Evaluation of On-eye Optical Performances of the RMY-100 Lens
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Evaluation of On-eye Optical Performances of the RMY-100 Lens
Protocol CR-6000
Version: 3.0, Amendment 2.0
Date: 05 June 2018
Investigational Products: 
RMY-100: Daily disposable soft contact lens made in etafilcon A material with an optical 
design for myopia control
Key 
Words:
Myopia 
control, 
Non-dispensing, 
Daily 
disposable, 
Etafilcon
A,
Orthokeratology, Wavefront aberration, Corneal topography, Accommodation, Off-axis 
refraction, Visual acuity
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, the International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP),1 ISO 14155,2 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 ···············15 
1. INTRODUCTION AND BACKGROUND·····················································17 
1.1. Name and Descriptions of Investigational Products······································17 
1.2. Intended Use of Investigational Products ··················································17 
1.3. Summary of Findings from Nonclinical Studies··········································17 
1.4. Summary of Known Risks and Benefits to Human Subjects ···························18 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study··················································································19 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES·······························19 
2.1. Objectives·······················································································19 
2.2. Endpoints ·······················································································19 
2.3. Hypotheses ·····················································································20 
3. TARGETED STUDY POPULATION···························································21 
3.1. General Characteristics ·······································································21 
3.2. Inclusion Criteria ··············································································21 
3.3. Exclusion Criteria ·············································································21 
3.4. Enrollment Strategy ···········································································22 
4. STUDY DESIGN AND RATIONALE··························································23 
4.1. Description of Study Design ·································································23 
4.2. Study Design Rationale·······································································23 
4.3. Enrollment Target and Study Duration·····················································24 
5. TEST ARTICLE ALLOCATION AND MASKING ··········································24 
5.1. Test Article Allocation········································································24 
5.2. Masking·························································································24 
5.3. Procedures for Maintaining and Breaking the Masking ·································24 
6. STUDY INTERVENTION ········································································24 
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6.1. Identity of Test Articles·······································································24 
6.2. Ancillary Supplies/Products ·································································25 
6.3. Administration of Test Articles······························································25 
6.4. Packaging and Labeling ······································································25 
6.5. Storage Conditions ············································································26 
6.6. Collection and Storage of Samples ·························································26 
6.7. Accountability of Test Articles······························································26 
7. STUDY EVALUATIONS ·········································································27 
7.1. Time and Event Schedule ····································································27 
7.2. Detailed Study Procedures ···································································28 
VISIT 1.............................................................................................................................28 
VISIT 2 (Test Group Only)..............................................................................................32 
FINAL EVALUATION ...................................................................................................37 
7.3. Unscheduled Visits············································································37 
7.4. Laboratory Procedures········································································39 
8. SUBJECTS COMPLETION/WITHDRAWAL ················································39 
8.1. Completion Criteria ···········································································39 
8.2. Withdrawal/Discontinuation from the Study ··············································39 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION···············40 
10. DEVIATIONS FROM THE PROTOCOL ······················································40 
11. STUDY TERMINATION ·········································································40 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS···············41 
13. ADVERSE EVENTS···············································································42 
13.1. Definitions and Classifications ······························································42 
13.2. Assessing Adverse Events····································································44 
13.2.1. Causality Assessment...........................................................................................44 
13.2.2. Severity Assessment.............................................................................................45 
13.3. Documentation and Follow-Up of Adverse Events·······································45 
13.4. Reporting Adverse Events····································································46 
13.4.1. Reporting Adverse Events to Sponsor..................................................................47 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities.47 
13.4.3. Event of Special Interest.......................................................................................48 
13.5. Reporting of Pregnancy·······································································48 
14. STATISTICAL METHODS·······································································48 
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14.1. General Considerations ·······································································48 
14.2. Sample Size Justification·····································································48 
14.3. Analysis Populations··········································································48 
14.4. Level of Statistical Significance·····························································49 
14.5. Primary Analysis ··············································································49 
14.6. Secondary Analysis ···········································································49 
14.7. Other Exploratory Analyses··································································50 
14.8. Interim Analysis ···············································································50 
14.9. Procedure for Handling Missing Data and Drop-Outs ···································50 
14.10. Procedure for Reporting Deviations from Statistical Plan ···························50 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING ····························50 
15.1. Electronic Case Report Form/Data Collection ············································50 
15.2. Subject Record ·················································································51 
16. DATA MANAGEMENT ··········································································52 
16.1. Access to Source Data/Document···························································52 
16.2. Confidentiality of Information·······························································52 
16.3. Data Quality Assurance·······································································52 
17. MONITORING······················································································52 
18. ETHICAL AND REGULATORY ASPECTS··················································53 
18.1. Study-Specific Design Considerations ·····················································53 
18.2. Investigator Responsibility···································································53 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)············53 
18.4. Informed Consent··············································································55 
18.5. Privacy of Personal Data ·····································································55 
19. STUDY RECORD RETENTION ································································56 
20. FINANCIAL CONSIDERATIONS······························································57 
21. PUBLICATION ·····················································································57 
22. REFERENCES ······················································································57 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ····60 
APPENDIX B: PARENT/PATIENT INSTRUCTION GUIDE ··································65 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ·······························66 
APPENDIX D: 
····67 
 LENS FITTING CHARACTERISTICS················································68 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
75 
 BIOMICROSCOPY SCALE ·····························································82 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION·····················88 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE·93 
 MEASUREMENT OF COAS WAVEFRONT ABERRATIONS ··················97 
 PATIENT REPORTED OUTCOMES ················································ 105 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING ······························································································· 107 
 TOPOGRAPHY MEASUREMENT USING MEDMONT E300 CORNEAL 
TOPOGRAPHER······················································································ 112 
 USING AN OPEN-FIELD AUTOREFRACTOR (WAM-5500) FOR 
MEASURING ACCOMMODATIVE RESPONSE AND OFF-AXIS REFRACTION ···· 113 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ·················· 123 
LISTING OF TABLES
Table 1: Test Articles.............................................................................................................. 25 
Table 2: Time and Events ....................................................................................................... 27 
LISTING OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 14 
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PROTOCOL TITLE, NUMBER, VERSION  
Title: Evaluation of On-eye Optical Performances of the RMY-100 Lens
Protocol Number: CR- 6000
Version: 3.0, Amendment 2.0
Date: 05 June 2018
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway, 
Jacksonville, FL 32256
MEDICAL MONITOR 
Address: 7500 Centurion Pkwy, W-2A, Jacksonville, FL 32256
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions.  General study related 
questions should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and provides 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations, ICH guidelines,1 ISO 141552
and the Declaration of Helsinki.3
Author
See Electronic Signature Report
DATE
Clinical 
Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Reviewer
Fellow Designated SME Review
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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SYNOPSIS  
Protocol Title
Evaluation of On-eye Optical Performances of the RMY-100 Lens
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 1
Trial Registration
The study will be registered on clinicaltrial.gov based on the following:  
This clinical study aims to understand the fundamental mechanisms of 
optical interventions for myopia control. The results of this study are 
expected to be published in peer-reviewed journals. In addition, this 
study will be conducted in Canada, clinicaltrial.gov registration is 
required by Health Canada.
