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

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Protocol Title: Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a 
Presbyopic Population  
 
Protocol CR-6400 
 
Version: 4.0 
                            
Date: 06 August 2020  
 
 
Investigational Products: JJV Investigational senofilcon A Multifocal Contact Lens  
 
Key Words:  Presbyopia, Multifocal, senofilcon A, Daily Wear, Reusable, Dispensing,  
 
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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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS .............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 19 
2.1. 
Objectives ................................................................................................................. 19 
2.2. 
Endpoints .................................................................................................................. 19 
2.3. 
Hypotheses ............................................................................................................... 21 
3. 
TARGETED STUDY POPULATION ........................................................................... 22 
3.1. 
General Characteristics ............................................................................................ 22 
3.2. 
Inclusion Criteria ...................................................................................................... 22 
3.3. 
Exclusion Criteria ..................................................................................................... 23 
3.4. 
Enrollment Strategy.................................................................................................. 23 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 24 
4.1. 
Description of Study Design .................................................................................... 24 
4.2. 
Study Design Rationale ............................................................................................ 24 
4.3. 
Enrollment Target and Study Duration .................................................................... 24 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 25 
5.1. 
Test Article Allocation ............................................................................................. 25 
5.2.   Masking...................................................................................................................... 25 
5.3.    Procedures for Maintaining and Breaking the Masking ........................................... 25 
6. 
STUDY INTERVENTION ............................................................................................. 26 
6.1. 
Identity of Test Articles............................................................................................ 26 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 27 
6.3. 
Administration of Test Articles ................................................................................ 27 
6.4. 
Packaging and Labeling ........................................................................................... 27 
6.5. 
Storage Conditions ................................................................................................... 28 
6.6. 
Collection and Storage of Samples .......................................................................... 28 
6.7. 
Accountability of Test Articles ................................................................................ 28 
7. 
STUDY EVALUATIONS .............................................................................................. 29 
7.1. 
Time and Event Schedule ......................................................................................... 29 
7.2. 
Detailed Study Procedures ....................................................................................... 32 
VISIT 1 ........................................................................................................................... 32 
VISIT 2 ........................................................................................................................... 37 
VISIT 3 ........................................................................................................................... 41 
FINAL EVALUATION .................................................................................................. 44 
7.3. 
Unscheduled Visits ................................................................................................... 44 
7.4. 
Laboratory Procedures ............................................................................................. 46 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 46 
8.1. 
Completion Criteria .................................................................................................. 46 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 47 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 47 
9.1. 
Systemic Medications .............................................................................................. 48 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 48 
11. 
STUDY TERMINATION ........................................................................................... 49 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 49 
13. 
ADVERSE EVENTS ................................................................................................... 50 
13.1. 
Definitions and Classifications ............................................................................. 50 
13.2. 
Assessing Adverse Events .................................................................................... 52 
13.2.1. 
Causality Assessment .................................................................................... 53 
13.2.2. 
Severity Assessment ...................................................................................... 53 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 53 
13.4. 
Reporting Adverse Events .................................................................................... 55 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 55 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
56 
13.4.3. 
Event of Special Interest ............................................................................... 56 
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13.5. 
Reporting of Pregnancy ........................................................................................ 56 
14. 
STATISTICAL METHODS ........................................................................................ 56 
14.1. 
General Considerations ......................................................................................... 56 
14.2. 
Sample Size Justification ...................................................................................... 57 
14.3. 
Analysis Populations ............................................................................................ 60 
14.4. 
Level of Statistical Significance ........................................................................... 60 
14.5. 
Primary Analysis .................................................................................................. 60 
14.6. 
Secondary Analysis .............................................................................................. 63 
14.7. 
Other Exploratory Analyses ................................................................................. 64 
14.8. 
Interim Analysis ................................................................................................... 64 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 64 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 64 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 64 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 64 
15.2. 
Subject Record ...................................................................................................... 65 
15.3 
ClinicalTrials.gov ................................................................................................. 65 
16. 
DATA MANAGEMENT............................................................................................. 65 
16.1. 
Access to Source Data/Document ........................................................................ 65 
16.2. 
Confidentiality of Information.............................................................................. 66 
16.3. 
Data Quality Assurance ........................................................................................ 66 
17. 
CLINICAL MONITORING ........................................................................................ 66 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 67 
18.1. 
Study-Specific Design Considerations ................................................................. 67 
18.2. 
Investigator Responsibility ................................................................................... 67 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 67 
18.4. 
Informed Consent ................................................................................................. 68 
18.5. 
Privacy of Personal Data ...................................................................................... 69 
19. 
STUDY RECORD RETENTION................................................................................ 70 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 71 
21. 
PUBLICATION ........................................................................................................... 71 
22. 
REFERENCES ............................................................................................................ 71 
APPENDIX A: 
 ..... 72 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 105 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 106 
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APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 109 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 110 
APPENDIX F: OCULAR DOMINANCE............................................................................ 111 
APPENDIX G: LENS FITTING GUIDE ............................................................................. 112 
APPENDIX H: 
 .................................... 114 
 DETERMINATION OF NEAR ADD ............................................................... 115 
 NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE .......... 121 
 LENS FITTING CHARACTERISTICS ............................................................ 124 
 SUBJECT REPORTED OCULAR SYMPTOMS ............................................. 130 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
............................................................................................................................................... 132 
 DETERMINATION OF SPHEROCYLINDRICAL REFRACTIONS ............. 138 
 BIOMICROSCOPY SCALE ............................................................................. 145 
 KERATOMETRY .............................................................................................. 151 
 DISTANCE AND NEAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 153 
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE .. 158 
 WHITE LIGHT LENS SURFACE WETTABILITY ........................................ 162 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 164 
APPENDIX I: COVID-19 RISK MITIGATION GUIDELINES ........................................ 170 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 180 
 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 14 
 
TABLE OF CONTENTS  
Table 1: Planned Enrollment by Strata and Site ..................................................................... 24 
Table 2: Test Articles .............................................................................................................. 26 
Table 3: Ancillary Supplies .................................................................................................... 27 
Table 4: Time and Events ....................................................................................................... 29 
Table 5: Disallowed systemic medications  ............................................................................ 48 
Table 6: Historical Studies Utilized for Sample Size Calculation ...........................................57 
Table 7: Descriptive summary of Efficacy Endpoints Period 1 Only - 2-Week Follow-up ....58 
Table 8: Descriptive Summary of Safety Endpoints All Available Data ................................58 
Table 9: Degrees of Borrowing Historical Data by Manufacturing Platform .........................59 
Table 10: Power Calculation by Endpoint/Hypothesis Assuming a Sample Size of 60 Subjects 
..................................................................................................................................................59 
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PROTOCOL TITLE, NUMBER, VERSION 
Protocol Title: Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a 
Presbyopic Population  
Protocol Number:  CR-6400    
Version: 4.0 
Date: 06 August 2020    
 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
 
MEDICAL MONITOR 
Name:  Thomas R. Karkkainen, OD, MS, FAAO 
 
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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SYNOPSIS  
Protocol Title 
Protocol Title: Clinical Evaluation of a Daily Wear Reusable 
Multifocal Optical Design in a Presbyopic Population  
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Development phase, Phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov. 
Test Article(s) 
Investigational Products: JJV Investigational Multifocal 
Contact Lens manufactured in senofilcon A material.  
Wear and Replacement 
Schedules 
Wear Schedule: The Test lenses are used as daily wear 
reusable.   
 
