Clinical Evaluation of Etafilcon A With Ketotifen
Phase: PHASE2
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Clinical Evaluation of etafilcon A with Ketotifen
Protocol CR-5930
Version: v3.0, Amendment 2.0
Date: 31 October 2017
Investigational Products: etafilcon A with 0.019 mg ketotifen (K-Lens)
Key Words: etafilcon A, etafilcon A with ketotifen, 1-DAY ACUVUE® Brand Contact Lenses, 
Daily Disposable, Dispensing, logMAR visual acuity, K-Lens, Placebo, Wearing Time, 
CLUE™ Handling, daily wear.
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc.  Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study... ................................................................................................................................ 18 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives................................................................................................................. 18 
2.2. 
Endpoints.................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria...................................................................................................... 19 
3.3. 
Exclusion Criteria..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration.................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 22 
5.1. 
Test Article Allocation............................................................................................. 22 
5.2. 
Masking.................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking Randomization Codes........................... 23 
6. 
STUDY INTERVENTION............................................................................................. 23 
6.1. 
Identity of Test Articles............................................................................................ 23 
6.2. 
Ancillary Supplies/Products..................................................................................... 24 
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6.3. 
Administration of Test Articles................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Collection and Storage of Samples .......................................................................... 24 
6.6. 
Accountability of Test Articles ................................................................................ 24 
7. 
STUDY EVALUATIONS.............................................................................................. 25 
7.1. 
Time and Event Schedule......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 26 
VISIT 1 ........................................................................................................................... 26 
VISIT 2 ........................................................................................................................... 31 
FINAL EVALUATION.................................................................................................. 32 
7.3. 
Unscheduled Visits................................................................................................... 32 
7.4. 
Laboratory Procedures ............................................................................................. 34 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 34 
8.1. 
Completion Criteria.................................................................................................. 34 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 34 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 35 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 35 
11. 
STUDY TERMINATION ........................................................................................... 35 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 36 
13. 
ADVERSE EVENTS................................................................................................... 37 
13.1. 
Definitions and Classifications............................................................................. 37 
13.2. 
Assessing Adverse Events.................................................................................... 39 
13.2.1 Causality Assessment........................................................................................ 39 
13.2.2 Severity Assessment ......................................................................................... 40 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 40 
13.4. 
Reporting Adverse Events.................................................................................... 41 
13.4.1 Reporting Adverse Events to Sponsor.............................................................. 42 
13.4.2 Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
…………………………………………………………………………………42 
13.4.3 Event of Special Interest................................................................................... 43 
13.5. 
Reporting of Pregnancy........................................................................................ 43 
14. 
STATISTICAL METHODS........................................................................................ 43 
14.1. 
General Considerations......................................................................................... 43 
14.2. 
Sample Size Justification...................................................................................... 43 
14.3. 
Analysis Populations ............................................................................................ 45 
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14.4. 
Level of Statistical Significance........................................................................... 45 
14.5. 
Primary Analysis .................................................................................................. 45 
14.6. 
Secondary Analysis .............................................................................................. 46 
14.7. 
Other Exploratory Analyses ................................................................................. 46 
14.8. 
Interim Analysis ................................................................................................... 46 
14.9. 
Procedure for Handling Missing Data and Drop-Outs......................................... 46 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 46 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 47 
15.1. 
Electronic Case Report Form/Data Collection..................................................... 47 
15.2. 
Subject Record...................................................................................................... 47 
16. 
DATA MANAGEMENT............................................................................................. 48 
16.1. 
Access to Source Data/Document ........................................................................ 48 
16.2. 
Confidentiality of Information.............................................................................. 48 
16.3. 
Data Quality Assurance........................................................................................ 48 
17. 
MONITORING............................................................................................................ 48 
18. 
ETHICAL AND REGULATORY ASPECTS............................................................. 49 
18.1. 
Study-Specific Design Considerations................................................................. 49 
18.2. 
Investigator Responsibility................................................................................... 49 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 49 
18.4. 
Informed Consent ................................................................................................. 51 
18.5. 
Privacy of Personal Data ...................................................................................... 52 
19. 
STUDY RECORD RETENTION................................................................................ 53 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 53 
21. 
PUBLICATION........................................................................................................... 54 
22. 
REFERENCES ............................................................................................................ 55 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 57 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 61 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 62 
APPENDIX D: CLINICAL TECHNICAL PROCEDURES 
...................................... 65 
 LENS FITTING CHARACTERISTICS.............................................................. 66 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS......................... 73 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 75 
 BIOMICROSCOPY SCALE ............................................................................... 82 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION.......................... 88 
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 93 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .......................... 97 
LISTING OF TABLES 
Table 1: Target number of subjects by arm and site............................................................... 21 
Table 2: Test Articles.............................................................................................................. 23 
Table 3: Time and Events ....................................................................................................... 25 
Table 4: Sample size for different scenarios of mean  ο and ߪ.............................................. 45 
LISTING OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 13 
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PROTOCOL TITLE, NUMBER, VERSION  
Title: Clinical Evaluation of etafilcon A with Ketotifen
Protocol Number: CR-5930
Version: 3.0, Amendment 2.0
Date: 31 October 2017
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name: Kristy Canavan, OD, FAAO
Title: Principal Research Optometrist
Address: 7500 Centurion Parkway, Jacksonville, FL 32256
Email: KCANAVA2@its.jnj.com
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone
within 24 hours of learning of a Serious Adverse Event.
The Medical Monitor may be 
contacted during business hours for adverse event questions.  General study related questions 
should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ICH guidelines,2 ISO 14155,1
and the Declaration of Helsinki.3
Author
See Electronic Signature Report
Brian Pall
Senior Principal Research Optometrist
Date
Clinical Operations 
Manager
See Electronic Signature Report
Date
Biostatistician
See Electronic Signature Report
Date
Data Management 
See Electronic Signature Report
Date
Reviewer
See Electronic Signature Report
Date
Approver
See Electronic Signature Report
Date
 