Test Article(s)
Investigational Products: 
RMY-100: Daily disposable soft contact lens made in etafilcon A 
material with an optical design for myopia control.
Wear and 
Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily disposable 
Subjects will wear the investigational test article during the study visits 
only. No study lenses will be dispensed for subjects to wear outside the 
office.
Objectives 
The primary objective of the study is to evaluate the on-eye optical 
performances of the RMY-100 lens and compare with eyes treated with 
orthokeratology.
The secondary objective of the study is to compare on-eye optical 
performances of the RMY-100 lens with eyes wearing sphero-
cylindrical correction lenses in the spectacle trial frame.
Study Endpoints
Primary endpoint:
x
Wavefront aberrations measured at distance (0.25 D target 
vergence) and near (4 D target vergence)
Secondary endpoint:
x
Off-axis refraction at both temporal and nasal fields of retina 
at ±10°, ±20°, ±30° with targets at 4 meters and ±30° only 
with targets at 25 cm.
Other observations:
x
Corneal and test article on-eye topography
x
On-axis accommodative response with target vergence of 
0.25 D, 1 D, 2 D, 3 D and 4 D
x
Slit lamp findings
x
LogMAR visual acuity under HLHC, LLHC, and HLLC 
conditions
x
Lens fit assessment
x
Subjective vision assessment (CLUE Vision questionnaire)
Study Design
This is a two-arm parallel, non-masked, bilateral, non-dispensing study 
with one Test arm and one concurrent, non-randomized Control arm.
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For subjects enrolled in the Test arm, investigational test articles will 
be bilaterally fitted to the subject’s eyes. Concurrently, a smaller 
sample of subjects who are established orthokeratology lens wearers 
will be enrolled to Control arm. Endpoint measures will be collected 
over one eye only (Test arm: OD only; Control arm: better OK fitted 
eyes). 
For subjects in the Test arm, there will be a total of 2 visits:
Visit 1: Screening, baseline endpoint measures with bare eye/spectacles 
Visit 2: Lens fitting, endpoint measures over the study lenses and final 
evaluation.
For the Control arm, subjects will be recruited through referrals from 
the university optometry clinic and independent Eye Care Professionals 
(ECPs) who will identify potential subjects by reviewing the case 
history of existing orthokeratology treated patients in their practices.
Only 
subjects 
with 
complete 
pre-treatment 
record, 
e.g., 
spherocylindrical refraction and corneal topography will be invited to
participate in the study. 
For subjects in the Control arm, there will be a total of 1 visit:
Visit 1: Screening, baseline and endpoint measures over the selected 
eyes.
See the flow chart at the end of the synopsis table for the schematic of 
the study visits and procedures of main observations (Figure 1).
Sample Size
Approximately 25 subjects will be enrolled in the Test arm of the study 
with a minimum of 20 subjects targeted to complete the study.
Approximately 20 subjects will be enrolled in the Control arm of the 
study with a minimum of 15 subjects targeted to complete the study.
Study Duration
The total duration of the study is estimated to be about 14 weeks, 
including an approximately 10-week enrollment period.
Anticipated Study 
Population
Healthy male and female subjects between 7 and 25 years of age 
(inclusive) (prefer 7-15 if available within timeline) with best sphere 
refraction between -1.00 D to -5.00 D (inclusive) and 1.00 D or less 
astigmatism.
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to be enrolled 
in the study: 
Inclusion Criteria after Screening:
1. Pediatric subjects (<18 years old) must read (or be read to), 
understand, and sign the Statement of Information and Assent and
receive a fully executed copy of the form.
2. Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of 
pediatric subjects must read, understand and sign the Statement of 
Informed Consent and receive a fully executed copy of the form.
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3. Appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
4. Between 7 and 25 years of age (inclusive).
5. Have normal eyes (i.e., no ocular medications or infections of any 
type).
Below inclusion criterion is for subjects to be enrolled to the Control
group only: 
6. Are existing orthokeratology patients whose current treatment has 
been stabilized for at least 1 months and with complete pre-
treatment record, e.g., spherocylindrical refraction and corneal 
topography. Pre-treatment wavefront aberration measures are 
preferred by not required.  
Inclusion Criteria after Baseline (apply to subjects to be enrolled to the 
Test group and to Control group subjects regarding their pre-OK 
treatment):
7. Vertex-corrected distance subjective best-sphere refraction must be 
between -1.00 D and -5.00 D (inclusive) in each eye.
8. Cylindrical refraction must be 1.00 D or less in each eye, by 
subjective sphero-cylindrical refraction. 
9. Have sphero-cylindrical best-corrected visual acuity of 20/25 or 
better in each eye.
Potential subjects who meet any of the following criteria will be 
excluded from participating in the study:
Exclusion Criteria after Screening:
1. Currently pregnant or lactating.
2. Any systemic allergies, infectious disease (e.g., hepatitis, 
tuberculosis), 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 and/or participation in 
the study. 
4. Any current use of ocular topical medication (occasional use of 
rewetting drops is allowed).
5. Any previous or planned ocular or intraocular surgery, including 
refractive surgery.
6. Participation in any contact lens or lens care product clinical trial 
within 7 days prior to study enrollment.
7. Employee or their children/relatives of investigational clinic (e.g., 
Investigator, Coordinator, Technician).
Below exclusion criteria are for subjects to be enrolled to the Test
group only
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8. Current or recent (within 30 days from enrollment) rigid lens 
wearers. 
