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

 
Johnson & Johnson Vision Care, Inc. 
 
Clinical Study Protocol 
 
 
Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population 
 
Protocol CR-6201 
 
Version: 4.0, Amendment 3.0 
                            
Date: 25 June 2018 
 
Investigational Products: JJV Investigational senofilcon A Multifocal Contact Lens and     
1-Day Acuvue® Moist Brand Multifocal Contact Lens 
 
Key Words: Presbyopia, Multifocal, etafilcon A, senofilcon A, Daily Wear, Daily 
Disposable, Reusable, Dispensing, Randomized  
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, or 
as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc.  Any supplemental information that may be added to this 
document is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and 
must be kept in confidence in the same manner as the contents of this document. 
 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study...................................................................................................................... 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives ................................................................................................................. 18 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
3.3. 
Exclusion Criteria ..................................................................................................... 19 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 21 
6. 
STUDY INTERVENTION ............................................................................................. 22 
6.1. 
Identity of Test Articles............................................................................................ 22 
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6.2 Ancillary Supplies/Products.......................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 23 
6.4. 
Packaging and Labeling ........................................................................................... 23 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 24 
7. 
STUDY EVALUATIONS .............................................................................................. 25 
7.1. 
Time and Event Schedule ......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 35 
VISIT 3 ........................................................................................................................... 39 
VISIT 4 ........................................................................................................................... 44 
VISIT 5 ........................................................................................................................... 50 
VISIT 6 ........................................................................................................................... 54 
VISIT 7 ........................................................................................................................... 59 
FINAL EVALUATION ................................................................................................ 61 
7.3. 
Unscheduled Visits ................................................................................................... 62 
7.4. 
Laboratory Procedures ............................................................................................. 64 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 64 
8.1. 
Completion Criteria .................................................................................................. 64 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 64 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 65 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 65 
11. 
STUDY TERMINATION ........................................................................................... 66 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 66 
13. 
ADVERSE EVENTS ................................................................................................... 68 
13.1. 
Definitions and Classifications ............................................................................. 68 
13.2. 
Assessing Adverse Events .................................................................................... 70 
13.2.1. 
Causality Assessment .................................................................................... 70 
13.2.2. 
Severity Assessment ...................................................................................... 71 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 71 
13.4. 
Reporting Adverse Events .................................................................................... 72 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 72 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 73 
13.4.3. 
Event of Special Interest ............................................................................... 73 
13.5. 
Reporting of Pregnancy ........................................................................................ 73 
14. 
STATISTICAL METHODS ........................................................................................ 74 
14.1. 
General Considerations ......................................................................................... 74 
14.2. 
Sample Size Justification ...................................................................................... 74 
14.3. 
Analysis Populations ............................................................................................ 75 
14.4. 
Level of Statistical Significance ........................................................................... 75 
14.5. 
Primary Analysis .................................................................................................. 75 
14.6. 
Secondary Analysis .............................................................................................. 76 
14.7. 
Other Exploratory Analyses ................................................................................. 76 
14.8. 
Interim Analysis ................................................................................................... 76 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 76 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 76 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 76 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 76 
15.2. 
Subject Record ...................................................................................................... 77 
16. 
DATA MANAGEMENT............................................................................................. 77 
16.1. 
Access to Source Data/Document ........................................................................ 77 
16.2. 
Confidentiality of Information.............................................................................. 78 
16.3. 
Data Quality Assurance ........................................................................................ 78 
17. 
MONITORING ............................................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 79 
18.1. 
Study-Specific Design Considerations ................................................................. 79 
18.2. 
Investigator Responsibility ................................................................................... 79 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 79 
18.4. 
Informed Consent ................................................................................................. 80 
18.5. 
Privacy of Personal Data ...................................................................................... 81 
19. 
STUDY RECORD RETENTION................................................................................ 82 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION ........................................................................................................... 83 
22. 
REFERENCES ............................................................................................................ 83 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 84 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 116 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 117 
APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 148 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 149 
APPENDIX F: OCULAR DOMINANCE............................................................................ 150 
APPENDIX G: Test LENS FITTING GUIDE ..................................................................... 151 
APPENDIX H: CONTROL LENS FITTING GUIDE ......................................................... 153 
APPENDIX I: 
) ...................................... 155 
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS ............................. 156 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING .................. 164 
 DETERMINATION OF NEAR ADDITION .................................................... 169 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE ....... 177 
 LENS FITTING CHARACTERISTICS ............................................................ 180 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ....................... 187 
, DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 189 
 BIOMICROSCOPY SCALE ............................................................................. 197 
 KERATOMETRY PROCEDURE ..................................................................... 203 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ........................ 205 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 210 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 213 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 218 
 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 13 
 
TABLE OF CONTENTS  
Table 1: Test Articles .............................................................................................................. 22 
Table 2: Ancillary Supplies .................................................................................................... 23 
Table 3: Time and Events ....................................................................................................... 25 
 
 
 
 
 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic 
Population 
 
Protocol Number:  CR-6201 
Version: 4.0, Amendment 3.0 
Date: 25 June 2018 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR 
Name:  Thomas R. Karkkainen, OD, MS, FAAO 
Title: Sr. Principal Research Optometrist 
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256 
 
Email: TKarkkai@its.jnj.com 
 
 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related 
questions should be directed towards your assigned clinical research associate. 
 
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File. 
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations,4 ICH 
guidelines,2 ISO 14155,1 and the Declaration of Helsinki.3 
 
 
 
Author 
 
 
See Electronic Signature Report 
 
 
 
Thomas R. Karkkainen, OD, MS, FAAO 
Sr. Principal Research Optometrist 
 
DATE 
 
 
 
 
 
Clinical Operations 
Manager 
 
 
See Electronic Signature Report 
 
 
 
 
Clinical Operations Manager 
 
 
DATE 
 
 
Biostatistician 
 
 
See Electronic Signature Report 
 
 
 
 
Biostatistician IV 
 
DATE 
 
 
Data Management  
 
 
See Electronic Signature Report 
 
 
 
 
Clinical Project Manager-Data and 
Systems 
 
 
DATE 
 
 
Reviewer 
 
 
See Electronic Signature Report 
 
 
 
 
Clinical Research Fellow 
 
DATE 
 
 
 
Approver 
 
 
 
See Electronic Signature Report 
 
 
 
 
Presbyopia Platform Sr. Manager 
 
 
DATE 
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SYNOPSIS  
Protocol Title 
Clinical Evaluation of a Reusable Multifocal Optical Design in 
a Presbyopic Population 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Phase 2  
Trial Registration 
This study will be registered on ClinicalTrials.gov. 
Test Article(s) 
Investigational Product: JJVC Investigational Multifocal 
Contact Lens manufactured in senofilcon A material.      
Marketed Product: 1-Day Acuvue® Moist Brand Multifocal 
Contact Lens. 
Wear and Replacement 
Schedules 
Wear Schedule: The Test and Control lens are used as daily 
wear (note: the test lens will be reusable and the control daily 
disposable).   
 
