Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process
Phase: NA
Conditions: Refractive Error Correction
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-6270    
 
Version: 1.0 
                            
Date: May 30, 2018 
 
 
Investigational Products: etafilcon A 
 
Key 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 ................................................................... 15 
1.1. 
Name and Descriptions of Investigational Products ...................................................... 15 
1.2. 
Intended Use of Investigational Products....................................................................... 15 
1.3. 
Summary of Findings from Nonclinical Studies ............................................................ 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ......................................... 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 16 
2.1. 
Objectives ....................................................................................................................... 16 
2.2. 
Endpoints ........................................................................................................................ 16 
2.3. 
Hypotheses ..................................................................................................................... 17 
3. 
TARGETED STUDY POPULATION ........................................................................... 18 
3.1. 
General Characteristics .................................................................................................. 18 
3.2. 
Inclusion Criteria ............................................................................................................ 18 
3.3. 
Exclusion Criteria ........................................................................................................... 18 
3.4. 
Enrollment Strategy........................................................................................................ 19 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 19 
4.1. 
Description of Study Design .......................................................................................... 19 
4.2. 
Study Design Rationale .................................................................................................. 20 
4.3. 
Enrollment Target and Study Duration .......................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 22 
5.1. 
Test Article Allocation ................................................................................................... 22 
5.2. 
Masking .......................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking................................................. 23 
6. 
STUDY INTERVENTION ............................................................................................. 23 
6.1. 
Identity of Test Articles.................................................................................................. 23 
6.2. 
Ancillary Supplies/Products ........................................................................................... 24 
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6.3. 
Administration of Test Articles ...................................................................................... 24 
6.4. 
Packaging and Labeling ................................................................................................. 24 
6.5. 
Storage Conditions ......................................................................................................... 25 
6.6. 
Collection and Storage of Samples ................................................................................ 25 
6.7. 
Accountability of Test Articles ...................................................................................... 25 
7. 
STUDY EVALUATIONS .............................................................................................. 26 
7.1. 
Time and Event Schedule ............................................................................................... 26 
7.2. 
Detailed Study Procedures ............................................................................................. 27 
VISIT 1 ................................................................................................................................. 27 
VISIT 2 ................................................................................................................................. 32 
VISIT 3 ................................................................................................................................. 34 
VISIT 4 ................................................................................................................................. 38 
FINAL EVALUATION ........................................................................................................ 39 
7.3. 
Unscheduled Visits ......................................................................................................... 40 
7.4. 
Laboratory Procedures ................................................................................................... 41 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 41 
8.1. 
Completion Criteria ........................................................................................................ 41 
8.2. 
Withdrawal/Discontinuation from the Study ................................................................. 41 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 42 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 42 
11. 
STUDY TERMINATION ........................................................................................... 42 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 43 
13. 
ADVERSE EVENTS ................................................................................................... 44 
13.1. 
Definitions and Classifications ................................................................................... 44 
13.2. 
Assessing Adverse Events .......................................................................................... 46 
13.2.1. 
Causality Assessment .......................................................................................... 46 
13.2.2. 
Severity Assessment ............................................................................................ 47 
13.3. 
Documentation and Follow-Up of Adverse Events .................................................... 47 
13.4. 
Reporting Adverse Events .......................................................................................... 48 
13.4.1. 
Reporting Adverse Events to Sponsor ................................................................ 49 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 49 
13.5. 
Event of Special Interest ............................................................................................. 50 
13.6. 
Reporting of Pregnancy .............................................................................................. 50 
14. 
STATISTICAL METHODS ........................................................................................ 50 
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14.1. 
General Considerations ............................................................................................... 50 
14.2. 
Sample Size Justification ............................................................................................ 50 
14.3. 
Analysis Populations .................................................................................................. 51 
14.4. 
Level of Statistical Significance ................................................................................. 52 
14.5. 
Primary Analysis ........................................................................................................ 52 
14.6. 
Secondary Analysis .................................................................................................... 53 
14.7. 
Other Analyses ........................................................................................................... 54 
14.8. 
Interim Analysis ......................................................................................................... 54 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ............................................... 54 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ......................................... 54 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 54 
15.1. 
Electronic Case Report Form/Data Collection ........................................................... 54 
15.2. 
Subject Record ............................................................................................................ 55 
16. 
DATA MANAGEMENT............................................................................................. 56 
16.1. 
Access to Source Data/Document .............................................................................. 56 
16.2. 
Confidentiality of Information.................................................................................... 56 
16.3. 
Data Quality Assurance .............................................................................................. 56 
17. 
MONITORING ............................................................................................................ 56 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 57 
18.1. 
Study-Specific Design Considerations ....................................................................... 57 
18.2. 
Investigator Responsibility ......................................................................................... 57 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) ................ 57 
18.4. 
Informed Consent ....................................................................................................... 58 
18.5. 
Privacy of Personal Data ............................................................................................ 59 
19. 
STUDY RECORD RETENTION................................................................................ 60 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 61 
21. 
PUBLICATION ........................................................................................................... 61 
22. 
REFERENCES ............................................................................................................ 62 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 63 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 70 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 71 
APPENDIX D: CLINICAL TECHNICAL PROCEDURES (CTP) .................................... 100 
, Limbal And Conjunctival (Bulbar) Redness ...................................................... 101 
, Expanded Sodium Fluorescein Corneal Staining ............................................... 109 
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, Lens Fitting Characteristics ................................................................................ 114 
 Subject Reported Ocular Symptoms .................................................................. 121 
 Front And Back Surface Lens Deposit Grading Procedure ............................... 123 
, Determination Of Distance Spherocylindrical Refractions ................................ 129 
 Biomicroscopy Scale .......................................................................................... 136 
 Distance And Near Visual Acuity Evaluation.................................................... 142 
, Etdrs Distance Visual Acuity Measurement Procedure ..................................... 147 
, Patient Reported Outcomes ................................................................................ 151 
, White Light Lens Surface Wettability ............................................................... 153 
, Visual Acuity Chart Luminance And Room Illumination Testing .................... 155 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 160 
 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ............................................................................................................ 13 
 
TABLE OF CONTENTS  
Table 1: Target number of subjects by arm and phase ................................................................. 22 
Table 2: Test Articles .................................................................................................................... 23 
Table 3: Ancillary Supplies .......................................................................................................... 24 
Table 4: Time and Events ............................................................................................................. 26 
Table 5: 1-week CLUE comfort and vision for 1 Day ACUVUE MOIST in historical studies .. 51 
Table 6: Power Analysis for CLUE scores ................................................................................... 51 
 
 
 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Clinical Evaluation of etafilcon A Contact Lenses Using a Novel Molding Process 
Protocol Number:  CR-6270 
Version: 1.0 
Date:  May 30, 2018 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR 
Name:  Brian Pall, OD, MS, FAAO 
Title: Senior Principal Research Optometrist 
Address: 7500 Centurion Parkway, Suite 100, Mail W-2A, Jacksonville, FL 32256 
 
Email: BPALL@its.jnj.com 
 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate. 
 
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File. 
 
 
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ICH guidelines,2 ISO 14155, and 
the Declaration of Helsinki.3  
 
 
 
Study Responsible
Clinician/Author
 
 
 
See Electronic Signature Report 
 
 
 
Brian Pall, OD, MS, FAAO 
Sr. Principal Research Optometrist 
 
DATE 
 
Clinical Operations 
Manager 
 
 
See Electronic Signature Report 
 
 
 
 
Manager, Clinical Operations 
 
DATE 
 
 
Biostatistician 
 
 
See Electronic Signature Report 
 
 
 
 
 
DATE 
 
 
Data Management  
Senior Manager, Biostatistics 
 
See Electronic Signature Report 
 
 
 
 
Clinical Project Mgr. Data & Systems 
 
DATE 
 
 
Reviewer 
 
 
See Electronic Signature Report 
 
 
 
 
Clinical Research Fellow 
 
DATE 
 
 
Approver 
 
 
See Electronic Signature Report 
 
 
 
 
Director - Global Sphere Platform  
 
DATE 
 
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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:   
• etafilcon A contact lenses made with a novel molding 
process (Test)  
• 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): 
• Overall comfort after 1-week of lens wear 
• Overall quality of vision after 1-week of lens wear 
 
Secondary endpoint(s):   
• Average daily wear time (in hour) 
• Monocular distance visual performance 
 
Additional Endpoints: 
• Slit lamp findings 
• Subject reported ocular symptoms 
• Lens fitting characteristics 
• Lens wettability 
• 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 
  
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 lenses 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 < 0.75D in each 
eye. 
8. The subject must have best corrected visual acuity of 
20/25 or better in each eye. 
 
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). 
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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 of investigational clinic (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. 
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 
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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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Figure 1: Study Flowchart 
 
 
 
 
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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 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
CTP 
 
 
Clinical Technical Procedure 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
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PP 
 
 
Predictive Probability 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
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: 
• etafilcon A contact lenses made with a novel molding process (Test). 
• 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). 
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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). 
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: 
• Overall comfort   
• 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: 
• Average daily wear time 
• 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. 
 
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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.  
 
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 
• Adverse events 
• Reasons for discontinuation 
• 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. 
 
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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. 
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. 
 
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). 
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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 of investigational clinic (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.  
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.   
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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 34.), 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.  
 
Historical data (see Sample Size Justification section) showed that the variances of CLUE comfort 
and vision scores of the Control lens (see Sample Size Justification section) 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. 
 
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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 
 
 
 
 
 
Subjects/site 
(Min-Max) 
 
 
 
 
 
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: 
 
• 
Informed consent has been obtained 
• 
Subject meets all the inclusion / exclusion criteria 
• 
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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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   
 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles, and must be labeled with the subject number and date of 
return.  Following final reconciliation of test articles by the monitor, the Investigator or monitor 
will return all unused test articles to JJVC. 
 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
Reference 
Site Instructions for Test Article Receipt and Test Article Accountability 
for additional information. 
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• Complete the Final Evaluation, indicating the reason that the subject was discontinued from 
the study 
• Record the spherocylindrical refraction with best corrected distance visual acuity  
• Collect used test article(s) (worn or brought to the visit) from the subject and discard them, 
unless otherwise stated in Section 7.2 
• 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 (PD). Major PDs 
must be reported to the sponsor within 24 hours after discovery of the PD.  The Investigator will 
report deviations per IRB/IEC requirements.  All deviations will be tracked and corrective actions 
implemented as appropriate.  
 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation immediately 
without notification to the sponsor.  Within 24 hours after the implemented deviation, the 
Investigator must notify and provide the rationale to the Sponsor and, as required, the IEC/IRB.  
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. 
 