9. History of orthokeratology treatment.
Exclusion Criteria after Baseline:
10. 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, aphakia, 
uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis 
sicca, history of recurrent corneal erosions, keratoconus, 
keratoconus suspect, pellucid marginal degeneration, entropion, 
ectropion, extrusions, chalazia, and recurrent styes. 
11. Any Grade 3 or greater slit lamp findings (eg, edema, corneal 
neovascularization, corneal staining, tarsal abnormalities, and 
conjunctival injection) on the FDA scale.
12. Any ocular abnormality that is contraindicated contact lens wear.
13. Any corneal scar within central 5 mm.
14. Binocular vision abnormality, intermittent strabismus or 
strabismus.
Below exclusion criteria are for subjects to be enrolled to the Test
group only
15. Any corneal distortion resulting from ocular diseases or previous 
hard or rigid gas permeable contact lens wear.
Disallowed 
Medications /
Interventions 
Any current use of ocular topical medication such as eye drops 
(occasional use of re-wetting drops is allowed) and ointments. 
Any medication and therapies that would normally contraindicate 
contact lens wear.
Measurements and 
Procedures
For the Test group, all measurements will be taken over bare eye; 
sphero-cylindrical spectacle trial lenses and the test articles for OD 
only, and for the Control group, over bare eye for the better 
orthokeratology treated eye only, under binocular viewing conditions,
unless otherwise specified:
x
Wavefront aberrations measured with target at distance (4 meters)
and near (25 cm).
x
Off-axis refraction at both temporal and nasal fields of retina at 
±10°, ±20°, ±30° with targets at 4 meters and ±30° only with 
targets at 25 cm.
x
On-axis accommodative response with target vergence of 0.25 D,
1 D, 2 D, 3 D and 4 D
x
Slit lamp findings (OD, OS)
x
LogMAR visual acuity under HLHC, LLHC, and HLLC 
conditions
x
Lens fit assessment (OD, OS)
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x
Subjective vision assessment (CLUE Vision questionnaire)
Microbiology or 
Other Laboratory 
Testing
None.
Study Termination
The occurrence of one or more Unanticipated Adverse Device Effect 
(UADE), or any SAE where relationship to study agent cannot be ruled 
out, 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.
Principal 
Investigator and 
Study Institution /
Site
A detailed description of the principal Investigator, the clinical site, 
and the institution is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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Figure 1: Study Flowchart
Visit 2 
Baseline
x
Slit lamp examination
x
Best-sphere refraction
x
Corneal topography
x
Bare eye wavefront aberrometry
Trial Fitting 
Lens-on-eye Measurements
x
Topography
x
Wavefront aberrometry
x
Accommodative response
x
Peripheral refraction
x
ETDRS VA
x
Subjective questionnaire
Potential Subjects Identified Based On:
Age: 18 - 25 yrs (inclusive) 
Ethnicity: any
Best sphere refraction: -1.00D to -5.00D
Cylinder: 1.00D or lower
General Population
x
Lens fit assessment
x
Over lens Snellen VA
x
Over refraction
Final Evaluation
Power modification?
Yes
No
Visit 1
Screening & Baseline
x
Sphero-cylindrical and best-sphere 
refraction
x
Slit lamp examination
x
Corneal topography
x
Wavefront aberrometry
x
Accommodative response
x
Peripheral refraction
x
ETDRS VA
Test Arm
Control Arm
Pre-identified OrthoK
subjects with complete 
pre-treatment records
Visit 1
Screening & Baseline
x
Sphero-cylindrical and best-sphere 
refraction
x
Slit lamp examination
Endpoint Measurements
x
Corneal topography
x
Wavefront aberrometry
x
Accommodative response
x
Peripheral refraction
x
ETDRS VA
x
Subjective questionnaire
Final Evaluation
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD
Plus Power Required for Near Use
ADE
Adverse Device Effect
AE
Adverse Event/Adverse Experience
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COAS
Complete Ophthalmic Analysis System
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CSF
Contrast Sensitivity Function
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 Council for Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
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PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
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1. INTRODUCTION AND BACKGROUND 
Among various optical interventions, orthokeratology (OK) has consistently shown to be 
effective in controlling myopia progression in clinical trials.4-15 It is commonly believed that 
OK controls myopia progression through introducing positive power in the periphery of the 
cornea relative to the center power. Such optical intervention has shown to shift the retinal 
image shell to the myopic direction, therefore, potentially eliminating retinal hyperopic 
defocus as a growth signal to the eye.16-23 With the hypothesis that the effectiveness of OK for 
myopia control is primarily optical driven, Johnson & Johnson Vision Care Myopia Control 
Platform developed the RMY-100 lens that is a soft contact lens with an optical design 
simulating the optical impact of an OK lens to the eye (the SimOK design). The safety and 
effectiveness of RMY-100 lens for controlling myopia progression was evaluated in 
The results of the study indicated that axial elongation of the eye in the RMY-100 
lens treated group was about 9% less than the spectacle lens control group. Although 
statistically significant, the magnitude of the effect was deemed clinically insignificant. In 
addition, there was no statistically significant difference in refraction change from baseline 
between the two study groups. Therefore, RMY-100 lens that simulates the optical impact of 
orthokeratology was largely ineffective in controlling myopia progression.25
Per the learning of 
 the study is designed with the objective of evaluating the on-eye 
optical performances of the RMY-100 lenses and comparing to the optical characteristics of 
eyes undergone orthokeratology treatment and with spectacle lens correction. The results of 
this study may provide information towards understanding of the mechanisms of 
orthokeratology for controlling myopia progression. 
1.1. Name and Descriptions of Investigational Products  
This study will test one investigational lens (RMY-100). The RMY-100 lens is a spherical soft 
contact lens with an aspheric optical design aimed to control myopia progression.
The RMY-100 lens is made of the same material and with the same manufacturing process as 
the marketed 1 Day Acuvue® Moist contact lenses. The diameter and base curve of the lens
fall within the US FDA cleared range of VISTAKON®(etafilcon A) contact lenses parameters.
Further details about the test articles are found in Section 6 of this protocol.
1.2. Intended Use of Investigational Products 
The intended use of the investigational test article is for daily disposable wear for correcting 
myopia and controlling the progression of myopia. During this study, each subject will wear 
the test article binocularly at the second visit of the study only, for no more than 3 hours. This 
is a non-dispensing study; no study lenses will be dispensed to the subjects to wear outside the 
study site.
