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

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population 
Phase II
Protocol CR-6372
Version: 2.0 Amendment 1
Date: 25 October 2019
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-6372, v 2.0
 
 
Page 1 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
TABLE OF CONTENTS
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 ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION ........................................................................... 20 
3.1. 
General Characteristics ............................................................................................ 20 
3.2. 
Inclusion Criteria ...................................................................................................... 20 
3.3. 
Exclusion Criteria ..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale ............................................................................................ 22 
4.3. 
Enrollment Target and Study Duration .................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 22 
5.1. 
Test Article Allocation ............................................................................................. 22 
5.2. 
Masking .................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION ............................................................................................. 23 
6.1. 
Identity of Test Articles............................................................................................ 23 
6.2. 
Ancillary Supplies/Products ..................................................................................... 24 
CR-6372, v 2.0
 
 
Page 2 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.3. 
Administration of Test Articles ................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 25 
6.5. 
Storage Conditions ................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS .............................................................................................. 27 
7.1. 
Time and Event Schedule ......................................................................................... 27 
7.2. 
Detailed Study Procedures ....................................................................................... 33 
VISIT 1 ........................................................................................................................... 33 
VISIT 2 ........................................................................................................................... 39 
VISIT 3 ........................................................................................................................... 44 
VISIT 4 ........................................................................................................................... 47 
VISIT 5 ........................................................................................................................... 52 
VISIT 6 ........................................................................................................................... 58 
FINAL EVALUATION .................................................................................................. 60 
7.3. 
Unscheduled Visits ................................................................................................... 61 
7.4. 
Laboratory Procedures ............................................................................................. 63 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 63 
8.1. 
Completion Criteria .................................................................................................. 63 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 63 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 64 
9.1. 
Systemic Medications .............................................................................................. 64 
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 .................................................................................... 69 
13.2.1. 
Causality Assessment .................................................................................... 69 
13.2.2. 
Severity Assessment ...................................................................................... 70 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 70 
13.4. 
Reporting Adverse Events .................................................................................... 71 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 71 
CR-6372, v 2.0
 
 
Page 3 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
72 
13.4.3. 
Event of Special Interest ............................................................................... 72 
13.5. 
Reporting of Pregnancy ........................................................................................ 73 
14. 
STATISTICAL METHODS ........................................................................................ 73 
14.1. 
General Considerations ......................................................................................... 73 
14.2. 
Sample Size Justification ...................................................................................... 73 
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 
15 
15.3  ClinicalTrials.gov ............................................................................................ 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. 
CLINICAL MONITORING ........................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 79 
18.1. 
Study-Specific Design Considerations ................................................................. 79 
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................................................................................ 82 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION ........................................................................................................... 83 
22. 
REFERENCES ............................................................................................................ 83 
CR-6372, v 2.0
 
 
Page 4 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 84 
APPENDIX B: PATIENT INSTRUCTION GUIDE  (To be provided separately) .......... 116 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 117 
APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 146 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 147 
APPENDIX F: OCULAR DOMINANCE............................................................................ 148 
APPENDIX G: LENS FITTING GUIDE ............................................................................. 149 
APPENDIX H: 
 .................................... 151 
LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS .................................. 152 
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING .................. 160 
 DETERMINATION OF NEAR ADDITION .................................................... 165 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE ....... 173 
 LENS FITTING CHARACTERISTICS ............................................................ 176 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ....................... 183 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
............................................................................................................................................... 185 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 191 
 BIOMICROSCOPY SCALE ............................................................................. 198 
 KERATOMETRY PROCEDURE ..................................................................... 204 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ........................ 206 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 211 
, PATIENT REPORTED OUTCOMES .............................................................. 215 
 WHITE LIGHT LENS SURFACE WETTABILITY ........................................ 217 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 219 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 225 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS
Table 1: Test Articles .............................................................................................................. 23 
Table 2: Ancillary Supplies .................................................................................................... 24 
Table 3: Time and Events ....................................................................................................... 27 
Table 4: Disallowed systemic medications (less than 6 months of continual use). ................ 64
CR-6372, v 2.0
 
 
Page 5 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL TITLE, NUMBER, VERSION
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 
II
Protocol Number:  CR-6372    
Version: 2.0 
Date: 25 October 2019    
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (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-6372, v 2.0
 
 
Page 6 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Clinical Evaluation of a Reusable Multifocal Optical Design 
in a Presbyopic Population Phase II
Sponsor
JJVC, 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 Products: JJV Investigational Multifocal 
Contact Lens manufactured in senofilcon A material.  
Approved Products: 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. The Test 
and Control lenses will also be replaced when lost or 
damaged
Objectives 
This primary objective of this pilot study is to evaluate the 
visual performance of the JJV Investigational senofilcon A 
Multifocal Contact Lens (Test) made using a new 
manufacturing process by comparison with 1-Day Acuvue®
Moist Brand Multifocal (Control). 
The secondary objective is to evaluate the clinical 
performance of the Test lens by comparisons with the control 
lens in the following areas: 
x
Vision (subjective) 
x
Comfort
x
Slit Lamp Findings
x
Patients’ reported ocular symptoms 
Study Endpoints
Primary Endpoints:
Binocular distance, intermediate and near visual performance 
under different lighting conditions. 
Secondary Endpoints: 
x
Overall quality of vision scores on CLUE scale 
x
Overall comfort scores on CLUE scale
x
Subject reported ocular symptoms 
x
Slit Lamp Findings
CR-6372, v 2.0
 
