Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material in a Low ADD Hyperopic Population
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol 
Evaluation of a Toric Multifocal Contact Lens Manufactured in Etafilcon Material 
in a Low ADD Hyperopic Population
Protocol CR-6278
Version: 1.0
Date: 12 July 2018.
Investigational Products: JJV Investigational Toric Multifocal Contact Lenses manufactured in 
etafilcon A material
Key Words: Presbyopia, Multifocal, Astigmatism, Daily Disposable, Dispensing, Etafilcon A
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required by 
International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it should 
not be further disclosed without the written permission of Johnson & Johnson Vision Care, Inc.  
Any supplemental information that may be added to this document is also confidential and 
proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in confidence in the same 
manner as the contents of this document. 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ................................................................................. 6 
SPONSOR NAME AND ADDRESS ............................................................................................. 6 
MEDICAL MONITOR ................................................................................................................... 6 
AUTHORIZED SIGNATURES ..................................................................................................... 7 
CHANGE HISTORY ...................................................................................................................... 8 
SYNOPSIS ...................................................................................................................................... 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .......................... 13 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 15 
1.1. 
Name and Descriptions of Investigational Products ........................................................ 15 
1.2. 
Intended Use of Investigational Products ........................................................................ 15 
1.3. 
Summary of Findings from Nonclinical Studies .............................................................. 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ........................................... 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study………... ............................................................................................................................ 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 16 
2.1. 
Objectives ......................................................................................................................... 16 
2.2. 
Endpoints ......................................................................................................................... 16 
2.3. 
Hypotheses ....................................................................................................................... 17 
3. 
TARGETED STUDY POPULATION .......................................................................... 17 
3.1. 
General Characteristics .................................................................................................... 17 
3.2. 
Inclusion Criteria .............................................................................................................. 18 
3.3. 
Exclusion Criteria ............................................................................................................ 18 
3.4. 
Enrollment Strategy ......................................................................................................... 19 
4. 
STUDY DESIGN AND RATIONALE ......................................................................... 19 
4.1. 
Description of Study Design ............................................................................................ 19 
4.2. 
Study Design Rationale .................................................................................................... 19 
4.3. 
Enrollment Target and Study Duration ............................................................................ 19 
5. 
TEST ARTICLE ALLOCATION AND MASKING .................................................... 19 
5.1. 
Test Article Allocation ..................................................................................................... 19 
5.2. 
Masking ............................................................................................................................ 20 
5.3. 
Procedures for Maintaining and Breaking the Masking .................................................. 20 
6. 
STUDY INTERVENTION ............................................................................................ 21 
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6.1. 
Identity of Test Articles ................................................................................................... 21 
6.2. 
Ancillary Supplies/Products ............................................................................................. 22 
6.3. 
Administration of Test Articles ........................................................................................ 22 
6.4. 
Packaging and Labeling ................................................................................................... 22 
6.5. 
Storage Conditions ........................................................................................................... 23 
6.6. 
Collection and Storage of Samples .................................................................................. 23 
6.7. 
Accountability of Test Articles ........................................................................................ 23 
7. 
STUDY EVALUATIONS ............................................................................................. 24 
7.1. 
Time and Event Schedule ................................................................................................ 24 
7.2. 
Detailed Study Procedures ............................................................................................... 27 
VISIT 1 ................................................................................................................................... 27 
VISIT 2 ................................................................................................................................... 35 
VISIT 3 ................................................................................................................................... 42 
FINAL EVALUATION .......................................................................................................... 45 
7.3. 
Unscheduled Visits .......................................................................................................... 45 
7.4. 
Laboratory Procedures ..................................................................................................... 47 
8. 
SUBJECTS COMPLETION/WITHDRAWAL ............................................................. 47 
8.1. 
Completion Criteria .......................................................................................................... 47 
8.2. 
Withdrawal/Discontinuation from the Study ................................................................... 47 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 48 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................... 48 
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 ............................................................................................ 53 
13.2.1. 
Causality Assessment ............................................................................................ 53 
13.2.2. 
Severity Assessment ............................................................................................. 53 
13.3. 
Documentation and Follow-Up of Adverse Events ..................................................... 54 
13.4. 
Reporting Adverse Events ............................................................................................ 55 
13.4.1. 
Reporting Adverse Events to Sponsor .................................................................. 55 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities . 56 
13.4.3. 
Event of Special Interest ....................................................................................... 56 
13.5. 
Reporting of Pregnancy ................................................................................................ 56 
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14. 
STATISTICAL METHODS .......................................................................................... 56 
14.1. 
General Considerations ................................................................................................ 56 
14.2. 
Sample Size Justification .............................................................................................. 57 
14.3. 
Analysis Populations .................................................................................................... 58 
14.4. 
Level of Statistical Significance ................................................................................... 58 
14.5. 
Primary Analysis .......................................................................................................... 58 
14.6. 
Secondary Analysis ...................................................................................................... 59 
14.7. 
Other Exploratory Analyses ......................................................................................... 59 
14.8. 
Interim Analysis ........................................................................................................... 59 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ................................................. 59 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ........................................... 59 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING .................................. 59 
15.1. 
Electronic Case Report Form/Data Collection ............................................................. 59 
15.2. 
Subject Record ............................................................................................................. 60 