Replacement Schedule: The Test lens will be replaced at the 
optimization visit.  The Test lenses will also be replaced 
when lost or damaged 
Objectives  
The purpose of this study is to demonstrate that the JJV 
Investigational senofilcon A Multifocal Contact Lens in its 
final lens design FAL100 (low add), FAL101(medium add) 
and FAL102 (high add), made in the Flexible Manufacturing 
Platform (FMP) meets the design validation requirements 
related to vision, eye health and fit acceptance.   
Study Endpoints 
Primary Endpoints 
• CLUE vision scores 
• LogMAR visual acuity scores  
• Unacceptable lens fit (Yes/No) 
• Grade 3 or Higher Biomicroscopy Findings (Yes/No) 
 
Secondary Endpoints 
• Number of lenses needed to fit (optimize) the 
subject’s vision 
Other Endpoints 
• Lens Deposits 
• CLUE comfort/handling scores 
• PRO individual questions 
 
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Study Design 
This is a single-masked (partial), controlled, dispensing 
clinical trial.  A total of approximately 60 subjects will be 
targeted to complete with a 1:1 allocation between strata 
(Hyperopes and Myopes).  Subjects will be fit in the study 
lens for approximately 2-4 days then return to undergo 
optimization, if required and wear the optimized pair for 
approximately 2 weeks. The primary endpoints will be 
CLUE vision scores, logMAR visual acuity, biomicroscopy 
findings and lens fit. 
 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
Sample Size 
A total of approximately 60 subjects will be targeted to 
complete. 
Study Duration 
The study will last approximately 2-3 months. 
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
invited to participate in the study.  Subjects will be adapted 
soft contact lens wearers in both eyes.  Additional 
information regarding the eligibility of the population can be 
found in the inclusion/exclusion criteria outlined below. 
Eligibility Criteria 
Potential subjects must satisfy all the following criteria to be 
enrolled in the study 
 
Inclusion Criteria after Screening: 
  
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol. 
3. The subject must be at least 40 years of age and not 
greater than 70 years of age at the time of consent. 
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
5. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. wears lenses a minimum of 2 
days per week for at least 6 hours per wear day, for 1 
month of more duration). 
6. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or 
monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire” (Appendix E). 
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Inclusion Criteria after Baseline: 
7. The subject’s distance spherical equivalent refraction 
(vertex corrected if ≥-4.25 D) must be in the range of 
-1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye. 
8. The subject’s refractive cylinder must be ≤0.75 D in 
each eye. 
9. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual 
acuity of 20/20-3 or better in each eye. 
 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
 
Exclusion Criteria after Screening: 
 
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies 
that may interfere with contact lens wear.   
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere 
with contact lens wear. This may include, but not be 
limited to, diabetes, hyperthyroidism, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases 
or any infectious diseases (e.g. hepatitis, tuberculosis). 
4. Any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, dacryocystorhinostomy, peripheral 
iridotomy/iridectomy, cataract surgery, retinal 
surgery, etc.). 
5. A history of amblyopia, strabismus or binocular 
vision abnormality. 
6. History of glaucoma, macular degeneration, recurrent 
corneal erosions, recurrent styes, herpetic keratitis, 
irregular cornea or pathological dry eye. 
7. Use of any of the following medications within 1 week 
prior to enrollment: oral retinoids, oral tetracyclines, 
oral phenothiazines, anticholinergics, corticosteroids.  
See Section 9.1 for additional information. 
8. Use of any ocular medication, with the exception of 
rewetting drops. 
9. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment. 
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10. Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
11. Any known hypersensitivity or allergic reaction to 
Optifree®Replenish® multi-purpose care solution, 
sodium fluorescein or non-preserved rewetting drop 
solutions. 
 
Exclusion Criteria after Baseline: 
 
12. Clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, 
tarsal abnormalities or bulbar injection, or any other 
corneal or ocular abnormalities which would 
contraindicate contact lens wear. 
13. Any current ocular infection or inflammation. 
14. Any current ocular abnormality that may interfere 
with contact lens wear. 
 
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.   
 
See section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
See Section 7.2 for the detailed procedures. 
Microbiology or Other 
Laboratory Testing 
None 
Study Termination 
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing of investigational product. In the event of 
a UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled. 
Ancillary Supplies/ Study-
Specific Materials 
Rewetting drops, lens cases, glass vials, saline, ETDRS light 
cabinet, distance (4M) logMAR charts, and Near logMAR 
charts. Optifree®Replenish® Contact Solution. 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File. 
 
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
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PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
  
 
 
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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better than 0.0 and the mean near logMAR acuity better than +0.1 logMAR.  This with true of 
the acuity at the initial fit as well as the 1 week and 2-week visits in the final lens pair.  There 
were two non-ocular adverse events that occurred during the study that were not related to any 
of the Test lenses.  
 
 was a dispensing parallel-ARM study and had a primary endpoint of logMAR visual 
acuity. There were 149 subjects that completed the study overall with 37 subjects completing 
in the ARM involving the study lenses that will be used in this study.  The lenses displayed 
clinically acceptable logMAR visual acuity after approximately 2 weeks of wear with the mean 
bright high contrast binocular logMAR acuity of -0.077, -0.083 and 0.049 for distance, 
intermediate and near respectively.   
 had four parallel ARMs with one of the ARMs being the test lenses evaluated in this 
study along with two other investigational test lenses and a control lens.  For the ARM with 
the lenses tested in this study there were no ocular adverse events reported and one non-ocular 
that was not related to the test article.  
 
 was a dispensing crossover study on myope subjects and had a primary endpoint of 
subject vision response. There were 53 subjects that completed the study as cohort.  The test 
lenses displayed clinically acceptable logMAR visual acuity after approximately 2 weeks of 
wear with the mean bright high contrast binocular logMAR acuity of -0.11, -0.07 and 0.06 for 
distance, intermediate and near respectively.  There was one adverse event in the study that 
was a non-significant temporal conjunctival hyperemia in the right eye after removal of their 
lenses.  The event resolved without any treatment.  
 
 was a dispensing crossover study on hyperope subjects and had a primary endpoint 
of subject vision response. There were 59 subjects that completed the study as cohort.  The test 
lenses displayed clinically acceptable logMAR visual acuity after approximately 2 weeks of 
wear with the mean bright high contrast binocular logMAR acuity of -0.05, -0.02 and 0.11 for 
distance, intermediate and near respectively.  One subject had a non-ocular serious adverse 
event of dehydration of moderate severity and received treatment for this event. Although the 
event was reported as resolved, the subject was permanently discontinued the study. The 
investigator considered the event to be not related to the study article/study procedure. Three 
episodes of ocular adverse events were reported. One subject had an ocular AE of non-
significant corneal foreign body of mild severity. The subject did not receive any treatment for 
this event. The event of non-significant corneal foreign body was reported as resolved and no 
action was taken with the study article. The investigator considered the event to be not related 
to the study article/study procedure. A second subject had two episodes (one in each eye) of 
significant infiltrative event (SIE) of moderate severity. The subject received treatment for 
these events. Although the events were reported as resolved, the subject was permanently 
discontinued the study. The investigator considered the events to be related to the study 
article/study procedure. 
 
 was a dispensing crossover study on hyperope subjects and had a primary endpoint 
of subject vision response. There were 42 subjects that completed the study as cohort.  The test 
lenses displayed clinically acceptable logMAR visual acuity after approximately 2 weeks of 
wear with the mean bright high contrast binocular logMAR acuity of -0.025, -0.045 and 0.173 
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2.3. Hypotheses 
All the following co-primary hypotheses must be satisfied in order to meet the study objectives.  
 