 
Page 9 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Study Design
This is a randomized-controlled, single-masked, crossover 
clinical trial.  There are two study lenses. Each lens will be 
dispensed for 3 ± 1 days and then an optimization visit will 
occur.  The final lens pair will be dispensed for 12 ± 2 days 
and the follow-up on the final lens pair will occur. The 
second study lenses will then be fit and the above sequence 
repeated.  
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
Up to 48 subjects will be enrolled  with a target completion 
of 40 subjects.
Study Duration
The study will last approximately 2-4 months.
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 
Inclusion Criteria after Screening: 
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol.
3. The subject must be at least 40 years of age and not 
greater than 70 years of age at the time of consent.
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
5. 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). 
6. 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”.
CR-6372, v 2.0
 
 
Page 10 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction 
must be in the range of +1.25 D to +3.75 D in each 
eye.
8. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH D in 
each eye.
9. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual 
acuity of 20/20-3 or better in each eye. 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
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 syndrome, and immunosuppressive diseases 
or any infectious diseases (e.g. hepatitis, tuberculosis).
4. Any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular 
vision abnormality. 
6. Use of any of the following medications within 1 week 
prior to enrollment: oral retinoid isotretinoin (e.g. 
Accutane), oral tetracyclines, oral phenothiazines, 
oral/topical/inhaled anticholinergics, systemic/topical
corticosteroids. 
7. Use of any ocular medication, with the exception of 
rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye.
11. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment.
12. Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician).
CR-6372, v 2.0
 
 
Page 11 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13. Any known hypersensitivity or allergic reaction to 
Optifree®Replenish® multi-purpose care solution, 
sodium fluorescein or  non-preserved  rewetting drop 
solutions. 
Exclusion Criteria after Baseline: 
14. Clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, 
tarsal abnormalities or bulbar injection, or any other 
corneal or ocular abnormalities which would 
contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, glaucoma, history of recurrent corneal 
erosions. 
16. Any current ocular infection or inflammation. 
17. Any current ocular abnormality that may interfere 
with contact lens wear.
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.  
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
See Section 7.2 for the detailed procedures.
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product. In the event of a 
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled.
Ancillary Supplies/ Study-
Specific Materials
Rewetting drops, lens cases, glass vials, saline, Early 
Treatment Diabetic Retinopathy Study (ETDRS) light 
cabinet, logMAR charts, and Near logMAR charts. 
Optifree®Replenish® Multipurpose Disinfecting 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-6372, v 2.0
 
 
Page 12 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
CR-6372, v 2.0
 
 
Page 14 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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-6372, v 2.0
 
 
Page 15 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
1.
INTRODUCTION AND BACKGROUND
Johnson & Johnson Vision (JJV) 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, 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 
Investigational senofilcon A multifocal lens refer to the Investigator Brochure.  Additional 
CR-6372, v 2.0
 
 
Page 16 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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
JJV has evaluated the test lenses in the previous clinical studies:
A summary of these studies is listed below.
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.  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. 
was a dispensing parallel-ARM study and had a primary endpoint of logMAR visual 
acuity. There were 149 subjects that completed the study overall with 37 subjects completing 
in the ARM involving the study lenses that will be used in this study.  The lenses displayed 
clinically acceptable logMAR visual acuity after approximately 2 weeks of wear with the mean 
bright high contrast binocular logMAR acuity of -0.077, -0.083 and 0.049 for distance, 
intermediate and near respectively.  
 had four parallel ARMs with one of the ARMs being the test lenses evaluated in this 
study along with two other investigational test lenses and a control lens.  For the ARM with 
the lenses tested in this study there were no ocular adverse events reported and one non-ocular 
that was not related to the test article. 
was a dispensing crossover study on myope subjects and had a primary endpoint of 
subject vision response. There were 53 subjects that completed the study as cohort.  The test
lenses displayed clinically acceptable logMAR visual acuity after approximately 2 weeks of 
wear with the mean bright high contrast binocular logMAR acuity of -0.11, -0.07 and 0.06 for 
distance, intermediate and near respectively.  There was one adverse event in the study that 
was a non-significant temporal conjunctival hyperemia in the right eye after removal of their 
lenses. The event resolved without any treatment.
was a dispensing crossover study on hyperope subjects and had a primary endpoint 
of subject vision response. There were 59 subjects that completed the study as cohort.  The test
lenses displayed clinically acceptable logMAR visual acuity after approximately 2 weeks of 
wear with the mean bright high contrast binocular logMAR acuity of -0.05, -0.02 and 0.11 for 
distance, intermediate and near respectively.  One subject had a non-ocular serious adverse 
event of dehydration of moderate severity and received treatment for this event. Although the 
event was reported as resolved, the subject was permanently discontinued the study. The 
investigator considered the event to be not related to the study article/study procedure. Three 
episodes of ocular adverse events were reported. One subject had an ocular AE of non-
CR-6372, v 2.0
 
