Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision Correction of Presbyopia
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for 
Monovision Correction of Presbyopia
Protocol CR-6349
Version: 5.0 Amendment 4
Date: 03 September 2019
Investigational Products: ACUVUE® OASYS with Transitions™
Key Words: Presbyopia, Monovision, senofilcon A, Daily Wear, Reusable, Dispensing
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, or 
as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc. 
Any supplemental information that may be added to this 
document is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and 
must be kept in confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study...................................................................................................................... 16 
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...................................................................................................... 17 
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..................................................... 20 
5.1. 
Test Article Allocation............................................................................................. 20 
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..................................................................................... 21 
6.3. 
Administration of Test Articles................................................................................ 22 
6.4. 
Packaging and Labeling ........................................................................................... 22 
6.5. 
Storage Conditions................................................................................................... 22 
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 ....................................................................................... 26 
VISIT 1 ........................................................................................................................... 26 
VISIT 2 ........................................................................................................................... 32 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 39 
FINAL EVALUATION.................................................................................................. 41 
7.3. 
Unscheduled Visits................................................................................................... 42 
7.4. 
Laboratory Procedures ............................................................................................. 44 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 44 
8.1. 
Completion Criteria.................................................................................................. 44 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 44 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 45 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 45 
11. 
STUDY TERMINATION ........................................................................................... 45 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 46 
13. 
ADVERSE EVENTS................................................................................................... 47 
13.1. 
Definitions and Classifications............................................................................. 47 
13.2. 
Assessing Adverse Events.................................................................................... 49 
13.2.1. 
Causality Assessment.................................................................................... 49 
13.2.2. 
Severity Assessment...................................................................................... 50 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 50 
13.4. 
Reporting Adverse Events.................................................................................... 51 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 52 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities....................................................................................................................... 52 
13.4.3. 
Event of Special Interest ............................................................................... 53 
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13.5. 
Reporting of Pregnancy........................................................................................ 53 
14. 
STATISTICAL METHODS........................................................................................ 53 
14.1. 
General Considerations......................................................................................... 53 
14.2. 
Sample Size Justification...................................................................................... 53 
14.3. 
Analysis Populations ............................................................................................ 54 
14.4. 
Level of Statistical Significance........................................................................... 54 
14.5. 
Primary Analysis .................................................................................................. 54 
14.6. 
Secondary Analysis .............................................................................................. 56 
14.7. 
Other Exploratory Analyses ................................................................................. 56 
14.8. 
Interim Analysis ................................................................................................... 56 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 56 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 56 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 56 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 56 
15.2. 
Subject Record...................................................................................................... 57 
16. 
DATA MANAGEMENT............................................................................................. 57 
16.1. 
Access to Source Data/Document ........................................................................ 57 
16.2. 
Confidentiality of Information.............................................................................. 58 
16.3. 
Data Quality Assurance........................................................................................ 58 
17. 
MONITORING............................................................................................................ 58 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 59 
18.1. 
Study-Specific Design Considerations ................................................................. 59 
18.2. 
Investigator Responsibility................................................................................... 59 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 59 
18.4. 
Informed Consent ................................................................................................. 60 
18.5. 
Privacy of Personal Data ...................................................................................... 61 
19. 
STUDY RECORD RETENTION................................................................................ 62 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 62 
21. 
PUBLICATION........................................................................................................... 63 
22. 
REFERENCES ............................................................................................................ 64 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 65 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 92 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 93 
APPENDIX D: BINOCULAR OVER REFRACTION ....................................................... 122 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE..................................... 123 
APPENDIX F: OCULAR DOMINANCE............................................................................ 124 
APPENDIX G: AST SENTIO CONTRAST SENSITIVITY TESTING............................. 125 
APPENDIX H: 
.................................... 132 
  LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS............................ 133 
  EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING................. 141 
  DETERMINATION OF NEAR ADDITION ................................................... 146 
  NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE...... 154 
  LENS FITTING CHARACTERISTICS........................................................... 157 
  SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS...................... 164 
  DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 166 
  BIOMICROSCOPY SCALE ............................................................................ 173 
  KERATOMETRY PROCEDURE.................................................................... 179 
  DISTANCE AND NEAR VISUAL ACUITY EVALUATION....................... 181 
DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
............................................................................................................................................... 186 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION
TESTING.............................................................................................................................. 190 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 196 
 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS
Table 1: Test Articles.............................................................................................................. 21 
Table 2: Ancillary Supplies .................................................................................................... 21 
Table 3: Time and Events ....................................................................................................... 24 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision 
Correction of Presbyopia
Protocol Number: CR-6349
Version: 5.0 Amendment 4
Date:  03 September 2019
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name:  Thomas R. Karkkainen, OD, MS, FAAO
Title: Sr. Principal Research Optometrist
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256
Email: TKarkkai@its.jnj.com
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related 
questions should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations,4 ICH 
guidelines,2 ISO 14155,1 and the Declaration of Helsinki.3
Author
See Electronic Signature Report
Thomas R. Karkkainen, OD, MS, FAAO
Sr. Principal Research Optometrist, 
Clinical Sciences
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Reviewer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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SYNOPSIS  
Protocol Title
Evaluation of A Marketed Silicone Hydrogel Spherical Lens 
Used for Monovision Correction of Presbyopia
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:  Over-labeled ACUVUE® OASYS 
with Transitions™
Wear and Replacement 
Schedules
Wear Schedule: The lenses will be used on a daily reusable 
basis.  