Primary Hypotheses: 
1. After approximately 2-weeks of wear, the mean overall quality of vision score of the 
Test lenses will be statistically better than 40 points for the myope population.  This 
will be recorded by the subject using the CLUE Follow-up Questionnaire. 
 
 
2. After approximately 2-weeks of wear, the mean overall quality of vision score for the 
Test lenses will be statistically better than 32 points for the hyperope population.  This 
will be recorded by the subject using the CLUE Follow-up Questionnaire. 
 
 
3. After approximately 2-weeks of wear, the mean distance, binocular, high luminance, 
high contrast logMAR visual acuity score of the Test lens will be statistically lower 
than 0.10 logMAR. 
 
 
4. After approximately 2-weeks of wear, the mean intermediate, binocular, high 
luminance, high contrast logMAR visual acuity score of the Test lens will be 
statistically lower than 0.17 logMAR. 
 
 
5. After approximately 2-weeks of wear the mean near, binocular, high luminance, high 
contrast logMAR visual acuity score of the Test lens will be statistically lower than 
0.17 logMAR. 
 
 
6. When wearing the Test lenses, the proportion (%) of eyes with at least one reported 
clinically significant slit-lamp finding (Grade 3 or 4) during the post-fit period will be 
significantly lower than 5%.  
 
 
7. When wearing the Test lenses, the proportion (%) of eyes with an unacceptable fit 
during the study will be statistically less than 5%. 
 
 
 
If all the primary hypotheses are met, the following secondary hypothesis will be tested. 
 
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Secondary Hypothesis: 
1. The proportion of subjects who obtain the optimum lens pair in 4 lenses or less will 
be at least 90% using a 95% level of confidence. 
 
 
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 at the time of 
enrolment.  They will be myopic or hyperopic and have presbyopia.     
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria after Screening: 
  
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol. 
3. The subject must be at least 40 years of age and not greater than 70 years of age at the 
time of consent. 
4. Subjects must own a wearable pair of spectacles if required for their distance vision. 
5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. wears lenses 
a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of more 
duration). 
6. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire” (Appendix E). 
 
Inclusion Criteria after Baseline: 
 
7. The subject’s distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) 
must be in the range of -1.25 D to -5.75 D or +0.75 D to +3.25 D in each eye. 
8. The subject’s refractive cylinder must be ≤0.75 D in each eye. 
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in 
each eye. 
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3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
Exclusion Criteria after Screening: 
 
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.   
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. 
hepatitis, tuberculosis). 
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, 
cataract surgery, retinal surgery, etc.). 
5. A history of amblyopia, strabismus or binocular vision abnormality. 
6. History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent 
styes, herpetic keratitis, irregular cornea or pathological dry eye. 
7. Use of any of the following medications within 1 week prior to enrollment: oral 
retinoids, oral tetracyclines, oral phenothiazines, anticholinergics,  corticosteroids.  See 
Section 9.1 for additional details. 
8. Use of any ocular medication, with the exception of rewetting drops. 
9. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment. 
10.  Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
11. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multi-
purpose care solution, sodium fluorescein or non-preserved rewetting drop solutions. 
 
Exclusion Criteria after Baseline: 
 
12. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact lens wear. 
13. Any current ocular infection or inflammation. 
14. Any current ocular abnormality that may interfere with contact lens wear. 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
 
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Table 1: Planned Enrollment by Strata and Site 
 
Myopes 
Hyperopes 
Total 
Enrollment Target 
40 
40 
80 
Randomized  
30 
30 
60 
Number of Enrolled per 
Site (min-max) Target 
2-6 
2-6 
 
 
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of 
approximately 60 eligible subjects (30 myopes and 30 Hyperopes) will be targeted to complete 
the study.  
 
The study begins with an initial visit, Visit 1 (Day 0), if a subject is found to meet all eligibility 
criteria, they will be fit with the study lens, in both eyes; otherwise the subject will be deemed 
ineligible and classified as a screen failure.  
 
If a subject is dispensed lenses at the initial visit, then two additional visits will be conducted. 
Visit 2 will occur 3 ± 1 days after Visit 1. At Visit 2 subjects will undergo lens optimization if 
the subject reports unsatisfactory vision or is unable to obtain 20/30 binocular distance visual 
acuity with the study lenses. Subjects will return for Visit 3 (Final Evaluation) after 12±2 days. 
At the final visit, subjects will undergo subjective and objective assessments of vision.  
 
Subjects will be advised to wear the study lenses every day while they are in the study for a 
minimum of 6 hours per day. The study lens will be replaced at the optimization visit. However, 
lost or damaged lenses maybe replaced when necessary. Unscheduled visit may be conducted.  
4.2. Study Design Rationale 
The study is intended to compare one study lens type and to characterize performance against 
predefined targets which are set in the Customer Requirements Document.  Due to the 
predefined performance criteria a single-arm study design was chosen.  The specifics of the 
lens design, beyond that the lenses are intended to correct for their distance and near vision, 
will be masked to the subject.  The final optimized lenses are dispensed for approximately 2 
weeks of reusable wear which is the intended use cycle of the lens.   
4.3. Enrollment Target and Study Duration 
A total of approximately 80 eligible subjects will be enrolled with 60 (30 myopes and 30 
hyperopes) targeted to complete the study.  The study is anticipated to last 2-3 months.   
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5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
The study lenses will be worn in a bilateral fashion using a single-arm design.  Due to the 
nature of the design no randomization is required.   
 
5.2.   Masking 
This is a single arm study and all subjects will be assigned to the same study lens. 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: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme if applicable 
3. Investigator or designee will pull the appropriate test articles from the study supply.  
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section 
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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.  
1.29 
Post-Fit GSI Product 
Performance 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the GSI 
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  
 
Instruct the Subject the following: 
• The lenses will be worn on a daily wear 
basis.  
 
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Record any adverse events or medical history 
changes from the previous study visit. 
2.2 
Wear time and 
Comfortable Wear 
time with Study 
lenses 
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
 
2.3 
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. 
 
2.4 
CLUE Questionnaire  The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
questionnaire.   
 
2.5 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
 
2.6 
Subjective 
Acceptance 
Record whether the subject’s distance and 
near vision with the lenses is acceptable. 
 
2.7 
Distance and Near 
Entrance Visual 
Acuity 
Measure the distance and near visual acuity 
OD, OS and OU to the nearest letter.  Record 
the results. 
 
