Clinical Evaluation of Fitting Investigational Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

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Clinical Study Protocol
Evaluation of the JJVC Investigational Toric Multifocal 
Contact Lens Fitting Guide
3URWRFRO &5
9HUVLRQ 2.0, Amendment 1
'DWH 14-Mar-2017 
Investigational Products: JJVC Investigational etafilcon A Toric Multifocal Contact Lens and 
1-Day Acuvue® Moist Brand Multifocal Contact Lens
Key Words: Multifocal, Astigmatism, etafilcon A, Non-Dispensing, Daily-wear, Presbyopia 
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This trial will be conducted in compliance with the protocol, the International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP), ISO 14155, the Declaration of 
Helsinki, and all applicable regulatory requirements.
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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-5913 v2.0, Amendment 1.0
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PROTOCOL TITLE, NUMBER, VERSION ......................................................................6 
SPONSOR NAME AND ADDRESS ..................................................................................6 
MEDICAL MONITOR ........................................................................................................6 
AUTHORIZED SIGNATURES ..........................................................................................7 
CHANGE HISTORY...........................................................................................................8 
SYNOPSIS ...........................................................................................................................9 
Figure 1: Study Flowchart ..............................................................................................13 
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 ...................................17 
2.1. 
Objectives .............................................................................................................17 
2.2. 
Endpoints ..............................................................................................................18 
2.3. 
Hypotheses ...........................................................................................................18 
3. TARGETED STUDY POPULATION ........................................................................18 
3.1. 
General Characteristics .........................................................................................18 
3.2. 
Inclusion Criteria ..................................................................................................19 
3.3. 
Exclusion Criteria .................................................................................................19 
3.4. 
Enrollment Strategy ..............................................................................................20 
4. STUDY DESIGN AND RATIONALE .......................................................................20 
4.1. 
Description of Study Design ................................................................................20 
4.2. 
Study Design Rationale ........................................................................................20 
4.3. 
Enrollment Target and Study Duration ................................................................20 
5. TEST ARTICLE ALLOCATION AND MASKING ..................................................21 
5.1. 
Test Article Allocation .........................................................................................21 
5.2. 
Masking ................................................................................................................21 
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5.3. 
Procedures for Maintaining and Breaking Randomization Codes .......................21 
6. STUDY INTERVENTION ..........................................................................................21 
6.1. 
Identity of Test Articles ........................................................................................21 
Table 1: Test Articles ......................................................................................................21 
6.2. 
Ancillary Supplies/Products .................................................................................23 
Table 2: Ancillary Supplies ............................................................................................23 
6.3. 
Administration of Test Articles ............................................................................23 
6.4. 
Packaging and Labeling .......................................................................................23 
6.5. 
Storage Conditions ...............................................................................................24 
6.6. 
Collection and Storage of Samples ......................................................................24 
6.7. 
Accountability of Test Articles ............................................................................24 
7. STUDY EVALUATIONS ...........................................................................................25 
7.1. 
Time and Event Schedule .....................................................................................25 
Table 3: Time and Events ...............................................................................................25 
7.2. 
Detailed Study Procedures ...................................................................................26 
VISIT 1 ...................................................................................................................... 26 
FINAL EVALUATION ............................................................................................ 30 
7.3. 
Unscheduled Visits ...............................................................................................30 
7.4. 
Laboratory Procedures .........................................................................................32 
8. SUBJECTS COMPLETION/WITHDRAWAL...........................................................32 
8.1. 
Completion Criteria ..............................................................................................32 
8.2. 
Withdrawal/Discontinuation from the Study .......................................................32 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ..............33 
10. DEVIATIONS FROM THE PROTOCOL ..................................................................33 
11. STUDY TERMINATION ...........................................................................................33 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ..............34 
13. ADVERSE EVENTS ...................................................................................................35 
13.1. Definitions and Classifications .............................................................................35 
13.2. Assessing Adverse Events ....................................................................................38 
13.2.1 Causality Assessment .................................................................................... 38 
13.2.2 Severity Assessment ...................................................................................... 38 
13.3. Documentation and Follow-Up of Adverse Events .............................................39 
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13.4. Reporting Adverse Events ....................................................................................40 
13.4.1 Reporting Adverse Events to Sponsor ........................................................... 40 
13.4.2 Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
41 
13.5. Event of Special Interest .......................................................................................41 
13.6. Reporting of Pregnancy ........................................................................................42 
14. STATISTICAL METHODS ........................................................................................42 
14.1. General Considerations ........................................................................................42 
14.2. Sample Size Justification ......................................................................................42 
14.3. Analysis Populations ............................................................................................43 
14.4. Level of Statistical Significance ...........................................................................43 
14.5. Primary Analysis ..................................................................................................43 
14.6. Secondary Analysis ..............................................................................................44 
14.7. Other Exploratory Analyses .................................................................................44 
14.8. Interim Analysis ...................................................................................................44 
14.9. Procedure for Handling Missing Data and Drop-Outs .........................................44 
14.10. Procedure for Reporting Deviations from Statistical Plan ...................................44 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................45 
15.1. Electronic Case Report Form/Data Collection .....................................................45 
15.2. Subject Record .....................................................................................................45 
16. DATA MANAGEMENT.............................................................................................46 
16.1. Access to Source Data/Document ........................................................................46 
16.2. Confidentiality of Information .............................................................................46 
16.3. Data Quality Assurance ........................................................................................46 
17. MONITORING ............................................................................................................47 
18. ETHICAL AND REGULATORY ASPECTS ............................................................47 
18.1. Study-Specific Design Considerations .................................................................47 
18.2. Investigator Responsibility ...................................................................................47 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) ..........48 
18.4. Informed Consent .................................................................................................49 
18.5. Privacy of Personal Data ......................................................................................49 
19. STUDY RECORD RETENTION................................................................................50 
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20. FINANCIAL CONSIDERATIONS ............................................................................51 
21. PUBLICATION ...........................................................................................................51 
REFERENCES ..................................................................................................................51 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 52 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................58 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................59 
APPENDIX D: CLINICAL TECHNICAL PROCEDURES (CTP) .................................88 
APPENDIX E: PRESBYOPIC SYMPTOMS ...................................................................89 
APPENDIX F: OCULAR DOMINANCE.........................................................................90 
APPENDIX G: FITTING GUIDE OPTION 1 ..................................................................91 
APPENDIX H: FITTING GUIDE OPTION 2 ..................................................................96 
APPENDIX I: SUBJECT PRODUCT CONCEPT..........................................................103 
APPENDIX J: ECP INTERVIEW DISCUSSION materials ..........................................105 
CTP-2002: LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS .............................131 
CTP-2003: EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING.............139 
CTP-2005: DETERMINATION OF NEAR ADD ..........................................................144 
CTP-2008: LENS FITTING CHARACTERISTICS .......................................................152 
CTP-2009: SUBJECT REPORTED OCULAR SYMPTOMS ........................................159 
CTP-2016: DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS ..............................................................................................................161 
CTP-2018: BIOMICROSCOPY SCALE ........................................................................168 
CTP-2025: DISTANCE AND NEAR VISUAL ACUITY EVALUATION ...................174 
CTP-2027: TORIC FIT EVALUATION .........................................................................179 
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Table 1: Test Articles .........................................................................................................21 
Table 2: Ancillary Supplies ...............................................................................................23 
Table 3: Time and Events ..................................................................................................25 
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Figure 1: Study Flowchart ...................................................................................................... 13 
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35272&2/ 7,7/( 180%(5 9(56,21
Title: Evaluation of the JJVC Investigational Toric Multifocal Contact Lens Fitting Guide
Protocol Number: CR-5913 
Version: 2.0, Amendment 1 
Date: 14-Mar-2017 
6321625 1$0( $1' $''5(66
Johnson & Johnson Vision Care, Inc. (JJVC) 
7500 Centurion Parkway,  
Jacksonville, FL 32256 
0(',&$/ 021,725
Name: Thomas R. Karkkainen, OD, MS, FAAO
Title: Sr. Principal Research Optometrist
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256 
24 Hour Contact Telephone: (904)254-0152 
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-5913 v2.0, Amendment 1.0
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$87+25,=(' 6,*1$785(6
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations, ICH 
guidelines, ISO 14155 and the Declaration of Helsinki. 
Author
Thomas R. Karkkainen, OD, MS, FAAO
Sr. Principal Research Optometrist
DATE
Clinical Operations 
Manager
Cynthia Marsh, CPOA
Clinical Operations Manager
DATE
Biostatistician
Jing Xu, PhD
Biostatistician IV
DATE
Data Management 
Randall Paulk
Clinical Project Manager-Data and 
Systems
DATE
Approver
Khaled Chehab
Presbyopia Platform Sr. Manager
DATE
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6<1236,6
Protocol Title
Evaluation of the JJVC Investigational Toric Multifocal 
Contact Lens Fitting Guide
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Phase 2
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s)
Investigational Products: etafilcon A Toric Multifocal Contact 
Lens
Marketed Products:1-Day Acuvue® Moist Brand Multifocal 
Contact Lens
Wear and Replacement 
Schedules
Wear Schedule: Daily Wear
Replacement Schedule: None- Non-dispensing study 
Objectives 
The primary objective of this study is an evaluation of the 
JJVC Investigational Toric Multifocal and 1-Day Acuvue® 
Moist Brand Multifocal Contact Lens fitting guides by Eye 
Care Providers (ECPs).
Study Endpoints
Primary endpoint: The maximum number of lens 
modifications for both eyes required by the ECP to optimize 
the lenses for vision.     
Secondary endpoint:  
1.
Subjective feedback from the ECP on the fitting guide 
process (i.e. intuitive nature of the fitting steps, 
adequate amount of information provided by the fitting 
guide, strengths and weaknesses, etc.) 
2.
Subjective feedback from the ECP regarding the layout 
of the fitting guide.
3.
Surveys of the subjects experience.
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Study Design
This study is a single arm, non-randomized, open label, non-
dispensing clinical trial. The key assessments for this study 
will be the number of fitting modifications and ECP feedback 
throughout the fit process while using the Fit Guide. Each ECP 
will fit at least 3 subjects and no more than 4. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations. 
Sample Size
A total of approximately 36 subjects will be enrolled into the 
study.  Approximately 28 are targeted to complete.
Study Duration
The study duration is anticipated to be approximately 1 week.
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below. 
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
1. The subject must read, understand, and sign the
STATEMENT OF INFORMED CONSENT and receive a    
fully executed copy of the form.
2. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol.
3. Healthy adult males or females that are at least 40 years of
age and no more than 70 years of age. 
4. The subject must either 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”.   
5. The subject is a current soft spherical or toric contact lens 
wearer (defined as a minimum of 6 hours of wear per day at 
least two days of the week for a minimum of 1 month prior to 
the study). 
6. The subject’s distance spherical equivalent or spherical 
component (if fit with toric lens) of their refraction must be in 
the range -1.25 D to -3.75 D in each eye.
7. The subject’s refractive cylinder must be 0.00D to -1.50 D
in at least one eye and no greater than -1.50D in either eye. 
8. The subject’s refractive cylinder axis must be 90°±30° or 
180°±30° in each eye. 
9. The subject’s ADD power must be in the range of +0.75 D
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to +2.50 D in each eye.
10. The subject must have best corrected visual acuity of 
20/20-3 or better in each eye. 
11. The subject must have a wearable pair of spectacles if 
required for their distance vision. 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Ocular or systemic allergies or disease, or use of medication 
which might interfere with contact lens wear.
2. Pregnancy or lactation.
3. Currently diagnosed with diabetes.  
4. Infectious diseases (e.g. hepatitis, tuberculosis) or an 
immune-suppressive disease (e.g. HIV). 
5. Clinically significant (Grade 3 or 4) corneal edema, corneal 
vascularization, corneal staining, tarsal abnormalities or bulbar 
injection, or any other corneal or ocular abnormalities which 
would contraindicate contact lens wear.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, 
dry eye, glaucoma, history of recurrent corneal erosions.
7. Any previous, or planned, ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, lid procedures, cataract 
surgery, retinal surgery, etc.). 
8. A history of amblyopia, strabismus or binocular vision 
abnormality. 
9. Any ocular infection or inflammation.
10. Any ocular abnormality that may interfere with contact 
lens wear.  
11. Use of any ocular medication, with the exception of 
rewetting drops. 
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment.
14. Employee of clinical site (e.g., Investigator, Coordinator, 
Technician)
Disallowed 
Medications/Interventions  
Any systemic medications that may affect contact lens wear 
and any ocular medications with the exception of rewetting 
drops.    
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Measurements and 
Procedures
The key assessments for this study will be the number of 
fitting modifications and ECP feedback throughout the fit 
process while using the Fit Guide. 
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
Eye-Cept® rewetting drops
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
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&20021/< 86(' $%%5(9,$7,216 $1' '(),1,7,216 2) 7(506
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
CTP 
 
