Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title: Evaluation of a daily disposable silicone hydrogel multifocal contact lens in 
myopes and hyperopes 
Protocol CR-6477
Version: 2.0
Date: 05 January 2022 
Investigational Products: JJVC Investigational Multifocal Contact Lenses manufactured in 
senofilcon A C3 
Keywords:   
Senofilcon A C3, Presbyopia, Daily Wear, Daily Disposable, Dispensing, Single arm
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products Summary of Findings from 
Nonclinical Studies ............................................................................................................. 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 ............................................................................................................... 20 
3. 
TARGETED STUDY POPULATION ........................................................................... 22 
3.1. 
General Characteristics ............................................................................................ 22 
3.2. 
Inclusion Criteria ...................................................................................................... 22 
3.3. 
Exclusion Criteria ..................................................................................................... 23 
3.4. 
Enrollment Strategy.................................................................................................. 24 
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 
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6.1. 
Identity of Test Articles............................................................................................ 26 
6.2. 
Ancillary ................................................................................................................... 26 
6.3. 
Supplies/Products ..................................................................................................... 26 
6.4. 
Administration of Test Articles ................................................................................ 27 
6.5. 
Packaging and Labeling ........................................................................................... 27 
6.6. 
Storage Conditions ................................................................................................... 27 
6.7. 
Collection and Storage of Samples .......................................................................... 27 
6.8. 
Accountability of Test Articles ................................................................................ 27 
7. 
STUDY EVALUATIONS .............................................................................................. 28 
7.1. 
Time and Event Schedule ......................................................................................... 28 
7.2. 
Detailed Study Procedures ....................................................................................... 31 
VISIT 1 ........................................................................................................................... 31 
VISIT 2 ........................................................................................................................... 37 
VISIT 3 ........................................................................................................................... 41 
FINAL EVALUATION .................................................................................................. 43 
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 ........................................................... 46 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 47 
9.1. 
Systemic Medications .............................................................................................. 47 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 47 
11. 
STUDY TERMINATION ........................................................................................... 48 
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 .................................................................................... 52 
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 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
........................................................................................................................56 
13.5. 
Event of Special Interest ....................................................................................... 56 
13.6. 
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 .................................................................................................. 61 
14.6. 
Secondary Analysis .............................................................................................. 65 
14.7. 
Other Exploratory Analysis .................................................................................. 67 
14.8. 
Interim Analysis ................................................................................................... 68 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 68 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 68 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 68 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 68 
15.2. 
Subject Record ...................................................................................................... 69 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 69 
16. 
DATA MANAGEMENT............................................................................................. 69 
16.1. 
Access to Source Data/Document ........................................................................ 69 
16.2. 
Confidentiality of Information.............................................................................. 69 
16.3. 
Data Quality Assurance ........................................................................................ 70 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 70 
17. 
CLINICAL MONITORING ........................................................................................ 70 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 71 
18.1. 
Study-Specific Design Considerations ................................................................. 71 
18.2. 
Investigator Responsibility ................................................................................... 71 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 71 
18.4. 
Informed Consent ................................................................................................. 72 
18.5. 
Privacy of Personal Data ...................................................................................... 73 
19. 
STUDY RECORD RETENTION................................................................................ 74 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 74 
21. 
PUBLICATION ........................................................................................................... 75 
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22. 
REFERENCES ............................................................................................................ 75 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 77 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 100 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 101 
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE .................................... 102 
APPENDIX E: OCULAR DOMINANCE ........................................................................... 103 
APPENDIX F: LENS FITTING GUIDE ............................................................................. 104 
APPENDIX G: BINOCULAR OVER REFRACTION ....................................................... 106 
APPENDIX H: 
 .................................... 107 
, Determination of Near Addition ........................................................................ 108 
, Near LogMAR Visual Acuity Measurement Procedure .................................... 114 
, Lens Fitting Characteristics ................................................................................ 117 
, Subject Reported Ocular Symptoms/Problems .................................................. 123 
, Determination of Distance Spherocylindrical Refractive Error ......................... 125 
, Biomicroscopy Scale .......................................................................................... 131 
, Distance and Near Snellen Visual Acuity Evaluation ........................................ 137 
, Distance LogMAR Visual Acuity Measurement Procedure .............................. 142 
, Patient Reported Outcomes ................................................................................ 146 
, Visual Acuity Chart Luminance and Room Illumination Testing ..................... 148 
APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION ................................ 157 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 169 
LIST OF TABLES
Table 1: Test Articles .............................................................................................................. 26 
Table 2: Ancillary Supplies .................................................................................................... 27 
Table 3: Time and Events ....................................................................................................... 28 
Table 4: Disallowed systemic medications ............................................................................. 47 
Table 5: Examples of major and minor protocol deviations ................................................... 48 
Table 6: Historical Studies Utilized for Sample Size Calculations ........................................ 57 
Table 7: Historical Data by Endpoint ..................................................................................... 58 
Table 8: Sample Size Estimates by Endpoint ......................................................................... 59 
Table 9: Clinical Studies Planned to be Utilized in Exploratory Meta-Analysis ................... 67 
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SYNOPSIS 
Protocol Title
Evaluation of a daily disposable silicone hydrogel multifocal 
contact lens in myopes and hyperopes
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Design Validation Study
Design control phase:  Phase 3
Trial Registration
This study will be registered on ClinicalTrials.gov.
