Design Validation of Senofilcon A With New UV-blocking Additive
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Title: Design Validation of senofilcon A with New UV-blocking Additive
Protocol: CR-6305
Version: 4.0, Amendment 3.0
Date: 14 November 2018
Investigational Products: ACUVUE OASYS® with Transitions™ Light Intelligent Technology™
Key Words: senofilcon A, ACUVUE OASYS®, ACUVUE OASYS with Transitions Light
Intelligent Technology, 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 14155,1the 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 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 15 
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 ...................................... 17 
2.1. 
Objectives..................................................................................................................17 
2.2. 
Endpoints...................................................................................................................18 
2.2.1 
Primary Efficacy Endpoints:..............................................................................18 
2.2.1. 
Primary Safety Endpoints: .................................................................................18 
2.2.2. 
Secondary Endpoints: ........................................................................................18 
2.2.3. 
Other Endpoints:................................................................................................19 
2.3. 
Hypotheses ................................................................................................................19 
2.3.1. 
Primary Hypotheses...........................................................................................19 
2.3.2. 
Secondary Hypotheses.......................................................................................20 
3. 
TARGETED STUDY POPULATION........................................................................... 20 
3.1. 
General Characteristics .............................................................................................20 
3.2. 
Inclusion Criteria.......................................................................................................21 
3.3. 
Exclusion Criteria......................................................................................................21 
3.3.1. 
Systemic Medications........................................................................................22 
3.4. 
Enrollment Strategy...................................................................................................23 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 23 
4.1. 
Description of Study Design .....................................................................................23 
4.2. 
Study Design Rationale.............................................................................................24 
4.3. 
Enrollment Target and Study Duration .....................................................................24 
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5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 24 
5.1. 
Test Article Allocation..............................................................................................24 
5.2. 
Masking.....................................................................................................................25 
5.3. 
Procedures for Maintaining and Breaking the Masking............................................25 
6. 
STUDY INTERVENTION............................................................................................. 26 
6.1. 
Identity of Test Articles.............................................................................................26 
6.2. 
Ancillary Supplies/Products......................................................................................26 
6.3. 
Administration of Test Articles.................................................................................26 
6.4. 
Packaging and Labeling ............................................................................................27 
6.5. 
Storage Conditions....................................................................................................27 
6.6. 
Collection and Storage of Samples ...........................................................................27 
6.7. 
Accountability of Test Articles .................................................................................27 
7. 
STUDY EVALUATIONS.............................................................................................. 28 
7.1. 
Time and Event Schedule..........................................................................................28 
7.2. 
Detailed Study Procedures ........................................................................................29 
VISIT 1 …………………………………………………………………………………29 
VISIT 2 …………………………………………………………………………………34 
FINAL EVALUATION...................................................................................................35 
7.3. 
Unscheduled Visits....................................................................................................36 
7.4. 
Laboratory Procedures ..............................................................................................37 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 37 
8.1. 
Completion Criteria...................................................................................................37 
8.2. 
Withdrawal/Discontinuation from the Study ............................................................37 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 38 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 38 
11. 
STUDY TERMINATION ........................................................................................... 38 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 39 
13. 
ADVERSE EVENTS................................................................................................... 40 
13.1. Definitions and Classifications..................................................................................40 
13.2. Assessing Adverse Events.........................................................................................42 
13.2.1. Causality Assessment.........................................................................................43 
13.2.2. Severity Assessment ..........................................................................................43 
13.3. Documentation and Follow-Up of Adverse Events ..................................................43 
13.4. Reporting Adverse Events.........................................................................................45 
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13.4.1. Reporting Adverse Events to Sponsor...............................................................45 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities46 
13.4.3. Event of Special Interest ....................................................................................46 
13.5. Reporting of Pregnancy.............................................................................................46 
14. 
STATISTICAL METHODS........................................................................................ 46 
14.1. General Considerations .............................................................................................46 
14.2. Sample Size Justification ..........................................................................................47 
14.3. Analysis Populations.................................................................................................51 
14.4. Level of Statistical Significance................................................................................51 
14.5. Primary Analysis.......................................................................................................51 
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..............................................57 
14.10. Procedure for Reporting Deviations from Statistical Plan........................................57 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 57 
15.1. Electronic Case Report Form/Data Collection..........................................................57 
15.2. Subject Record ..........................................................................................................57 
16. 
DATA MANAGEMENT............................................................................................. 58 
16.1. Access to Source Data/Document.............................................................................58 
16.2. Confidentiality of Information ..................................................................................58 
16.3. Data Quality Assurance.............................................................................................58 
17. 
MONITORING............................................................................................................ 59 
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)...............60 
18.4. Informed Consent......................................................................................................61 
18.5. Privacy of Personal Data...........................................................................................61 
19. 
STUDY RECORD RETENTION................................................................................ 62 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 63 
21. 
PUBLICATION........................................................................................................... 63 
22. 
REFERENCES ............................................................................................................ 63 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 65 
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APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 72 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 73 
APPENDIX D: 
...................................... 76 
 LENS FITTING CHARACTERISTICS.............................................................. 77 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS......................... 84 
, FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 86 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 92 
 BIOMICROSCOPY SCALE ............................................................................... 99 
 KERATOMETRY PROCEDURE..................................................................... 105 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION........................ 107 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE112 
, PATIENT REPORTED OUTCOMES .............................................................. 116 
, WHITE LIGHT LENS SURFACE WETTABILITY........................................ 118 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING.............................................................................................................................. 120 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 128 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS 
Table 1: Disallowed systemic medications (less than one year of continual use).................. 23 
Table 2: Test Articles.............................................................................................................. 26 
Table 3: Ancillary Supplies .................................................................................................... 26 
Table 4: Time and Events ....................................................................................................... 28 
Table 5: Historical Studies Included in Sample Size Calculation .......................................... 47 
 
 
Table 8: Descriptive Summary of Mechanical Lens Fitting Pooled Across all Historical Studies
................................................................................................................................................. 48 
Table 9: Descriptive Summary of Slit Lamp Findings Pooled Across all Historical Studies 48 
 