 
Clinical Technical Procedure
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure
ICF 
 
 
Informed Consent Form
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes
PD 
 
 
Protocol Deviation 
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PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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Secondary Objective(s)  
1. Subjective feedback from the ECP on the fitting guide process (i.e. intuitive nature of 
the fitting steps, adequate amount of information provided by the fitting guide, 
strengths and weaknesses, etc.)
2. Subjective feedback from the ECP regarding the layout of the fitting guide. 
3. Surveys of the subjects experience.
Exploratory Objective(s) Not Applicable 
 (QGSRLQWV
The endpoints will be the number of lenses required for optimization of vision (i.e. ease of 
fit) and subjective responses from the ECPs regarding the materials/process used for fitting 
the lenses as well as subjective responses from the subjects. 
Primary Endpoint(s) 
Number of lenses required to optimize vision. 
Secondary Endpoint(s)  
1. Subjective feedback from the ECP on the fitting guide process (i.e. intuitive nature of 
the fitting steps, adequate amount of information provided by the fitting guide, 
strengths and weaknesses, etc.) 
2. Subjective feedback from the ECP regarding the layout of the fitting guide.
3. Surveys of the subjects experience.
Other Observation(s)  
 +\SRWKHVHV
Primary Hypotheses
The maximum number of modification required by the ECP to optimize vision will not 
exceed one modification in more than 50% of the subjects.   
Secondary Hypotheses
Not Applicable 
Other Hypotheses 
Not applicable

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Healthy male and female volunteers who are presbyopic will be recruited for the study. The 
subjects will all be adapted wearers of soft contact lenses in both eyes. 
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 ,QFOXVLRQ &ULWHULD
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. Healthy adult males or females that are at least 40 years of age and no more than 70 
years of age.
4. The subject must either 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”.   
5. The subject is a current soft spherical or toric contact lens wearer (defined as a 
minimum of 6 hours of wear per day at least two days of the week for a minimum of 
1 month prior to the study). 
6. The subject’s distance spherical equivalent or spherical component (if fit with a toric 
lens) of their refraction must be in the range -1.25 D to -3.75 D in each eye.
7. The subject’s refractive cylinder must be 0.00 D to -1.50 D in at least one eye and no 
greater than -1.50 D in either eye. 
8. The subject’s refractive cylinder axis must be 90°±30° or 180°±30° in each eye. 
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D in each eye.
10. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. 
11. The subject must have a wearable pair of spectacles if required for their distance 
vision. 
 ([FOXVLRQ &ULWHULD
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
1. Ocular or systemic allergies or disease, or use of medication which might interfere 
with contact lens wear.
2. Pregnancy or lactation.
3. Currently diagnosed with diabetes.  
4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease 
(e.g. HIV).
5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal 
staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear.
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history 
of recurrent corneal erosions. 
7. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
8. A history of amblyopia, strabismus or binocular vision abnormality. 
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9. Any ocular infection or inflammation.
10. Any ocular abnormality that may interfere with contact lens wear.  
11. Use of any ocular medication, with the exception of rewetting drops. 
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment.
14. Employee of clinical site (e.g., Investigator, Coordinator, Technician) 
 (QUROOPHQW 6WUDWHJ\
Study subjects will be recruited from the potentially eligible subjects identified in the clinical 
site’s subject database.   

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 'HVFULSWLRQ RI 6WXG\ 'HVLJQ
This study is a single arm, non-randomized, open label, bilateral, non-dispensing clinical 
trial. There is one study visit.  Each subject will wear lenses for approximately 30-90 
minutes.  The key assessments for this study will be the number of fitting modifications and 
ECP feedback throughout the fit process while using the Fit Guide. Each ECP will fit at least 
3 subjects and no more than 4.  At the conclusion of the study subjects will not have access to 
the investigational lenses.  The marketed Moist Multifocal lenses can be obtained from their 
own ECP, at the subjects discretion, however no marketed product or contact lens 
prescriptions will be given to the subject to use outside of this clinical trial.
 6WXG\ 'HVLJQ 5DWLRQDOH
The primary aim of the study is to obtain ECP feedback on the fitting process of the lenses.  
With this aim in mind, the study design attempts to create the typical multifocal contact lens 
fitting scenario encountered in routine clinical practice. The primary purpose of the study is 
to obtain feedback on the ease of fitting and fitting guide for the multifocal toric lenses and 
as such there is no need for a Control lens or masking of any of the study personnel.  
 (QUROOPHQW 7DUJHW DQG 6WXG\ 'XUDWLRQ
x
Approximately 36 subjects will be enrolled in the study with 28 targeted to complete 
the cohort.  All subjects will have at least -1.00D to -1.50D of refractive cylinder in at 
least one eye.  There will be an attempt to evenly distribute the number of subject 
with -1.00 to -1.50 in each eye and -1.00 to -1.50 in only one eye.  
x
The study will take place at one site and have one study visit per subject.  Each ECP 
will fit a minimum of 3 subjects and a maximum of 4.   
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Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
 &ROOHFWLRQ DQG 6WRUDJH RI 6DPSOHV
Test articles will be disposed of after use and not collected unless associated with an Adverse 
Event.  When possible, any lens or Test article associated with an Adverse Events and/or a 
Product Quality Complaint must be retained and stored in a glass vial with moderate solution 
pending directions from the sponsor for potential return back to JJVC. 
 $FFRXQWDELOLW\ RI 7HVW $UWLFOHV
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment 
documentation for the Test article accountability records.  
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study 
site personnel listed on the Site Delegation Log. All Test articles must be accounted.  This 
includes: 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits 
2. What was returned to the Investigator unused 
3. The number and reason for unplanned replacements.   
The Investigator will collect all unused Test articles from the subjects at the end of the 
subject’s participation. Subject returned unused Test articles must be separated from the 
clinical study inventory of un-dispensed Test articles, and must be labeled with the subject 
number and date of return.  Following final reconciliation of Test articles by the monitor, the 
Investigator or monitor will package and return all unused Test articles to JJVC. 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately
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of 15 minutes.
1.21
Toric Fit
Evaluation (if 
applicable)
The principal or Co-Investigator will evaluate 
the toric fit after lens settling and record:
• The rotational position to the nearest degree 
• Lens stability with blink
• Lens stability with eye versions 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens stability 
is worse than 5 degrees movement with blink.  
If toric fit is unacceptable, remove the lenses, 
perform biomicroscopy and proceed to final 
evaluation.
1.22
Lens Fit
Assessment
The principal or Co-Investigator will evaluate 
the general lens fit.  Lens fit will be assessed in 
primary gaze, upgaze & Josephson push up 
test.
An unacceptable lens fit will be any one or 
more of the following: 
• presence of limbal exposure (appearance of 
clear cornea) in any gaze
• presence of edge lift
• Presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, upgaze, 
and push-up). 
If either lens is deemed unacceptable, the 
subject   will   be   discontinued   from   the 
study.  Perform a slit-lamp evaluation and 
complete the Final Evaluation
1.23
ECP Fitting with Fit 
Guide 
The ECP will follow the fitting guide to assess 
the vision provided by the lenses and will 
determine if a lens change is needed. The 
fitting activities of the ECP will be videotaped.
During the fitting of the lenses the ECP may 
use the slit lamp to evaluate the fit of the lens.  
If this assessment takes place the results will 
not be recorded.  
Appendix 
G/H
Acuvue 
Fitting 
Guide 
1.24
Modifications (if 
necessary)
The ECP will modify the lenses based upon 
the subject’s responses in accordance with the 
Fitting Guide. Two Modifications allowed. If 
Appendix 
G/H
Acuvue 
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discretion of the Investigator, rinse the 
subject’s eyes thoroughly with preservative-
free saline.
U.6
Exit Visual Acuity 
Record the subject’s exit distance visual 
acuity (OD, OS and OU) to the nearest letter 
with the subjects wearing the study provided 
spectacle glasses. 
 /DERUDWRU\ 3URFHGXUHV
Not Applicable 