 
Page 17 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Secondary Endpoints: 
x
Overall quality of vision scores on CLUE scale 
x
Overall comfort scores on CLUE scale
x
Subject reported ocular symptoms 
x
Slit Lamp Findings
Other Endpoints(s)  
x
Lens fitting characteristics (lens centration, lens movement, overall lens fitting 
acceptability)
x
Average daily wear time (in Hours) 
x
Corneal staining 
x
Ocular redness (bulbar and limbal) 
x
Summary of number of lenses needed to fit (optimize) the subject
x
Lens deposits 
x
Overall handling scores on CLUE scale 
x
Product performance survey questionnaire  
Adverse events, number and reasons for discontinuation, number and reasons for unscheduled. 
lens replacement including lens damage will be monitored and descriptively evaluated. 
CLUE™is a validated patient reported outcomes (PRO) questionnaire to assess patient-
experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a 
contact-lens wearing population in the US, ages 18-65. Derived CLUE™ scores using Item 
Response Theory (IRT) follow a normal distribution with a population average score of 60 
(SD 20), where higher scores indicate a more favorable/positive response with a range of 0-
120. A 5-point increase in an average CLUE™ score translates into 10% shift in the 
distribution of scores for population of soft contact lens wearers.7
2.3.
Hypotheses
Primary Hypotheses:
The Test lens will be non-inferior to the Control lens with respect to binocular contact lens-
corrected visual performance at near, intermediate and distance under high luminance high 
contrast, Dim luminance high contrast and high luminance low contrast conditions. A non-
inferiority margin of 0.05 on logMAR scale will be used. 
Secondary Hypotheses:
No secondary hypotheses will be tested. All secondary endpoints will be evaluated with 
summary tables (see Section 14 for more details). The following will be calculated: 
x
Average (SD) comfort scores on CLUE scale by study lens at each follow-up visit 
x
Proportion of eyes with clinically significant (Grade 3 or 4) slit lamp findings. 
x
Proportion of eyes with reported ocular symptoms.  
CR-6372, v 2.0
 
 
Page 19 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening: 
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. The subject must be at least 40 years of age and not greater than 70 years of age at the 
time of consent. 
4. Subjects must own a wearable pair of spectacles if required for their distance vision.
5. 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 or more 
duration). 
6. 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” (Appendix E). 
Inclusion Criteria after Baseline: 
7. The subject’s distance spherical equivalent refraction must be in the range of +1.25 D 
to +3.75 D in each eye.
8. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH D in each eye.
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in 
each eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.  
CR-6372, v 2.0
 
 
Page 20 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 syndrome, and immunosuppressive diseases or any infectious diseases (e.g. 
hepatitis, tuberculosis). 
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular vision abnormality. 
6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid 
isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines, oral/topical/inhaled
anticholinergics, systemic/topical corticosteroids. 
7. Use of any ocular medication, with the exception of rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment.
12. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
13. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multi-
purpose care solution, sodium fluorescein or non-preserved rewetting drop solutions. 
Exclusion Criteria after Baseline: 
14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact lens wear. 
15. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions.
16. Any current ocular infection or inflammation. 
17. Any current ocular abnormality that may interfere with contact lens wear.
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
The clinical study is a randomized-controlled, single-masked, cross-over clinical trial.  There 
are two study lenses. Each lens will be dispensed for 3±1 days and an optimization visit will 
occur.  The final lens pair will be dispensed for 12±2 days and the follow-up on the final lens 
pair will occur. The second study lenses will then be fit and the above sequence repeated.  
CR-6372, v 2.0
 
 
Page 21 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.   
The cross-over study design was chosen to control for variables that may impact the lens 
performance between subjects.  A washout period will be used to minimize the chances of a
significant carry over effect impacting the primary/secondary endpoints measured in the study.
4.3.
Enrollment Target and Study Duration
Up to 48 eligible subjects will be enrolled with 40 targeted to complete the study.  The 
anticipated study duration is approximately 3 months.
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.
Randomization must be performed at the initial visit. The following must have occurred prior 
to randomization: 
• Informed consent has been obtained 
• It has been determined that the subject meets all the inclusion / exclusion criteria
• Subject history and baseline information has been collected 
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 (partial) study with the subjects being masked. Subjects will be aware 
that there are differences in modalities between lens types however they will not be told 
anything regarding the optical design other than the design is intended to correct for their 
spherical refractive error and presbyopia.  Subjects will be unaware of the identity of the
assigned investigational products. Investigators and clinical site personnel involved in the data 
collection will be aware of the identity of the assigned investigational products.  
CR-6372, v 2.0
 
 
Page 22 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.4.
Packaging and Labeling
The test articles will be packaged in blisters, as the primary packaging. The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic bags 
as the secondary packaging form. The sample study label is shown below: 
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
CR-6372, v 2.0
 
 
Page 25 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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-6372, v 2.0
 
 
Page 26 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
read a book, magazine or similar for near 
vision.  
1.25
Study Lens Distance 
and Near Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
Note: Use the ETDRS 2000 Series Chart 1 or 
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
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
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
Appendix 
G (Fitting 
Guide) 
CR-6372, v 2.0
 