16. 
DATA MANAGEMENT ............................................................................................... 60 
16.1. 
Access to Source Data/Document ................................................................................ 60 
16.2. 
Confidentiality of Information ..................................................................................... 61 
16.3. 
Data Quality Assurance ................................................................................................ 61 
17. 
MONITORING ........................................................................................................ …..61 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................... 62 
18.1. 
Study-Specific Design Considerations ......................................................................... 62 
18.2. 
Investigator Responsibility ........................................................................................... 62 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .................. 62 
18.4. 
Informed Consent ......................................................................................................... 63 
18.5. 
Privacy of Personal Data .............................................................................................. 64 
19. 
STUDY RECORD RETENTION .................................................................................. 65 
20. 
FINANCIAL CONSIDERATIONS ............................................................................... 65 
21. 
PUBLICATION ............................................................................................................. 66 
22. 
REFERENCES ............................................................................................................... 66 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ........... 67 
APPENDIX B: PATIENT INSTRUCTION GUIDE .................................................................... 84 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ............................................... 85 
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ............................................. 86 
APPENDIX E: OCULAR DOMINANCE .................................................................................... 87 
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APPENDIX F: Test LENS FITTING GUIDE .............................................................................. 88 
APPENDIX G: BINOCULAR OVER REFRACTION ................................................................ 90 
APPENDIX H: 
 ............................................. 91 
, LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS ........................................... 92 
, EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING ........................ 100 
, DETERMINATION OF NEAR ADD ..................................................................... 105 
, NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE ................ 113 
, LENS FITTING CHARACTERISTICS .................................................................. 116 
, SUBJECT REPORTED OCULAR SYMPTOMS ................................................... 123 
, DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS125 
, BIOMICROSCOPY SCALE .................................................................................... 132 
, KERATOMETRY .................................................................................................... 138 
, DISTANCE AND NEAR VISUAL ACUITY EVALUATION .............................. 140 
, TORIC FIT EVALUATION .................................................................................... 145 
, ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE ........... 149 
, LENS INSERTION AND REMOVAL .................................................................... 153 
, VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.....................................................................................................................................156 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .............................. 161 
TABLE OF CONTENTS  
Figure 1: Study Flowchart .............................................................................................................. 12 
TABLE OF CONTENTS  
Table 1: Test Articles ...................................................................................................................... 21 
Table 2: Ancillary Supplies ............................................................................................................ 22 
Table 3: Time and Events ............................................................................................................... 24 
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SYNOPSIS 
Protocol Title
Evaluation of a Toric Multifocal Contact Lens Manufactured in 
Etafilcon Material in a Low ADD Hyperopic Population
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256
Clinical Phase
Development phase, Phase 2
Trial Registration
This study will be registered on ClinicalTrials.gov. 
Test Article(s)
Investigational Product: JJVC Investigational Toric Multifocal 
Contact Lens manufactured in etafilcon A material.
Wear and Replacement 
Schedules 
Wear Schedule: The lenses will be used on a daily disposable 
basis. 
Replacement Schedule: The lenses will be replaced after a day of 
wear.
Objectives 
Primary Objective(s)
The primary objectives of this study are an evaluation of the 
clinical performance of logMAR visual acuity and subjective 
visual response.
Study Endpoints
Primary endpoints: logMAR visual acuity, and subjective visual 
response.
Study Design
The study is a bilateral, single masked, single-arm, 3-visit 
dispensing study.  There will be one study treatment, with the 
subject being in the treatment for approximately 12-16 days. A
total of approximately 36 eligible subjects will be targeted to 
complete the study (low Add hyperopes only).  The subjects will 
be fit in the study lens and wear the study lenses for 6-8 days 
then undergo optimization and wear the optimized pair for 6-8
days.  The primary endpoints of this study are logMAR visual 
acuity and subjective visual response.  
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
A total of approximately 40 eligible subjects will be enrolled 
with 36 subjects targeted to complete.
Study Duration
The study will last approximately 2 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 inform consent has been obtained.   
For a detailed list of procedures see the time and events schedule 
listed below.
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to be 
enrolled in the study:
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1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol.
3. The subject must be at least 40 and not more than 70 years of 
age at the time of screening.
4. The subject’s distance spherical component of their refraction 
must be in the range of +1.25 D to +3.75 D in each eye. 
5. The subject’s refractive cylinder must be -1.00 to -1.50 D in 
each eye.
6. The subject’s ADD power must be in the range of +0.75 D to 
+1.50 D in each eye. 
7. Subject’s refractive cylinder axis must be within 90°±30° or 
180°±30° in each eye. 
8. The subject must have best corrected visual acuity of 20/20-3
or better in each eye.
9. Subjects must own a wearable pair of spectacles if required 
for their distance vision. 
10. The subject must already be wearing a presbyopic contact 
lens correction (e.g., reading spectacles over contact lenses, 
multifocal or monovision contact lenses, etc.) or if not 
respond positively to at least one symptom on the 
“Presbyopic Symptoms Questionnaire”.  
Potential subjects who meet any of the following criteria will be 
excluded from participating in the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may 
interfere with contact lens wear.  
3. Any active or ongoing systemic disease, autoimmune disease, 
or use of medication, which may interfere with contact lens 
wear. This may include, but not be limited to, diabetes, 
hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne 
rosacea, Stevens-Johnson syndrome, and immunosuppressive 
diseases or any infectious diseases (e.g. hepatitis, 
tuberculosis).
4. Clinically significant (Grade 3 or 4) corneal edema, corneal 
vascularization, corneal staining, tarsal abnormalities or 
bulbar injection, or any other corneal or ocular abnormalities 
which would contraindicate contact lens wear. 
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry 
eye, glaucoma, history of recurrent corneal erosions. 
6. Any previous, or planned, ocular or intraocular surgery (e.g. 
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radial keratotomy, PRK, LASIK, lid procedures, cataract 
surgery, retinal surgery, etc.).
7. A history of amblyopia, strabismus or binocular vision 
abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with
contact lens wear.
10. Use of any of the following oral medications within 1 week 
prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), 
oral tetracyclines, topical scopolamine, oral antihistamines 
(e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
11. Use of any ocular medication, with the exception of rewetting 
drops. 
12. History of herpetic keratitis.
13. Participation in any contact lens or lens care product clinical 
trial within 30 days prior to study enrollment. 
14.  Employee or immediate family member of an employee of 
clinical site (e.g., Investigator, Coordinator, Technician).
15. Any known hypersensitivity or allergic reaction to Eye-Cept®
rewetting drop solution.
Disallowed 
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) medications 
that may affect contact lens wear.  
Measurements and 
Procedures
logMAR Visual acuity and Subjective responses for vision using 
the CLUE questionnaire. 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, 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
Eye-Cept® Rewetting drops and saline for storing worn lenses.
Principal Investigator(s) and 
Study Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council on Harmonization
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
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PIG 
 