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Subjects are considered to have completed the study if they:  
x
provided informed consent;  
x
they are eligible;
x
have not withdrawn/discontinued for any reason described in Section 8.2; 
x
Complete all study visits
 :LWKGUDZDO'LVFRQWLQXDWLRQ IURP WKH 6WXG\
A subject will be withdrawn from the study for any of the following reasons:
x
Subject death during the study period 
x
Subject withdrawal of consent 
x
Subject not compliant to protocol  
x
Subject lost to follow-up  
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant)
x
Subject develops significant or serious adverse events causing discontinuation of 
study lens wear  
x
Subjects who have experienced a Corneal infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x
Subject not compliant with study lens wear schedule
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit
For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled) 
x
Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study 
x
Record the spherocylindrical refraction with best corrected distance visual acuity  
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x
Collect used Test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused Test article(s) from the subject 
An additional subject may be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 

35(678'< $1' &21&20,7$17 ,17(59(17,210(',&$7,21
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: Any ocular medications with the exception of 
rewetting drops.
Concomitant therapies that are disallowed include: Any therapies that may contraindicate 
lens wear. 

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Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements. All 
deviations will be tracked and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as
required, the IEC/IRB.  

678'< 7(50,1$7,21
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, and JJVC safety review committee, the 
study may be terminated. 
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.
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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.

352&('85( )25 +$1'/,1* 352'8&7 48$/,7< &203/$,176
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.   
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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 or not 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 (Refer to 
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 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented. 

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 'HILQLWLRQV DQG &ODVVLILFDWLRQV
$GYHUVH (YHQW $( – An AE is any untoward (unwanted) medical occurrence in a patient 
or clinical investigation subject administered a Test article, study treatment or study 
procedure whether or not caused by the Test article, study treatment or procedure.  An AE 
can therefore be any unfavorable or unintended sign (including an abnormal finding), 
symptom, or disease temporally associated with the use of the Test article, study treatment, 
or study procedure whether or not related to the Test article, study treatment, or study 
procedure. 
An AE includes any condition (including a pre-existing condition) that:
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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 
6HULRXV $GYHUVH (YHQW 6$( – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening 
event, a significant persistent or permanent change, impairment, damage, or 
disruption to the subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the Test article
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition. 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber) 
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
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6LJQLILFDQW $GYHUVH (YHQWV – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the Test article (excluding Serious Adverse
Events).   
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA 
x
Other Grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
1RQ6LJQLILFDQW $GYHUVH (YHQWV – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the Test article.
However, the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following: 
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event,
which necessitates temporary lens discontinuation < 2 weeks 
$GYHUVH 'HYLFH (IIHFW $'( – A sub-set of AEs, and include only those adverse events 
that are cause by or related to the investigational device.
8QDQWLFLSDWHG $GYHUVH 'HYLFH (IIHFW 8$'( – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the Test article,
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the Test article that relates to the rights, safety 
and welfare of subjects.
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 $VVHVVLQJ $GYHUVH (YHQWV
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly.  Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1) 
x
Causality or Relatedness – i.e. the relationship between the Test article, study 
treatment or study procedures and the adverse event (not related; unlikely related; 
possibly related; related - see definition in Section 13.2.1) 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2).  
x
Outcome – Not Recovered or Not Resolved; Recovering or Resolving; Recovered or 
Resolved with Sequelae; Recovered or Resolved; Death Related to Adverse Event;
Unknown 
x
Actions Taken – None; temporarily discontinued; permanently discontinued; other 
action taken

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&DXVDOLW\ $VVHVVPHQW – A determination of the relationship between an adverse event and 
the Test article, study treatment, or study procedure. The Test article, study treatment or 
study procedure relationship for each adverse event shall be determined by the Investigator 
using these explanations: 
x
Not Related- An adverse event that is not related to the use of the Test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the Test article, 
or to the study treatment or study procedures. An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship 
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge. 

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6HYHULW\ $VVHVVPHQW – 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:
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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
 'RFXPHQWDWLRQ DQG )ROORZ8S RI $GYHUVH (YHQWV
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the Test article, study treatment or study procedure.  Adverse events 
reported before the use of Test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following: 
x
Adverse event (diagnosis not symptom) 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to Test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event
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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 or not 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. 
 5HSRUWLQJ $GYHUVH (YHQWV
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 or not the 
adverse event was considered to be related to the Test article, study treatment or study 
procedures. 
13.4.1
5HSRUWLQJ $GYHUVH (YHQWV WR 6SRQVRU
6HULRXV6LJQLILFDQW $GYHUVH (YHQWV
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
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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 
8QDQWLFLSDWHG 6HULRXV $GYHUVH 'HYLFH (IIHFW 8$'(
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. 
1RQ6HULRXV $GYHUVH (YHQWV
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
5HSRUWLQJ $GYHUVH (YHQWV WR WKH 5HVSRQVLEOH ,(&,5% DQG +HDOWK $XWKRULWLHV
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.
 (YHQW RI 6SHFLDO ,QWHUHVW
None 
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 5HSRUWLQJ RI 3UHJQDQF\
Subjects reporting pregnancy (by self-report) during the course of 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. 
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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 for all 
baseline variables, efficacy variables and safety variables as appropriate.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation (SD), 
median, minimum and maximum). Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
Summaries will be presented by study lens type and will be performed separately by 
completion status. All analyses will be conducted on per-protocol population (see section 
14.3).   
 6DPSOH 6L]H -XVWLILFDWLRQ
There will be one testing site: VRC (
).  A total of approximately 30 eligible subjects 
will be enrolled into the study at this site. At least 24 subjects will complete this study. There 
have been no prior historical studies to evaluate the number of modifications needed in the 
Test article. As such, the sample size calculation was not based on any power analysis with 
regard to the primary endpoint.   
CR-5913 v2.0, Amendment 1.0
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Using the POWER procedure in SAS 9.4, below is the summary of sample size required 
based on the different assumptions of the true percentage of subjects with at most one 
modification.  
x
Percentage of subjects with at most one modification 
True Percentage (%)
# of subjects needed
Power
70
56
0.913
75
35
0.924
80
23
0.928
 $QDO\VLV 3RSXODWLRQV
Not Applicable 
6DIHW\ 3RSXODWLRQ
All subjects who were administered any Test article excluding subjects who drop out prior to 
administering any Test article. At least one observation should be recorded. 
3HU3URWRFRO 3RSXODWLRQ
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file. 
,QWHQWWR7UHDW ,77 3RSXODWLRQ
All randomized subjects regardless of actual treatment and subsequent withdrawal from 
study or deviation from protocol. At least one observation should be recorded. 
 /HYHO RI 6WDWLVWLFDO 6LJQLILFDQFH
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
 3ULPDU\ $QDO\VLV
Primary efficacy analysis: 
Due to the potential low incidence rates of unacceptable lens fitting, summary statistics will 
be firstly used to evaluate the percentage of the subjects with at most one optimization per-
protocol population.  
Due to the potential low incidence rates of unacceptable lens fitting, summary statistics will 
be firstly used to evaluate the percentage of the subjects with at most one optimization per-
protocol population.  
CR-5913 v2.0, Amendment 1.0
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If applicable, a generalized linear mixed model with a binary distribution and logit link 
function will be applied to the number of modifications (1=at most one modification; 0 = 
more than one modification).  Age, gender and subjects’ add power will be included in the 
model as fixed effects when appropriate. ECP and subject will be included as random effect. 
The proportion of subjects with at most one optimization will be calculated with 95% 
confidence interval. If the lower limit of the confidence interval is greater than 50%, the 
statistical superiority will be concluded.
If the incidence rate is too low or there are problems with the convergence of the above 
model, Agresti methods or Fisher’s exact test for binomial proportion will be used to 
evaluate the confidence intervals of the corresponding endpoints. 
 6HFRQGDU\ $QDO\VLV
This is not applicable. 
 2WKHU ([SORUDWRU\ $QDO\VHV
This is not applicable. 
 ,QWHULP $QDO\VLV
This not applicable. 
 3URFHGXUH IRU +DQGOLQJ 0LVVLQJ 'DWD DQG 'URS2XWV
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a 
parametric regression method used to make at least 5 imputations.
 3URFHGXUH IRU 5HSRUWLQJ 'HYLDWLRQV IURP 6WDWLVWLFDO 3ODQ
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.
CR-5913 v2.0, Amendment 1.0
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9&7 