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SYNOPSIS  
Protocol Title
Clinical Evaluation of etafilcon A with ketotifen
Sponsor
Johnson & Johnson Vision Care, Inc., 7500 Centurion 
Parkway, Jacksonville, FL  32256
Clinical Phase
Developmental phase: Phase 2
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products:
K-Lens: etafilcon A with 0.019 mg ketotifen
Placebo: 1·Day ACUVUE® Brand Contact Lens
Wear and Replacement 
Schedules
Wear Schedule: Daily Disposable
Replacement Schedule: Daily
Objectives 
The purpose of this study is to evaluate the clinical
performance of K-Lens produced on the new J&J Vision Care,
Inc. manufacturing line in Limerick, Ireland.
Study Endpoints
The primary endpoint is monocular contact lens best-
corrected distance visual acuity on logMAR scale. This will 
be evaluated under high luminance and high contrast 
conditions at 4 meters from ETDRS charts at 1-Week
Follow-up Visit.
The secondary endpoints are:
x
Proportion of eyes with significant (Grade 3 or 4) slit 
lamp findings
x
Proportion of eyes with unacceptable lens fitting
Adverse events, subject reported ocular symptoms, 
subjective assessment of lens handling, number and reasons 
for discontinuation, number and reasons for unscheduled lens 
replacement including lens damage will be monitored and
summarized.
Study Design
This is a randomized, double-masked, bilateral, controlled, 
two-arm parallel group, multi-site, 1-Week dispensing study.
Subjects are scheduled for 2 study visits:
x
Visit 1: Initial screening, baseline evaluation, lens 
assignment, lens dispensing and clinical assessments
x
Visit 2: Follow-up visit 6 to 9 days after the initial 
visit with clinical assessments and exit procedures.
See the flowchart at the end of the synopsis for the schematic 
of the study visits and procedures of main observations.
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Sample Size
This study will target to enroll approximately 132 subjects
with a target completion of 80 subjects in the K-Lens arm
and 40 in the Placebo arm.
Study Duration
The study duration will be approximately 8 weeks
Anticipated Study 
Population
The study populations will be healthy normal habitual 
contact lens wearers that are at least 18 years old and less 
than 40 years.
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol
3. Between 18 and 39 (inclusive) years of age at the time 
of baseline visit
4. The subject must be a habitual lens wearer for a least 
6 days/week and for a minimum of 8 hours per day 
over the last month.
5. The subject’s contact lens correction must be in the 
range of -1.00 D to -6.00 D (inclusive) in each eye.
6. The subject’s refractive cylinder must be 1.00 D or 
less in each eye 
7. Have a spherocylindrical best corrected visual acuity 
of 20/30 or better in each eye (Snellen Visual Acuity)
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
1. Currently pregnant or lactating
2. Any systemic disease (e.g., Sjögren’s Syndrome), 
allergies, 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis), contagious immunosuppressive diseases 
(e.g., HIV), autoimmune disease (e.g. rheumatoid 
arthritis), or other diseases, by self-report, which are 
known to interfere with contact lens wear and/or 
participation in the study
3. Use of systemic medications (e.g., chronic steroid use) 
that are known to interfere with contact lens wear 
4. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study. This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal 
distortion 
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5. Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear, history of 
strabismus, or current monovision, multi-focal, or 
toric contact lens correction.
6. Any current use of rewetting drops or ocular 
medication
7. Any previous, or planned (during the course of the 
study) ocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.)
8. Any grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the FDA 
Biomicroscopy Scale
9. Any previous history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer 
or round peripheral scar), or any other ocular 
abnormality that would contraindicate contact lens 
wear
10. Any known hypersensitivity or allergic reaction to 
ketotifen
11. Participation in any eye drop, contact lens or lens care 
product clinical trial within 14 days prior to study 
enrollment
12. Employee
or immediate family member of an 
employee
of 
clinical 
site 
(e.g., 
Investigator, 
Coordinator, Technician)
Disallowed 
Medications/Interventions
No ocular medications (Rx or OTC) or any systemic 
medications that (e.g., chronic steroid use) are known to 
interfere with contact lens wear
Measurements and
Procedures
Monocular contact lens best-corrected distance visual acuity
(measured via logMAR visual acuity charts)
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product.  In the event of a 
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled.
Ancillary Supplies/ Study-
Specific Materials
None
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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 
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
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
CT
Center Thickness
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
logMAR
Logarithm of Minimal Angle of Resolution
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OS
Left Eye
OTC
Over the Counter
OU
Both Eyes
PD
Protocol Deviation
PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
Rx
Prescription
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
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SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND 
The etafilcon A with ketotifen contact lens is being developed as a novel drug/device 
combination product that incorporates the anti-allergy agent ketotifen with the same material 
as the 1•DAY ACUVUE® Brand disposable contact lens (etafilcon A daily disposable contact
lens). This new product will be referred to hereafter as K-Lens. The control 1•DAY ACUVUE®
Brand disposable contact lens will be referred to hereafter as Placebo. Ocular allergy, and the
discomfort associated with its signs and symptoms, is a common cause of contact lens
intolerance and of seasonal exacerbation of eye allergy symptoms in contact lens wearers.5,6
The creation of a concomitant system of an anti-allergy agent and a contact lens will offer
significant advantages over existing therapies in that it allows contact lens users to continue
wearing their lenses during the allergy season while preventing ocular itching associated with
allergic conjunctivitis.
Ketotifen fumarate, a benzocycloheptathiophene derivative, is an approved noncompetitive H1
receptor antagonist that stabilizes mast cells and prevents eosinophil accumulation, thus 
providing multiaction therapy. Ketotifen fumarate ophthalmic solution is an effective, safe, 
