................................................................................ 53 
14.1. 
General Considerations ......................................................................................... 53 
14.2. 
Sample Size Justification ...................................................................................... 53 
14.3. 
Analysis Populations ............................................................................................ 55 
14.4. 
Level of Statistical Significance ........................................................................... 55 
14.5. 
Primary Analysis .................................................................................................. 55 
14.6. 
Secondary Analysis .............................................................................................. 56 
14.7. 
Other Exploratory Analyses ................................................................................. 57 
14.8. 
Interim Analysis ................................................................................................... 57 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 57 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 57 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 58 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 58 
15.2. 
Subject Record ...................................................................................................... 58 
16. 
DATA MANAGEMENT............................................................................................. 59 
16.1. 
Access to Source Data/Document ........................................................................ 59 
16.2. 
Confidentiality of Information.............................................................................. 59 
16.3. 
Data Quality Assurance ........................................................................................ 59 
17. 
MONITORING ............................................................................................................ 60 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................. 60 
18.1. 
Study-Specific Design Considerations ................................................................. 60 
18.2. 
Investigator Responsibility ................................................................................... 60 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 61 
18.4. 
Informed Consent ................................................................................................. 62 
18.5. 
Privacy of Personal Data ...................................................................................... 63 
19. 
STUDY RECORD RETENTION ................................................................................ 64 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 64 
21. 
PUBLICATION ........................................................................................................... 65 
22. 
REFERENCES ............................................................................................................ 65 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 66 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 73 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 74 
APPENDIX D:
 .................................... 103 
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, Limbal & Conjunctival (Bulbar) Redness .......................................................... 104 
, Expanded Sodium Fluorescein Corneal Staining ............................................... 112 
, Lens Fitting Characteristics ................................................................................ 117 
, Subject Reported Ocular Symptoms/Problems .................................................. 124 
, Front And Back Surface Lens Deposit Grading Procedur ................................. 126 
, Determination Of Distance Spherocylindrical Refractions ................................ 132 
, Biomicroscopy Scale .......................................................................................... 139 
, Distance And Near Visual Acuity Evaluation .................................................... 145 
, Distance Logmar Visual Acuity Measurement Procedure ................................. 150 
, Patient Reported Outcomes ................................................................................ 154 
, White Light Lens Surface Wettability ............................................................... 156 
, Visual Acuity Chart Luminance And Room Illumination Testing .................... 158 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 164 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS  
Table 1: Target number of subjects by arm and phase ........................................................... 23 
Table 2: Test Articles .............................................................................................................. 25 
Table 3: Ancillary Supplies .................................................................................................... 25 
Table 4: Time and Events ....................................................................................................... 27 
Table 5: 1-week CLUE comfort and vision for 1 Day ACUVUE MOIST in historical studies
................................................................................................................................................. 54 
Table 6: Power Analysis for CLUE scores ............................................................................. 54 
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SYNOPSIS 
Protocol Title
Clinical Evaluation of etafilcon A Contact Lenses Using a 
Novel Molding Process
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Post Marketing, Phase 4 
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products:
x
etafilcon A contact lenses made with a novel molding 
process (Test) 
x
etafilcon A contact lenses made with the current molding 
process (Control).
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily
Objectives 
To evaluate the clinical performance of etafilcon A lenses 
made with a novel molding process (Test) by comparison to 
etafilcon A lenses made with the current molding process 
(Control).
Study Endpoints
Co-primary endpoint(s):
x
Overall comfort after 1-week of lens wear
x
Overall quality of vision after 1-week of lens wear
Secondary endpoint(s):   
x
Average daily wear time (in hour) 
x
Monocular distance visual performance
Additional Endpoints:
x
Slit lamp findings
x
Subject reported ocular symptoms
x
Lens fitting characteristics
x
Lens wettability
x
Adverse events
Study Design
This study is a multi-site, group sequential, adaptive, 
randomized, double-masked, 2×2 crossover design, 1-week 
dispensing study.  Subjects will wear bilaterally both Test and 
Control lenses in a random order for 1-week each as a daily 
disposable modality with a wash-out period of 1 week between 
the wearing periods.   
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
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Sample Size
In Phase 1, up to 160 eligible subjects will be enrolled and 
randomized into the study to ensure that approximately 150 
subjects complete as cohort.  An interim analysis will dictate if 
additional subjects will be enrolled in Phase 2 up to a 
maximum of 260.
Study Duration
For Phase 1, the study will last approximately 3 months and 
include an enrollment period of 3 weeks.
Anticipated Study 
Population 
Healthy male and female volunteers (at least 18 and not more 
than 70 years old) who are habitual wearers of daily 
disposable contact lenses (approximately 80% 1-Day 
ACUVUE Moist, approximately 20% other daily disposable 
hydrogel contact lens brands) and have a spectacle 
astigmatism of <0.75D in both eyes.  
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:  
Inclusion Criteria after Screening
The 
subject 
must 
read, 
understand, 
and 
sign 
the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form. 
1. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
2. Must be at least 18 and not more than 70 years of age 
(including 70) at the time of screening. 
3. The subject must be a habitual and adapted wearer of 
hydrogel daily disposable brand contact lenses in both 
eyes (at least 1 month of daily wear).
4. The subject must have normal eyes (i.e., no ocular 
medications or infections of any type). 
Inclusion Criteria after Baseline
5. The 
subject’s 
required 
spherical 
contact 
lens 
prescription must be in the range of -1.00 to -4.50 D in 
each eye.
6. The subject’s refractive cylinder must be < 0.75D in 
each eye.
7. The subject must have best corrected visual acuity of 
20/25 or better in each eye. 
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Exclusion Criteria after Screening
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Currently pregnant or lactating (subjects who become 
pregnant during the study will be discontinued). 
2. Any systemic disease, autoimmune disease, or use of 
medication that may interfere with contact lens wear.  
3. Any previous, or planned, ocular or interocular surgery 
(e.g., radial keratotomy, PRK, LASIK, etc.). 
4. Any ocular infection. 
5. Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product 
clinical trial within 14 days prior to study enrollment.
8. History of binocular vision abnormality or strabismus.
9. Any infectious disease (e.g., hepatitis, tuberculosis) or 
a contagious immunosuppressive disease (e.g., HIV, by 
self-report).
10. Suspicion of or recent history of alcohol or substance 
abuse.
11. History of serious mental illness.  
12. History of seizures.
13. Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician)
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal 
distortion  
15. Any Grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the Food and 
Drug Administration (FDA) classification scale 
16. Any previous history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer 
or round peripheral scar), or any other ocular 
abnormality that may contraindicate contact lens wear.