Test Article(s)
Investigational Product:  JJVC Investigational Multifocal 
Contact Lenses manufactured in senofilcon A C3
Wear and Replacement 
Schedules
Wear Schedule: The test lenses will be used on a daily 
disposable basis.   
Replacement Schedule: The lenses will be replaced after a day 
of wear.
Objectives 
The objective of this study is to demonstrate that the JJV 
Investigational senofilcon A C3 Multifocal Contact Lens in its 
final lens design made in the 4GT Manufacturing Platform 
meets the validation requirements related to objective and 
subjective vision, eye health and fit acceptance.  
Study Endpoints
Primary Endpoints
x
CLUE vision scores 
x
LogMAR visual acuity scores  
x
Unacceptable lens fit (Yes/No)
x
Grade 3 or Higher Biomicroscopy Findings (Yes/No) 
Secondary Endpoints 
x
Number of lenses needed to fit (optimize) the 
subject’s vision 
x
CLUE comfort scores
x
CLUE handling scores 
Study Design
This is a single-masked, single-arm, dispensing clinical trial. 
Up to 120 subjects will be enrolled into the study with the aim 
of completing approximately 100 subjects.  The subjects will 
be fit at (Visit 1) in the study lens and wear the lens for 3±1 
day then undergo optimization (Visit 2) and wear the 
optimized pair for approximately 1 week (7±1 day). At the 
follow-up visit (Visit 3), logMAR acuity and final subjective 
responses will be collected and the subject will be exited from 
the study.   
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).
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Sample Size
Approximately 120 eligible subjects will be enrolled (72 
myopes and 48 hyperopes) with 100 subjects targeted to 
complete (60 myopes and 40 hyperopes).
Study Duration
The study will last approximately 2 to 3 months.
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below.  All volunteers will 
have baseline measurements taken to ensure eligibility.  The 
baseline procedures will occur after informed consent has 
been obtained.  Subjects will have medical and contact lens 
history recorded, baseline questionnaires completed, and 
refractive and anterior segment status determined.  For a detail 
flowchart of procedures below.
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Eligibility Criteria -
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study 
Inclusion Criteria after Screening:
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form.
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Be at least 40 years of age and not greater than 70 years 
of age at the time of consent.
4. Own a wearable pair of spectacles if required for their 
distance vision.
5. Be an adapted soft contact lens wearer in both eyes 
(i.e. worn lenses a minimum of 2 days per week for at 
least 6 hours per wear day, for 1 month or more 
duration). 
6. 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”. 
Inclusion Criteria at Baseline:
7. The subject’s distance spherical equivalent refraction 
YHUWH[FRUUHFWHGLI-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. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQ
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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Eligibility Criteria –
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic 
allergies that may interfere with contact lens wear.  
3. Have 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. Have 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. Have a history of amblyopia, strabismus or binocular 
vision abnormality. 
6. Use of any of the following medications within 1 week 
prior to enrollment: oral retinoid, oral tetracyclines, 
anticholinergics, oral phenothiazines, oral/inhaled 
corticosteroids.  See section 9.1 for further examples.
7. Use of any ocular medication, with the exception of 
rewetting drops. 
8. Have a history of herpetic keratitis.
9. Have a history of irregular cornea.
10. Have a history of pathological dry eye. 
11. Have Participated in any contact lens or lens care 
product clinical trial within 30 days prior to study 
enrollment.
12. Be and employee or immediate family member of an 
employee 
of 
clinical 
site 
(e.g., 
Investigator, 
Coordinator, Technician). 
13. Have any known hypersensitivity or allergic reaction 
to non-preserved rewetting drop solutions or sodium 
fluorescein.
Exclusion Criteria at Baseline:
The subject must not: 
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14. Have clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal 
or ocular abnormalities which would contraindicate 
contact lens wear.
15. Have any current ocular infection or inflammation. 
16. Have 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 in the protocol for details regarding disallowed 
systemic medications.
Measurements and 
Procedures
logMAR acuity, subjective responses, biomicroscopy and fit 
evaluations. 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any serious adverse event (SAE) where 
relationship to study agent cannot be ruled out, may result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Non-Preserved Rewetting drops, lens cases, glass vials, saline, 
ETDRS light cabinet, 4 M logMAR charts, and Near logMAR 
charts.
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, ACRONYMS 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
COVID-19 
 
Coronavirus Disease 2019 
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 
NAVQ  
 
Near Activity Visual Questionnaire
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 
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PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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In 
 30 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.057 and 0.091 at distance and near respectively. There was one adverse event 
reported during the study.  The subject experienced mild upper respiratory virus and did not 
receive any treatment for this event.  The event resolved and the subject completed the study.  