Table 11: Sample Size Estimates and Power Calculations for Primary Endpoints................ 50 
Table 12: Sample Size Estimates and Power Calculations for Secondary Endpoints............ 50 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Design Validation of senofilcon A with New UV-blocking Additive
Protocol Number:  CR-6305
Version: 4.0, Amendment 3.0
Date: 14 November 2018
SPONSOR NAME AND ADDRESS
Johnson & Johnson Vision Care, Inc. (JJVCI)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR
Name:  John R. Buch, O.D., M.S., F.A.A.O.
Title:  Senior Principal Research Optometrist
Address:  7500 Centurion Parkway, Suite 100, Jacksonville, FL 32256
Email: jbuch@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 / Study 
Responsible Clinician
See Electronic Signature Report
John R. Buch, O.D., M.S.
Senior Principal Research Optometrist, JJVCI
DATE
Clinical Operations 
Manager
See Electronic Signature Report
Clinical Operations Manager, JJVCI
DATE
Biostatistician
See Electronic Signature Report
Biostatistician II, JJVCI
DATE
Biostatistician
See Electronic Signature Report
Reviewer
Sr. Manager, Biostatistics JJVCI
DATE
Data Management 
See Electronic Signature Report
Clinical Project Manager – Data & Systems,
JJVCI
DATE
Reviewer
See Electronic Signature Report
Clinical Research Fellow, JJVCI
DATE
Approver
See Electronic Signature Report
Dir. Sphere - Light Management - Lens care,
JJVCI
DATE
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SYNOPSIS 
Protocol Title
Design Validation of senofilcon A with New UV-blocker
Additive
Sponsor
JJVCI, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Design input validation
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products:  senofilcon A with new UV-blocking 
additive (i.e., ACUVUE OASYS with Transitions Light 
Intelligent Technology).
Control Products:  senofilcon A without new UV-blocking 
additive (i.e., ACUVUE OASYS®).
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: 2 weeks
Objectives 
The primary purpose of this randomized study is to demonstrate
that the 4GT Test lens senofilcon A with new UV-blocker, in its 
final lens design ECL600, meets the design validation 
requirements related to overall CLUE comfort, logMAR visual 
acuity, quality of vision in bright light, eye health, and fit 
acceptance.
Study Endpoints
Primary endpoints: logMAR visual performance, slit lamp 
findings (Graded 3 or higher), fit acceptance, overall CLUE 
comfort and satisfaction of vision in bright light.
Secondary endpoints: CLUE handling and CLUE overall quality 
of vision.
Study Design
This is a 2-visit, multi-site, partially subject-masked, 2-arm 
parallel, controlled, randomized and dispensing trial. Subjects 
will be randomized to one of two study lenses for the entire 
duration of the study. The study lenses will be worn for a period 
of 2 weeks each in a bilateral fashion. Subjects will be advised 
to wear the study lens for a minimum of 5 days per week for at 
least 6 hours per day.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1Figure 1).
Sample Size
Multiple external investigational sites will enroll approximately 
236 subjects with the intent of completing approximately 224.
Study Duration
The study is approximately two weeks per subject.  The 
enrollment period is approximately two weeks, resulting in a 
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total study duration of approximately four weeks from first 
subject first visit to last subject last visit.
Anticipated Study 
Population
Healthy adult males and females of any race and ethnicity will 
be recruited.  All subjects will be habitual wearers of spherical 
soft contact lenses.
Eligibility Criteria
(Inclusion)
Potential subjects must satisfy all of the following criteria to be 
enrolled in the study:
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth 
in this clinical protocol.
3. Between 18 and 49 (inclusive) years of age at the time of
informed consent.
4. Eligible presbyopes will be those that wear full distance 
contact lenses in both eyes, then wear reading glasses over 
them when needed for near vision.
5. The subject is a current spherical soft contact lens wearer in 
both eyes with a minimum of 6 hours/day and 5 days/week 
wear time over the last 30 days by self-report.
6. Subjects must be able and willing to wear the study lenses 
at least 6 hours a day, a minimum of 5 days per week
7. Subjects must own a wearable pair of distance spectacles. 
8. The subject’s vertex-corrected spherical equivalent distance
refraction must be in the range of -1.00 to -6.00 D (inclusive) 
in each eye.
9. The subject’s refractive cylinder must be 0.00 to -1.00 D 
(inclusive) in each eye.
10. The subject must have a spherocylindrical best corrected 
distance Snellen visual acuity of 20/25+3 or better in each 
eye.
Eligibility Criteria
(Exclusion)
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
1. Currently pregnant or lactating (subjects who become 
pregnant during the study will be discontinued).
2. Any active or ongoing systemic disease (e.g., Sjögren’s 
Syndrome), infectious disease (e.g., hepatitis, tuberculosis), 
contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g. rheumatoid arthritis).
3. Subjects taking suspect oral medications for less than one 
year.  (See Section 3.3.1 for suspect medications and more 
details).
4. Any prescribed or over the counter (OTC) ocular medication.
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5. Any known hypersensitivity or allergic reaction to Optifree®
PureMoist® multi-purpose care solution or Eye-Cept®
rewetting drop solution.
6. Toric, extended wear, monovision or multi-focal contact lens 
correction.
7. Any previous or planned (during the course of the study) 
ocular surgery (e.g., PRK, LASIK, etc.).
8. Participation in any contact lens or lens care product clinical 
trial within 30 days prior to study enrollment.
9. Participation in clinical trials involving the Test lens within 
3 months prior to study enrollment.
10. Employee or immediate family member of an employee of 
clinical site (e.g., Investigator, Coordinator, Technician).
11. Binocular vision abnormality or strabismus by self-report or 
prior medical history.
12. History of recurrent corneal erosions, herpetic keratitis, or 
pathological dry eye.
13. Any active ocular allergies, infections or other ocular 
abnormalities (entropion, ectropion, extrusions, chalazia, 
recurrent styes, glaucoma) that the investigator determines 
may interfere with the outcomes of this study or otherwise 
contraindicate participation in the study.
14. Any Grade 2 or greater slit lamp findings (e.g., edema, 
corneal 
neovascularization, 
corneal 
staining, 
tarsal 
abnormalities, conjunctival injection) on the FDA Slit Lamp 
Classification Scale.
15. Any previous history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer or 
round peripheral scar) within the past 3 years of otherwise 
successful contact lens wear.
Disallowed 
Medications/Interventions 
Suspect oral medications listed in Section 3.3.1 taken for less 
than one year on a continual (year-round, routine) basis.  Any 
prescribed or over the counter (OTC) ocular medication.
Measurements and 
Procedures
Monocular distance visual acuity on logMAR scale using 
ETDRS charts, physiological responses, fitting characteristics, 
individual performance item (CLUE subjective question),
CLUE overall comfort, vision and handling.
Microbiology or Other 
Laboratory Testing
The optical bench will be used to measure the light transmission 
characteristics for all worn Test lenses.  The findings are for 
internal information only and will not be part of the final report.
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 
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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® and preservative free rewetting 
drops/artificial tears
Principal Investigator(s) and 
Study Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is
included in the study Trial Master File.  
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD
Plus Power Required for Near Use
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COAS
Complete Ophthalmic Analysis System
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRD
Customer Requirement Document
CRF
Case Report Form
CRO
Contract Research Organization
CT
Center Thickness
CTP
Clinical Technical Procedure
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IPP
Individual Patient Profiles
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVCI
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
OTC
Over the Counter
OU
Both Eyes
PD
Protocol Deviation
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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
UV
Ultraviolet
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND
Medical devices include everything from simple tongue depressors to contact lenses to complex 
programmable pacemakers. 
Global regulations and standards require medical device 
manufacturers to have a quality system for the design, manufacture, packaging, labeling, and 
storage of finished medical devices. As a result, JJVCI must have a quality system that complies 
with several sets of regulations and standards from around the globe:
•
US: FDA Quality System Regulation 21 CFR Part 820
•
Europe: MDD 93/42/EEC ISO 13485:2003 Quality management systems
•
Japan: Japan MHLW Ministerial Ordinance 169, 2004
•
Canada: Canadian Medical Device Regulations
The investigational product used in this study was FDA-approved in April 2018.  The intent of this 
study is to validate that the product meets all quality system/design control requirements in 
accordance with federal regulations.  
The Test and Control contact lenses used in this study are both manufactured with senofilcon A 
material – the Test lens will contain the new UV-blocker.  The new UV-blocker darkens in the 
presence of ultraviolet (UV) and high energy visible (HEV) light and lightens in its absence.  That 
is, it has photochromic properties.  Since no other photochromic contact lens is commercially 
available, the choice of predicate device was based on the similarity of base material.
In addition to correcting myopia and hyperopia, the Test lens will attenuate bright light.  The lens 
has been evaluated on over 1,000 subjects with an excellent safety profile as described in the 
Investigator’s Brochure (IB).5 It is intended for daily wear only and replaced every two weeks.
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1.1.
Name and Descriptions of Investigational Products 
Test lens:  ACUVUE OASYS with Transitions Light Intelligent Technology.  This product is made 
with a version of senofilcon A that has been modified with the addition of the new UV-blocker.
Control lens: ACUVUE OASYS®.  This product is also made with senofilcon A making the 
comparison to the Test lens as valid as possible.  
The Test and Control lenses are otherwise made with the same with respect to overall lens diameter 
(14.0 mm) and base curve radius (8.4 mm).  The Test lens is approximately 15 microns thicker in 
the center than the Control lens (0.85 vs. 0.70 mm, respectively).  Further details about the test 
articles are found in Section 6 of this protocol.
1.2.
Intended Use of Investigational Products
The intended use of the investigative product is for correcting myopia and for the attenuation of 
bright light.  During the study, each study article will be worn bilaterally in daily wear, reusable
modality for at least 6 hours per day, and at least 5 days per week. The subject will wear only one 
of the study lenses for two weeks.
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical trials 
on humans. For the most comprehensive nonclinical information regarding ACUVUE OASYS 
Transitions refer to the latest version of the Investigator’s Brochure. 
1.4.
Summary of Known Risks and Benefits to Human Subjects
The benefits to the subject are the same for any contact lens, namely the correction of their 
refractive error, with the added benefit of the attenuation of bright light for those subjects 
randomized to wear the Test lens.
The risks to the subject are the same for any contact lens, namely those stated in the Informed 
Consent Form (ICF), with the added precaution that the Test lens should be worn on both eyes.  
Wearing only one photochromic lens may cause disturbances in motion perception when the lens 
is activated.  
For the most comprehensive risk and benefit information regarding ACUVUE OASYS Transitions
refer to the latest version of the Investigator’s Brochure.  
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study
Prior clinical data is summarized in the Investigator’s Brochure.  
The literature is absent of any articles pertaining to soft contact lenses containing the new type of 
UV-blocker.  A list of relevant literature references pertaining to glare, eyestrain, and light filtering 
is provided:
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1. Agarwal, S., Goel, D., & Sharma, A. (2013). Evaluation of the factors which contribute to 
the ocular complaints in computer users. J Clin Diagn Res,7(2), 331-335.
2. Eperjesi, F., Fowler, C. W., & Evans, B. J. (2002). Do tinted lenses or filters improve visual 
performance in low vision? A review of the literature. Ophthalmic and Physiological 
Optics, 22(1), 68-77.
3. Hickcox, K. S., Narendran, N., Bullough, J. D., & Freyssinier, J. P. (2013). Effect of 
different coloured luminous surrounds on LED discomfort glare perception. Lighting 
Research and Technology, 1477153512474450.
4. Leguire, L. E., & Suh, S. (1993). Effect of light filters on contrast sensitivity function in 
normal and retinal degeneration subjects. Ophthalmic and Physiological Optics, 13(2), 
124-128.
5. Morse, R. S. (1985, October). Glare filter preference: influence of subjective and objective 
indices of glare, sharpness, brightness, contrast and color. In Proceedings of the Human 
Factors and Ergonomics Society Annual Meeting(Vol. 29, No. 8, pp. 782-786). SAGE 
Publications.
6. Pérez-Carrasco, M. J., Puell, M. C., Sánchez-Ramos, C., López-Castro, A., & Langa, A. 
(2005). Effect of a yellow filter on contrast sensitivity and disability glare after laser in situ 
keratomileusis under mesopic and photopic conditions. Journal of Refractive Surgery, 
21(2), 158-165.
7. Sheedy, J. E., Hayes, J., & ENGLE, J. (2003). Is all asthenopia the same?. Optometry & 
Vision Science, 80(11), 732-739.
8. Steen, R., Whitaker, D., Elliott, D. B., & Wild, J. M. (1994). Age-related effects of glare 
on luminance and color contrast sensitivity. Optometry & Vision Science, 71(12), 792-796.
9. Vincent, A. J., Spierings, E. L., & Messinger, H. B. (1989). A controlled study of visual 
symptoms and eye strain factors in chronic headache. Headache: The Journal of Head and 
Face Pain, 29(8), 523-527.
10. Wilkins, A. J., & Evans, B. J. (2010). Visual stress, its treatment with spectral filters, and 
its relationship to visually induced motion sickness. Applied Ergonomics, 41(4), 509-515.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objectives
The primary purpose of this randomized study is to demonstrate that the 4GT Test lens senofilcon 
A with new UV-blocker, in its final lens design ECL600, meets the design validation requirements
related to overall CLUE comfort, logMAR visual acuity, quality of vision in bright light, eye 
health, and fit acceptance.
Secondary Objectives
The secondary objective of this study is to demonstrate that the Test lens is equal or better than 
marketed product senofilcon A (ACUVUE OASYS®, Johnson & Johnson Vision Care, Inc.) with 
regards to overall CLUE vision and handling.
Other observations of interest include adverse events, keratometry, surface characteristics
(deposits and wettability), daily wear time, reasons for discontinuation, and lens damage.
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2.2.
Endpoints 
2.2.1
Primary Efficacy Endpoints:
CLUE Overall Comfort
Overall comfort scores will be assessed using the Contact Lens User Experience (CLUE™)7
questionnaire at the two-week follow-up.  CLUE is a validated patient-reported outcomes 
questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, 
vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65.
Derived CLUE™ scores using Item Response Theory (IRT) follow a normal distribution with a 
population average score of 60 (SD 20), where higher scores indicate a more favorable/positive 
response with a range of 0-120. A 5-point increase in an average CLUE™ score translates into 
10% shift in the distribution of scores for population of soft contact lens wearers.7 The handling 
scores will be generated using the flexMIRT software Version 3 or higher (Chapel Hill, NC).
Distance Monocular Contact Lens Visual Acuity   
Distance monocular contact lens visual performance (logMAR) is assessed for each subject eye at 
the two-week follow-up evaluation using EDTRS charts using high illumination and high contrast 
charts.
Vision Satisfaction in Bright Lighting
Vision satisfaction in bright lighting will be assessed using the individual item (Item ID: V015_1) 
“I was satisfied with the quality of my vision in bright lighting” from the CLUE™ questionnaire. 
This item uses the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor 
Disagree, 4: Agree and 5: Strongly Agree. 
2.2.1. Primary Safety Endpoints:
Slit Lamp Findings (Grade 3 or Higher)
Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and 
unscheduled).  The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed 
and will include corneal infiltrates. 
Fit Acceptance Rate
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject 
eye.  Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only.  
Fit rates of the Control lens will also be collected but are not a primary endpoint.
2.2.2. Secondary Endpoints:
CLUE Overall Vision and Handling 
Overall vision and handling scores will be assessed using the Contact Lens User Experience 
(CLUE)7 questionnaire at the two-week follow-up.
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2.2.3. Other Endpoints:
Average daily wear time (in Hours):
Average daily wear time will be calculated as the number of hours between subjects reported 
time of insertion and time of removal of the study lenses, on an average day, at 2-Week Follow-
up evaluation.
Subject’s Reported Ocular Symptoms:
Frequency and severity by eye of subject’s reported ocular symptoms and problems with the study 
lens at fitting and post-fitting evaluation visits including unscheduled visits. 
Severity of the symptoms can be:
x
0 = Not Applicable or Not Recorded;
x
1 = Mild and results in little or no interference with lens wear;
x
2 = Moderate AND/OR occasionally interferes with lens wear;
x
3 = Severe AND/OR frequently interferes with lens wear.
The related procedure is explained in 
 of the study protocol.
Lens fitting characteristics:
Frequency by eye of mechanical lens fitting characteristics at fitting and 2-Week Follow-up 
evaluations. Lens fitting characteristics to be reported are:
x
Lens Centration Grade
x
Decentered Direction
x
Limbal Exposure Grade
x
Edge Lift (Present or Absent)
x
Primary Gaze Movement Grade
x
Upgaze Movement Grade
x
Lens Tightness Grade (Push-up Test) 
x
Acceptable Fitting (yes/no)
Additional Endpoints
x
Adverse events
x
Discontinuation
x
Reasons for discontinuation
x
Unscheduled lens replacement
x
Reasons for unscheduled lens replacement including lens damage.
2.3.
Hypotheses
2.3.1. Primary Hypotheses
All the following primary hypotheses must be met for the objectives of this study to be satisfied:
1. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will have 
patient reported comfort at the 2-Week Follow Up visit that is non-inferior to that of 
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subjects wearing predicate device on a daily wear basis.  A non-inferiority margin of -5
CLUE points will be used.
2. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will report 
distance monocular visual acuity (logMAR: bright room luminance/high contrast charts)
at the 2-Week Follow Up visit that is non-inferior to that of subjects wearing predicate 
device on a daily wear basis. A non-inferiority margin of 0.05 logMAR will be used.
3. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will have 
patient reported outcome (Agree and Strongly Agree) on the Quality of Vision in Bright 
Light at the 2-Week Follow Up visit that is non-inferior to that of subjects wearing 
predicate device on a daily wear basis. A non-inferiority margin of 10% will be used.
4. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will have 
a percentage of any Grade 3 or higher slit lamp findings at all visits (scheduled and 
unscheduled) that is non-inferior to that of subjects wearing predicate device on a daily 
wear basis. A non-inferiority margin of 5% will be used.
5. At least 90% of eyes wearing the JJVCI Investigational contact lenses on a daily wear basis 
will have acceptable fits across the fitting and follow-up visits.
2.3.2. Secondary Hypotheses
1. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will have 
patient reported handling at the 2-Week Follow Up visit that is non-inferior to that of 
subjects wearing predicate device on a daily wear basis.  A non-inferiority margin of -5
CLUE points will be used.
2. Subjects wearing the JJVCI Investigational contact lenses on a daily wear basis will have 
patient reported vision at the 2-Week Follow Up visit that is non-inferior to that of subjects 
wearing predicate device on a daily wear basis.  A non-inferiority margin of -5 CLUE 
points will be used.
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Healthy adults of any race or ethnicity will be invited to participate.  The eligible participants will 
be habitual wearers of spherical soft contact lenses as described below in Sections 3.2 and 3.3.  
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3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 18 and 49 (inclusive) years of age at the time of informed consent.
4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then 
wear reading glasses over them when needed for near vision.
5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 
6 hours/day and 5 days/week wear time over the last 30 days by self-report.
6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a 
minimum of 5 days per week
7. Subjects must own a wearable pair of distance spectacles. 
Inclusion Criteria after Baseline
8. The subject’s vertex-corrected spherical equivalent distance refraction must be in the range 
of -1.00 to -6.00 D (inclusive) in each eye.
9. The subject’s refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.
10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 
20/25+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 (subjects who become pregnant during the study will be 
discontinued).
2. Any active or ongoing systemic disease (e.g., Sjögren’s Syndrome), infectious disease 
(e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g. rheumatoid arthritis).
3. Subjects taking suspect oral medications for less than one year.  (See Section 3.3.1 for 
suspect medications and more details).
4. Any prescribed or over the counter (OTC) ocular medication.
5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose 
care solution or Eye-Cept® rewetting drop solution.
6. Toric, extended wear, monovision or multi-focal contact lens correction.
7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, 
LASIK, etc.).
8. Participation in any contact lens or lens care product clinical trial within 30 days prior to 
study enrollment.
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9. Participation in clinical trials involving the Test lens within 3 months prior to study 
enrollment.
10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, 
Coordinator, Technician).
11. Binocular vision abnormality or strabismus by self-report or prior medical history.
12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
Exclusion Criteria after Baseline
13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may 
interfere with the outcomes of this study or otherwise contraindicate participation in the 
study.
14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal 
staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification 
Scale.
15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., 
past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise 
successful contact lens wear.
3.3.1. Systemic Medications
Certain systemic medications are known to have a higher likelihood to interfere with contact lens 
wear, chiefly by disrupting the tear film.  Several articles1,2,3, websites4,5, and text book chapters6,7
discuss this topic with the general consensus shown in Table 1.  Subjects taking these medications 
on a continual (year-round, routine) basis that have demonstrated successful contact lens wear for 
at least one year will generally be allowed to participate in this study.  Subjects taking these 
medications on a routine basis but less than one year will not be allowed to participate in the study.  
Note that subjects taking these medications on a temporary basis (e.g., antihistamines for seasonal 
allergy) will be allowed to participate if the medication has sufficient time to leave the body prior 
to the study.  This is dependent on the half-life of the drug, body weight / fat, age, genetics, liver / 
kidney function, and metabolism of the subject.  Given these unknowns, subjects taking the 
medications on a temporary basis must have ceased that medication at least one month prior to 
signing the informed consent.
                                                