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Disallowed 
Medications/Interventions 
Disallowed medications include any medication that may 
interfere with contact lens wear (at the investigator’s 
discretion).  
Measurements and 
Procedures
Subjective assessments, physiological responses, fitting 
characteristics
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
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
Sterile rewetting drops
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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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
 
 
 
CWT  
 
Comfortable Wear Time
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
HLLC  
 
High Luminance With Low Contrast Charts 
HIPAA 
 
Health Insurance Portability and Accountability Act
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on 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
LLHC  
 
Low Luminance With High Contrast Charts
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MPMVA 
 
Maximum Plus To Maximum Visual Acuity
OD 
 
 
Right Eye 
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide
PP 
 
 
Predictive Probability
PQC 
 
 
Product Quality Complaint 
PRK 
 
 
Photorefractive Keratectomy
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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
WT 
 
 
Wear Time
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1.
INTRODUCTION AND BACKGROUND
In the spirit of continuous improvement, JJVC has identified a potential process change in 
the how etafilcon A is manufactured, specifically in the base curve mold material.  It is 
hypothesized that this process change may decrease lens defects, increase yields, and 
improve lens edge and optical quality.  The purpose of this clinical trial is to demonstrate 
whether these process changes have any clinically relevant impact on the clinical 
performance of the contact lens.
1.1.
Name and Descriptions of Investigational Products 
The investigational products are: 
x
etafilcon A contact lenses made with a novel molding process (Test).
x
etafilcon A contact lenses made with the current molding process (Control). 
1.2.
Intended Use of Investigational Products
The intended use of the investigative products is for correcting refractive error.  During the 
study, each Test article will be worn bilaterally in daily wear, daily disposable modality for at 
least 8 hours per day for approximately 1 week. 
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.  For the most comprehensive nonclinical information regarding etafilcon A 
refer to the latest version of the package insert for this study (APPENDIX C: PACKAGE 
INSERT (APPROVED PRODUCT).
1.4.
Summary of Known Risks and Benefits to Human Subjects
For the most comprehensive risk and benefit information regarding etafilcon A product refer 
to the latest version of the package insert (APPENDIX C: PACKAGE INSERT 
(APPROVED PRODUCT).
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
See Package Inserts for 1-DAY ACUVUE® MOIST. (APPENDIX C: PACKAGE INSERT 
(APPROVED PRODUCT).
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2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective(s)
To evaluate the clinical performance of etafilcon A contact lenses made with a novel molding 
process by comparison to etafilcon A contact lenses made with the existing molding process 
in the following area: 
x
Overall comfort  
x
Overall quality of vision
Secondary Objective(s)
To evaluate the clinical performance of etafilcon A lenses made with a new molding process 
by comparison to etafilcon A lenses made with the existing molding process in the following 
area:
x
Average daily wear time
x
Monocular distance visual performance
2.2.
Endpoints 
Primary Endpoint(s)
CLUE Comfort and Vision Scores: 
The co-primary endpoints for this study are subjective assessment of comfort and quality of 
vision after 7±2 days of wearing the study lenses as a daily disposable.  
Subjective assessment of comfort and vision will be performed using the Contact Lens User 
ExperienceTM (CLUE) questionnaire.  CLUE is a validated patient reported outcomes 
(PRO) questionnaire used to assess patient experience attributes of soft contact lenses 
(comfort, vision, handling, and packaging) in a US contact-lens wearing population between 
18 and 65 years of age.  CLUE composite scores are derived using Item Response Theory 
(IRT) and follow a normal distribution with a population average score of 60 (SD 20), where 
higher scores indicate a more favorable/positive response.  A 5-point increase in an average 
CLUE score translates into 10% shift in the distribution of scores for the population of soft 
disposable contact lens wearers.
Secondary Endpoint(s) 
Average daily wear time (in hours): 
Average daily wear time will be calculated as the number of hours between subjects reported 
time of insertion and time of removal of the study lenses, on an average day, at 1-Week 
Follow up evaluation. 
Visual performance
Visual performance will be calculated as monocular contact lens-corrected distance visual 
acuity using a logMAR visual acuity scale.  This will be evaluated under high luminance and 
high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study 
(ETDRS) charts at the 1 Week Follow-up visit.  
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Other Endpoint(s) 
Slit Lamp Findings 
Frequency and severity by eye of slit lamp findings (SLFs) including conjunctival injection, 
corneal edema, corneal neovascularization, corneal staining, tarsal abnormalities or any other
complications.  SLFs will be evaluated at fitting and post-fitting evaluation visits including 
unscheduled visits.
Subject’s Reported Ocular Symptoms 
Frequency and severity by eye of subject’s reported ocular symptoms and problems with the 
study lens at fitting and post-fitting evaluation visits including unscheduled visits. 
Lens Fitting characteristics
Frequency by eye of mechanical lens fitting characteristics including lens centration and lens
movement and overall lens fitting acceptability at fitting and 1-week follow-up evaluations.  
Lens wettability:
Frequency and Grade by eye of lens wettability at 1-Week Follow-up evaluation.  
The following will be monitored and descriptively evaluated 
x
Adverse events 
x
Reasons for discontinuation 
x
Lens damage
2.3.
Hypotheses
Primary Hypotheses: 
There are two co-primary hypotheses in this study. Both of them must be me to satisfy the 
primary objective of the study. 
1. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
comfort score at the follow-up visit.  A non-inferiority margin of -5 points will be 
used. 
2. The Test lens will be non-inferior to the Control lens with respect to overall CLUE 
vision score at the follow-up visit.  A non-inferiority margin of -5 points will be used. 
Secondary Hypotheses:
1. The Test lens will be non-inferior to the Control lens with respect to average daily 
wear time at 1-week follow-up visit.  A non-inferiority margin of 1 hour will be used. 
2. The Test lens will be non-inferior to the Control lens with respect to logMAR visual 
performance (using ETDRS visual acuity charts) at the follow-up visit.  A non-
inferiority margin of 0.05 logMAR will be used. 
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3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (approximately 80% 1 
Day ACUVUE MOIST, approximately 20% any other brand of hydrogel daily disposable 
contact lens) and have a spectacle astigmatism of <0.75 D in both eyes.  Up to 250 subjects 
will be enrolled to ensure approximately 240 subjects successfully complete the study.  
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1. The subject must 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. Must be at least 18 and not more than 70 years of age (including 70) at the time of 
screening.