'$7$ +$1'/,1* $1' 5(&25' .((3,1*$5&+,9,1*
 (OHFWURQLF &DVH 5HSRUW )RUP'DWD &ROOHFWLRQ
The data for this study will be captured on electronic case report forms (eCRFs) using 
Bioclinica Express version 5.5 EDC system). An authorized data originator will enter study 
data into the eCRFs using the EDC system. Data collected on equipment that is not captured 
in EDC will be formatted to the specification of the JJVC database manager and sent to JJVC
for analysis.  
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy 
and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
will be authorized to gain access to the subject recordation for the purposes of monitoring 
and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate 
and complete data collection. Data will be transmitted from the clinical site to a secure 
central database as forms are completed or updated, ensuring information accuracy, security, 
and confidentiality. After the final database lock, the Investigator will be provided with 
Individual Patient Profiles (IPP) including the full audit trail on electronic media in PDF 
format for all of the study data. The IPP must be retained in the study files as a certified copy 
of the source data for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011. 
 6XEMHFW 5HFRUG
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
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9&7 
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.

'$7$ 0$1$*(0(17
 $FFHVV WR 6RXUFH 'DWD'RFXPHQW
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. 
 &RQILGHQWLDOLW\ RI ,QIRUPDWLRQ
Information concerning the investigational product and patent application processes, 
scientific data or other pertinent information is confidential and remains the property of 
JJVC.  The Investigator may use this information for the purposes of the study only. It is 
understood by the Investigator that JJVC will use information developed in this clinical study 
in connection with the development of the investigational product and therefore may disclose 
it as required to other clinical investigators and to regulatory agencies. In order to allow the 
use of the information derived from this clinical study, the Investigator understands that 
he/she has an obligation to provide complete test results and all data developed during this 
study to the Sponsor. 
 'DWD 4XDOLW\ $VVXUDQFH
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. 
CR-5913 v2.0, Amendment 1.0
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9&7 

021,725,1*
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x
Ensuring the rights and wellbeing of subjects are protected 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and  
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient Test article and supplies 
x
Clarifying questions regarding the study 
x
Resolving study issues or problems that may arise
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan 

(7+,&$/ $1' 5(*8/$725< $63(&76
 6WXG\6SHFLILF 'HVLJQ &RQVLGHUDWLRQV
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. 
 ,QYHVWLJDWRU 5HVSRQVLELOLW\
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), 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 2013 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), and applicable regulatory requirements.
CR-5913 v2.0, Amendment 1.0
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9&7 
 ,QGHSHQGHQW (WKLFV &RPPLWWHH RU ,QVWLWXWLRQDO 5HYLHZ %RDUG ,(&,5%
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol and, if applicable, amendments 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information) and amendments 
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless 
not required, as documented by IEC/IRB) 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), the informed consent form, applicable recruiting materials, 
and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved. 
During the study the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol amendments 
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects 
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s) 
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the Test 
articles, according to the IRB’s requirements 
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
CR-5913 v2.0, Amendment 1.0
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9&7 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable. 
 ,QIRUPHG &RQVHQW
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable 
regulatory requirements, and Sponsor policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject. 
 3ULYDF\ RI 3HUVRQDO 'DWD
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 Data Protection Act of 1998 and other applicable personal data 
protection and security laws and regulations.  Appropriate measures will be employed to 
safeguard these data, to maintain the confidentiality of the person’s related health and 
medical information, to properly inform the concerned persons about the collection and 
processing of their personal data, to grant them reasonable access to their personal data and 
to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
CR-5913 v2.0, Amendment 1.0
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9&7 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
x
adequate, relevant, and not excessive in relation to said purposes 
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential 

678'< 5(&25' 5(7(17,21
In compliance with the ICH/GCP guidelines, the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP Section 8, Essential Documents for the Conduct of 
a Clinical Trial, 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. 
CR-5913 v2.0, Amendment 1.0
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Essential documents must be retained until at least 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 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. 

),1$1&,$/ &216,'(5$7,216
Remuneration for study services and expenses will be set forth in detail in the Investigator’s 
Research Agreement. The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation.
Case Report Forms will be completed in real time according to the study procedures 
specified in the study protocol.  Case Report Forms should be completed and reviewed and 
signed as applicable by the Investigator within 3 days of visit completion.  Data queries must 
be addressed with complete responses within 3 days of generation.  JJVC reserves the right to 
withhold remuneration until these activities are addressed.
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 

38%/,&$7,21
This study will be registered on ClinicalTrials.gov by the Sponsor
5()(5(1&(6
None. 
CR-5913 v2.0, Amendment 1.0
Page 51 of 183
JJVC CONFIDENTIAL

9&7 
$33(1',; $ 3$7,(17 5(3257(' 287&20(6 678'< 48(67,211$,5(6
CR-5913 v2.0, Amendment 1.0
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9&7 
$33(1',; % 3$7,(17 ,16758&7,21 *8,'(
Not Applicable: Non-Dispensing Study 
CR-5913 v2.0, Amendment 1.0
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JJVC CONFIDENTIAL

9&7 
$33(1',; & 3$&.$*( ,16(57 $33529(' 352'8&7
1-Day Acuvue® Moist Brand Multifocal Contact Lens  
Investigational Product: Not Applicable 
CR-5913 v2.0, Amendment 1.0
Page 59 of 183
JJVC CONFIDENTIAL

3 
 
DESCRIPTION 
The 1-DAY ACUVUE® MOIST® Brand Contact Lenses, 1-DAY ACUVUE® MOIST® Brand Contact Lenses for 
ASTIGMATISM, and 1-DAY ACUVUE® MOIST® Brand MULTIFOCAL Contact Lenses are soft (hydrophilic) 
contact lenses available as spherical, toric, and multifocal lenses and include LACREON® Technology.    
The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid 
cross-linked with 1, 1, 1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. These 
lenses are tinted blue using Reactive Blue Dye #4 to make the lenses more visible for handling. 
A benzotriazole UV absorbing monomer is used to block UV radiation. The UV Blocking averages 97% in 
the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm. 
Lens Properties: 
The physical/optical properties of the lens are: 
x 
Specific Gravity (calculated):   
0.98 – 1.13 
x 
Refractive Index:   
1.40 
x 
Light Transmittance:  
85% minimum 
x 
Surface Character:   
Hydrophilic 
x 
Water Content:   
58% 
x 
Oxygen Permeability: 
VALUE 
METHOD 
21.4 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) @ 35°C 
Fatt (boundary corrected, edge corrected) 
 
28.0 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) @ 35°C 
Fatt (boundary corrected, non-edge corrected) 
 
 
CR-5913 v2.0, Amendment 1.0
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JJVC CONFIDENTIAL

4 
 
AVAILABLE LENS PARAMETERS 
The 1-DAY ACUVUE® MOIST® Contact Lenses are hemispherical shells of the following dimensions: 
x 
Diameter:  
 
14.2 mm  
x 
Center Thickness:  
0.084 mm to 0.230 mm (varies with power) 
x 
Base Curve: 
 
8.5 mm, 9.0 mm 
x 
Powers:  
 
-0.50D to -6.00D (in 0.25D increments) 
 
 
 
-6.50D to -12.00D (in 0.50D increments) 
 
 
 
+0.50D to +6.00D (in 0.25D increments) 
The 1-DAY ACUVUE® MOIST® Contact Lenses for ASTIGMATISM are hemitoric  shells of the following 
dimensions: 
x 
Diameter:  
 
14.5 mm  
x 
Center Thickness:  
0.090 mm to 0.189 mm (varies with power) 
x 
Base Curve: 
 
8.5 mm  
x 
Powers:  
 
Plano to -6.00D (in 0.25D increments) 
 
 
 
-6.50D to -9.00D (in 0.50D increments) 
 
 
 
Cylinders:  -0.75D, -1.25D, -1.75D 
Axis:  10°, 20°, 60°, 70°, 80°, 90°, 100°, 110°, 120°, 160°, 170°, 
180°  
 
Plano to -6.00D (in 0.25D increments) 
 
 
 
-6.50D to -9.00D (in 0.50D increments) 
 
 
 
Cylinder:  -2.25D 
Axis:  20°, 90°, 160°, 180°  
 
+0.25D to +4.00D (in 0.25D increments) 
 
 
 
Cylinders:  -0.75D, -1.25D, -1.75D 
Axis:  20°, 70°, 90°, 110°, 160°, 180°  
The 1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses are hemispherical  shells of the following 
dimensions: 
x 
Diameter:  
 
14.3 mm  
x 
Center Thickness:  
0.084 mm to 0.197 mm (varies with power) 
x 
Base Curve: 
 
8.4 mm  
x 
Powers:  
 