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding the RMY-
100 lenses refer to the latest version of the Investigator's Brochure for the RMY-100 lens.26
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1.4. Summary of Known Risks and Benefits to Human Subjects 
The benefit of controlling myopia progression is considered to be substantial27 as the 
prevalence and incidence of myopia has been increasing substantially over the past few 
decades.28-30 In addition, significant health risks have been associated with myopia, including
glaucoma, cataract, retinal detachment and myopic macular degeneration. Therefore, it can be 
considered most advantageous to control the progression of myopia and start treatment at an 
early age when myopia is at a low level. Based on theoretical predication, it is estimated that 
an effect of reducing myopia progression by 33% and 50% will result in a reduction in risk 
population (defined as the percentage of myopes being 5.00 D or higher) by 73% and over 
90%, respectively.31
The risks associated with the wear of contact lenses for myopia control includes 1) contact lens 
risks in general population; 2) contact lens risks in pediatric population; and 3) risks 
specifically associated with the RMY-100 lens, such as potential sub-optimal visual 
performances and long-term physiological and/or neurological impact. The assessment 
regarding the above identified risks concluded that the risks associated with the RMY-100 lens
are expected to be the same as those normally attributed to the wear of soft hydrophilic contact 
lenses on a daily wear basis. In addition, the daily disposable modality of the investigational 
lenses further reduces risks associated with lens care and the use of care products (eg, cleaning, 
disinfecting, rinsing and storage, etc.). Anticipated adverse reactions with these lenses are the 
same as any other soft contact lens as listed in this study protocol Section 13.1. Due to the 
unique optical design of the RMY-100 lens, visual performance of these lenses may not be 
equivalent to that of lenses with a conventional spherical lens design. To manage the risk, 
special attention will be paid to visual acuity, visual complaints (eg, blurry vision or visual 
artifacts such as ghosting or haloes, etc.), and subjective visual acceptance while fitting the 
study lenses. In addition, the study lens power may be modified based on the refraction over 
the study lens and visual acuity. Finally, if lenses are to be dispensed for wear at home, specific 
criteria regarding visual acuity and subjective vision acceptance will be imposed so that no 
study lenses will be dispensed and the subject will be discontinued from the study unless these 
vision criteria are met. Because the current study is a non-dispensing study with the maximum
lens exposure time for each subject being limited to less than 3 hours, risks associated with 
vision as a result of the unique optical design of the RMY-100 lens are minimal and potential
long-term physiological/neurological impact are not applicable to this study.
Per the risk-to-benefit analysis, it is proposed that the benefits of slowing myopia progression 
outweigh the risks associated with daily disposable soft contact lens wear. Per the clinical study 
risk assessment, this study is considered a non-significant risk study based 1) the study is a 
non-dispensing study; and 2) although the investigational lens is optically designed for the 
intent of myopia control, the lens will be used in this study for myopia correction only with 
limited wear time (i.e., subjects will wear study lenses for less than 3 hours). 
For the most comprehensive risk and benefit information regarding RMY-100 lenses refer to 
the latest version of the Investigator's Brochure for the RMY-100 lens.26
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1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The review of the scientific literature examined the current state of published information 
contact lens safety and myopia control with soft contact lenses. Potential applicable literature 
was identified through a literature search on PubMed.org dated back to 1980’s, as well as 
through examination of review articles published on the subject. A list of relevant literature 
references is provided in latest version of the Investigator's Brochure for the RMY-100 lens.26
To date, there have been a total of five clinical studies conducted during the development of 
the RMY-100 lenses.25,32-35
Among these studies, four
were to evaluated the physiology responses and vision, comfort, 
handling and fit performances of the RMY-100 to ensure that the lens has satisfactory 
performances to be further evaluated in the long-term (up to 2 years), myopia control clinical 
trial in a pediatric population 
. There were no serious, significant, or unanticipated 
ocular adverse events and no loss of best corrected visual acuity with wear of study test articles 
reported in these past clinical studies. For detailed information regarding prior clinical data 
refer to the latest version of the Investigator's Brochure for the RMY-100 lens.26
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
The objective of the study is to evaluate the on-eye optical performances of the RMY-100
lenses and comparing to the optical characteristics of eyes undergone orthokeratology 
treatment and with spectacle lens correction.
This is an exploratory study for providing information towards understanding the difference in 
optical impact between RMY-100 lens and orthokeratology and the mechanisms of 
orthokeratology for controlling myopia progression.
Primary Objective:
The primary objective of the study is to evaluate the on-eye optical performances of the 
RMY-100 lens, and compare with eyes treated with orthokeratology.
Secondary Objective: 
The secondary objective of the study is to compare the on-eye optical performances of the 
RMY-100 lens with eyes wearing sphero-cylindrical correction in the spectacle trial frame.
2.2. Endpoints  
Primary Endpoint
The primary endpoint of this study is wavefront aberrations measured at 4-meter distance 
(0.25 D target vergence) and near (25 cm with 4 D target vergence).
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Secondary Endpoint
The secondary endpoint of this study is Off-axis refraction at both temporal and nasal fields of 
retina at ±10°, ±20°, ±30° with targets at 4 meters and ±30° only with targets at 25 cm.
Other Exploratory Endpoints and observations include:
x
Corneal and test article on-eye topography
x
Accommodative response with target vergence of 0.25 D, 1 D, 2 D, 3 D and 4 D
x
Slit lamp findings
x
LogMAR visual acuity under HLHC, LLHC, and HLLC conditions
x
Lens fit assessment
x
Subjective vision assessment (CLUE Vision)
2.3. Hypotheses 
Primary Hypotheses:
1.
After the 10-minute lens settling period, distance (4 meters) spherical aberration (Z40)
measured with RMY-100 on the eye will be similar or larger than that measured from 
the post-OK eyes. 
2.
After the 10-minute lens settling period, near (25 cm) spherical aberration (Z40)
measured with RMY-100 on the eye will be similar or larger than that measured from 
the post-OK eyes.
Secondary Hypotheses:
1.
After the 10-minute lens settling period, distance (4 m) off-axis refraction at ±30°
retinal eccentricity measured with RMY-100 on the eye will be similar or larger than 
that measured from the post-OK eyes. 
