Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
 
 
 
 
Johnson & Johnson Vision Care, Inc. 
 
Clinical Study Protocol 
 
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population 
Phase II 
 
Protocol CR-6267 
 
Version: 2.0 Amendment 1 
                            
Date: 22 June 2018 
 
Investigational Products: JJV Investigational senofilcon A Multifocal Contact Lens and     
1-Day Acuvue® Moist Brand Multifocal Contact Lens 
 
Key Words: Presbyopia, Multifocal, etafilcon A, senofilcon A, Daily Wear, Daily 
Disposable, Reusable, Dispensing, Randomized  
 
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. 
 
CR-6267, v2.0
 
Page 1 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study...................................................................................................................... 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives ................................................................................................................. 18 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION ............................................................................................. 22 
CR-6267, v2.0
 
Page 2 of 218
JJVC CONFIDENTIAL

 
 
 
 
6.1. 
Identity of Test Articles............................................................................................ 22 
6.2 Ancillary Supplies/Products.......................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 23 
6.4. 
Packaging and Labeling ........................................................................................... 23 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 24 
7. 
STUDY EVALUATIONS .............................................................................................. 25 
7.1. 
Time and Event Schedule ......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 35 
VISIT 3 ........................................................................................................................... 39 
VISIT 4 ........................................................................................................................... 44 
VISIT 5 ........................................................................................................................... 50 
VISIT 6 ........................................................................................................................... 55 
VISIT 7 ........................................................................................................................... 59 
FINAL EVALUATION .................................................................................................. 62 
7.3. 
Unscheduled Visits ................................................................................................... 62 
7.4. 
Laboratory Procedures ............................................................................................. 64 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 64 
8.1. 
Completion Criteria .................................................................................................. 64 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 64 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 65 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 65 
11. 
STUDY TERMINATION ........................................................................................... 65 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 66 
13. 
ADVERSE EVENTS ................................................................................................... 67 
13.1. 
Definitions and Classifications ............................................................................. 67 
13.2. 
Assessing Adverse Events .................................................................................... 70 
13.2.1. 
Causality Assessment .................................................................................... 70 
13.2.2. 
Severity Assessment ...................................................................................... 70 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 71 
13.4. 
Reporting Adverse Events .................................................................................... 72 
CR-6267, v2.0
 
Page 3 of 218
JJVC CONFIDENTIAL

 
 
 
 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 72 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 73 
13.4.3. 
Event of Special Interest ............................................................................... 73 
13.5. 
Reporting of Pregnancy ........................................................................................ 73 
14. 
STATISTICAL METHODS ........................................................................................ 74 
14.1. 
General Considerations ......................................................................................... 74 
14.2. 
Sample Size Justification ...................................................................................... 74 
14.3. 
Analysis Populations ............................................................................................ 74 
14.4. 
Level of Statistical Significance ........................................................................... 75 
14.5. 
Primary Analysis .................................................................................................. 75 
14.6. 
Secondary Analysis .............................................................................................. 75 
14.7. 
Other Exploratory Analyses ................................................................................. 75 
14.8. 
Interim Analysis ................................................................................................... 76 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 76 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 76 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 76 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 76 
15.2. 
Subject Record ...................................................................................................... 77 
16. 
DATA MANAGEMENT............................................................................................. 77 
16.1. 
Access to Source Data/Document ........................................................................ 77 
16.2. 
Confidentiality of Information.............................................................................. 77 
16.3. 
Data Quality Assurance ........................................................................................ 78 
17. 
MONITORING ............................................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 78 
18.1. 
Study-Specific Design Considerations ................................................................. 78 
18.2. 
Investigator Responsibility ................................................................................... 79 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 79 
18.4. 
Informed Consent ................................................................................................. 80 
18.5. 
Privacy of Personal Data ...................................................................................... 81 
19. 
STUDY RECORD RETENTION................................................................................ 81 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION ........................................................................................................... 82 
22. 
REFERENCES ............................................................................................................ 83 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 84 
CR-6267, v2.0
 
Page 4 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX B : PATIENT INSTRUCTION GUIDE .......................................................... 116 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 117 
APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 148 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 149 
APPENDIX F: OCULAR DOMINANCE............................................................................ 150 
APPENDIX G: Test LENS FITTING GUIDE ..................................................................... 151 
APPENDIX H: CONTROL LENS FITTING GUIDE ......................................................... 153 
APPENDIX I: CLINICAL TECHNICAL PROCEDURES (CTP) ...................................... 155 
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS ............................. 156 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING .................. 164 
 DETERMINATION OF NEAR ADDITION .................................................... 169 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE ....... 177 
 LENS FITTING CHARACTERISTICS ............................................................ 180 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ....................... 187 
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 189 
 BIOMICROSCOPY SCALE ............................................................................. 196 
 KERATOMETRY PROCEDURE ..................................................................... 202 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ........................ 204 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 209 
 Visual Acuity Chart Luminance and Room Illumination Testing ..................... 213 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 218 
 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 13 
 
TABLE OF CONTENTS  
Table 1: Test Articles .............................................................................................................. 22 
Table 2: Ancillary Supplies .................................................................................................... 23 
Table 3: Time and Events ....................................................................................................... 25 
 
 
 
 
CR-6267, v2.0
 
Page 5 of 218
JJVC CONFIDENTIAL

 
 
 
 
PROTOCOL TITLE, NUMBER, VERSION 
Title: Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic 
Population Phase II 
 
Protocol Number:  CR-6267 
Version: 2.0 Amendment 1 
Date: 22 June 2018 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision (JJV) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR 
Name:  Thomas R. Karkkainen, OD, MS, FAAO 
Title: Sr. Principal Research Optometrist 
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256 
 
Email: TKarkkai@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. 
CR-6267, v2.0
 
Page 6 of 218
JJVC CONFIDENTIAL

 
 
 
 
SYNOPSIS  
Protocol Title 
Clinical Evaluation of a Reusable Multifocal Optical Design in 
a Presbyopic Population Phase II 
Sponsor 
JJV, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Development phase, Phase 2  
Trial Registration 
This study will be registered on ClinicalTrials.gov. 
Test Article(s) 
Investigational Product: JJV Investigational Multifocal 
Contact Lens manufactured in senofilcon A material.  
Marketed Product:  1-Day Acuvue® Moist Brand Multifocal 
Contact Lens. 
Wear and Replacement 
Schedules 
Wear Schedule: The Test and Control lenses are used as daily 
wear (note: the Test lens will be reusable and the Control lens 
daily disposable).   
 