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JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The study 
can be terminated by the Principal Investigator at the individual clinical site due to specific clinical 
observations, if in their opinion, after a discussion with JJVC, it is determined that it would be 
unwise to continue at the clinical site.    
 
JJVC (and the IEC/IRB and Data Monitoring Committee [DMC], if applicable) will evaluate all 
adverse events.  If it is determined that an adverse event presents an unreasonable risk, the 
investigation, or that part of the investigation presenting the risk, will be terminated, as soon as 
possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify 
the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication that 
alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, and 
site personnel, etc. The following are not considered product quality complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and PRO 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site 
• Lens replacements that occur due to drops/fall-outs 
• Damage deemed by clinicians or clinical staff to be caused by handling by the user, and 
not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where there is 
no deficiency alleged by the subject 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the appropriate 
COM/CRA and Clinical QA representative. In cases where the EDC system in use is not 
configured to send automatic notifications or when an EDC system is not used, the COM/CRA is 
responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness) 
• Who received the complaint 
• Study number 
• Clinical site information (contact name, site ID, telephone number) 
• Lot number(s) 
• Unique Subject Identifier(s) 
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• 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) 
• Is a congenital anomaly/birth defect, or 
• 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 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or 
greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – 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: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other Grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
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.   
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Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, but 
not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
Note 1 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: 
• Seriousness/Classifications (see definition in Section 13.1) 
• Causality or Relatedness – i.e. the relationship between the test article, study treatment or 
study procedures and the adverse event (not related; unlikely related; possibly related; 
related - see definition in Section 13.2.1) 
• 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)   
• Outcome – not recovered or not resolved; recovering or resolving; recovered or resolved 
with sequelae; recovered or resolved; death related to adverse event; unknown 
• 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: 
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• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
• Unlikely Related – An adverse event for which an alternative explanation is more likely, 
e.g. concomitant treatment, concomitant disease(s), or the relationship of time suggests that 
a causal relationship is not likely 
• Possibly Related – An adverse event that might be due to the use of the test article, or to 
the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive.  The relationship in time is reasonable.  
Therefore, the causal relationship cannot be excluded 
• Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s).  The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event as 
determined by the Investigator or reported to him/her by the subject.  The assessment of severity 
is made irrespective of test article, study treatment or study procedure relationship or seriousness 
of the event and should be evaluated according to the following scale: 
• Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere with 
the subject’s daily activities 
• Moderate – Event is bothersome, possible requiring additional therapy, and may interfere 
with the subject’s daily activities 
• Severe – Event is intolerable, necessitates additional therapy or alteration of therapy and 
interferes with the subject’s daily activities 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) 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.   
 
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It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  Such 
documentation will include the following: 
• Adverse event (diagnosis not symptom) 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, 
and depth, etc.)  
• Date the clinical site was notified  
• Date and time of onset 
• Date and time of resolution 
• Adverse event classification, severity, and relationship to test articles, as applicable 
• Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements 
• Any referral to another health care provider if needed 
• Outcome, ocular damage (if any) 
• Likely etiology 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the event 
 
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 
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requirements (Section 13.4.2).  The report will comment whether the adverse event was considered 
to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring during 
the study period as soon as possible by e-mail, 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: 
• Notify the Sponsor immediately 
• Obtain and maintain in the subject’s records all pertinent medical information and medical 
judgment for colleagues who assisted in the treatment and follow-up of the subject 
• Provide the Sponsor with a complete case history which includes a statement as to whether 
the event was or was not related to the use of the test article 
• Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to national 
regulations 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator will 
submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later than 24 
hours after the Investigator first learns of the effect.  This report is in addition to the immediate 
notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the evaluation 
to FDA, the IEC/IRB and participating Investigators within 10 working days after the Sponsor first 
receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported to 
the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth by 
their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth by 
their local governing Health Authorities. 
 
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The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the event 
is recorded as an Adverse Event.  Once discontinued, pregnant participants and their fetuses will 
not be monitored for study related purposes.  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 
CR-5777 
66 
56.38 
24.655 
66 
65.04 
22.824 
CR-5778 
68 
63.87 
24.693 
68 
65.17 
22.110 
CR-5800 
138 
58.72 
22.643 
138 
61.24 
20.643 
CR-5801 
142 
57.21 
21.341 
142 
61.71 
19.345 
CR-5870 
142 
60.10 
26.356 
142 
63.52 
23.652 
CR-5991 
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-
subject correlation (ρ).  The results are summarized below: 
 
Table 6: Power Analysis for CLUE scores 
Sample Size (N) 
Inter-subject 
 correlation (ρ) 
Power (%) 
σ = 24 
Power (%) 
σ = 26 
 
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.  
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 1 observation should be recorded. 
 
 
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Per-Protocol (PP) 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 PDs 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.  
 
Safety variables will be summarized on the safety population whereas efficacy variables will be 
summarized on the per-protocol and Intent-to-Treat population.  The primary and secondary 
analyses will be conducted on both IIT and PP populations.  
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.  
 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as 
follows: 
 
𝐻0: Δ < -5 
𝐻𝐴: Δ ≥ -5 
 
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where Δ is the CLUE score mean difference between Test lens and Control 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 -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: 
 
𝐻0: Δ < -1 
𝐻𝐴: Δ ≥ -1 
 
where Δ is the mean difference in average daily wearing time between Test lens and Control 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.  
 
The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as 
follows: 
 
𝐻0: Δ > 0.05 
𝐻𝐴: Δ ≤ 0.05 
 
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where Δ is the mean difference in logMAR between Test lens and Control lens (Test minus 
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 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:  
• If non-inferiority can be concluded, test for superiority. If superiority can be concluded 
stop the study for early success. Otherwise, calculate the predictive probability (PP) of 
superiority. If PP < 0.20, stop the study. If PP ≥ 0.80, continue the trial and recruit the 
Phase 2. 
•  If non-inferiority can’t be concluded. Calculate the PP of non-inferiority. If PP < 0.20, 
stop the study. If PP ≥ 0.80, continue the trial and recruit the Phase 2. 
 
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. 
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 
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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:  
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• reason for early discontinuation of test article or withdrawal from the study, if applicable 
 
The subject record is the eCRF or an external record.  The author of an entry in the subject record 
must be identifiable.  The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
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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. 
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: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
• Ensuring the rights and wellbeing of subjects are protected 
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• Ensuring adequate resources, including facilities, laboratories, equipment, and qualified 
clinical site personnel 
• Ensuring that PDs are documented with corrective action plans, as applicable 
• Ensuring that the clinical site has sufficient test article and supplies 
• Clarifying questions regarding the study 
• Resolving study issues or problems that may arise 
• 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. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol and, if applicable, amendments 
• Sponsor-approved informed consent form (ICF) (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information) and amendments 
• Sponsor-approved subject recruitment materials 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB) 
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• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
• Any other documents that the IEC/IRB requests to fulfill its obligation 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the ICF, applicable recruiting materials, and subject compensation programs, 
and the Sponsor has received a copy of this approval. This approval letter must be dated and must 
clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following documents 
to the IEC/IRB for their review and approval, where appropriate: 
• Protocol amendments 
• Revision(s) to ICF and any other written materials to be provided to subjects 
• If applicable, new or revised subject recruitment materials approved by the Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure amendments or new edition(s) 
• Summaries of the status of the study (at least annually or at intervals stipulated in guidelines 
of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of the 
study 
• Major PDs as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• Any other requirements of the IEC/IRB 
 
For protocol amendments that increase subject risk, the amendment and applicable ICF revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the 
change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request should 
be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about 
the study completion.  Documentation of this notification must be retained at the clinical site and 
a copy provided to the Contract Research Organization (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 
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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 ICF 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 ICF 
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 ICFs 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.  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 ICF, 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 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 
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the express permission of the subject concerned, with the exception of Sponsor personnel (monitor, 
auditor), IEC/IRB and regulatory organizations in the context of their investigation related 
activities that, as part of the investigation will have access to the CRFs and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be limited 
to those data that are necessary to investigate the efficacy, safety, quality, and utility of the 
investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
• processed fairly and lawfully 
• collected for specified, explicit, and legitimate purposes and not further processed in a way 
incompatible with these purposes 
• adequate, relevant, and not excessive in relation to said purposes 
• accurate and, where necessary, kept current 
 
Explicit consent for the processing of personal data will be obtained from the participating subject 
before collection of data. Such consent should also address the transfer of the data to other entities 
and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps should 
be taken to respond to such a request, taking into consideration the nature of the request, the 
conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to personal 
data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines, 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/GCP 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.2 
 
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. 
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If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will accept 
the responsibility. The Sponsor must be notified in writing of the name and address of the new 
custodian. Under no circumstance shall the Investigator relocate or dispose of any study documents 
before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations such 
as: 
• Continuing an ineligible subject in the study 
• Scheduling a study visit outside the subject’s acceptable visit range 
 
JJVC reserves the right to withhold final remuneration until all study related activities have been 
completed, such as: 
• Query resolution 
• Case Report Form signature 
• Completion of any follow-up action items  
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
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22. REFERENCES 
1. 
ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good 
clinical practice. 
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP): 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html  
3. 
Declaration of Helsinki – Ethical principles for Medical Research Involving Human 
Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html. 
4. 
United States (US) Code of Federal Regulations (CFR). In 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR . 
5. 
Health Information Portability and Accountability Act (HIPAA). In 
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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PRO SPECIFICATIO
 1 Final  2018-05-04
Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATIO
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Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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PRO SPECIFICATIO
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Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
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 1 Final  2018-05-04
Protocol 6270                 Johnson & Johnson Vision Care, Inc.                  Confidential
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A Patient Instruction Guide will be provided separately.   
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-DAY ACUVUE® MOIST 
 