For near measures use the ETDRS 2000 
Series Chart 1 or 2.  
The acuity will be recorded to the nearest 
letter OD, OS and OU. 
 
2.8 
Distance Over-
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results and distance visual acuity OD and 
OS.   
The results of the distance over-refraction 
may also be checked for the impact on near 
vision under monocular and/or binocular 
conditions.    
 
2.9 
Determination of 
Lens Optimization 
If the subject reports unsatisfactory vision, or 
is unable to obtain 20/30 distance visual 
  
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If any of these slit lamp findings are Grade 3 
or higher, an AE must be recorded. All AEs 
must be followed to resolution. After 
resolution the subject will be discontinued 
and Final evaluation completed. 
 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.   
2.14 
Insertion of Study 
Lenses 
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.12 above.   
 
2.15 
PRO (MRD) 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
questionnaire. 
 
2.16 
Distance and Near 
Exit Visual Acuity 
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place.  
For near measures use the ETDRS 2000 
Series Chart 1 or 2.  
The acuity will be recorded to the nearest 
letter OD, OS and OU. 
  
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
 
2.17 
Dispensing Criteria 
The lenses will be dispensed for 10-14 days. 
• 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. 
 
2.18 
Patient Instructions  
 
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 
 
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7.3 and 7.9 EV (394-597 lux). 
• Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV (181-
208 cd/m2). 
• Guillon-Poling, Near Chart Luminance 
Acceptable Range 10.8-11.1 EV (223-
274 cd/m2). 
•  
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 Deposits 
Grade and record the amount of front and 
back surface lens deposits for both eyes. 
 
3.12 
Lens Wettability 
Grade the wettability of the lenses. 
 
3.13 
Lens Removal 
Have the subject remove the study lenses and 
store in saline in a labeled glass vial. 
 
NOTE: Lenses do not need to be stored in a 
refrigerator. 
 
3.14 
Biomicroscopy 
Perform Biomicroscopy OD and OS. FDA 
Slit Lamp Classification Scales* will be used 
to grade the findings.  
 
 
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8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
• Subject death during the study period 
• Subject withdrawal of consent 
• Subject not compliant to protocol  
• Subject lost to follow-up  
• Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant) 
• Subject develops significant or serious adverse events causing discontinuation of study 
lens wear  
• Subjects who have experienced a Corneal Infiltrative Event (CIE) 
• Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment) 
• Subject missed any 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.  
 
 
 
 
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11. STUDY TERMINATION 
 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
 
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 
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appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
• Who received the complaint. 
• Study number. 
• Clinical site information (contact name, site ID, telephone number). 
• Lot number(s). 
• Unique Subject Identifier(s). 
• Indication of who first observed complaint (site personnel or subject). 
• OD/OS indication, along with whether the lens was inserted. 
• Any related AE number if applicable. 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
• Eye Care Provider objective (slit lamp) findings if applicable. 
• Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1 
 
An AE includes any condition (including a pre-existing condition) that: 
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1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
• Death 
• Serious deterioration in the health of the subject that resulted in any of the following: 
• Life-threatening illness or injury 
• Permanent or persistent impairment of a body structure or a body function 
• Hospitalization or prolongation of patient hospitalization 
• Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• Chronic disease 
• Fetal distress, fetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
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• 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 – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
NOTE 1: to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1 
 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
• Seriousness/Classifications (see definition in Section 13.1). 
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• 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. 
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) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
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reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
• Adverse event (diagnosis not symptom). 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
• Date the clinical site was notified. 
• Date and time of onset. 
• Date and time of resolution. 
• Adverse event classification, severity, and relationship to test articles, as applicable. 
• Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
• Any referral to another health care provider if needed. 
• Outcome, ocular damage (if any). 
• Likely etiology. 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event. 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
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 
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be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
• Notify the Sponsor immediately. 
• 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 
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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.  
 
Pregnant participants are not discontinued from contact lens or solution related studies for 
safety concerns, but due to general concerns relating to pregnancy and contact lens use. 
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or 
visual acuity that occur secondary to systemic hormonal changes, and not due to unforeseen 
health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock. 
 
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4MCLM: Multi Cavity Lens Machine  
 
Summaries of efficacy data pooled across all the 6 studies are presented in Table 5. Results 
showed that near, intermediate and distance VA have similar variation across studies, 
therefore a 0.11 was utilized for the variation in the power calculation for all positions. 
Historical data have shown that the average CLUE vision score of Hyperopes is lower that of 
myopes.  
 
Table 7: Descriptive summary of Efficacy Endpoints Period 1 Only - 2-Week Follow-up 
Endpoint  
Mean 
Median 
Standard 
Deviation Minimum Maximum 
Distance VA (3m) 
-0.077 
-0.100 
0.1026 
-0.320 
0.560 
Intermediate VA (64cm) 
-0.054 
-0.060 
0.1014 
-0.300 
0.360 
Near VAR (40cm) 
0.077 
0.060 
0.1100 
-0.260 
0.460 
Hyperopes’ CLUE Vision score  
47.71 
48.07 
17.514 
10.22 
93.50 
Myopes’ CLUE Vision score  
56.46 
53.37 
19.227 
21.51 
108.04 
 
The proportion of eyes with Grade 3 or higher SLFs and the proportion of eyes with 
unacceptable lens fittings pooled across all historical studies is presented in the table below. 
As shown, there was only 1 unacceptable lens fitting in any of the 6 historical study while 
there have been 5 eyes with reported Grade 3 or higher SLFs.  
 
Table 8: Descriptive Summary of Safety Endpoints All Available Data  
Endpoint 
Test  
n(%) 
Unacceptable lens fitting 
1 (0.2) 
SLF Grade 3+ 
5 (1.4) 
Total Eyes (N) 
350 
Total Subjects  
175 
%= nx100/N 
 
Safety Analysis  
Our plan for  safety  analysis is to incorporate historical individual subject data from the 6 
studies using power prior distributions in a Bayesian framework (see section 14.5). The level 
of influence of historical data on current is determined by a discounting factor a constrained 
between 0 and 1 (0 ≤ a0≤ 1). a0 = 0 corresponds to no borrowing of the historical data; while 
a0 = 1 corresponds to full borrowing (See section 14.5 for more details). For this study we 
considered a low level of borrowing ranging by 0.1 and 0.30 based on the manufacturing 
platform where the historical study lens was made from.  Table 7 displays the number of 
subjects and the degrees of borrowing that will be used in the safety analysis. The approved 
investigational product will be manufactured from the FMP platform; therefore, the borrowing 
strength is larger to lenses from the FMP platform. Furthermore, the TAM21 platform is 
considered equivalent with respect to lens performance and lenses from these platforms are 
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given the same borrowing strength as those from the FMP platform. While all historical studies 
used the lens in its final design, lenses made from the pilot line are only given a borrowing 
strength of 10%.  
 