Replacement Schedule: The Test lens will be replaced at the 
optimization visit.  The Control lens will be replaced after 
each day of wear as well as the optimization visit and the visit 
after the first week of wear in the optimized pair.    The Test 
and Control lenses will also be replaced when lost or damaged. 
Objectives  
This study is an evaluation of the visual performance, 
subjective response, lens fit and ocular physiological response 
of the JJV Investigational senofilcon A Multifocal Contact 
Lens.  The Test lens will be compared to the 1-Day Acuvue® 
Moist Brand Multifocal Contact Lens manufactured in 
etafilcon A material for CLUE subjective vision.  
Study Endpoints 
Primary endpoints:  CLUE vision scores  
Other observations:  logMAR visual acuity scores, lens fit, 
summary of number of lenses needed to fit (optimize) the 
subject, CLUE comfort/handling scores, corneal staining, and 
ocular redness. 
Study Design 
This is a single-masked, randomized-controlled, dispensing 
clinical trial.  A total of approximately 60 eligible hyperopic 
subjects will be targeted to complete the study.  The subjects 
will be fit in each study lens and wear the lens for 2-4 days 
then undergo optimization, if applicable, and wear the 
optimized pair for approximately 2 weeks with a follow-up at 
1 week. The primary endpoints will be CLUE vision scores. 
Sample Size 
A total of approximately 60 subjects will be targeted to 
complete. 
Study Duration 
The study will last approximately 2-4 months. 
CR-6267, v2.0
 
Page 9 of 218
JJVC CONFIDENTIAL

 
 
 
 
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
invited to participate in the study.  Subjects will be adapted 
soft contact lens wearers in both eyes.  Additional information 
regarding the eligibility of the population can be found in the 
inclusion/exclusion criteria outlined below. 
Eligibility Criteria 
Potential subjects must satisfy all the following criteria to be 
enrolled in the study 
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol. 
3. The subject must be between 40 and 70 years of age 
(inclusive). 
4. The subject’s distance spherical equivalent refraction 
must be in the range of +1.25 D to +3.75 D in each 
eye. 
5. The subject’s refractive cylinder must be ≤0.75 D in 
each eye. 
6. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D. 
7. The subject must have best corrected visual acuity of 
20/20-3 or better in each eye. 
8. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
9. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 8 hours per wear day, for 1 
month of more duration). 
10. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or 
monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”. 
 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that 
may interfere with contact lens wear.   
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere with 
contact lens wear. This may include, but not be limited 
to, diabetes, hyperthyroidism, Sjögren’s syndrome, 
xerophthalmia, acne rosacea, Stevens-Johnson 
CR-6267, v2.0
 
Page 10 of 218
JJVC CONFIDENTIAL

 
 
 
 
syndrome, and immunosuppressive diseases or any 
infectious diseases (e.g. hepatitis, tuberculosis). 
4. Clinically significant (Grade 3 or 4) corneal edema, 
corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal 
or ocular abnormalities which would contraindicate 
contact lens wear. 
5. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, dry eye, glaucoma, history of recurrent corneal 
erosions. 
6. Any previous, or planned, ocular or intraocular surgery 
(e.g. radial keratotomy, PRK, LASIK, lid procedures, 
cataract surgery, retinal surgery, etc.). 
7. A history of amblyopia, strabismus or binocular vision 
abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with 
contact lens wear. 
10. Use of any of the following oral medications within 1 
week prior to enrollment: oral retinoid isotretinoin (e.g. 
Accutane), oral tetracyclines, topical scopolamine, oral 
antihistamines (e.g., Chlor-Trimeton, and Benadryl), 
systemic steroids. 
11. Use of any ocular medication, with the exception of 
rewetting drops. 
12. History of herpetic keratitis. 
13. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment. 
14.  Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
15. Any known hypersensitivity or allergic reaction to 
Optifree®Replenish® multi-purpose care solution or 
Eye-Cept® rewetting drop solution. 
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.   
Measurements and 
Procedures 
See Section 7.2 for the detailed procedures.  
Microbiology or Other 
Laboratory Testing 
None 
CR-6267, v2.0
 
Page 11 of 218
JJVC CONFIDENTIAL

 
 
 
 
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 
Eye-Cept Rewetting drops, lens cases, glass vials, saline, 
ETDRS light cabinet, logMAR charts, and Near logMAR 
charts. Optifree®Replenish® Contact Solution. 
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.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 12 of 218
JJVC CONFIDENTIAL

 
 
 
 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCC  
 
Binocular Crossed Cylinder 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLDEQ-8 
 
Contact Lens Dry Eye Questionnaire-8 
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 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council for 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, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
LSM  
 
Least Square Means 
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 
CR-6267, v2.0
 
Page 14 of 218
JJVC CONFIDENTIAL

 
 
 
 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 15 of 218
JJVC CONFIDENTIAL

 
 
 
 
1. INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision recently launched a multifocal contact lens, 1-DAY ACUVUE® 
Moist Multifocal.  The lens is the only marketed soft multifocal lens to have its optical 
design optimized for the changes that occur in pupil size with refractive error.  The modality 
for the lens is daily disposable.  There is a desire to evaluate the same optical design in a 
reusable modality.  The purpose of this study is to evaluate a multifocal optical design 
manufactured from senofilcon-A material and compare the visual performance to the 1-DAY 
ACUVUE® Moist Multifocal. 
1.1. Name and Descriptions of Investigational Products  
Test Lens: JJV Investigational senofilcon-A Multifocal Contact Lens-The lens has the same 
optical design, diameter, base curve and aspheric back surface design as the 1-Day Acuvue® 
Moist Brand Multifocal.  The lens is manufactured in senofilcon-A.        
 
Control Lens:  Marketed 1-Day Acuvue® Moist Brand Multifocal Contact Lenses 
1.2. Intended Use of Investigational Products 
Both lenses are intended to correct spherical refractive error and presbyopia.  The Test lenses 
are intended to be used as a 2-week, reusable, daily wear lens.  The lenses require use of a 
care system to clean and disinfect the lenses.  The control lenses are daily wear lenses that 
are disposed of at the end of each wear cycle.  No care system is required for the control 
lenses.  
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 JJV 
investigational senofilcon-A multifocal refer to the latest version of the Investigator 
Brochure. 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The Investigational multifocal contact lenses are designed as a continuous asphere providing 
for the correction of refractive spherical ammetropia and presbyopia.  The material is a 
silicone hydrogel material, senofilcon-A.   
 
The 1-Day Acuvue® Moist Brand Multifocal Contact Lens is a currently marketed product 
that is made of the etafilcon-A material.  The contact lenses are available as continuous 
aspheres providing for the correction of a subjects refractive spherical ammetropia and 
presbyopia. 
 