 
Page 36 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 1.21-1.27 
will be repeated for each modification. 
1.29
Post-Fit PRO (MRD)
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.
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
1.32
Patient Instructions
for Daily Disposable 
Lenses (if 
applicable)
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
CR-6372, v 2.0
 
 
Page 37 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses. 
x
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. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
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 (if 
applicable)
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
CR-6372, v 2.0
 
 
Page 38 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Note: Subjects must have worn lenses for at 
least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
2.4
PRO (CLUE) 
Questionnaire   
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
questionnaire.  
2.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
2.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
2.7
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU to the nearest letter.  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.
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 
Appendix G
(Fitting
Guide)  
CR-6372, v 2.0
 
 
Page 40 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
If any of these slit lamp findings are Grade 3
or higher, an AE must be recorded. All AEs 
must be followed to resolution.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
2.14
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.12 above.  
2.15
PRO (MRD)
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
questionnaire.
2.16
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.
2.17
Dispensing Criteria
The lenses will be dispensed for 10-14 days.
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
2.18
Patient Instructions
for Daily 
Disposable Lenses
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
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. 
CR-6372, v 2.0
 
 
Page 42 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses. 
x
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. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
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:
x
The lenses will be worn on a daily wear 
basis.  
x
OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
CR-6372, v 2.0
 
 
Page 43 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
(40 cm).
Note:
x
The room illuminance must be between 
7.3 and 7.9 EV (394-597 lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV (181-
208 cd/m2). 
x
Guillon-Poling, Near Chart Luminance 
Acceptable Range 10.8-11.1 EV (223-
274 cd/m2). 
x
Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles)
3.9
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
3.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
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. 
3.11
Lens Deposits
Grade and record the amount of front and 
back surface lens deposits for both eyes.
3.12
Lens Wettability
Grade the wettability of the lenses.
3.13
Collection of 
unworn lenses (if 
applicable)
Collect unworn lenses returned by the 
subject.
CR-6372, v 2.0
 
 
Page 46 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
4.9
Lens Insertion
Subjects will insert the lenses themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be 
shipped back to the Sponsor. Complete the 
Quality Product Complaint form.
4.10
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
4.11
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.  
4.12
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.
4.13
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.   
4.14
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: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
CR-6372, v 2.0
 
 
Page 49 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
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.
4.15
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.   
If modifications are required steps 4.8-4.14 
will be repeated for each modification
Appendix 
G (Fitting 
Guide) 
4.16
Post-Fit PRO (MRD) 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire.
4.17
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. 
4.18
Dispensing Criteria
The lenses will be dispensed for 2-4 days.
CR-6372, v 2.0
 
 
Page 50 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
4.19
Patient Instructions 
for Daily Disposable 
Lenses (if 
applicable)
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
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. 
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses. 
x
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. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
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.
CR-6372, v 2.0
 
 
Page 51 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
5.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit. 
Record any adverse events or medical history 
changes from the previous study visit.
5.2
Wear time and 
Comfortable Wear 
time with Study 
lenses
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
5.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
Note: Subjects must have worn lenses for at 
least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
5.4
PRO (CLUE)
Questionnaire  
The subject will evaluate the vision 
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 subject’s 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.   
CR-6372, v 2.0
 
 
Page 53 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 and steps 4.8-4.14 in 
Visit 4 Fitting, allowing for at least 10 
minutes of settling time between each lens 
modification.
Appendix G
(Fitting 
Guide)  
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 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
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. 
5.11
Collection of 
unworn lenses (if 
applicable)
Collect unworn lenses returned by the subject 
when lens power has been optimized  
Note: If lens power was not changed allow 
the subject to use the unworn lenses 
dispensed at Visit 4 and dispense enough 
CR-6372, v 2.0
 
 
Page 54 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Lenses must have an acceptable general 
lens fit.
5.18
Patient Instructions 
for Daily 
Disposable Lenses
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.
x
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. 
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses. 
x
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. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
 
 
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.
5.19
Patient Instructions 
for Daily Reusable 
Wear Lenses
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
CR-6372, v 2.0
 
 
Page 56 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
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 12±2 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-6372, v 2.0
 
 
Page 57 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts  
Intermediate (64 cm) High Contrast and Low 
Contrast
Near (40 cm) High Contrast and Low 
Contrast
Distance, Dim Illuminance (with Distance
goggles) 
High Contrast ETDRS Charts  
4M-HC#4, HC#5, HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm). 
Note:
x
The room illuminance must be between 
7.3 and 7.9 EV (394-597 lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV (181-
208 cd/m2). 
x
Guillon-Poling, Near Chart Luminance 
Acceptable Range 10.8-11.1 EV (223-
274 cd/m2). 
x
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: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
CR-6372, v 2.0
 
 
Page 59 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study then it must be reported to IEC/IRB. This is a "Major Deviation".   
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation. 
Protocol waivers are prohibited 
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
CR-6372, v 2.0
 
 
Page 65 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (
for test article return instructions).
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 
CR-6372, v 2.0
 
 
Page 66 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1
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 adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function 
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x
Chronic disease
x
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
CR-6372, v 2.0
 