1 Gomes, José Alvaro P., et al. "TFOS DEWS II iatrogenic report." The ocular surface 15.3 (2017): 511-538.
2 Silbert, Joel A. "A review of therapeutic agents and contact lens wear." Journal of the American Optometric 
Association 67.3 (1996): 165-172.
3 Muntingh, G. L. "Drug and contact lens interactions." South African Family Practice 47.8 (2005): 24-28.
4 https://www.clspectrum.com/issues/2003/september-2003/medication-effects-on-the-anterior-segment-and-con
5 http://www.richmondeye.com/ocular-side-effects-of-medications/
6 Lima, Claudia Assis, Newton Kara-Jose, and Jason J. Nichols. "Indications, Contraindications, and Selection of 
Contact Lenses." Contact Lenses in Ophthalmic Practice. Springer, New York, NY, 2004. 7-16.
7 Bartlett, Jimmy D., and Siret D. Jaanus. "Clinical ocular pharmacology." (2008): 575-578.
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five (5) days per week for at least six (6) hours per day for a period of two weeks. There is no 
planned lens replacement scheduled for during this study.
4.2.
Study Design Rationale
The purpose of this study is to provide evidence that the investigational contact lens, senofilcon A 
with new-UV blocker meets all criteria specified by the Customer Requirements Document 
(CRD).  Since this contact lens was approved for daily wear at a replacement rate of 2-weeks, a 
parallel study design with a 2-week follow-up evaluation was chosen as the most optimal design
to evaluate the criteria specified in the CRD.
4.3.
Enrollment Target and Study Duration
x
Approximately 112 subjects are targeted to complete the Test arm of the study, and an 
additional 112 subjects are targeted to complete the Control arm of the study.  
x
10 clinical sites will be recruited to participate, and each site will enroll approximately 20-
24 subjects.  
x
Enrollment is defined at the point when the Informed Consent is signed.  Termination is 
defined at the completion of the Final Evaluation.
x
Each site will have approximately 2 weeks to enroll all their subjects unless otherwise 
approved by the Sponsor.  Each subject will be in the study approximately 2 weeks, making 
the entire study approximately 4 weeks in duration.
Table 2: Target number of subjects by arm and site
Test
Control
Total
Randomization 
116
116
232
Completion
112
112
224
Number of sites
10
10
10
Subjects/site (Min-Max)
10-12
10-12
20-24
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
A computer-generated randomization scheme will be used to randomly assign subjects, in blocks 
of 4, to one of the two possible study lenses (TEST or CONTROL). The random scheme will be 
generated using the PROC PLAN procedure from Statistical Analysis System (SAS) Software 
Version 9.4 or higher (SAS Institute, Cary, NC).
The study site must follow the randomization scheme provided and complete enrollment according 
to the randomization list and not pre-select or assign subjects. The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting. The following must have 
occurred prior to randomization:
x
Informed consent has been obtained
x
Subject meets all the inclusion / not meets exclusion criteria
x
Subject history and baseline information has been collected.
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5.2.
Masking
The dynamic nature of the Test lens makes it impossible to completely mask the study lens 
assignment.  The subjects will be aware if they are wearing a photochromic lens or 
non-photochromic lens due to the function nature of the photochromic dye.  Additionally, there is 
a slight difference in physical appearance between the Test and Control lenses when the Test lens 
is activated by outdoor light that makes it difficult to mask investigative personnel.  However, the 
Control lens will be masked in the event that OASYS is the subject’s habitual lens by chance, 
making this a partial-subject masked study.
Every attempt will be made to keep the other clinical trial personnel involved in the study (e.g. 
Data management, Biostatistician and Clinical Operations) unaware of the lens assignment.  The 
identity of the study lenses will be masked by over labeling the blister packs with a label containing 
the study number, lot number, sphere power, expiration date and the randomization codes. Only 
the personnel involved in the over labeling and the Statistician generating the randomization 
scheme will have access to the decode information translating the randomization codes into Test
and Control arms. The medical monitor will also have access to the decode information in case 
breaking the mask is necessary for the urgent medical treatment of a subject.
5.3.
Procedures for Maintaining and Breaking the Masking
The test articles mask shall not be broken unless information concerning the lens type is necessary 
for the urgent medical treatment of a subject.  The Sponsor must be notified before the mask is 
broken.
When dispensing test articles, the following steps should be followed to maintain randomization 
codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens fitting 
schedule/randomization scheme to obtain the test article assignment for that subject prior 
to dispensing
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply.  All 
test articles that are opened, whether dispensed (placed/fit on eye or dispensed outside the 
clinical site) or not, must be recorded on the Test Article Accountability Log in the 
“Dispensed” section
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6.4.
Packaging and Labeling
The Control articles will be packaged in their commercial blister packs with investigational over-
label to mask their identity.  The Test articles will be packaged in blisters as the primary packaging 
and labeled with investigational foil. The test articles will be in plastic bags as the secondary 
packaging form. The sample study label is shown below:
6.5.
Storage Conditions
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must be 
kept under secure conditions and out of direct sunlight.
6.6.
Collection and Storage of Samples
All worn study lenses will be collected from the subject, placed in labeled glass vials with Opti-
Free® PureMoist®, and stored refrigerated or frozen until they are shipped back to the Sponsor.  
The lenses will be shipped in special containers to keep the lenses refrigerated.
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 back to JJVCI.
6.7.
Accountability of Test Articles
JJVCI will provide the Investigator with sufficient quantities of study articles 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:
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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
x
Subject out of visit window visit with two or more days
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
x
Collect all unused test article(s) from the subject
An additional subject will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as the 
final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.
Suspect disallowed oral medications taken for less than one year on a continual (year-round, 
routine) basis are listed in Section 3.3.1.  Document any prescribed or over the counter (OTC) 
ocular medication currently being taken.
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 
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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.
JJVCI 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 JJVCI, it is determined that it would be 
unwise to continue at the clinical site.   
JJVCI (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part of 
the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify 
the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication that 
alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or 
performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, and 
site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, and 
not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where there is 
no deficiency alleged by the subject
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the appropriate 
COM/CRA and Clinical QA representative. In cases where the EDC system in use is not 
configured to send automatic notifications or when an EDC system is not used, the COM/CRA is 
responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
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x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.)
x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if available), or 
rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel to 
determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint results in 
an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this protocol. If 
the AE/SAE was potentially the result of a product quality related deficiency, these procedures 
also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the PQC 
forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or 
other persons, whether or not related to the investigational medical device. 
Note 1 to entry: This definition includes events related to the investigational medical device or 
the comparator.
Note 2 to entry: This definition includes events related to the procedures involved.
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
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 
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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, or
x
Requires intervention to prevent permanent damage (the use of the test article resulting in
a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function).  Important medical events that may 
not result in death, be life-threatening, or require hospitalization may be considered an SAE 
when, based upon appropriate medical judgment, they may jeopardize the patient or subject 
and may require medical or surgical intervention to prevent one of the outcomes listed in 
the above definition
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or 
greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse Events).  
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)
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x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and usually 
do not warrant discontinuation (temporary or permanent) of the test article.  However, the 
Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, but 
not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation <2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of 
the investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, the test article, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan, Investigator’s Brochure or protocol, or any other unanticipated serious
problem associated with the test article that relates to the rights, safety and welfare of subjects.
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)
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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
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.
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Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All Adverse 
Events including local and systemic reactions not meeting the criteria for “serious adverse events” 
shall be captured on the appropriate case report form or electronic data system. All adverse events 
occurring while the subject is enrolled in the study must be documented appropriately regardless 
of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom)
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, 
and depth, etc.) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the event
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF.  Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature.  If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration of 
the event at each level of intensity to be performed.  Adverse events characterized as intermittent 
require documentation of the onset and duration of each episode. Changes in the assessment of 
relationship to the Test Article shall also be clearly documented.
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 
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resolution of the adverse event or until referral to an appropriate health care provider, as 
recommended by the Investigator. Non-ocular adverse events that are not related to the test article, 
study treatment, or study procedures may be recorded as “ongoing” without further follow-up.
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone as 
soon as possible and no later than 24 hours from discovery for any serious /significant adverse 
events, and 2 days from discovery for any non-significant adverse event.  In addition, a written 
report will be submitted by the Principal Investigator to the IEC/IRB according to their 
requirements (Section 13.4.2).  The report will comment whether the adverse event was considered 
to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring during 
the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 hours 
following discovery of the event.  The Investigator is obligated to pursue and obtain information 
requested by the Sponsor in addition to that information reported on the eCRF. All subjects 
experiencing a serious/significant adverse event must be followed up and all outcomes must be 
reported.
When medically necessary, the Investigator may break the randomization code to determine the 
identity of the treatment that the subject received.  The Sponsor and study monitor should be 
notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and medical 
judgment for colleagues who assisted in the treatment and follow-up of the subject
x
Provide the Sponsor with a complete case history which includes a statement as to whether 
the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to national 
regulations
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.
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Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported to 
the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth by 
their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth by 
their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.4.3. Event of Special Interest
None.
13.5. Reporting of Pregnancy
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the event 
is recorded as an Adverse Event.  Once discontinued, pregnant participants and their fetuses will 
not be monitored for study related purposes.  At the Investigator’s discretion, the study participant 
may be followed by the Investigator through delivery. However, this data will not be collected as 
part of the clinical study database.  Pregnant participants are not discontinued from contact lens or
solution related studies for safety concerns, but due to general concerns relating to pregnancy and 
contact lens use.  Specifically, pregnant women are discontinued due to fluctuations in refractive 
error and/or visual acuity that occur secondary to systemic hormonal changes, and not due to 
unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The SAP 
will be developed and finalized prior to database lock.