Replacement Schedule: The test lens will be replaced at the 
optimization visit. The Control lens will be replaced after each 
day of wear as well as the optimization visit and the visit after 
the first week of wear in the optimized pair. The Test and 
Control lenses will also be replaced when lost or damaged. 
Objectives  
This study is an evaluation of the visual performance, 
subjective response, lens fit and ocular physiological response 
of the JJV Investigational senofilcon A Multifocal Contact 
Lens.  The test lenses will be compared to the 1-Day Acuvue® 
Moist Brand Multifocal Contact Lens manufactured in 
etafilcon A material for CLUE subjective vision.  
Study Endpoints 
Primary endpoints:  CLUE vision scores  
Other observations:  logMAR visual acuity scores, lens fit, 
summary of number of lenses needed to fit (optimize) the 
subject, CLUE comfort/handling scores, corneal staining, and 
ocular redness. 
Study Design 
This is a single-masked, randomized-controlled, dispensing 
clinical trial.  A total of approximately 60 eligible myopic 
subjects will be targeted to complete the study.  The subjects 
will be fit in each study lens and wear the lens for 2-4 days 
then undergo optimization, if applicable, and wear the 
optimized pair for approximately 2 weeks with a follow-up at 
1 week. The primary endpoints will be CLUE vision scores. 
Sample Size 
A total of approximately 60 subjects will be targeted to 
complete. 
Study Duration 
The study will last approximately 2-4 months. 
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Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
invited to participate in the study.  Subjects will be adapted 
soft contact lens wearers in both eyes.  Additional information 
regarding the eligibility of the population can be found in the 
inclusion/exclusion criteria outlined below.       
Eligibility Criteria 
Potential subjects must satisfy all the following criteria to be 
enrolled in the study 
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol. 
3. The subject must be between 40 and 70 years of age 
(inclusive). 
4. The subject’s distance spherical equivalent refraction 
must be in the range of -1.25 D to -3.75 D in each eye. 
5. The subject’s refractive cylinder must be ≤0.75 D in 
each eye. 
6. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D. 
7. The subject must have best corrected visual acuity of 
20/20-3 or better in each eye. 
8. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
9. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 8 hours per wear day, for 1 
month of more duration). 
10. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or 
monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”. 
 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that 
may interfere with contact lens wear.   
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere with 
contact lens wear. This may include, but not be limited 
to, diabetes, hyperthyroidism, Sjögren’s syndrome, 
xerophthalmia, acne rosacea, Stevens-Johnson 
syndrome, and immunosuppressive diseases or any 
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infectious diseases (e.g. hepatitis, tuberculosis). 
4. Clinically significant (Grade 3 or 4) corneal edema, 
corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal 
or ocular abnormalities which would contraindicate 
contact lens wear. 
5. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, dry eye, glaucoma, history of recurrent corneal 
erosions. 
6. Any previous, or planned, ocular or intraocular surgery 
(e.g. radial keratotomy, PRK, LASIK, lid procedures, 
cataract surgery, retinal surgery, etc.). 
7. A history of amblyopia, strabismus or binocular vision 
abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with 
contact lens wear. 
10. Use of any of the following oral medications within 1 
week prior to enrollment: oral retinoid isotretinoin (e.g. 
Accutane), oral tetracyclines, topical scopolamine, oral 
antihistamines (e.g., Chlor-Trimeton, and Benadryl), 
systemic steroids. 
11. Use of any ocular medication, with the exception of 
rewetting drops. 
12. History of herpetic keratitis. 
13. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment. 
14.  Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
15. Any known hypersensitivity or allergic reaction to 
Optifree®Replenish® multi-purpose care solution or 
Eye-Cept® rewetting drop solution. 
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.   
Measurements and 
Procedures 
logMAR Visual acuity and Subjective responses for vision 
using the CLUE questionnaire.  
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. 
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Ancillary Supplies/ Study-
Specific Materials 
 See Section 7.2 for the detailed procedures. 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCC  
 
Binocular Crossed Cylinder 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLDEQ-8 
 
Contact Lens Dry Eye Questionnaire-8 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council for Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
LSM  
 
Least Square Means 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
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OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1. INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision recently launched a multifocal contact lens, 1-DAY ACUVUE® 
Moist Multifocal.  The lens is the only marketed soft multifocal lens to have its optical 
design optimized for the changes that occur in pupil size with refractive error.  The modality 
for the lens is daily disposable.  There is a desire to evaluate the same optical design in a 
reusable modality.  The purpose of this study is to evaluate a multifocal optical design 
manufactured from senofilcon-A material and compare the visual performance to the 1-DAY 
ACUVUE® Moist Multifocal. 
1.1. Name and Descriptions of Investigational Products  
Test Lens: JJV Investigational senofilcon-A Multifocal Contact Lens-The lens has the same 
optical design, diameter, base curve and aspheric back surface design as the 1-Day Acuvue® 
Moist Brand Multifocal.  The lens is manufactured in senofilcon-A.        
 
Control Lens:  Marketed 1-Day Acuvue® Moist Brand Multifocal Contact Lens. 
1.2. Intended Use of Investigational Products 
Both lenses are intended to correct spherical refractive error and presbyopia.  The test lenses 
are intended to be used as a 2-week, reusable, daily wear lens.  The lenses require use of a 
care system to clean and disinfect the lenses.  The control lenses are daily wear lenses that 
are disposed of at the end of each wear cycle.  No care system is required for the control 
lenses.  
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.  For the most comprehensive nonclinical information regarding JJV 
investigational senofilcon-A multifocal refer to the latest version of the Investigator 
Brochure. 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The Investigational multifocal contact lenses are designed as a continuous asphere providing 
for the correction of refractive spherical ammetropia and presbyopia.  The material is a 
silicone hydrogel material, senofilcon-A.   
 
The 1-Day Acuvue® Moist Brand Multifocal Contact Lens is a currently marketed product 
that is made of the etafilcon-A material.  The contact lenses are available as continuous 
aspheres providing for the correction of a subjects refractive spherical ammetropia and 
presbyopia. 
 
The intent of the Test lens is daily wear, reusable lens that the subject wears while awake.  
This lens is not intended for extended wear.  Anticipated risks and adverse reactions with this 
lens are similar to other soft daily wear contact lenses used to correct presbyopia.  A listing 
of examples of adverse reactions is found in the Section 13 of this protocol.  The investigator 
should follow normal clinical guidelines regarding examination and care of subjects who 
participate in this trial. For the most comprehensive clinical information regarding the JJV 
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Investigational senofilcon-A multifocal lens refer to the Investigator Brochure.  Additional 
details on the 1-Day Acuvue® Moist Brand Multifocal Contact Lens can be found in the 
package insert in Appendix C. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
JJV has evaluated the test lenses in a previous study 
.  The study was a dispensing 
clinical trial with primary end points of logMAR visual acuity at fit and CLUE vision scores 
at 1 week.  The study was a cross-over design with a marketed product serving as the control.  
Subjects were fit in the lenses and wore them for 2-4 then attended the first follow-up visit to 
determine if lens optimization was required.  The lenses were than worn for an additional 
2 weeks with a 1-week follow-up during that period.  There were 32 subjects that completed 
the study as cohort.  The test lens displayed good visual acuity with the mean distance and 
intermediate logMAR acuity better than 0.0 and the mean near logMAR acuity better than 
+0.1 logMAR.  This with true of the acuity at the initial fit as well as the 1 week and 2-week 
visits in the final lens pair.  There were two non-ocular adverse events that occurred during 
the study that were not related to any of the test lenses.   
 