The intent of the Test lens is daily wear, reusable lens that the subject wears while awake.  
This lens is not intended for extended wear.  Anticipated risks and adverse reactions with this 
lens are similar to other soft daily wear contact lenses used to correct presbyopia.  A listing 
of examples of adverse reactions is found in the Section 13 of this protocol.  The investigator 
should follow normal clinical guidelines regarding examination and care of subjects who 
participate in this trial. For the most comprehensive clinical information regarding the JJV 
CR-6267, v2.0
 
Page 16 of 218
JJVC CONFIDENTIAL

 
 
 
 
Investigational senofilcon-A multifocal lens refer to the Investigator Brochure.  Additional 
details on the 1-Day Acuvue® Moist Brand Multifocal Contact Lens can be found in the 
package insert in Appendix C. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
  The study was a dispensing 
clinical trial with primary end points of logMAR visual acuity at fit and CLUE vision scores 
at 1 week.  The study was a cross-over design with a marketed product serving as the control.  
Subjects were fit in the lenses and wore them for 2-4 then attended the first follow-up visit to 
determine if lens optimization was required.  The lenses were than worn for an additional 2 
weeks with a 1-week follow-up during that period.  There were 32 subjects that completed 
the study as cohort.  The Test lens displayed good visual acuity with the mean distance and 
intermediate logMAR acuity better than 0.0 and the mean near logMAR acuity better than 
+0.1 logMAR.  This with true of the acuity at the initial fit as well as the 1 week and 2-week 
visits in the final lens pair.  There were two non-ocular adverse events that occurred during 
the study that were not related to any of the Test lenses.  
 
which at the writing of this protocol has 
completed data collection, however does not have a completed clinical study report.  During 
the study there were no serious adverse events reported.    
 
In addition to the above study, JJV had tested similar optical designs that have been 
manufactured in a similar material however those lenses were worn as daily disposable 
lenses.  
 
   
 
was a non-dispensing evaluation with a primary endpoint of logMAR visual acuity.  
There were 22 subjects that completed the trial per protocol.  In this study, the lenses 
provided clinically acceptable visual acuity with the mean bright high contrast binocular 
logMAR acuity of -0.016, -0.028 and 0.086 for distance, intermediate and near respectively.  
There were no adverse events reported during the study.   
 
was a dispensing clinical trial with the primary endpoint of logMAR visual acuity.  
There were 21 subjects that completed the trial per protocol.  The lenses displayed clinically 
acceptable logMAR visual acuity after approximately 10 days of wear with the mean bright 
high contrast binocular logMAR acuity of -0.082, -0.042 and 0.054 for distance, intermediate 
and near respectively.  There were two adverse events reported during the study one that was 
non-ocular and not related to the test articles the other was an ocular adverse event, contact 
lens induced peripheral ulcer, that was classified as likely related to the study lens.  The event 
resolved with treatment and the subject was discontinued from the study.  For additional 
details refer to the Investigator Brochure for this study. 
CR-6267, v2.0
 
Page 17 of 218
JJVC CONFIDENTIAL

 
 
 
 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES   
2.1. Objectives  
This study is an evaluation of the visual performance, subjective response, lens fit and ocular 
physiological response of the JJV Investigational senofilcon A Multifocal Contact Lens.  The 
Test lenses will be compared to the 1-Day Acuvue® Moist Brand Multifocal Contact Lens 
manufactured in etafilcon A material for CLUE subjective vision.  
 
Primary Objective 
This study is an evaluation of how the subjective response of the JJV Investigational 
senofilcon A Multifocal Contact Lens compares to the 1-Day Acuvue® Moist Brand 
Multifocal Contact Lens manufactured in etafilcon A material. 
2.2. Endpoints  
The study endpoints will be the subjective CLUE Vision scores.  Additional endpoints will 
be logMAR visual acuity at distance, intermediate and near a summary of lenses needed to fit 
(optimize) the subject, CLUE comfort/handling scores, the lens fit and ocular physiological 
responses.   
 
Primary Endpoints 
• CLUE vision scores 
 
Other Observation(s)  
• LogMAR visual acuity scores  
• Lens fit 
• Corneal staining 
• Ocular redness (bulbar and limbal) 
• Summary of lenses needed to fit (optimize) the subject 
• CLUE comfort/handling scores 
• PRO individual questions 
2.3. Hypotheses 
The following primary hypothesis will be tested throughout this investigation.  
 
Primary Hypothesis: 
1. After 14 to 20 days of wear, the PRO CLUE vision score for the Test lenses will be 
statistically better than 32 points.  This will be recorded by the subject using the 
CLUE Follow-up Questionnaire. 
 
If the primary hypothesis is met, the following secondary hypothesis will be tested. 
 
CR-6267, v2.0
 
Page 18 of 218
JJVC CONFIDENTIAL

 
 
 
 
Secondary Hypothesis: 
1. After 14 to 20 days of wear, the PRO CLUE vision score for the Test lenses will be 
non-inferior to the control lens.  A non-inferiority margin of 5 CLUE points will be 
used.  This will be recorded by the subject using the CLUE Follow-up Questionnaire. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female subjects who are habitual soft contact lens wearers will be 
recruited.  Subjects will be at least 40 years of age and not older than 70 years of age.  They 
will be hyperopic and have presbyopia.    
3.2. Inclusion Criteria 
Potential subjects must satisfy all the following criteria to be enrolled in the study:  
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol. 
3. The subject must be between 40 and 70 years of age (inclusive). 
4. The subject’s distance spherical equivalent refraction must be in the range of +1.25 D 
to +3.75 D in each eye. 
5. The subject’s refractive cylinder must be ≤0.75 D in each eye. 
6. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
7. The subject must have distance best corrected visual acuity of 20/20-3 or better in 
each eye. 
8. Subjects must own a wearable pair of spectacles if required for their distance vision. 
9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses 
a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more 
duration). 
10. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire”. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.   
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, 
CR-6267, v2.0
 
Page 19 of 218
JJVC CONFIDENTIAL

 
 
 
 
Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious 
diseases (e.g. hepatitis, tuberculosis). 
4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal 
staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear. 
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history 
of recurrent corneal erosions. 
6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 
7. A history of amblyopia, strabismus or binocular vision abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with contact lens wear. 
10. Use of any of the following oral medications within 1 week prior to enrollment: oral 
retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral 
antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 
11. Use of any ocular medication, with the exception of rewetting drops. 
12. History of herpetic keratitis. 
13. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment. 
14.  Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multi-
purpose care solution or Eye-Cept® rewetting drop solution. 
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 
The clinical study is a randomized-controlled, single-masked, cross-over clinical trial.  There 
are two study treatments. A total of approximately 60 eligible hyperopic subjects will be 
targeted to complete the study. Each Test article will be dispensed for 3±1 days and an 
optimization visit will occur.  The final lens pair will be dispensed for 7±1 days and the first 
follow-up on the final lens pair will occur.  The lenses will be dispensed for an additional 
7±1 days and the final lens measurements will be made. The second study lenses will then be 
fit and the above sequence repeated.   
4.2. Study Design Rationale  
The study is intended to compare two study lens types and the initial performance, in terms 
of the subjective response after a period of lens dispensing.  The lenses are dispensed to 
determine the subjective responses and the comparison is made after a total of 14-20 days of 
wear.   
CR-6267, v2.0
 