 
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The 
lenses are t
inted b
lue us
ing React
ive B
lue Dye #4 to make the 
lenses more 
v
is
ib
le for hand
l
ing. A benzotr
iazo
le UV absorb
ing monomer 
is used to b
lock UV 
rad
iat
ion. 
Lens Properties:
The phys
ica
l/opt
ica
l propert
ies of the 
lens are:
• Spec
iﬁ
 c Grav
ity (ca
lcu
lated):  0.98 – 1.12
• Refract
ive Index: 
1.40
• L
ight Transm
ittance:
85% m
in
imum
• Surface Character:
Hydroph
i
l
ic
• Water Content:
58%
• Oxygen Permeab
i
l
ity (D/k):
VALUE
METHOD
21.4 x 1011 (cm
2/sec)
(m
l O
2/m
l x mm Hg) @ 35°C  
Fatt (boundary corrected,
 edge corrected)
28.0 x 1011 (cm
2/sec)
(m
l O
2/m
l x mm Hg) @ 35°C
Fatt (boundary corrected,
 non-edge corrected)
Lens Parameters Ranges:
• D
iameter (DIA):
12.0 mm to 15.0 mm
• Center Th
ickness:
Var
ies w
ith power
• Base Curve (BC):
7.85 mm to 10.00 mm
• Spher
ica
l Power (D):
-20.00D to +20.00D
• Cy
l
inder Power (CYL): 
-0.25D to -10.00D
• Ax
is (AXIS):
2.5° to 180°
• ADD Powers:
+0.25D to +4.00D
AVAILABLE LENS PARAMETERS
1-DAY ACUVUE® MOIST Brand Contact Lenses are hem
ispher
ica
l she
l
ls of the 
fo
l
low
ing d
imens
ions:
Diameter (DIA):
14.2 mm
Center Thickness:
3
0 084 mm to 0.230 mm (var
ies w
ith power)
CR-6270, v10 
VCT-0007 (7) 
Page 74 of 160
JJVC CONFIDENTIAL

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 hem
itor
ic 
she
l
ls of the fo
l
low
ing d
imens
ions:
Diameter (DIA):
14.5 mm
Center Thickness:
0.090 mm to 0.189 mm (var
ies w
ith power)
Base Curve (BC):
8.5 mm
Powers (D):
+0.00 to -6.00D (
in 0.25D 
increments)
Cy
l
inders (CYL): -0.75D, -1.25D, -1.75D, -2.25D*
Ax
is (AXIS): 10° to 180° 
in 10° 
increments
*-2.25D cy
l
inder 
is ava
i
lab
le 
in 10°, 20°, 70°, 80°, 90°, 
100°, 110°, 160°, 170°, 180° axes on
ly
-6.50D to -9.00D (
in 0.50D 
increments)
Cy
l
inders (CYL): -0.75D, -1.25D, -1.75D, -2.25D*
Ax
is (AXIS): 10°, 20°, 60°, 70°, 80°, 90°, 100°, 110°, 
120°, 160°, 170°, 180°
*-2.25D cy
l
inder 
is ava
i
lab
le 
in 20°, 90°, 160°, 180° 
axes on
ly
+0.25D to +4.00D (
in 0.25D 
increments)
Cy
l
inders (CYL): -0.75D, -1.25D, -1.75D
Ax
is (AXIS): 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses are hem
ispher
ica
l 
she
l
ls of the fo
l
low
ing d
imens
ions:
Diameter (DIA):
14.3 mm
Center Thickness:
0.084 mm to 0.207 mm (var
ies w
ith power)
Base Curve (BC):
8.4 mm
Powers (D):
+6.00D to -9.00D (
in 0.25D 
increments)
Near ADD Powers 
(MAX ADD):
4
Low Near ADD (LOW): +1.25D
Med
ium Near ADD (MID): +1.75D
H
igh Near ADD (HGH): +2.50D
CR-6270, v10 
VCT-0007 (7) 
Page 75 of 160
JJVC CONFIDENTIAL

1-DAY ACUVUE® MOIST Brand Contact Lenses (etaﬁ
 
lcon A) V
is
ib
i
l
ity T
inted w
ith 
UV B
locker vs. 24 yr
. o
ld human cornea and 25 yr
. o
ld human crysta
l
l
ine 
lens. 
*The data are representat
ive measurements taken through the centra
l 3-5 mm port
ion for the 
th
innest marketed 
lens (-3.00D 
lens, 0.084 mm center th
ickness).
1 Lerman, S., Rad
iant Energy and the Eye, MacM
i
 
lan, New York, 1980, p. 58, ﬁ
 gure 2-21
2 Wax
ler
, M., H
itch
ins, V
.M., Opt
ica
l Rad
iat
ion and V
isua
l Hea
lth, CRC Press, Boca Raton, F
lor
ida, 
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 p
laced on the cornea, acts as a 
refract
ing med
ium to focus 
l
ight rays on the ret
ina.
The UV B
lock
ing 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 ent
ire power 
range.
TRANSMITTANCE CURVES
1-DAY ACUVUE
® MO
IST
Brand Contact Lenses*
24 YR. OLD HUMAN 
CORNEA1
25 YR. OLD HUMAN
CRYSTALLINE LENS2
5
CR-6270, v10 
VCT-0007 (7) 
Page 76 of 160
JJVC CONFIDENTIAL

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 
ind
icated for da
i
ly 
d
isposab
le wear for the opt
ica
l correct
ion of refract
ive ametrop
ia (myop
ia and 
hyperop
ia) 
in phak
ic or aphak
ic persons w
ith non-d
iseased eyes who may have 
1.00D or 
less of ast
igmat
ism.
1-DAY ACUVUE® MOIST Brand Contact Lenses for ASTIGMATISM are 
ind
icated 
for da
i
ly d
isposab
le wear for the opt
ica
l correct
ion of refract
ive ametrop
ia (myop
ia 
and hyperop
ia) 
in phak
ic or aphak
ic persons w
ith non-d
iseased eyes who may 
have 0.50D to 3.00D of ast
igmat
ism.
1-DAY ACUVUE® MOIST Brand MULTIFOCAL Contact Lenses are 
ind
icated 
for da
i
ly d
isposab
le wear for the opt
ica
l correct
ion of d
istance and near v
is
ion 
in 
presbyop
ic phak
ic or aphak
ic persons w
ith non-d
iseased eyes who may have 
4.00D of ADD power or 
less and 0.75D or 
less of ast
igmat
ism.
The 
lenses conta
in a UV B
locker to he
lp protect aga
inst transm
iss
ion of harmfu
l 
UV rad
iat
ion to the cornea and 
into the eye.
When prescr
ibed for da
i
ly d
isposab
le use, no c
lean
ing or d
is
infect
ion 
is requ
ired. 
Lenses shou
ld be d
iscarded upon remova
l.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these lenses when any of the following conditions exist:
6
•  Acute or subacute 
inﬂ
 ammat
ion or 
infect
ion of the anter
ior chamber of 
the eye.
•  Any eye d
isease, 
in
jury
, or abnorma
l
ity that affects the cornea, 
con
junct
iva, or eye
l
ids.
•  Severe 
insufﬁ
 c
iency of 
lacr
ima
l secret
ion (dry eye).
•  Cornea
l hypoesthes
ia (reduced cornea
l sens
it
iv
ity).
CR-6270, v10 
VCT-0007 (7) 
Page 77 of 160
JJVC CONFIDENTIAL

•  Any system
ic d
isease that may affect the eye or be exaggerated by 
wear
ing contact 
lenses.
•  A
l
lerg
ic react
ions of ocu
lar surfaces or adnexa that may be 
induced or 
exaggerated by wear
ing contact 
lenses or use of contact 
lens so
lut
ions.
•  Ocu
lar 
irr
itat
ion due to a
l
lerg
ic react
ions wh
ich may be caused by use 
of contact 
lens so
lut
ions (
i.e., rewett
ing drops) that conta
in chem
ica
ls or 
preservat
ives (such as mercury
, Th
imerosa
l, etc.) to wh
ich some peop
le 
may deve
lop an a
l
lerg
ic response.
•  Any act
ive cornea
l 
infect
ion (bacter
ia
l, funga
l, protozoa
l, or v
ira
l).
•  If eyes become red or 
irr
itated.
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 prescr
ibed for da
i
ly wear
, pat
ients shou
ld be 
instructed not to wear 
the
ir 
lenses wh
i
le s
leep
ing. C
l
in
ica
l stud
ies have shown that when 
lenses 
are worn overn
ight, the r
isk of u
lcerat
ive kerat
it
is 
is greater than among 
those who do not wear them overn
ight.
3
7
•  Stud
ies have shown that contact 
lens wearers who are smokers have a 
h
igher 
inc
idence of adverse react
ions than nonsmokers.
•  Prob
lems w
ith contact 
lenses or 
lens care products cou
ld resu
lt 
in 
ser
ious 
in
jury to the eye. Pat
ients shou
ld be caut
ioned that proper use 
and care of contact  enses and 
le s care p oducts are essent
ia
l for the 
safe use of these products
CR-6270, v10 
VCT-0007 (7) 
Page 78 of 160
JJVC CONFIDENTIAL

•  The overa
l
l r
isk of u
lcerat
ive kerat
it
is may be reduced by carefu
l
ly 
fo
l
low
ing d
irect
ions for 
lens care.
3 New Eng
land Journa
l of Med
ic
ine, 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 wh
i
le wear
ing them.
WARNING:
Water can harbor m
icroorgan
isms that can 
lead to severe 
infect
ion, 
v
is
ion 
loss, or b
l
indness. If 
lenses have been submersed 
in water when 
part
ic
ipat
ing 
in water sports or sw
imm
ing 
in poo
ls, hot tubs, 
lakes, or 
oceans, the pat
ient shou
ld be 
instructed to d
iscard them and rep
lace 
them w
ith a new pa
ir
. The Eye Care Profess
iona
l shou
ld be consu
lted for 
recommendat
ions regard
ing wear
ing 
lenses dur
ing any act
iv
ity 
invo
lv
ing 
water
.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
•  Due to the sma
l
l number of pat
ients enro
l
led 
in c
l
in
ica
l 
invest
igat
ion of 
lenses, a
l
l refract
ive powers, des
ign conﬁ
 gurat
ions, or 
lens parameters 
ava
i
lab
le 
in the 
lens mater
ia
l are not eva
luated 
in s
ign
iﬁ
 cant numbers. 
Consequent
ly
, when se
lect
ing an appropr
iate 
lens des
ign and 
parameters, the Eye Care Profess
iona
l shou
ld cons
ider a
l
l character
ist
ics 
of the 
lens that can affect 
lens performance and ocu
lar hea
lth, 
inc
lud
ing 
oxygen permeab
i
l
ity
, wettab
i
l
ity
, centra
l and per
iphera
l th
ickness, and 
opt
ic zone d
iameter
.
The potent
ia
l 
impact of these factors on the pat
ient’s ocu
lar hea
lth 
shou
ld be carefu
l
ly we
ighed aga
inst the pat
ient’s need for refract
ive 
correct
ion; therefore, the cont
inu
ing ocu
lar hea
lth of the pat
ient and 
lens 
performance on the eye shou
ld be carefu
l
ly mon
itored by the prescr
ib
ing 
Eye Care Profess
iona
l.
•  Pat
ients who wear these 
lenses to correct presbyop
ia us
ing monov
is
ion 
(or mod
iﬁ
 ed monov
is
ion us
ing 1-DAY ACUVUE
®
8
 MOIST Brand 
MULTIFOCAL) may not ach
ieve the best corrected v
isua
l acu
ity for e
ither 
far or near v
is
ion. V
isua
l requ
irements vary w
ith the 
ind
iv
idua
l and shou
ld 
be cons
idered when se e t
ing  h  most appropr
iate type of 
lens for each 
pat
ient.
CR-6270, v10 
VCT-0007 (7) 
Page 79 of 160
JJVC CONFIDENTIAL