Replacement Schedule: The lenses will be worn for 
approximately 2 weeks.  A new set of lenses will be given to 
the subject at Visit 3 and the lenses will also be replaced if lost 
or damaged.
Objectives 
This study is an evaluation of the visual performance and 
subjective responses of ACUVUE® OASYS with 
Transitions™ fit as monovision.
Study Endpoints
Primary endpoints: logMAR visual acuity scores, and CLUE 
vision scores
Other endpoints: qCSF (Site 1036 only) 
Study Design
This is a single-masked, dispensing clinical trial.  A total of 
approximately 48 myopic and 32 hyperopic eligible subjects 
will be targeted to complete the study.  At Visit 1, the subjects 
will be fit in the study lens, optimized if required and wear the 
study lenses for approximately 2 weeks. 
At Visit 2, the endpoints will be measured, and the subjects 
will be scheduled for Visit 3 after a 7±3 day wash-out.
The subjects will return to Visit 3 and complete a baseline and 
be fit with the same lens power that was dispensed at Visit 1
(No Optimizations). 
The subjects will return for Visit 4 after wearing the final lens 
pair for approximately 2 weeks. The endpoint measurements
will be repeated, and the final evaluation completed.
The primary endpoints will be visual performance scores and 
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the CLUE vision scores.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations.
Sample Size
A total of approximately 80 will be targeted to complete.
Study Duration
The study will last approximately 3 to 5 months.
Anticipated Study 
Population
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below.  All volunteers will 
have baseline measurements taken to ensure eligibility.  The 
baseline procedures will occur after informed consent has been 
obtained.  Subjects will have medical and contact lens history 
recorded, baseline questionnaires completed, and refractive 
and anterior segment status determined.  
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study
Inclusion Criteria after Screening
1. The subject must read, understand, and sign
the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form.
2. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol.
3. The subject must be between 40 and 70 years of age at the 
time of screening.
4. Subjects must own a wearable pair of spectacles if required 
for their distance vision.
5. The subject must be an adapted monovision soft contact 
lens wearer in both eyes (i.e., worn lenses a minimum of 2 
days per week for at least 8 hours per wear day, for 1 
month of more duration).
Inclusion Criteria after Baseline
6. The subject’s distance spherical equivalent refraction must 
be in the range of +3.50 D to -4.00 D in each eye.
7. The subject’s refractive cylinder must be ≤1.00 D in each 
eye.
8. The subject’s ADD power must be in the range of +0.75 D 
to +2.50 D.
9. The subject must have best corrected distance visual acuity 
of 20/20-3 or better in each eye.
Potential subjects who meet any of the following criteria will
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be excluded from participating in the study: 
Exclusion Criteria after Screening
1. Currently Pregnant or lactating.
2. 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, recurrent herpes simplex/zoster, 
Sjögren’s syndrome, xerophthalmia, acne rosacea, 
Stevens-Johnson syndrome, and immunosuppressive 
diseases or any infectious diseases (e.g., hepatitis, 
tuberculosis).
3. Use of any of the following medications within 1 week 
prior to enrollment: oral retinoid isotretinoin (e.g., 
Accutane), oral tetracyclines, oral phenothiazines (e.g., 
Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), 
systemic steroids.
4. Any previous, or planned, ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, lid procedures, 
cataract surgery, retinal surgery, dacryocystorhinostomy, 
etc.).
5. Use of any ocular medication, with the exception of 
rewetting drops.
6. Participation in any contact lens or lens care product 
clinical trial within 7 days prior to study enrollment.
7. Employee or immediate family member of an employee of 
clinical site (e.g., Investigator, Coordinator, Technician).
8. Any known hypersensitivity or allergic reaction to OPTI-
FREE® Puremoist® care cleaning solution, non-preserved 
rewetting drop solution or sodium fluorescein.