All data summaries and statistical analyses will be performed using the SAS software Version 9.4
or higher (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  Unscheduled 
visits will be summarized separately and will be excluded from the statistical analysis.
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.
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14.2. Sample Size Justification
This study was designed and powered to show non-inferiority of the Test lens compared to the 
Control lens with respect to logMAR Visual Acuity, Slit Lamp Findings (Grade 3 or higher) and 
CLUE comfort. It was assumed there was no difference between the Test and Control lens with 
respect to slit lamp findings and a 1 letter difference (0.02) between the Test and Control lenses 
with respect to visual acuity logMAR. Based on data from 3 historical studies, it was assumed 
there was a 2-point difference between the Test and Control lenses with respect to CLUE comfort
based on the summary statistics from the first period of the historical studies. 
In addition to the endpoints mentioned above, this study was also powered to demonstrate 
non-inferiority of the Test lens relative to the Control lens with respect to vision satisfaction in 
bright lighting and the proportion of eyes with acceptable fitting while the Test lens is significantly 
superior to 90%. 
Unless otherwise specified, the sample size was calculated to achieve a statistical power of at least 
80% and a type I error of 5%. 
A total of 5 historical studies were utilized in the sample size calculation. Table 6 displays the 
studies, their corresponding study design and the number of subjects enrolled and completed per-
protocol.  
Table 6: Historical Studies Included in Sample Size Calculation 
Study
Study Design
Endpoints Collected 
No.
Enrolled
No. Completed 
Per-Protocol
2X3 Crossover
CLUE, SLF Lens Fit
135
132
2X3 Crossover
CLUE, Visual Acuity 
(logMAR), SLF, Lens 
Fit
133
121
2X3 Crossover
CLUE, SLF Lens Fit
92
78
Single-Arm
SLF, Lens Fit
54
48
Single-Arm
SLF, Lens Fit
56
41
Table 7: Descriptive Summary of CLUE Scores by Domain Pooled Across Historical Studies 
– 2-Week Follow-up Evaluation Period 1 only  
CLUE Domain 
[Mean(SD)1]
Test 
Control
Comfort  
66.66 (21.066) 
63.90 (24.197)
Handling 
69.32 (18.454)
71.11 (20.429)
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Overall Quality of Vision 
64.49 (17.221)
64.44 (23.351)
1SD = Standard Deviation
Table 8: Descriptive Summary of Visual Acuity (logMAR) -
– 2-Week Follow-up
Evaluation- Period 1 only 
Visual Acuity High 
Illumination High Contrast
Test 
Control
[Mean(SD)1]
-0.088 (0.0.0862) 
-0.0622 (0.0740) 
1SD = Standard Deviation
Table 9: Descriptive Summary of Mechanical Lens Fitting Pooled Across all Historical Studies    
Any Unacceptable Lens Fit1
[n(%)]
Test n (%)
Control n (%)
Fitting Evaluation 
0(0.0) 
0 (0.0)  
2-Week Follow-up
0 (0.0) 
0 (0.0) 
¹The percent of any unacceptable fit is calculated using Total Unique eyes as a denominator 
Table 10: Descriptive Summary of Slit Lamp Findings Pooled Across all Historical Studies
%= nx100/N; SD=Standard Deviation 
¹All SLF reported for this study are combined for the purposes of summarizing
² The percent (%) of Any Grade 2 is calculated using the Total Unique Eyes as the denominator
SLF Grade 2
Test n (%)
Control n (%)
Corneal Edema
0 (0.0) 
0 (0.0) 
Conjunctival Injection
59 (6.86) 
59 (21.85) 
Tarsal Abnormalities
51 (5.93) 
24 (8.89) 
Corneal Neovascularization
3 (0.35) 
0 (0.0) 
Corneal Staining
3 (0.35) 
0 (0.0) 
Other Findings
0 (0.0)  
0 (0.0) 
Total Eyes (N)
860
270
Any SLF Grade 2²
116 (13.48) 
83 (33.74) 
Any SLF Grade 3+
0 (0.0) 
0 (0.0) 
Total Unique Eyes
860
270
Total Unique Subjects
430
135
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Table 11: Descriptive Summary of Individual Item from 
– 2-Week Follow-up
Questionnaire Item/ Response
Test 
Control
Vision Satisfaction in Bright Light [n(%)] 
Strongly Agree
72 (29.75)
51 (21.07) 
Agree
129 (53.31) 
130 (53.72) 
Neither Agree Nor Disagree
24 (9.92) 
21 (8.68)
Disagree
17 (7.02) 
33 (13.64) 
Strongly Disagree
0 (0.0) 
7 (2.89) 
CLUE Comfort Scores 
With respect to CLUE comfort, based on historical data from Period 1, a mean difference of 2 
points was assumed and a standard deviation of 21, an additive equivalence test in PROC Power 
for two sample means was used to Test for non-inferiority. A non-inferiority margin of -5 points 
was used since this is considered to be no more than a 10% shift in the distribution of CLUE scores.  
Mechanical Lens Fit (Test Lens) 
The estimated sample size to test the primary hypothesis (H0 PT ≤ P0, H1: PT > P0) is 100. The 
sample size was calculated using PROC POWER for one sample proportion using an exact Test 
of a Binomial Proportion.
Visual Performance (logMAR)
Sample size calculation for visual performance (logMAR) was carried out using an approximation 
of the power of an F-test derived from the non-centrality parameter calculated form the observed 
F statistic of a linear model.8
Model details:
visual performance was analyzed using a linear mixed model. Lens type was included as the only 
fixed effect.  A compound symmetric (CS) covariance matrix was used to model the correlation 
between measurements on the same subject across study periods.  Below is the variance-
covariance matrix used in the visual performance model. 
෍
ቀ0.004047
0.002894
0.002894
0.004737ቁ
௏௜௦௨௔௟ ஺௖௨௜௧௬
Slit Lamp Findings
There were no Grade 3 or higher SLFs observed in any of the historical studies. Assuming no 
difference between study lenses and a correlation 0.70 between left and right eyes within the same 
subject (intra-subject correlation), a reference rate of no more than 5% was assumed (worse-case 
scenario) with a non-inferiority odds ratio margin of 2. A total of 2000 replicating trials were 
simulated, each replicated sample was analyzed using a generalized estimating equation (GEE) 
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model with a binary distribution and the logit as the link function. Each model included lens type 
as the only fixed, eye was included as a random effect. The Odds ratio and corresponding 95% 
confidence interval was used estimate differences between the Test and Control lenses. The upper 
limit of each 95% confidence interval was compared to 2; if the upper limit was below 2 then 
NI=1; otherwise NI=0. Statistical power was calculated as the average NI. A sample size of 224 
(112 per arm) was chosen to achieve a minimum statistical power of 80%.  
Using a reference rate for the control of 5% and no more than a 5% difference between the Test 
and Control lenses translate to an odds ratio margin of 2. A reference rate of 5% was used as the
worst-case scenario.
Individual Questionnaire Items
Vision satisfaction in bright lighting sample size estimates were calculated using historical data 
from CR-5960.7 One-thousand boot strap samples were simulated based on the historical data. For 
each replicated sample a generalized linear mixed model was used with a multinomial distribution 
and the cumulative logit as the link function. Lens type was included in the model as the only fixed 
effect. 
Using a reference rate of 50% for the Control lens and assuming no difference between the Test 
and Control a 10% difference translate to a cumulative odds ratio margin of 0.67. the reference 
rate of 0.50 was used as the worst-case scenario. 
Table 12: Sample Size Estimates and Power Calculations for Primary Endpoints
Endpoint
Number per 
Subjects to 
Complete
Power
Distance Monocular Visual Acuity (logMAR)
30
86%
SLFs (Grade 3 or Higher)
224
80%
Acceptable lens Fit (Test Lens Only)
100
82%
CLUE Comfort
224
87%
Vision Satisfaction in Bright Lighting
40
87%
Table 13: Sample Size Estimates and Power Calculations for Secondary Endpoints
Endpoint
Number per Subjects to 
Complete
Power
CLUE Handling
224
63%
CLUE Overall Quality of Vision
224
71%
As indicated in Table 12 and 13 above, the sample size chosen for this study was primary driven 
by slit lamp findings (Grade 3 or higher) and overall comfort.  The plan is to enroll 236 eligible 
subjects (118 subject per arm) with a target of 112 subjects to complete each arm in the study. 
During the enrollment period, the subject drop-out rate with be closely monitored, if an 
unexpectedly high dropout rate is observed, then the targeted total enrollment number maybe be 
increased accordingly to ensure that a minimum of 224 subjects complete the study. 
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14.3. Analysis Populations
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock (Per-
Protocol Population). Justification of excluding subjects with protocol deviations in the per-
protocol population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study or 
deviation from protocol. At least one observation should be recorded.
Safety variables will be summarized on both safety and PP populations whereas efficacy variables will 
be summarized on the per-protocol and Intent-to-Treat population.
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:
All the efficacy analyses will be conducted on PP population. As sensitivity analysis, the efficacy 
analysis will be repeated on the ITT population
regardless of missing data.
Visual Acuity
Distance monocular visual acuity (logMAR) will be tested under bright illumination low contrast 
conditions at the 2-week follow-up evaluation and will be analyzed using a Bayesian normal 
random-effects model to compare the Test and Control lenses. The regression model will include 
lens type as the only fixed effect. Clinical site and subject will be included as random effects. Other 
subject characteristics such as gender and age will be included as fixed effects when appropriate. 
The Model:
Let ݕ௜௝௞௟the visual acuity (logMAR) for the ݈௧௛subject at the ݇௧௛site, assigned to the ݅௧௛lens for 
the ݆௧௛eye.  The likelihood for ݕ௜௝௞௟is constructed as follows: 
ݕ௜௝௞௟~ N(ߤ௜௝௞௟, ߪ௜௝௞௟
ଶ)
Where, 
μ௜௝௞௟= μ଴+ ߚଵܮ݁݊ݏ+  ߛ௟(௞) + ߙ௞
In this model, lens we define ܮ݁݊ݏ௟=0 for the Control lens and ܮ݁݊ݏ௜=1 for the Test lens. So ߚଵ
stands for the difference between the Test and Control lens with respect to logMAR visual 
performance. A negative ߚଵindicates the Test performed better than the Control lens. 
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We assume random subject  effects are independent and identically distributed (i.i.d) as ߛ௝~ N(0, 
ߪ௦௨௕௝௘௖௧
ଶ
) as random subject and, the random site effect is i.i.d as  ߙ௞~ N(0, ߪ௦௜௧௘
ଶ
) for i=1,2 (lens),  
j=1, 2  (eye), k=1, 2, 3, 4, 5, 6 (site). 
For the β coefficients, independent non-informative priors N(0, 1000) will be used. For the 
variance of random effects ߪ௘௬௘
ଶ and ߪ௦௜௧௘
ଶ
independent non-informative conjugate priors inverse-
gamma(0.001, 0.001) will be used. For ߪ௜௝௞௟
ଶ, non-informative conjugate priors inverse-
gamma(0.001, 0.001) will be used where ߪ௜௝௞௟
ଶ, is the variance of  ݕ௜௝௞௟. The metropolis sampler 
algorithm as implemented in the SAS/STAT MCMC 14.2 procedure will be used to estimate the 
posterior distribution of the unknown parameters. Inferences will be made based on the 95% 
posterior credible intervals for relevant parameters. 
Hypothesis Testing 
The null and alternative hypothesis for visual acuity (logMAR) to test for non-inferiority of the 
Test lens relative to the Control lens is as follows: 
ܪ௢: ߚଵ≥ 0.05
ܪ஺: ߚଵ< 0.05
Non-inferiority will be declared if the upper limit of the 95% credible interval of the difference 
between the Test and Control is below 0.05, i.e. P(ߚଵ< 0.05) ≥ 0.975.
CLUE Overall Comfort 
CLUE Comfort scores will be analyzed using a Bayesian normal random-effects model to compare 
the Test and Control lenses at the 2-week follow-up evaluation. The regression model will include 
baseline CLUE comfort scores and lens type as fixed effects. Clinical site will be included as 
random effects. Other subject characteristics such as age, gender, race and iris category will be 
included as fixed covariates when appropriate. 
The Model: 
Let ݕ௜௝௞௟denote the CLUE Comfort score for the ݇௧௛subject at the ݆௧௛site, assigned to the  ݅௧௛
lens. The likelihood for ݕ௜௝௞௟is constructed as follows: 
ݕ௜௝௞௟~ N(ߤ௜௝௞௟, ߪ௜௝௞௟
ଶ)
Where 
μ௜௝௞௟= μ଴+  ߚଵܮ݁݊ݏ+ ߚଶbaseline +  ߛ௞
In this model, we define Lens=0 for the Control lens and Lens = 1 for the Test lens. So ߚଵstands 
for the difference between the Test and Control lens with respect to CLUE comfort; A positive ߚଵ
indicates the Test performed better than the Control. 
We assume random site effects are independent and identically distributed (i.i.d) as  ߛ௝~ N(0, 
ߪ௦௜௧௘
ଶ
)  for site for i=1,  2 (lens), j=1,  2, 3, 4, 5, 6 (site), k=1…..n (subject/site) .
For the β coefficients, independent non-informative priors N(0, 1000) will be used. For the 
variance of random effect of ߪ௦௜௧௘
ଶ
an independent non-informative conjugate prior, inverse-gamma 
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(0.001, 0.001) will be used. Starting values for the mean and variance of CLUE scores will be 60 
and 400 (since standard deviation of CLUE is normalized to be 20), respectively. The Metropolis 
sampler algorithm as implemented in the SAS/STAT MCMC 14.214 procedure will be used to 
estimate the posterior distribution of the unknown parameters. Inferences will be made based on 
the 95% posterior credible intervals for relevant parameters. 
Hypothesis Testing
The null and alternative hypotheses for CLUE comfort non-inferiority of the Test lens relative to 
the Control lens are as follows: 
ܪ௢: ߚଵӊ -5
ܪ஺: ߚଵ> -5
Non-inferiority will be declared if the lower bound of the 2-sided 95% credible interval of the 
difference between the Test lens and the Control lens is greater than -5, i.e., P(ߚଵ> -5) ≥ 0.975. 
Vision Satisfaction in Bright Lighting
Vision satisfaction in bright lighting at the 2-week follow-up evaluation will be analyzed using a 
Bayesian multinomial model for ordinal data.  The regression model will include lens type as the 
only fixed effect. Clinical site will be included as a random effect. Other subject characteristics 
such as age, gender, race and iris category will be included when appropriate. 
The Model:
Let ݕ௜௝௞= (ݕ௜௝௞ଵ, ݕ௜௝௞ଶ, ݕ௜௝௞ଷ, ݕ௜௝௞ସ, ݕ௜௝௞ହ) denote the rating for the ݇௧௛subject, from the ݆௧௛site, 
assigned to the ݅௧௛study lens. Possible values of ݕ௜௝௞are 1if the subject rating of vision satisfaction 
in bright lighting are X and 0 otherwise (x=1 for Strongly Agree and X=5 for Strongly Disagree, 
respectively).  The likelihood is constructed as follows: 
ݕ௜௝௞~ Multinomial (ܲ௜௝௞ଵ,  ܲ௜௝௞ଶ, ܲ௜௝௞ଷ, ܲ௜௝௞ସ, ܲ௜௝௞ହ)
ܲ௜௝௞ଵ= ߛ௜௝௞ଵ
ܲ௜௝௞௑= ߛ௜௝௞௑-ߛ௜௝௞(௑ିଵ) 2 ≤ n ≤4
ܲ௜௝௞ହ= 1 −෍ܲ௜௝௞௑
௫ୀଵ,..ସ
Logit(ߛ௜௝௞௟௠௑)= ߠ௡+ ߚଵܮ݁݊ݏ+   ߛ௝
Where ߠ௡is the intercept for levels n=1,2,3,4, ܲ௜௝௞ଵ= Pr (ߛ௜௝௞ଵ= 1) with respect to the vision 
satisfaction in bright lighting item. We assume the random clinical site effects are i.i.d as  ߛ௝~N(0, 
ߪ௦௜௧௘
ଶ
) for i=1,2 (lens), j=1, 2, 3, 4, 5, 6(site) and k=1,…..n (subject/site)
In this model, the lens I will be determined by the period j and sequence k, therefore i is denoted 
as a function of j and k. We define ܮ݁݊ݏ௜=0 for the Control lens and ܮ݁݊ݏ௜=1 for the Test lens. 
Page 53 of 128