•  F
luoresce
in, a ye
l
low dye, shou
ld not be used wh
i
le the 
lenses are on 
the eyes. The 
lenses absorb th
is dye and become d
isco
lored. Whenever 
ﬂ
 uoresce
in 
is used 
in eyes, the eyes shou
ld be ﬂ
 ushed w
ith a ster
i
le 
sa
l
ine so
lut
ion that 
is recommended for 
in-eye use.
•  Eye Care Profess
iona
ls shou
ld 
instruct the pat
ient to remove 
lenses 
immed
iate
ly 
if the eyes become red or 
irr
itated.
 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
•  Before 
leav
ing the Eye Care Profess
iona
l’s ofﬁ
 ce, the pat
ient shou
ld 
be ab
le to prompt
ly remove the 
lenses or shou
ld have someone e
lse 
ava
i
lab
le who can remove the 
lenses for h
im or her
.
•  DO NOT use 
if the ster
i
le b
l
ister package 
is opened or damaged.
•  A
lways wash and r
inse hands before hand
l
ing 
lenses. Do not get 
cosmet
ics, 
lot
ions, soaps, creams, deodorants, or sprays 
in the eyes or 
on the 
lenses. It 
is best to put on 
lenses before putt
ing on makeup.
•  DO NOT touch contact 
lenses w
ith the ﬁ
 ngers or hands 
if the hands are 
not free of fore
ign mater
ia
ls, as m
icroscop
ic scratches of the 
lenses may 
occur
, caus
ing d
istorted v
is
ion and/or 
in
jury to the eye.
•  Carefu
l
ly fo
l
low the hand
l
ing, 
insert
ion, remova
l, and wear
ing 
instruct
ions 
in the Pat
ient Instruct
ion Gu
ide for these 
lenses and those prescr
ibed by 
the Eye Care Profess
iona
l.
•  A
lways hand
le 
lenses carefu
l
ly and avo
id dropp
ing them.
•  Never use tweezers or other too
ls to remove 
lenses from the 
lens 
conta
iner
. S
l
ide the 
lens up the s
ide of the bow
l unt
i
l 
it 
is free of the 
conta
iner
.
•  Do not touch the 
lens w
ith ﬁ
 ngerna
i
ls.
Lens Wearing Precautions:
9
•  If the 
lens st
icks (stops mov
ing) on the eye, fo
l
low the recommended 
d
irect
ions 
in “Care for St
ick
ing (Non-Mov
ing) Lenses.” The 
lens shou
ld 
move free
ly on the eye for the cont
inued hea
lth of the eye. If non-
movement of the 
lens cont
inues, the pat
ient shou
ld be 
instructed to 
immed
iate
ly consu
lt h
is or her Eye Care Profess
iona
l.
•  Never wear 
lenses beyond the per
iod recommended by the Eye Care 
Profess
iona
l. CR-6270, v10 
VCT-0007 (7) 
Page 80 of 160
JJVC CONFIDENTIAL

•  The pat
ient shou
ld be adv
ised to never a
l
low anyone e
lse to wear the
ir 
lenses. They have been prescr
ibed to ﬁ
 t the
ir eyes and to correct the
ir 
v
is
ion to the degree necessary
. Shar
ing 
lenses great
ly 
increases the 
chance of eye 
infect
ions.
•  If aeroso
l products, such as ha
irspray
, are used wh
i
le wear
ing 
lenses, 
exerc
ise caut
ion and keep eyes c
losed unt
i
l the spray has sett
led.
•  Avo
id a
l
l harmfu
l or 
irr
itat
ing vapors and fumes wh
i
le wear
ing 
lenses.
Lens Care Precautions:
•  The pat
ient shou
ld be 
informed that no c
lean
ing or d
is
infect
ion 
is needed 
when 
lenses are worn for da
i
ly d
isposab
le wear
. Pat
ients shou
ld a
lways 
d
ispose of 
lenses when removed and have spare 
lenses or spectac
les 
ava
i
lab
le.
Other Topics to Discuss with Patients:
•  A
lways contact the Eye Care Profess
iona
l before us
ing any med
ic
ine 
in 
the eyes.
•  Certa
in med
icat
ions, such as ant
ih
istam
ines, decongestants, d
iuret
ics, 
musc
le re
laxants, tranqu
i
l
izers, and those for mot
ion s
ickness may cause 
dryness of the eye, 
increased 
lens awareness, or b
lurred v
is
ion. Shou
ld 
such cond
it
ions ex
ist, proper remed
ia
l measures shou
ld be prescr
ibed. 
•  Ora
l contracept
ive users cou
ld deve
lop v
isua
l changes or changes 
in 
lens to
lerance when us
ing contact 
lenses. Pat
ients shou
ld be caut
ioned 
accord
ing
ly
.
•  As w
ith any contact 
lens, fo
l
low-up v
is
its are necessary to assure the 
cont
inu
ing hea
lth of the pat
ient’s eyes. The pat
ient shou
ld be 
instructed 
as to a recommended fo
l
low-up schedu
le.
Who Should Know That the Patient is Wearing Contact Lenses?
10
•  Pat
ients shou
ld 
inform a
l
l doctors (Hea
lth Care Profess
iona
ls) about 
be
ing a contact 
lens wearer
.
•  Pat
ients shou
ld a
lways 
inform the
ir emp
loyer of be
ing a contact 
lens 
wearer
. Some 
jobs may requ
ire use of eye protect
ion equ
ipment or may 
requ
ire that the pat
ient not wear contact 
lenses.
CR-6270, v10 
VCT-0007 (7) 
Page 81 of 160
JJVC CONFIDENTIAL

ADVERSE REACTIONS
The patient should be informed that the following problems may occur 
when wearing contact lenses:
11
•  The eye may burn, st
ing, and/or 
itch.
•  There may be 
less comfort than when the 
lens was ﬁ
 rst p
laced on the 
eye.
•  There may be a fee
l
ing of someth
ing 
in the eye (fore
ign body
, scratched 
area).
•  There may be the potent
ia
l for some temporary 
impa
irment due to 
per
iphera
l 
inﬁ
 
ltrates, per
iphera
l cornea
l u
lcers, or cornea
l eros
ion. There 
may be the potent
ia
l for other phys
io
log
ica
l observat
ions, such as 
loca
l 
or genera
l
ized edema, cornea
l neovascu
lar
izat
ion, cornea
l sta
in
ing, 
in
ject
ion, tarsa
l abnorma
l
it
ies, 
ir
it
is, and con
junct
iv
it
is, some of wh
ich are 
c
l
in
ica
l
ly acceptab
le 
in 
low amounts.
•  There may be excess
ive water
ing, unusua
l eye secret
ions, or redness 
of the eye.
•  Poor v
isua
l acu
ity
, b
lurred v
is
ion, ra
inbows or ha
los around ob
jects, 
photophob
ia, or dry eyes may a
lso occur 
if the 
lenses are worn 
cont
inuous
ly or for too 
long a t
ime.
The pat
ient shou
ld be 
instructed to conduct a s
imp
le 3-part se
lf-exam
inat
ion at 
least once a day
. They shou
ld ask themse
lves:
•  How do the 
lenses fee
l on my eyes?
•  How do my eyes 
look?
•  Have I not
iced a change 
in my v
is
ion? 
If the pat
ient reports any prob
lems, he or she shou
ld be 
instructed to 
IMMEDIATELY REMOVE THE LENS. If the prob
lem or d
iscomfort stops, the 
pat
ient shou
ld d
iscard the 
lens and p
lace a new fresh 
lens on the eye.
If after 
insert
ing the new 
lens, the prob
lem cont
inues, the pat
ient shou
ld be 
d
irected to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR HER 
EYE CARE PROFESSIONAL.
The pat
ient shou
ld be adv
ised that when any of the above symptoms occur
, 
a ser
ious cond
it
ion such as 
infect
ion, cornea
l u
lcer
, neovascu
lar
izat
ion, or 
ir
it
is 
may be present. He or she shou
ld be 
instructed to seek 
immed
iate profess
iona
l 
ident
iﬁ
 cat
ion of the prob
lem and prompt treatment to avo
id ser
ious eye damage.
CR-6270, v10 
VCT-0007 (7) 
Page 82 of 160
JJVC CONFIDENTIAL

GENERAL FITTING GUIDELINES
A. Patient Selection
Pat
ients se
lected to wear these 
lenses shou
ld be chosen based on: 
• Mot
ivat
ion to wear 
lenses 
• Ab
i
l
ity to fo
l
low 
instruct
ions regard
ing 
lens wear
• Genera
l hea
lth 
• Ab
i
l
ity to adequate
ly hand
le and care for the 
lenses 
• Ab
i
l
ity to understand the r
isks and beneﬁ
 ts of 
lens wear
Pat
ients who do not meet the above cr
iter
ia shou
ld not be prov
ided w
ith contact 
lenses. 
B. Pre-ﬁ tting Examination
In
it
ia
l eva
luat
ion of the pat
ient shou
ld beg
in w
ith a thorough case h
istory 
to determ
ine 
if there are any contra
ind
icat
ions to contact 
lens wear
. Dur
ing 
the case h
istory
, the pat
ient’s v
isua
l needs and expectat
ions shou
ld be 
determ
ined as we
l
l as an assessment of the
ir overa
l
l ocu
lar
, phys
ica
l, and 
menta
l hea
lth. 
Preced
ing the 
in
it
ia
l se
lect
ion of tr
ia
l contact 
lenses, a comprehens
ive ocu
lar 
eva
luat
ion shou
ld be performed that 
inc
ludes, but 
is not 
l
im
ited to, the 
measurement of d
istance and near v
isua
l acu
ity
, d
istance and near refract
ive 
prescr
ipt
ion (
inc
lud
ing determ
in
ing the preferred read
ing d
istance for 
presbyopes), keratometry
, and b
iom
icroscop
ic eva
luat
ion. 
Based on th
is eva
luat
ion, 
if 
it 
is determ
ined that the pat
ient 
is e
l
ig
ib
le to wear 
these 
lenses, the Eye Care Profess
iona
l shou
ld proceed to the 
lens ﬁ
 tt
ing 
instruct
ions as out
l
ined be
low. 
C.  Initial Power Determination
A spectac
le refract
ion shou
ld be performed to estab
l
ish the pat
ient’s base
l
ine 
refract
ive status and to gu
ide 
in the se
lect
ion of the appropr
iate 
lens power
. 
Remember to compensate for vertex d
istance 
if the refract
ion 
is greater than 
±4.00D.
D.  Base Curve Selection (Trial Lens Fitting)
12
The fo
l
low
ing tr
ia
l 
lenses shou
ld be se
lected for pat
ients regard
less of 
keratometry read
ings. However  cornea
l curv ture measurements shou
ld be 
performed to estab
l
ish the pat
ient’s base
l
ine ocu
lar status. 
CR-6270, v10 
VCT-0007 (7) 
Page 83 of 160
JJVC CONFIDENTIAL