9. History of herpetic keratitis.
10. Entropion, ectropion, chalazia, glaucoma, history of 
recurrent corneal erosions.
11. A history of amblyopia, strabismus or binocular vision 
abnormality.
Exclusion Criteria after Baseline
12. 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.
13. Any ocular infection or inflammation.
14. Any ocular abnormality that may interfere with contact 
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lens wear.
15. Any active or ongoing ocular or systemic allergies that 
may interfere with contact lens wear.  
Disallowed 
Medications/Interventions 
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. 
Measurements and 
Procedures
logMAR Visual acuity, Subjective responses for vision using 
the CLUE questionnaire, qCSF (Site 1036 only). 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, will result in stopping further dispensing 
investigational product.  In the event of a UADE or SAE, the 
Sponsor Medical Monitor may unmask the treatment regimen
of subject(s) and may discuss this with the Principal 
Investigator before any further subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials
OPTI-FREE® Puremoist® multi-purpose care solution, 
Rewetting drops, lens cases, glass vials, saline, ETDRS light 
cabinet, logMAR charts, and Near logMAR charts. 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD
Plus Power Required For Near Use
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BCC
Binocular Crossed Cylinder
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLDEQ-8
Contact Lens Dry Eye Questionnaire-8
CLUE
Contact Lens User Experience
COAS
Complete Ophthalmic Analysis System
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CT
Center Thickness
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Council for Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
LSM
Least Square Means
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
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OHSR
Office for Human Subjects Research
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision has recently launched a new spherical contact lens, ACUVUE®
OASYS with Transitions™, that has photochromic properties.  The purpose of this study is 
to evaluate the performance of the lens when fit as monovision in a presbyopic population 
who habitually wear monovision correction.
1.1.
Name and Descriptions of Investigational Products  
Test Lens: Over-labeled ACUVUE® OASYS with Transitions™.
1.2.
Intended Use of Investigational Products 
The study lenses are spherical lenses intended to correct refractive ametropia (myopia or 
hyperopia) in subjects who may have 1.00 D or less of refractive astigmatism. The lenses are
intended to be used as a 2-week, reusable, daily wear lens.  The lenses require use of a care 
system to clean and disinfect the lenses.
1.3.
Summary of Findings from Nonclinical Studies 
See the ACUVUE® OASYS with Transitions™package insert in APPENDIX C: PACKAGE 
INSERT (APPROVED PRODUCT).
1.4.
Summary of Known Risks and Benefits to Human Subjects 
See the ACUVUE® OASYS with Transitions™ package insert in APPENDIX C: PACKAGE 
INSERT (APPROVED PRODUCT).
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Refer to the ACUVUE® OASYS with Transitions™ package insert in APPENDIX C:
PACKAGE INSERT (APPROVED PRODUCT).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
This study is an evaluation of the visual performance and subjective response of ACUVUE®
OASYS with Transitions™ fit as monovision.
2.2.
Endpoints  
The study endpoints will be the subjective CLUE Vision scores and logMAR visual acuity.  
Additional endpoints will be quantitative contrast sensitivity function (qCSF) measured at 
site 1036.
Primary Endpoint
x
logMAR visual acuity scores, and CLUE vision scores
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Secondary Endpoint
x
N/A
Other Observations
x
qCSF (Site 1036 only)
2.3.
Hypotheses 
The following primary hypotheses will be tested throughout this investigation. 
Primary Hypotheses:
1. After 10 to 14 days of wear, the distance, binocular, high luminance, high contrast
visual acuity score for the Test lens will be statistically better than +0.01 logMAR.  
2. After 10 to 14 days of wear, the intermediate, binocular, high luminance, high 
contrast visual acuity score for the Test lens will be statistically better than +0.17 
logMAR. 
3. After 10 to 14 days of wear, the near, binocular, high luminance, high contrast visual 
acuity score for the Test lens will be statistically better than +0.17 logMAR. 
4. After the first 10 to 14 days of wear, the PRO CLUE vision scores for the Test lens
will be statistically better than 32 CLUE points. This will be recorded by the subject 
using the CLUE Follow-up Questionnaire from Visit 2.
If all the primary hypotheses are met, the following secondary hypotheses will be tested.
Secondary Hypotheses:
The PRO CLUE vision scores after the second 10 to 14 days wear cycle (Visit 4) will 
be statistically better than the score after the first 10 to 14 days wear cycle (Visit 2).  
This will be recorded using the CLUE Follow-up Questionnaire.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
Healthy male and female subjects who are habitual soft contact lens wearers will be 
recruited.  Subjects will be at least 40 years of age and not older than 70 years of age.  They 
will be myopic or hyperopic and have presbyopia.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED
CONSENT and receive a fully executed copy of the form.