The test lenses have also been evaluated in 
 which at the writing of this protocol has 
completed data collection, however does not have a completed clinical study report.  During 
the study there were no serious adverse events reported 
 
In addition to the above study, JJV had tested similar optical designs that have been 
manufactured in a similar material however those lenses were worn as daily disposable 
lenses.  The lenses were tested in 
 details of which are included 
below.   
 
 was a non-dispensing evaluation with a primary endpoint of logMAR visual acuity.  
There were 22 subjects that completed the trial per protocol.  In this study, the lenses 
provided clinically acceptable visual acuity with the mean bright high contrast binocular 
logMAR acuity of -0.016, -0.028 and 0.086 for distance, intermediate and near respectively.  
There were no adverse events reported during the study.   
 
 was a dispensing clinical trial with the primary endpoint of logMAR visual acuity.  
There were 21 subjects that completed the trial per protocol.  The lenses displayed clinically 
acceptable logMAR visual acuity after approximately 10 days of wear with the mean bright 
high contrast binocular logMAR acuity of -0.082, -0.042 and 0.054 for distance, intermediate 
and near respectively.  There were two adverse events reported during the study one that was 
non-ocular and not related to the test articles the other was an ocular adverse event, contact 
lens induced peripheral ulcer, that was classified as likely related to the study lens.  The event 
resolved with treatment and the subject was discontinued from the study.  For additional 
details refer to the Investigator Brochure for this study. 
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2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES   
2.1. Objectives  
This study is an evaluation of the subjective response, lens fit and ocular physiological 
response of the JJV Investigational senofilcon A Multifocal Contact Lens.  The test lenses 
will be compared to the 1-Day Acuvue® Moist Brand Multifocal Contact Lens manufactured 
in etafilcon A material for CLUE subjective vision.  
 
Primary Objective 
This study is an initial evaluation of how the visual performance and subjective response of 
the JJV Investigational senofilcon A Multifocal Contact Lens compares to the 1-Day 
Acuvue® Moist Brand Multifocal Contact Lens manufactured in etafilcon A material. 
2.2. Endpoints  
The study endpoints will be the subjective CLUE Vision scores.  Additional endpoints will 
be logMAR visual acuity at distance, intermediate and near a summary of lenses needed to fit 
(optimize) the subject, CLUE comfort/handling scores, the lens fit and ocular physiological 
responses.   
 
Primary Endpoints 
· CLUE vision scores 
 
Other Observation(s)  
· LogMAR visual acuity scores  
· Lens fit 
· Corneal staining 
· Ocular redness (bulbar and limbal) 
· Summary of lenses needed to fit (optimize) the subject 
· CLUE comfort/handling scores 
· PRO individual questions. 
2.3. Hypotheses 
The following primary hypothesis will be tested throughout this investigation.  
 
Primary Hypothesis: 
1. After 14 to 20 days of wear, the PRO CLUE vision score for the test lenses will be 
statistically better than 40 points.  This will be recorded by the subject using the 
CLUE Follow-up Questionnaire. 
 
If the primary hypothesis is met, the following secondary hypothesis will be tested. 
 
Secondary Hypothesis: 
1. After 14 to 20 days of wear, the PRO CLUE vision score for the test lenses will be 
non-inferior to the control lens.  A non-inferiority margin of 5 CLUE points will be 
used.  This will be recorded by the subject using the CLUE Follow-up Questionnaire. 
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3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female subjects who are habitual soft contact lens wearers will be 
recruited.  Subjects will be at least 40 years of age and not older than 70 years of age.  They 
will be myopic and have presbyopia.    
3.2. Inclusion Criteria 
Potential subjects must satisfy all the following criteria to be enrolled in the study:  
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol. 
3. The subject must be between 40 and 70 years of age (inclusive). 
4. The subject’s distance spherical equivalent refraction must be in the range of -1.25 D 
to -3.75 D in each eye. 
5. The subject’s refractive cylinder must be ≤0.75 D in each eye. 
6. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
7. The subject must have distance best corrected visual acuity of 20/20-3 or better in 
each eye. 
8. Subjects must own a wearable pair of spectacles if required for their distance vision. 
9. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses 
a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more 
duration). 
10. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire”. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.   
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, 
Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious 
diseases (e.g. hepatitis, tuberculosis). 
4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal 
staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear. 
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history 
of recurrent corneal erosions. 
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6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 
7. A history of amblyopia, strabismus or binocular vision abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with contact lens wear. 
10. Use of any of the following oral medications within 1 week prior to enrollment: oral 
retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral 
antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids. 
11. Use of any ocular medication, with the exception of rewetting drops. 
12. History of herpetic keratitis. 
13. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment. 
14.  Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multi-
purpose care solution or Eye-Cept® rewetting drop solution. 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
The clinical study is a randomized-controlled, single-masked, cross-over clinical trial.  There 
are two study treatments. A total of approximately 60 eligible myopic subjects will be 
targeted to complete the study. Each Test article will be dispensed for 3±1 days and an 
optimization visit will occur.  The final lens pair will be dispensed for 7±1 days and the first 
follow-up on the final lens pair will occur.  The lenses will be dispensed for an additional 
7±1 days and the final lens measurements will be made. The second study lenses will then be 
fit and the above sequence repeated.   
4.2. Study Design Rationale  
The study is intended to compare two study lens types and the initial performance, in terms 
of subjective response after a period of lens dispensing.  The lenses are dispensed to 
determine the subjective responses and the comparison is made after a total of 14-20 days of 
wear.   
 
The cross-over study design was chosen to control for variables that may impact the lens 
performance between subjects.  It was determined that a washout was not required as 
previous studies on similar populations with similar multifocal designs did not show a 
significant carry over effect on the primary/secondary endpoints measured in the study.      
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4.3. Enrollment Target and Study Duration 
A total of approximately 70 eligible subjects will be enrolled with 60 targeted to complete 
the study.   
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover design 
with 2 lens types and 2 periods. Using a computer-generated randomization scheme provided 
by the study biostatistician, each subject will randomly be assigned to one of two unique 
sequences (Test/Control or Control/Test).  Randomization will be stratified by site. 
 
Permuted block randomization will be used to avoid bias in the assignment of subjects to 
treatment, and to enhance the validity of statistical comparisons across treatment groups. 
Each block will contain two different lens trial sequences. 
 
The order of lens wear will be based on the randomization scheme assigned to the study site.   
The study site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. 
5.2. Masking 
This is a single-masked study with the subjects being masked. Subjects will be unaware of 
the identity of the investigational product. Investigators and clinical site personnel involved 
in the data collection will not be masked as to the identity of the investigational product.  
 
Under normal circumstances, the mask should not be broken until all subjects have 
completed the study and the database is finalized. Otherwise, the mask should be broken only 
if specific emergency treatment/course of action would be dictated by knowing the treatment 
status of the subject. In such cases, the Investigator may, in an emergency, contact the 
medical monitor.  In the event the mask is broken, the Sponsor must be informed as soon as 
possible. The date, time, and reason for the unmasking must be documented in the subject 
record. The Investigator is also advised not to reveal the study treatment assignment to the 
clinical site or Sponsor personnel.  
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
5.3. Procedures for Maintaining and Breaking the Masking 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject.  The Sponsor must be notified before 
the mask is broken. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
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6.5. Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6. Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
6.7. Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study article and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records.  
 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study 
site personnel listed on the Site Delegation Log.  All test articles must be accounted.  This 
includes: 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits  
2. What was returned to the Investigator unused 
3. The number and reason for unplanned replacements   
 
The Investigator will collect all unused test articles from the subjects at the end of the 
subject’s participation. Subject returned unused test articles must be separated from the 
clinical study inventory of un-dispensed test articles, and must be labeled with the subject 
number and date of return.  Following final reconciliation of test articles by the monitor, the 
Investigator or monitor will return all unused test articles to the Sponsor. 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
 
  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information 
 
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symptoms questionnaire. 
1.10 
Entrance Visual 
Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the subject’s 
habitual contact lenses in place.  
    