• 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 tr
ia
l 
lens shou
ld be p
laced on each of the pat
ient’s eyes and eva
luated 
after the pat
ient has ad
justed to the 
lenses.
1.  Cr
iter
ia of a Proper
ly F
it Lens
A proper
ly ﬁ
 t 
lens w
i
l
l center and comp
lete
ly cover the cornea (
i.e., no 
l
imba
l exposure), have sufﬁ
 c
ient movement to prov
ide tear exchange 
under the contact 
lens w
ith the b
l
ink, and be comfortab
le. The 
lens 
shou
ld move free
ly when man
ipu
lated d
ig
ita
l
ly w
ith the 
lower 
l
id, and then 
return to 
its proper
ly centered pos
it
ion when re
leased.
2.  Cr
iter
ia of a F
lat F
itt
ing Lens
A ﬂ
 at ﬁ
 tt
ing 
lens may exh
ib
it one or more of the fo
l
low
ing character
ist
ics: 
decentrat
ion, 
incomp
lete cornea
l coverage (
i.e., 
l
imba
l exposure), 
excess
ive movement w
ith the b
l
ink and/or edge standoff. If the 
lens 
is 
judged to be ﬂ
 at ﬁ
 tt
ing, 
it shou
ld not be d
ispensed to the pat
ient.
3.  Cr
iter
ia of a Steep F
itt
ing Lens
A steep ﬁ
 tt
ing 
lens may exh
ib
it one or more of the fo
l
low
ing 
character
ist
ics: 
insufﬁ
 c
ient movement w
ith the b
l
ink, con
junct
iva
l 
indentat
ion, and res
istance when push
ing the 
lens up d
ig
ita
l
ly w
ith 
the 
lower 
l
id. If the 
lens 
is 
judged to be steep ﬁ
 tt
ing, 
it shou
ld not be 
d
ispensed to the pat
ient.
If the 
in
it
ia
l tr
ia
l base curve 
is 
judged to be ﬂ
 at or steep ﬁ
 tt
ing, the a
lternate 
base curve, 
if ava
i
lab
le, shou
ld be tr
ia
l ﬁ
 t and eva
luated after the pat
ient has 
ad
justed to the 
lens. The 
lens shou
ld move free
ly when man
ipu
lated d
ig
ita
l
ly 
w
ith the 
lower 
l
id, and then return to a proper
ly centered pos
it
ion when 
re
leased. If res
istance 
is encountered when push
ing the 
lens up, the 
lens 
is 
ﬁ
 tt
ing t
ight
ly and shou
ld not be d
ispensed to the pat
ient.
E.  Final Lens Power (Spherical)
13
A spher
ica
l over-refract
ion shou
ld be performed to determ
ine the ﬁ
 na
l 
lens 
power after the 
lens ﬁ
 t 
is 
judged acceptab
le. The spher
ica
l over-refract
ion 
shou
ld be comb
ined w
ith the tr
ia
l 
lens power to determ
ine the ﬁ
 na
l 
lens 
prescr
ipt
ion. The pat
ient shou
ld exper
ience good v
isua
l acu
ity w
ith the 
correct 
lens power un ess the e 
is ex ess
ive  es dua
l ast
igmat
ism.
CR-6270, v10 
VCT-0007 (7) 
Page 84 of 160
JJVC CONFIDENTIAL

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 v
is
ion 
is acceptab
le, perform a s
l
it 
lamp exam
inat
ion to assess adequate ﬁ
 t 
(centrat
ion and movement). If the ﬁ
 t 
is acceptab
le, d
ispense the 
lenses and 
instruct the pat
ient to return 
in one week for reassessment (see 
PATIENT 
MANAGEMENT sect
ion).
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.
A
lthough most aspects of the ﬁ
 tt
ing procedure are 
ident
ica
l for a
l
l types of soft 
contact 
lenses, 
inc
lud
ing tor
ic 
lenses, there are some add
it
iona
l steps and/or 
ru
les to fo
l
low to assure the proper ﬁ
 t of tor
ic 
lenses. 
The on
ly new steps you must fo
l
low 
in prescr
ib
ing 1-DAY ACUVUE® MOIST 
for ASTIGMATISM are that you must determ
ine the stab
i
l
ity
, repeatab
i
l
ity
, and 
dr
ift ang
le of the 
lens ax
is so that you can prescr
ibe the correct 
lens ax
is for the 
pat
ient. 
A. How to Determine Lens Cylinder and Axis Orientation
1.  Locate the Orientation Marks 
To he
lp determ
ine the proper or
ientat
ion of the tor
ic 
lens, you’
l
l ﬁ
 nd two 
pr
imary marks approx
imate
ly 1 mm from the 
lens edge represent
ing the 
vert
ica
l pos
it
ion on oppos
ite ends of the 
lens at 6 and 12 o’c
lock (F
ig. 1). 
Because of the 
lens’ ba
l
last
ing system, e
ither mark can represent the ver-
t
ica
l pos
it
ion – there 
is no “top” and “bottom” as 
in a pr
ism-ba
l
lasted 
lens. 
You don’t need to v
iew both marks to assess or
ientat
ion; s
imp
ly 
look for the 
6 o’c
lock mark as you wou
ld w
ith a pr
ism-ba
l
lasted 
lens.
14
TORIC FITTING GUIDELINES
CR-6270, v10 
VCT-0007 (7) 
Page 85 of 160
JJVC CONFIDENTIAL

     Figure 1
You’
l
l need a s
l
it 
lamp b
iom
icroscope w
ith a 1 to 2 mm para
l
le
lep
iped 
beam to h
igh
l
ight the marks when the 
lens 
is ﬁ
 tted to the eye. There are a 
number of techn
iques you can use to 
improve the v
is
ib
i
l
ity of the 6 o’c
lock 
mark. Us
ing a para
l
le
lep
iped beam and med
ium magn
iﬁ
 cat
ion (10x or 15x), 
s
low
ly pan down the 
lens, 
look
ing 
just be
low the d
irect 
i
l
lum
inat
ion at the 
retro
i
l
lum
inated area. Back
l
ight
ing the mark th
is way shou
ld make 
it more 
v
is
ib
le. Somet
imes man
ipu
lat
ing the 
lower 
l
id may be necessary to uncover 
the mark.
2.  Observe Lens Rotation and Stability 
Observe the pos
it
ion and stab
i
l
ity of the “bottom” mark. It usua
l
ly stab
i
l
izes 
at the 6 o’c
lock pos
it
ion. If 
it does, ca
lcu
lat
ion of the 
lens power w
i
l
l be 
stra
ightforward. The 6 o’c
lock pos
it
ion 
is not a “must”; however
, the 
abso
lute requ
irement 
is that the ax
is pos
it
ion be stab
le and repeatab
le. 
The mark may stab
i
l
ize somewhat 
left or r
ight (dr
ift) of the vert
ica
l mer
id
ian 
and st
i
l
l enab
le you to ﬁ
 t a tor
ic 
lens for that eye, as 
long as the 
lens a
lways 
returns to the same “dr
ift ax
is” pos
it
ion after sett
l
ing. The dev
iat
ion can 
be compensated for 
in the ﬁ
 na
l prescr
ipt
ion. Your ob
ject
ive 
is to ensure 
that whatever pos
it
ion the 
in
it
ia
l 
lens assumes near 6 o’c
lock, th
is pos
it
ion 
must be stab
le and repeatab
le. W
ith fu
l
l eye movement or heavy b
l
ink, you 
may see the marks sw
ing away
, but they must return qu
ick
ly to the or
ig
ina
l 
stab
le pos
it
ion. If the 
lens does not return qu
ick
ly
, you may need to se
lect 
a d
ifferent 
lens. 
3.  Assessing Rotation 
Imag
ine the eye as a c
lock d
ia
l and every hour represents a 30° 
interva
l. If 
the or
ientat
ion mark of the 
in
it
ia
l 
lens stab
i
l
izes somewhat 
left or r
ight of the 
vert
ica
l pos
it
ion, the ﬁ
 na
l 
lens w
i
l
l or
ient on the eye w
ith the same dev
iat
ion. 
You can use an ax
is ret
icu
le 
in the s
l
it 
lamp or use a 
l
ine-scr
ibed 
lens 
in a 
spectac
le tr
ia
l frame to measure or est
imate the “dr
ift ang
le” of the cy
l
inder 
ax
is. 
To compensate for th
is “dr
ift,” measure or est
imate the “dr
ift,” then add 
or subtract 
it from the refract
ive ax
is to determ
ine the correct cy
l
inder 
ax
is. Use the LARS (Left Add, R
ight Subtract) method to determ
ine wh
ich 
d
irect
ion to compensate.
 