and well-tolerated therapy for the management of ocular allergy with a duration of action of 
up to 12 hours as demonstrated in the conjunctival allergen challenge mode.7, 8
K-Lens has been evaluated for safety, tolerability, and efficacy (prevention of ocular itching)
in previous studies.9-20 The results of these studies have shown it to be safe, tolerable and
efficacious. Two (2) pivotal Phase 3 studies have shown that K-Lens was effective in the
prevention of ocular itching associated with allergic conjunctivitis at 15 minutes and 12 hours 
following lens insertion.16, 17 The goal of this study is to evaluate the clinical performance of 
K-Lens produced on the new J&J Vision Care, Inc. manufacturing line in Limerick, Ireland,
in a population of normal, healthy, habitual contact lens wearers.  
1.1.
Name and Descriptions of Investigational Products  
The K-Lens is a combination product consisting of an etafilcon A soft hydrophilic contact 
lens with 0.019 mg ketotifen.  Additional information pertaining to the device and drug 
components is listed below:
Device component – The device component is an etafilcon A soft contact lens equivalent to 
1-DAY ACUVUE® Brand Contact Lenses.  This product is currently cleared by Food & 
Drug Administration (FDA) under 510(k) K013973. The predicate device in this 510(k) was 
ACUVUE® (etafilcon A) Brand Contact Lenses, approved by FDA under PMA N18-033.
The etafilcon A soft hydrophilic contact lenses have an extensive history on the United States 
(US) market and are indicated for the correction of refractive ametropia (myopia and 
hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less 
of astigmatism.  Lenses are to be worn as a daily wear contact lens (periods of less than 
24 hours while awake) and disposed of after removal.
Drug component – The drug component, ketotifen, is the active ingredient in the currently 
marketed eye drop, ZADITOR®
(ketotifen fumarate ophthalmic solution, 0.035%) 
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manufactured by Alcon Pharmaceuticals. ZADITOR® was originally approved under NDA 
21-0166 in 1999 as a prescription drug for the prevention of ocular itching associated with 
allergic conjunctivitis (selective H1 antihistamine/mast cell stabilizer) and switched to over-
the-counter in 2006 (NDA 21-066/S011).  The drug component may use the Reference Listed 
Drug under NDA 021066 (ZADITOR® [ketotifen fumarate ophthalmic solution, 0.035%]).
1.2.
Intended Use of Investigational Products 
The proposed intended use of K-Lens, a daily disposable contact lens, is to provide vision 
correction while preventing ocular itching associated with allergic conjunctivitis. The 
prevention of itch has been demonstrated to last through 12 hours in clinical studies; however, 
the contact lens may be worn for longer than 12 hours for vision correction.
The intended users are phakic or aphakic patients who are suitable for contact lens wear and 
experience ocular allergic itch due to allergic conjunctivitis and who do not have red eye(s) or 
more than 1.00 D of astigmatism. 
1.3.
Summary of Findings from Nonclinical Studies 
K-Lens was shown to be biocompatible and tolerable on eye. Specifically, K-Lens extracts 
were shown to be non-cytotoxic, non-ocular irritating and non-sensitizing. The extracts of K 
Lens in a packing solution were not mutagenic. K-Lens placed on rabbit eyes has been shown 
to be non-irritating and non-toxic to the eye, and without systemic toxicity following a 
minimum seven hours of daily lens wear for up to 6 months.21
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.
For the most comprehensive nonclinical information regarding K-Lens, refer to the latest 
version of the Investigator’s Brochure.21
1.4.
Summary of Known Risks and Benefits to Human Subjects 
K-Lens has been evaluated for safety, tolerability, and efficacy (prevention of ocular itching) 
in previous studies.9-20
The results from the Phase 3 safety trials for K-Lens have shown that the risks to wearing 
K-Lens are not substantially increased as compared to other non-medicated contact lenses 
worn in a daily disposable modality or the use of ketotifen fumarate ophthalmic drops. The 
ocular adverse events with the highest reported incidence from the Phase 3 safety trials were
instillation site irritation (3.7%), dry eye (0.9%), eye irritation (0.8%). All non-ocular adverse 
events from the two Phase 3 safety trials were assessed by the Investigators as not related to 
study medication.
The benefits of K-Lens include the correction of refractive error and the prevention of itch 
associated with allergic conjunctivitis.
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For the most comprehensive clinical information regarding K-Lens refer to the latest version 
of the Investigator’s Brochure.21
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
K-Lens is an investigational drug/device combination product and the clinical results have yet 
to be published. Additionally, there are no known publications reporting clinical data with a 
contact lens containing an anti-allergy medication.
K-Lens has been evaluated in previous studies.9-20 for safety, tolerability, and efficacy 
(prevention of ocular itching). Additionally, in the previous K-Lens studies, visual acuity was 
assessed using Snellen visual acuity charts which are commonly used in clinical practice. The 
proposed clinical study will assess visual acuity using logMAR (ETDRS) charts which are
more commonly used in clinical research studies. By collecting data from both types of visual 
acuity charts, a more comprehensive assessment of visual acuity with K-Lens will be obtained.
For additional clinical information regarding K-Lens, refer to the latest version of the
Investigator’s Brochure.21
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
The purpose of this study is to evaluate the clinical performance of K-Lens produced on the 
new J&J Vision Care, Inc. manufacturing line in Limerick, Ireland. 
2.2.
Endpoints  
Primary Endpoint
The primary endpoint is monocular contact lens-corrected distance visual acuity using a
logMAR visual acuity scale. This will be evaluated under high luminance and high contrast 
conditions at 4 meters from ETDRS charts at the 1-week follow-up visit.
Secondary Endpoint(s) 
x
Proportion of eyes with clinically significant (Grade 3 or 4) slit lamp findings.
x
Proportion of eyes with unacceptable lens fitting.
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 1-Week Follow-
up evaluation.
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Subjective assessment of lens handling:
Lens handling will be assessed using Contact Lens User ExperienceTM (CLUE) questionnaire 
at 1-Week Follow-up evaluation. CLUE™ is a validated patient reported outcomes (PRO) 
questionnaire to assess patient-experience attributes of soft 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.22  
 