Table 9: Degrees of Borrowing Historical Data by Manufacturing Platform  
Manufacturing Platform 
Number of Subjects 
Level of borrowing (a0) 
FMP 
23 
0.3 
TAM21 
66 
0.3 
Pilot Line (SCLM, MCLM) 
86 
0.1 
 
 We calculated the required sample size with and without borrowing historical data. To achieve 
a minimum of 80% power with a 2-sided type I error rate of 5%, the required sample size with 
no borrowing (a0 = 0) was 120 subjects (240 eyes); while the sample size with borrowing was 
60 subjects (120 eyes). The sample calculation in each scenario of borrowing was conducted 
using a Monte Carlo simulation of 1000 trials of samples of size 120 subjects (240 eyes) were 
drawn from a multivariate binary distribution assuming a compound symmetric (CS) 
covariance structure between left and right eye from the same subject. Assuming a true 
proportion of eyes with grade 3 or higher SLFs of p=0.014 and a correlation of ρ=0.70 between 
left and right eyes. The same approach was considered for the proportion of eyes with 
unacceptable fitting assuming a true proportion of eyes with unacceptable fit  of p=0.01 and a 
correlation of ρ=0.80 between left and right eyes.  
 
The sample size was mainly driven by safety analysis, the power calculation of the efficacy 
analysis showed that a sample size of 60 subjects is sufficiently large to test the efficacy 
hypotheses. No borrowing was considered for the primary efficacy analysis. Table 8 
summarize the statistical power of a sample size of 60 subjects (120 eyes) for all endpoints.  
 
Table 10: Power Calculation by Endpoint/Hypothesis Assuming a Sample Size of 60 Subjects 
Endpoint 
Borrowing 
Hypothesis (HA) 
Power (%) 
Grade 3 or Higher SLFs 
Yes 
pt < 0.05 
80 
Unacceptable lens tit 
Yes 
pt < 0.05 
90 
VA Distance 
No 
µt <  +0.10  
> 99 
VA Intermediate 
No 
µt < +0.17 
> 99 
VA Near 
No 
µt < +0.17 
> 99 
CLUE Vision (Hyperopes) 
No 
µt ≥ 32 
99 
CLUE Vision (Myopes) 
No 
µt ≥ 40 
99 
 
The power calculation of the efficacy analyses (CLUE and VA)  was conducted using historical 
data presented in Table 5 above using PROC POWER for one sample means test for 
equivalence to test each hypothesis.  
 
The plan is to enroll 80 eligible subjects with a target completion of 60 subjects. During the 
enrollment period, the subject drop-out rate with be closely monitored, if an unexpectedly high 
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dropout rate is observed, then the targeted total enrollment number maybe be increased 
accordingly to ensure that a minimum of 60 subjects complete the study. 
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 randomized 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 Safety analysis: 
 
Strategy of Incorporating Historical Data: 
Safety analysis will be performed by incorporating of historical data from studies: 
 
. All these studies evaluated the same 
Test lens that was built in different manufacturing platforms to the same in vitro product 
requirements and are also considered to be representative of final commercial production. The 
historical individual data will be incorporated using  is the power prior distribution (Ibrahim 
and Chen; 2000)11.  
 
Let (y, z) and (y0, z0) denote the data from current study, and from historical data respectively, 
p the proportion of eyes with response 1 and ρ the correlation between left and right eyes. To 
construct a power prior distribution for parameter of interests (p, ρ), we use the formula 
 
P(p, ρ | y0, z0, a0) ∝ L(p, ρ | y0, z0) a0 π0(p, ρ), 
 
where L(p, ρ | y0, z0)  ∝ P(y0, z0 | p, ρ) is the likelihood of (p, ρ) based on the historical data 
and a0 is a discounting parameter constrained between 0 and 1. This parameter a0 controls the 
amount of the historical data we are borrowing: a0 = 0 corresponds to no incorporation of the 
historical data, while a0 = 1 corresponds to full borrowing of historical data.  We set a0 = 0.30 
for historical data of the Test lens was made in FMP and TAM21 platforms and a0 = 0.10 for 
Test lens made in the pilot line. 
 
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The posterior distribution of (p, ρ) given the current and historical data is  
 
P(p, ρ | y, z, y0, z0, a0) ∝ L(p, ρ | y, z)L(p, ρ | y0, z0) a0 π0(p, ρ), 
 
where L(p, ρ | y, z)  ∝ P(y, z | p, ρ) is the likelihood of (p, ρ) based on the current data. 
 
 
Primary Safety Analyses: 
Slit lamp finding grade 3 or higher and unacceptable lens fitting responses (yes/no) will be 
analyzed separately on the safety population using the Bayesian model described below. A 
sensitivity analysis will be conducted with no borrowing of historical data. 
 
The Model: 
Let Y1 and Y2 denote the binary outcomes for the left and right eyes, respectively, when 
wearing the test lens. Considering the correlation, ρ, between Y1 and Y2, the distribution of 
the sum Y = Y1 + Y2 is obtained by the mixture of two variables. One of them follow a 
binomial distribution Bin(2, p) with mixing probability (1-𝜌𝜌) and the other one follows a 
modified Bernoulli distribution MBern(p), taking value 0 and 2 rather than conventional 0 and 
1, with mixing probability p: 
 
P(Y = y| p, ρ) = (1- ρ)Bin(2, p)IA1 +  ρMBern(p)IA2; 
where IA1 = {0, 1, 2} and IA2 = {0, 2} 
 
To overcome the complexity of the mixture likelihood a latent variable Zi, i = 1, 2 is introduced 
in the model to indicate in which component of the model the observation yi, i=1, 2, belongs 
to, that is, 
 
zi = ൜1, if the observation belong to the MBern(p),
0, if the observation belong to the Bin(2, p)   
 
The joint distribution of the augmented data (Yi, Zi), i=1, 2, is given by 
P(Y = yi, Z = zi| p, ρ) =  ρzipyizi/2(1 −p)(2−yi)zi/2(1 −ρ)1−zi ൬2
yi൰pyi(1−zi)(1 −p)(2−yi)(1−zi) 
 
The posterior distribution of (p, ρ) given (y, z), (y0, z0) and a0 is 
 
P (p, ρ | | y, z, y0, z0, a0) = P (y, z | p, ρ) P (y0, z0| p, ρ)a0 π0(p, ρ) 
 
where, π0 is joint prior distribution of (p, ρ). Here we assume p and ρ to be independent with a 
prior beta (α, β) for p and uniform (0,1) for ρ. Hence the joint distribution of (p, ρ) is given by 
π0 (p, ρ| α, β) ∝ pα -1(1-p)β-1. The Metropolis sampler algorithm as implemented in the 
SAS/STAT MCMC Procedure will be used to estimate the posterior distributions of the 
parameters (p, ρ). Inferences will be made based on a posterior credible interval for the relevant 
parameters.  
 
Hypothesis testing for safety endpoints will be conducted as follows: 
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• Slit Lamp Finding: the Null hypothesis will be rejected if the upper bound of the 2-
sided 95% credible interval of the posterior estimate of the proportion of eyes with 
grade 3 or higher SLFS is below 5%. 
 