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2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. The subject must be between 40 and 70 years of age at the time of screening.
4. Subjects must own a wearable pair of spectacles if required for their distance vision.
5. The subject must be an adapted monovision soft contact lens wearer in both eyes (i.e., 
worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 
month of more duration).
Inclusion Criteria after Baseline:
6. The subject’s distance spherical equivalent refraction must be in the range of +3.50 D 
to -4.00 D in each eye.
7. The subject’s refractive cylinder must be ≤1.00 D in each eye.
8. The subject’s ADD power must be in the range of +0.75 D to +2.50 D.
9. The subject must have best corrected distance visual acuity of 20/20-3 or better in 
each eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:
Exclusion Criteria after Screening:
1. Currently Pregnant or lactating.
2. 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, recurrent herpes simplex/zoster, Sjögren’s syndrome, 
xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive 
diseases or any infectious diseases (e.g., hepatitis, tuberculosis).
3. Use of any of the following medications within 1 week prior to enrollment: oral 
retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines (e.g., 
Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), systemic steroids.
4. Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, dacryocystorhinostomy, 
etc.).
5. Use of any ocular medication, with the exception of rewetting drops.
6. Participation in any contact lens or lens care product clinical trial within 7 days prior 
to study enrollment.
7. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician).
8. Any known hypersensitivity or allergic reaction to OPTI-FREE® Puremoist® care 
cleaning solution, non-preserved rewetting drop solution or sodium fluorescein.
9. History of herpetic keratitis.
10. Entropion, ectropion, chalazia, glaucoma, history of recurrent corneal erosions.
11. A history of amblyopia, strabismus or binocular vision abnormality
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Exclusion Criteria after Baseline
12. 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.
13. Any ocular infection or inflammation.
14. Any ocular abnormality that may interfere with contact lens wear.
15. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
The clinical study is a single-ARM, single-masked, clinical trial. The mask will be a partial 
mask in that the lenses will be over-labeled and the specific brand of the contact lens will not 
be disclosed to the subject however the subject will be aware of the photochromic properties 
of the contact lens. There is one study treatment with two wearing cycles. A total of 
approximately 80 eligible subjects will be targeted to complete the study. The test article in 
the first wearing cycle will be dispensed for 12±2 days and at the follow-up the final lens 
measurements will occur. Subjects will complete a 7±3 days washout and then return for the 
second wearing cycle. New lenses with same power of the final pair from Visit 1 will be 
dispensed and the above sequence repeated. The lens in the second wearing cycle will not be 
optimized.
4.2.
Study Design Rationale 
The study is intended to evaluate the initial performance, of a photochromic lens fit as 
monovision, in terms of the subjective response and visual acuity, after a period of lens
dispensing.  The single-ARM study is used as the performance will be measured against 
historical performance measures used in previous multifocal contact lens studies.  A washout 
period and lens re-dispensing was used to evaluate the reproducibility and repeatability of the 
subjective vision response.
4.3.
Enrollment Target and Study Duration 
A total of 80 subjects (48 myopes and 32 Hyperopes) are targeted to complete the study. 
The study will last approximately 3-5 months.
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5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
The study lenses will be worn in a bilateral fashion using a single-arm design with 1 lens 
type and 2 wearing cycles.
5.2.
Masking 
This is a single-masked study with the subjects being masked.  The lenses from different 
wearing cycles will be over-labeled using different letters so that the subjects don’t know for 
sure the lenses are identical. 
Under normal circumstances, the mask should not be broken until all subjects have
completed the study and the database is finalized.  Otherwise, the mask should be broken 
only if specific emergency treatment/course of action would be dictated by knowing the 
treatment status of the subject.  In such cases, the Investigator may, in an emergency, contact 
the medical monitor.  In the event the mask is broken, the Sponsor must be informed as soon 
as possible.  The date, time, and reason for the unmasking must be documented in the subject 
record.  The Investigator is also advised not to reveal the study treatment assignment to the 
clinical site or Sponsor personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject.  The Sponsor must be notified before 
the mask is broken.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing
2. Investigator or designee will record the subject’s number on the appropriate line of 
the randomization scheme if applicable.
3. Investigator or designee will pull the appropriate test articles from the study supply.  
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section.
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6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending
directions from the sponsor for potential return to JJV.
6.7.