 
Page 67 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other Grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
CR-6372, v 2.0
 
 
Page 68 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements.
CR-6372, v 2.0
 
 
Page 70 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
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 
CR-6372, v 2.0
 
 
Page 71 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately. 
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.4.3. Event of Special Interest
None 
CR-6372, v 2.0
 
 
Page 72 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data will 
not be collected as part of the clinical study database. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
All data summaries and statistical analyses will be performed using the SAS software version 
9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each subject/eye 
will be used when available for summarization and statistical analysis.  Unscheduled visits will 
be summarized separately and will be excluded from the statistical analysis.
Summary tables (Descriptive statistics and/or frequency tables) will be provided by lens type 
for all baseline variables, efficacy variables and safety variables as appropriate. Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD],
median, minimum and maximum). Frequency count and percentage of subjects or eyes within 
each category will be provided for categorical data.
14.2. Sample Size Justification
The study was powered to demonstrate non-inferiority of the Test lens relative to the Control 
with respect to binocular visual performance with minimum of 90% power and two-sided type 
I error of 5%.   Assuming no difference between Test and Control, the required sample size to 
achieve non-inferiority for distance, intermediate and near visual performance at different 
lighting conditions are summarized in Table 5. The intra-class correlation (ICC) and standard 
deviations (STD) used in the sample size calculations were from a similar study (CR6267).
The sample size calculations were conducted using the SAS procedure PROC POWER for 
paired t-test.
Table 5: Required sample to achieve non-inferiority
Distance
Lighting Condition
STD
Test
STD 
Control
ICC
Sample 
Size 
Distance
High Luminance High Contrast
0.091
0.094
0.60
31
High Luminance Low Contrast
0.091
0.105
0.68
29
Low Luminance High Contrast 
with Distance Goggles
0.101 
0.092 
0.64 
31
CR-6372, v 2.0
 
 
Page 73 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Intermediate
High Luminance High Contrast
0.095
0.116
0.68
34
High Luminance Low Contrast
0.107
0.129
0.71
38
Low Luminance High Contrast 
with Near Goggles
0.125 
0.152 
0.81 
36
Near
High Luminance High Contrast
0.086
0.113
0.63
36
High Luminance Low Contrast
0.103
0.130
0.69
40
Low Luminance High Contrast 
with Near Goggles
0.115 
0.137 
0.73 
40
STD: standard deviation, ICC: intra-class correlation
After adjusting for 7% drop-outs or lost to follow-up, the plan is to enroll 48 subjects with a 
target completion of 40 subjects.  
14.3. Analysis Populations 
The following analysis populations will be defined and used in the analysis and presentation 
of the data.  
 
All Enrolled:  
All Enrolled Population includes all subjects with recorded data in the electronic Case Report 
Form (eCRF) database  
 
Intent-To-Treat (ITT):  
Intent-to-treat will include all the subjects who were randomized to study treatment. Subjects 
will be analyzed as per randomized treatment. At least one observation should be 
recorded. Discontinued subjects, subjects with major protocol deviations and ineligible 
subjects who were inadvertently randomized will be included in the ITT analyses.  
 
Safety Population:  
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation for safety endpoints should be recorded 
(e.g. ocular symptom, slit-lamp finding, etc.) or on after treatment start date. Subjects will be 
analyzed as per treatment received.  
 
Per Protocol (PP)  
All subjects who have successfully completed the study and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification of excluding subjects with protocol deviations from the per-protocol population 
set will be documented in a memo to file.
The primary analysis will be conducted on the per-protocol population. A sensitivity analysis 
will be conducted on the ITT population.  
CR-6372, v 2.0
 
 
Page 74 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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  
Visual Performance:
Binocular visual performance at 2-week follow-up visit will be analyzed separately by lighting 
condition and distance using a Bayesian repeated measurement random-effects model to 
compare between Test and Control lenses.  Each regression model will include baseline values, 
lens type, lens wearing sequence and lens wearing period as fixed effects and investigational 
site as random effect.  Other subject characteristics such as age, gender will be included as 
fixed effects when appropriate.  Unstructured covariance matrix will be used to model the 
residual errors among observations within subjects.  Non informative prior distributions will 
be used for the coefficients in the models as well as for the error terms.  Independent vague 
normal N(0,1000) priors will be used for the regression coefficients, inverse gamma IG(0.001, 
0.001) for the variance of the random effect site and inverse Wishart for the residual errors.  A 
Markov-Chain Monte Carlo (MCMC) sampling algorithm will be used to carry out the 
marginal posterior distributions of the parameters.  Results will be reported as regression 
coefficient mean estimates with 95% credible intervals.
 The null and alternative hypotheses for non-inferiority of Test lens relative to Control are as
follows: 
ܪ0: ǻ!
ܪܣ: ǻ
ZKHUHǻLVWKHSRVWHULRUPHDQGLIIHUHQFHLQYLVXDOSHUIRUPDQFHEHWZHHQ7HVWDQG&RQWURO7HVW
minus Control).  Non-inferiority will be declared if the upper bound of the credible interval of 
the posterior mean difference is less than 0.05.   
The primary analysis will be conducted on the per-protocol population. A sensitivity analysis 
will be conducted on the ITT population. 
14.6. Secondary Analysis 
All secondary endpoints will be summarized with descriptive statistics at baseline and follow-
up visits for each study lens type. Safety variables will be summarized on safety population 
and efficacy variables on both per-protocol and ITT populations.  
14.7. Other Exploratory Analyses  
Comfort and Vision CLUE Scores
CLUE comfort and vision CLUE scores will be analyzed separately using the same statistical 
PHWKRGGHVFULEHGLQWKHSULPDU\ DQDO\VLV 3RVWHULRU PHDQ GLIIHUHQFHVįLQ&/8(VFRUHV
between Test and Control will be calculated with 95% credible intervals. The probability of 
achieving non-inferiority using a margin of -5 point in the CLUE scale, 3Uį-5 | data), will 
be calculated.
CR-6372, v 2.0
 