4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand 
contact lens in both eyes (at least 1 month of daily wear). 
5. The subject must have normal eyes (i.e., no ocular medications or infections of any 
type). 
Inclusion Criteria after Baseline
6. The subject’s required spherical contact lens prescription must be in the range of 
-1.00 to  -4.50 D in each eye. 
7. The subject’s refractive cylinder must be < 0.75 D in each eye.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye. 
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3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from 
participating in the study: 
Exclusion Criteria after Screening:
1. Currently pregnant or lactating (subjects who become pregnant during the study 
will be discontinued).
2. Any systemic disease, autoimmune disease, or use of medication that may 
interfere with contact lens wear.  
3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, 
PRK, LASIK, etc.).
4. Any ocular infection. 
5. Any corneal distortion resulting from previous hard or rigid gas permeable 
contact lens wear.
6. Monovision or multi-focal contact lens correction.
7. Participation in any contact lens or lens care product clinical trial within 14 days 
prior to study enrollment. 
8. History of binocular vision abnormality or strabismus. 
9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious 
immunosuppressive disease (e.g., HIV, by self-report).
10. Suspicion of or recent history of alcohol or substance abuse. 
11. History of serious mental illness.  
12. History of seizures.
13. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician) 
Exclusion Criteria after Baseline
14. Any ocular allergies, infections or other ocular abnormalities that are known to 
interfere with contact lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent 
styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal 
distortion. 
15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) 
on the FDA classification scale.
16. Any previous history or signs of a contact lens-related corneal inflammatory event 
(e.g., past peripheral ulcer or round peripheral scar), or any other ocular 
abnormality that may contraindicate contact lens wear.
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
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4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This study is a multi-site, group sequential, adaptive, randomized, double-masked, 2×2 
crossover design, 1-week dispensing study.  Subjects will wear bilaterally both Test and 
Control lenses in a random order for 1-week each as a daily disposable modality with a wash-
out period of 1 week between the wearing periods.   
Period 1: 
At study Visit 1, subjects will be consented and screened for inclusion/exclusion criteria.  If a 
subject is found to meet all eligibility criteria (see Section 3.4.), they will be randomly 
assigned to either Test/Control or Control/Test sequence using 1:1 ratio (i.e. 1/2 of subjects 
on the Test/Control sequence and 1/2 on the Control/Test sequence). Subjects will fit the first 
pair of lens in both eyes based on the sequence assigned; otherwise, the subject will be 
deemed ineligible for this study. Subjects will be advised to wear the study lenses at least 8 
hours a day for a minimum of 6 days. 
Successfully dispensed subjects at the Visit 1 will be scheduled for a follow-up visit (Visit 2).  
The follow-up visit will occur approximately 7±2 days after the Visit 1.  Unscheduled 
follow-up visits may occur during the study.  At this visit, CLUE comfort and vision, slit 
lamp findings will be captured. 
Wash-out period: 
After completion of Visit 2, there is a 7 to 9 day washout period during which subjects may 
use their habitual products.
Period 2: 
Following the washout period, the subject returns for Visit 3 and post-washout baseline 
evaluation will take place prior to lens fitting.  After baseline evaluation, subject will be 
fitted and dispensed with the second pair of lens in the assigned sequence.  Subjects will be 
advised to wear the study lenses at least 8 hours a day for a minimum of 6 days. 
Visit 4 takes place 7±2 days after Visit 3, at which CLUE comfort and vision, slit lamp 
findings, final evaluation will take place. 
Both study lenses will be worn as a daily disposable modality.  JJVC will provide the 
investigational sites with sufficient quantities of study lenses and supplies to complete the 
study. 
4.2.
Study Design Rationale
The crossover study design will allow each subject to evaluate both the Test and Control 
lenses and will help to reduce potential intra-subject variation.  To reduce any potential 
carryover effect, a 7 to 9 days washout period was considered between the wearing periods.  
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Historical data (see Sample Size Justification Section 14.2) showed that the variances of 
CLUE comfort and vision scores of the Control lens were ranging between 21 and 26 for 
comfort scores and between 19 and 23 for vision.  To overcome the uncertainty of the 
variance estimate we considered an adaptive design approach to allow for modifications 
based on interim results, with a maximum of 250 evaluable subjects and a minimum of 150 
subjects.    
The Test lenses and Control lenses will be manufactured on the same manufacturing line 
with the same process specifications other than those specific novel variables that are being 
evaluated in this clinical study.  Both lenses will be worn as daily disposable modality, 
therefore 1-week wearing period was considered sufficiently longer to assess the primary and 
secondary objectives of the study. 
4.3.
Enrollment Target and Study Duration
This is a group sequential, adaptive design where the enrollment will be performed in two 
phases. In the first phase, up to 160 subjects will be initially enrolled and approximately 150 
are targeted to complete the study. An interim analysis will be performed when all subjects 
have completed Phase 1. The interim analysis will be used to estimate if more subjects are 
needed. If needed, additional subjects will be added to the study, in phase 2, up to a 
maximum of 260.  
The population to be studied will be healthy male and female volunteers (at least 18 and not 
more than 70 years old) who are habitual wearers of daily disposable (approximately 80% 1 
Day ACUVUE MOIST, approximately 20% any other brand of hydrogel daily disposable 
contact lens) and have a spectacle astigmatism of <0.75 D in both eyes.  Up to 165 subjects 
will be enrolled to ensure approximately 150 subjects successfully complete the study.   
There will be a total of 4 visits and the study duration for Phase 1 will be approximately 3 
months: 
Visit 1: (Day 0): Baseline Screening and Initial Randomization/Dispensing Visit 
Treatment #1
Visit 2: (Day 5-9): 1-Week Follow-Up Visit with first pair of study 
lenses/Dispensing Visit Treatment #2
Visit 3: (Approximately 1 Week from Visit 2):  Post wash-out baseline and 
Dispensing Visit for Treatment #2
Visit 4: (Day 5-9 from Visit 3): 1-Week Follow-up Visit with second pair of study 
lenses and study exit 
The Investigator is responsible for ensuring that all subjects entering the study conform to 
subject selection criteria.  The number of subjects targeted for randomization and completion 
are as follows:
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Table 1: Target number of subjects by arm and phase 
Phase 1
Phase 2
All
Test/Control
Control/Test
Test/Control
Control/Test
Total
Randomization
80
80
50
50
260
Completion
75
75
45
45
250
Number of sites
12
12
12
12
12
Subjects/site 
(Min-Max)
5-10 
5-10 
3-8 
3-8 
15-30 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover 
design.  A computer-generated randomization scheme will be used to randomly assign 
subjects, in block of 2, to one of the two possible lens wear sequences: Test/Control or 
Control/Lens.  The random scheme will be generated using the PROC PLAN procedure from 
Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC).