The investigator considered the event to be unrelated related to study article/procedure.6
In 
 41 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.104 and 0.058 at distance and near respectively. There were no adverse events 
reported during the study.7    
In 
 67 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.078 and 0.062 at distance and near respectively.  There were six adverse of 
events during the study.  Two of the six were ocular adverse events were related to the 
control lens.  Both were corneal infiltrative events; one was non-significant and the other was 
significant and both were classified as possibly related to the contact lenses.9   
 was a single masked, randomized controlled, dispensing clinical trial and had a 
primary endpoint of logMAR visual acuity.  There were 60 subjects that completed the study 
per the protocol.  The lenses displayed good clinical vision performance with binocular, high 
luminance, high contrast logMAR visual acuity of -0.132, -0.066 and 0.072 at distance, 
intermediate and near respectively.  There were four adverse of events during the study.  
Three of the four were non-ocular adverse events.  Two of those not related to the study 
lenses and one (headache) was related to the Control Contact lens.  There was one ocular 
adverse event (non-significant infiltrative event) that was possibly related to the test lens.10   
 was a single masked, randomized controlled, dispensing clinical trial on hyperopic 
presbyopes and had a primary endpoint of logMAR visual acuity.  There were 64 subjects 
that completed the study per the protocol.  The lenses displayed good clinical vision 
performance with binocular, high luminance, high contrast logMAR visual acuity of -0.083, -
0.013 and 0.090 at distance, intermediate and near respectively.  There were four adverse of 
events during the study.  Three of the four were non-ocular adverse events.  None of the non-
ocular adverse events were related to the test articles.  There was one ocular adverse event 
(non-significant) that was mild corneal staining that was not related to the test lens.101  
 was a single masked, randomized controlled, dispensing, 3x3 crossover clinical 
trial on hyperopic presbyopes and had a primary endpoint of subjective vision responses.  
There were 34 subjects that completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.10, -0.04 and 0.06 at distance, intermediate and near respectively.  There were no 
adverse events reported during the study.12   
 was a single masked, randomized controlled, dispensing clinical trial on myopic 
presbyopes and had a primary endpoint of logMAR visual acuity.  There were 66 subjects 
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that completed the study per the protocol.  The lenses displayed good clinical vision 
performance with binocular, high luminance, high contrast logMAR visual acuity of -0.128, -
0.061 and 0.057 at distance, intermediate and near respectively.  There was one adverse of 
event during the study.  The one ocular adverse event was a non-significant grade 2 or less 
slit lamp finding requiring treatment.  The event was classified as related and occurred while 
wearing the control lens.13
For information about the Investigational product refer to the CR-6477 Investigational 
Brochure. 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective:
The objective of this study is to demonstrate that the JJV Investigational senofilcon A C3 
Multifocal Contact Lens in its final lens design made in the 4GT Manufacturing Platform meets 
the validation requirements related to objective and subjective vision, eye health and fit 
acceptance.
Secondary Objective:
The secondary objective of this study is to determine that the lenses meet the users’ needs in
overall subjective vision, lens handling, comfort and lens fit success.  
2.2.
Endpoints 
Primary Efficacy Endpoints: 
Visual Performance (logMAR)
Visual Performance will be assessed binocularly at the 1-week follow-up evaluation under high 
luminance high contrast conditions. At distance (4 meters), VA is assessed using ETDRS 
Charts; while near (40 cm) and intermediate (64 cm) assessments will be made using reduced 
Guillon-Poling charts. See 
 in Appendix H for details 
regarding the collection of visual acuity (logMAR) visual ability.
Subjective Vision  
Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) 
questionnaire at the 1-week follow-up evaluation. CLUE™ is a validated patient-reported 
outcomes questionnaire to assess patient-experience attributes of soft, disposable contact 
lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the 
US, ages 18-65.  Derived CLUE™ scores using Item Response Theory (IRT) follow a normal 
distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response with a range of 0-120.  A 5-point increase in an average CLUE™ 
score translates into 10% shift in the distribution of scores for population of soft contact lens23. 
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Primary Safety Endpoints:
Slit Lamp Findings (SLF) 
Slit Lamp Findings (Grade 3 or higher) will be assessed for each subject eye at all study visits 
(schedule and unscheduled). SLFs will be evaluated and classified using the FDA Grading 
scale rating from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 
representing successively worse findings (i.e. Grade 1=trace, Grade 2= mile, Grade 
3=moderate and Grade 4= severe). The percentage of eyes with Grade 3 or higher slit lamp 
findings will be analyzed and will include corneal infiltrates. See 
in Appendix H 
for more details on the collect of SLFs.  
Unacceptable Lens Fit 
Unacceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each 
subject eye. Unacceptable fit is a binary response where Y=1 if lens fit is unacceptable and 
Y=0 otherwise. Unacceptable fit was defined as unacceptable if any one of the following 
criteria:
• 
limbal exposure at primary gaze or with extreme eye movement; 
•
edge lift;
• 
excessive movement in primary up gaze; 
•
insufficient movement in all three of the following conditions: primary gaze, up gaze, 
and push up test. 