• Unacceptable Len Fit: The Null hypothesis will be rejected if the upper bound of the 
2-sided 95% credible interval of the posterior estimate of the proportion of eyes with 
unacceptable lens fitting is below 5%. 
If no SLF findings of Grade 3 or higher or unacceptable lens fit is observed, alternative analysis 
methods will be considered. More details will be provided in the statistical analysis plan.  
Primary Efficacy Analyses: 
Efficacy analysis will be conducted the Intent-to-Treat Population (ITT) without borrowing 
from historical data. A sensitivity analysis will be performed by incorporating historical 
historical data. The level of borrowing used in the safety analysis will be considered. Further 
sensitivity analyses on the Per-Protocol Population will also be considered. 
 
CLUE Vision 
CLUE vision scores will be analyzed using a Bayesian normal random effects model for 
repeated measures. The model will include baseline clue score, age, add power, gender, 
timepoint (3-day and 2-week follow-up evaluations) and strata (Hyperopes and Myopes) and 
the interaction between timepoint and strata as fixed effects.  Site will be included as a random 
effect. An unstructured (UN) covariance structure will be used to model the residual errors 
from measurements within the same subject across timepoints. Heterogeneous residuals 
covariance structures (R-side) across strata will be considered when appropriate. Non-
informative priors will be used for the unknown parameter. For the β coefficients, independent 
non-informative priors N(0, 1000) will be used. For the variance of random effect 𝜎𝜎𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
2
 an 
independent non-informative conjugate prior inverse-gamma(0.001, 0.001) will be used. For 
the residual covariance structure an inverse-Wishart distribution will be used. Inferences will 
be carried out using the 95% posterior credible intervals for relevant parameters.  
 
Hypothesis testing for CLUE Vision Scores endpoints will be conducted separately for each 
stratum: 
• Hyperopes: The Null hypothesis will be rejected if the lower bound of the 2-sided 95% 
credible interval of the clue vision posterior mean estimate is above 32. 
 
• Myopes: The Null hypothesis will be rejected if the lower bound of the 2-sided 95% 
credible interval of the clue vision posterior mean estimate is above 40. 
 
Visual Acuity 
Binocular high luminance, high contrast (HLHC) visual acuity (logMAR) at the 2-week 
follow-up evaluation will be analyzed using a Bayesian normal random-effects model for 
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repeated measures. The model will include strata (Hyperope and Myope), add power, age, 
gender, position (40cm, 64cm and 3m) and the interaction between strata and position as fixed 
effects. Site and will be included as a random effect. An unstructured (UN) covariance structure 
will be used to model the residual errors from measurements within the same subject across 
different positions. Heterogeneous residuals covariance structures (R-side) across position will 
be considered when appropriate. Non-informative priors will be used for the unknown 
parameter. For the β coefficients, independent non-informative priors N(0, 1000) will be used. 
For the variance of random effect 𝜎𝜎𝑠𝑠𝑠𝑠𝑠𝑠𝑠𝑠
2
 an independent non-informative conjugate prior 
inverse-gamma(0.001, 0.001) will be used. For the residual covariance structure an inverse-
Wishart distribution will be used. Inferences will be carried out using the 95% posterior 
credible intervals for relevant parameters.  
 
Hypothesis testing for visual acuity (logMAR) endpoints will be conducted separately for each 
position: 
• Distance: The Null hypothesis will be rejected if the upper bound of the 2-sided 95% 
credible interval the binocular HLHC VA posterior mean estimate is lower than +0.10 
logMAR. 
 
• Intermediate: The Null hypothesis will be rejected if the upper bound of the 2-sided 
95% credible interval the binocular HLHC VA posterior mean estimate is lower than 
+0.17 logMAR. 
 
• Near: The Null hypothesis will be rejected if the upper bound of the 2-sided 95% 
credible interval the binocular HLHC VA posterior mean estimate is lower than +0.17 
logMAR. 
14.6. Secondary Analysis 
The secondary Hypothesis will be conducted on the Intent-to-Treat without borrowing 
historical data.  
 
Proportion of Subjects with Optimal Lens Pair 
The number of lenses used for each subject will be calculated as the original pair (2) plus all 
the required modifications to reach the optimal pair. In this study the minimum number of 
lenses per subject used would be 2 where the max would be 6. The data will be dichotomized 
as 1 if the subject was able to achieve optimal lens pair in 4 lenses or less and 0 otherwise. The 
binary response will be analyzed using Bayesian logistic regression random-effects model to 
estimate the proportion of eyes that reached optimal lens pair in 4 lenses or less.  The regression 
model will include strata (Hyperope and Myope), add power, age, gender, event (fitting, 
optimization, 2-week follow-up) and the interaction between strata by event. Site will be 
included in the model as a random effect. Non-informative priors will be used for the unknown 
parameter. For the β coefficients, independent non-informative priors N(0, 1000) will be used. 
For the variance of random effects of σsite
2
 non-informative conjugate prior, inverse-gamma 
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(0.001, 0.001) will be used. Inferences will be made based on the posterior credible interval 
for the relevant parameters.  
 
The null hypothesis will be rejected if the lower bound of the 2-sided 95% credible interval the 
proportion of subjects is above 90%.  
14.7. Other Exploratory Analyses  
Not Applicable 
14.8. Interim Analysis 
There will not be an interim analysis performed on this study.  
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
fully Bayesian imputation by imputing missing values. 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system EDC system (Bioclinica). An authorized data originator will enter study data into the 
eCRFs using the EDC system. Data collected on equipment that is not captured in EDC will 
be formatted to the specification of the JJVC database manager and sent to JJVC for analysis.  
 
External Data Sources for this study include: Not Applicable 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
 
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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. 
 
15.3ClinicalTrials.gov  
Several prior studies have been performed with the investigational lenses therefore this study 
does not meet the definition of an early feasibility study and is required to be registered on 
ClinicalTrials.gov. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
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clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, 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. 
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• Ensuring that the clinical site has sufficient test article and supplies. 
• Clarifying questions regarding the study. 
• Resolving study issues or problems that may arise. 
• Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol. 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information). 
• 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. 
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• Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
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 revisions 
• 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 revisions  
• 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 revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
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principles that originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 
guidelines,  applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
• processed fairly and lawfully. 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
• adequate, relevant, and not excessive in relation to said purposes. 
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• accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
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. 
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20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
• Continuing an ineligible subject in the study. 
• Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
• Query resolution. 
• Case Report Form signature. 
• Completion of any follow-up action items. 
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. EU MDR 2017/745 
7. 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. 
8. 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  
 
To be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
 
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APPENDIX D: BINOCULAR OVER REFRACTION 
 
 
 
 
 
 
 
       
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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APPENDIX F: OCULAR DOMINANCE 
 
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APPENDIX G: LENS FITTING GUIDE 
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 DETERMINATION OF NEAR ADD 
 
 
 
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Title:                          Determination of Near Addition 
Document Type:       Work Instructions 
Document Number:  CTP-2005 
Revision Number:  4 
Page 4 of 5 
6 
If the tentative ADD is too strong (too much plus), ask the patient to place the 
near point card at the desired test distance. Place -0.25D in front of both eyes 
(using +/- 0.25D flippers or loose trial lenses) and ask him/her to compare the 
tentative ADD with and without the -0.25D. If adding -0.25D does not reduce 
clarity add the -0.25D to the tentative ADD and repeat the procedure. Continue 
to add -0.25D until the patient begins to have a reduction in clarity. 
 