Accountability of Test Articles 
JJV will provide the Investigator with sufficient quantities of study article and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment 
documentation for the test article accountability records. 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study 
site personnel listed on the Site Delegation Log.  All test articles must be accounted.  This 
includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits 
2. What was returned to the Investigator unused
3. The number and reason for unplanned replacements  
The Investigator will collect all unused test articles from the subjects at the end of the 
subject’s participation. Subject returned unused test articles must be separated from the 
clinical study inventory of un-dispensed test articles and must be labeled with the subject 
number and date of return.  Following final reconciliation of test articles by the monitor, the 
Investigator or monitor will return all unused test articles to the Sponsor.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
  Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information
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1.13
Keratometry 
Keratometry will be performed OD and OS 
and the steep and flat dioptric power and 
corresponding meridians recorded.
1.14
Subjective Refraction
and Distance Visual 
Acuity
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and distance 
visual acuity to the nearest letter.
Note: Best distance visual acuity with sphero-
cylindrical refraction must be at least 20/20-3
in each eye for the subject to be eligible in the 
study.
1.15
Near ADD 
Determination
The near reading addition will be determined 
using the binocular crossed cylinder technique 
(BCC) at 40 cm followed by optimization in a
trial frame in step 1.16 below.
1.16
Ocular Dominance
Determine the distance ocular dominance with 
the best distance correction in place using a 
+1.00-blur test. If the results are equivocal use 
the sighting dominance test to determine the 
dominant eye used for the study.
Appendix F
1.17
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses (or 
flippers) under binocular conditions. 
1.18
Near Visual Acuity
Using the ETDRS 2000 Series Chart 1 or 2
near card placed at 40 cm.  Record the near 
visual acuity OD, OS and OU at 40 cm.
1.19
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading.
Corneal Staining Assessment
 will 
be graded in 1.0 increments.
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.  
1.20
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be answered 
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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
Modifications
If the subject reports unsatisfactory vision or is
unable to obtain 20/30 distance visual acuity
OU with the lenses, then a modification must
be attempted. If the subject reports satisfactory
vision with the lenses a modification is not
required, however at the Investigator’s 
discretion and based upon their findings on the
measured visual acuity and/or over- refraction
the investigator may make a modification.
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Allow 
at least 10 minutes of settling time between 
each lens modification attempted.   
If modifications are required steps 1.21-1.27
will be repeated for each modification. 
1.29
PRO (MRD) Post-Fit 
Questionnaire
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO (MRD)
questionnaire.
1.30
Distance and Near
Exit Visual Acuity
Distance and near Snellen visual acuity will be 
measured for each eye with the study contact 
lenses in place. 
For near measures use the ETDRS 2000 Series 
Chart 1 or 2. The acuity will be recorded to the
nearest letter OD, OS and OU. 
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Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
1.31
Dispensing Criteria
The lenses will be dispensed for 10-14 days.
x
Distance Snellen acuity equal to or better 
than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
1.32
Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
OPTI-FREE® Puremoist® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided. 
x
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.
Note: In the event a lens is lost or damaged,
the subject will return to the investigator site 
for replacement. As much as reasonably 
possible, a damaged lens should be returned to 
the investigational site and then returned to 
the Sponsor. If lens damage is present, 
complete the Product Quality Complaint 
Form. The lens will be stored in labeled vial 
with sterile saline and returned to the Sponsor.
1.33
Schedule 
The subject will be scheduled to return for 
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Near (40 cm)
High and Low Contrast ETDRS Charts        
4M- HC#1, HC#2, HC#3 and LC#1, LC#2, 
LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#4, 
HC#5, HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for Dim
luminance (Dim luminance will be 
simulated by using the goggles)
2.9
Binocular Contrast       
Sensitivity (CS) 
Measurement (Site 
1036 only)
Measure the subject’s Binocular CS at 4M,
distance. The measurement is made using the 
attached work aid. See section 4 to set the trial 
number (set to 25) and section 5 to execute the 
test.
Appendix 
G
2.10
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.  
Note: No lens changes are allowed based on 
the over-refraction.  
Appendix 
D
2.11
Lens Fit Assessment:
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear the 
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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.
2.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
Note: Lenses do not need to be stored in a 
refrigerator.
2.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the 
findings. 
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
 will
be graded in 1.0 increments.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops or 
saline may be instilled.  
2.14
Exit Visual Acuity
Distance and near Snellen visual acuity will be 
measured for each eye with the subject’s 
habitual correction 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.  
2.15
Subject Instructions
Subjects will complete a wash out period of 
7±3 days.
Instruct the subjects they can wear their 
habitual contacts or glasses during the washout
period.
2.16
Schedule Next Visit
The subject will be scheduled to return for 
their next visit in 4-10 days.
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3.14
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and up 
gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp
evaluation, and complete the Final Evaluation 
form.
3.15
PRO (MRD) Post-Fit 
Questionnaire
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms
of the study lenses using the PRO (MRD) 
questionnaire.