Page 20 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
The cross-over study design was chosen to control for variables that may impact the lens 
performance between subjects.  It was determined that a washout was not required as 
previous studies on similar populations with similar multifocal designs did not show a 
significant carry over effect on the primary/secondary endpoints measured in the study.      
4.3. Enrollment Target and Study Duration 
A total of approximately 70 eligible subjects will be enrolled with 60 targeted to complete 
the study.   
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 
with 2 lens types and 2 periods.  Using a computer-generated randomization scheme 
provided by the study biostatistician, each subject will randomly be assigned to one of two 
unique sequences (Test/Control or Control/Test).  Randomization will be stratified by site. 
 
Permuted block randomization will be used to avoid bias in the assignment of subjects to 
treatment, and to enhance the validity of statistical comparisons across treatment groups. 
Each block will contain two different lens trial sequences. 
 
The order of lens wear will be based on the randomization scheme assigned to the study site.   
The study site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. 
5.2. Masking 
This is a single-masked study with the subjects being masked. Subjects will be unaware of 
the identity of the investigational product. Investigators and clinical site personnel involved 
in the data collection will not be masked as to the identity of the investigational product.  
 
Under normal circumstances, the mask should not be broken until all subjects have 
completed the study and the database is finalized. Otherwise, the mask should be broken only 
if specific emergency treatment/course of action would be dictated by knowing the treatment 
status of the subject. In such cases, the Investigator may, in an emergency, contact the 
medical monitor.  In the event the mask is broken, the Sponsor must be informed as soon as 
possible. The date, time, and reason for the unmasking must be documented in the subject 
record. The Investigator is also advised not to reveal the study treatment assignment to the 
clinical site or Sponsor personnel.  
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
CR-6267, v2.0
 
Page 21 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 
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 
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 to JJV. 
6.7. Accountability of Test Articles 
JJV will provide the Investigator with sufficient quantities of study article 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 the Sponsor. 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information 
 
CR-6267, v2.0
 
Page 24 of 218
JJVC CONFIDENTIAL

 
 
 
 
2 near card placed at 40 cm to measure the 
Near visual acuity 
1.26 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results.  
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
 
1.27 
Subjective Lens Fit 
Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
• The subject should not proceed to wear the 
lenses if any of the following is observed: 
• presence of limbal exposure (appearance of 
clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form. 
 
1.28 
Modifications 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted. If the subject reports satisfactory 
vision with the lenses a modification is not 
required, however at the Investigator’s 
discretion and based upon their findings on the 
measured visual acuity and/or over- refraction 
the investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Follow 
the fitting guide allowing for at least 10 
minutes of settling time between each lens 
modification attempted.    
Appendix 
G and H 
(Fitting 
Guides) 
CR-6267, v2.0
 
Page 32 of 218
JJVC CONFIDENTIAL

 
 
 
 
If modifications are required steps 1.21-1.27 
will be repeated for each modification.  
1.29 
Post-Fit 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
1.30 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed.  
 
1.31 
Dispensing Criteria 
The lenses will be dispensed for 2-4 days. 
• Distance Snellen acuity equal to or better 
than 20/30 OU 
• Subject must indicate that the vision is 
acceptable. 
• Subject must indicate that the comfort of 
the lenses is acceptable. 
• Lenses must have an acceptable general 
lens fit. 
 
1.32 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
 
CR-6267, v2.0
 
Page 33 of 218
JJVC CONFIDENTIAL

 
 
 
 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• A patient instruction booklet will be 
provided. 
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
1.33 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
• If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• A patient instruction booklet will be 
provided. 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
 
CR-6267, v2.0
 
Page 34 of 218
JJVC CONFIDENTIAL

 
 
 
 
2 near card placed at 40 cm to measure the 
Near visual acuity 
2.8 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results 
and distance visual acuity OD and OS.   
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
 
2.9 
Determination of 
Lens Optimization 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.   
Follow the fitting guide allowing for at least 
10 minutes of settling time between each lens 
modification attempted. 
Appendix 
G and H 
(Fitting 
Guides)  
2.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
• The subject should not proceed to wear the 
lenses if any of the following is observed: 
• presence of limbal exposure (appearance of 
clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
  
CR-6267, v2.0
 
Page 36 of 218
JJVC CONFIDENTIAL

 
 
 
 
• Subject must indicate that the comfort of 
the lenses is acceptable. 
• Lenses must have an acceptable general 
lens fit. 
2.18 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• A patient instruction booklet will be 
provided. 
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
2.19 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
 
CR-6267, v2.0
 
Page 38 of 218
JJVC CONFIDENTIAL

 
 
 
 
unit increments will be used in the grading.  
Corneal Staining Assessment 
 will 
be graded in 1.0 increments. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.   
3.13 
Insertion of Study 
Lenses 
Dispense the subject new lenses if wearing the 
daily disposable lenses that match the Distance 
and ADD power of the lenses that were 
removed in Step 3.11 above. 
 
Subjects that are wearing the daily reusable 
wear lenses will reinsert the lenses that were 
temporarily stored. 
 
3.14 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2.  The acuity will be recorded to 
the nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
 
3.15 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
• Distance Snellen acuity equal to or better 
than 20/30 OU 
• Subject must indicate that the vision is 
acceptable. 
• Subject must indicate that the comfort of 
the lenses is acceptable. 
• Lenses must have an acceptable general 
lens fit. 
 
3.16 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis. 
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
 
CR-6267, v2.0
 
Page 42 of 218
JJVC CONFIDENTIAL

 
 
 
 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
3.17 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
• If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
 
CR-6267, v2.0
 
of 218
JJVC CONFIDENTIAL

 
 
 
 
from the other worn lenses that will be shipped 
back to the Sponsor. Complete the Quality 
Product Complaint form. 
4.16 
Lens Settling  
Allow the study lenses to settle for a minimum 
of 10 minutes. 
 
4.17 
Determine Visual 
Satisfaction 
Determine if the subject’s vision is acceptable 
with the lenses.  Allow the subject to look 
down a hallway or out of a window for 
distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision.   
 