 
Page 75 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Further exploratory analysis will be conducted if necessary, at the discretion of the Study 
Responsible Clinician. 
14.8. Interim Analysis
No interim analysis is planned in this study
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis may be conducted using 
multiple imputation methods.
The SAS/STAT procedures PROC MI and PROC 
MIANALYZE will be utilized with a parametric regression method used to make at least 20 
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 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 JJVC database manager and sent to JJVC for analysis.  
External Data Sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
CR-6372, v 2.0
 
 
Page 76 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
15
15.3 ClinicalTrials.gov  
This trial will be registered on clincaltrials.gov 
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
CR-6372, v 2.0
 
 
Page 77 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
CR-6372, v 2.0
 
 
Page 78 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
CR-6372, v 2.0
 
 
Page 79 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current 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. 
CR-6372, v 2.0
 
 
Page 80 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
CR-6372, v 2.0
 
 
Page 81 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
CR-6372, v 2.0
 
 
Page 82 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. EU MDR 2017/745 
7. Wirth, R.J., et al., Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci, 2016. 93(8): p. 801-8. 
CR-6372, v 2.0
 
 
Page 83 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
CR-6372, v 2.0
 
 
Page 84 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
1
CR-6372, v 2.0
 
 
Page 85 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
2
CR-6372, v 2.0
 
 
Page 86 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
3
CR-6372, v 2.0
 
 
Page 87 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
4
CR-6372, v 2.0
 
 
Page 88 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
5
CR-6372, v 2.0
 
 
Page 89 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
6
CR-6372, v 2.0
 
 
Page 90 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
7
CR-6372, v 2.0
 
 
Page 91 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
8
CR-6372, v 2.0
 
 
Page 92 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
9
CR-6372, v 2.0
 
 
Page 93 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
10
CR-6372, v 2.0
 
 
Page 94 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
11
CR-6372, v 2.0
 
 
Page 95 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
12
CR-6372, v 2.0
 
 
Page 96 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
13
CR-6372, v 2.0
 
 
Page 97 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
14
CR-6372, v 2.0
 
 
Page 98 of 225
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
15
CR-6372, v 2.0
 
 
Page 99 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
16
CR-6372, v 2.0
 
 
Page 100 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
17
CR-6372, v 2.0
 
 
Page 101 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
18
CR-6372, v 2.0
 
 
Page 102 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
19
CR-6372, v 2.0
 
 
Page 103 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
20
CR-6372, v 2.0
 
 
Page 104 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
21
CR-6372, v 2.0
 
 
Page 105 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
22
CR-6372, v 2.0
 
 
Page 106 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
23
CR-6372, v 2.0
 
 
Page 107 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
24
CR-6372, v 2.0
 
 
Page 108 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
25
CR-6372, v 2.0
 
 
Page 109 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
26
CR-6372, v 2.0
 
 
Page 110 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
27
CR-6372, v 2.0
 
 
Page 111 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
28
CR-6372, v 2.0
 
 
Page 112 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
29
CR-6372, v 2.0
 
 
Page 113 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
30
CR-6372, v 2.0
 
 
Page 114 of 225
JVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
31
CR-6372, v 2.0
 
 
Page 115 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE 
(TO 
BE 
PROVIDED 
SEPARATELY)
CR-6372, v 2.0
 
 
Page 116 of 225
JVC 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)
3
CR-6372, v 2.0
 
 
Page 119 of 225
JVC 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
4
CR-6372, v 2.0
 
 
Page 120 of 225
JVC 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
5
CR-6372, v 2.0
 
 
Page 121 of 225
JVC 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).
6
CR-6372, v 2.0
) 
 
Page 122 of 225
JVC 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.
7
CR-6372, v 2.0
 
 
Page 123 of 225
JVC 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.
8
CR-6372, v 2.0
) 
 
Page 124 of 225
JVC 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.
9
CR-6372, v 2.0
 
 
Page 125 of 225
JVC 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.
10
CR-6372, v 2.0
 
 
Page 126 of 225
JVC 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.
11
CR-6372, v 2.0
 
 
Page 127 of 225
JVC 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. 
12
CR-6372, v 2.0
) 
 
Page 128 of 225
JVC 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.
13
CR-6372, v 2.0
 
 
Page 129 of 225
JVC 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
14
CR-6372, v 2.0
 