With the additional power in place, measure the range of clear focus (i.e., clear 
focus zone). 
 
Repeat this step until the near point is approximately midway in the clear 
zone.  
If the desired test distance is… 
Then 
Approximately midway within 
the clear focus zone 
No further adjustments 
are necessary.  
Near the edge of the clear focus 
zone closest to the patient 
Add -0.25D and measure 
the range of clear focus 
again.  
Near the edge of the clear focus 
zone furthest from the patient 
Add +0.25D and measure 
the range of clear focus 
again.  
7 
If the tentative ADD is too weak (too much minus), ask the patient to place 
the near point card at the desired test distance. Place +0.25D in front of both 
eyes (using +/- 0.25D flippers or loose trial lenses) and ask him/her to 
compare the tentative ADD with and without the +0.25D. If adding +0.25D 
improves clarity (visual acuity), add the +0.25D to the tentative ADD and 
repeat the procedure.  Continue to add +0.25D until no more improvement in 
near visual acuity is achieved at the desired test distance.  
NOTE:  Be careful to question the patient to ensure that he/she is 
actually seeing an improvement in visual acuity.     
With this in place, measure the range of clear focus for the near point card.  
 
Repeat this step until the near point is approximately midway within the 
clear zone. 
If the desired test distance is… 
Then 
Approximately midway within 
the clear focus zone 
No further adjustments 
are necessary.  
At the edge of the clear focus 
zone closest to the patient 
Add -0.25D and measure 
the range of clear focus 
again.  
At the edge of the clear focus 
zone furthest from the patient 
Add +0.25D and measure 
the range of clear focus 
again.  
 
5. GRADING SCALE 
 
• 
ADD Power: Diopters (0.25D increments) 
• 
Distance tested and range of clear focus: cm (one unit increments) 
• 
Visual Acuity: Snellen 
 
 
       
 
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Page 5 of 5 
6. REFERENCES 
 
• 
Carlson, NB, et. al. (1996) Fused Cross Cylinder, in Clinical Procedures for Ocular Examination 2nd ed.  
(Appleton and Lange, Samford CT): 188-190. 
• 
Grosvenor, TP (1982). The Binocular Vision Examination, Chapter 9 in Primary Care Optometry: A 
clinical manual. Grosvensor, TP (Professional Press, Chicago):189-200. 
• 
Michaels, DD (1985) Refracting the Aging Eye, Chapter 20 in Visual Optics and Refraction. A clinical 
approach.  Michaels, DD.  (Mosby, St.Louis): 414-425. 
• 
Patorgis, CJ (1987).  Presbyopia, Chapter 8 in Diagnosis and Management in Vision Care.  Amos J 
(Butterworths, Boston): 226-235. 
 
7. TRAINING REQUIREMENTS 
 
       The training requirement for this document is “Read Only.” 
 
 
 
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CTP-2006, NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
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Title:                          Near LogMAR Visual Acuity Measurement Procedure 
Document Type:       Work Instructions 
Document Number:  CTP-2006 
Revision Number:  8 
Page 2 of 2 
Is unable to read at 
least 3 letters on the 
top line of the chart 
Move the subject closer, to 33cm, or further away,   
to 50cm, from the chart (depending on what 
improves their vision) and repeat the step 2,, unless 
the study protocol states that this is not allowed.   
Record the new test distance in the CRF and proceed 
to the next step. 
Can’t correctly read 
3 or more letters 
after moving the 
chart to 33 and/or 
50 cm test distance, 
or if moving the 
chart was not 
allowed in the 
protocol 
Record the number of letters missed in the top line 
proceed to step 6.  If using EDC, you will need to 
answer an automated query. 
3 
It is required that responses are recorded starting from a line where no letters 
are missed.   For lines where no letters are missed, check the “None” box in 
EDC next to that line of letters (or record “0” missing next to the line if 
recording on paper).  After the subject passes the first attempted line, instruct 
the subject to continue reading lines down through the chart. For each line 
read, line through letters that are missed by the subject and record the number 
of letters missed next to each line. For each subsequent line read, check the 
box next to each letter missed by the subject, or check the “None” box if no 
letters are missed.  NOTE: If recording on paper, place a line through each 
letter missed, or mark a line through the entire row of letters if they are 
all missed, and then record the number of letters missed (0 to 5) next to 
each line.   
4 
Encourage the subject to try to continue to read each line.  
If the subject says he/she cannot see the next line, encourage him/her to take 
his/her best guess. 
5 
Stop the test only when the subject misses three or more letters on a single 
line.  (NOTE:  If the subject misses three letters on a line, and there are 
still letters that they haven’t attempted to read have the subject attempt to 
read the remaining letters and record the results.) Otherwise, continue to 
encourage the subjects to keep reading the next line below till reaching the 
bottom line. If subjects correctly read all 5 letters on the last line, stop the test 
and record 0 missing without moving subjects further away from the chart. 
6 
Repeat procedure with the same eye or complete the other eye the appropriate 
number of times, per protocol requirement. 
 
5. REFERENCES 
 
• 
Guillon, M., D.P. Lydon, and R.T. Solman, Effect of target contrast and luminance on soft contact lens 
and spectacle visual performance. Curr Eye Res, 1988. 7(7): p. 635-48. 
 
6. DATA MANAGEMENT 
 
The electronic data capture system will automatically convert logMAR visual acuity if the chart is used at a 
distance other than what it was designed for.  The formula to compute logMAR score at a different distance 
other than the chart specified distance is:   LogMAR2 = LogMAR1 + log10(D1/D2), 
 
7. TRAINING REQUIREMENT 
 
The training requirement for this document is “Read Only.”  
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CTP-2008, LENS FITTING CHARACTERISTICS 
 
 
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Title:                          Lens Fitting Characteristics 
Document Type:       Work Instructions 
Document Number:  CTP-2008 
Revision Number:  5 
Page 4 of 5 
 
Attachment A 
Example of Lens Centration Rating 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Revision Number:  5 
Page 5 of 5 
Attachment B 
Example of Evaluation of Primary Gaze Movement 
 
 
 
 
 
 
 
 
 
 
 
 
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CTP-2009, SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
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CTP-2011, 
FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE 
 
 
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• Attachment B:  Examples of the deposition grading scale.  
 
 
REFERENCES 
• Mandell, R.B. (1988). Contact Lens Practice. Charles C. Thomas, Springfield, IL, pp 628-
643. 
 
 
 
 
 
• Minno, G.E., Eckel, L., Groemminger, S., Minno, B., & Wrzosek, T. (1991). Quantitative 
Analysis of Protein Deposits on Hydrophilic Soft Contact Lenses: I. Comparison to 
Visual Methods of Analysis. II. Deposit Variation among FDA Lens Material Groups. 
Optometry and Vision Science, 68 (11): 865-872. 
 
 
TRAINING     
The training requirement for this document is “Read Only.” 
REQUIRE- 
MENTS 
 
 
 
CASE REPORT  
See Attachment C 
FORM MODULE 
 
 
 
 
 
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Attachment A 
 
 
NOTE:  The deposition need not be uniform in size.  The total area of deposition on the lens is determined by 
adding all regions with debris together.   
 