Independent vague N(0, 1000) priors for the regression coefficients ߚ௜i=1,…5. For ߠ௡, we are 
considering the following priors 
π0(θ1) ~ N(0,100)
π0(θ2| θ1) ~ N(0,100)I(θ>θ1)
π0(θ3| θ2) ~ N(0,100)I(θ>θ2)
π0(θ4| θ3) ~ N(0,100)I(θ>θ3)
For the variance of random effects independent vague normal priors will also be used; ߪ௦
ଶ ~inverse-
gamma(0.001, 0.001). The Metropolis sample algorithim as implemented in the SAS/Stat MCMC 
Procedure will be used to estimate the posterior distributions of the unknown parameters. 
Inferences will be made based on the posterior credible interval for the relevant parameters.
Hypothesis Testing
The null and alternative hypotheses for non-inferiority are as follows: 
ܪ݋:  ݌ݐ- ݌ܿ≤ -0.1
ܪܣ:  ݌ݐ- ݌ܿ> -0.1
where p୘and pେare the proportions of patients with positive response (agree or strongly agree) in
Test group and Control group, respectively. Non-inferiority will be established if the lower limit 
of the 2-sided 95% credible interval of the difference (݌்− ݌஼) is above -0.1 (i.e. P(݌ݐ- ݌ܿ> -
0.1|data) ≥ 0.975.
Primary Safety Analysis: 
Safety analysis will be conducted on safety population by treatment actually received by
subjects. 
Acceptable Lens Fit:
Acceptable lens fit will be analyzed using a Bayesian beta-binomial models for correlated binary 
data. The regression model will include lens type as the only fixed effects
The Model:
Let Y1 and Y2 denote the binary outcomes of acceptable lens fit for the left and right eyes, 
respectively, when wearing the test lens. Considering the correlation, ρ, between Y1 and Y2, the 
distribution of the sum Y = Y1 + Y2 is obtained by the mixture of two variables. One of them 
follow a binomial distribution Bin(2, p) with mixing probability (1-p) and the other one follows a 
modified Bernoulli distribution MBern(p), taking value 0 and 2 rather than conventional 0 and 1, 
with mixing probability p:
P(Y = y| p, ρ) = (1- ρ)Bin(2, p)IA1 +  ρMBern(p)IA2
Where IA1 = {0, 1, 2} and IA2 = {0, 2}
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To overcome the complexity of the mixture likelihood a latent variable Zi, i = 1, 2 is introduced in 
the model to indicate in which component of the model the observation yi, i=1, 2, belongs to, that 
is,
z୧= ൜1, if the observation belong to the MBern(p),
0, if the observation belong to the Bin(2, p)  
The joint distribution of the augmented data (Yi, Zi), i=1, 2, is given by
P(Y = y୧, Z = z୧| p, ρ) =  ρ୸౟p୷౟୸౟/ଶ(1 −p)(ଶି୷౟)୸౟/ଶ(1 −ρ)ଵି୸౟൬2
y୧൰p୷౟(ଵି୸౟)(1 −p)(ଶି୷౟)(ଵି୸౟)
The posterior distribution of (p, ρ) given (y, z) is
P (p, ρ | z, y)  = P (y, z| p, ρ) π0 (p, ρ),
Where, π0 is joint prior distribution of (p, ρ). Here we assume p and ρ to be independent with a 
prior beta(α,β) for p and uniform(0,1) for ρ. Hence the joint distribution of (p, ρ) is given by π0 (p, 
ρ| α, β)∝pα -1(1-p) β-1. The Metropolis sampler algorithm as implemented in the SAS/STAT 
MCMC Procedure will be used to estimate the posterior distributions of the parameters (p, ρ).
Inferences will be made based on a posterior credible interval for the relevant parameters.
Hypothesis Testing
With respect to Acceptable lens fit the null and alternative hypothesis for superiority is as 
follows:
H଴= p୘≤ 0.90 
Hଵ= p୘>  0.90
Where, p୘represents the proportion of subject eyes that achieve acceptable fit for the Test lens.
Success for acceptable fit will be declared if the lower bound of the 2-sided 95% credible 
interval of the proportion is greater than 0.90; i.e. P(p୘> 0.90) ≥.975.
If the full planned model fails to converge, reduced versions may be considered.
Slit Lamp Findings
Grade 3 or higher slit lamp findings will be analyzed using a Bayesian Logistic regression random-
effects model to compare the Test and Control lenses.  The regression model will include baseline 
slit lamp findings and lens type. Site and subject will be included in the model as random effects. 
Let ݕ௜௝௞௟=1 if a Grade 3 or higher SLF is observed and ݕ௜௝௞=0 otherwise for the ݈௧௛subject, from 
the ݇௧௛site, assigned to the ݅௧௛study lens for the ݆௧௛ eye.
y୧୨୩୪ ~ Binary (p୧୨୩୪) 
 