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization:
x
Informed consent has been obtained 
x
Subject meets all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected. 
5.2.
Masking
This is a double-masked study where subjects, investigators are masked to the identity of the 
study lenses during the study period.  Every attempt will be made to keep the other clinical 
trial personnel involved in the study (e.g. data management, biostatistician) unaware of the 
identity of the study lenses. 
The identity of the study lenses will be masked by over labeling the blister packs with a label 
containing the study number, lot number, sphere power, expiration date and the 
randomization codes.  Only the personnel involved in the over labeling and the statistician 
generating the randomization scheme will have access to the decode information translating 
the randomization codes into Test and Control groups.  The Biostatistician performing the 
interim analysis will have access to the decode information to run the interim analysis.  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. 
5.3.
Procedures for Maintaining and Breaking the Masking
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject.  The Sponsor must be notified before 
the mask is broken.  The Biostatistician performing the interim analysis should keep the 
decode information in a secure location and should not share it with the personnel involved 
in the study until the all subjects have completed the study and the database is finalized. 
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/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of 
the randomization scheme 
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
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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/Investigators to the identity of the lens. The test articles will 
be in investigational cartons sealed with a tamper evident seal, commercial cartons, or in 
plastic bags as the secondary packaging form. The sample study label is shown below:       
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 
Lenses that are being collected will be stored wet (using saline solution) in separate glass 
vials with labels that minimally contain study number, date, subject number, and eye from 
which the lens was removed.
When possible, any lens or test article associated with an Adverse Events 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 back 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 article 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 
3. The number and reason for unplanned replacements   
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8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons: 
x Subject death during the study period 
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 causing discontinuation of 
study lens wear 
x Subjects who have experienced a Corneal Infiltrative Event (CIE)
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x Subject misses any study visits  
x Subject not compliant with study lens wear schedule 
x Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort, or unacceptable fit.
For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled) 
x
Complete the Final Evaluation, indicating the reason that the subject was
discontinued from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the subject.
An additional subject will be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: See Section 3.3   
Concomitant therapies that are disallowed include: See Section 3.3   
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
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. 
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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.  
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.   
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.   
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
monitors, and site personnel, etc. The following are not considered product quality 
complaints: 
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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 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented. 
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13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: 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 
3. 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 untoward medical occurrence that: 
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening 
event, a significant persistent or permanent change, impairment, damage, or 
disruption to the subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article 
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
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Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
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 – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  
However, the Investigator may choose to treat 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 to entry: 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 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – 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; 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; severe for all events - 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;
unknown 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; 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) begins 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. He/she will 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
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x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, 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 
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, fax, 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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13.4.3. Event of Special Interest
None 
13.5. 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.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
will not be collected as part of the clinical study database.  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.  A stand-alone Statistical Analysis Plan (SAP) with more details will be 
finalized before the interim analysis is undertaken.
All data summaries and statistical analyses will be performed using the SAS software 
Version 9.4 or higher (SAS Institute, Cary, NC).  Throughout the analysis of data, the results 
for each subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD], 
median, minimum and maximum).  Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
14.2. Sample Size Justification
An adaptive sample size approach is used to allow for modifications based on interim results, 
with a maximum of 250 evaluable subjects and a minimum of 150 subjects.  The enrollment 
of subjects will be conducted in two phases.  In the first phase, up to 160 subjects will be 
initially enrolled with a target completion of 150 subjects.  An interim analysis will take 
place after initial enrolled subjects have completed the study.  This interim analysis will be 
used for an early claim of success (i.e. demonstrate non-inferiority).  If needed, additional 
subjects will be added to the study, in phase 2, up to a maximum of 260 (see Interim Analysis 
Section for more details).
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The initial sample size of 150 considered in phase 1 was based on historical data from 6 
double masked randomized bilateral multi-site studies with the 1 Day ACUVUE MOIST.  
The table below summarizes the primary endpoints data these studies.
Table 5: 1-week CLUE comfort and vision for 1 Day ACUVUE MOIST in historical studies
CLUE Comfort
CLUE Vision
N
Mean
STD
N
Mean
STD
66
56.38
24.655
66
65.04
22.824
68
63.87
24.693
68
65.17
22.110
138
58.72
22.643
138
61.24
20.643
142
57.21
21.341
142
61.71
19.345
142
60.10
26.356
142
63.52
23.652
70
72.05
21.487
70
72.81
20.624
Total
626
60.49
23.93
626
63.99
21.67
There are no historical data available on how the Test lens will perform against the Control 
lens.  Here we assume no difference between Test and Control lens with respect to comfort 
and vision.  The statistical power was calculated for different scenarios of sample sizes (N), 
SDs and inter-VXEMHFWFRUUHODWLRQȡ7KHUHVXOWVDUHVXPPDUL]HGEHORZ
Table 6: Power Analysis for CLUE scores
Sample Size (N)
Inter-subject
FRUUHODWLRQȡ
Power (%)
ı 
Power (%)
ı 
150
0.4
0.638
0.570
0.5
0.717
0.648
0.6
0.809
0.744
200
0.4
0.763
0.695
0.5
0.834
0.772
0.6
0.906
0.857
250
0.4
0.850
0.790
0.5
0.907
0.857
0.6
0.956
0.923
Under the assumption of no difference between Test and Control, the power analysis results 
showed that a sample size between 150 and 250 is considered sufficiently large to 
demonstrate the non-inferiority. The power analysis was conducted using the PROC POWER 
procedure available in SAS for paired tests.  
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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 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 and subsequent withdrawal from 
study or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
Type I error will be controlled for multiplicity across interim analysis and final analysis.  The 
operating characteristics of this adaptive trial will be provided in the SAP.
14.5. Primary Analysis  
The co-primary endpoints for this study are the CLUE comfort and the CLUE vision scores 
evaluated after 1-week of lens wear.  The primary analysis will be conducted on per-protocol 
and ITT populations.  Both primary hypotheses must be met to meet the primary objective of 
the study. 