Slit-lamp findings:
Frequency and severity by eye of slit lamp findings (SLFs) including conjunctival injection, 
corneal edema, corneal neovascularization, corneal staining, tarsal abnormalities or any other 
complications. SLFs will be evaluated at fitting and post-fitting evaluation visits including 
unscheduled visits.
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.
Lens fitting characteristics:
Frequency by eye of mechanical lens fitting characteristics including lens centration and lens
movement and overall lens fitting acceptability at fitting and 1-Week Follow-up evaluations.
Adverse events, number and reasons for discontinuation, number and reasons for unscheduled
lens replacement including lens damage will be monitored and descriptively evaluated.
2.3.
Hypotheses 
Primary Hypotheses
The K-Lens will be non-inferior to the Placebo lens with respect to monocular distance 
contact lens-corrected visual acuity. A non-inferiority margin of 0.1 logMAR (one line) units 
will be used.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
The study populations will be healthy normal habitual contact lens wearers that are at least 18 
years old and less than 40 years old.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form
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2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
3. Between 18 and 39 (inclusive) years of age at the time of baseline visit
4. The subject must be a habitual lens wearer for a least 6 days/week and for a minimum 
of 8 hours per day over the last month.
5. The subject’s contact lens correction must be in the range of -1.00 D to -6.00 D
(inclusive) in each eye.
6. The subject’s refractive cylinder must be 1.00 D or less in each eye
7. Have a spherocylindrical best corrected visual acuity of 20/30 or better in each eye
(Snellen Visual Acuity)
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
1. Currently pregnant or lactating
2. Any systemic disease (e.g., Sjögren’s Syndrome), allergies, infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which 
are known to interfere with contact lens wear and/or participation in the study
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with 
contact lens wear 
4. Any ocular allergies, infections or other ocular abnormalities that are known to interfere 
with contact lens wear and/or participation in the study. This may include, but not be 
limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, or corneal distortion 
5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens 
wear, history of strabismus, or current monovision, multi-focal, or toric contact lens 
correction.
6. Any current use of rewetting drops or ocular medication
7. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK, etc.)
8. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival injection) on the
FDA 
Biomicroscopy Scale
9. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., 
past peripheral ulcer or round peripheral scar), or any other ocular abnormality that 
would contraindicate contact lens wear
10. Any known hypersensitivity or allergic reaction to ketotifen
11. Participation in any eye drop, contact lens or lens care product clinical trial within 14
days prior to study enrollment
12. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician)
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3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This is a randomized, double masked, bilateral, controlled, two-arm parallel group, multi-site,
1-week dispensing study. Approximately 132 subjects will be screened and randomly assigned 
to either K-Lens or Placebo using 2:1 ratio (i.e. 2/3 of subjects on the K-Lens arm and 1/3 on 
the Placebo arm). The goal is for a sample size of 120 (80 subjects in K-lens and 40 subjects 
in Placebo) after subjects who withdraw or are lost-to-follow-up.
The study begins with an Initial Visit (Visit 1). If a subject is found to meet all eligibility 
criteria (see Section 34.), they will be randomized and fit with either the K-Lens or Placebo
lens in both eyes based on the randomization scheme provided to the investigators;
otherwise, the subject will be deemed ineligible for this study. 
Successfully dispensed subjects at the initial visit will be scheduled for a follow-up visit
(Visit 2). The follow-up visit will occur approximately 6 to 9 days after the Initial Visit.
Unscheduled follow-up visits may occur during the study. Subjects will be advised to wear 
the study lenses at least 8 hours a day for a minimum of 6 days.
Both study lenses will be worn as a daily disposable modality. J&J Vision will provide the 
investigational sites with sufficient quantities of study lenses and supplies to complete the 
study.
The Investigator is responsible for ensuring that all subjects entering the study conform to 
subject selection criteria. The number of subjects targeted for randomization and completion 
are as follows:
Table 1: Target number of subjects by arm and site
K-Lens
Placebo
Total
Randomization 
88
44
132
Completion
80
40
120
Number of sites
6
6
6
Subjects/site (Min-Max)
12-16
5-9
20-24
4.2.
Study Design Rationale 
Randomized, double masked, controlled designs are the gold standard to perform scientifically
sound evaluations of the intervention by reducing bias associated with the conduct and 
interpretation of a clinical trial and avoiding confounding from other factors. The unequal 
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assignment using 2:1 K-Lens versus Placebo ratio was considered to gain additional 
information on the K-Lens produced on the new JJVC manufacturing line in Limerick, Ireland.
4.3.
Enrollment Target and Study Duration 
x
This study will target to enroll approximately 132 subjects (88 subjects in K-lens arm 
and 44 in Placebo arm) with a minimum of 120 subjects to complete (80 subjects in K-
lens arm and 40 in Placebo arm).
x