15
 
CR-6270, v10 
VCT-0007 (7) 
Page 86 of 160
JJVC CONFIDENTIAL

B. Final Lens Power
When the d
iagnost
ic 
lens has 
its ax
is a
l
igned 
in the same mer
id
ian as the 
pat
ient’s refract
ive ax
is, a spherocy
l
indr
ica
l over-refract
ion may be performed 
and v
isua
l acu
ity determ
ined. However
, 
in the case of crossed axes, such as 
when the d
iagnost
ic 
lens ax
is 
is d
ifferent from the spectac
le cy
l
inder ax
is, 
it 
is 
not adv
isab
le to perform a fu
l
l spherocy
l
indr
ica
l over-refract
ion because of the 
d
ifﬁ
 cu
lty 
in comput
ing the resu
ltant power
. A spher
ica
l over-refract
ion w
ithout 
cy
l
inder refract
ion may be performed.
If the requ
ired cy
l
inder correct
ion fa
l
ls between two ava
i
lab
le cy
l
inder powers, 
it 
is recommended to prescr
ibe the 
lower cy
l
inder power 
lens. See be
low for 
instruct
ions on how to determ
ine the ﬁ
 na
l 
lens power
.
1.  For the Sphere 
If sphere a
lone or comb
ined sphere and cy
l
inder Rx > 4.00D, compensate 
for vertex d
istance. If sphere a
lone or comb
ined sphere and cy
l
inder 
Rx < ±4.00D, vertex compensat
ion 
is not necessary
.
2.  For the Cylinder
Ad
just the ax
is by the dr
ift ang
le us
ing the LARS method. Choose a cy
l
inder 
that 
is ≤ 0.50D from the refract
ive cy
l
inder
.
3.  Case Examples
Example 1
16
Man
ifest (spectac
le) refract
ion:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a d
iagnost
ic 
lens for each eye w
ith ax
is 180°. P
lace the 
lens on 
each eye and a
l
low a m
in
imum of 3 m
inutes for 
it to equ
i
l
ibrate, based on 
the pat
ient’s 
in
it
ia
l response to the 
lens. If the 
lens has not yet stab
i
l
ized, 
recheck unt
i
l stab
le.
Check the or
ientat
ion of the ax
is mark. If the bottom ax
is mark 
is 
in the 6 
o’c
lock pos
it
ion on both eyes, choose the appropr
iate cy
l
inder as 
l
isted 
prev
ious
ly
. If the 
lens has not yet stab
i
l
ized, recheck unt
i
l stab
le.
Here 
is the Rx prescr
ibed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
CR-6270, v10 
VCT-0007 (7) 
Page 87 of 160
JJVC CONFIDENTIAL

Example 2
Man
ifest (spectac
le) refract
ion:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose d
iagnost
ic 
lenses of -3.00D / -0.75D x 90° for the r
ight eye and 
-4.50D / -1.75D x 90° for the 
left eye, the nearest 
lenses ava
i
lab
le to the 
spher
ica
l power and ax
is needed. For the 
left eye, s
ince the man
ifest 
refract
ion ca
l
led for -4.75D, compensat
ing for vertex d
istance the sphere 
is reduced by 0.25D to -4.50D. The cy
l
inder power w
i
l
l be -1.75D. P
lace 
the 
lens on each eye and a
l
low a m
in
imum of 3 m
inutes for 
it to equ
i
l
ibrate, 
based on the pat
ient's 
in
it
ia
l response to the 
lens. If the 
lens has not yet 
stab
i
l
ized, recheck unt
i
l stab
le.
R
ight Eye
The or
ientat
ion mark on the r
ight 
lens rotates 
left from the 6 o’c
lock pos
it
ion 
by 10° and rema
ins stab
le 
in th
is pos
it
ion. Compensat
ion for th
is rotat
ion 
shou
ld be done as fo
l
lows:
Compensate the 10° ax
is dr
ift by add
ing 
it to the man
ifest refract
ion ax
is.
Here 
is the Rx prescr
ibed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The or
ientat
ion mark on the 
left 
lens rotates r
ight from the 6 o’c
lock pos
it
ion 
by 10° and rema
ins stab
le 
in th
is pos
it
ion. Compensat
ion for th
is rotat
ion 
shou
ld be done as fo
l
lows:
Compensate for the 10° ax
is dr
ift by subtract
ing 
it from the man
ifest 
refract
ion ax
is. 
Here 
is the Rx prescr
ibed:
O.S. -4.50D / -1.75D x 80° 
If v
is
ion 
is acceptab
le, perform a s
l
it 
lamp exam
inat
ion to assess adequate 
ﬁ
 t (centrat
ion and movement). If ﬁ
 t 
is acceptab
le, d
ispense the 
lenses 
instruct
ing the pat
ient to return 
in one week for reassessment (see 
PATIENT MANAGEMENT sect
ion).
17
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.
CR-6270, v10 
VCT-0007 (7) 
Page 88 of 160
JJVC CONFIDENTIAL

A.  Presbyopic Needs Assessment & Patient Education
Mu
lt
ifoca
l contact 
lenses may produce comprom
ise to v
is
ion under certa
in 
c
ircumstances and the pat
ient shou
ld understand that they m
ight not ﬁ
 nd 
the
ir v
is
ion acceptab
le 
in spec
iﬁ
 c s
ituat
ions (
i.e., read
ing a menu 
in a d
im 
restaurant, dr
iv
ing at n
ight 
in ra
iny/foggy cond
it
ions, etc.). Therefore, caut
ion 
shou
ld be exerc
ised when the pat
ient 
is wear
ing the correct
ion for the ﬁ
 rst 
t
ime unt
i
l they are fam
i
l
iar w
ith the v
is
ion prov
ided 
in v
isua
l
ly cha
l
leng
ing 
env
ironments. Occupat
iona
l and env
ironmenta
l v
isua
l demands shou
ld 
be cons
idered. If the pat
ient requ
ires cr
it
ica
l v
isua
l acu
ity and stereops
is, 
it 
shou
ld be determ
ined by tr
ia
l whether th
is pat
ient can funct
ion adequate
ly 
w
ith 1-DAY ACUVUE® MOIST MULTIFOCAL. Wear
ing these 
lenses may not 
be opt
ima
l for act
iv
it
ies such as:
• V
isua
l
ly demand
ing s
ituat
ions such as operat
ing potent
ia
l
ly dangerous 
mach
inery or perform
ing other potent
ia
l
ly hazardous act
iv
it
ies; and
• Dr
iv
ing automob
i
les (e.g., dr
iv
ing at n
ight). Pat
ients who cannot meet 
the
ir state dr
iver’s 
l
icense requ
irements w
ith the 1-DAY ACUVUE
® MOIST 
MULTIFOCAL shou
ld be adv
ised to not dr
ive w
ith th
is correct
ion, OR may 
requ
ire that add
it
iona
l over-correct
ion be prescr
ibed.
1-DAY ACUVUE® MOIST MULTIFOCAL 
is not recommended for pat
ients 
who have -1.00D or greater of refract
ive cy
l
inder as th
is 
leve
l of uncorrected 
cy
l
inder may 
lead to add
it
iona
l v
isua
l comprom
ise. These 
lenses are ava
i
lab
le 
in the fo
l
low
ing ADD powers: 
• Lens “LOW” = 
low near ADD 
lens (Max ADD +1.25) 
• Lens “MID” = med
ium near ADD 
lens (Max ADD +1.75) 
• Lens “HGH” = h
igh near ADD 
lens (Max ADD +2.50)
B.  Initial Power Determination
A spectac
le refract
ion shou
ld be performed to estab
l
ish the pat
ient’s base
l
ine 
refract
ive status and to gu
ide 
in the se
lect
ion of the appropr
iate 
lens power
. 
Remember to compensate for vertex d
istance 
if the refract
ion 
is greater 
than ±4.00D. Determ
ine the spher
ica
l equ
iva
lent d
istance prescr
ipt
ion for a 
mu
lt
ifoca
l pat
ient. Determ
ine the eye dom
inance us
ing one of the methods 
be
low:
18
MULTIFOCAL FITTING GUIDELINES
CR-6270, v10 
VCT-0007 (7) 
Page 89 of 160
JJVC CONFIDENTIAL

Method 1    Determ
ine wh
ich eye 
is the “s
ight
ing eye.” Have the pat
ient po
int 
to an ob
ject at the far end of the room. Cover one eye. If the 
pat
ient 
is st
i
l
l po
int
ing d
irect
ly at the ob
ject, the eye be
ing used 
is 
the dom
inant (s
ight
ing) eye.
Method 2    Determ
ine wh
ich eye does not accept added p
lus power
. P
lace a 
+1.00D hand-he
ld tr
ia
l 
lens 
in front of one eye and then the other 
wh
i
le the d
istance refract
ive error correct
ion 
is 
in p
lace for both 
eyes wh
i
le the pat
ient 
is v
iew
ing the d
istance v
isua
l acu
ity chart. 
The eye w
ith the p
lus over 
it that the pat
ient not
ices the greatest 
reduct
ion 
in v
is
ion 
is determ
ined to be the dom
inant eye.
C. Select the Initial Trial Lens 
1.  For each eye, se
lect the tr
ia
l 
lens d
istance power that 
is c
losest to the 
pat
ient’s d
istance spher
ica
l equ
iva
lent. Remember to compensate for 
vertex d
istance 
if the refract
ion 
is greater than ±4.00D.
2.  Se
lect the near power of the 
lens based on the pat
ients ADD range as 
fo
l
lows: 
• ADD: +0.75D to +1.25D use a 
low near ADD (LOW) 
lens on each eye 
• ADD: +1.50D to +1.75D use a med
ium near ADD (MID) 
lens on each 
eye 
• ADD: +2.00D to +2.50D use a med
ium near ADD (MID) on the 
dom
inant eye and a h
igh near ADD (HGH) 
lens on the non-dom
inant 
eye
3.  A
l
low the 
lenses to sett
le for a m
in
imum of 10 m
inutes. 
4.  Assess d
istance and near v
is
ion b
inocu
lar
ly and monocu
lar
ly
. 
5.  Demonstrate the v
is
ion under var
ious 
l
ight
ing cond
it
ions (norma
l and 
decreased 
i
l
lum
inat
ion) and at d
istance, 
intermed
iate, and near
. 
6.  Make ad
justments 
in power as necessary based on the d
istance over-
refract
ion. The use of hand-he
ld tr
ia
l 
lenses 
is recommended. Check the 
impact on d
istance and near v
is
ion.
7. If v
is
ion 
is st
i
l
l unacceptab
le, make ad
justments 
in power as necessary 
(see "Mu
lt
ifoca
l Troub
leshoot
ing" be
low). If d
istance and near v
is
ion 
are acceptab
le, perform a s
l
it 
lamp exam
inat
ion to assess adequate 
ﬁ
 t (centrat
ion and movement). If ﬁ
 t 
is acceptab
le, d
ispense the 
lenses 
instruct
ing the pat
ient to return 
in one week for reassessment (see 
PATIENT MANAGEMENT
19
 sec
 i n)
CR-6270, v10 
VCT-0007 (7) 
Page 90 of 160
JJVC CONFIDENTIAL