2.
After the 10-minute lens settling period, near (25 cm) off-axis refraction at ±30°
retinal eccentricity measured with RMY-100 on the eye will be similar or larger than 
that measured from the post-OK eyes.
Other Hypotheses:
1.
After the 10-minute lens settling period, the slope of accommodative response 
measured with RMY-100 on the eye will be similar as that measured from the post-
OK eyes. 
2.
After the 10-minute lens settling period, distance (4 m) and near (25 cm) wavefront 
aberrations, off-axis refractions within ±30° retinal eccentricity, and the slope of 
accommodative response measured with RMY-100 on the eye will be different from 
that measured with spectacle trial lenses on eye.
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3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female subjects between ages of 7 and 25 years (inclusive) with best sphere-
refraction between -1.00 D to -5.00 D (inclusive) and 1.00 D or less astigmatism will be 
recruited. Subjects must have healthy eyes and satisfy all the eligibility criteria at enrollment. 
There are no restrictions as to gender or race/ethnicity. Subjects may be neophytes or current 
soft contact lens wearers.
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening:
1. Pediatric subjects (<18 years old) must read (or be read to), understand, and sign the 
Statement of Information and Assent and receive a fully executed copy of the form.
2. Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must 
read, understand and sign the Statement of Informed Consent and receive a fully executed 
copy of the form.
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. Between 7 and 25 years of age (inclusive).
5. Have normal eyes (i.e., no ocular medications or infections of any type).
Below inclusion criterion is for subjects to be enrolled to the Control group only: 
6. Are existing orthokeratology patients whose current treatment has been stabilized for at 
least 1 months and with complete pre-treatment record, e.g., spherocylindrical refraction 
and corneal topography. Pre-treatment wavefront aberration measures are preferred by not 
required.
Inclusion Criteria after Baseline (apply to subjects to be enrolled to the Test group and to 
Control group subjects regarding their pre-OK treatment):
7. Vertex-corrected distance subjective best-sphere refraction must be between -1.00 D
and -5.00 D (inclusive) in each eye.
8. Cylindrical refraction must be 1.00 D or less in each eye, by subjective sphero-cylindrical 
refraction. 
9. Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
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Exclusion Criteria after Screening:
1. Currently pregnant or lactating.
2. Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), 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 and/or participation in the study. 
4.
Any current use of ocular topical medication (occasional use of re-wetting drops is 
allowed).
5. Any previous or planned ocular or intraocular surgery, including refractive surgery.
6. Participation in any contact lens or lens care product clinical trial within 7 days prior to 
study enrollment.
7. Employee or their children/relatives of investigational clinic (e.g., Investigator, 
Coordinator, Technician).
Below exclusion criteria are for subjects to be enrolled to the Test group only
8. Current or recent (within 30 days from enrollment) rigid lens wearers. 
9. History of orthokeratology treatment.
Exclusion Criteria after Baseline:
10. 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, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis 
sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid 
marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes. 
11. Any Grade 3 or greater slit lamp findings (eg, edema, corneal neovascularization, corneal 
staining, tarsal abnormalities, and conjunctival injection) on the FDA scale.
12. Any ocular abnormality that is contraindicated contact lens wear.
13. Any corneal scar within central 5mm
14. Binocular vision abnormality, intermittent strabismus or strabismus.
Below exclusion criteria are for subjects to be enrolled to the Test group only
15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas 
permeable contact lens wear.
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.
In addition, the Control group subjects will be recruited through referrals from the university 
optometry clinic and independent Eye Care Professionals (ECPs) who will identify potential
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subjects by reviewing the case history of existing orthokeratology treated patients in their 
practices.
It is anticipated that the age distribution is likely to be different between the two study groups, 
e.g., orthokeratology patients may be of younger age than soft contact lens patients. Therefore, 
the study site is encouraged to recruit subjects in each study group with similar age, gender 
and baseline refraction distributions. Specifically, the site will aim to enroll approximately 15 
subjects in the Test group who match the subjects enrolled in the Control group with regard to 
age, gender and baseline refraction as much as possible. The clinical site is encouraged to 
enroll subjects between 7 and 15 years of age, if available within the enrollment timeline. 
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a two-arm parallel, non-masked, bilateral, non-dispensing study with one Test arm and 
one concurrent, non-randomized Control arm.
For subjects enrolled in the Test arm, investigational test articles will be bilaterally fitted to the 
subject’s eyes. Concurrently, a smaller sample of subjects who are established orthokeratology 
lens wearers will be enrolled to Control arm. Endpoint measures will be collected over one eye 
only (Test arm: OD only; Control arm: better OK fitted eyes, eg, better centration and better 
myopia correction outcome, etc., based on the investigator’s judgement. If both eyes are treated 
equally well, choose OD). 
For subjects in the Test arm, there will be a total of 2 visits:
Visit 1: Screening, baseline endpoint measures with bare eye/spectacle trial lenses
Visit 2: Lens fitting, endpoint measures over the study lenses and final evaluation.
For the Control arm, the investigators will pre-identify subjects through reviewing the case 
history of existing orthokeratology treated patients. Only subjects with complete pre-treatment 
record, e.g., spherocylindrical refraction and corneal topography will be invited to participate 
in the study. 
For subjects in the Control arm, there will be a total of 1 visit:
Visit 1: Screening, baseline and endpoint measures over the selected eyes.  
Study participants will have no access to test articles at study closure.
4.2. Study Design Rationale 
The study was designed to evaluate the on-eye optical performance of the RMY-100 lens. The 
RMY-100 lens was designed to have an optical profile that simulates the optical effect of an 
orthokeratology lens on the eye. As such optical characteristics and effects of RMY-100 lens 
on the eye, including wavefront aberrations, especially spherical aberration, lens-on-eye 
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topography, accommodative responses and off-axis refraction, will be measured and compared 
with those measured from eyes of patients of current orthokeratology treatment. 
Due to the two populations to be investigated are different, ie., non-OK patients that will be fit 
with soft contact lenses and current over-night OK patients with no vison correction during the 
day, the study is designed to be a non-randomized, two-arm parallel, non-masked study.   
4.3. Enrollment Target and Study Duration 
Approximately 25 subjects will be enrolled in the Test arm of the study with a minimum of 20 
subjects targeted to complete the study.