Subjects will be considered enrolled in this trial only after they have reviewed and 
signed the informed consent.
x
The study duration will be approximately 8 weeks and there will be a total of 2 visits
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
Subjects will be randomly assigned to either K-Lens or Placebo arm based on a computer-
generated randomization schedule prepared before the start of the study. The randomization 
will be stratified by investigational site and randomly permuted blocks of 3 assignments will 
be used to achieve 2:1 K-Lens versus Placebo ratio within each study site. 
Randomization must be performed at the initial visit. The following must have occurred prior 
to randomization: 
x
Informed consent has been obtained 
x
It has been determined that the subject meets all the inclusion / exclusion criteria 
x
Subject history and baseline information has been collected 
When the trial fitting assessment is ready to be conducted, the following steps should be 
followed:
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme to obtain the study 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 were opened, whether dispensed or not, must be recorded on the 
Test Article Accountability Log in the “Lenses Dispensed” section. 
5.2.
Masking 
This is a double-masked study where subjects, investigators are masked to the identity of the 
study lenses during the study period. 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 identity of the study lenses.  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 
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6.2.
Ancillary Supplies/Products  
None allowed.
6.3.
Administration of Test Articles 
Test articles will be dispensed to subject meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the Investigator and/or the Sponsor.
6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. The test article will be 
over-labeled to mask the subject/Investigators to the identity of the lens. The test articles will
be in investigational cartons sealed with a tamper evident seal.
Storage Conditions
Test articles will be maintained at controlled room temperature.  Controlled room temperature 
is the temperature maintained thermostatically that encompasses at the usual and customary 
working environment of 20°–25°C (68°–77°F).
Excursions between 15° and 30°C (59° and 86°F) are allowed and transient spikes up to 40°C 
are permitted as long as they do not exceed 24 hours.
Temperatures above 30°C that exceed 24 hours and any temperature spikes above 40°C will 
require a non-conformance investigation.  The investigation will be conducted by the J&J 
Vision, R&D Quality Systems Stability Group.  As part of the investigation conclusions, a 
final disposition of the lots involved with the temperature excursion will be required.  
Test articles should remain in their closed secondary cartons during storage to minimize light 
exposure.
Test articles must be kept under secure conditions.
6.5.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending
directions from the sponsor for potential return back to J&J Vision.
6.6.
Accountability of Test Articles 
J&J Vision Care, Inc. 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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1.16
Lens Power 
Modification (if 
applicable)
Adjust the lens power if the subject’s best 
sphere over-refraction is not plano. 
One power modification is allowed.
If the subject’s best sphere over-refraction is 
not plano, the subject will have to return no
sooner than the following day, since subjects 
are not allowed to wear more than one lens 
per eye per day. When a subject returns for 
another lens, new baseline information must 
be recorded (starting with step 1.7), and then 
proceed per protocol through the remaining 
Visit 1 steps.  
1.17
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended
symptoms questionnaire.
1.18
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and push up test.
Note: if lens fit is unacceptable subject will 
be discontinued from the study.
1.19
Distance ETDRS 
LogMAR Visual 
Acuity
Perform monocular distance ETDRS 
LogMAR visual acuity test at a 4-meter 
distance over the test eye only under the 
following condition:
x
bright illumination (e.g., >400 lux),
high luminance, with high contrast 
charts (HLHC); 
The Precision Vision 4-meter high contrast 
ETDRS charts (Chart 1 and Chart 2) will be 
used.
One measurement will be recorded per eye.
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1.20
Exit Snellen VA
Record subjects’ distance visual acuity, OD, 
OS and OU to the nearest letter.
1.21
Continuance
For the subject to continue in the study, they 
must meet all three of the following criteria:
x
Visual acuity is 20/30 or better OD 
and OS
x
The lens fit is acceptable OD and OS
x
Investigator approval.  If the 
Investigator does not approve the 
dispensing of the first study lens, then 
the study is terminated for that 
subject.
1.22
Dispense
The lenses will be dispensed for a 6-9 day 
wearing period.  During this time, they will 
be instructed to wear the lenses at least 6 days 
and at least 8 hours per day that they are 
worn.
x
Dispense enough lenses to last the 
subject to their scheduled follow-up
visit.  Do not dispense extras*.
x
The lenses will be worn as daily 
wear/daily disposable only.
x
Rewetting drops are not permitted 
x
A patient instruction booklet will be 
provided.
x
Subjects will be scheduled for their 1-
week follow-up visit, 
* Note: In the event a lens is lost or 
damaged, the subject will return to the 
clinical site for replacement.  As much as 
reasonably possible, a damaged lens and 
packaging should be returned to the clinical 
site (wet, if possible) and then returned to the 
Sponsor.  If lens damage is present, complete 
the Product Quality Complaint Form.  The 
lens will be stored in labeled vial with saline, 
and clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
 