 
Patient Instruction Guide
PQC 
 
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
Johnson & Johnson Vision recently launched a multifocal contact lens, 1-DAY ACUVUE Moist 
Multifocal.  The lens is recommended for presbyopes who have -0.75 D of refractive cylinder.  
There is a considerable population of presbyopic patients who have greater than -0.75 D of 
cylinder, in one or both eyes.  Currently there are a limited number of soft toric multifocal lenses 
available and they have limited success as evidenced by the very small market share.  To meet 
this unmet need Johnson & Johnson Vision has undertaken a toric multifocal development 
program leveraging the Moist Multifocal optical design and adding toric correction and lens 
stabilization that is currently utilized in the 1-Day Moist for Astigmatism lens.  
A previous study 
 evaluating this novel multifocal toric lens was completed on 
hyperopic subjects and the lens displayed acceptable clinical performance.  The population in that 
study was skewed toward the higher ADD subjects.  The purpose of this study was to evaluate the 
same design in a low ADD hyperopic population.   
1.1.
Name and Descriptions of Investigational Products 
Investigational Product:  Toric Multifocal Contact manufactured in etafilcon A material.
Refer to Table 1 in Section 6.1 of the protocol.    
1.2.
Intended Use of Investigational Products
The lenses are intended to correct refractive astigmatism, hyperopia and presbyopia.  The lenses 
will be used in a population of presbyopes who have -1.00 D to -1.50 D of cylinder and add 
powers of +0.75 D to +1.50 D. 
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical trials 
on humans. For the most comprehensive nonclinical information regarding JJVC Toric Multifocal 
Contact Lens manufactured in etafilcon A material refer to the latest version of the CR-6278 
Investigator's Brochure. 
1.4.
Summary of Known Risks and Benefits to Human Subjects
For the most comprehensive risk and benefit information regarding JJVC Toric Multifocal 
Contact Lens manufactured in etafilcon A material refer to the latest version of the CR-6278 
Investigator’s Brochure and Informed Consent. 
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study
The toric multifocal contact lens system has been evaluated in clinical trials in 
See summary details of the studies below.  
In 
57 subjects completed the study as cohort.  The study was a Single-Arm study in 
hyperopic presbyopes with against the rule astigmatism.  Lenses were dispensed and worn for 
approximately two weeks of wear.  The mean binocular high luminance, high contrast distance 
acuity was -0.049 logMAR and near was 0.059 logMAR.  There was one non-ocular adverse 
event (sprained left toe) that was not related to the study lens.  The subject completed the study.      
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In 
19 subjects completed the study as cohort.  The study was a Single-Arm study in 
hyperopic presbyopes who had with the rule astigmatism.  Lenses were dispensed and worn for 
approximately two weeks of wear.  The mean binocular high luminance, high contrast distance 
acuity was 0.066 logMAR and near was 0.103 logMAR.  There was one serious adverse event 
that was reported that was non-ocular and not related to the study lens.  The subject had 
cholecystitis and the event resolved 2 days after the event start date and the subject was 
permanently discontinued from the study.  
In 
89 subjects completed the study as cohort.  The study was a Single-Arm study in 
myopic presbyopes who had with or against the rule astigmatism.  Lenses were dispensed and 
worn for approximately two weeks of wear.  The mean binocular high luminance, high contrast 
distance acuity was -0.090 logMAR and near was 0.031 logMAR.  There were two non-ocular 
adverse events, one serious adverse event that was reported that was non-ocular adverse events 
(upper respiratory tract infection and cold/allergy symptoms) that were not related to the study
lenses.  Both subjects completed the study.  
In 
 67 subjects completed the study as cohort.  The study was a Single-Arm study in 
myopic presbyopes with astigmatism.  Lenses were dispensed and worn for approximately two 
weeks of wear.  The mean binocular high luminance, high contrast distance acuity was -0.101 
logMAR and near was 0.024 logMAR.  Two ocular events were reported by 1 subject during the 
study.  The subject experienced non-significant irritation and redness of mild severity in both the 
eyes.  Though the event resolved on the same day of occurrence without any treatment, the study 
lens was permanently discontinued and subject did not complete the study.  The event was
considered to be very likely related to the study treatment. 
In 
 62 subjects completed the study as cohort.  The study was a Single-Arm study in 
hyperopic presbyopes with astigmatism.  Lenses were dispensed and worn for approximately two 
weeks of wear.  The mean binocular high luminance, high contrast distance acuity was -0.023 
logMAR and near was 0.103 logMAR.  There was one non-ocular adverse event (nausea) that was 
determined to be not related to the study lenses.    
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective
The primary objectives of this study are an evaluation of the clinical performance of logMAR 
visual acuity and subjective visual response.   
Secondary Objective
Not applicable.   
2.2.
Endpoints 
Primary Endpoint 
The primary endpoints of this study are logMAR visual acuity and subjective visual response.  
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Secondary Endpoint 
Not applicable.
Other Exploratory Endpoint(s) 
Not Applicable 
2.3.
Hypotheses
The following hypotheses will be tested throughout this investigation.  
Primary Hypotheses 
1. After 12-16 days of wear, the binocular bright, high contrast distance (4M) logMAR visual 
acuity of the test lens will be statistically better than +0.1 logMAR. This will be 
determined using ETDRS LogMAR acuity testing charts. 
2. After 12-16 days of wear, the binocular bright, high contrast near (40cm) logMAR visual 
acuity of the test lens will be statistically better than +0.17 logMAR. This will be 
determined using Guillon/Poling LogMAR acuity testing charts.   
3. After 12-16 days of wear, the PRO CLUE vision score for the test lenses will be 
statistically better than 32 points.  This will be recorded by the subject using the CLUE 
follow-up questionnaire. 
Secondary Hypotheses
Not applicable. 
Other Hypotheses 
Not applicable. 
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The population to be studied will consist of adapted contact lens wearers who have astigmatism in 
both eyes. Approximately 40 eligible subjects will be enrolled with 36 targeted to complete the 
study. Subjects will be targeted to be enrolled who have -1.00D to -1.50D of astigmatism in both
eyes. 
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3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT 
and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical 
protocol. 
3. The subject must be at least 40 and not more than 70 years of age at the time of screening.
4. The subject’s distance spherical component of their refraction must be in the range of +1.25 D 
to +3.75 D in each eye. 
5. The subject’s refractive cylinder must be -1.00 to -1.50 D in each eye. 
6. The subject’s ADD power must be in the range of +0.75 D to +1.50 D in each eye. 
7. Subject’s refractive cylinder axis must be within 90°±30° or 180°±30° in each eye. 
8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
9. Subjects must own a wearable pair of spectacles if required for their distance vision.
10. The subject must already be wearing a presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic Symptoms Questionnaire”.  
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating in 
the study:  
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.  
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which 
may interfere with contact lens wear. This may include, but not be limited to, diabetes, 
hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, Stevens-Johnson 
syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, 
tuberculosis).
4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, 
tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which 
would contraindicate contact lens wear.
5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of 
recurrent corneal erosions.
6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, 
lid procedures, cataract surgery, retinal surgery, etc.). 
7. A history of amblyopia, strabismus or binocular vision abnormality. 
8. Any current ocular infection or inflammation. 
9. Any current ocular abnormality that may interfere with contact lens wear.