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.   
 
1.11 
Lens Removal  
Have the subject remove their habitual lenses 
and store in an approved storage solution. 
 
1.12 
Keratometry  
Keratometry will be performed OD and OS 
and the steep and flat dioptric power and 
corresponding meridians recorded. 
 
1.13 
Subjective Refraction 
and Distance Visual 
Acuity 
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and distance 
visual acuity to the nearest letter. 
 
Note:  Best distance visual acuity with sphero-
cylindrical refraction must be at least 20/20-3 
in each eye for the subject to be eligible in the 
study. 
 
1.14 
Near ADD 
Determination 
The near reading addition will be determined 
using the binocular crossed cylinder technique 
(BCC) at 40 cm followed by optimization in a 
trial frame in step 1.16 below. 
 
1.15 
Ocular Dominance 
Determine the distance ocular dominance with 
the best distance correction in place using a 
+1.00-blur test. If the results are equivocal use 
the sighting dominance test to determine the 
dominant eye used for the study. 
Appendix F 
1.16 
ADD Refinement  
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses (or 
flippers) under binocular conditions.  
 
1.17 
Near Visual Acuity 
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm.  Record the near 
visual acuity OD, OS and OU at 40 cm. 
 
1.18 
Biomicroscopy 
 
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.   
 
For the conjunctival redness 
 0.5-
unit increments will be used in the grading.  
Corneal Staining Assessment 
) will 
be graded in 1.0 increments. 
If any of these slit lamp findings are Grade 3 
 
 
 
 
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1.26 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results.  
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
 
1.27 
Subjective Lens Fit 
Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
· The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form. 
 
1.28 
Modifications 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted. If the subject reports satisfactory 
vision with the lenses a modification is not 
required, however at the Investigator’s 
discretion and based upon their findings on the 
measured visual acuity and/or over- refraction 
the investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Follow 
the fitting guide allowing for at least 10 
minutes of settling time between each lens 
modification attempted.    
If modifications are required steps 1.21-1.27 
will be repeated for each modification.  
Appendix 
G and H 
(Fitting 
Guides) 
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1.29 
Post-Fit 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
1.30 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed.  
 
1.31 
Dispensing Criteria 
The lenses will be dispensed for 2-4 days. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
1.32 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
· A new lens will be opened and worn each 
day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
 
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during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
· A patient instruction booklet will be 
provided. 
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
1.33 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
· If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
· A patient instruction booklet will be 
provided. 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
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Distance Visual 
Acuity 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results 
and distance visual acuity OD and OS.   
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
2.9 
Determination of 
Lens Optimization 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.   
Follow the fitting guide allowing for at least 
10 minutes of settling time between each lens 
modification attempted. 
Appendix 
G and H 
(Fitting 
Guides)  
2.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
· The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.  
  
2.11 
Collection of unworn 
lenses (if applicable) 
Collect unworn lenses returned by the subject 
when lens power has been optimized  
 
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Note: If lens power was not changed allow the 
subject to use the unworn lenses dispensed at 
Visit 1 and dispense enough lenses of the same 
power to last the subject until their next visit. 
2.12 
Lens Removal 
The study lenses will be removed and 
discarded. 
 
2.13 
Biomicroscopy 
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the 
findings.  
For the conjunctival redness 
) 0.5-
unit increments will be used in the grading.  
Corneal Staining Assessment 
 will 
be graded in 1.0 increments. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.   
 
 
 
2.14 
Insertion of Study 
Lenses 
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.12 above.   
 
2.15 
PRO Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
2.16 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
 
2.17 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
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2.18 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
· A new lens will be opened and worn each 
day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
· A patient instruction booklet will be 
provided. 
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
2.19 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
· If determined necessary by the Investigator 
 
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To be counted as a day of wear at this visit the 
Subject must have worn the study lenses for 6 
hours prior to the visit. 
3.4  
PRO and CLDEQ-8 
Questionnaires 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire.   
 
3.5  
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire 
 
3.6  
Subjective 
Acceptance 
Record whether the subjects distance and near 
vision with the lenses is acceptable. 
 
3.7  
Distance and Near 
Entrance Visual 
Acuity 
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
 
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
 
3.8  
Visual Performance 
Distance (3M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OU for 
the following: 
Distance, Bright Illuminance 
ETDRS Charts 3M-HC#3 and LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts Intermediate 
(64 cm) High Contrast (1 Chart) and Low 
Contrast (1 Chart). 
Near (40 cm) High Contrast (1 Chart) and Low 
Contrast (1 Chart). 
 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 3M-HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast (1 Chart at each distance) 
Intermediate (64 cm) and Near (40 cm). 
 
Note: 
· The room illuminance must be 
between 7.3 and 7.9 EV. 
· Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7. 
· Guillon-Poling, Near Chart 
Luminance Acceptable EV Range 
10.8-11.1. 
 
 
 
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· Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles) 
3.9  
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.   
Note: No lens changes are allowed based on 
the over-refraction.   
Appendix 
D 
3.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
· The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.  
  
3.11 
Lens Removal 
Have the subject wearing the daily disposable 
lenses remove and discard the lenses. 
 
Subjects that are wearing the daily wear lens 
will remove and temporarily store in a lens 
case in OPTI-FREE® Replenish® to be 
reinserted after biomicroscopy. 
 
3.12 
Biomicroscopy 
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the 
findings.  
For the conjunctival redness 
 0.5-
unit increments will be used in the grading.  
Corneal Staining Assessment 
 will 
be graded in 1.0 increments. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.   
 
 
 
3.13 
Insertion of Study 
Dispense the subject new lenses if wearing the 
 
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Lenses 
daily disposable lenses that match the Distance 
and ADD power of the lenses that were 
removed in Step 3.11 above. 
 
Subjects that are wearing the daily reusable 
wear lenses will reinsert the lenses that were 
temporarily stored. 
3.14 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
 
3.15 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
3.16 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis. 
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
· A new lens will be opened and worn each 
day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
 
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· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
3.17 
Patient Instructions  
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
· If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
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LC#1, LC#2 and LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts High Contrast 
and Low Contrast Intermediate (64 cm) and 
Near (40 cm). 
 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 3M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64 cm) and Near (40 cm). 
 
Note: 
· The room illuminance must be 
between 7.3 and 7.9 EV. 
· Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7. 
· Guillon-Poling, Near Chart 
Luminance Acceptable EV Range 
10.8-11.1. 
· Do not use the Mesopic filter for Dim   
luminance (Dim luminance will be 
simulated by using the goggles). 
4.8  
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.  Note:  No lens changes are allowed 
based on the over-refraction.     
Appendix 
D 
4.9  
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
 
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distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision.   
4.18 
Study Lens Distance 
and Near Visual 
Acuity 
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
 
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
 
4.19 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results.  
The results of the distance over-refraction may 
also be checked for the impact on near vision 
under monocular and/or binocular conditions.    
 