Eyes with multiple unacceptable fitting events was counted only once. See 
 in 
Appendix H for additional details regarding lens fit assessments.
Secondary Endpoints 
x
CLUETM Vision score  
x
CLUETM Comfort score
x
CLUETM Handling core
x
Lens Fit Success (Number of lenses needed to fit (optimize) the subject’s vision) 
2.3.
Hypotheses
Co-Primary Safety Hypotheses 
1. 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 
statistically less than 5%.  
2. When wearing the Test lenses, the proportion (%) of eyes with an unacceptable fit 
during the study will be statistically less than 5%.
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Both co-primary safety hypotheses must be met in order to test any co-primary efficacy 
hypotheses.   
Co-Primary Efficacy Hypotheses: 
1. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
quality of vision score of the Test lenses will be statistically better than 41 points for 
the myope population.  This will be recorded by the subject using the CLUE Follow-
up Questionnaire. 
2. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
quality of vision score for the Test lenses will be statistically better than 36 points for 
the hyperope population. This will be recorded by the subject using the CLUE 
Follow-up Questionnaire. 
3. After approximately 1-week of wear in the optimized Test lenses, the mean distance, 
binocular, high luminance, high contrast logMAR visual acuity score of the Test lens 
will be statistically lower than 0.0 logMAR. 
4. After approximately 1-week of wear in the optimized Test lenses, 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 1-week of wear in the optimized Test lenses, the mean near, 
binocular, high luminance, high contrast logMAR visual acuity score of the Test lens 
will be statistically lower than 0.17 logMAR.
All safety and efficacy co-primary hypotheses must be satisfied in order to meet the 
study objectives and to test any secondary hypotheses. 
Secondary Hypotheses 
1. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
quality of vision score of the Test lenses will be statistically better than 46 points for 
the myope population.  This will be recorded by the subject using the CLUE Follow-
up Questionnaire. 
2. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
quality of vision score for the Test lenses will be statistically better than 41 points for 
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the hyperope population.  This will be recorded by the subject using the CLUE Follow-
up Questionnaire. 
3. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
comfort score for the Test lenses will be statistically better than 52 points.  This will be 
recorded by the subject using the CLUE Follow-up Questionnaire.   
4. After approximately 1-week of wear in the optimized Test lenses, the mean overall 
handling score for the Test lenses will be statistically better than 53 points.  This will 
be recorded by the subject using the CLUE Follow-up Questionnaire.  
5. The percentage of subjects who obtain the optimum lens pair in 4 lenses or less will be 
statistically better than  90%. 
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. Subjects enrolled 
in this study will be either myopic or hyperopic and have presbyopia.    
3.2.
Inclusion Criteria
Potential subjects must satisfy all the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening:
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be at least 40 years of age and not greater than 70 years of age at the time of consent.
4. Own a wearable pair of spectacles if required for their distance vision.
5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 6 hours per wear day, for 1 month or more duration). 
6. 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”. 
Inclusion Criteria at Baseline:
7. TKHVXEMHFW¶VGLVWDQFHVSKHULFDOHTXLYDOHQWUHIUDFWLRQYHUWH[FRUUHFWHGLI-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. 
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9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each 
eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.  
3. Have 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. Have 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. Have a history of amblyopia, strabismus or binocular vision abnormality. 
6. Use of any of the following medications within 1 week prior to enrollment: oral 
retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled 
corticosteroids.  See section 9.1 for further examples.
7. Use of any ocular medication, with the exception of rewetting drops. 
8. Have a history of herpetic keratitis.
9. Have a history of irregular cornea.
10. Have a history of pathological dry eye. 
11. Have Participated in any contact lens or lens care product clinical trial within 30 days 
prior to study enrollment. 
12. Be and employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
13. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop 
solutions or sodium fluorescein. 
Exclusion Criteria at Baseline:
The subject must not: 
14. Have clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear.
15. Have any current ocular infection or inflammation. 
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16. Have any current ocular abnormality that may interfere with contact lens wear.  
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a single-masked, single-arm, dispensing clinical trial. Up to 120 subjects (72 myopes 
and 48 hyperopes) will be enrolled into the study with the aim of completing approximately 
100 subjects (60 myopes and 40 hyperopes).   
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 1 
week of daily disposable wear which is the intended modality of the lenses.
4.3.
Enrollment Target and Study Duration
A total of approximately 120 eligible subjects will be enrolled (72 myopes and 48 hyperopes)  
with 100 subjects targeted to complete (60 myopes and 40 hyperopes).  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, however, the identity of the test 
device will be masked.   
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.  
5.3.
Procedures for Maintaining and Breaking the Masking
The identity of the test article 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. 
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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7.4.
Laboratory Procedures 
Not Applicable 
8.
SUBJECTS COMPLETION/WITHDRAWAL 
8.1.