10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid 
isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., 
Chlor-Trimeton, and Benadryl), systemic steroids. 
11. Use of any ocular medication, with the exception of rewetting drops. 
12. History of herpetic keratitis.
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13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study 
enrollment. 
14.  Employee or immediate family member of an employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
15. Any known hypersensitivity or allergic reaction to Eye-Cept® rewetting drop solution. 
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or utilizing 
Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
The study is a bilateral, single masked, single-arm, 3-visit dispensing study.  There will be one 
study treatment, with the subject being in the treatment for approximately 12-16 days. A total of 
approximately 36 eligible subjects will be targeted to complete the study (low Add hyperopes 
only).  The subjects will be fit in the study lens and wear the study lenses for 6-8 days then 
undergo optimization and wear the optimized pair for 6-8 days.  The primary end points are 
logMAR visual acuity and subjective visual response.
4.2.
Study Design Rationale
The study design is single-arm and the performance will be compared to previously set criteria for 
visual acuity and subjective vision response. 
4.3.
Enrollment Target and Study Duration
A total of approximately 40 eligible subjects will be enrolled with 36 subjects targeted to 
complete. The study will last approximately 2 months. 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
This study is a single-masked (subject masked), single-arm, dispensing clinical trial. Due to the 
nature of the study randomization is not required. All eligible subjects will be assigned to wear the 
same test article according to the lens wearing schedule.  
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5.2.
Masking
Masking will be used to reduce potential bias. Subjects will be unaware of the identity of the 
investigational product. Investigators and clinical site personnel involved in the data collection 
will not be masked as to the identity of the investigational product.  
Under normal circumstances, the mask should not be broken until all subjects have completed the 
study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In the 
event the mask is broken, the Sponsor must be informed as soon as possible. The date, time, and 
reason for the unmasking must be documented in the subject record. The Investigator is also 
advised not to reveal the study treatment assignment to the clinical site or Sponsor personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
5.3.
Procedures for Maintaining and Breaking the Masking
The test articles mask shall not be broken unless information concerning the lens type is necessary 
for the urgent medical treatment of a subject.  The Sponsor must be notified before the mask is 
broken. 
When dispensing test articles, the following steps should be followed to maintain randomization 
codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens fitting 
schedule/randomization scheme to obtain the test article assignment for that subject prior 
to dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply.  All 
test articles that are opened, whether dispensed (placed/fit on eye or dispensed outside the 
clinical site) or not, must be recorded on the Test Article Accountability Log in the 
“Dispensed” section. 
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degree
At three (3) minutes after insertion: Record:
   1.   The   rotational   position   to   the nearest 
degree
1.23
Left Lens Insertion
Subjects will insert the left lens themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be shipped 
back to the Sponsor. Complete the Quality 
Product Complaint form.
1.24
Timed Settled for Left 
Lens
The investigator will start a stopwatch as
soon as the left lens is inserted.
Note:  All lenses in this study have scribe 
marks at 6 o’clock and 12 o’clock positions 
and rotation measurements are made relative 
to a vertical reference line.
Record base nasal or base temporal rotation to 
the nearest degree.
At one (1) minute after insertion: Record:
   1.   The   rotational   position   to   the nearest 
degree 
At three (3) minutes after insertion: Record:
   1.   The   rotational   position   to   the nearest 
degree
1.25
Lens Settling 
Allow the study lenses to settle for a minimum 
of 15 minutes.
1.26
Toric Fit 
Evaluation 
After lens settling, record:
• The rotational position to the nearest 
degree
•
Lens stability with blink 
• Lens stability with eye versions 
• Toric fit acceptable or unacceptable Toric
lens fit will be unacceptable if lenses rotated
more than 40 degrees, or lens stability is worse
than 5 degrees movement with blink.  If toric 
fit is unacceptable, remove, store, and label the 
lenses, and proceed to final evaluation. 
1.27
Subjective Lens Fit
Evaluate and grade lens centration, primary gaze 
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Assessment 
movement, upgaze movement and tightness 
(push-up test). 
x
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance of 
clear cornea) in any gaze 
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, upgaze, 
and push-up).
If either lens is deemed unacceptable, the subject 
will be discontinued from the study.  Remove the 
lenses, perform a slit-lamp evaluation, and 
complete the Final Evaluation form.
1.28
Determine Visual 
Satisfaction
Determine if the subject’s vision is acceptable 
with the lenses.  Allow the subject to look down 
a hallway or out of a window for distance vision 
assessments, and for them to read a book, 
magazine or similar for near vision.  
1.29
Study Lens Distance 
and Near Visual 
Acuity
Measure the distance and near visual acuity OD, 
OS and OU to the nearest letter.  Record the 
results.
Note: Use the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm to measure the Near 
visual acuity.
1.30
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and OS 
using loose lenses outside of the phoropter under 
ambient room illumination.  The distance over-
refraction may also be refined under binocular 
conditions.   
Record the results.  The results of the distance 
over-refraction may also be checked for the 
impact on near vision under monocular and/or 
binocular conditions.   
1.31
Lens Power 
Modification (if 
applicable) 
If the subject reports unsatisfactory vision,
or is unable to obtain 20/30 distance visual 
acuity OU with the lenses than a modification 
must be attempted. If the subject reports 
satisfactory vision with the lenses a modification 
is not required however may at the Investigators 
discretion based upon their findings on the 
measured visual acuity and/or over- refraction.
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Select the reason(s) for lens change (select
all that apply):
• The settled lens rotation is such that one of the 
other available lens cylinder axis would be   
better (use LARS rule to determine the 
replacement lens cylinder axis)
•   Power Modification needed
•   Unsatisfactory Vision
•   Other (specify reason)
If one or both lenses are modified, repeat steps 
1.20 through 1.30 for one or both eyes as
appropriate. 
A maximum of two lens modifications are 
allowed.
1.32
Post-Fit Questionnaire
The subject will evaluate the vision 
characteristics, comfort characteristics, handling 
characteristics, and visual symptoms of the study 
lenses using the PRO questionnaire.
1.33
Insertion and 
Removal Training 
(I/R) (if applicable)
Neophytes and / or lapsed wearers who the 
investigator determines I/R training is required 
will receive training on lens insertion, lens 
removal, lens care and general contact lens 
safety information.
Additional lenses may be used if necessary to 
complete the I&R training. Record the lens 
information on the Lens log and in EDC.
Note: Instruct the Neophytes / Lapsed wearer 
subjects to follow this wear schedule for the 
study lenses: 
Dispensing day: 6 hours of wear
Day 1: 6-8 hours of wear
Day 2: 6-10 hours of wear
Day 3: 6-12 hours of wear
Day 4 and subsequent days: 6 to all waking 
hours of wear
1.34
Determination of I/R 
Success (if 
applicable) 
The subject must be able to successfully insert
and remove the contact lenses to be dispensed 
lenses and continue in the study.
Note: If the subject is not able to successfully 
insert and remove the contact lenses the subject 
will be discontinued. 
Remove the lenses and complete the Final 
Evaluation.
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1.35
Exit Distance and
Near Visual Acuity