CLUE Comfort and Vision scores 
CLUE comfort and vision scores will be analyzed separately using a Bayesian repeated 
measurement random-effects model to compare between Test and Control lenses.  Each 
regression model will include baseline values, lens type, lens wearing sequence and lens 
wearing period as fixed effects and investigational site as random effect.  Other subject 
characteristics such as age, gender and will also be included as fixed effects when 
appropriate.  Unstructured covariance matrix will be used to model the residual errors among 
observations within subjects.  Non-informative prior distributions will be used for the 
coefficients in the models as well as for the error terms.  Independent vague normal 
N(0,1000) priors will be used for the regression coefficients, inverse gamma IG(0.001, 
0.001) for the variance of the random effect site and inverse Wishart for the residual errors.  
The Metropolis sampler algorithm as implemented in the SAS MCMC Procedure will be 
used to carry out parameter estimation.  Results will be reported as regression coefficient 
mean estimates with credible intervals.  
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The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪ0ǻ-5 
ܪܣ: ǻ-5 
ZKHUHǻLVWKH&/8(VFRUHPHDQGLIIHUHQFHEHWZHHQ7HVWOHQVDQG&RQWUROOHQV7HVWPLQXV
Control).  Non-inferiority will be declared if the lower bound of the credible interval of the 
mean difference between Test and Control is greater than -5.  Superiority will be declared if 
the lower bound of the credible interval of the mean difference between Test and Control is 
greater than 0.  The superiority test will be performed only if non-inferiority is established.
14.6. Secondary Analysis  
Average Daily Wearing Time
Average daily wear time will be analyzed using the same Bayesian model described in the 
primary analysis.
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪ0ǻ-1 
ܪܣ: ǻ-1 
ZKHUHǻLVWKHPHDQGLIIHUHQFHLQDYHUDJHGDLO\ZHDULQJWLPHEHWZHHQ7HVWOHQVDQG&RQWURO
lens (Test minus Control).  Non-inferiority will be declared if the lower bound of the credible 
interval of the mean difference between Test and Control is greater than -1.  Superiority will 
be declared if the lower bound of the credible interval of the mean difference between Test 
and Control is greater than 0.  The superiority test will be performed only if non-inferiority is 
established.
Visual Performance
Monocular distance visual performance in logMAR scale will be analyzed using a Bayesian 
repeated measurement random-effects model to compare between Test and Control lenses.  
The regression model will include baseline values, lens type, lens wearing sequence and lens 
wearing period as fixed effects; and investigational site and patient as random effects.  Other 
subject characteristics such as age, gender and will also be included as fixed effects when 
appropriate. Unstructured covariance matrix will be used to model the residual errors among 
observations within same eye and subject across wearing periods.  Non-informative prior 
distributions will be used for the coefficients in the models as well as for the error terms.  
Independent vague normal N(0,1000) priors will be used for the regression coefficients, 
inverse gamma IG(0.001, 0.001) for the variance of the random effect site and inverse 
Wishart for the residual errors.  The Metropolis sampler algorithm as implemented in the 
SAS MCMC Procedure will be used to carry out parameter estimation.  Results will be 
reported as regression coefficient mean estimates with credible intervals. 
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The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪ0ǻ!0.05 
ܪܣ: ǻ0.05 
ZKHUHǻLVWKHPHDQGLIIHUHQFHLQORJ0$5EHWZHHQ7HVWOHQVDQG&RQWUROOHQV7HVWPLQXV
Control).  Non-inferiority will be declared if the upper bound of the credible interval of the 
mean difference between Test and Control is less than 0.05.   
14.7. Other Exploratory Analyses  
A subgroup analysis will be conducted by considering only subjects who are habitual users of 
1 Day ACUVE Moist.  Further exploratory analysis will be conducted if necessary at the 
discretion of the Study Responsible Clinician.
14.8. Interim Analysis
This is a group sequential adaptive trial with stopping rules for non-inferiority and 
superiority.  The study will be conducted in two phases. In Phase 1, up to 160 subjects will 
be enrolled with a target completion of 150. The data from Phase 1 will then be analyzed to 
see if non-inferiority/superiority can be concluded. The following stopping rules will be 
considered:  
x
If non-inferiority can be concluded, test for superiority. If superiority can be 
concluded stop the study for early success. Otherwise, calculate the predictive 
SUREDELOLW\33RIVXSHULRULW\,I33VWRSWKHVWXG\,I33FRQWLQXHWKH
trial and recruit the Phase 2.
x
If non-inferiority can’t be concluded. Calculate the PP of non-inferiority. If PP < 
VWRSWKHVWXG\,I33FRQWLQXHWKHWULDODQGUHFUXLWWKH3KDVH
More details will be provided in the SAP.
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 may be considered by 
automatically sampling all missing values and incorporating them in the Markov chain for 
the parameters using the PROC MCMC procedure.
14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change. 
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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 an 
EDC system from Bioclinica.  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 Date 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.  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 
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. 
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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 
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. 
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17. 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 amendments, 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.  Only subjects who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent voluntarily will be enrolled. 
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 
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 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
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18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol and, if applicable, amendments 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information) and amendments 
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, amendments (if any), 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 amendments
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 amendments or new edition(s) 
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
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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 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 ICH2 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. 
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has 
been fully explained. The assent and consent forms must be signed before performance of 
any study-related activity. The assent and consent forms that are used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms 
should be in accordance with principles that originated in the Declaration of Helsinki,3
current ICH2 and GCP guidelines, applicable regulatory requirements, and Sponsor policy.   
Before entry into the study or pre-screening, the Investigator or an authorized member of the 
clinical site personnel must explain to the potential subject and parent and/or legal guardian 
the aims, methods, reasonably anticipated benefits, and potential hazards of the study or pre-
screening, and any discomfort it may entail. Subjects and parent and/or legal guardian will be 
informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. They will be informed that choosing not to participate will not affect 
the care the subject will receive.  
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Finally, they will be told that the Investigator will maintain a subject identification register 
for the purposes of long-term follow-up if needed and that their records may be accessed by 
health authorities and authorized Sponsor personnel without violating the confidentiality of 
the subject, to the extent permitted by the applicable law(s) or regulations. By signing the 
assent and informed consent form, the subject is authorizing such access and agrees to be 
contacted after study completion by health authorities and authorized Sponsor personnel for 
the purpose of obtaining consent for additional safety evaluations if needed. 
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 with the Health Information Portability and Accountability Act (HIPAA) in 
the United States5 and other applicable personal data protection and security laws and 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
x
adequate, relevant, and not excessive in relation to said purposes 
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
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The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents. 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
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. 
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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
This study will be registered on ClinicalTrials.gov by the Sponsor. 
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 Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
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. 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-DAY ACUVUE® MOIST
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The lenses 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. 