3.16
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and OU. 
Note: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
3.17
Dispensing Criteria
The lenses will be dispensed for 12±2 days.
x
Distance Snellen acuity equal to or better 
than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
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3.18
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
OPTI-FREE® Puremoist® solution will be 
used in a rub regime to disinfect and store 
the lenses each night in the lens case 
provided. 
x
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
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit.
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for replacement. As much as reasonably 
possible, a damaged lens should be returned 
to the investigational site and then returned to 
the Sponsor. If lens damage is present, 
complete the Product Quality Complaint 
Form. The lens will be stored in labeled vial 
with sterile saline and returned to the 
Sponsor.
3.19
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 12±2 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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Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#4, 
HC#5, HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be
simulated by using the goggles)
4.9
Binocular Contrast       
Sensitivity (CS) 
Measurement (Site 
1036 only)
Measure the subject’s Binocular CS at 4M, 
distance. The measurement is made using the 
attached work aid. See section 4 to set the trial 
number (set to 25) and section 5 to execute the 
test.
Appendix 
G
4.10
Binocular Distance 
Over-refraction and
Distance Visual 
Acuity
Perform a binocular over-refraction and record 
the OD and OS results and distance visual 
acuity.  
Note: No lens changes are allowed based on 
the over-refraction.   
Appendix 
D
4.11
Lens Fit Assessment:
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
The subject should not proceed to wear the
lenses if any of the following is observed:
x
presence of limbal exposure (appearance of 
clear cornea) in any gaze
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7.4.
Laboratory Procedures  
Not Applicable.
8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
x
provided informed consent
x
they are eligible
x
completed all study visits
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject death during the study period
x
Subject withdrawal of consent
x
Subject not compliant to protocol 
x
Subject lost to follow-up
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant)
x
Subject develops significant or serious adverse events causing discontinuation of 
study lens wear 
x
Subjects who have experienced a Corneal Infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x
Subject 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 6.7.
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.
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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 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.
JJV 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 JJV, it is determined 
that it would be unwise to continue at the clinical site.   
JJV (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.
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12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.  
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
monitors, and site personnel, etc. The following are not considered product quality 
complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations 
where there is no deficiency alleged by the subject
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in 
use is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
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 
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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
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 
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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).  
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
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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.
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 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; 
unknown
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other.
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
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x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. 
An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded
x
Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject.  The 
assessment of severity is made irrespective of test article, study treatment or study procedure 
relationship or seriousness of the event and should be evaluated according to the following 
scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) 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)
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x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, 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.
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.
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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
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. 
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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 Statistical Analysis 
System (SAS) software Version 9.4 (SAS Institute, Cary, NC). Throughout the analysis of 
data, the results for each subject/eye will be used when available for summarization and 
statistical analysis.  Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis.
Summary tables (Descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate. Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD], 
median, minimum and maximum). Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
Summaries will be presented by study lens type and will be performed separately by 
completion status (Safety Population or Per-Protocol Population). All analyses will be 
conducted on per-protocol population (see Section 14.3).
14.2. Sample Size Justification 
A total of 80 subjects (48 myopes and 32 hyperopes) are targeted to complete the 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.
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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 (intermediate and 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
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population).  Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All subjects regardless of actual treatment and subsequent withdrawal from study or 
deviation from protocol.  At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analysis  
Primary efficacy analysis:
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Binocular, high luminance, high contrast logMAR visual acuity will be analyzed using a 
linear mixed model. The model will include the experimental design factors: distance
(distance/intermediate/near) and time point (2 week or 4 week) as fixed effects; and site and 
subject nested in site as random effects. Other baseline characteristics known to be important 
such as age, gender, subject group (myope/hyperope), and/or ADD power will be included as 
fixed covariates when appropriate. The covariance between residual errors from the same 
subject at the same time point across distances will be selected based on the finite-sample 
corrected Akaike’s Information Criterion.6 Covariance structures considered will include: 
Homogenous Compound Symmetry (CS), Heterogeneous Compound Symmetry (CSH), 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.
Heterogeneous models across study populations and/or distance will be considered using a 
log-likelihood ratio test.  
Comparisons will be carried out using 95% confidence intervals (CIs) constructed of Least-
square means (LSM) from the linear mixed models.  Statistical superiority will be concluded 
if the upper limit of the confidence intervals of the Test lens is below +0.10 logMAR for 
distance, and below +0.17 logMAR for intermediate and near.