Distance and near Snellen visual acuity will
be measured for each eye to the nearest letter 
with the study contact lenses in place.  
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the 
nearest letter OD, OS and OU. 
Note: The distance visual acuity must be at
least 20/30 OU for the lenses to be dispensed.
1.36
Dispensing
Criteria
The lenses will be dispensed for 6-8 days.
• Distance Snellen acuity equal to or better
than 20/30 OU
•
Subject must indicate that the vision is 
acceptable. 
•
Subject must indicate that the
comfort of the lenses is acceptable. 
•
Lenses must have an acceptable toric and 
general lens fit. 
1.37
Subject Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to the 
subject to wear for the required number of 
days until their follow-up visit. No additional 
lenses will be dispensed.
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all unworn 
study lenses. 
x
No cleaning or disinfecting solutions will be 
used. If determined necessary by the 
Investigator sterile non-preserved rewetting 
drops may be dispensed to be used as needed 
for dryness. 
x
Subjects will be instructed to wear lenses for 
a minimum of 6 hours a day, every day 
during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study lenses.
x
A patient instruction booklet will be 
provided. 
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Note: In the event a lens is lost or damaged, the 
subject will return to the investigator site for 
replacement. As much as reasonably possible, a 
damaged lens should be returned to the 
investigational site and then returned to the 
Sponsor.  If lens damage is present, complete the 
Product Quality Complaint Form. The lens will 
be stored in labeled vial with sterile saline, and 
returned to the Sponsor.
1.38
Schedule 
Follow-up 
The subject will be scheduled to return for their 
follow-up appointment in 7±1 day. 
Note: To count the follow-up visit as a day of 
wear the Subject must have worn the study 
lenses for 6 hours prior to the visit.
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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 missed two consecutive study visits  
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
An additional subject may be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as the 
final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications and therapies are medications or therapies that contraindicate contact lens 
wear.  See the Exclusion criteria for specific details. 
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Major protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation.  The Investigator will report deviations per IRB/IEC requirements.  All deviations will 
be tracked and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation immediately 
without notification to the sponsor. Within 24 hours after the implemented deviation, the 
Investigator must notify and provide the rationale to the Sponsor and, as required, the IEC/IRB.  
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or any 
SAE where the relationship to study agent cannot be ruled out, may result in stopping further 
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dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask the 
treatment regimen for the subject(s) and will discuss this with the Investigator before any further 
subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always has 
the discretion to initiate stopping the study based on patient safety or if information indicates the 
study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The study 
can be terminated by the Principal Investigator at the individual clinical site due to specific 
clinical observations, if in their opinion, after a discussion with JJVC, it is determined that it 
would be unwise to continue at the clinical site.    
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part of 
the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify 
the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication that 
alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, and 
site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, and 
not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where there is 
no deficiency alleged by the subject 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the appropriate 
COM/CRA and Clinical QA representative. In cases where the EDC system in use is not 
configured to send automatic notifications or when an EDC system is not used, the COM/CRA is 
responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
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Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint 
x
Study number 
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s) 
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
x
Eye Care Provider objective (slit lamp) findings if applicable 
x
Confirmation of product availability for return (and tracking information, if available), or 
rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel to 
determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint results in 
an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this protocol. If 
the AE/SAE was potentially the result of a product quality related deficiency, these procedures 
also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the PQC 
forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device or the 
comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
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An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of the 
study  
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, or 
progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening event, a 
significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect
x
Requires intervention to prevent permanent damage (the use of the test article resulting in 
a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function).  Important medical events that may 
not result in death, be life-threatening, or require hospitalization may be considered an 
SAE when, based upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the outcomes 
listed in the above definition
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or 
greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse Events).   
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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 – Those conditions that are usually asymptomatic and usually
do not warrant discontinuation (temporary or permanent) of the test article.  However, the 
Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, but 
not limited to the following: 
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions 
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, the test article, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan, Investigator’s Brochure or protocol, or any other unanticipated serious 
problem associated with the test article that relates to the rights, safety and welfare of subjects.
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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; 
related - see definition in Section 13.2.1) 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of intensity 
of the adverse event (mild; moderate; severe for all events - see definition in Section 0)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or resolved 
with sequelae; recovered or resolved; death related to adverse event; unknown 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other 
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 
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
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13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study it 
will be recorded and reported as an AE. Untoward medical events reported after the subject’s exit 
from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All Adverse 
Events including local and systemic reactions not meeting the criteria for “serious adverse events” 
shall be captured on the appropriate case report form or electronic data system. All adverse events 
occurring while the subject is enrolled in the study must be documented appropriately regardless 
of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom) 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, 
and depth, etc.)  
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any) 
x
Likely etiology 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the event 
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.
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Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or been 
satisfactorily resolved.  If further treatment beyond licensure is required, the patient will be 
referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  If a 
subject is discontinued from the study, it will be the responsibility of the Investigator to record the 
reason for discontinuation.  The Investigator will also document the adverse event appropriately 
and complete the Adverse Event eCRF. Any subjects with ongoing adverse events related to the 
test article, study treatment or study procedures, as of the final study visit date, should be followed 
to resolution of the adverse event or until referral to an appropriate health care provider, as 
recommended by the Investigator. Non-ocular adverse events that are not related to the test 
article, study treatment, or study procedures may be recorded as “ongoing” without further 
follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone as 
soon as possible and no later than 24 hours from discovery for any serious /significant adverse 
events, and 2 days from discovery for any non-significant adverse event.  In addition, a written 
report will be submitted by the Principal Investigator to the IEC/IRB according to their 
requirements (Section 13.4.2).  The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring during 
the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 hours 
following discovery of the event.  The Investigator is obligated to pursue and obtain information 
requested by the Sponsor in addition to that information reported on the eCRF. All subjects 
experiencing a serious/significant adverse event must be followed up and all outcomes must be 
reported. 
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 
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Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator will 
submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later than 24 
hours after the Investigator first learns of the effect.  This report is in addition to the immediate 
notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after the 
Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported to 
the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth by 
their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest
None. 
13.5. Reporting of Pregnancy
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the event 
is recorded as an Adverse Event.  Once discontinued, pregnant participants and their fetuses will 
not be monitored for study related purposes.  At the Investigator’s discretion, the study participant 
may be followed by the Investigator through delivery. However, this data will not be collected as 
part of the clinical study database.  Pregnant participants are not discontinued from contact lens or 
solution related studies for safety concerns, but due to general concerns relating to pregnancy and 
contact lens use.  Specifically, pregnant women are discontinued due to fluctuations in refractive 
error and/or visual acuity that occur secondary to systemic hormonal changes, and not due to 
unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
All data summaries and statistical analyses will be performed using the SAS software Version 9.4 
or higher (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. Unscheduled 
visits will be summarized separately and will be excluded from the statistical analysis.
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Summary tables (Descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum and 
maximum). Frequency count and percentage of subjects or eyes within each category will be 
provided for categorical data. 
Summaries will be presented by study lens type and will be performed separately by completion 
status. All analyses will be conducted on per-protocol population (see Section 14.3).   
14.2. Sample Size Justification
A total of approximately 40 eligible subjects will be enrolled into the study at this site. At least 36 
subjects will complete this study. 
Using the POWER procedure in SAS 9.4, below is the summary of sample size required based on 
the different assumptions of the true LogMAR visual acuity and CLUE scores. The sample size 
was calculated for the non-inferiority tests (using 0.05 as the margin) with at least 90% of 
statistical power and 2-sided type I error of 0.05. Assuming the true LogMAR visual acuity is 
between 0.00 to 0.05 (distance) or 0.08 to 0.12 (near), and true CLUE vision score is between 38
to 42 points.
x
Binocular LogMAR visual acuity (distance)
True Value
Estimated Standard 
Deviation
# of subjects needed
Actual 
Power
0.00
0.12
18
0.915
0.02
0.12
26
0.904
0.05
0.12
63
0.902
x
Binocular LogMAR visual acuity (near)
True Value
Estimated Standard 
Deviation
# of subjects needed
Actual 
Power
0.08
0.12
21
0.905
0.10
0.12
33
0.901
0.12
0.12
63
0.902
x
CLUE vision score 
True Value
Estimated Standard 
Deviation
# of subjects needed
Actual 
Power
38
17
87
0.902
40
17
50
0.903
42
17
33
0.906
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14.3. Analysis Populations
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock (Per-
Protocol Population). Justification of excluding subjects with protocol deviations in the per-
protocol population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All assigned subjects regardless of actual treatment and subsequent withdrawal from study or 
deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
LogMAR Visual Acuity
Binocular, high luminance, high contrast visual performance on logMAR scale will be analyzed 
using a linear mixed model.  Each regression model will include the experimental design factors: 
distance as fixed effects. Other baseline characteristics known of importance such as age, gender, 
and/or add power will be included as fixed covariates when appropriate. Subject nested in site 
will be included as random covariates when appropriate.  The covariance between residual errors 
from the same subject across different charts will be selected based on the finite-sample corrected 
Akaike’s Information Criterion.6 Covariance structures considered may include: Homogenous 
compound symmetry (CS) and Unstructured covariance structure (UN). The structure that returns 
the lowest Akaike Information Criteria Corrected (AICC) will be selected as the structure that 
best fit the data.
Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models. Statistically superiority will be concluded if the 
upper limits of the confidence intervals are below the thresholds for corresponding distances. 
CLUE Vision Scores
CLUE vision scores will be analyzed using a linear mixed model adjusting for baseline values as 
fixed covariate. The model will include the experimental design factors: time (6-8 day or 12-16 
day) as fixed effects. Other baseline characteristics known of importance such as age, gender, 
and/or add power will be included as fixed covariates when appropriate. The covariance between 
residual errors from the same subject across different time will be selected based on the finite-
sample corrected Akaike’s Information Criterion.6 Covariance structures considered may include: 
Homogenous compound symmetry (CS) and Unstructured covariance structure (UN). The 
structure that returns the lowest Akaike Information Criteria Corrected (AICC) will be selected as 
the structure that best fit the data.
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Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models for each time. Statistically superiority will be 
concluded if the lower limit of the confidence interval is greater than 32 points. 
In all models, the Kenward and Roger method7 will be used for the calculation of the denominator 
of degrees of freedom.
14.6. Secondary Analysis 
Not Applicable. 
14.7. Other Exploratory Analyses 
Not Applicable. 
14.8. Interim Analysis
Not Applicable. 
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included in 
the summary tables and listings.  
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. Past 
clinical trials don’t provide the evidence that subject dropout is systematic or not-at-random. To 
evaluate the impact of missing data, sensitivity analysis will be conducted using multiple 
imputation methods if the proportion of subject dropout is greater than the 15%. The SAS/STAT 
procedures PROC MI and PROC MIANALYZE will be utilized with a parametric regression 
method used to make at least 5 imputations. 
14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections.  There are no known 
reasons for which it is planned to deviate from these analysis methods.  If for any reason a change 
is made, the change will be documented in the study report along with a justification for the 
change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using the 
EDC system. Data collected on equipment that is not captured in EDC will be formatted to the 