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated): 
0.98 – 1.12
• Refractive Index: 
1.40
• Light Transmittance:
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
58%
• Oxygen Permeability (D/k):
VALUE
METHOD
21.4 x 10 11 (cm2/sec)
(ml O2/ml x mm Hg) @ 35°C  
Fatt (boundary corrected, edge corrected)
28.0 x 10 11 (cm2/sec)
(ml O2/ml x mm Hg) @ 35°C
Fatt (boundary corrected, non-edge corrected)
Lens Parameters Ranges:
• Diameter (DIA):
12.0 mm to 15.0 mm
• Center Thickness:
Varies with power
• Base Curve (BC):
7.85 mm to 10.00 mm
• Spherical Power (D):
-20.00D to +20.00D
• Cylinder Power (CYL):
-0.25D to -10.00D
• Axis (AXIS):
2.5° to 180°
• ADD Powers:
+0.25D to +4.00D
AVAILABLE LENS PARAMETERS
1-DAY ACUVUE® MOIST Brand Contact Lenses are hemispherical shells of the 
following dimensions:
Diameter (DIA):
14.2 mm
Center Thickness:
0.084 mm to 0.230 mm (varies with power)
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Base Curve (BC):
8.5 mm, 9.0 mm
Powers (D):
-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)
1-DAY ACUVUE® MOIST Brand Contact Lenses for ASTIGMATISM are hemitoric 
shells of the following dimensions:
Diameter (DIA):
14.5 mm
Center Thickness:
0.090 mm to 0.189 mm (varies with power)
Base Curve (BC):
8.5 mm
Powers (D):
+0.00 to -6.00D (in 0.25D increments)
Cylinders (CYL): -0.75D, -1.25D, -1.75D, -2.25D*
Axis (AXIS): 10° to 180° in 10° increments
*-2.25D cylinder is available in 10°, 20°, 70°, 80°, 90°, 
100°, 110°, 160°, 170°, 180° axes only
-6.50D to -9.00D (in 0.50D increments)
Cylinders (CYL): -0.75D, -1.25D, -1.75D, -2.25D*
Axis (AXIS): 10°, 20°, 60°, 70°, 80°, 90°, 100°, 110°, 
120°, 160°, 170°, 180°
*-2.25D cylinder is available in 20°, 90°, 160°, 180° 
axes only
+0.25D to +4.00D (in 0.25D increments)
Cylinders (CYL): -0.75D, -1.25D, -1.75D
Axis (AXIS): 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses are hemispherical 
shells of the following dimensions:
Diameter (DIA):
14.3 mm
Center Thickness:
0.084 mm to 0.207 mm (varies with power)
Base Curve (BC):
8.4 mm
Powers (D):
+6.00D to -9.00D (in 0.25D increments)
Near ADD Powers 
(MAX ADD):
Low Near ADD (LOW): +1.25D
Medium Near ADD (MID): +1.75D
High Near ADD (HGH): +2.50D
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1-DAY ACUVUE® MOIST Brand Contact Lenses (etaﬁ lcon A) Visibility Tinted with 
UV Blocker vs. 24 yr. old human cornea and 25 yr. old human crystalline lens. 
*The data are representative measurements taken through the central 3-5 mm portion for the 
thinnest marketed lens (-3.00D lens, 0.084 mm center thickness).
1 Lerman, S., Radiant Energy and the Eye, MacMi lan, New York, 1980, p. 58, ﬁ gure 2-21
2 Waxler, 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 on the retina.
The UV Blocking for these lenses averages 97% in the UVB range of 280 nm to 
315 nm and 82% in the UVA range of 316 nm to 380 nm for the entire power 
range.
TRANSMITTANCE CURVES
1-DAY ACUVUE® MOIST
Brand Contact Lenses*
24 YR. OLD HUMAN 
CORNEA1
25 YR. OLD HUMAN
CRYSTALLINE LENS2
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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)
1-DAY ACUVUE® MOIST Brand 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 
1.00D or less of astigmatism.
1-DAY ACUVUE® MOIST Brand Contact Lenses 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.
1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses are indicated 
for daily disposable wear for the optical correction of distance and near vision in 
presbyopic phakic or aphakic persons with non-diseased eyes who may have 
4.00D of ADD power or less and 0.75D or less of astigmatism.
The lenses contain a UV Blocker to help protect against transmission of harmful 
UV radiation to the cornea and into the eye.
When prescribed for daily disposable use, no cleaning or disinfection is required. 
Lenses should be discarded upon removal.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these lenses when any of the following conditions exist:
• Acute or subacute 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).
• Corneal hypoesthesia (reduced corneal sensitivity).
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• 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 
EXPERIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness, or
• Other Eye Problems,
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY 
REMOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not to wear 
their lenses while sleeping. Clinical studies have shown that when lenses 
are worn overnight, the risk of ulcerative keratitis is greater than among 
those who do not wear them overnight.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.
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• 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
Instruction 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 investigation of 
lenses, all refractive powers, design conﬁ gurations, or lens parameters 
available in the lens material are not evaluated in signiﬁ cant numbers. 
Consequently, when selecting an appropriate lens design and 
parameters, the Eye Care Professional should consider all characteristics 
of the lens that can affect lens performance and ocular health, including 
oxygen permeability, wettability, central and peripheral thickness, and 
optic zone diameter.
The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and lens 
performance on the eye should be carefully monitored by the prescribing 
Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using monovision 
(or modiﬁ ed monovision using 1-DAY ACUVUE® MOIST Brand 
MULTIFOCAL) 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.
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• 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 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.
• DO NOT touch contact lenses with the ﬁ ngers or hands if the hands are 
not free of foreign materials, as microscopic scratches of the lenses may 
occur, causing distorted vision and/or injury to the eye.
• Carefully follow the handling, insertion, removal, and wearing instructions 
in the Patient Instruction Guide for these lenses 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. 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 recommended 
directions in “Care for Sticking (Non-Moving) Lenses.” 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.
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• 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 hairspray, 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.
Lens Care Precautions:
• The patient should be informed that no cleaning or disinfection is needed 
when lenses are worn for daily disposable wear. Patients should always 
dispose of lenses when removed and have spare lenses or spectacles 
available.
Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medicine in 
the eyes.
• Certain medications, such as antihistamines, decongestants, diuretics, 
muscle relaxants, tranquilizers, and those for motion sickness may cause 
dryness of the eye, increased lens awareness, or blurred vision. Should 
such conditions exist, proper remedial measures should be prescribed. 