p୧୨୩୪= 
exp ( β଴+ ߚ1ܮ݁݊ݏ+ βଶBaseline SLF୪ +  ߛ݇+  ߜ݈)
1 + exp ( β଴+ ߚ1ܮ݁݊ݏ+ βଶBaseline SLF୪ +  ߛ݇+  ߜ݈) 
 
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We assume the random effect for subject are i.i.d as  ߜ௟~N(0, ߪ௦௨௕௝௘௖௧/௦௜௧௘
ଶ
) for the random for 
clinical site are i.i.d as  ߛ௞~N(0, ߪ௦௜௧௘
ଶ
) for i=1,2 (lens), j=1, 2 (eye), k=1, 2, 3, 4, 5, 6 (site) and 
l=1,…n (subject/site). 
In this model, we define ܮ݁݊ݏ௜=0 for the Control lens and ܮ݁݊ݏ௜=1 for the Test lens. For the β
coefficients, independent non-informative priors N(0, 10000) will be used. For the variance of 
random effects of σୱ୳ୠ୨ୣୡ୲
ଶ
andσୱ୧୲ୣ
ଶ
, independent non-informative conjugate priors inverse-gamma 
(0.001, 0.001) will be used. The Metropolis-Hastings algorithm as implemented in the SAS/STAT 
14.2 PROC MCMC procedure will be used to estimate posterior distributions of the unknown 
parameters. Inferences will be made based on the posterior credible interval for the relevant 
parameters. 
Hypothesis Testing
The null and alternative hypothesis for Non-inferiority is as follows: 
H଴= p୘− pେ≥0.05
Hଵ= p୘− pେ< 0.05 ,
where p୘and pେare the proportions of Grade 3 or higher SLFs in Test group and Control group, 
respectively.
Non-inferiority will be established if the upper limit of the 2-sided 95% credible interval of the 
difference (݌்− ݌஼) is below 0.05(i.e. p(݌்− ݌஼< 0.05|data) ≥.975).
If the full planned model fails to converge, reduced versions may be considered. In the event that 
the number of Grade 3 or higher SLFs is too small Grade 2 or higher SLFs will be analyzed and 
tested as described above.
14.6. Secondary Analysis 
Secondary efficacy analysis:
CLUE Overall Quality of Vision and Handling
CLUE Overall Quality of Vision and Handling will be analyzed using the same statistical method 
described for CLUE Overall Comfort
Secondary safety analysis:
Not Applicable
14.7. Other Exploratory Analyses 
Not applicable. 
14.8. Interim Analysis
There will not be an interim analysis performed on this study. 
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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 may be considered by automatically sampling 
all missing values and incorporating them in the Markov chain for the parameters using the PROC 
MCMC procedure.
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 JJVCI database manager and sent to JJVCI 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 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
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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, JJVCI must be contacted and 
notified in writing within 24 hours.
16.2. Confidentiality of Information
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVCI.  The 
Investigator may use this information for the purposes of the study only. It is understood by the 
Investigator that JJVCI 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.
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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 JJVCI 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 JJVCI and for inspection by local and 
regulatory authorities.
17. MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained
x
Ensuring the rights and wellbeing of subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and qualified 
clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
x
Reviewing of study records and source documentation verification in accordance with the 
monitoring plan
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 
Page 59 of 128