Approximately 20 subjects will be enrolled in the Control arm of the study with a minimum of 
15 subjects targeted to complete the study.
The study will be conducted at one clinical site.
The total duration of the study enrollment will be approximately 10 weeks, unless otherwise 
approved by the Sponsor. The total duration of the study is expected to be 14 weeks (including 
the enrollment period).
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
This is a non-randomized study. The study lens (RMY-100) will be fit bilaterally to the Test 
group subjects at the second visit of the study only.
5.2. Masking 
This is a non-masked study.
5.3. Procedures for Maintaining and Breaking the Masking 
Not applicable. 
6. STUDY INTERVENTION 
6.1. Identity of Test Articles  
The following contact lenses will be used in this study:
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articles will be in 6-pack cartons with the appropriate country-specific language on the
secondary packaging.
The sample study labels are shown below:
Primary Package
Secondary Package Label
6.5. Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6. Collection and Storage of Samples 
No samples will be collected as part of the study procedures.
When possible, any 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 JJVC.
6.7. Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted.  This includes:
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x With sphero-cylindrical correction in the 
spectacle trial frame with Distance target (4 m)
x With sphero-cylindrical correction in the 
spectacle trial frame with Near target (25 cm)
For Control group subjects (better OK treated eye):
x Bare eye with Distance target (4 m)
x Bare eye with Near target (25 cm)
Note: For subjects in the Control group, their latest
wavefront aberration data prior to orthokeratology 
treatment will also be collected, if available.
1.13
Accommodative 
Response
Collect sphero-cylindrical auto-refraction with
target vergence of 0.25 D, 1 D, 2 D, 3 D and 4 D,
respectively. Three repeated measurements per 
each target vergence:
For Test group subjects (OD only):
x With sphero-cylindrical correction in the 
spectacle trial frame over the eye
For Control group subjects (better OK treated eye):
x Bare eye
1.14
Off-axis 
Refraction
Collect off-axis refraction with an open-field 
autorefractor under the following conditions, 3 
repeated measures per each condition:
x With distance targets (4 m) at field angles of 0°,
±10°, ±20°, and ±30°;
x With near targets (25 cm) at field angles of ±30°
only.
For Test group subjects (OD only):
x Bare Eye, with Distance target (4 m): 0°, ±10°,
±20°, and ±30°
x With sphero-cylindrical correction in the 
spectacle trial frame over the eye, with Distance 
target (4 m): ±10°, ±20°, and ±30°
x With sphero-cylindrical correction in the 
spectacle trial frame over the eye, with Near 
target (25 cm): ±30°
For Control group subjects (better OK treated eye):
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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
are eligible;
x
completed all visits through the final visit
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, and unable to complete the 
scheduled visit
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)
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
An additional subject will be enrolled if a subject discontinues from the study prematurely
during the study enrollment period.
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
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9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: any medication that the investigator feels would 
be contraindicated in contact lens wear.
Concomitant therapies that are disallowed include: any therapies that the investigator feels 
would be contraindicated in 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. 
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.   
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.
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12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”.
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e., tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether 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.)
x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
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Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved.
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”2
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 (eg, a sight threatening event, a
significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function).  Important medical events that 
may not result in death, be life-threatening, or require hospitalization may be 
considered an SAE when, based upon appropriate medical judgment, they may 
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jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).  
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other Grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - eg Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include,
but not limited to the following:
x
Non-Significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
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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.”2
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 – ie, 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, or 
unknown.
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
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x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, eg 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, eg, 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, eg,
concomitant treatment of concomitant disease(s).  The relationship in time is very 
suggestive, eg, it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject.  The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  
Such documentation will include the following:
x
Adverse event (diagnosis not symptom)
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x
Drawings or photographs (where appropriate) that detail the finding (eg, 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 
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 
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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 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
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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 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each subject/eye 
will be used when available for summarization and statistical analysis.  Unscheduled visits will 
be summarized separately and will be excluded from the statistical analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
All statistical analysis will be conducted on the per-protocol population defined in 
Section 14.3.
14.2. Sample Size Justification 
This is a pilot study for assessing the investigational test articles. As such, the sample size was 
not determined based on any power analysis with regard to the primary endpoint.  The collected 
data will be used to design future trials.
14.3. Analysis Populations 
Safety Population:
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All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
Due to the exploratory nature of the study, adjustment for multiple comparison will not be 
performed. 
14.5. Primary Analysis  
Primary efficacy analysis:
Distance and near wavefront aberration, specifically, spherical aberration (Z40), will be 
analyzed using a linear mixed model. Each model will include the experimental design factors: 
treatment, distance and treatment by distance interaction and subject as random effect. Other 
baseline characteristics known of importance such as age and gender will be included as fixed 
covariates when appropriate. Kenward and Roger method will be used for the calculation of 
the denominator of degrees of freedom.36
Comparisons between the treatment groups will be carried out using 95% confidence intervals 
constructed of least-square means (LSM) differences (RMY-100 minus OK) from the linear 
mixed models at each distance. Statistical difference will be concluded in the lower limit is 
greater than 0 or the upper limit is less than 0. 
14.6. Secondary Analysis 
Secondary efficacy analysis:
Off-axis refraction at ±30° retinal eccentricities with targets at both distance (4 m) and near 
(25 cm) will be analyzed using a linear mixed model. Each model will include the experimental 
design factors: treatment, distance and treatment by distance interaction and subject as random 
effect. Other baseline characteristics known of importance such as age and gender will be 
included as fixed covariates when appropriate. Kenward and Roger method will be used for 
the calculation of the denominator of degrees of freedom.36
Comparisons between the treatment groups will be carried out using 95% confidence intervals 
constructed of least-square means (LSM) differences (RMY-100 minus OK) from the linear 
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mixed models at each distance. Statistical difference will be concluded in the lower limit is 
greater than 0 or the upper limit is less than 0. 
14.7. Other Exploratory Analyses 
Summary statistical analysis will be provided for the following other observations:
x
Corneal and test article on-eye topography
x
Accommodative response with target vergence of 0.25 D, 1 D, 2 D, 3 D and 4 D
x
Slit lamp findings (OD, OS)
x
LogMAR visual acuity under HLHC, LLHC, and HLLC conditions (OD, OU)
x
Lens fit assessment (OD, OS)
x
Subjective vision assessment (CLUE Vision)
14.8. Interim Analysis 
Not applicable.