Completion Criteria
Subjects are considered to have completed the study if they:  
x
provided informed consent. 
x
they are eligible.
x
completed all study visits
8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons: 
x
Subject withdrawal of consent. 
x
Subject not compliant to protocol  
x
Subject lost to follow-up. 
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear  
x
Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment).
x
Subject not compliant with study lens wear schedule 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation 
Additional subjects will 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. 
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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: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
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x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
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 apply and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: 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 devices.
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury 
x
Permanent or persistent impairment of a body structure or a body function 
x
Hospitalization or prolongation of patient hospitalization 
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
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x
Chronic disease 
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
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x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
NOTE 1: 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: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.
Unanticipated Adverse Device Effect (UADE) – A UADE is 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: 
x
Seriousness/Classifications (see definition in section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 13.2.2). 
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown. 
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or 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: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
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x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
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x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x
Any referral to another health care provider if needed. 
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
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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 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: 
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
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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 to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest
None 
13.6. 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. 
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC).14  Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis.
Summary tables (Descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate. Continuous variables 
will be summarized with descriptive statistics (n, mean, standard deviation [SD], median, 
minimum and maximum). Frequency count and percentage of subjects or eyes within each 
category will be provided for categorical data.
Summaries will be presented by separately for each time point (Baseline, fitting, 3-Day follow-
up, 1-week follow-up) and will be performed separately by completion status (Safety 
Population, Per-Protocol Population or Intent-to-treat, when appropriate).   
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=5%). All co-primary safety and co-primary efficacy hypotheses must be met to test any 
secondary hypotheses. 
Secondary hypotheses (except for lens fit success) will be tested with using an overall two-
sided family-wise type I error rate of 5% (1% individually). Lens fit success will be tested 
using a 99% credible interval. 
14.5. Primary Analysis  
Primary Safety Analyses:
All primary safety analysis will be conducted on the safety population.  
Grade 3 or Higher SLF 
Grade 3 of Higher SLFs will be analyzed using a Bayesian beta-binomial model with correlated 
binary data17.
The Model:
Let ܻଵ and ܻଶdenote the binary outcomes of lens fit acceptance (Yes/No) in left and right eyes, 
respectively, across dispensing and follow-up visits when wearing the Test lens. Considering 
the correlation, ߩ, between ܻଵ and ܻଶ, the distribution of the sum ܻ = ܻଵ + ܻଶ is obtained by 
the mixture of two variables. One of them follow a binomial distribution ܤ݅݊(2, ݌) with mixing 
probability (1 െ ߩ) and the other one follows a modified Bernoulli distribution, ܯܤ݁ݎ݊(݌),
taking value 0 and 2 rather than conventional 0 and 1, with mixing probability ߩ:
ܲ(ܻ =  ݕ| ݌, ߩ) = (1 െ ߩ)ܤ݅݊(2, ݌)ܫ஺ଵ +   ߩܯܤ݁ݎ݊(݌)ܫ஺ଶ ,
where ܫ஺ଵ = {0, 1, 2}, ܫ஺ଶ= {0, 2} and ݌is the probability of success (i.e., acceptable lens 
fitting).  
To overcome the complexity of the mixture likelihood a latent variable ܼ௜, i = 1, 2 is introduced 
in the model to indicate in which component of the model the observation ݕ௜, i=1, 2, belongs 
to, that is,
ܼ௜= 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 (ܻ௜, ܼ௜), ݅= 1, 2, is given by 
P(Y = y୧, Z = z୧| p, ɏ)
=  ɏ୸౟p୷౟୸౟/ଶ(1 െp)(ଶି୷౟)୸౟/ଶ(1 െɏ)ଵି୸౟൬2
y୧൰p୷౟(ଵି୸౟)(1 െp)(ଶି୷౟)(ଵି୸౟)
The probability p links to the regression variables through a logit transformation as follow: 
logit (p) =  Ⱦ଴+ Ⱦଵlens
It is assumed that Ⱦ଴, Ⱦଵ and ߩto be independent with a non-informative prior N(0, 1000) for 
Ⱦ଴ and Ⱦଵ, and beta(0.5, 0.5) for ߩ. The Metropolis sampler algorithm as implemented in the 
SAS/STAT MCMC Procedure14 will be used to estimate the posterior distributions of the 
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parameters (Ⱦ଴, Ⱦଵ, ߩ). Inferences will be made based on a posterior credible interval for the 
relevant parameters.  
Bayesian Estimation and Statistical Evaluation of Hypothesis:
Superiority of the Test lens relative to the pre-defined threshold with respect to Grade 3 or 
higher will be evaluated using Bayesian statistics. 
Primary Safety Hypothesis 1:  
The null and alternative hypotheses for evaluating superiority of the Test lens relative to 5% 
are as follows: 
ܪ଴: ݌୘൒0.05
ܪ஺: ݌୘< 0.05,
where ݌୘is the probability of a Grade 3 or higher SLF across all study visits for Test lens. 