 
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7.4.
Laboratory Procedures  
Not Applicable
8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they:
x
provided informed consent; 
x
they are eligible;
x
have not withdrawn/discontinued from the study for any reason described in Section 
8.2
x
completed all visits through the final visit 2
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject death during the study period
x
Subject withdrawal of consent
x
Subject not compliant to protocol 
x
Subject lost to follow-up 
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant)
x
Subject develops significant or serious adverse events causing discontinuation of study 
lens wear. Greater than 2 consecutive days of missed lens wear will lead to 
discontinuation.
x
Subjects who have experienced a Corneal Infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x
Subject missed any study visits
x
Subject not compliant with study lens wear schedule
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled)
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2.
x
Collect all unused test article(s) from the subject
An additional subject will not be enrolled if a subject discontinues from the study prematurely.
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In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.
The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications or any concomitant therapies that are disallowed for this study 
include: Any ocular medications or any systemic medications that (e.g., chronic steroid use) 
that are known to interfere with contact lens wear.
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. 
Any protocol deviation that could impact the primary endpoints will result in the subject being 
excluded from the Per-Protocol analysis population.
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.   
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JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”.
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether or not 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.)
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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 (Refer to Form Control No. VCT-0152 
for test article return instructions)
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device. 
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved.
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study 
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect, or
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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)
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:
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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)
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, study treatment, or study procedure. The test article, study treatment or study 
procedure relationship for each adverse event shall be determined by the Investigator using 
these explanations:
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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.
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.  
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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 or not a subject reporting with an adverse event will continue in the 
study.  If a subject is discontinued from the study, it will be the responsibility of the Investigator 
to record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
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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 or not 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.
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 
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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 course of 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. For more details, refer to the stand-alone Statistical Analysis Plan (SAP).
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.
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.
14.2. Sample Size Justification 
The study is designed to evaluate the clinical performance of K-Lens produced on the new 
JJVC manufacturing line in Limerick, Ireland with the primary objective to show that the K-
Lens is non-inferior to the Placebo lens with respect to best-corrected distance visual acuity.
The plan is to enroll 132 eligible subjects with a target completion of 120 subjects (80 subjects 
in K-Lens and 40 subjects in Placebo). 
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The sample size of 120 subjects is considered sufficiently large to test for non-inferiority with 
a minimum statistical power of 85% and two-sided type I error of 0.05. Assuming a perfect 
correlation between left eye visual acuity and the right eye visual acuity (worst case scenario),
the total sample size (n) required to achieve 85% power with two-sided type I error of 0.05 
was calculated for different scenarios of mean difference (ο = K-Lens – Placebo) and common 
standard deviation (ߪ)  in the two arms. The results are summarized in the Table below:
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Table 4: Sample size for different scenarios of mean  ο and ߪ
ο
ߪ
n
0
0.05
15
0
0.01
45
0.04
0.05
33
0.04
0.1
117
The sample size calculation was conducted using the PROC POWER Procedure (SAS/STAT 
14.1, SAS Institute, 2015) for two-sample means with allocation weight of 2:1. 
Justification of Non-inferiority margin:
The non-inferiority margin of one line loss on best-corrected distance visual acuity was
considered based on the work done by Jane E. Lovie-Kitchin and Brian Brown on evaluating 
the repeatability and intercorrelations of five standard vision tests in subjects with normal 
vision.  The authors concluded that one line change is, on average, a useful criterion to adopt 
on clinical decision making23.
14.3. Analysis Populations 
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. 
Justification of excluding subjects with protocol deviations in the per-protocol population set 
will be documented in a memo to file.
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.
The primary analyses will be performed on per-protocol population. Additional sensitivity
analyses may be conducted on the safety population.
14.4. Level of Statistical Significance 
All planned analysis will be conducted with an overall type I error rate of 5%. Unless otherwise 
specified, all statistical tests will be 2-sided.
14.5. Primary Analysis  
Contact lens monocular distance best-corrected visual acuity on logMAR scale will be 
analyzed using a linear mixed effects model to test for non-inferiority of K-Lens relative to 
Placebo. Lens group will be included as fixed effects in the model; and investigator site as 
random effect. The covariance matrix between the left eye visual acuity and right eye visual 
acuity will be selected based on the finite-sample Corrected Akaike’s Information Criterion.24
Covariance structures considered include Compound Symmetry (CS) and Unstructured (UN).
The covariance structure that returns the lowest AICC will be selected as the structure that best 
fit the data. Heterogeneous covariance structures across study lens groups will be considered 