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 5 imputations.
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted to 
the specification of the JJVC database manager and sent to JJVC for analysis. 
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External Date Sources for this study include: Exported WAM sphero-cylindrical refraction 
measurements in the format of Excel files, Medmont corneal topography data in the format of 
raw data files (e.g., (.axl, .tgl, .dst, .hgt) and COAS wavefront aberration data in the format of 
raw data files (e.g., .DVB, .F8 and .WFB).
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 ISO14155:2011.2
15.2. Subject Record 
At a minimum, subject record should be available for the following:
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
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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:
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
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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 and parents/legal guardians of pediatric subjects will be fully informed of 
the risks and requirements of the study and, during the study, subjects and parents/legal 
guardians of pediatric subjects will be given any new information that may affect their decision 
to continue participation.  Subjects and parents/legal guardians of pediatric 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 (for pediatric subjects, their parents/legal guardians) who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent/assent (pediatric subjects parental consent and subject assent will be obtained)
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),1 and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),1 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
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x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval 
letter must be dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s)
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
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 or assent and parental consent for minors according to 
local requirements after the nature of the study has been fully explained. The consent form for 
adults and assent and parental consent for minors must be signed before performance of any 
study-related activity. The consent form for adults and assent and parental consent for minors
that is used must be approved by both the Sponsor and by the reviewing IEC/IRB. The 
informed consent for adults and assent and parental consent for minors is in accordance with
principles that originated in the Declaration of Helsinki,3 current ICH1 and ISO 141552 GCP 
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 subjects and their parents or guardians (if applicable) the
aims, methods, reasonably anticipated benefits, and potential hazards of the study, and any 
discomfort it may entail. Subjects and parents or guardians (if applicable) will be informed that 
their participation is voluntary and that they may withdraw consent to participate at any time. 
The subject and parent or guardian (if applicable) 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 and assent (if applicable) should be appropriately recorded by 
means of the subject's dated signature on the consent form, or the minor subject’s signature on 
the assent and the parent or guardian signature on the consent form. After having obtained the
signed assent/consent form(s), a copy will be provided to the subject and parent or guardian (if 
applicable).
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 (eg, name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States37 and other applicable personal data protection and security laws and regulations.  
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,1 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 ICH1 and ISO 141552 GCP guidance 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 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 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.
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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
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov based on the following:
This clinical study aims to understand the fundamental mechanisms of optical interventions 
for myopia control. The results of this study are expected to be published in peer-reviewed 
journals. In addition, this study will be conducted in Canada, clinicaltrial.gov registration is 
required by Health Canada.
22. REFERENCES 
1.
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html.
2.
ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects - Godd
Clinical Practice. Available at: https://www.iso.org/standard/45557.html.
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3.
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html.
4.
Cho P, Cheung SW, Edwards M. The longitudinal orthokeratology research in children 
(LORIC) in Hong Kong: a pilot study on refractive changes and myopic control. Curr 
Eye Res. 2005;30(1):71-80.
5.
Walline JJ, Jones LA, Sinnott LT. Corneal reshaping and myopia progression. Br J 
Ophthalmol. 2009;93(9):1181-1185.
6.
Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial 
elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011;52(5):2170-2174.
7.
Cho P, Cheung SW. Retardation of myopia in Orthokeratology (ROMIO) study: a 2-year 
randomized clinical trial. Invest Ophthalmol Vis Sci. 2012;53(11):7077-7085.
8.
Hiraoka T, Kakita T, Okamoto F, Takahashi H, Oshika T. Long-term effect of overnight 
orthokeratology on axial length elongation in childhood myopia: a 5-year follow-up
study. Invest Ophthalmol Vis Sci. 2012;53(7):3913-3919.
9.
Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia 
control with orthokeratology contact lenses in Spain: refractive and biometric changes. 
Invest Ophthalmol Vis Sci. 2012;53(8):5060-5065.
10. Chen C, Cheung SW, Cho P. Myopia control using toric orthokeratology (TO-SEE 
study). Invest Ophthalmol Vis Sci. 2013;54(10):6510-6517.
11. Lin HJ, Wan L, Tsai FJ, et al. Overnight orthokeratology is comparable with atropine in 
controlling myopia. BMC ophthalmology. 2014;14:40.
12. Swarbrick HA, Alharbi A, Watt K, Lum E, Kang P. Myopia Control during 
Orthokeratology Lens Wear in Children Using a Novel Study Design. Ophthalmology. 
2014.
13. Zhu MJ, Feng HY, He XG, Zou HD, Zhu JF. The control effect of orthokeratology on 
axial length elongation in Chinese children with myopia. BMC ophthalmology. 
2014;14:141.
14. Si JK, Tang K, Bi HS, Guo DD, Guo JG, Wang XR. Orthokeratology for myopia 
control: a meta-analysis. Optom Vis Sci. 2015;92(3):252-257.
15. Sun Y, Xu F, Zhang T, et al. Orthokeratology to control myopia progression: a meta-
analysis. PloS one. 2015;10(4):e0124535.
16. Charman WN, Mountford J, Atchison DA, Markwell EL. Peripheral refraction in 
orthokeratology patients. Optom Vis Sci. 2006;83(9):641-648.
17. Kang P, Swarbrick H. Peripheral refraction in myopic children wearing orthokeratology 
and gas-permeable lenses. Optom Vis Sci. 2011;88(4):476-482.
18. Mathur A, Atchison DA. Effect of orthokeratology on peripheral aberrations of the eye. 
Optom Vis Sci. 2009;86(5):E476-484.
19. Queiros A, Gonzalez-Meijome JM, Jorge J, Villa-Collar C, Gutierrez AR. Peripheral 
refraction in myopic patients after orthokeratology. Optom Vis Sci. 2010;87(5):323-329.
20. Chen Z, Niu L, Xue F, et al. Impact of pupil diameter on axial growth in 
orthokeratology. Optom Vis Sci. 2012;89(11):1636-1640.
21. Zhong Y, Chen Z, Xue F, Zhou J, Niu L, Zhou X. Corneal power change is predictive of 
myopia progression in orthokeratology. Optom Vis Sci. 2014;91(4):404-411.