Based on Bayesian posterior probability distribution of the proportion ݌், superiority is 
interpreted as 95% probability of Test being statistically lower than the threshold of 5% (i.e., 
݌୘< 0.05). If the upper bound of the 95% central posterior credible interval is below 0.05, it 
can be concluded that there is 95% probability that the Test lens is superior to 5% (statistically 
less than) based on the observed sample.  
In the case of zero clinically significant SLF, a Bayesian hierarchical model accounting for 
zero event problem will be considered18.  
Unacceptable Lens Fitting 
Lens fit acceptance will be analyzed using a Bayesian beta-binomial model with correlated 
binary data17.
Bayesian Estimation and Statistical Evaluation of Hypothesis:
Superiority of the Test lens relative to the pre-defined threshold with respect to unacceptable 
lens fitting will be evaluated using Bayesian statistics. 
Primary Safety Hypothesis 2:  
The null and alternative hypotheses for evaluating superiority of the Test lens relative to 5% 
are as follows: 
ܪ଴: ݌୘൒0.05
ܪ஺: ݌୘< 0.05,
where ݌୘is the probability of event (i.e., probability of unacceptable lens fitting while wearing 
the test lens). Based on Bayesian posterior probability distribution of the proportion ݌்,
superiority is interpreted as 95% probability of the Test lens being statistically lower than the 
pre-defined threshold of 5% (i.e., ݌୘< 0.05) with respect to unacceptable lens fitting rate. If 
the upper bound of the 95% central posterior credible interval is below 0.05, it can be 
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concluded that there is 95% probability that the Test lens is superior to the 5% threshold 
(statistically less) based on the observed sample.  
In the case of all eyes have an acceptable lens fit (i.e., zero unacceptable lens fit), a Bayesian 
hierarchical model accounting for zero event problem will be considered. Details of this model 
will be provided in the stand-along SAP18.   
Primary Efficacy Analyses: 
All primary efficacy analyses will be conducted on the intent-to-treat population.  
Threshold utilized in hypothesis testing related to CLUE vision scores were based on a meta-
analysis of CLUE vision scores for the Market leader for multifocal lenses, Air Optix21.   
CLUE Vision Scores 
Mean population estimates and two-sided 95% confidence intervals will be computed 
separately for each stratum (hyperopes and myopes) using a bootstrap methodology. At least 
a total of 20000 bootstrap iterations will be used following the suggestions of Samuelson and 
Petrick19. A minimum threshold of 4000 bootstrap iterations was recommended for an 
alpha=0.05, however, since each test will be performed using alpha=0.01, it is more 
appropriate to increase number of bootstrap iterations. The assessment of the impact of the 
autocorrelation for between subjects repeated measurements, is defined by the difference 
between the observed statistic compared to the bootstrapped population mean (bias= observed 
minus bootstrapped population mean). This approach was recommended for all estimations of 
statistical inference since this approach accommodates correlated data. The bootstrap analysis 
that will be performed followed a procedure as discussed by Davison, AC and Hinkley, DV20. 
Primary Efficacy Hypothesis 1:  
The null and alternative hypothesis to test for superiority of Myopes relative to the threshold 
41 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑41
ܪ஺: ߤ்௘௦௧> 41
Where ߤ்௘௦௧, represents the population mean for Myopes at the 1-week follow-up with respect 
to CLUE vision scores. Superiority will be declared if the lower limit of the 95% CI is above 
41.
Primary Efficacy Hypothesis 2: 
The null and alternative hypothesis to test for superiority of Hyperopes relative to the threshold 
36 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑36
ܪ஺: ߤ்௘௦௧> 36
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Where ߤ்௘௦௧, represents the population mean for Hyperopes at the 1-week follow-up with 
respect to CLUE vision scores. Superiority will be declared if the lower limit of the 95% CI is
above 36.   
Visual Performance (logMAR) 
Binocular HLHC visual performance will utilize the same bootstrapping methodology as 
described above for CLUE vision. However, with respect to VP, mean population estimates 
and two-sided 95% confidence intervals will be computed separately for each distance 
(distance 4m, intermediate 64cm and near 40cm) but will combine the hyperopic and myopic 
populations. At least a total of 20000 bootstrap iterations will be used following the suggestions 
of Samuelson and Petrick19. A minimum threshold of 4000 bootstrap iterations was 
recommended for an alpha=0.05, however, since each test will be performed using alpha=0.01, 
it is more appropriate to increase number of bootstrap iterations. The assessment of the impact 
of the autocorrelation for between subjects repeated measurements, is defined by the difference
between the observed statistic compared to the bootstrapped population mean (bias= observed 
minus bootstrapped population mean). This approach was recommended for all estimations of 
statistical inference since this approach accommodates correlated data. The bootstrap analysis 
that will be performed followed a procedure as discussed by Davison, AC and Hinkley, DV20.  
Primary Efficacy Hypothesis 3:
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of Aurora relative to the threshold 0.0 logMAR are as follows: 
ܪ௢: ߤ்௘௦௧൒0 logMAR 
ܪ஺: ߤ்௘௦௧< 0 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to distance HLHC visual performance. Superiority will be declared if the upper limit of the 
95% CI is below 0.0.   