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when appropriate. The log-likelihood ratio test will be used to test for the homogeneity between 
the residual covariance structures. The Kenward and Roger method will be used to calculate 
the denominator degree of freedom.25
The null and alternative hypotheses for non-inferiority of K-Lens relative to Placebo are as 
follows:
ܪ଴ǣ ο൒ͲǤͳ
ܪ஺ǣ ο൏ͲǤͳ,
where ο is the mean difference in visual acuity between K-Lens and Placebo (K-Lens minus 
Placebo). The non-inferiority test will be based on the least-square mean difference (K-Lens
minus Placebo) and corresponding 95% confidence interval calculated using the final selected 
model. The upper bound of the 95% confidence interval will be compared to the non-inferiority 
margin of 0.1 LogMAR. If the upper bound is less than 0.1, K-Lens will be considered non-
inferior to Placebo with respect to visual Acuity.
14.6. Secondary Analysis 
Secondary endpoints will be summarized descriptively using all available data including data 
from unscheduled visits. 
14.7. Other Exploratory Analyses  
No exploratory analysis is planned for this study. Further analysis may be conducted at the 
discretion of the study responsible clinician at the end of the study.
14.8. Interim Analysis 
There will not be an interim analysis performed for this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed as the number of missing values is expected to 
be low. 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, a sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than 15%.
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.
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15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the 
Bioclinica system. An authorized data originator will enter study data into the eCRFs using the 
Bioclinica system. Data collected on equipment that is not captured in Bioclinica will be 
formatted to the specification of the JJVC database manager and sent to JJVC 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.
15.2. Subject Record 
At a minimum, subject record should be available for the following:
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record.
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Adverse event notes must be reviewed and initialed by the Investigator.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
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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), and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 2013 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), 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
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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
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.
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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.
If involving vulnerable population, provide description of specific informed consent process. 
Below is an example for study involving children as subjects:
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has been 
fully explained. The assent and consent forms must be signed before performance of any study-
related activity. The assent and consent forms that are used must be approved by both the 
Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms should be in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH2 and
GCP guidelines, applicable regulatory requirements, and Sponsor policy.  Before entry into the 
study or pre-screening, the Investigator or an authorized member of the clinical site personnel 
must explain to the potential subject and parent and/or legal guardian the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study or pre-screening, and any 
discomfort it may entail. Subjects and parent and/or legal guardian will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. They 
will be informed that choosing not to participate will not affect the care the subject will receive.  
Finally, they will be told that the Investigator will maintain a subject identification register for 
the purposes of long-term follow-up if needed and that their records may be accessed by health 
authorities and authorized Sponsor personnel without violating the confidentiality of the 
subject, to the extent permitted by the applicable law(s) or regulations. By signing the assent 
and informed consent form, the subject is authorizing such access and agrees to be contacted 
after study completion by health authorities and authorized Sponsor personnel for the purpose 
of obtaining consent for additional safety evaluations if needed.
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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 States26 and other applicable personal data protection and security laws and 
regulations27.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
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.
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19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a JJVC
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations
such as:
x
Continuing an ineligible subject in the study
x
Scheduling a study visit outside the subject’s acceptable visit range
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution
x
Case Report Form signature
x
Completion of any follow-up action items
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21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor.
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22. Wirth, R.J., et al., Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci, 2016. 93(8): p. 801-8.
23. Lovie-Kitchin, J.E. and B. Brown, Repeatability and intercorrelations of standard 
vision tests as a function of age. Optom Vis Sci, 2000. 77(8): p. 412-20.
24. Keselman, H., et al., A comparison of two approaches for selecting covariance 
structures in the analysis of repeated measurement. Communications in Statistics, 
1998. Simulation & Computation(27): p. 591-604.
25. Kenward, M.G. and J.H. Roger, Small Sample Inference for Fixed Effects from 
Restricted Maximum Likelihood. Biometrics 1997. 53(3): p. 983-997.
26. Health Information Portability and Accountability Act (HIPAA). 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html 
27. Data Protection Act. http://www.legislation.gov.uk/ukpga/1998/29/contents  
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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PRO SPECIFICATION Version 1 Final  2017-07-17
Protocol 5930                 Johnson & Johnson Vision Care, Inc.                  Confidential
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PRO SPECIFICATION Version 1 Final  2017-07-17
Protocol 5930                 Johnson & Johnson Vision Care, Inc.                  Confidential
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PRO SPECIFICATION Version 1 Final  2017-07-17
Protocol 5930                 Johnson & Johnson Vision Care, Inc.                  Confidential
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
Patient Instruction Guide will be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1·DAY ACUVUE®
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APPENDIX D: CLINICAL TECHNICAL PROCEDURES
 