22. Gonzalez-Meijome JM, Faria-Ribeiro MA, Lopes-Ferreira DP, Fernandes P, Carracedo 
G, Queiros A. Changes in Peripheral Refractive Profile after Orthokeratology for 
Different Degrees of Myopia. Curr Eye Res. 2015:1-9.
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23. Kang P, Fan Y, Oh K, Trac K, Zhang F, Swarbrick HA. The effect of multifocal soft 
contact lenses on peripheral refraction. Optom Vis Sci. 2013;90(7):658-666.
24. Cheng X. 
 (VIS-CR-005505/A) Controlling Myopia 
Progression through Optical Intervention. July 26, 2015.
25. Cheng X. 
 (VIS-CR-005505/A) Controlling Myopia Progression 
through Optical Intervention. May 21, 2017.
26. Cheng X. Investigator's Brochure: RMY-100 Lens. October 10, 2017.
27. Vitale S, Sperduto RD, Ferris FL, 3rd. Increased prevalence of myopia in the United 
States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009;127(12):1632-1639.
28. Lin LL, Shih YF, Hsiao CK, Chen CJ, Lee LA, Hung PT. Epidemiologic study of the 
prevalence and severity of myopia among schoolchildren in Taiwan in 2000. J Formos 
Med Assoc. 2001;100(10):684-691.
29. Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese 
schoolchildren: 1983 to 2000. Ann Acad Med Singapore. 2004;33(1):27-33.
30. Xu L, Wang Y, Li Y, Cui T, Li J, Jonas JB. Causes of blindness and visual impairment 
in urban and rural areas in Beijing: the Beijing Eye Study. Ophthalmology. 
2006;113(7):1134 e1131-1111.
31. Brennan NA. Predicted Reduction in High Myopia for Various Degrees of Myopia 
Control. Annual Clinical Conference of the British Contact Lens Association; 2012.
32. Cheng X. 
 Evaluating the Fit, Optical and Visual 
Performance of Simulated Ortho K Lenses. October 6, 2010.
33. Cheng X. 
 Evaluating the fit, handling and comfort 
performances of new SAM designs. May 3, 2013.
34. Cheng X
 Evaluating the vision, lens fit, physiology and 
handling performances of two new SAM designs. April 19, 2013.
35. Ritchey E. 
 Evaluationg the Fit, Optical and Visual 
Performances of Variable LSA, SimOK & Zero SA Lenses. January 28, 2014.
36. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997(53):983–997.
37. Health Information Portabiltiy and Accountabiltiy Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html.
38. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)    
 
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PRO SPECIFICATIO
 1 Final  2017-10-13
Protocol 6000                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATIO
 1 Final  2017-10-13
Protocol 6000                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATIO
 1 Final  2017-10-13
Protocol 6000                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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PRO SPECIFICATIO
 1 Final  2017-10-13
Protocol 6000                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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APPENDIX B: PARENT/PATIENT INSTRUCTION GUIDE  
A parent/patient instruction guide, contact lens insertion and removal instructions, insertion 
and removal instructional video, and a study pamphlet will be provided to study participants 
and their parents separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)   
Not Applicable
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APPENDIX D: 
 
x
Lens Fitting Characteristics 
x
 Determination of Distance Spherocylindrical Refractions
x
 Biomicroscopy Scale
x
 Distance and Near Visual Acuity Evaluation
x
 Distance LogMAR Visual Acuity Measurement Procedure
x
 Measurement of COAS Wavefront Aberrations 
x
 Patient Reported Outcomes
x
Visual Acuity Chart Luminance and Room Illumination Testing
x
Topography Measurement Using Medmont E300 Corneal Topographer
x
 Using an Open-field Autorefractor (WAM-5500) for Measuring 
Accommodative Response and Off-axis Refraction
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 LENS FITTING CHARACTERISTICS 
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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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Title:
Distance and Near Visual Acuity Evaluation 
Page 4 of 4
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE 
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 MEASUREMENT OF COAS WAVEFRONT ABERRATIONS   
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Page 6 of 7
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 PATIENT REPORTED OUTCOMES 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
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

Title:
VisualAcuityChartLuminanceandRoomIlluminationTesting




Page 3 of 4 

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

Title:
VisualAcuityChartLuminanceandRoomIlluminationTesting





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
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 TOPOGRAPHY MEASUREMENT USING MEDMONT E300 
CORNEAL TOPOGRAPHER 
Work aid will be provided separately.
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 USING AN OPEN-FIELD AUTOREFRACTOR (WAM-5500) FOR 
MEASURING ACCOMMODATIVE RESPONSE AND OFF-AXIS REFRACTION 
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Page 9 of 9 
The training requirement for this document is “read only”. 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6000 Evaluation of On-eye Optical Performances of the RMY-
100 Lens
Version and Date: Version 3.0, Amendment 2.0, 05-Jun-2018
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to GCP and ICH guidelines,1 the Declaration of 
Helsinki,3 ISO 14155,2 United States (US) Code of Federal Regulations (CFR),38 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 ICH1 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 ICH1 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/1529076111567-tv_crf_rpt_14792_2_15062018_1121 html[6/15/2018 11:25:55 AM]
Electronic Signature Report
Job Name: VIS-CR-006000/A-R&D Clinical Study
Revision: VIS-CSPR-005828/3-Clinical Protocol
Title: VIS Clinical Study Protocol Approval
Status: Approved
System: Vision Care R&D Knowledge Management
Generated By:  Thomas, Ashley
Generated On: 2018-06-15 11:21:50
Signoff Details
Function/Role 
Approval Details 
Biostatistician
Approval
Participant
WWID
Decision
Decision Date
Xu, Jasper
1015493
Approved
2018-06-14T15:55:49
Function/Role
Approval Details 
Clinician
Approval
Participant
WWID
Decision
Decision Date
Cheng, Xu
330285
Approved
2018-06-14T17:01:29
Function/Role
Approval Details 
Clinical Research
Manager
Approval
Participant
WWID
Decision
Decision Date
Balsamo,Margaret
1011701
Approved
2018-06-14T15:37:05
Function/Role
Approval Details 
Other Approval
Participant
WWID
Decision
Decision Date
Paulk, Randall
375676
Approved
2018-06-15T10:49:17
Moody, Kurt
358947
Approved
2018-06-14T15:45:33
Brennan, Noel
1018516
Approved
2018-06-14T15:50:52