D. Multifocal Troubleshooting
Unacceptable Near Vision
If 
it has been determ
ined that no change 
is requ
ired based on the over-
refract
ion, then add +0.25D to the spher
ica
l power of the non-dom
inant eye.
Unacceptable Distance Vision
If 
it has been determ
ined that no change 
is requ
ired based on the over-
refract
ion, then make the changes as 
l
isted be
low:
• If the pat
ient 
is wear
ing two "LOW" ADD 
lenses, change the dom
inant 
eye to a 1-DAY ACUVUE
® MOIST sphere 
lens w
ith a power equa
l to the 
spher
ica
l equ
iva
lent d
istance prescr
ipt
ion.
• If the pat
ient 
is wear
ing two "MID" ADD 
lenses, change the ADD power 
in 
the dom
inant eye to the "LOW" ADD power
.
• If the pat
ient 
is wear
ing a "MID" ADD 
lens 
in the dom
inant eye and a 
"HGH" ADD 
lens 
in the non-dom
inant eye, change the non-dom
inant eye 
to a "MID" ADD 
lens and add +0.25D to the d
istance power
.
E. Adaptation
V
isua
l
ly demand
ing s
ituat
ions shou
ld be avo
ided dur
ing the 
in
it
ia
l wear
ing 
per
iod. A pat
ient may at ﬁ
 rst exper
ience some m
i
ld b
lurred v
is
ion, d
izz
iness, 
headaches and a fee
l
ing of s
l
ight 
imba
lance. You shou
ld exp
la
in the 
adaptat
iona
l symptoms to the pat
ient. These symptoms may 
last for a br
ief 
m
inute or for severa
l weeks. The 
longer these symptoms pers
ist, the poorer 
the prognos
is for successfu
l adaptat
ion.
To he
lp 
in the adaptat
ion process, the pat
ient can be adv
ised to ﬁ
 rst use the 
lenses 
in a comfortab
le, fam
i
l
iar env
ironment such as 
in the home.
Some pat
ients fee
l that automob
i
le dr
iv
ing performance may not be opt
ima
l 
dur
ing the adaptat
ion process. Th
is 
is part
icu
lar
ly true when dr
iv
ing at n
ight. 
Before dr
iv
ing a motor veh
ic
le, 
it may be recommended that the pat
ient be 
a passenger ﬁ
 rst to make sure that the
ir v
is
ion 
is sat
isfactory for operat
ing 
an automob
i
le. Dur
ing the ﬁ
 rst severa
l weeks of wear (when adaptat
ion 
is 
occurr
ing), 
it may be adv
isab
le for the pat
ient to on
ly dr
ive dur
ing opt
ima
l 
dr
iv
ing cond
it
ions. After adaptat
ion and success w
ith these act
iv
it
ies, the 
pat
ient shou
ld be ab
le to dr
ive under other cond
it
ions w
ith caut
ion.
20
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.
CR-6270, v10 
VCT-0007 (7) 
Page 91 of 160
JJVC CONFIDENTIAL

A. Patient Selection
1. Monovision Needs Assessment
For a good prognos
is, the pat
ient shou
ld have adequate
ly corrected 
d
istance and near v
isua
l acu
ity 
in each eye. The amb
lyop
ic pat
ient or the 
pat
ient w
ith s
ign
iﬁ
 cant ast
igmat
ism (greater than 1.00D) 
in one eye may not 
be a good cand
idate for monov
is
ion correct
ion w
ith these 
lenses.
Occupat
iona
l and env
ironmenta
l v
isua
l demands shou
ld be cons
idered. 
If the pat
ient requ
ires cr
it
ica
l v
is
ion (v
isua
l acu
ity and stereops
is), 
it shou
ld 
be determ
ined by tr
ia
l whether th
is pat
ient can funct
ion adequate
ly w
ith 
monov
is
ion correct
ion. Monov
is
ion contact 
lens wear may not be opt
ima
l 
for act
iv
it
ies such as:
• V
isua
l
ly demand
ing s
ituat
ions such as operat
ing potent
ia
l
ly dangerous 
mach
inery or perform
ing other potent
ia
l
ly hazardous act
iv
it
ies; and
• Dr
iv
ing automob
i
les (e.g., dr
iv
ing at n
ight). Pat
ients who cannot meet 
the
ir state dr
iver’s 
l
icense requ
irements w
ith monov
is
ion correct
ion 
shou
ld be adv
ised to not dr
ive w
ith th
is correct
ion, OR may requ
ire that 
add
it
iona
l over-correct
ion be prescr
ibed.
2. Patient Education
A
l
l pat
ients do not funct
ion equa
l
ly we
l
l w
ith monov
is
ion correct
ion. Pat
ients 
may not perform as we
l
l for certa
in tasks w
ith th
is correct
ion as they have 
w
ith spectac
les (mu
lt
ifoca
l, b
ifoca
l, tr
ifoca
l, readers, progress
ives). Each 
pat
ient shou
ld understand that monov
is
ion, as we
l
l as other presbyop
ic 
a
lternat
ives, can create a v
is
ion comprom
ise that may reduce v
isua
l acu
ity 
and depth percept
ion for d
istance and near tasks. Therefore, caut
ion 
shou
ld be exerc
ised when the pat
ient 
is wear
ing the correct
ion for the ﬁ
 rst 
t
ime unt
i
l they are fam
i
l
iar w
ith the v
is
ion prov
ided 
in v
isua
l
ly cha
l
leng
ing 
env
ironments (e.g., read
ing a menu 
in a d
im
ly 
l
it restaurant, dr
iv
ing at n
ight 
in ra
iny/foggy cond
it
ions, etc.). Dur
ing the ﬁ
 tt
ing process, 
it 
is necessary for 
the pat
ient to rea
l
ize the d
isadvantages as we
l
l as the advantages of c
lear 
near v
is
ion, and stra
ight ahead and upward gaze that monov
is
ion contact 
lenses prov
ide.
21
MONOVISION FITTING GUIDELINES
CR-6270, v10 
VCT-0007 (7) 
Page 92 of 160
JJVC CONFIDENTIAL

B. Eye Selection
1.  Ocular Preference Determination Methods
Genera
l
ly
, the non-dom
inant eye 
is corrected for near v
is
ion. The fo
l
low
ing 
two methods for eye dom
inance can be used.
Method 1    Determ
ine wh
ich eye 
is the “s
ight
ing eye.” Have the pat
ient 
po
int to an ob
ject at the far end of the room. Cover one eye. 
If the pat
ient 
is st
i
l
l po
int
ing d
irect
ly at the ob
ject, the eye 
be
ing used 
is the dom
inant (s
ight
ing) eye.
Method 2    Determ
ine wh
ich eye w
i
l
l accept the added power w
ith the 
least reduct
ion 
in v
is
ion. P
lace a hand-he
ld tr
ia
l 
lens equa
l to 
the spectac
le near ADD 
in front of one eye and then the other 
wh
i
le the d
istance refract
ive error correct
ion 
is 
in p
lace for 
both eyes. Determ
ine whether the pat
ient funct
ions best w
ith 
the near ADD 
lens over the r
ight or 
left eye.
2.  Other Eye Selection Methods
Other methods 
inc
lude the “Refract
ive Error Method” and the “V
isua
l 
Demands Method.”
Refract
ive Error Method
For an
isometrop
ic correct
ion, 
it 
is genera
l
ly best to ﬁ
 t the more hyperop
ic 
(
less myop
ic) eye for d
istance and the more myop
ic (
less hyperop
ic) eye 
for near
.
V
isua
l Demands Method
Cons
ider the pat
ient’s occupat
ion dur
ing the eye se
lect
ion process to 
determ
ine the cr
it
ica
l v
is
ion requ
irements. If a pat
ient’s gaze for near tasks 
is usua
l
ly 
in one d
irect
ion, correct the eye on that s
ide for near
.
Examp
le: A secretary who p
laces copy to the 
left s
ide of the desk w
i
l
l 
funct
ion best w
ith the near 
lens on the 
left eye.
C.  Special Fitting Characteristics
1.  Unilateral Vision Correction
22
There are c
ircumstances where on
ly one contact 
lens 
is requ
ired. As an 
examp
le, an emmetrop
ic pat
ient wou
ld on
ly requ
ire a near 
lens, whereas 
a b
i
latera
l myope wou
ld requ
ire correct
ive 
lenses on both eyes. 
CR-6270, v10 
VCT-0007 (7) 
Page 93 of 160
JJVC CONFIDENTIAL

Examp
les:
A presbyop
ic emmetrop
ic pat
ient who requ
ires a +1.75D ADD wou
ld 
have a +1.75D 
lens on the near eye and the other eye 
left w
ithout 
correct
ion.
A presbyop
ic pat
ient requ
ir
ing a +1.50D ADD who 
is -2.50D myop
ic 
in 
the r
ight eye and -1.50D myop
ic 
in the 
left eye may have the r
ight eye 
corrected for d
istance and the 
left eye uncorrected for near
.
2.  Near ADD Determination
A
lways prescr
ibe the 
lens power for the near eye that prov
ides opt
ima
l 
near acu
ity at the m
idpo
int of the pat
ient’s hab
itua
l read
ing d
istance. 
However
, when more than one power prov
ides opt
ima
l read
ing 
performance, prescr
ibe the 
least p
lus (most m
inus) of the powers.
3.  Trial Lens Fitting
A tr
ia
l ﬁ
 tt
ing 
is performed 
in the ofﬁ
 ce to a
l
low the pat
ient to exper
ience 
monov
is
ion correct
ion. Lenses are ﬁ
 t accord
ing to the GENERAL 
FITTING GUIDELINES 
23
for base curve se
lect
ion descr
ibed 
in th
is 
Package Insert.
Case h
istory and a standard c
l
in
ica
l eva
luat
ion procedure shou
ld be used 
to determ
ine the prognos
is. Determ
ine the d
istance correct
ion and the 
near correct
ion. Next, determ
ine the near ADD. W
ith tr
ia
l 
lenses of the 
proper power 
in p
lace, observe the react
ion to th
is mode of correct
ion.
A
l
low the 
lenses to sett
le for about 20 m
inutes w
ith the correct power 
lenses 
in p
lace. Wa
lk across the room and have the pat
ient 
look at 
you. Assess the pat
ient’s react
ion to d
istance v
is
ion under these 
c
ircumstances. Then have the pat
ient 
look at fam
i
l
iar near ob
jects such 
as a watch face or ﬁ
 ngerna
i
ls. Aga
in assess the react
ion. As the pat
ient 
cont
inues to 
look around the room at both near and d
istance ob
jects, 
observe the react
ions. On
ly after these v
is
ion tests are comp
leted, shou
ld 
the pat
ient be asked to read pr
int. Eva
luate the pat
ient’s react
ion to 
large 
pr
int (e.g., typewr
itten copy) at ﬁ
 rst and then graduate to newspr
int and 
ﬁ
 na
l
ly sma
l
ler type s
izes.
After the pat
ient’s performance under the above cond
it
ions 
is comp
leted, 
tests of v
isua
l acu
ity and read
ing ab
i
l
ity under cond
it
ions of moderate
ly 
d
im 
i
l
lum
inat
ion shou
ld be attempted.
CR-6270, v10 
VCT-0007 (7) 
Page 94 of 160
JJVC CONFIDENTIAL