CLUE Vision
Overall quality of vision scores will be analyzed using a linear mixed model adjusting for 
baseline values as fixed covariates. The model will include the experimental design factors: 
time point (2 week or 4 week) as the fixed effect; and site and subject nested in site as 
random effects. Other baseline characteristics known to be important such as age, gender, 
subject group (myope/hyperope), and/or ADD power will be included as fixed covariates 
when appropriate. The covariance between residual errors from the same subject across lens 
wearing periods/time point will be selected based on the finite-sample corrected Akaike’s 
Information Criterion.6 Covariance structures considered may include: Homogenous 
compound symmetry (CS) and Unstructured covariance structure (UN). The structure that 
returns the lowest Akaike Information Criteria Corrected (AICC) will be selected as the 
structure that best fit the data. 
Primary Hypothesis:
Comparisons will be carried out using 95% confidence intervals constructed of least-square
means (LSM) from the linear mixed models of CLUE vision scores at the end of first 
wearing cycle (2 week). Statistically superiority will be concluded if the lower limit of the 
confidence intervals of the test lens are greater than 32 points.
Secondary Hypothesis:
Comparisons between the wearing cycles (2 week vs 4 week) will be carried out using 95% 
confidence intervals constructed of least-square means (LSM) differences (4 week – 2 week)
from the linear mixed model. The superiority will be established if the lower confidence limit 
is above 0.
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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 
Secondary efficacy analysis:
See section 14.5
14.7. Other Exploratory Analyses 
Not Applicable.
14.8. Interim Analysis 
Not Applicable.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be 
included in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. 
The SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a 
parametric regression method used to make at least 5 imputations.
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an 
EDC system (Bioclinica). An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJV database manager and sent to JJV for analysis. 
External Date Sources for this study include:
Not Applicable.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy 
and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
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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, JJV 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 JJV.  
The Investigator may use this information for the purposes of the study only. It is understood 
by the Investigator that JJV 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 JJV 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 JJV 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
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x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan.
18.  ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, 
during the study, subjects will be given any new information that may affect their decision to 
continue participation.  Subjects will be told that their consent to participate in the study is 
voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled.  Only subjects who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent voluntarily will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP 
is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
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, 
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and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s)
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB.
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
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be informed that their participation is voluntary and that they may withdraw consent to 
participate at any time. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature.
After having 
obtained the consent, a copy of the informed consent form must be given to the subject.
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and 
regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
18.5. Privacy of Personal Data 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
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 
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steps should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). 
The Investigator/Institution will take measures to
prevent accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. 
These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform 
the Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJV.
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 JJV management representative prior to study initiation.
JJV 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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JJV 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.
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22.  REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
6. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation.
1998;27:591-604.
7. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983–997.
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide will be provided separately.
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
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APPENDIX D: BINOCULAR OVER REFRACTION 
Binocular Over-refraction Technique
1. Place trial frame on subject
2. Add +1.00 D sphere to OS
3. Add + 0.50DS OD and check VA
-
if VA remained unchanged or improved, repeat step 3 
-
if VA decreased, add minus until best VA first achieved *note: add minus for 0.5 
seconds to avoid reflex accommodation. 
4. Record VA
5. Change +1.00 D sphere to OD
6. Repeat steps 3 and 4
 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
Presbyopic Symptoms Questionnaire
1. Do you notice that you often have to hold things farther away so that you can read 
them?
2. Do you notice that you often have difficulty focusing on near objects (i.e., 
experiencing blurry vision when looking at things close-up)?
3. Do you often have headaches or eyestrain, or feel fatigued, when reading or 
conducting other near activities?
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc.?
5. Do you often have difficulty reading under dim or low light?
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APPENDIX G: AST SENTIO CONTRAST SENSITIVITY TESTING 
Work Aid: AST Sentio Contrast Sensitivity Testing
OBJECTIVE 
To provide instructions for capturing contrast sensitivity data using the AST Sentio Pro 
Instrument.
DESCRIPTION  
The AST Sentio is a vision testing system that consists of a monitor, internal computer, 
custom software, and remote control for registering user responses. The display, computer, 
and software are contained in one unit; the remote is separate. During testing, the monitor 
will show test patterns of varying sizes and contrasts. The particular pattern that is displayed 
during the test is determined by the custom software. During a test session, 25 or 50 triplets 
of test letters will be displayed, and the operator will record the patient’s responses using the 
remote.  After a test session is complete, the custom software will calculate the following.
Area under the log contrast sensitivity function from 1.5 cycles per degree to 18 cycles per 
degree output of a testing session. This metric is referred to as the AULCFS.
The highest spatial frequency at which a stimulus at full contrast is visible. This is equivalent 
to the intersection of the CSF curve and the X-axis.  This metric is referred to as CFS Acuity.
MATERIALS 
AST Sentio Pro Monitor display with internal computer (see Figure 1).