Primary Efficacy Hypotheses 4 and 5:
The null and alternative hypothesis for binocular intermediate and near HLHC visual 
performance to test for superiority of Aurora relative to the threshold 0.17 logMAR are as 
follows: 
ܪ௢: ߤ்௘௦௧൒0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to HLHC visual performance. Superiority will be declared if the upper limit of the 95% CI 
for either intermediate or near is below 0.17.   
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14.6. Secondary Analysis  
All secondary analyses will be conducted on the Intent-to-Treat population.  
Threshold utilized in hypothesis testing related to CLUE vision, comfort and handling scores 
were based on a meta-analysis of CLUE vision, comfort and handling scores for the Market 
leader for multifocal lenses, Air Optix21.   
CLUE Vision
Secondary hypotheses 1 and 2 will be tested using the same estimates and 95% CIs from the 
analysis as described for CLUE Vision in section 14.5. The hypotheses tests will be performed 
separately for Hyperopes and Myopes using 2-sided 95% confidence intervals constructed for 
the population mean at the 1-week follow-up evaluation.
Secondary Hypothesis 1:  
The null and alternative hypothesis to test for superiority of  Myopes relative to the threshold 
46 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑46
ܪ஺: ߤ்௘௦௧> 46
Where ߤ்௘௦௧, represents the population mean for Aurora Hyperopes at the 1-week follow-up 
with respect to CLUE vision scores. Superiority will be declared if the lower limit of the 95% 
CI is above 46.   
Secondary Hypothesis 2:  
The null and alternative hypothesis to test for superiority of Hyperopes relative to the threshold 
41 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑41
ܪ஺: ߤ்௘௦௧> 41
Where ߤ்௘௦௧, represents the population mean for Aurora Hyperopes at the 1-week follow-up 
with respect to CLUE vision scores. Superiority will be declared if the lower limit of the 95% 
CI is above 41.   
CLUE Comfort and Handling 
Mean population estimates and 95% CIs for CLUE comfort and handling will be calculated 
separately using bootstrapping techniques. For both  comfort and handling scores, a minimum 
of 20000 bootstrap iterations will be used following the suggestions of Samuelson and 
Petrick19. A minimum threshold of 4000 bootstrap iterations was recommended for an 
alpha=0.05, however, since each test will be performed using alpha=0.01, it is more 
appropriate to increase number of bootstrap iterations. The assessment of the impact of the 
autocorrelation for between subjects repeated measurements, is defined by the difference 
between the observed statistic compared to the bootstrapped population mean (bias= observed 
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minus bootstrapped population mean). This approach was recommended for all estimations of 
statistical inference since this approach accommodates correlated data. The bootstrap analysis 
that will be performed followed a procedure as discussed by Davison, AC and Hinkley, DV20.
Secondary hypotheses 3 and 4 will be tested using the data from hyperopes and myopes 
combined since there is not a significant difference in performance between these two 
populations. The hypotheses tests will be performed separately for Comfort and Handling 
using 2-sided 95% confidence intervals constructed for the population means at the 1-week 
follow-up evaluation. 
Secondary Hypothesis 3:  
The null and alternative hypothesis to test for superiority for Comfort of the Test lens relative 
to the threshold 52 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑52
ܪ஺: ߤ்௘௦௧> 52
Where ߤ்௘௦௧, represents the population mean for the Test lens at the 1-week follow-up with 
respect to CLUE comfort scores. Superiority will be declared if the lower limit of the 95% CI 
is above 52.   
Secondary Hypothesis 4:  
The null and alternative hypothesis to test for superiority for Handling of Test lens relative to 
the threshold 53 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑53
ܪ஺: ߤ்௘௦௧> 53
Where ߤ்௘௦௧, represents the population mean for the Test lens at the 1-week follow-up with 
respect to CLUE Handling scores. Superiority will be declared if the lower limit of the 95% 
CI is above 53.   
Number of Lenses Required to Achieve Optimization 
Number of lenses required to achieve lens optimization will be analyzed using a Bayesian beta-
binomial model with correlated binary data17.  
Bayesian Estimation and Statistical Evaluation of Hypothesis:
Superiority of the Test lens relative to the pre-defined threshold with respect to unacceptable 
lens fitting will be evaluated using Bayesian statistics. The null and alternative hypotheses for 
evaluating superiority of the Test lens relative to 5% are as follows: 
ܪ଴: ݌୘൑0.90
ܪ஺: ݌୘> 0.90,
where ݌୘is the probability of event (i.e., proportion of subjects to achieve optimization in 4 
lenses or less while wearing the test lens). Based on Bayesian posterior probability distribution 
of the proportion ݌், superiority is interpreted as 95% probability of the Test lens being 
statistically greater than the pre-defined threshold of 90% (i.e., ݌୘> 0.90) with respect to 
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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 
multiple imputation methods if the proportion of subject dropout is greater than the 10%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations.