specification of the JJVC database manager and sent to JJVC for analysis
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The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy and 
completeness and signed by the Investigator.  The sponsor or sponsor’s representatives will be 
authorized to gain access to the subject recordation for the purposes of monitoring and auditing 
the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of the 
study data. The IPP must be retained in the study files as a certified copy of the source data for the 
study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication 
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if applicable
The subject record is the eCRF or an external record.  The author of an entry in the subject record 
must be identifiable.  The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator.
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the clinical 
site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be contacted and 
notified in writing within 24 hours. 
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16.2. Confidentiality of Information
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC.  The 
Investigator may use this information for the purposes of the study only. It is understood by the 
Investigator that JJVC will use information developed in this clinical study in connection with the 
development of the investigational product and therefore may disclose it as required to other 
clinical investigators and to regulatory agencies. In order to allow the use of the information 
derived from this clinical study, the Investigator understands that he/she has an obligation to 
provide complete test results and all data developed during this study to the Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of qualified 
investigators and appropriate clinical sites and review of protocol procedures with the Principal 
Investigator.  The Principal Investigator, in turn, must ensure that all Sub-Investigators and 
clinical site personnel are familiar with the protocol and all study-specific procedures and have 
appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the start 
of the study.  The Sponsor will review case report forms for accuracy and completeness remotely 
during the conduct of the study, during monitoring visits, and after transmission to data 
management.  Any data discrepancies will be resolved with the Investigator or designee, as 
appropriate. 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct of 
clinical trials.  The clinical sites will provide direct access to study-related source data/documents 
and reports for the purpose of monitoring and auditing by JJVC and for inspection by local and 
regulatory authorities.
17. MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x
Ensuring the rights and wellbeing of subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and qualified
clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise 
x
Reviewing of study records and source documentation verification in accordance with the 
monitoring plan
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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.  Only subjects who are fully able to understand the risks, 
benefits, and potential adverse events of the study, and provide their consent voluntarily will be 
enrolled. 
18.2. Investigator Responsibility
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP is an 
international ethical and scientific quality standard for designing, conducting, recording, and 
reporting studies that involve the participation of human subjects. Compliance with this standard 
provides public assurance that the rights, safety, and well-being of study subjects are protected, 
consistent with the principles of the Declaration of Helsinki 64th WMA General Assembly 20133
and that the clinical study data are credible.  The Investigator must maintain clinical study files in 
accordance with Section 8 of the ICH E6 guidelines on Good Clinical Practice (GCP),2 and 
applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol and, if applicable, amendments 
x
Sponsor-approved informed consent form (and any other written materials to be provided 
to the subjects)
x
Investigator’s Brochure (or equivalent information) and amendments 
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB) 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval 
letter must be dated and must clearly identify the documents being approved. 
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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 amendments
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s) 
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of the 
study 
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor and by 
the reviewing IEC/IRB. The informed consent is in accordance with principles that originated in 
the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable regulatory 
requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site personnel 
must explain to potential subject the aims, methods, reasonably anticipated benefits, and potential 
hazards of the study, and any discomfort it may entail. Subjects will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time.  
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The subject will be given sufficient time to read the informed consent form and the opportunity to 
ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data
The collection, processing and disclosure of personal data and medical information related to the 
Study Subject, and personal data related to Principal Investigator and any clinical site personnel 
(e.g., name, clinic address and phone number, curriculum vitae) is subject to compliance with the 
Health Information Portability and Accountability Act (HIPAA) in the United States4 and other 
applicable personal data protection and security laws and regulations.  Appropriate measures will 
be employed to safeguard these data, to maintain the confidentiality of the person’s related health 
and medical information, to properly inform the concerned persons about the collection and 
processing of their personal data, to grant them reasonable access to their personal data and to 
prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party without 
the express permission of the subject concerned, with the exception of Sponsor personnel 
(monitor, auditor), IEC/IRB and regulatory organizations in the context of their investigation 
related activities that, as part of the investigation will have access to the CRFs and subject 
records.
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,2 the Investigator/Institution will maintain all CRFs 
and all subject records that support the data collected from each subject, as well as all study 
documents as specified in ICH/GCP2 and all study documents as specified by the applicable 
regulatory requirement(s). The Investigator/Institution will take measures to prevent accidental or 
premature destruction of these documents. 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region or until at least two (2) years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents will be 
retained for a longer period if required by the applicable regulatory requirements or instructed by 
the Sponsor. It is the responsibility of the Sponsor to inform the Investigator/Institution as to 
when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of the 
new custodian. Under no circumstance shall the Investigator relocate or dispose of any study 
documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study 
x
Scheduling a study visit outside the subject’s acceptable visit range 
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JJVC reserves the right to withhold final remuneration until all study related activities have been 
completed, such as:
x
Query resolution 
x
Case Report Form signature 
x
Completion of any follow-up action items 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — Good 
Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-
ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. Keselman HJA, J.; Kowalchuk, R. K.; and Wolfinger, R. D. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated Measures. 
Communications in Statistics—Simulation and Computation. 1998;27(3):591–604. 
7. Kenward MG and Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics, 1997;53:983–997. 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
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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 F: TEST LENS FITTING GUIDE 
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APPENDIX G: BINOCULAR OVER REFRACTION
      