4.20 
Subjective Lens Fit 
Assessment 
Evaluate overall lens fit acceptance (acceptable 
or unacceptable) based on centration, 
movement and other fitting characteristics. 
  
An unacceptable fit is deemed by one of the 
following criteria:  
· limbal exposure at primary gaze or with 
extreme eye movement; 
· edge lift; 
· excessive movement in primary and up 
gaze; or  
· insufficient movement in all three of 
the following conditions: primary gaze, 
up gaze, and Josephson push up. 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form. 
 
4.21 
Modifications 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
Appendix 
G (Fitting 
Guide) 
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investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Follow 
the fitting guide allowing for at least 10 
minutes of settling time between each lens 
modification attempted.    
If modifications are required steps 4.14-4.20 
will be repeated for each modification 
4.22 
Post-Fit 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
4.23 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed.  
 
4.24 
Dispensing Criteria 
The lenses will be dispensed for 2-4 days. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
4.25 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
· A new lens will be opened and worn each 
 
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day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved rewetting 
drops may be dispensed to be used as 
needed for dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
· A patient instruction booklet will be 
provided. 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to the 
Sponsor.  If lens damage is present, complete 
the Product Quality Complaint Form.  The 
lens will be stored in labeled vial with sterile 
saline, and returned to the Sponsor. 
4.26 
Patient Instructions 
for Daily Reusable 
Wear Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
· If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
· A patient instruction booklet will be 
 
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5.6  
Subjective 
Acceptance 
Record whether the subjects distance and near 
vision with the lenses is acceptable. 
 
5.7  
Distance and Near 
Entrance Visual 
Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
5.8  
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter 
under ambient room illumination.  The 
distance over-refraction may also be refined 
under binocular conditions.  Record the results 
and distance visual acuity OD and OS.  The 
results of the distance over-refraction may also 
be checked for the impact on near vision under 
monocular and/or binocular conditions.    
 
5.9  
Determination of 
Lens Optimization 
If the subject reports unsatisfactory vision, or is 
unable to obtain 20/30 distance visual acuity 
OU with the lenses then a modification must be 
attempted.  
If the subject reports satisfactory vision with 
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.   
Follow the fitting guide allowing for at least 
10 minutes of settling time between each lens 
modification attempted. 
Appendix 
G and H 
(Fitting 
Guides)  
5.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
  
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movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.  
5.11 
Collection of unworn 
lenses (if applicable) 
Collect unworn lenses returned by the subject 
when lens power has been optimized  
 
Note: If lens power was not changed allow the 
subject to use the unworn lenses dispensed at 
Visit 4 and dispense enough lenses of the same 
power to last the subject until their next visit. 
 
5.12 
Lens Removal 
The study lenses will be removed and 
discarded. 
 
 
5.13 
Biomicroscopy 
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the 
findings.  
For the conjunctival redness
 0.5-
unit increments will be used in the grading.  
Corneal Staining Assessment 
will 
be graded in 1.0 increments. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.   
 
 
 
5.14 
Insertion of Study 
Lenses 
Dispense the subject new lenses that match the 
distance and ADD power of the lenses that 
were removed in Step 5.12 above.   
 
5.15 
PRO Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire. 
 
5.16 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
 
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dispensed. 
5.17 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
5.18 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis. 
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
additional lenses will be dispensed. 
· A new lens will be opened and worn each 
day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
 
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Concomitant 
Medications Review 
and record any changes from the previous 
study visit. 
Record any adverse events or medical history 
changes from the previous study visit. 
6.2  
Wear Time 
Record the hours the subject has worn the 
study lenses and the comfortable wear time on 
the day of follow-up. 
 
6.3  
Compliance 
Record the subject’s compliance with wearing 
the study lenses.   
 
Note: Subjects must have worn lenses for at 
least 6 hours per day  
To be counted as a day of wear at this visit the 
Subject must have worn the study lenses for 6 
hours prior to the visit. 
 
6.4  
PRO Questionnaires 
and CLDEQ-8   
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO 
questionnaire.   
 
6.5  
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire 
 
6.6  
Subjective 
Acceptance 
Record whether the subjects distance and near 
vision with the lenses is acceptable. 
 
6.7  
Distance and Near 
Entrance Visual 
Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.  
 
6.8  
Visual Performance 
Distance (3M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OU for 
the following: 
Distance, Bright Illuminance 
ETDRS Charts 3M-HC#3 and LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts Intermediate 
(64 cm) High Contrast (1 Chart) and Low 
Contrast (1 Chart). 
Near (40 cm) High Contrast (1 Chart) and Low 
Contrast (1 Chart). 
 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 3M-HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
 
 
 
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High Contrast (1 Chart at each distance) 
Intermediate (64 cm) and Near (40 cm). 
 
Note: 
· The room illuminance must be 
between 7.3 and 7.9 EV. 
· Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7. 
· Guillon-Poling, Near Chart 
Luminance Acceptable EV Range 
10.8-11.1. 
· Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles) 
6.9  
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.   
Note: No lens changes are allowed based on 
the over-refraction.    
Appendix 
D 
6.10 
Lens Fit Assessment: 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
· presence of limbal exposure (appearance of 
clear cornea) in any gaze 
· presence of edge lift 
· presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.  
  
6.11 
Lens Removal 
Have the subject wearing the daily disposable 
lenses remove and discard the lenses. 
 
Subjects that are wearing the daily reusable 
wear lens will remove and temporarily store in 
a lens case in OPTI-FREE® Replenish® to be 
reinserted after biomicroscopy. 
 
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6.12 
Biomicroscopy 
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the 
findings.  
For the conjunctival redness 
) 0.5-
unit increments will be used in the grading.  
Corneal Staining Assessment (CTP-2003) will 
be graded in 1.0 increments. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.   
 
 
 
6.13 
Insertion of Study 
Lenses 
Dispense the subject new lenses if wearing the 
daily disposable lenses that match the Distance 
and ADD power of the lenses that were 
removed in Step 6.11 above. 
 
Subjects that are wearing the daily wear lenses 
will reinsert the lenses that were temporarily 
stored. 
 
6.14 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
 
6.15 
Dispensing Criteria 
The lenses will be dispensed for 7±1 day. 
· Distance Snellen acuity equal to or better 
than 20/30 OU 
· Subject must indicate that the vision is 
acceptable. 
· Subject must indicate that the comfort of 
the lenses is acceptable. 
· Lenses must have an acceptable general 
lens fit. 
 
6.16 
Patient Instructions 
for Daily Disposable 
Lenses 
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis. 
· Only enough lenses will be dispensed to 
the subject to wear for the required number 
of days until their follow-up visit. No 
 
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additional lenses will be dispensed. 
· A new lens will be opened and worn each 
day. 
· Instruct the subject to bring back all 
unworn study lenses. 
· No cleaning or disinfecting solutions will 
be used. If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
· Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
 
 
Note:  In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement.  As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with sterile saline, and returned to the 
Sponsor. 
 
6.17 
Patient Instructions 
for Daily Reusable 
Wear Lenses  
Instruct the Subject the following: 
· The lenses will be worn on a daily wear 
basis.  
· OPTI-FREE® Replenish® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided.  
· If determined necessary by the Investigator 
sterile non-preserved rewetting drops may 
be dispensed to be used as needed for 
dryness. 
· Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every day 
during the study. 
 