4.18 
Study Lens Distance 
and Near Visual 
Acuity 
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
 
4.19 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results.  
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
 
4.20 
Subjective Lens Fit 
Assessment 
Evaluate overall lens fit acceptance (acceptable 
or unacceptable) based on centration, 
movement and other fitting characteristics. 
  
An unacceptable fit is deemed by one of the 
following criteria:  
• limbal exposure at primary gaze or with 
extreme eye movement; 
• edge lift; 
• excessive movement in primary and up 
gaze; or  
• insufficient movement in all three of 
the following conditions: primary gaze, 
up gaze, and Josephson push up. 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form. 
 
4.21 
Modifications 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
Appendix 
G (Fitting 
CR-6267, v2.0
 
Page 47 of 218
JJVC CONFIDENTIAL

 
 
 
 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Follow 
the fitting guide allowing for at least 10 
minutes of settling time between each lens 
modification attempted.    
If modifications are required steps 4.14-4.20 
will be repeated for each modification 
Guide) 
4.22 
Post-Fit 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
4.23 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed.  
 
4.24 
Dispensing Criteria 
The lenses will be dispensed for 2-4 days. 
• Distance Snellen acuity equal to or better 
than 20/30 OU 
• Subject must indicate that the vision is 
acceptable. 
• Subject must indicate that the comfort of 
the lenses is acceptable. 
• Lenses must have an acceptable general 
lens fit. 
 
4.25 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
 
CR-6267, v2.0
 
Page 48 of 218
JJVC CONFIDENTIAL

 
 
 
 
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved rewetting 
drops may be dispensed to be used as 
needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• A patient instruction booklet will be 
provided. 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to the 
Sponsor.  If lens damage is present, complete 
the Product Quality Complaint Form.  The 
lens will be stored in labeled vial with sterile 
saline, and returned to the Sponsor. 
4.26 
Patient Instructions 
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
• If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
• Subjects will be instructed to wear lenses 
 
CR-6267, v2.0
 
Page 49 of 218
JJVC CONFIDENTIAL

 
 
 
 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire.   
5.5  
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire 
 
5.6  
Subjective 
Acceptance 
Record whether the subjects distance and near 
vision with the lenses is acceptable. 
 
5.7  
Distance and Near 
Entrance Visual 
Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
5.8  
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results 
and distance visual acuity OD and OS.  The 
results of the distance over-refraction may also 
be checked for the impact on near vision under 
monocular and/or binocular conditions.    
 
5.9  
Determination of 
Lens Optimization 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.   
Follow the fitting guide allowing for at least 
10 minutes of settling time between each lens 
modification attempted. 
Appendix 
G and H 
(Fitting 
Guides)  
5.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
The subject should not proceed to wear the 
  
CR-6267, v2.0
 
Page 51 of 218
JJVC CONFIDENTIAL

 
 
 
 
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
5.17 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
• Distance Snellen acuity equal to or better 
than 20/30 OU 
• Subject must indicate that the vision is 
acceptable. 
• Subject must indicate that the comfort of 
the lenses is acceptable. 
• Lenses must have an acceptable general 
lens fit. 
 
5.18 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis. 
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
 
CR-6267, v2.0
 
Page 53 of 218
JJVC CONFIDENTIAL

 
 
 
 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
5.19 
Patient Instructions 
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
• If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
5.20    Schedule  
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days. 
 
Note: To count the follow-up visit as a day of 
wear the Subject must have worn the study 
lenses for 6 hours prior to the visit. 
 
 
 
CR-6267, v2.0
 
Page 54 of 218
JJVC CONFIDENTIAL

 
 
 
 
Contrast (1 Chart). 
Near (40 cm) High Contrast (1 Chart) and Low 
Contrast (1 Chart). 
 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 3M-HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast (1 Chart at each distance) 
Intermediate (64 cm) and Near (40 cm). 
 
Note: 
• The room illuminance must be 
between 7.3 and 7.9 EV. 
• Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7. 
• Guillon-Poling, Near Chart 
Luminance Acceptable EV Range 
10.8-11.1. 
• Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles) 
6.9  
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.   
Note: No lens changes are allowed based on 
the over-refraction.    
Appendix 
D 
6.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
• presence of limbal exposure (appearance of 
clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
  
CR-6267, v2.0
 
Page 56 of 218
JJVC CONFIDENTIAL

 
 
 
 
• Lenses must have an acceptable general 
lens fit. 
6.16 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis. 
• Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
• A new lens will be opened and worn each 
day. 
• Instruct the subject to bring back all 
unworn study lenses. 
• No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
6.17 
Patient Instructions 
for Daily Reusable 
Wear Lenses  
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
• OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
 
CR-6267, v2.0
 
Page 58 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
For discontinued subjects, the Investigator will: 
• Complete the current visit (scheduled or unscheduled) 
• 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 may be enrolled if a subject discontinues from the study prematurely.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.  
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear.  See the Exclusion criteria for specific details.  
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
 
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 
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJV safety review committee, 
the study may be terminated. This potential stopping rule is established based on our trial 
involving approximately 200 subjects wearing the investigational soft contact lens for up to 3 
years with an assumed MK rate that is below 0.2% per patient-year. The rate of 0.2% per 
patient year is the established rate for extended wear lenses in adults, which was requested by 
the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA response to a 
CR-6267, v2.0
 
Page 65 of 218
JJVC CONFIDENTIAL

 
 
 
 
pre-IDE submission. To be conservative, 200 independent patient years were used in the 
calculation. The probability of observing 2 cases or more incidents of MK is 0.061, and 3 
cases or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient year).  
 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJV 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 JJV, it is determined 
that it would be unwise to continue at the clinical site.    
 
JJV (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.   
 
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
monitors, and site personnel, etc. The following are not considered product quality 
complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (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 
CR-6267, v2.0
 
Page 66 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
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) 
• Indication of who first observed complaint (site personnel or subject) 
• OD/OS indication, along with whether the lens was inserted 
• Any related AE number if applicable 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
• Eye Care Provider objective (slit lamp) findings if applicable 
• Confirmation of product availability for return (and tracking information, if 
available), or rationale if product is not available for return 
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
CR-6267, v2.0
 
Page 67 of 218
JJVC CONFIDENTIAL

 
 
 
 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include 
any condition resulting from concomitant illnesses, reactions to concomitant 
medications, or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event 
 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
• Results in death 
• Is life threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
• 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 
• 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 
 
CR-6267, v2.0
 
Page 68 of 218
JJVC CONFIDENTIAL

 
 
 
 
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.   
 
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 
CR-6267, v2.0
 
Page 69 of 218
JJVC CONFIDENTIAL

 
 
 
 
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 0)   
• 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: 
• 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 
CR-6267, v2.0
 
Page 70 of 218
JJVC CONFIDENTIAL

 
 
 
 
• 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.   
 