 
 
 
 
 
 
 
 
 
 
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Attachment B 
 
a) Grade 1:  1 – 5% lens area  
 
 
 
  b) Grade 2:  6 - 15% lens area 
       
              
 
 
c) Grade 3:  16 - 25% lens area 
 
 
 
   d) Grade 4:  ≥26% lens area  
       
                
  
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Attachment C 
 
 
 
 
 
OD  
 
 
 
 
 
 
 
OS 
 
SURFACE DEPOSITS: 
 
1. 
Front Surface Deposits:  
1   
None 
4 
Moderate 
 
1   
None 
4 
Moderate 
2   
Slight 
5 
Severe 
 
2   
Slight 
5 
Severe 
3    
Mild 
 
 
 
3    
Mild 
 
 
 
2. 
Back Surface Deposits: 
1   
None 
4 
Moderate 
 
1   
None 
4 
Moderate 
2   
Slight 
5 
Severe 
 
2   
Slight 
5 
Severe 
3    
Mild 
 
 
 
3    
Mild 
 
 
 
Scale: 
Grade 0 
None 
No deposition. 
Grade 1 
Slight 
Deposition, which occupies 1-5% of the lens surface area. 
Grade 2  
Mild 
Deposition, which occupies 6-15% of the lens surface area. 
Grade 3 
Moderate 
Deposition, which occupies 16-25% of the lens surface area. 
Grade 4  
Severe 
Deposition, which occupies 26% of the lens surface area. 
 
 
 
 
 
 
CR-6400, v 4.0
VCT-0007 (10) 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
CTP-2016, DETERMINATION OF SPHEROCYLINDRICAL REFRACTIONS 
 
 
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VCT-0007 (10) 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
CTP-2018, BIOMICROSCOPY SCALE 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 KERATOMETRY 
 
 
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DISTANCE 
AND 
NEAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
 
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Title: 
Distance and Near Visual Acuity Evaluation 
Document Type: 
Clinical Test Procedure 
  
 
 
 
Page 4 of 4 
 
 
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 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
WHITE LIGHT LENS SURFACE WETTABILITY 
 
 
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Johnson & Johnson Vision Care, Inc. 
 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Work Instructions 
  
 
 
Page 1 of 5 
 
CR-6400, v 4.0
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Work Instructions 
  
 
 
 
Page 2 of 5 
 
 
 
 
 
 
 
 
 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Work Instructions 
  
 
 
 
Page 4 of 5 
 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Work Instructions 
  
 
 
 
Page 5 of 5 
 
 
CR-6400, v 4.0
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX I: COVID-19 RISK MITIGATION GUIDELINES 
 
 
CR-6400, v 4.0
 
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Title: 
Guidelines for COVID-19 Risk Mitigation 
Document Type: 
Work Instruction 
Document Number: 
VWI-0081 
Revision Number: 1 
 
Page 1 of 9 
1.0 
PURPOSE 
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
in the United States (US) participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during 
the COVID-19 pandemic.  
2.0 
SCOPE 
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites in the US.  These 
guidelines do not apply to study sites outside of the US.  The guidance provided in this document is in effect 
from the date of approval through the date of retirement of this Work Instruction. At a minimum, this Work 
Instruction will be reviewed and updated on a quarterly basis, as appropriate. 
NOTE:  Sites outside of the US will be evaluated on a site by site basis subject to local health authority 
guidance. 
3.0 
DEFINITIONS 
 
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements. 
 
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
doctors of optometry (O.D.), optometric professionals, and optometry students. Doctors of optometry take a 
leading role in patient care with respect to eye and vision care, as well as general health and well-being. As 
primary health care providers, doctors of optometry have extensive, ongoing training to examine, diagnose, 
treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the eye. The 
American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care. 
Center for Disease Control (CDC): The Centers for Disease Control and Prevention is a national public 
health institute in the United States. It is a United States federal agency, under the Department of Health 
and Human Services, and is headquartered in Atlanta, Georgia.   
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).  
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols. 
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.  
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial. 
CR-6400, v 4.0
 
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CR-6400, v 4.0
 
Page 172 of 180
JJVC CONFIDENTIAL

Title: 
Guidelines for COVID-19 Risk Mitigation 
Document Type: 
Work Instruction 
Document Number: 
VWI-0081 
Revision Number: 1 
 
Page 5 of 9 
RESOURCE LINKS 
 
• 
OSHA Training 
https://www.osha.gov/SLTC/covid-19/controlprevention.html   
 
Personal Protective Equipment (PPE) Training 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html 
 
• 
I&R Training 
ACUVUE® LensAssist: https://www.acuvue.com/lensassist    
 
• 
Clinic Preparedness Guides 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html  
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=  
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide 
 
• 
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses 
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf  
 
4.1.3 
Protocol Compliance Investigator(s) Signature Page:  
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation.  
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
4.1.4 
Study Site Initiation Training Slides:  
Will include suggestions to help mitigate potential transmission of COVID-19.  Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients, 
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment. 
5.0 
GUIDANCE FOR REMOTE SUBJECT VISITS 
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.   
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted  to the extent possible.  Discussions with the subject during remote assessments 
may include: 
CR-6400, v 4.0
 
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JJVC CONFIDENTIAL

Title: 
Guidelines for COVID-19 Risk Mitigation 
Document Type: 
Work Instruction 
Document Number: 
VWI-0081 
Revision Number: 1 
 
Page 8 of 9 
6.1.3 
Study Site Closure:   
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).   
 
 
 
CR-6400, v 4.0
 
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JJVC CONFIDENTIAL

Title: 
Guidelines for COVID-19 Risk Mitigation 
Document Type: 
Work Instruction 
Document Number: 
VWI-0081 
Revision Number: 1 
 
Page 9 of 9 
Attachment A: Study Site Correspondence 
 
XXXX XX, 2020 
 
 
 
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>> 
 
 
Dear <<Principle Investigator>> and Study Team, 
 
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities.  
 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within.  
 
Protocol: 
• 
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section. 
Protocol Signature Page: 
 
• 
Will include a statement indicating the Principle Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation. 
 
Informed Consent: 
  
• 
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document. 
COVID-19 Risk Control Checklist for Clinical Studies: 
• 
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.    
 
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).   
 
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time.  
 
 
Please file this letter in your site file study correspondence.  
 
 
CR-6400, v 4.0
 
Page 179 of 180
JJVC CONFIDENTIAL

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6400 Protocol Title: Clinical Evaluation of a Daily Wear Reusable 
Multifocal Optical Design in a Presbyopic Population  
 
Version and Date: 4.0 06 August 2020 
 
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. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct the study in 
compliance with all local, state, and governmental guidelines for COVID-19 risk mitigation. 
 
Principal 
Investigator: 
 
 
  
 
Signature 
 
 
 Date 
 
Name and Professional Position (Printed) 
  
 
Institution/Site: 
 
  
 
Institution/Site Name 
 
 
  
 
Institution/Site Address 
  
 
CR-6400, v 4.0
 
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JJVC CONFIDENTIAL