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of the study lenses using the PRO 
questionnaire.   
7.5  
Subject Reported 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
7.6  
Distance and Near 
Entrance Visual 
Acuity 
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place.  
    
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU.   
 
7.7  
Visual Performance 
Distance (3M) 
Intermediate (64 cm)  
Near (40 cm) 
Visual performance will be recorded OD, OS, 
and OU for the following: 
Distance, Bright Illuminance 
ETDRS Charts 3M-HC#1, HC#2, HC#3 and 
LC#1, LC#2 and LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts High Contrast 
and Low Contrast Intermediate (64 cm) and 
Near (40 cm). 
 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 3M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64 cm) and Near (40 cm). 
 
Note: 
· The room illuminance must be 
between 7.3 and 7.9 EV. 
· Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7. 
· Guillon-Poling, Near Chart 
Luminance Acceptable EV Range 
10.8-11.1 
· Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles) 
 
 
 
7.8  
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.   
Note:  No lens changes are allowed based on 
the over-refraction.   
Appendix 
D 
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Sphero-cylindrical 
Refraction and 
Distance Exit Visual 
Acuity 
sphero-cylindrical refraction will be 
performed.   
 
Record the refraction and distance visual 
acuity to the nearest letter. 
 
F.2  
Subject Disposition 
Indicate if the subject completed the study 
successfully.  If subject discontinued from the 
study indicate the reason. 
 
7.3. Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected at a minimum: 
· Chief complaint prompting the visit.  If the reason is an adverse event, the applicable 
eCRF for the adverse event must be completed and subject record completed as 
appropriate 
· Date and time of the visit and all procedures completed at the unscheduled visit 
· Review of adverse event and concomitant medications 
· Documentation of any test article dispensed or collected from the subject, if 
applicable 
· Slit lamp findings (using the Slit Lamp Classification Scale) 
 
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject 
record must be completed documenting the date and primary reason for withdrawal and the 
study CRA notified. 
 
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained.  If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider.  
 
 
 
 
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· Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment) 
· Subject missed two consecutive study visits 
· Subject not compliant with study lens wear schedule  
· 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: 
· Complete the current visit (scheduled or unscheduled) 
· Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study 
· Record the spherocylindrical refraction with best corrected distance visual acuity  
· Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2 
· Collect all unused test article(s) from the subject 
 
An additional subject may be enrolled if a subject discontinues from the study prematurely.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.  
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear.  See the Exclusion criteria for specific details.  
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
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11. STUDY TERMINATION 
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC safety review 
committee, the study may be terminated. This potential stopping rule is established based on 
our trial involving approximately 200 subjects wearing the investigational soft contact lens 
for up to 3 years with an assumed MK rate that is below 0.2% per patient-year. The rate of 
0.2% per patient year is the established rate for extended wear lenses in adults, which was 
requested by the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA 
response to a pre-IDE submission. To be conservative, 200 independent patient years were 
used in the calculation. The probability of observing 2 cases or more incidents of MK is 
0.061, and 3 cases or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient 
year).  
 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.    
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.   
 
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
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monitors, and site personnel, etc. The following are not considered product quality 
complaints: 
· Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)” 
· Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site 
· Lens replacements that occur due to drops/fall-outs 
· Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations 
where there is no deficiency alleged by the subject 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in 
use is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
· Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness) 
· Who received the complaint 
· Study number 
· Clinical site information (contact name, site ID, telephone number) 
· Lot number(s) 
· Unique Subject Identifier(s) 
· Indication of who first observed complaint (site personnel or subject) 
· OD/OS indication, along with whether the lens was inserted 
· Any related AE number if applicable 
· Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
· Eye Care Provider objective (slit lamp) findings if applicable 
· Confirmation of product availability for return (and tracking information, if 
available), or rationale if product is not available for return (Refer to Form Control 
 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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13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include 
any condition resulting from concomitant illnesses, reactions to concomitant 
medications, or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event 
 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
· Results in death 
· Is life threatening 
· Requires in-patient hospitalization or prolongation of existing hospitalization 
· Results in persistent or significant disability/incapacity (e.g., a sight threatening 
event, a significant persistent or permanent change, impairment, damage, or 
disruption to the subject’s body) 
· Is a congenital anomaly/birth defect 
· Requires intervention to prevent permanent damage (the use of the test article 
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
· Microbial Keratitis (MK) 
· Iritis (including cells in the anterior chamber) 
· Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater 
· Central Corneal Opacity 
· Central Corneal Neovascularization 
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· Uveitis 
· Endophthalmitis 
· Hypopyon 
· Hyphemia 
· Penetration of Bowman’s Membrane 
· Persistent Epithelial Defect 
· Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
· Contact Lens Induced Peripheral Ulcer (CLPU) 
· Significant Infiltrative Events (SIE) 
· Superior Epithelial Arcuate Lesions (SEALs) 
· Any Temporary Loss of > 2 Lines of BSCVA 
· Other grade 3 or higher corneal findings, such as abrasions or edema 
· Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
· Asymptomatic Corneal Scar 
· Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  
However, the Investigator may choose to treat as a precautionary measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following: 
· Non-significant Infiltrative Event (NSIE) 
· Contact Lens Papillary Conjunctivitis (CLPC) 
· Superficial Punctate Keratitis (SPK) 
· Conjunctivitis: Bacterial, Viral, Allergic 
· Blepharitis 
· Meibomianitis 
· Contact Dermatitis 
· Localized Allergic Reactions 
· Any corneal event not explicitly defined as serious or significant adverse event, 
which necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
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Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1 
 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly.  Elements of categorization will include: 
· Seriousness/Classifications (see definition in Section 13.1) 
· Causality or Relatedness – i.e. the relationship between the test article, study 
treatment or study procedures and the adverse event (not related; unlikely related; 
possibly related; related - see definition in Section 13.2.1) 
· Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)   
· Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; 
unknown 
· Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and 
the test article. The test article relationship for each adverse event should be determined by 
the investigator using these explanations: 
· Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
· Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely 
· Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded 
· Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship 
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge 
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13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject.  The 
assessment of severity is made irrespective of test article, study treatment or study procedure 
relationship or seriousness of the event and should be evaluated according to the following 
scale: 
· Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities 
· Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities 
· Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following: 
· Adverse event (diagnosis not symptom) 
· Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
· Date the clinical site was notified  
· Date and time of onset 
· Date and time of resolution 
· Adverse event classification, severity, and relationship to test articles, as applicable 
· Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements 
· Any referral to another health care provider if needed 
· Outcome, ocular damage (if any) 
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· Likely etiology 
· Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate 
Assessment eCRF.  Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature.  If cultures are collected, the date of culture 
collection and laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study 
visit date, should be followed to resolution of the adverse event or until referral to an 
appropriate health care provider, as recommended by the Investigator. Non-ocular adverse 
events that are not related to the test article, study treatment, or study procedures may be 
recorded as “ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or 
telephone as soon as possible and no later than 24 hours from discovery for any serious 
/significant adverse events, and 2 days from discovery for any non-significant adverse event.  
In addition, a written report will be submitted by the Principal Investigator to the IEC/IRB 
according to their requirements (Section 13.4.2).  The report will comment whether the 
adverse event was considered to be related to the test article, study treatment or study 
procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
 
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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: 
· Notify the Sponsor immediately 
· Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject 
· Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article 
· Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect.  This report is in addition to 
the immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
forth by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines 
set forth by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest 
None 
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event.  Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
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will not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur 
secondary to systemic hormonal changes, and not due to unforeseen health risks to the 
mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
All data summaries and statistical analyses will be performed using the SAS software 
Version 9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis. 
 