ethical and scientific quality standard for designing, conducting, recording, and reporting studies 
that involve the participation of human subjects. Compliance with this standard provides public 
assurance that the rights, safety, and well-being of study subjects are protected, consistent with the 
principles of the Declaration of Helsinki 64th WMA General Assembly 20133 and that the clinical 
study data are credible.  The Investigator must maintain clinical study files in accordance with 
Section 8 of the ICH E6 guidelines on Good Clinical Practice (GCP),2 and applicable regulatory 
requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol and, if applicable, amendments
x
Sponsor-approved informed consent form (and any other written materials to be provided 
to the subjects)
x
Investigator’s Brochure (or equivalent information) and amendments
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval letter 
must be dated and must clearly identify the documents being approved.
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
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x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request should 
be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about 
the study completion.  Documentation of this notification must be retained at the clinical site and 
a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent
Each subject must give written consent according to local requirements after the nature of the study 
has been fully explained. The consent form must be signed before performance of any study-
related activity. The consent form that is used must be approved by both the Sponsor and by the 
reviewing IEC/IRB. The informed consent is in accordance with principles that originated in the 
Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable regulatory 
requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site personnel 
must explain to potential subject the aims, methods, reasonably anticipated benefits, and potential 
hazards of the study, and any discomfort it may entail. Subjects will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. 
The subject will be given sufficient time to read the informed consent form and the opportunity to 
ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the
consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data
The collection, processing and disclosure of personal data and medical information related to the 
Study Subject, and personal data related to Principal Investigator and any clinical site personnel 
(e.g., name, clinic address and phone number, curriculum vitae) is subject to compliance with the 
Health Information Portability and Accountability Act (HIPAA) in the United States11 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, 
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monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party without 
the express permission of the subject concerned, with the exception of Sponsor personnel (monitor, 
auditor), IEC/IRB and regulatory organizations in the context of their investigation related 
activities that, as part of the investigation will have access to the CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be limited 
to those data that are necessary to investigate the efficacy, safety, quality, and utility of the 
investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a way 
incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating subject 
before collection of data. Such consent should also address the transfer of the data to other entities 
and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps should 
be taken to respond to such a request, taking into consideration the nature of the request, the 
conditions of the study, and the applicable laws and regulations.
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 
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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 JJVCI.
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 JJVCI
management representative prior to study initiation.
JJVCI 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
JJVCI reserves the right to withhold final remuneration until all study related activities have been 
completed, such as:
x
Query resolution
x
Case Report Form signature
x
Completion of any follow-up action items 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor.
22. REFERENCES
1.
ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good
clinical practice.
2.
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP): 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
3.
Declaration of Helsinki – Ethical principles for Medical Research Involving Human 
Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html.
4.
United States (US) Code of Federal Regulations (CFR). In 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR (Ed.).
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5.
Buch, J. 
Design Validation of senofilcon A with New UV-blocking Additive. 2018
6.
Buch, J. 
).Clinical Evaluation of Test 
Lenses Manufactured with Different Curing Methods.2017
7.
Buch, J.
 Evaluation of Approved 
and Investigational Contact Lenses. 2018
8.
Buch, J.
 Contact Lenses with New 
UV-blocker Manufactured with Different Techniques. August 01, 2018 
9.
Buch, J. 
Diagnostic Contact Lens 
Fitting with new UV-blocker Prototype: Study 1.April 24 2018 
10.
Buch, J. 
).Diagnostic Contact Lens 
Fitting with new UV-blocker Prototype: Study 2.May 08 2018 
11.
Health Information Portability and Accountability Act (HIPAA). In 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html (Ed.).
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
Page 66 of 128

PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
Page 70 of 128

PRO SPECIFICATION Version 1 Final  2018-08-31
Protocol 6305                 Johnson & Johnson Vision Care, Inc.                  Confidential
6
Page 71 of 128

APPENDIX B: PATIENT INSTRUCTION GUIDE 
A Patient Instruction Guide will be provided separately.
Page 72 of 128

APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
ACUVUE OASYS®
Page 73 of 128

APPENDIX D: 
x
Lens Fitting Characteristics
x
Subject Reported Ocular Symptoms/Problems
x
 Front and Back Surface Lens Deposit Grading Procedure
x
Determination of Distance Spherocylindrical Refractions
x
Biomicroscopy Scale
x
 Keratometry Procedure
x
Distance and Near Visual Acuity Evaluation
x
 Distance LogMAR Visual Acuity Measurement Procedure
x
 Patient Reported Outcomes
x
 White Light Lens Surface Wettability
x
 Visual Acuity Chart Luminance and Room Illumination Testing
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 LENS FITTING CHARACTERISTICS
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

Page 4 of 6 
 
 
 
 
 
 
 
CR-6305, v4.0 Amendment 3.0
 
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JJVCI CONFIDENTIAL

Page 5 of 6 
 CR-6305, v4.0 Amendment 3.0
 
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JJVCI CONFIDENTIAL

Page 6 of 6 
 
 
 
 
 
 
 
CR-6305, v4.0 Amendment 3.0
 
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JJVCI CONFIDENTIAL

 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

Page 4 of 5 
 CR-6305, v4.0 Amendment 3.0
 
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JJVCI CONFIDENTIAL

Page 5 of 5 
 CR-6305, v4.0 Amendment 3.0
 
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JJVCI CONFIDENTIAL

 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL
REFRACTIONS
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 BIOMICROSCOPY SCALE
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 KERATOMETRY PROCEDURE
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

 PATIENT REPORTED OUTCOMES
CR-6305, v4.0 Amendment 3.0
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JJVCI CONFIDENTIAL

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Patient Reported Outcomes 
  
CR-6305, v4.0 Amendment 3.0
 
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 WHITE LIGHT LENS SURFACE WETTABILITY
CR-6305, v4.0 Amendment 3.0
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION
TESTING
CR-6305, v4.0 Amendment 3.0
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CR-6305, v4.0 Amendment 3.0
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6305: Design Validation of senofilcon A with New UV-blocking
Additive
Version and Date: 4.0, Amendment 3.0 14 November 2018
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration 
of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual 
country laws/regulations and to comply with its obligations, subject to ethical and safety 
considerations. The Principal Investigator is responsible for ensuring that all clinical site 
personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP guidelines 
regarding clinical trials during and after study completion.
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board (IRB), 
except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to 
all ICH2regulations 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
CR-6305, v4.0 Amendment 3.0
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