• 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 equipment or may 
require that the patient not wear contact lenses.
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ADVERSE REACTIONS
The patient should be informed that the following problems may occur 
when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on the 
eye.
• There may be a feeling of something in the eye (foreign body, scratched 
area).
• There may be the potential for some temporary impairment due to 
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 conjunctivitis, some of which are 
clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or redness 
of the eye.
• Poor visual acuity, blurred vision, rainbows or halos around objects, 
photophobia, or dry eyes may also occur if the lenses are worn 
continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examination at 
least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, the 
patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR HER 
EYE CARE PROFESSIONAL.
The patient should be advised that when any of the above symptoms occur, 
a serious condition such as infection, corneal ulcer, neovascularization, or iritis 
may be present. He or she should be instructed to 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
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risks 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 
keratometry readings. However, corneal curvature measurements should be 
performed to establish the p
ular status. 
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• 
1-DAY ACUVUE® MOIST: 8.5 mm/14.2 mm
• 
1-DAY ACUVUE® MOIST for ASTIGMATISM: 8.5 mm/14.5 mm
• 
1-DAY ACUVUE® MOIST MULTIFOCAL: 8.4 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 characteristics: 
decentration, incomplete corneal coverage (i.e., limbal exposure), 
excessive movement with the blink and/or edge standoff. If the lens is 
judged to be 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 
characteristics: insufﬁ cient movement with the blink, conjunctival 
indentation, and resistance when pushing the lens up digitally with 
the lower lid. If the lens is judged to be steep ﬁ tting, it should not be 
dispensed to the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t and evaluated after the patient has 
adjusted to the lens. The lens should move freely when manipulated digitally 
with the lower lid, and then return to a properly centered position when 
released. If resistance is encountered when pushing the lens up, the lens is 
ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should experience good visual acuity with the 
correct lens power unless there is excessive residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate ﬁ t 
(centration and movement). If the ﬁ t is acceptable, dispense the lenses and 
instruct the patient to return in one week for reassessment (see PATIENT 
MANAGEMENT section).
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.
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 1-DAY ACUVUE® MOIST 
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 ver-
tical 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.
TORIC FITTING GUIDELINES
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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 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. Compensation for this rotation 
should be done as follows:
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 
PATIENT MANAGEMENT section).
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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A.  Presbyopic Needs Assessment & Patient Education
Multifocal contact lenses may produce compromise to vision under certain 
circumstances and the patient should understand that they might not ﬁ nd 
their vision acceptable in speciﬁ c situations (i.e., reading a menu in a dim 
restaurant, driving at night in rainy/foggy conditions, etc.). Therefore, caution 
should be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually challenging 
environments. Occupational and environmental visual demands should 
be considered. If the patient requires critical visual acuity and stereopsis, it 
should be determined by trial whether this patient can function adequately 
with 1-DAY ACUVUE® MOIST MULTIFOCAL. Wearing these lenses 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 
their state driver’s license requirements with the 1-DAY ACUVUE® MOIST 
MULTIFOCAL should be advised to not drive with this correction, OR may 
require that additional over-correction be prescribed.
1-DAY ACUVUE® MOIST MULTIFOCAL is not recommended for patients 
who have -1.00D or greater of refractive cylinder as this level of uncorrected 
cylinder may lead to additional visual compromise. These lenses are available 
in the following ADD powers: 
• 
Lens “LOW” = low near ADD lens (Max ADD +1.25) 
• 
Lens “MID” = medium near ADD lens (Max ADD +1.75) 
• 
Lens “HGH” = high near ADD lens (Max ADD +2.50)
B.  Initial Power Determination
A spectacle refraction should be performed to establish the patient’s baseline 
refractive status and to guide in the selection of the appropriate lens power. 
Remember to compensate for vertex distance if the refraction is greater 
than ±4.00D. Determine the spherical equivalent distance prescription for a 
multifocal patient. Determine the eye dominance using one of the methods 
below:
MULTIFOCAL FITTING GUIDELINES
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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 does not accept added plus power. Place a 
+1.00D hand-held trial lens in front of one eye and then the other 
while the distance refractive error correction is in place for both 
eyes while the patient is viewing the distance visual acuity chart. 
The eye with the plus over it that the patient notices the greatest 
reduction in vision is determined to be the dominant eye.
C. Select the Initial Trial Lens 
1.  For each eye, select the trial lens distance power that is closest to the 
patient’s distance spherical equivalent. Remember to compensate for 
vertex distance if the refraction is greater than ±4.00D.
2.  Select the near power of the lens based on the patients ADD range as 
follows: 
• 
ADD: +0.75D to +1.25D use a low near ADD (LOW) lens on each eye 
• 
ADD: +1.50D to +1.75D use a medium near ADD (MID) lens on each 
eye 
• 
ADD: +2.00D to +2.50D use a medium near ADD (MID) on the 
dominant eye and a high near ADD (HGH) lens on the non-dominant 
eye
3.  Allow the lenses to settle for a minimum of 10 minutes. 
4.  Assess distance and near vision binocularly and monocularly. 
5.  Demonstrate the vision under various lighting conditions (normal and 
decreased illumination) and at distance, intermediate, and near. 
6.  Make adjustments in power as necessary based on the distance over-
refraction. The use of hand-held trial lenses is recommended. Check the 
impact on distance and near vision.
7. If vision is still unacceptable, make adjustments in power as necessary 
(see "Multifocal Troubleshooting" below). If distance and near vision 
are acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If ﬁ t is acceptable, dispense the lenses 
instructing the patient to return in one week for reassessment (see 
PATIENT MANAGEMENT section).
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D. Multifocal Troubleshooting
Unacceptable Near Vision
If it has been determined that no change is required based on the over-
refraction, then add +0.25D to the spherical power of the non-dominant eye.
Unacceptable Distance Vision
If it has been determined that no change is required based on the over-
refraction, then make the changes as listed below:
• 
If the patient is wearing two "LOW" ADD lenses, change the dominant 
eye to a 1-DAY ACUVUE® MOIST sphere lens with a power equal to the 
spherical equivalent distance prescription.
• 
If the patient is wearing two "MID" ADD lenses, change the ADD power in 
the dominant eye to the "LOW" ADD power.
• 
If the patient is wearing a "MID" ADD lens in the dominant eye and a 
"HGH" ADD lens in the non-dominant eye, change the non-dominant eye 
to a "MID" ADD lens and add +0.25D to the distance power.