AST Sentio Remote (see Figure 1).
Figure 1: AST Sentio Pro Monitor (main unit) and Remote. The monitor has a USB port for 
data export. To start the remote, press the On/O button once. When the remote is on, to put 
the device into a hold mode, press the On/O button. The remote has a micro-USB port for 
charging.
 
SETUP 
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TESTING 
Ensure that the remote is charged.
Ensure that the subject is positioned at the proper viewing distance (4 meters). 
Ensure the subject’s eyes, in primary gaze, are at 130 cm ± 10 cm from the ground.
Ensure that there is no glare on the screen or in the subject’s field of view.
Instruct the subject as follows.
Inform the subject that they will be presented with letters of different sizes and contrast 
(faintness) on the monitor. These letters may not have a familiar appearance; they may be 
modified for testing purposes. 
Inform the subject that they will be shown a short demonstration to familiarize them with the 
letters and procedure.
Inform the subject that they will encounter letters that they will not be able to identify or see 
and this is not an indication of poor visual performance. The purpose of the test is to find the 
limits of visual performance.
Inform the subject that if the subject is unsure about a letter, they should still respond. If this
happens during the test, encourage the subject to respond.
Start the system by pressing the On/O button on the remote. The two screens in Figure 3 
should be visible (one following the other).
Figure 3: After pressing the On/O button the system will power up and the Sentio remote will 
connect to the computer software. The screen on the left will be visible on the Sentio remote 
while the remote is attempting to connect. After the connection is made, the screen (Main 
Screen) will appear on the Sentio remote.
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To start a test, press the “>” button on the main screen. This will advance to the setup screen 
on the Sentio Remote (see Figure 5).
Figure 5: Left image shows main screen; right image shows setup screen
Using the setup screen on the Sentio Remote, enter the subject ID (see protocol governing 
test).
Choose the appropriate eye (OS or OS) or both eyes (OU). See protocol governing test.
Press the “>” button to start the test.
When the test is started, the monitor will show three letters with decreasing (left to right) 
visibility. The Sentio remote will show the correct identity of these letters. Be certain that the 
subject cannot see the Sentio remote screen.
Record the subject response as either correct (check mark) or incorrect (X). See Figure 6. 
Encourage the subject to name a letter; however, if the subject will not name a letter, record
“no answer”.
If the subject cannot see which letter is under consideration, or any letter, the test 
administrator can highlight the area containing the letter by pressing the prompt button (see 
Figure 6).
Press the “>” button to advance to the next trial. See Figure 6.
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Press the “Finish Test” button on the top right of the results screen (see Figure 7). After this 
is done a dialog box will appear (see Figure 8).
Figure 8: dialog box that will appear after pressing the “Finish Test” button on the results
screen
To finish the test, press the “return to main” button in the dialog box (see Figure 8).
To start a new test with the same subject, press the “Same” button (see Figure 8).
To start a new test with a new subject, press the “New” button (see Figure 8).
FOLLOWING A TEST
Exportation of Data
Press the “Return to Main” button. See 5.22.
All data are stored on the computer’s hard drive and exportation of data may occur at any 
time. To export the data, insert a USB drive into the USB port on the front column of the 
cart.
At the main screen on the Sentio remote, click the export data button. You will be prompted 
with a dialog box asking to enter a password (see Figure 9). Enter a password (see protocol). 
After entering a password, press either “Export New”, which will export the last data set, or 
press “Export All”, which will export all subject data. Two files will be exported: a PDF and 
a JAVA file; each contains the data shown on the results screen.
Continue Testing
Press either the “Same” or “New” buttons. See 5.23 and 5.24.
Power Down
To turn the device off, press the On/O button on the Sentio remote. The monitor will count 
down for 10 seconds before powering down. If you wish to stop this, press the On/O button 
again; this will stop the device from powering down.
The device will power down if left inactive for some period of time. To restart the device, 
press the On/O button. Ongoing test results will be saved.
Do not unplug the device during testing; data for an ongoing test will not be saved.
REFERENCES
AST Sentio Pro Instructions for Use. Software version 1.1. IfU version 2016-08-07.
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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
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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  LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS 
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Page 3 of 7
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  EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
 
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  DETERMINATION OF NEAR ADDITION 
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  NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
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  LENS FITTING CHARACTERISTICS  
 
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  SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
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  DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
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  BIOMICROSCOPY SCALE 
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  KERATOMETRY PROCEDURE 
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  DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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  DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE 
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  VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
CR-6349 Evaluation of A Marketed Silicone Hydrogel Spherical Lens Used for Monovision 
Correction of Presbyopia
Version and Date: 5.0 Amendment 4 03 September 2019
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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