An 
in
it
ia
l unfavorab
le response 
in the ofﬁ
 ce, wh
i
le 
ind
icat
ive of a guarded 
prognos
is, shou
ld not 
immed
iate
ly ru
le out a more extens
ive tr
ia
l under 
the usua
l cond
it
ions 
in wh
ich a pat
ient funct
ions.
4. Adaptation
V
isua
l
ly demand
ing s
ituat
ions shou
ld be avo
ided dur
ing the 
in
it
ia
l wear
ing 
per
iod. A pat
ient may at ﬁ
 rst exper
ience some m
i
ld b
lurred v
is
ion, 
d
izz
iness, headaches, and a fee
l
ing of s
l
ight 
imba
lance. You shou
ld 
exp
la
in the adaptat
iona
l symptoms to the pat
ient. These symptoms may 
last for a br
ief m
inute or for severa
l weeks. The 
longer these symptoms 
pers
ist, the poorer the prognos
is for successfu
l adaptat
ion. 
To he
lp 
in the adaptat
ion process, the pat
ient can be adv
ised to ﬁ
 rst use 
the 
lenses 
in a comfortab
le, fam
i
l
iar env
ironment such as 
in the home.
Some pat
ients fee
l that automob
i
le dr
iv
ing performance may not be 
opt
ima
l dur
ing the adaptat
ion process. Th
is 
is part
icu
lar
ly true when 
dr
iv
ing at n
ight. Before dr
iv
ing a motor veh
ic
le, 
it may be recommended 
that the pat
ient be a passenger ﬁ
 rst to make sure that the
ir v
is
ion 
is 
sat
isfactory for operat
ing an automob
i
le. Dur
ing the ﬁ
 rst severa
l weeks of 
wear (when adaptat
ion 
is occurr
ing), 
it may be adv
isab
le for the pat
ient to 
on
ly dr
ive dur
ing opt
ima
l dr
iv
ing cond
it
ions. After adaptat
ion and success 
w
ith these act
iv
it
ies, the pat
ient shou
ld be ab
le to dr
ive under other 
cond
it
ions w
ith caut
ion.
D. Other Suggestions
The success of the monov
is
ion techn
ique may be further 
improved by hav
ing 
your pat
ient fo
l
low the suggest
ions be
low:
• Have a th
ird contact 
lens (d
istance power) to use when cr
it
ica
l 
d
istance v
iew
ing 
is needed.
• Have a th
ird contact 
lens (near power) to use when cr
it
ica
l near 
v
iew
ing 
is needed.
• Have supp
lementa
l spectac
les to wear over the monov
is
ion 
contact 
lenses for spec
iﬁ
 c v
isua
l tasks may 
improve the success of 
monov
is
ion correct
ion. Th
is 
is part
icu
lar
ly app
l
icab
le for those pat
ients 
who cannot meet state dr
iver’s 
l
icens
ing requ
irements w
ith monov
is
ion 
correct
ion.
• 
24
Make use of proper 
i
l
lum
inat
ion when carry
ing out v
isua
l tasks.
CR-6270, v10 
VCT-0007 (7) 
Page 95 of 160
JJVC CONFIDENTIAL

Monov
is
ion ﬁ
 tt
ing success can be 
improved by the fo
l
low
ing suggest
ions:
• Reverse the d
istance and near eyes 
if a pat
ient 
is hav
ing troub
le 
adapt
ing.
• Reﬁ
 ne the 
lens powers 
if there 
is troub
le w
ith adaptat
ion. Accurate 
lens power 
is cr
it
ica
l for presbyop
ic pat
ients.
• Emphas
ize the beneﬁ
 ts of c
lear near v
is
ion, and stra
ight ahead and 
upward gaze w
ith monov
is
ion.
The dec
is
ion to ﬁ
 t a pat
ient w
ith monov
is
ion correct
ion 
is most appropr
iate
ly 
left to the Eye Care Profess
iona
l 
in con
junct
ion w
ith the pat
ient after carefu
l
ly 
cons
ider
ing the pat
ient’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
• Fo
l
low the accepted standard of care 
in ﬁ
 tt
ing and fo
l
low
ing up w
ith your 
pat
ient, e.g., Amer
ican Optometr
ic Assoc
iat
ion standard of care. 
• Schedu
le the appropr
iate fo
l
low-up exam
inat
ion. 
• Preferab
ly
, at the fo
l
low-up v
is
its, 
lenses shou
ld have been worn for at 
least s
ix hours. 
• Prov
ide the pat
ient w
ith a copy of the PATIENT INSTRUCTION GUIDE for 
these 
lenses, wh
ich 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 wear
ing schedu
le shou
ld be determ
ined by the Eye Care Profess
iona
l. 
Regu
lar checkups, as determ
ined by the Eye Care Profess
iona
l, are a
lso 
extreme
ly 
important.
Pat
ients tend to over wear the 
lenses 
in
it
ia
l
ly
. The Eye Care Profess
iona
l shou
ld 
emphas
ize the 
importance of adher
ing to the 
in
it
ia
l max
imum wear
ing schedu
le. 
Max
imum wear
ing t
ime shou
ld be determ
ined by the Eye Care Profess
iona
l 
based upon the pat
ient’s phys
io
log
ica
l eye cond
it
ion  because 
ind
iv
idua
l 
response to contact 
lenses var
ies. 
25
WEARING SCHEDULE
CR-6270, v10 
VCT-0007 (7) 
Page 96 of 160
JJVC CONFIDENTIAL

The max
imum suggested wear
ing t
ime 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 
ind
icated for da
i
ly d
isposab
le wear and shou
ld be d
iscarded 
upon remova
l.
When d
isposed of after a s
ing
le da
i
ly use, these 
lenses may reduce the r
isk of 
deve
lop
ing g
iant pap
i
l
lary con
junct
iv
it
is.4
When worn as a da
i
ly d
isposab
le 
lens, these 
lenses may prov
ide 
improved 
comfort for many pat
ients who exper
ience m
i
ld d
iscomfort and 
itch
ing 
assoc
iated w
ith a
l
lerg
ies dur
ing contact 
lens wear
, compared to 
lenses rep
laced 
at 
interva
ls of greater than 2 weeks.
C
l
in
ica
l research has shown that when worn on a da
i
ly d
isposab
le bas
is, these 
lenses may prov
ide 
improved comfort for 2 out of 3 pat
ients who reported 
suffer
ing from d
iscomfort assoc
iated w
ith a
l
lerg
ies dur
ing contact 
lens wear
.
4 The CLAO Journa
l, Ju
ly 1999, Vo
lume 25, Number 3
The Eye Care Profess
iona
l shou
ld rev
iew w
ith pat
ients that no c
lean
ing or 
d
is
infect
ion 
is needed w
ith da
i
ly d
isposab
le 
lenses. Pat
ients shou
ld a
lways 
d
ispose of 
lenses when they are removed and have rep
lacement 
lenses or 
spectac
les ava
i
lab
le.
For comp
lete 
informat
ion concern
ing contact 
lens hand
l
ing and care, refer to 
the PATIENT INSTRUCTION GUIDE for these 
lenses. Cop
ies are ava
i
lab
le for 
down
load at www.acuvue.com. 
Care for Sticking (Non-Moving) Lenses
Dur
ing remova
l, 
if the 
lens st
icks to the eye, the pat
ient shou
ld be 
instructed 
to app
ly a few drops of the recommended 
lubr
icat
ing or rewett
ing so
lut
ion 
REPLACEMENT SCHEDULE
26
LENS CARE DIRECTIONS
CR-6270, v10 
VCT-0007 (7) 
Page 97 of 160
JJVC CONFIDENTIAL

d
irect
ly to the eye and wa
it unt
i
l the 
lens beg
ins to move free
ly on the eye before 
remov
ing 
it. If non-movement of the 
lens cont
inues after a few m
inutes, the 
pat
ient shou
ld immediately consu
lt the Eye Care Profess
iona
l.
The pat
ient shou
ld be 
informed that 
if chem
ica
ls of any k
ind (househo
ld 
products, garden
ing so
lut
ions, 
laboratory chem
ica
ls, etc.) are sp
lashed 
into 
the eyes, the pat
ient shou
ld:  FLUSH EYES IMMEDIATELY WITH TAP WATER 
AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A 
HOSPITAL EMERGENCY ROOM WITHOUT DELAY
.
Each UV-absorb
ing ster
i
le 
lens 
is supp
l
ied 
in a fo
i
l-sea
led p
last
ic package 
conta
in
ing buffered sa
l
ine so
lut
ion w
ith pov
idone. The p
last
ic package 
is marked 
w
ith the fo
l
low
ing: 
• 1-DAY ACUVUE® MOIST: base curve, power
, d
iameter
, 
lot number
, and 
exp
irat
ion date
• 1-DAY ACUVUE® MOIST for ASTIGMATISM: base curve, power
, 
d
iameter
, cy
l
inder
, ax
is, 
lot number
, and exp
irat
ion date
• 1-DAY ACUVUE® MOIST MULTIFOCAL: base curve, power
, d
iameter
, 
ADD power
, 
lot number
, and exp
irat
ion date
A
l
l ser
ious adverse exper
iences and adverse react
ions observed 
in pat
ients 
wear
ing these 
lenses or exper
ienced w
ith these 
lenses shou
ld be reported to:
Johnson & Johnson V
is
ion Care, Inc.
7500 Centur
ion Parkway
Jacksonv
i
l
le, FL 32256
USA
Te
l: 1-800-843-2020
www.acuvue.com
EMERGENCIES
HOW SUPPLIED
27
REPORTING OF ADVERSE REACTIONS
CR-6270, v10 
VCT-0007 (7) 
Page 98 of 160
JJVC CONFIDENTIAL

 
 
 
 
 
APPENDIX D: CLINICAL TECHNICAL PROCEDURES 
 
 
• 
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS 
• 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
• 
 LENS FITTING CHARACTERISTICS 
• 
 SUBJECT REPORTED OCULAR SYMPTOMS 
• 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 
• 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
• 
 BIOMICROSCOPY SCALE 
• 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
• 
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
• 
 PATIENT REPORTED OUTCOMES 
• 
 WHITE LIGHT LENS SURFACE WETTABILITY 
• 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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 LIMBAL AND 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 
 
 
 
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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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Title: 
Distance and Near Visual Acuity Evaluation 
Document Type: 
 
  
 
 
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 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
 
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WHITE LIGHT LENS SURFACE WETTABILITY 
 
 
 
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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: 
 
  
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
 
  
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6270 Clinical Evaluation of etafilcon A Contact Lenses Using a 
Novel Molding Process      
Version and Date: 1.0 30 May 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 Helsinki3 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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