+6.00D to -9.00D (in 0.25D increments) 
x 
ADD Powers: 
 
+1.25 (LOW), +1.75 (MID), +2.50 (HGH) 
 
 
CR-5913 v2.0, Amendment 1.0
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7 
 
x 
Ocular irritation due to allergic reactions which may be caused by use of contact lens 
solutions (i.e., rewetting drops) that contain chemicals or preservatives (such as mercury or 
Thimerosal, etc.) to which some people may develop an allergic response 
x 
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by 
wearing contact lenses  
x 
Any active corneal infection (bacterial, fungal, protozoal, or viral) 
x 
If eyes become red or irritated 
WARNINGS 
Patients should be advised of the following warnings pertaining to contact lens wear: 
 
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP RAPIDLY AND LEAD TO LOSS OF 
VISION; IF THE PATIENT EXPERIENCES: 
x 
Eye Discomfort, 
x 
Excessive Tearing, 
x 
Vision Changes, 
x 
Loss of Vision, 
x 
Eye Redness, or 
x 
Other Eye Problems  
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY 
CONTACT THE EYE CARE PROFESSIONAL. 
When prescribed for daily wear, patients should be instructed not to wear lenses while sleeping.  Clinical 
studies have shown that the risk of serious adverse reactions is increased when lenses are worn 
overnight, and that the risk of ulcerative keratitis is greater for extended wear contact lens users than 
for daily wear users.3 
Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse 
reactions than nonsmokers. 
Problems with contact lenses or lens care products could result in serious injury to the eye. Patients 
should be cautioned that proper use and care of contact lenses and lens care products are essential for 
the safe use of these products. 
The overall risk of ulcerative keratitis may be reduced by carefully following directions for lens care. 
3New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783 
 
 
CR-5913 v2.0, Amendment 1.0
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8 
 
Specific Instructions for Use and Warnings: 
x 
Water Activity 
Instruction for Use 
Do not expose contact lenses to water while wearing them.  
WARNING: 
Water can harbor microorganisms that can lead to severe infection, vision loss, or 
blindness.  If lenses have been submersed in water when participating in water sports or 
swimming in pools, hot tubs, lakes, or oceans, the patient should be instructed to discard 
them and replace them with a new pair. The Eye Care Professional should be consulted for 
recommendations regarding wearing lenses during any activity involving water. 
PRECAUTIONS 
Special Precautions for Eye Care Professionals:  
x 
Due to the small number of patients enrolled in clinical investigation of lenses, all refractive 
powers, design configurations, or lens parameters available in the lens material are not 
evaluated in significant numbers. Consequently, when selecting an appropriate lens design 
and parameters, the Eye Care Professional should consider all characteristics of the lens that 
can affect lens performance and ocular health, including oxygen permeability, wettability, 
central and peripheral thickness, and optic zone diameter. 
The potential impact of these factors on the patient's ocular health should be carefully 
weighed against the patient's need for refractive correction; therefore, the continuing 
ocular health of the patient and lens performance on the eye should be carefully monitored 
by the prescribing Eye Care Professional. 
x 
Patients who wear these lenses to correct presbyopia using monovision (or modified 
monovision using 1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses) may not achieve 
the best corrected visual acuity for either far or near vision. Visual requirements vary with 
the individual and should be considered when selecting the most appropriate type of lens 
for each patient.  
x 
Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. The lenses 
absorb this dye and become discolored. Whenever fluorescein is used in eyes, the eyes 
should be flushed with a sterile saline solution that is recommended for in-eye use. 
x 
Eye Care Professionals should instruct the patient to remove lenses immediately if the eyes 
become red or irritated. 
 
 
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Eye Care Professionals should carefully instruct patients about the following care regimen 
and safety precautions: 
Handling Precautions: 
x 
Before leaving the Eye Care Professional's office, the patient should be able to promptly 
remove lenses or should have someone else available who can remove the lenses for him or 
her.  
x 
DO NOT use if the sterile blister package is opened or damaged.  
x 
Always wash and rinse hands before handling lenses. Do not get cosmetics, lotions, soaps, 
creams, deodorants, or sprays in the eyes or on the lenses. It is best to put on lenses before 
putting on makeup. Water-based cosmetics are less likely to damage lenses than oil-based 
products.  
x 
DO NOT touch contact lenses with the fingers or hands if the hands are not free of foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
x 
Carefully follow the handling, insertion, removal, and wearing instructions in the "Patient 
Instruction Guide" for these lenses and those prescribed by the Eye Care Professional. 
x 
Always handle lenses carefully and avoid dropping them. 
x 
Never use tweezers or other tools to remove lenses from the lens container unless 
specifically indicated for that use. Slide the lens up the side of the bowl until it is free of the 
container. 
x 
Do not touch the lens with fingernails.  
Lens Wearing Precautions: 
x 
If the lens sticks (stops moving) on the eye, follow the recommended directions in "Care for 
a Sticking (Non-Moving) Lens.” The lens should move freely on the eye for the continued 
health of the eye. If non-movement of the lens continues, the patient should be instructed 
to immediately consult his or her Eye Care Professional. 
x 
Never wear lenses beyond the period recommended by the Eye Care Professional. 
x 
The patient should be advised to never allow anyone else to wear their lenses.  They have 
been prescribed to fit their eyes and to correct their vision to the degree necessary.  Sharing 
lenses greatly increases the chance of eye infections. 
x 
If aerosol products, such as hair spray, are used while wearing lenses, exercise caution and 
keep eyes closed until the spray has settled. 
x 
Avoid all harmful or irritating vapors and fumes while wearing lenses.  
Lens Care Precautions: 
x 
The patient should be informed that no cleaning or disinfection is needed when lenses are 
worn for daily disposable wear.  Patients should always dispose of lenses when removed and 
have spare lenses or spectacles available.  
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Other Topics to Discuss with Patients: 
x 
Always contact the Eye Care Professional before using any medicine in the eyes.  
x 
Certain medications, such as antihistamines, decongestants, diuretics, muscle relaxants, 
tranquilizers, and those for motion sickness may cause dryness of the eye, increased lens 
awareness, or blurred vision. Should such conditions exist, proper remedial measures should 
be prescribed. Depending on the severity, this could include the use of lubricating drops that 
are indicated for use with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used.  
x Oral contraceptive users could develop visual changes or changes in lens tolerance 
when using contact lenses. Patients should be cautioned accordingly.  
x 
As with any contact lens, follow-up visits are necessary to assure the continuing health of 
the patient's eyes. The patient should be instructed as to a recommended follow-up 
schedule. 
Who Should Know That the Patient is Wearing Contact Lenses? 
x 
Patients should inform all doctors (Health Care Professionals) about being a contact lens 
wearer.  
x 
Patients should always inform their employer of being a contact lens wearer. Some jobs may 
require use of eye protection equipment or may require that the patient not wear contact 
lenses.  
ADVERSE REACTIONS 
The patient should be informed that the following problems may occur when wearing contact lenses: 
x 
The eye may burn, sting and/or itch. 
x 
There may be less comfort than when the lens was first placed on the eye. 
x 
There may be a feeling of something in the eye (foreign body, scratched area). 
x 
There may be the potential for some temporary impairment due to peripheral infiltrates, 
peripheral corneal ulcers, or corneal erosion. There may be the potential for other 
physiological observations, such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjunctivitis; some of which are 
clinically acceptable in low amounts. 
x 
There may be excessive watering, unusual eye secretions, or redness of the eye. 
x 
Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or dry 
eyes may also occur if the lenses are worn continuously or for too long a time. 
 
 
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The patient should be instructed to conduct a simple 3-part self-examination at least once a day. They 
should ask themselves: 
x 
How do the lenses feel on my eyes? 
x 
How do my eyes look? 
x 
Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to IMMEDIATELY REMOVE THE LENS.  
If the problem or discomfort stops, the patient should discard the lens and place a new fresh lens on the 
eye. 
If after inserting the new lens, the problem continues, the patient should be directed to IMMEDIATELY 
REMOVE THE LENS AND CONTACT HIS OR HER EYE CARE PROFESSIONAL. 
The patient should be instructed NOT to use a new lens as self-treatment for the problem.  
The patient should be advised that when any of the above symptoms occur, a serious condition such as 
infection, corneal ulcer, neovascularization, or iritis may be present. He or she should be instructed to 
seek immediate professional identification of the problem and prompt treatment to avoid serious eye 
damage. 
GENERAL FITTING GUIDELINES 
A. Patient Selection 
Patients selected to wear these lenses should be chosen based on:  
x 
Motivation to wear lenses  
x 
Ability to follow instructions regarding lens wear  
x 
General health  
x 
Ability to adequately handle and care for the lenses  
x 
Ability to understand the risk and benefits of lens wear  
Patients who do not meet the above criteria should not be provided with contact lenses.  
B. Pre-fitting Examination 
Initial evaluation of the patient should begin with a thorough case history to determine if there are any 
contraindications to contact lens wear. During the case history, the patient’s visual needs and 
expectations should be determined as well as an assessment of their overall ocular, physical, and mental 
health.  
 