Summary tables (Descriptive statistics and/or frequency tables) will be provided 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 (Safety Population or Per-Protocol Population). All analyses will be 
conducted on per-protocol population (see Section 14.3).   
14.2. Sample Size Justification 
Historical study 
tested hyperopes in presbyopic population. The data from 
 
was used to estimate the sample size of the study. There was no historical data for myopes 
yet, so the performance of the myopes was assumed to be the same as hyperopes. 
 
Using the POWER procedure in SAS 9.4, it required at least 59 myopic subjects to complete 
the study to satisfy all the primary and secondary hypotheses with overall type I error 0.05 
and power no less than 90%. At the end of this section, a summary table of the sample sizes 
required for each individual hypothesis is provided.  
 
Primary Hypothesis: 
Criteria 
# of subjects needed 
Power 
CLUE Vision 
>40 
42 
0.9 
 
 
 
 
Secondary Hypothesis 
Criteria 
# of subjects needed 
Power 
CLUE Vision 
Test-Control>=-5 
59 
0.9 
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14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
All subjects regardless of actual treatment and subsequent withdrawal from study or 
deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
Primary efficacy analysis: 
 
CLUE Vision: 
Overall quality of vision scores will be analyzed using a linear mixed model adjusting for 
baseline values as fixed covariates. The model will include the experimental design factors: 
sequence of lens wear, period, lens type, time point and interaction between lens and time 
point as fixed effects. The covariance between residual errors from the same subject across 
lens wearing periods/time point will be selected based on the finite-sample corrected 
Akaike’s Information Criterion (Keselman et al. 1998)6. Covariance structures considered 
may include: Homogenous compound symmetry (CS) and Unstructured covariance structure 
(UN). The structure that returns the lowest Akaike Information Criteria Corrected (AICC) 
will be selected as the structure that best fit the data.  
 
Primary Hypothesis: 
Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models of CLUE vision scores for each study 
population. Statistically superiority will be concluded if the lower limit of the confidence 
intervals of the test lens are greater than the thresholds for the corresponding populations. 
 
Secondary Hypothesis: 
Comparisons between the test lens and control lens at each time point (1 week and 2 weeks) 
will be carried out using 95% confidence intervals constructed of least-square means (LSM) 
differences (Test minus Control) from the linear mixed model. The non-inferiority of the test 
lens relative to the control will be concluded if the lower confidence limit of LSM difference 
is above the non-inferiority margin -5. The superiority will be established if the lower 
confidence limit is above 0. 
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In all models, the Kenward and Roger method (Kenward and Roger, 1997)7 will be used for 
the calculation of the denominator of degrees of freedom. 
 
14.6. Secondary Analysis 
See Section 14.5. 
14.7. Other Exploratory Analyses 
Not Applicable. 
14.8. Interim Analysis 
Not Applicable. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a 
parametric regression method used to make at least 5 imputations. 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an 
EDC system (Bioclinica). An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis.  
 
External Date Sources for this study include:  
Not Applicable 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy 
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and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
will be authorized to gain access to the subject recordation for the purposes of monitoring 
and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate 
and complete data collection. Data will be transmitted from the clinical site to a secure 
central database as forms are completed or updated, ensuring information accuracy, security, 
and confidentiality. After the final database lock, the Investigator will be provided with 
Individual Patient Profiles (IPP) including the full audit trail on electronic media in PDF 
format for all of the study data. The IPP must be retained in the study files as a certified copy 
of the source data for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2011.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
· subject identification 
· eligibility 
· study identification 
· study discussion 
· provision of and date of informed consent 
· visit dates 
· results of safety and efficacy parameters as required by the protocol 
· a record of all adverse events 
· follow-up of adverse events 
· medical history and concomitant medication 
· test article receipt/dispensing/return records 
· date of study completion 
· reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
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16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, 
scientific data or other pertinent information is confidential and remains the property of 
JJVC.  The Investigator may use this information for the purposes of the study only. It is 
understood by the Investigator that JJVC will use information developed in this clinical study 
in connection with the development of the investigational product and therefore may disclose 
it as required to other clinical investigators and to regulatory agencies. In order to allow the 
use of the information derived from this clinical study, the Investigator understands that 
he/she has an obligation to provide complete test results and all data developed during this 
study to the Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the 
conduct of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include: 
· Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
· Ensuring the rights and wellbeing of subjects are protected 
· Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel 
· Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
· Ensuring that the clinical site has sufficient test article and supplies 
· Clarifying questions regarding the study 
· Resolving study issues or problems that may arise 
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· Reviewing of study records and source documentation verification in accordance with 
the monitoring plan 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, 
during the study, subjects will be given any new information that may affect their decision to 
continue participation.  Subjects will be told that their consent to participate in the study is 
voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled.  Only subjects who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent voluntarily will be enrolled. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP 
is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
· Final protocol and, if applicable, amendments 
· Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
· Investigator’s Brochure (or equivalent information) and amendments 
· Sponsor-approved subject recruitment materials 
· Information on compensation for study-related injuries or payment to subjects for 
participation in the study 
· Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless 
not required, as documented by IEC/IRB) 
· Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
· Any other documents that the IEC/IRB requests to fulfill its obligation 
 
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), the informed consent form, applicable recruiting materials, 
Page 79 of 190

and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
· Protocol amendments 
· Revision(s) to informed consent form and any other written materials to be provided 
to subjects 
· If applicable, new or revised subject recruitment materials approved by the Sponsor 
· Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
· Investigator’s Brochure amendments or new edition(s) 
· Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
· Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
· New information that may adversely affect the safety of the subjects or the conduct of 
the study 
· Major protocol deviations as required by the IEC/IRB 
· Report of deaths of subjects under the Investigator's care 
· Notification if a new Investigator is responsible for the study at the clinical site 
· Any other requirements of the IEC/IRB 
 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines,  
applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
Page 80 of 190

informed that their participation is voluntary and that they may withdraw consent to 
participate at any time.  
 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject. 
 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States4 and other applicable personal data protection and security laws and 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records. 
18.5. Privacy of Personal Data 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
· processed fairly and lawfully 
· collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
· adequate, relevant, and not excessive in relation to said purposes 
· accurate and, where necessary, kept current 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
Page 81 of 190

should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical 
Research Agreement.  The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol 
violations such as: 
· Continuing an ineligible subject in the study 
· Scheduling a study visit outside the subject’s acceptable visit range 
 
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JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
· Query resolution 
· Case Report Form signature 
· Completion of any follow-up action items  
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation. 1998; 
27:591-604. 
7. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997; 53:983–997. 
 