 
Page 130 of 225
JVC CONFIDENTIAL

     Figure 1
You’
l
l need a s
l
it 
lamp b
iom
icroscope w
ith a 1 to 2 mm para
l
le
lep
iped 
beam to h
igh
l
ight the marks when the 
lens 
is ﬁ
 tted to the eye. There are a 
number of techn
iques you can use to 
improve the v
is
ib
i
l
ity of the 6 o’c
lock 
mark. Us
ing a para
l
le
lep
iped beam and med
ium magn
iﬁ
 cat
ion (10x or 15x), 
s
low
ly pan down the 
lens, 
look
ing 
just be
low the d
irect 
i
l
lum
inat
ion at the 
retro
i
l
lum
inated area. Back
l
ight
ing the mark th
is way shou
ld make 
it more 
v
is
ib
le. Somet
imes man
ipu
lat
ing the 
lower 
l
id may be necessary to uncover 
the mark.
2.  Observe Lens Rotation and Stability 
Observe the pos
it
ion and stab
i
l
ity of the “bottom” mark. It usua
l
ly stab
i
l
izes 
at the 6 o’c
lock pos
it
ion. If 
it does, ca
lcu
lat
ion of the 
lens power w
i
l
l be 
stra
ightforward. The 6 o’c
lock pos
it
ion 
is not a “must”; however
, the 
abso
lute requ
irement 
is that the ax
is pos
it
ion be stab
le and repeatab
le. 
The mark may stab
i
l
ize somewhat 
left or r
ight (dr
ift) of the vert
ica
l mer
id
ian 
and st
i
l
l enab
le you to ﬁ
 t a tor
ic 
lens for that eye, as 
long as the 
lens a
lways 
returns to the same “dr
ift ax
is” pos
it
ion after sett
l
ing. The dev
iat
ion can 
be compensated for 
in the ﬁ
 na
l prescr
ipt
ion. Your ob
ject
ive 
is to ensure 
that whatever pos
it
ion the 
in
it
ia
l 
lens assumes near 6 o’c
lock, th
is pos
it
ion 
must be stab
le and repeatab
le. W
ith fu
l
l eye movement or heavy b
l
ink, you 
may see the marks sw
ing away
, but they must return qu
ick
ly to the or
ig
ina
l 
stab
le pos
it
ion. If the 
lens does not return qu
ick
ly
, you may need to se
lect 
a d
ifferent 
lens. 
3.  Assessing Rotation 
Imag
ine the eye as a c
lock d
ia
l and every hour represents a 30° 
interva
l. If 
the or
ientat
ion mark of the 
in
it
ia
l 
lens stab
i
l
izes somewhat 
left or r
ight of the 
vert
ica
l pos
it
ion, the ﬁ
 na
l 
lens w
i
l
l or
ient on the eye w
ith the same dev
iat
ion. 
You can use an ax
is ret
icu
le 
in the s
l
it 
lamp or use a 
l
ine-scr
ibed 
lens 
in a 
spectac
le tr
ia
l frame to measure or est
imate the “dr
ift ang
le” of the cy
l
inder 
ax
is. 
To compensate for th
is “dr
ift,” measure or est
imate the “dr
ift,” then add 
or subtract 
it from the refract
ive ax
is to determ
ine the correct cy
l
inder 
ax
is. Use the LARS (Left Add, R
ight Subtract) method to determ
ine wh
ich 
d
irect
ion to compensate.
  
15
CR-6372, v 2.0
 
 
Page 131 of 225
JVC 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°
16
CR-6372, v 2.0
 
 
Page 132 of 225
JVC 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.
17
CR-6372, v 2.0
 
 
Page 133 of 225
JVC 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
18
CR-6372, v 2.0
 
 
Page 134 of 225
JVC 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).
19
CR-6372, v 2.0
 
 
Page 135 of 225
JVC 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.
20
CR-6372, v 2.0
 
 
Page 136 of 225
JVC 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
21
CR-6372, v 2.0
 
 
Page 137 of 225
JVC 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. 
22
CR-6372, v 2.0
 
 
Page 138 of 225
JVC 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.
23
CR-6372, v 2.0
 
 
Page 139 of 225
JVC 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.
24
CR-6372, v 2.0
 
 
Page 140 of 225
JVC 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
25
CR-6372, v 2.0
 
 
Page 141 of 225
JVC 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
26
CR-6372, v 2.0
 
 
Page 142 of 225
JVC 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
27
CR-6372, v 2.0
 
 
Page 143 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
CR-6372, v 2.0
 
 
Page 145 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: BINOCULAR OVER REFRACTION
CR-6372, v 2.0
 
 
Page 146 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE
CR-6372, v 2.0
 
 
Page 147 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: OCULAR DOMINANCE
CR-6372, v 2.0
 
 
Page 148 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
CR-6372, v 2.0
 
 
Page 152 of 225
JVC CONFIDENTIAL

Attachment A  Efron Grading Scale for Limbal Redness (0.5 unit increments)
Page 3 of 7 
 CR-6372, v 2.0
 
 
Page 155 of 225
JVC CONFIDENTIAL

Attachment B
Efron Grading Scale for Limbal Redness (1.0 unit increments)
Page 4 of 7 
 CR-6372, v 2.0
 