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APPENDIX H: 
 
 
x
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
x
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
x
DETERMINATION OF NEAR ADD
x
NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE
x
LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
x
BIOMICROSCOPY SCALE
x
KERATOMETRY
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
 TORIC FIT EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
 LENS INSERTION AND REMOVAL
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
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REQUIRE_ 
MENTS
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Page 7 of 7 
 
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EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
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Page 4 of 4 
 
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DETERMINATION OF NEAR ADD
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NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
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Page 1 of 2 
 
  
  
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Page 2 of 2 
 
 
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LENS FITTING CHARACTERISTICS
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SUBJECT REPORTED OCULAR SYMPTOMS
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
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Page 2 of 6
  
 
  
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BIOMICROSCOPY SCALE
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KERATOMETRY
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Page 1 of 1
    
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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Title:
Distance and Near Visual Acuity Evaluation
Document Type:
Clinical Test Procedure
Document Number: 
Revision Number: 3
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TORIC FIT EVALUATION
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ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 4 
 
Page 1 of 3 
 
  
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 4 
 
Page 2 of 3 
 
 
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LENS INSERTION AND REMOVAL
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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: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 2 
 
Page 1 of 4
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 2 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 2 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 2 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6278 Evaluation of a Toric Multifocal Contact Lens 
Manufactured in Etafilcon Material in a Low ADD Hyperopic Population 
Version and Date: 1.0 12 July 2018 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and 
GCP guidelines regarding clinical trials during and after study completion. 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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