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.  
CR-6267, v2.0
 
Page 71 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the test article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study 
visit date, should be followed to resolution of the adverse event or until referral to an 
appropriate health care provider, as recommended by the Investigator. Non-ocular adverse 
events that are not related to the test article, study treatment, or study procedures may be 
recorded as “ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or 
telephone as soon as possible and no later than 24 hours from discovery for any serious 
/significant adverse events, and 2 days from discovery for any non-significant adverse event.  
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements (Section 13.4.2).  The report will comment whether the 
adverse event was considered to be related to the test article, study treatment or study 
procedures. 
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 
CR-6267, v2.0
 
Page 72 of 218
JJVC CONFIDENTIAL

 
 
 
 
• 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. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest 
None 
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event.  Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
will not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur 
secondary to systemic hormonal changes, and not due to unforeseen health risks to the 
mother or fetus. 
CR-6267, v2.0
 
Page 73 of 218
JJVC CONFIDENTIAL

 
 
 
 
Intent-to-Treat (ITT) Population: 
All subjects regardless of actual treatment and subsequent withdrawal from study or 
deviation from protocol.  At least one observation should be recorded. 
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
Primary efficacy analysis: 
 
CLUE Vision: 
Overall quality of vision scores will be analyzed using a linear mixed model adjusting for 
baseline values as fixed covariates. The model will include the experimental design factors: 
sequence of lens wear, period, lens type, time point and interaction between lens and time 
point as fixed effects. The covariance between residual errors from the same subject across 
lens wearing periods/time point will be selected based on the finite-sample corrected 
Akaike’s Information Criterion (Keselman et al. 1998)6. Covariance structures considered 
may include: Homogenous compound symmetry (CS) and Unstructured covariance structure 
(UN).  The structure that returns the lowest Akaike Information Criteria Corrected (AICC) 
will be selected as the structure that best fit the data.  
 
Primary Hypothesis: 
Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models of CLUE vision scores for each study 
population. Statistically superiority will be concluded if the lower limit of the confidence 
intervals of the test lens are greater than 32 points. 
 
Secondary Hypothesis: 
Comparisons between the test lens and control lens at each time point (1 week and 2 weeks) 
will be carried out using 95% confidence intervals constructed of least-square means (LSM) 
differences (Test minus Control) from the linear mixed model. The non-inferiority of the test 
lens relative to the control will be concluded if the lower confidence limit of LSM difference 
is above the non-inferiority margin -5. The superiority will be established if the lower 
confidence limit is above 0. 
 
In all models, the Kenward and Roger method (Kenward and Roger, 1997)7 will be used for 
the calculation of the denominator of degrees of freedom. 
 
14.6. Secondary Analysis 
See section 14.5. 
14.7. Other Exploratory Analyses 
Not Applicable 
CR-6267, v2.0
 
Page 75 of 218
JJVC CONFIDENTIAL

 
 
 
 
14.8. Interim Analysis 
Not Applicable 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a 
parametric regression method used to make at least 5 imputations. 
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 (Bioclinica). An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJV database manager and sent to JJV 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.  
CR-6267, v2.0
 
Page 76 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
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. 
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, JJV 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 JJV.  
The Investigator may use this information for the purposes of the study only. It is understood 
by the Investigator that JJV 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. 
CR-6267, v2.0
 
Page 77 of 218
JJVC CONFIDENTIAL

 
 
 
 
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 JJV 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 JJV 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 
• Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel 
• Ensuring that protocol deviations 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 
CR-6267, v2.0
 
Page 78 of 218
JJVC CONFIDENTIAL

 
 
 
 
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 (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) 
• 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 informed consent form, applicable recruiting materials, 
and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
• Protocol amendments 
• Revision(s) to informed consent form 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) 
CR-6267, v2.0
 
Page 79 of 218
JJVC CONFIDENTIAL

 
 
 
 
• 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 protocol deviations 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 informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines,  
applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
informed that their participation is voluntary and that they may withdraw consent to 
participate at any time.  
 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject. 
 
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 
CR-6267, v2.0
 
Page 80 of 218
JJVC CONFIDENTIAL

 
 
 
 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records. 
18.5. Privacy of Personal Data 
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,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
CR-6267, v2.0
 
Page 81 of 218
JJVC CONFIDENTIAL

 
 
 
 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJV. 
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 JJV management representative prior to study initiation. 
 
JJV 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 
 
JJV 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. 
CR-6267, v2.0
 
Page 82 of 218
JJVC CONFIDENTIAL

 
 
 
 
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation. 
1998;27:591-604. 
7. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983–997. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 83 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
CR-6267, v2.0
 
Page 84 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
CR-6267, v2.0
 
Page 85 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
CR-6267, v2.0
 
Page 86 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
CR-6267, v2.0
 
Page 87 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
CR-6267, v2.0
 
Page 88 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
CR-6267, v2.0
 
Page 89 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
6
CR-6267, v2.0
 
Page 90 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
7
CR-6267, v2.0
 
Page 91 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
8
CR-6267, v2.0
 
Page 92 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
9
CR-6267, v2.0
 
Page 93 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
10
CR-6267, v2.0
 
Page 94 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
11
CR-6267, v2.0
 
Page 95 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
12
CR-6267, v2.0
 
Page 96 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
13
CR-6267, v2.0
 
Page 97 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
14
CR-6267, v2.0
 
Page 98 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
n 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
15
CR-6267, v2.0
) 
Page 99 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
16
CR-6267, v2.0
 
Page 100 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
17
CR-6267, v2.0
 
Page 101 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
18
CR-6267, v2.0
 
Page 102 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
19
CR-6267, v2.0
 
Page 103 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
20
CR-6267, v2.0
 
Page 104 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
21
CR-6267, v2.0
 
Page 105 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
22
CR-6267, v2.0
 
Page 106 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
23
CR-6267, v2.0
 
Page 107 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
24
CR-6267, v2.0
 
Page 108 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
25
CR-6267, v2.0
 
Page 109 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
26
CR-6267, v2.0
 
Page 110 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
27
CR-6267, v2.0
 
Page 111 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
28
CR-6267, v2.0
 
Page 112 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
29
CR-6267, v2.0
 
Page 113 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
30
CR-6267, v2.0
 
Page 114 of 218
JJVC CONFIDENTIAL

PRO SPECIFICATIO
n 1 Final  2018-04-03
Protocol 6267                 Johnson & Johnson Vision Care, Inc.                  Confidential
31
CR-6267, v2.0
) 
Page 115 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX B : PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide will be provided separately. 
CR-6267, v2.0
 