 
 Lens Fitting Characteristics
 Subject Reported Ocular Symptoms/Problems
 Determination of Distance Spherocylindrical Refractions
 Biomicroscopy Scale
 Distance and Near Visual Acuity Evaluation
 Distance logMAR Visual Acuity Measurement Procedure
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 LENS FITTING CHARACTERISTICS 
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Page 4 of 6 
 
 
 
 
 
 
 
 
 
 
 
 
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Page 5 of 6 
 
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Page 6 of 6 
 
 
 
 
 
 
 
 
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VCT-0007 (6)
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
 
 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
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 BIOMICROSCOPY SCALE 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-5930 Clinical Evaluation of etafilcon A with Ketotifen
Version and Date: v3.0, Amendment 2.0 31 October 2017
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 ICH 2 regulations and GCP guidelines regarding clinical trials during and after study 
completion.
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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Electronic Signature Report
file:///C|/Siemens/tc11/rac/temp/1509719668700-tv_crf_rpt_34464_0_03112017_1034 html[11/3/2017 10:34:58 AM]
Electronic Signature Report
Job Name: VIS-CR-005930/A-R&D Clinical Study
Revision: VIS-CSPR-005767/3-Clinical Protocol
Title: VIS Clinical Study Protocol Approval
Status: Approved
System: Vision Care R&D Knowledge Management
Generated By:  Cook, Kara
Generated On: 2017-11-03 10:34:26
Signoff Details
Function/Role 
Approval Details 
Biostatistician
Approval
Participant
WWID
Decision
Decision Date
Toubouti, Moulay Youssef
373334
Approved
2017-11-03T09:38:08
Function/Role
Approval Details 
Clinician
Approval
Participant
WWID
Decision
Decision Date
Pall, Brian
176727
Approved
2017-11-01T21:52:13
Function/Role
Approval Details 
Clinical Research
Manager
Approval
Participant
WWID
Decision
Decision Date
Anderson, Annette
6558
Approved
2017-11-01T16:26:50
Function/Role
Approval Details 
Other Approval
Participant
WWID
Decision
Decision Date
Paulk, Randall
375676
Approved
2017-11-03T09:47:57
Moody, Kurt
358947
Approved
2017-11-01T15:52:46
Dalton, Joseph
372536
Approved
2017-11-01T16:15:48