E. 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.
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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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 
their state driver’s license requirements with monovision correction 
should be advised to not drive with this correction, OR may require that 
additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correction. Patients 
may not perform as well for certain tasks with this correction as they have 
with spectacles (multifocal, bifocal, trifocal, readers, progressives). Each 
patient should understand that monovision, as well as other presbyopic 
alternatives, can create a vision compromise that may reduce visual acuity 
and depth perception for distance and near tasks. Therefore, caution 
should be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually challenging 
environments (e.g., reading a menu in a dimly lit 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.
MONOVISION FITTING GUIDELINES
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The following 
two methods for eye dominance can be used.
Method 1    Determine which eye is the “sighting eye.” Have the patient 
point to an object at the far end of the room. Cover one eye. 
If the patient is still pointing directly at the object, the eye 
being used is the dominant (sighting) eye.
Method 2    Determine which eye will accept the added power with the 
least reduction in vision. Place a hand-held trial lens equal to 
the spectacle near ADD in front of one eye and then the other 
while the distance refractive error correction is in place for 
both eyes. Determine whether the patient functions best with 
the near ADD lens over the right or left eye.
2. Other Eye Selection Methods
Other methods include the “Refractive Error Method” and the “Visual 
Demands Method.”
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more hyperopic 
(less myopic) eye for distance and the more myopic (less hyperopic) eye 
for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process to 
determine the critical vision requirements. If a patient’s gaze for near tasks 
is usually in one direction, correct the eye on that side for near.
Example: A secretary who places copy to the left side of the desk will 
function best with the near lens on the left eye.
C.  Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. As an 
example, an emmetropic patient would only require a near lens, whereas 
a bilateral myope would require corrective lenses on both eyes. 
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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 eye 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 a standard clinical evaluation procedure should be used 
to determine the prognosis. Determine the distance correction and the 
near correction. Next, determine the near ADD. With trial lenses of the 
proper power in place, observe the reaction to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct power 
lenses in place. Walk across the room and have the patient look at 
you. Assess the patient’s reaction to distance vision under these 
circumstances. Then have the patient look at familiar near objects such 
as a watch face or ﬁ ngernails. Again assess the reaction. As the patient 
continues to look around the room at both near and distance objects, 
observe the reactions. Only after these vision tests are completed, should 
the patient be asked to read print. Evaluate the patient’s reaction to large 
print (e.g., typewritten copy) at ﬁ rst and then graduate to newsprint and 
ﬁ nally smaller type sizes.
After the patient’s performance under the above conditions is completed, 
tests of visual acuity and reading ability under conditions of moderately 
dim illumination should be attempted.
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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 
your patient follow the suggestions below:
• Have a third contact lens (distance power) to use when critical 
distance viewing is needed.
• Have a third contact lens (near power) to use when critical near 
viewing is needed.
• Have 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
• Follow the accepted standard of care in ﬁ tting and following up with your 
patient, e.g., American Optometric Association standard of care. 
• Schedule the appropriate follow-up examination. 
• Preferably, at the follow-up visits, lenses should have been worn for at 
least six hours. 
• Provide the patient with a copy of the PATIENT INSTRUCTION GUIDE for 
these lenses, which can be found at www.acuvue.com. REVIEW THESE 
INSTRUCTIONS WITH THE PATIENT SO THAT HE OR SHE CLEARLY 
UNDERSTANDS THE PRESCRIBED WEARING AND REPLACEMENT 
SCHEDULES.
The wearing schedule should be determined by the Eye Care Professional. 
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to over wear the lenses initially. The Eye Care Professional should 
emphasize the importance of adhering to the initial maximum wearing schedule. 
Maximum wearing time should be determined by the Eye Care Professional 
based upon the patient’s physiological eye condition, because individual 
response to contact lenses varies. 
WEARING SCHEDULE
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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
These lenses are indicated for daily disposable wear and should be discarded 
upon removal.
When disposed of after a single daily use, these lenses may reduce the risk of 
developing giant papillary conjunctivitis.4
When worn as a daily disposable lens, these lenses may provide improved 
comfort for many patients who experience mild discomfort and itching 
associated with allergies during contact lens wear, compared to lenses replaced 
at intervals of greater than 2 weeks.
Clinical research has shown that when worn on a daily disposable basis, these 
lenses may provide improved comfort for 2 out of 3 patients who reported 
suffering from discomfort associated with allergies during contact lens wear.
4 The CLAO Journal, July 1999, Volume 25, Number 3
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 replacement lenses or 
spectacles available.
For complete information concerning contact lens handling and care, refer to 
the PATIENT INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com. 
Care for Sticking (Non-Moving) Lenses
During removal, if the lens sticks to the eye, the patient should be instructed 
to apply a few drops of the recommended lubricating or rewetting solution 
REPLACEMENT SCHEDULE
LENS CARE DIRECTIONS
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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.
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.
Each UV-absorbing sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with povidone. The plastic package is marked 
with the following: 
• 
1-DAY ACUVUE® MOIST: base curve, power, diameter, lot number, and 
expiration date
• 
1-DAY ACUVUE® MOIST for ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, lot number, and expiration date
• 
1-DAY ACUVUE® MOIST MULTIFOCAL: base curve, power, diameter, 
ADD power, lot number, and expiration date
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
EMERGENCIES
HOW SUPPLIED
REPORTING OF ADVERSE REACTIONS
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APPENDIX D: 
 
 
LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
LENS FITTING CHARACTERISTICS
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
BIOMICROSCOPY SCALE
DISTANCE AND NEAR VISUAL ACUITY EVALUATION
DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
PATIENT REPORTED OUTCOMES
WHITE LIGHT LENS SURFACE WETTABILITY
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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Limbal & Conjunctival (Bulbar) Redness
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Expanded Sodium Fluorescein Corneal Staining
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Lens Fitting Characteristics
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Subject Reported Ocular Symptoms/Problems
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, Front And Back Surface Lens Deposit Grading Procedure 
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Determination Of Distance Spherocylindrical Refractions
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 Biomicroscopy Scale 
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Distance And Near Visual Acuity Evaluation
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 Distance Logmar Visual Acuity Measurement Procedure
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 1 of 3 
 
  
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
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Patient Reported Outcomes
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White Light Lens Surface Wettability
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REQUIREMENTS
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Visual Acuity Chart Luminance And Room Illumination Testing
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
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Title:
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Document Number: 
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Title:
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Document Number: 
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Title:
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Document Number: 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6307 Clinical Evaluation of Etafilcon A Contact Lenses 
Using a Novel Molding Process 
Version and Date: v1.0 August 8, 2018 
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. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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