Page 116 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
ACUVUE OASYS® 
1-DAY ACUVUE® MOIST MULTIFOCAL 
1-DAY ACUVUE® MOIST 
CR-6267, v2.0
 
Page 117 of 218
JJVC CONFIDENTIAL

CR-6267, v2.0
 
Page 118 of 218
JJVC CONFIDENTIAL

 
CR-6267, v2.0
 
Page 119 of 218
JJVC CONFIDENTIAL

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:
0.084 mm to 0.230 mm (var
ies w
ith power)
CR-6267, v2.0
3
 
Page 122 of 218
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):
Low Near ADD (LOW): +1.25D
Med
ium Near ADD (MID): +1.75D
H
igh Near ADD (HGH): +2.50D
CR-6267, v2.0
4
 
Page 123 of 218
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
l
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 th, 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
CR-6267, v2.0
5
 
Page 124 of 218
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:
•  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-6267, v2.0
6
 
Page 125 of 218
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
•  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 
lenses and 
lens care products are essent
ia
l for the 
safe use of these products.
CR-6267, v2.0
7
 
Page 126 of 218
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
® 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
lect
ing the most appropr
iate type of 
lens for each 
pat
ient.
CR-6267, v2.0
8
 
Page 127 of 218
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:
•  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-6267, v2.0
9
 
Page 128 of 218
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?
•  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-6267, v2.0
10
 
Page 129 of 218
JJVC CONFIDENTIAL

ADVERSE REACTIONS
The patient should be informed that the following problems may occur 
when wearing contact lenses:
•  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-6267, v2.0
11
 
Page 130 of 218
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)
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 curvature measurements shou
ld be 
performed to estab
l
ish the pat
ient’s base
l
ine ocu
lar status. 
CR-6267, v2.0
12
 
Page 131 of 218
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)
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
less there 
is excess
ive res
idua
l ast
igmat
ism.
CR-6267, v2.0
13
 
Page 132 of 218
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.
TORIC FITTING GUIDELINES
CR-6267, v2.0
14
 
Page 133 of 218
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.
  
CR-6267, v2.0
15
 
Page 134 of 218
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
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-6267, v2.0
16
 
Page 135 of 218
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).
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-6267, v2.0
17
 
Page 136 of 218
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:
MULTIFOCAL FITTING GUIDELINES
CR-6267, v2.0
18
 
Page 137 of 218
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 sect
ion).
CR-6267, v2.0
19
 
Page 138 of 218
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.
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-6267, v2.0
20
 
Page 139 of 218
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.
MONOVISION FITTING GUIDELINES
CR-6267, v2.0
21
 
Page 140 of 218
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
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-6267, v2.0
22
 
Page 141 of 218
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 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-6267, v2.0
23
 
Page 142 of 218
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.
• Make use of proper 
i
l
lum
inat
ion when carry
ing out v
isua
l tasks.
CR-6267, v2.0
24
 
Page 143 of 218
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. 
WEARING SCHEDULE
CR-6267, v2.0
25
 
Page 144 of 218
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
LENS CARE DIRECTIONS
CR-6267, v2.0
26
 
Page 145 of 218
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
REPORTING OF ADVERSE REACTIONS
CR-6267, v2.0
27
 
Page 146 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
APPENDIX D: BINOCULAR OVER REFRACTION 
 
Binocular Over-refraction Technique 
 
1. Place trial frame on subject 
2. Add +1.00 D sphere to OS 
3. Add + 0.50DS OD and check VA 
 
      - 
if VA remained unchanged or improved, repeat step 3  
- 
if VA decreased, add minus until best VA first achieved *note: add minus for 0.5 
seconds to avoid reflex accommodation.  
4. Record VA 
5. Change +1.00 D sphere to OD 
6. Repeat steps 3 and 4 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 148 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
 
Presbyopic Symptoms Questionnaire 
 
1. Do you notice that you often have to hold things farther away so that you can read 
them? 
2. Do you notice that you often have difficulty focusing on near objects (i.e., 
experiencing blurry vision when looking at things close-up)? 
3. Do you often have headaches or eyestrain, or feel fatigued, when reading or 
conducting other near activities? 
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc.? 
5. Do you often have difficulty reading under dim or low light? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 149 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX G: TEST LENS FITTING GUIDE 
Step 1. 
Choose the first lens based on the best spherical equivalent refraction and ADD power for 
both eyes.   Select the first lens per table 1 below.   
 
Table 1.  Initial Lens Selection   
 
ADD 
 
 
 
 
 
 
 
 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
 
Non-
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
HGH 
 
HGH 
 
HGH 
 
Assess the subject’s vision at distance and near after the lens has settled (10 minutes).  If the 
vision is acceptable continue with the fit assessment and dispensing as per the protocol.   
 
If the vision is not acceptable, ensure that the proper initial lens power was selected by 
performing a distance over-refraction with +/- 0.25D trial lenses (or flippers) to determine if 
a change in the initial lens power is required (note:  the over-refraction should be performed 
outside of the phoropter in normal room illumination).  Recheck both distance and near 
vision with the over-refraction in place.  If a change in the initial lens power is not required 
refer to the fitting steps listed below in step 2 (table 2).   
 
Step 2. 
   
Table 2.  Lens change if required. * 
Distance 
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
ACUVUE® 
OASYS®       
2-WEEK 
Sphere  
ACUVUE®
OASYS®       
2-WEEK 
Sphere  
ACUVUE® 
OASYS®       
2-WEEK 
Sphere  
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID
+ 
 
MID
+ 
 
MID
+ 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 151 of 218
JJVC CONFIDENTIAL

 
 
 
 
Near  
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW+ 
 
LOW+ 
 
LOW+ 
 
MID+ 
 
MID+ 
 
HGH+ 
 
HGH+ 
 
HGH+ 
 
*Note:  a + following the contact lens design indicates to add +0.25 D to the distance contact 
lens power on the non-dominant eye (see example below).   
 
Example:  The subject is a +1.75 ADD and has a near complaint and it is determined a 
change in lens pairs is needed.  Referring to table 2 near complaint section, under 
the +1.75 ADD it states to keep the dominant eye the same (i.e. MID) and add 
+0.25D to the non-dominant eye (i.e. MID+).        
 
Subjects spherical equivalent distance refraction   
OD: +2.50 
OS:  +3.00 (OS non-dominant eye) 
 
The new lens chosen should be as follows: 
OD: +2.50 MID ADD (i.e. no change)  
OS:  +3.25 MID ADD 
 
Step 3.  
If after the above lens modifications have been attempted and the subject’s vision is still not 
satisfactory, and additional optimizations are allowed by the protocol, lens changes may be 
attempted, based on the Investigator’s clinical experience, to determine if acceptable vision 
can be achieved.   
   