 
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Preceding the initial selection of trial contact lenses, a comprehensive ocular evaluation should be 
performed that includes, but is not limited to, the measurement of distance and near visual acuity, 
distance and near refractive prescription (including determining the preferred reading distance for 
presbyopes), keratometry, and biomicroscopic evaluation.  
Based on this evaluation, if it is determined that the patient is eligible to wear these lenses, the Eye Care 
Professional should proceed to the lens fitting instructions outlined below.  
C. Initial Power Determination 
A spectacle refraction should be performed to establish the patient’s baseline refractive status and to 
guide in the selection of the appropriate lens power. Remember to compensate for vertex distance if 
the refraction is greater than ±4.00D.  
D. Base Curve Selection (Trial Lens Fitting) 
The following trial lenses should be selected for patients regardless of keratometry readings.  However, 
corneal curvature measurements should be performed to establish the patient’s baseline ocular status. 
x 
1-DAY ACUVUE® MOIST®:   8.5 mm/14.2 mm 
x 
1-DAY ACUVUE® MOIST® for ASTIGMATISM:   8.5 mm/14.5 mm  
x 
1-DAY ACUVUE® MOIST® MULTIFOCAL: 8.4 mm/14.3 mm 
The trial lens should be placed on each of the patient’s eyes and evaluated after the patient has 
adjusted to the lenses.  
1. Criteria of a Properly Fit Lens  
A properly fit lens will center and completely cover the cornea (i.e., no limbal exposure), have 
sufficient movement to provide tear exchange under the contact lens with the blink, and be 
comfortable. The lens should move freely when manipulated digitally with the lower lid, and then 
return to its properly centered position when released.  
2. Criteria of a Flat Fitting Lens  
A flat fitting lens may exhibit one or more of the following characteristics: decentration, 
incomplete corneal coverage (i.e., limbal exposure), excessive movement with the blink and/or 
edge standoff. If the lens is judged to be flat fitting, it should not be dispensed to the patient. 
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3. Criteria of a Steep Fitting Lens  
 
A steep fitting lens may exhibit one or more of the following characteristics: insufficient 
movement with the blink, conjunctival indentation, and resistance when pushing the lens up 
digitally with the lower lid. If the lens is judged to be steep fitting, it should not be dispensed to 
the patient. 
If the initial trial base curve is judged to be flat or steep fitting, the alternate base curve, if available, 
should be trial fit and evaluated after the patient has adjusted to the lens. The lens should move freely 
when manipulated digitally with lower lid, and then return to a properly centered position when 
released. If resistance is encountered when pushing the lens up, the lens is fitting tightly and should not 
be dispensed to the patient. 
E. Final Lens Power (Spherical) 
A spherical over-refraction should be performed to determine the final lens power after the lens fit is 
judged acceptable. The spherical over-refraction should be combined with the trial lens power to 
determine the final lens prescription. The patient should experience good visual acuity with the correct 
lens power unless there is excessive residual astigmatism.  
Example 1 
Diagnostic lens: 
-2.00D 
 
Spherical over-refraction: 
-0.25D 
 
Final lens power: 
-2.25D 
 
Example 2 
Diagnostic lens: 
-2.00D 
 
Spherical over-refraction: 
+0.25D  
 
Final lens power: 
-1.75D 
If vision is acceptable, perform a slit lamp examination to assess adequate fit (centration and 
movement). If the fit is acceptable, dispense the lenses and instruct the patient to return in one week 
for reassessment (see dispensing and follow-up information in PATIENT MANAGEMENT).  
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download at www.acuvue.com. 
 
 
 
 
 
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TORIC FITTING GUIDELINES 
Although most aspects of the fitting procedure are identical for all types of soft contact lenses, including 
toric lenses, there are some additional steps and/or rules to follow to assure the proper fit of toric 
lenses.  
 
The only new steps you must follow in prescribing the 1-DAY ACUVUE® MOIST® Contact Lenses for 
ASTIGMATISM are that you must determine the stability, repeatability, and drift angle of the lens axis so 
that you can prescribe the correct lens axis for your patient.  
 
A. How to Determine Lens Cylinder and Axis Orientation for 1-DAY ACUVUE® MOIST® Contact Lenses 
for ASTIGMATISM  
 
1. Locate the Orientation Marks  
To help determine the proper orientation of the toric lens, you’ll find two primary marks 
approximately 1 mm from the lens edge representing the vertical position on opposite ends of 
the lens at 6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, either mark can 
represent the vertical position – there is no “top” and “bottom” as in a prism-ballasted lens. You 
don’t need to view both marks to assess orientation; simply look for the 6 o’clock mark as you 
would with a prism-ballasted lens. 
 
Figure 1 
You’ll need a slit lamp biomicroscope with a 1 to 2 mm parallelepiped beam to highlight the 
marks when the lens is fitted to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped beam and medium 
magnification (10x or 15x), slowly pan down the lens, looking just below the direct illumination 
at the retroilluminated area. Backlighting the mark this way should make it more visible. 
Sometimes manipulating the lower lid may be necessary to uncover the mark.  
 
2. Observe Lens Rotation and Stability  
Observe the position and stability of the “bottom” mark. It usually stabilizes at the 6 o’clock 
position. If it does, calculation of the lens power will be straightforward. The 6 o’clock position is 
not a “must”; however, the absolute requirement is that the axis position be stable and 
repeatable.  
 
 
 
 
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The mark may stabilize somewhat left or right (drift) of the vertical meridian and still enable you 
to fit a toric lens for that eye, as long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the final prescription. Your objective is to 
ensure that whatever position the initial lens assumes near 6 o’clock, this position must be 
stable and repeatable. With full eye movement or heavy blink, you may see the marks swing 
away, but they must return quickly to the original stable position. If the lens does not return 
quickly, you may need to select a different lens.  
 
Assessing Rotation  
Imagine the eye as a clock dial and every hour represents a 30° interval. If the orientation mark 
of the initial lens stabilizes somewhat left or right of the vertical position, the final lens will 
orient on the eye with the same deviation. You can use an axis reticule in the slit lamp or use a 
line-scribed lens in a spectacle trial frame to measure or estimate the “drift angle” of the 
cylinder axis.  
 
To compensate for this “drift,” measure or estimate the “drift,” then add or subtract it from the 
refractive axis to determine the correct cylinder axis. Use the LARS (Left Add, Right Subtract) 
method to determine which direction to compensate. 
 
B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian as the patient’s refractive axis, a 
spherocylindrical over-refraction may be performed and visual acuity determined. However, in the 
case of crossed axes, such as when the diagnostic lens axis is different from the spectacle cylinder 
axis, it is not advisable to perform a full spherocylindrical over-refraction because of the difficulty in 
computing the resultant power. A spherical over-refraction without cylinder refraction may be 
performed. 
If the required cylinder correction falls between two available cylinder powers, it is recommended to 
prescribe the lower cylinder power lens. See below for instructions on how to determine the final 
lens power. 
For the Sphere  
If sphere alone or combined sphere and cylinder Rx > 4.00D, compensate for  vertex distance.  
If sphere alone or combined sphere and cylinder Rx < 4.00D, vertex compensation is not necessary. 
 
 
 
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For the Cylinder 
Adjust the axis by the drift angle using the LARS method. Choose a cylinder that is ч 0.50D from the 
refractive cylinder. 
Case Examples 
Example 1: 
Manifest (spectacle) refraction: 
O.D. -2.50 / -1.25 x 180  20/20 
O.S. -2.00 / -1.00 x 180  20/20 
Choose a diagnostic lens for each eye with axis 180°. Place the lens on each eye and allow a 
minimum of 3 minutes for it to equilibrate, based on the patient’s initial response to the lens. 
Check the orientation of the axis mark. If the bottom axis mark is in the 6 o’clock position on both 
eyes, choose the appropriate cylinder as listed previously. 
Here is the Rx prescribed: 
O.D. -2.50 / -1.25 x 180   
O.S. -2.00 / -0.75 x 180   
Example 2: 
Manifest (spectacle) refraction: 
O.D. -3.00 / -1.00 x 90  20/20   
O.S. -4.75 / -2.00 x 90  20/20   
Choose a diagnostic lens of -3.00 / -0.75 x 90 for the right eye and -4.50 / -1.75 x 90 for the left eye, 
the nearest lenses available to the spherical power and axis needed. Place the lens on each eye and 
allow a minimum of 3 minutes for it to equilibrate. 
Right Eye 
The orientation mark on the right lens rotates left by 10° from the 6 o’clock position and remains 
stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest refraction axis.  
Here is the Rx prescribed:  
O.D. -3.00 / -0.75 x 100 
 
 
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Left Eye 
The orientation mark on the left lens rotates right by 10° from the 6 o’clock position and remains 
stable in this position. 
Since the manifest refraction called for a power of -4.75D, compensating for vertex distance the 
sphere is reduced by 0.25D to -4.50D. The cylinder power will be -1.75D. Compensate for the 10° 
axis drift to the right by subtracting it from the manifest refraction axis.  
Here is the Rx prescribed:  
O.S. -4.50 / -1.75 x 80  
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.  
MULTIFOCAL FITTING GUIDELINES 
A. Presbyopic Needs Assessment & Patient Education 
Multifocal contact lenses may produce compromise to vision under certain circumstances and the 
patient should understand that they might not find their vision acceptable in specific situations (i.e., 
reading a menu in a dim restaurant, driving at night in rainy/foggy conditions, etc.). Therefore, 
caution should be exercised when the patient is wearing the correction for the first time until they 
are familiar with the vision provided in visually challenging environments. Occupational and 
environmental visual demands should be considered. If the patient requires critical visual acuity and 
stereopsis, it should be determined by trial whether this patient can function adequately with the 
1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses. Wearing the  
1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses may not be optimal for activities such as: 
1. Visually demanding situations such as operating potentially dangerous machinery or performing 
other potentially hazardous activities; and 
2. Driving automobiles (e.g., driving at night). Patients who cannot meet their state driver’s license 
requirements with the 1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses should be advised 
to not drive with this correction, OR may require that additional over-correction be prescribed. 
1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses are not recommended for patients who have 
-1.00D or greater of refractive cylinder as this level of uncorrected cylinder may lead to additional 
visual compromise.  
 