14.10.Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis.  
External data sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
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.  
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The content and structure of the eCRFs are compliant with ISO14155:2020.Error! Reference source 
not found.
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: This study is not an 
early feasibility study.  
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
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 
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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. 
16.4. Data Monitoring Committee (DMC)
Not Applicable.  
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
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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. Subjects will only be enrolled if the subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide
their consent voluntarily. 
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(R2)
guidelines on Good Clinical Practice (GCP),Error! Reference source not found. 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 2013Error! Reference source not found. and that the clinical study data 
are credible. The Investigator must maintain clinical study files in accordance with section 8 
of the ICH E6(R2) guidelines on Good Clinical Practice (GCP),Error! Reference source not found. and 
applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
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During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,Error! Reference source not found.Error! Reference 
source not found. current ICH GCPError! Reference source not found. and ISO 14155:2020Error! Reference source not 
found. 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 
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that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
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) and other 
applicable personal data protection and security laws and regulations.15,16 Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the 
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
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. 
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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,the Investigator/Institution will maintain all CRFs 
and all subject records that support the data collected from each subject, as well as all study 
documents as specified in ICH GCP and all study documents as specified by the applicable 
regulatory requirement(s).Error! Reference source not found. The Investigator/Institution will take 
measures to prevent accidental or premature destruction of these documents. 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
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x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
There is no plan to publish the outcome of this investigation. 
22. REFERENCES
1.
ISO 14155:2020: 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.
Karkkainen TR.  Investigator Brochure CR-6477  . 
6.
Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Multifocal Contact Lens with an UV Blocker Additive. June 25, 2019 
7.
Thomas R. Karkkainen.  Clinical Study Report 
Dispensing evaluation of daily disposable multifocal contact lenses in a population of 
hyperopic presbyopes. March 18, 2020 
8.
Thomas R. Karkkainen.  Clinical Study Report 
 Evaluation 
of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population. January 
06, 2021 
9.
Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population. April 05, 
2021
10. Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Novel Multifocal Contact Lens in a Myopic Population. May 21, 2021 
11. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Investigational Daily Disposable Multifocal Contact Lenses Produced with Different 
Manufacturing Processes. February 10, 2021 
12. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Daily Disposable Multifocal Contact Lenses Made With Two Different Manufacturing 
Processes. April 19, 2021 
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13. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Investigational Daily Disposable Multifocal Contact Lenses Produced with Different 
Manufacturing Processes in Myopes. April 23, 2021 
14. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute Inc.  
15. Health Information Portability and Accountability Act (HIPAA). Available at 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
16. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at http://data.europa.eu/eli/reg/2017/745/2017-05-05
17. Diniz CAR, Tutia MH, Leite JG. Bayesian analysis of a correlated binomial model. 
Brazilian Journal of Probability and Statistics. 2010;24(1).
18. Chen Z, McGee M. A Bayesian Approach to Zero-Numerator Problems Using 
Hierarchical Models. Journal of Data Science. 2021;6(2):261-268.
19. Samuelson F, Petrick N. Comparing image detection algorithms using resampling. 3rd
IEEE International Symposium on Biomedical Imaging: Nano to Macro, 2006.
20. Davison AC, Hinkley DV. Bootstrap methods and their applications. Cambridge 
University Press, 1997 
21. Cannon J. Technical Report 
  An Integrated Analysis of Evaluating 
Subjective Vision, Comfort and Handling for Multifocal Air Optix Habitual Contact 
Lens Wearers. November 1, 2021.  
22. Whitehead, A. (2002). Meta-analysis of controlled clinical trials (Vol. 7). John Wiley & 
Sons. 
23. Wirth RJ, Edwards MC, Henderson M, et al. Development of the Contact Lens User 
Experience: CLUE Scales. Optom Vis Sci. 2016;93(8):801-808.
24. Bonferroni C. Calculation of the insurance groups of heads. Studies in Honour of 
Professor Salvatore Ortu Carboni. 1935;Rome: Italy:13-60
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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APPENDIX B: PATIENT INSTRUCTION GUIDE 
. 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
Not applicable.
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APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE
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APPENDIX G: BINOCULAR OVER REFRACTION
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DETERMINATION OF NEAR ADDITION
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Title:                          Determination of Near Addition 
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Determination of Near Addition 
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 5 
  
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Clinical Study Protocol
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NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
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LENS FITTING CHARACTERISTICS
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6 
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SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR
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Document Type:  
Document Number:
Revision Number:  5 
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BIOMICROSCOPY SCALE
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DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE
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PATIENT REPORTED OUTCOMES
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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Document Number:
Revision Number:  4 
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Revision Number:  4 
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Revision Number:  4 
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Document Type:  
Document Number:
Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
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APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6477 Protocol Title: Evaluation of a daily disposable silicone hydrogel 
multifocal contact lens in myopes and hyperopes 
Version and Date: 2.0 05 January 2022
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155:2020,1 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 I of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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