 
Page 156 of 225
JVC CONFIDENTIAL

Attachment C  Efron Grading Scale for Bulbar Redness (0.5 unit increments)
Page 5 of 7 
 CR-6372, v 2.0
 
 
Page 157 of 225
JVC CONFIDENTIAL

Attachment D
Efron Grading Scale for Bulbar Redness (1.0 unit increments)
Page 6 of 7 
 CR-6372, v 2.0
 
 
Page 158 of 225
JVC CONFIDENTIAL

Attachment E
Page 7 of 7 
 CR-6372, v 2.0
 
 
Page 159 of 225
JVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
CR-6372, v 2.0
 
 
Page 160 of 225
JVC CONFIDENTIAL

 
Page 3 of 4 
 
    
  
CR-6372, v 2.0
 
 
Page 163 of 225
JJVC CONFIDENTIAL

 
Page 4 of 4 
 CR-6372, v 2.0
 
 
Page 164 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DETERMINATION OF NEAR ADDITION
CR-6372, v 2.0
 
 
Page 165 of 225
JJVC CONFIDENTIAL

Page 4 of 7
    
CR-6372, v 2.0
 
 
Page 169 of 225
JJVC CONFIDENTIAL

Page 5 of 7
  
                        
           
CR-6372, v 2.0
 
 
Page 170 of 225
JJVC CONFIDENTIAL

Page 6 of 7
CR-6372, v 2.0
 
 
Page 171 of 225
JJVC CONFIDENTIAL

Page 7 of 7
Attachment B 
CR-6372, v 2.0
 
 
Page 172 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
CR-6372, v 2.0
 
 
Page 173 of 225
JJVC CONFIDENTIAL

 
Page 2 of 2 
 
 
 
CR-6372, v 2.0
 
 
Page 175 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
LENS FITTING CHARACTERISTICS
CR-6372, v 2.0
 
 
Page 176 of 225
JJVC CONFIDENTIAL

Page 4 of 6 
 
Attachment A
Example of Lens Centration Rating
 
 
 
 
 
 
 
 
 
 
 
CR-6372, v 2.0
 
 
Page 180 of 225
JJVC CONFIDENTIAL

Page 5 of 6 
 
Attachment B
Example of Evaluation of Primary Gaze Movement
 
CR-6372, v 2.0
 
 
Page 181 of 225
JJVC CONFIDENTIAL

Page 6 of 6 
 
 
 
 
 
 
 
 
CR-6372, v 2.0
 
 
Page 182 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
CR-6372, v 2.0
 
 
Page 183 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE
CR-6372, v 2.0
 
 
Page 185 of 225
JJVC CONFIDENTIAL

Page 2 of 5 
 
 
 
 
 
 
  
 
 
 
CR-6372, v 2.0
 
 
Page 187 of 225
JJVC CONFIDENTIAL

Page 4 of 5 
 
Attachment B 
CR-6372, v 2.0
 
 
Page 189 of 225
JJVC CONFIDENTIAL

Page 5 of 5 
 
Attachment C 
CR-6372, v 2.0
 
 
Page 190 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
CR-6372, v 2.0
 
 
Page 191 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
BIOMICROSCOPY SCALE
CR-6372, v 2.0
 
 
Page 198 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
KERATOMETRY PROCEDURE 
CR-6372, v 2.0
 
 
Page 204 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DISTANCE AND NEAR VISUAL ACUITY EVALUATION
CR-6372, v 2.0
 
 
Page 206 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT
PROCEDURE
CR-6372, v 2.0
 
 
Page 211 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PATIENT REPORTED OUTCOMES
CR-6372, v 2.0
 
 
Page 215 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
WHITE LIGHT LENS SURFACE WETTABILITY
CR-6372, v 2.0
 
 
Page 217 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
CR-6372, v 2.0
 
 
Page 219 of 225
JJVC CONFIDENTIAL

 
 
Title:
Visual Acuity Chart Luminance and Room Illumination Testing
 
Page 1 of 5
 
CR-6372, v 2.0
 
 
Page 220 of 225
JJVC CONFIDENTIAL

 
 
Title:
Visual Acuity Chart Luminance and Room Illumination Testing
 
Page 2 of 5
 
CR-6372, v 2.0
 
 
Page 221 of 225
JJVC CONFIDENTIAL

 
 
Title:
Visual Acuity Chart Luminance and Room Illumination Testing
 
Page 4 of 5
 
APPENDIX A: CHART LUMINANCE VERIFICATION LOG
CR-6372, v 2.0
 
 
Page 223 of 225
JJVC CONFIDENTIAL

 
 
Title:
Visual Acuity Chart Luminance and Room Illumination Testing
 
Page 5 of 5
 
APPENDIX C: CONVERSION TABLE FOR “EV’ TO “LUX” FOR ROOM ILLUMINATION
CR-6372, v 2.0
 
 
Page 224 of 225
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6372 Clinical Evaluation of a Reusable Multifocal Optical 
Design in a Presbyopic Population Phase II 
Version and Date: 2.0 25 October 2019 
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-6372, v 2.0
 
 
Page 225 of 225
JJVC CONFIDENTIAL