 
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The 1-DAY ACUVUE® MOIST® MULTIFOCAL Contact Lenses are available in the following ADD 
powers:  
x Lens “LOW” = “low” near ADD lens (Max ADD +1.25)  
x Lens “MID” = “medium” near ADD lens (Max ADD +1.75)  
x Lens “HGH” = “high” near ADD lens (Max ADD +2.50) 
B. Initial Power Determination 
A spectacle refraction should be performed to establish the patient’s baseline refractive status and 
to guide in the selection of the appropriate lens power. Remember to compensate for vertex 
distance if the refraction is greater than ±4.00D. Determine the spherical equivalent distance 
prescription for a multifocal patient. Determine the eye dominance using one of the methods 
below: 
Method 1:   Determine which eye is the “sighting eye.” Have the patient point to an object at the 
far end of the room. Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye. 
 
Method 2:   Determine which eye does not accept added plus power. Place a +1.00D hand-held 
trial lens in front of one eye and then the other while the distance refractive error 
correction is in place for both eyes while the patient is viewing the distance visual 
acuity chart. The eye with the plus over it that the patient notices the greatest 
reduction in vision is determined to be the dominant eye. 
C. Select the Initial Trial Lens  
1. 
For each eye, select the trial lens distance power that is closest to the patient’s distance 
spherical equivalent. Remember to compensate for vertex distance if the refraction is greater 
than ±4.00D. 
2. 
Select the near power of the lens based on the patients ADD range as follows:  
x ADD: +0.75 to +1.25 use a “LOW” near ADD lens on each eye  
x ADD: +1.50 to +1.75 use a “MID” near ADD lens on each eye  
x ADD: +2.00 to +2.50 use a “MID” near ADD on the dominant eye and a “HGH” near ADD 
lens on the non-dominant eye 
3. 
Allow the lenses to settle for a minimum of 10 minutes.  
4. 
Assess distance and near vision binocularly and monocularly.  
5. 
Demonstrate the vision under various lighting conditions (normal and decreased illumination) 
and at distance, intermediate, and near.  
 
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6. 
Make adjustments in power as necessary based on the distance over-refraction.  The use of 
hand held trial lenses is recommended.  Check the impact on distance and near vision. 
7. 
If vision is still unacceptable, make adjustments in power as necessary (see “Multifocal 
Troubleshooting” below). If distance and near vision are acceptable, perform a slit lamp 
examination to assess adequate fit (centration and movement). If fit is acceptable, dispense the 
lenses instructing the patient to return in one week for reassessment (see dispensing and 
follow up information in PATIENT MANAGEMENT). 
D. Multifocal Troubleshooting 
Unacceptable Near Vision: 
If it has been determined that no change is required based on the over-refraction, then add +0.25D to 
the spherical power of the non-dominant eye.  
 
Unacceptable Distance Vision:  
If it has been determined that no change is required based on the over-refraction, then make the 
changes as listed below: 
x 
If the patient is wearing two “LOW” ADD lenses, change the dominant eye to a 
1-DAY ACUVUE® MOIST® sphere lens with a power equal to the spherical equivalent distance 
prescription. 
x 
If the patient is wearing two “MID” ADD lenses, change the ADD power in the dominant eye to 
the “LOW” ADD power. 
x 
If the patient is wearing a “MID” ADD lens in the dominant eye and a “HGH” ADD lens in the 
non-dominant eye, change the non-dominant eye to a “MID” ADD lens and add +0.25D to the 
distance power. 
 
E. Adaptation 
Visually demanding situations should be avoided during the initial wearing period. A patient may 
at first experience some mild blurred vision, dizziness, headaches and a feeling of slight 
imbalance. You should explain the adaptational symptoms to the patient. These symptoms may 
last for a brief minute or for several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation. 
To help in the adaptation process, the patient can be advised to first use the lenses in a 
comfortable familiar environment such as in the home. 
 
 
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Some patients feel that automobile driving performance may not be optimal during the 
adaptation process. This is particularly true when driving at night. Before driving a motor 
vehicle, it may be recommended that the patient be a passenger first to make sure that their 
vision is satisfactory for operating an automobile. During the first several weeks of wear (when 
adaptation is occurring), it may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the patient should be able to 
drive under other conditions with caution. 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download at www.acuvue.com. 
MONOVISION FITTING GUIDELINES 
A. Patient Selection 
Monovision Needs Assessment 
For a good prognosis, the patient should have adequately corrected distance and near visual acuity in 
each eye. The amblyopic patient with significant astigmatism (greater than 1.00D) in one eye may not be 
a good candidate for monovision correction with these lenses. 
Occupational and environmental visual demands should be considered. If the patient requires critical 
vision (visual acuity and stereopsis), it should be determined by trial whether this patient can function 
adequately with monovision correction. Monovision contact lens wear may not be optimal for activities 
such as: 
1. Visually demanding situations such as operating potentially dangerous machinery or 
performing other potentially hazardous activities; and 
2. Driving automobiles (e.g., driving at night). Patients who cannot meet their state driver’s 
license requirements with monovision correction should be advised to not drive with this 
correction, OR may require that additional over-correction be prescribed. 
Patient Education 
All patients do not function equally well with monovision correction. Patients may not perform as well 
for certain tasks with this correction as they have with spectacles (multifocal, bifocal, trifocal, readers, or 
progressives). Each patient should understand that monovision, as well as other presbyopic alternatives, 
can create a vision compromise that may reduce visual acuity and depth perception for distance and 
near tasks. Therefore, caution should be exercised. During the  
 
 
 
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fitting process, it is necessary for the patient to realize the disadvantages as well as the advantages of 
clear near vision, and straight ahead and upward gaze that monovision contact lenses provide.  
B. Eye Selection 
Generally, the non-dominant eye is corrected for near vision. The following two methods for eye 
dominance can be used. 
1. Ocular Preference Determination Methods 
Method 1:  
Determine which eye is the “sighting eye.” Have the patient point to an object at 
the far end of the room. Cover one eye. If the patient is still pointing directly at 
the object, the eye being used is the dominant (sighting) eye. 
Method 2: 
Determine which eye will accept the added power with the least reduction in 
vision. Place a hand-held trial lens equal to the spectacle near ADD in front of 
one eye and then the other while the distance refractive error correction is in 
place for both eyes. Determine whether the patient functions best with the near 
ADD lens over the right or left eye. 
Other methods include the “Refractive Error Method” and the “Visual Demands Method.” 
2. Refractive Error Method 
For anisometropic correction, it is generally best to fit the more hyperopic (less myopic) eye for 
distance and the more myopic (less hyperopic) eye for near. 
3. Visual Demands Method 
Consider the patient’s occupation during the eye selection process to determine the critical 
vision requirements. If a patient’s gaze for near tasks is usually in one direction, correct the eye 
on that side for near. 
Example: 
A secretary who places copy to the left side of the desk will function best with the near lens on 
the left eye. 
C. Special Fitting Characteristics 
1. Unilateral Vision Correction Requirement 
There are circumstances where only one contact lens is required. As an example, an emmetropic 
patient would only require a near lens, whereas a bilateral myope would require corrective 
lenses on both eyes. 
 
 
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Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD would have a +1.75D lens on the 
near eye and the other eye left without correction. 
A presbyopic patient requiring a +1.50D ADD who is –2.50D myopic in the right eye and –1.50D 
myopic in the left eye may have the right eye corrected for distance and the left eye uncorrected 
for near. 
2. Near ADD Determination 
Always prescribe the lens power for the near eye that provides optimal near acuity at the 
midpoint of the patient’s habitual reading distance. However, when more than one power 
provides optimal reading performance, prescribe the least plus (most minus) of the powers.  
3. Trial Lens Fitting 
A trial fitting is performed in the office to allow the patient to experience monovision correction. 
Lenses are fit according to the GENERAL FITTING GUIDELINES for base curve selection described 
in this guide. 
Case history and standard clinical evaluation procedure should be used to determine the 
prognosis. Determine the distance correction and the near correction. Next determine the near 
ADD. With trial lenses of the proper power in place, observe the reaction to this mode of 
correction. 
Allow the lenses to settle for about 20 minutes with the correct power lenses in place. Walk 
across the room and have the patient look at you. Assess the patient’s reaction to distance 
vision under these circumstances. Then have the patient look at familiar near objects such as a 
watch face or fingernails. Again assess the reaction. As the patient continues to look around the 
room at both near and distance objects, observe the reactions. Only after these vision tests are 
completed should the patient be asked to read print. Evaluate the patient’s reaction to large 
print (e.g., typewritten copy) at first and then graduate to news print and finally smaller type 
sizes. 
After the patient’s performance under the above conditions is completed, tests of visual acuity 
and reading ability under conditions of moderately dim illumination should be attempted.  
An initial unfavorable response in the office, while indicative of a guarded prognosis, should not 
immediately rule out a more extensive trial under the usual conditions in which a patient 
functions.  
 