 
 
 
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide will be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
ACUVUE OASYS® 
1-DAY ACUVUE® MOIST MULTIFOCAL 
1-DAY ACUVUE® MOIST 
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APPENDIX D: BINOCULAR OVER REFRACTION 
 
Binocular Over-refraction Technique 
 
1. Place trial frame on subject 
2. Add +1.00 D sphere to OS 
3. Add + 0.50DS OD and check VA 
 
      - 
if VA remained unchanged or improved, repeat step 3  
- 
if VA decreased, add minus until best VA first achieved *note: add minus for 0.5 
seconds to avoid reflex accommodation.  
4. Record VA 
5. Change +1.00 D sphere to OD 
6. Repeat steps 3 and 4 
 
 
 
 
 
 
 
 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
 
Presbyopic Symptoms Questionnaire 
 
1. Do you notice that you often have to hold things farther away so that you can read 
them? 
2. Do you notice that you often have difficulty focusing on near objects (i.e., 
experiencing blurry vision when looking at things close-up)? 
3. Do you often have headaches or eyestrain, or feel fatigued, when reading or 
conducting other near activities? 
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc.? 
5. Do you often have difficulty reading under dim or low light? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX G: TEST LENS FITTING GUIDE 
Step 1. 
Choose the first lens based on the best spherical equivalent refraction and ADD power for 
both eyes.   Select the first lens per table 1 below.   
 
Table 1.  Initial Lens Selection   
 
ADD 
 
 
 
 
 
 
 
 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
 
Non-
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
HGH 
 
HGH 
 
HGH 
 
Assess the subject’s vision at distance and near after the lens has settled (10 minutes).  If the 
vision is acceptable continue with the fit assessment and dispensing as per the protocol.   
 
If the vision is not acceptable, ensure that the proper initial lens power was selected by 
performing a distance over-refraction with +/- 0.25D trial lenses (or flippers) to determine if 
a change in the initial lens power is required (note:  the over-refraction should be performed 
outside of the phoropter in normal room illumination).  Recheck both distance and near 
vision with the over-refraction in place.  If a change in the initial lens power is not required 
refer to the fitting steps listed below in step 2 (table 2).   
 
Step 2. 
   
Table 2.  Lens change if required. * 
Distance 
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
ACUVUE® 
OASYS®       
2-WEEK 
Sphere  
ACUVUE®
OASYS®       
2-WEEK 
Sphere  
ACUVUE® 
OASYS®       
2-WEEK 
Sphere  
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID
+ 
 
MID
+ 
 
MID
+ 
 
 
 
 
 
 
 
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Near  
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW+ 
 
LOW+ 
 
LOW+ 
 
MID+ 
 
MID+ 
 
HGH+ 
 
HGH+ 
 
HGH+ 
 
*Note:  a + following the contact lens design indicates to add +0.25 D to the distance contact 
lens power on the non-dominant eye (see example below).   
 
Example:  The subject is a +1.75 ADD and has a near complaint and it is determined a 
change in lens pairs is needed.  Referring to table 2 near complaint section, under 
the +1.75 ADD it states to keep the dominant eye the same (i.e. MID) and add 
+0.25D to the non-dominant eye (i.e. MID+).        
 
Subjects spherical equivalent distance refraction   
OD: -2.50 
OS:  -3.00 (OS non-dominant eye) 
 
The new lens chosen should be as follows: 
OD: -2.50 MID ADD (i.e. no change)  
OS:  -2.75 MID ADD 
 
Step 3.  
If after the above lens modifications have been attempted and the subject’s vision is still not 
satisfactory, and additional optimizations are allowed by the protocol, lens changes may be 
attempted, based on the Investigator’s clinical experience, to determine if acceptable vision 
can be achieved.   
   
 
 
 
 
 
 
 
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APPENDIX H: CONTROL LENS FITTING GUIDE 
Step 1. 
Choose the first lens based on the best spherical equivalent refraction and ADD power for 
both eyes.   Select the first lens per table 1 below.   
 
Table 1.  Initial Lens Selection   
 
ADD 
 
 
 
 
 
 
 
 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
 
Non-
Dominant Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
HGH 
 
HGH 
 
HGH 
 
Assess the subject’s vision at distance and near after the lens has settled (10 minutes).  If the 
vision is acceptable continue with the fit assessment and dispensing as per the protocol.   
 
If the vision is not acceptable, ensure that the proper initial lens power was selected by 
performing a distance over-refraction with +/- 0.25D trial lenses (or flippers) to determine if 
a change in the initial lens power is required (note:  the over-refraction should be performed 
outside of the phoropter in normal room illumination).  Recheck both distance and near 
vision with the over-refraction in place.  If a change in the initial lens power is not required 
refer to the fitting steps listed below in step 2 (table 2).   
 
Step 2. 
   
Table 2.  Lens change if required. * 
Distance 
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
1-Day 
ACUVUE® 
Moist 
 
 
1-Day 
ACUVUE® 
Moist 
 
 
1-Day 
ACUVUE® 
Moist 
 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID
+ 
 
MID
+ 
 
MID
+ 
 
 
 
 
 
 
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Near  
Complaint 
 
 
 
 
 
 
 
 
ADD 
+0.75 
+1.00 
+1.25 
+1.50 
+1.75 
+2.00 
+2.25 
+2.50 
Dominant 
Eye 
 
LOW 
 
LOW 
 
LOW 
 
MID 
 
MID 
 
MID 
 
MID 
 
MID 
Non-
Dominant 
Eye 
 
LOW+ 
 
LOW+ 
 
LOW+ 
 
MID+ 
 
MID+ 
 
HGH+ 
 
HGH+ 
 
HGH+ 
 
*Note:  a + following the contact lens design indicates to add +0.25 D to the distance contact 
lens power on the non-dominant eye (see example below).   
 
Example:  The subject is a +1.75 ADD and has a near complaint and it is determined a 
change in lens pairs is needed.  Referring to table 2 near complaint section, under 
the +1.75 ADD it states to keep the dominant eye the same (i.e. MID) and add 
+0.25D to the non-dominant eye (i.e. MID+).        
 
Subjects spherical equivalent distance refraction   
OD: -2.50 
OS:  -3.00 (OS non-dominant eye) 
 
The new lens chosen should be as follows: 
OD: -2.50 MID ADD (i.e. no change)  
OS:  -2.75 MID ADD 
 
Step 3.  
If after the above lens modifications have been attempted and the subject’s vision is still not 
satisfactory, and additional optimizations are allowed by the protocol, lens changes may be 
attempted based on the Investigator’s clinical experience, to determine if acceptable vision 
can be achieved.   
 
 
 
 
 
 
 
 
 
 
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APPENDIX I: CLINICAL TECHNICAL PROCEDURES (CTP) 
 
 
· 
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
· 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
· 
 DETERMINATION OF NEAR ADD 
· 
 NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
· 
 LENS FITTING CHARACTERISTICS 
· 
 SUBJECT REPORTED OCULAR SYMPTOMS 
· 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
· 
 BIOMICROSCOPY SCALE 
· 
  KERATOMETRY 
· 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
· 
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
· 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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, LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS 
 
 
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Page 7 of 7 
 
 
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 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
 
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 DETERMINATION OF NEAR ADDITION 
 
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 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
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 LENS FITTING CHARACTERISTICS  
 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
 
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 BIOMICROSCOPY SCALE 
 
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 KERATOMETRY PROCEDURE 
 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE 
 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6201 Clinical Evaluation of a Reusable Multifocal Optical 
Design in a Presbyopic Population 
 
Version and Date: 4.0, Amendment 3.0 25 June 2018 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and 
GCP guidelines regarding clinical trials during and after study completion. 
 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization. 
 
Principal 
Investigator: 
 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
 
Institution/Site: 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
Institution/Site Address 
 
 
 
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