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 152 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX H: CONTROL LENS FITTING GUIDE 
Step 1. 
Choose the first lens based on the best spherical equivalent refraction and ADD power for 
both eyes.   Select the first lens per table 1 below.   
 
Table 1.  Initial Lens Selection   
 
ADD 
 
 
 
 
 
 
 
 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
 
Non-
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
HGH 
 
HGH 
 
HGH 
 
Assess the subject’s vision at distance and near after the lens has settled (10 minutes).  If the 
vision is acceptable continue with the fit assessment and dispensing as per the protocol.   
 
If the vision is not acceptable, ensure that the proper initial lens power was selected by 
performing a distance over-refraction with +/- 0.25D trial lenses (or flippers) to determine if 
a change in the initial lens power is required (note:  the over-refraction should be performed 
outside of the phoropter in normal room illumination).  Recheck both distance and near 
vision with the over-refraction in place.  If a change in the initial lens power is not required 
refer to the fitting steps listed below in step 2 (table 2).   
 
Step 2. 
   
Table 2.  Lens change if required. * 
Distance 
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
1-Day 
ACUVUE® 
Moist 
 
 
1-Day 
ACUVUE® 
Moist 
 
 
1-Day 
ACUVUE® 
Moist 
 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID
+ 
 
MID
+ 
 
MID
+ 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 153 of 218
JJVC CONFIDENTIAL

 
 
 
 
Near  
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW+ 
 
LOW+ 
 
LOW+ 
 
MID+ 
 
MID+ 
 
HGH+ 
 
HGH+ 
 
HGH+ 
 
*Note:  a + following the contact lens design indicates to add +0.25 D to the distance contact 
lens power on the non-dominant eye (see example below).   
 
Example:  The subject is a +1.75 ADD and has a near complaint and it is determined a 
change in lens pairs is needed.  Referring to table 2 near complaint section, under 
the +1.75 ADD it states to keep the dominant eye the same (i.e. MID) and add 
+0.25D to the non-dominant eye (i.e. MID+).        
 
Subjects spherical equivalent distance refraction   
OD: -2.50 
OS:  -3.00 (OS non-dominant eye) 
 
The new lens chosen should be as follows: 
OD: -2.50 MID ADD (i.e. no change)  
OS:  -2.75 MID ADD 
 
Step 3.  
If after the above lens modifications have been attempted and the subject’s vision is still not 
satisfactory, and additional optimizations are allowed by the protocol, lens changes may be 
attempted based on the Investigator’s clinical experience, to determine if acceptable vision 
can be achieved.   
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 154 of 218
JJVC CONFIDENTIAL

 
 
 
 
APPENDIX I: 
 
 
 
• 
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
• 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
• 
 DETERMINATION OF NEAR ADD 
• 
 NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
• 
 LENS FITTING CHARACTERISTICS 
• 
 SUBJECT REPORTED OCULAR SYMPTOMS 
• 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
• 
 BIOMICROSCOPY SCALE 
• 
  KERATOMETRY 
• 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
• 
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
• 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 155 of 218
JJVC CONFIDENTIAL

 
 
 
 
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS 
 
 
CR-6267, v2.0
 
Page 156 of 218
JJVC CONFIDENTIAL

  
 
 
 
 
Page 3 of 7 
 
CR-6267, v2.0
 
Page 159 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 4 of 7 
 
CR-6267, v2.0
 
Page 160 of 218
JJVC CONFIDENTIAL

  
 
 
 
 
 
Page 5 of 7 
 
CR-6267, v2.0
 
Page 161 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 6 of 7 
 
CR-6267, v2.0
 
Page 162 of 218
JJVC CONFIDENTIAL

 
 
 
 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
 
CR-6267, v2.0
 
Page 164 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 
 
Page 4 of 4 
 
CR-6267, v2.0
 
Page 168 of 218
JJVC CONFIDENTIAL

 
 
 
 
 DETERMINATION OF NEAR ADDITION 
 
CR-6267, v2.0
 
Page 169 of 218
JJVC CONFIDENTIAL

Page 4 of 7 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
  
 
     
  
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
CR-6267, v2.0
 
Page 173 of 218
JJVC CONFIDENTIAL

Page 5 of 7 
 
 
 
  
 
 
 
 
  
 
 
                        
 
 
 
 
   
 
                         
 
 
 
   
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 174 of 218
JJVC CONFIDENTIAL

Page 7 of 7 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 176 of 218
JJVC CONFIDENTIAL

 
 
 
 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
CR-6267, v2.0
 
Page 177 of 218
JJVC CONFIDENTIAL

 
 
 
 
 LENS FITTING CHARACTERISTICS  
 
CR-6267, v2.0
 
Page 180 of 218
JJVC CONFIDENTIAL

Page 4 of 6 
 
 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 184 of 218
JJVC CONFIDENTIAL

Page 5 of 6 
 
 
 
 
CR-6267, v2.0
 
Page 185 of 218
JJVC CONFIDENTIAL

Page 6 of 6 
 
 
 
 
CR-6267, v2.0
 
Page 186 of 218
JJVC CONFIDENTIAL

 
 
 
 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
CR-6267, v2.0
 
Page 187 of 218
JJVC CONFIDENTIAL

 
 
 
 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
 
CR-6267, v2.0
 
Page 189 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
BIOMICROSCOPY SCALE 
 
CR-6267, v2.0
 
Page 196 of 218
JJVC CONFIDENTIAL

 
 
 
 
 KERATOMETRY PROCEDURE 
 
CR-6267, v2.0
 
Page 202 of 218
JJVC CONFIDENTIAL

 
 
 
 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
CR-6267, v2.0
 
Page 204 of 218
JJVC CONFIDENTIAL

 
 
 
 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE 
 
CR-6267, v2.0
 
Page 209 of 218
JJVC CONFIDENTIAL

 
 
 
 
 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
 
 
 
 
 
 
 
CR-6267, v2.0
 
Page 213 of 218
JJVC CONFIDENTIAL

 
 
 
  
 
Page 3 of 4 
 
CR-6267, v2.0
 
Page 216 of 218
JJVC CONFIDENTIAL

 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 4 of 4 
 
CR-6267, v2.0
 
Page 217 of 218
JJVC CONFIDENTIAL

 
 
 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
 
CR-6267 Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic 
Population 
 
Version and Date: 2.0 Amendment 1 22 June 2018 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and 
GCP guidelines regarding clinical trials during and after study completion. 
 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization. 
 
Principal 
Investigator: 
 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
 
Institution/Site: 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
Institution/Site Address 
 
 
 
CR-6267, v2.0
 
Page 218 of 218
JJVC CONFIDENTIAL