 
 
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4. Adaptation 
Visually demanding situations should be avoided during the initial wearing period. A patient may 
at first experience some mild blurred vision, dizziness, headaches, and a feeling of slight 
imbalance. You should explain the adaptation symptoms to the patient. These symptoms may 
last for a brief minute or for several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation. 
To help in the adaptation process, the patient can be advised to first use the lenses in a 
comfortable familiar environment such as in the home. 
Some patients feel that automobile driving performance may not be optimal during the 
adaptation process. This is particularly true when driving at night. Before driving a motor vehicle, 
it may be recommended that the patient be a passenger first to make sure that their vision is 
satisfactory for operating an automobile. During the first several weeks of wear (when 
adaptation is occurring), it may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the patient should be able to drive 
under other conditions with caution.  
5. Other Suggestions 
The success of the monovision technique may be further improved by having your patient follow 
the suggestions below: 
 
Have a third contact lens (distance power) to use when critical distance viewing is needed. 
 
Have a third contact lens (near power) to use when critical near viewing is needed. 
 
Have supplemental spectacles to wear over the monovision contact lenses for specific visual 
tasks may improve the success of monovision correction. This is particularly applicable for 
those patients who cannot meet their state driver’s license requirements with a monovision 
correction. 
 
Make use of proper illumination when carrying out visual tasks. 
Monovision fitting success can be improved by the following suggestions: 
 
Reverse the distance and near eyes if a patient is having trouble adapting. 
 
Refine the lens powers if there is trouble with adaptation. Accurate lens power is critical for 
presbyopic patients. 
 
Emphasize the benefits of clear near vision, and straight ahead and upward gaze with 
monovision. 
 
 
CR-5913 v2.0, Amendment 1.0
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24 
 
The decision to fit a patient with monovision correction is most appropriately left to the Eye Care 
Professional in conjunction with the patient after carefully considering the patient’s needs. 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download at www.acuvue.com. 
PATIENT MANAGEMENT 
Dispensing Visit 
Each sterile lens is supplied in a foil-sealed plastic package containing buffered saline solution with 
povidone. To remove the lens from the container, peel back the foil seal, place a finger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of the container.  
 
Evaluate the physical fit and visual acuity of the lens on each eye. 
 
Teach the patient how to apply and remove his or her lenses.  
 
Explain daily disposable lens wear and schedule a follow-up examination. 
 
Provide the patient with a copy of the PATIENT INSTRUCTION GUIDE for these lenses.  
Copies are available for download at www.acuvue.com. 
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE OR SHE CLEARLY 
UNDERSTANDS THE PRESCRIBED WEARING AND REPLACEMENT SCHEDULES. 
Follow-Up Examinations 
Follow-up care (necessary to ensure continued successful contact lens wear) should include routine 
periodic progress examinations, management of specific problems, if any, and a review with the patient 
of the wear schedule, daily disposable modality, and proper lens handling procedures. 
A. Recommended Follow-up Examination Schedule (complications and specific problems 
should be managed on an individual patient basis): 
1. 
One week from the initial lens dispensing to patient 
2. 
One month post-dispensing 
3. 
Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least six hours.  
 
 
 
CR-5913 v2.0, Amendment 1.0
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JJVC CONFIDENTIAL

25 
 
B. Recommended Procedures for Follow-Up Visits: 
1. 
Solicit and record patient’s symptoms, if any. 
2. 
Measure visual acuity monocularly and binocularly at distance and near with the 
contact lenses.  
3. 
Perform an over-refraction at distance and near to check for residual refractive 
error. 
4. 
With the biomicroscope, judge the lens fitting characteristics (as described in 
the GENERAL FITTING GUIDELINES) and evaluate the lens surface for deposits 
and damage. 
5. 
Following lens removal, examine the cornea and conjunctiva with the 
biomicroscope and fluorescein (unless contraindicated).  
 
The presence of vertical corneal striae in the posterior central cornea 
and/or corneal neovascularization is indicative of excessive corneal 
edema. 
 
The presence of corneal staining and/or limbal-conjunctival hyperemia 
can be indicative of an unclean lens, a reaction to solution preservatives, 
excessive lens wear and/or a poorly fitting lens. 
 
Papillary conjunctival changes may be indicative of an unclean and/or 
damaged lens.  
6. 
Periodically perform keratometry and spectacle refractions. The values should 
be recorded and compared to the baseline measurements. 
If any observations are abnormal, use professional judgment to alleviate the problem and restore the 
eye to optimal conditions. If the criteria for successful fit are not satisfied during any follow-up 
examinations, repeat the patient’s trial fitting procedure and refit the patient. 
WEARING SCHEDULE 
The wearing schedule should be determined by the Eye Care Professional.  Regular checkups, as 
determined by the Eye Care Professional, are also extremely important.  
Patients tend to over wear the lenses initially. The Eye Care Professional should emphasize the 
importance of adhering to the initial maximum wearing schedule.  Maximum wearing time should be 
determined by the Eye Care Professional based upon the patient’s physiological eye condition, because 
individual response to contact lenses varies.  
 
 
CR-5913 v2.0, Amendment 1.0
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26 
 
The maximum suggested wearing time for these lenses is: 
Day 
Hours 
1 
6-8 
2 
8-10 
3 
10-12 
4 
12-14 
5 and after 
all waking hours 
 
REPLACEMENT SCHEDULE 
These lenses are indicated for daily disposable wear and should be discarded upon removal. 
When disposed of after a single daily use, these lenses may reduce the risk of developing giant papillary 
conjunctivitis.4 
When worn as a daily disposable lens, these lenses may provide improved comfort for many patients 
who experience mild discomfort and itching associated with allergies during contact lens wear, 
compared to lenses replaced at intervals of greater than 2 weeks.  
Clinical Research has shown that when worn on a daily disposable basis, these lenses may provide 
improved comfort for 2 out of 3 patients who reported suffering from discomfort associated with 
allergies during contact lens wear. 
4 The CLAO Journal, July 1999, Volume 25, Number 3 
LENS CARE DIRECTIONS 
When lenses are prescribed for daily disposable wear, the Eye Care Professional should provide the 
patient with appropriate and adequate warnings and instructions for daily disposable lens wear at the 
time they are dispensed.   
The Eye Care Professional should review with patients that no cleaning or disinfection is needed with 
disposable lenses. Patients should always dispose of lenses when they are removed and have spare 
lenses or spectacles available.  
 
 
 
 
 
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27 
 
Basic Instructions 
x 
Always wash, rinse, and dry hands before handling contact lenses. 
x 
Do not use saliva or anything other than the recommended solutions for lubricating or rewetting 
lenses. Do not put lenses in the mouth. 
x 
Eye Care Professionals may recommend a lubricating/rewetting solution which can be used to 
wet (lubricate) lenses while they are being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens 
If the lens sticks (stops moving), the patient should be instructed to apply a few drops of the 
recommended lubricating or rewetting solution directly to the eye and wait until the lens begins to 
move freely on the eye before removing it. If non-movement of the lens continues after a few minutes, 
the patient should immediately consult the Eye Care Professional. 
EMERGENCIES 
The patient should be informed that if chemicals of any kind (household products, gardening solutions, 
laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY 
WITH TAP WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A HOSPITAL 
EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED 
Each sterile lens is supplied in a foil-sealed plastic package containing buffered saline solution with 
povidone. The plastic package is marked with the following: 
x 
1-DAY ACUVUE® MOIST®:   base curve, power, diameter, lot number, and expiration date 
x 
1-DAY ACUVUE® MOIST® for ASTIGMATISM:   base curve, power, diameter, cylinder, axis, lot 
number, and expiration date 
x 
1-DAY ACUVUE® MOIST® MULTIFOCAL:    base curve, power, diameter, ADD, lot number, and 
expiration date 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5913 v2.0, Amendment 1.0
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JJVC CONFIDENTIAL

 
 
REPORTING OF ADVERSE REACTIONS 
All serious adverse experiences and adverse reactions observed in patients wearing these lenses or 
experienced with these lenses should be reported to: 
 
 
 
 
 
 
 
 
 
Johnson & Johnson Vision Care, Inc. 
7500 Centurion Parkway 
Jacksonville, FL 32256 
USA 
Tel: 1-800-843-2020 
www.acuvue.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
©Johnson & Johnson Vision Care Companies 2015 
Printed in USA 
Revision date: 09/14 
 
Revision number: M-09-14-00 
 
 
1-DAY ACUVUE® MOIST® and LACREON® are Trademarks of Johnson & Johnson Vision Care Companies 
CR-5913 v2.0, Amendment 1.0
Page 87 of 183
JJVC CONFIDENTIAL

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x
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
x
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
x
 DETERMINATION OF NEAR ADD 
x
  LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS 
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
x
 BIOMICROSCOPY SCALE 
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
x
 TORIC FIT EVALUATION 
CR-5913 v2.0, Amendment 1.0
Page 88 of 183
JJVC CONFIDENTIAL

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1. Do you notice that you often have to hold things farther away so that you could read 
them?
2. Do you notice that you often have difficulty focusing on near objects (i.e., 
experiencing blurry vision when looking at things close-up)? 
3. Do you often have headaches or eyestrains, or feel fatigued, when read or conduct 
other near activities?
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc.?
5. Do you often have difficulty reading under dim or low light? 
CR-5913 v2.0, Amendment 1.0
Page 89 of 183
JJVC CONFIDENTIAL

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Protocol Number and Title: CR-5913 Evaluation of the JJVC Investigational Toric 
Multifocal Contact Lens Fitting Guide    
Version and Date: v2.0, Amendment 1.0 March 14, 2017 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to GCP and ICH guidelines, the Declaration of 
Helsinki, ISO 14155, United States (US) Code of Federal Regulations (CFR), 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 ICH 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 ICH 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-5913 v2.0, Amendment 1.0
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JJVC CONFIDENTIAL