Evaluating Visual Acuity and Initial Fit Performance of Two Soft Contact Lenses
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title
Evaluating visual acuity and initial fit performance of two soft contact lenses
Protocol CR-6441
Version: 2.0
Date: 06 May 2021
Investigational Products: 
Daily disposable soft contact lenses made in senofilcon A material.
Test Lens: EMO-200
Control Lens: EMO-118
Key Words: myopia, soft contact lens, non-dispensing, daily wear, daily disposable, 
senofilcon A, logMAR visual acuity, lens fit, pediatric population
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS.............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS.................... 16 
1. INTRODUCTION AND BACKGROUND ..................................................................... 18 
1.1. Name and Descriptions of Investigational Products ................................................. 18 
1.2. Intended Use of Investigational Products.................................................................. 18 
1.3. Summary of Findings from Nonclinical Studies....................................................... 19 
1.4. Summary of Known Risks and Benefits to Human Subjects.................................... 19 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study.......................................................................................................................... 20 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ........................................ 21 
2.1. Objectives.................................................................................................................. 21 
2.2. Endpoints................................................................................................................... 21 
2.3. Hypotheses ................................................................................................................ 22 
3. TARGETED STUDY POPULATION............................................................................. 22 
3.1. General Characteristics.............................................................................................. 22 
3.2. Inclusion Criteria....................................................................................................... 22 
3.3. Exclusion Criteria...................................................................................................... 23 
3.4. Enrollment Strategy................................................................................................... 24 
4. STUDY DESIGN AND RATIONALE............................................................................ 24 
4.1. Description of Study Design ..................................................................................... 24 
4.2. Study Design Rationale............................................................................................. 25 
4.3. Enrollment Target and Study Duration ..................................................................... 25 
5. TEST ARTICLE ALLOCATION AND MASKING....................................................... 26 
5.1. Test Article Allocation .............................................................................................. 26 
5.2. Masking..................................................................................................................... 26 
5.3. Procedures for Maintaining and Breaking the Masking............................................ 27 
6. STUDY INTERVENTION............................................................................................... 27 
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6.1. Identity of Test Articles............................................................................................. 27 
6.2. Ancillary Supplies/Products...................................................................................... 28 
6.3. Administration of Test Articles................................................................................. 28 
6.4. Packaging and Labeling ............................................................................................ 29 
6.5. Storage Conditions .................................................................................................... 29 
6.6. Collection and Storage of Samples ........................................................................... 29 
6.7. Accountability of Test Articles ................................................................................. 29 
7. STUDY EVALUATIONS................................................................................................ 30 
7.1. Time and Event Schedule.......................................................................................... 30 
7.2. Detailed Study Procedures ........................................................................................ 31 
VISIT 1......................................................................................................................... 31 
FINAL EVALUATION ............................................................................................... 36 
7.3. Unscheduled Visits.................................................................................................... 37 
7.4. Laboratory Procedures .............................................................................................. 38 
8. SUBJECTS COMPLETION/WITHDRAWAL................................................................ 38 
8.1. Completion Criteria................................................................................................... 38 
8.2. Withdrawal/Discontinuation from the Study ............................................................ 39 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................... 39 
9.1. Systemic Medications................................................................................................ 40 
10. DEVIATIONS FROM THE PROTOCOL....................................................................... 41 
11. STUDY TERMINATION ................................................................................................ 42 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS................... 42 
13. ADVERSE EVENTS........................................................................................................ 44 
13.1. Definitions and Classifications.................................................................................. 44 
13.2. Assessing Adverse Events......................................................................................... 47 
13.2.1.Causality Assessment............................................................................................... 47 
13.2.2.Severity Assessment ................................................................................................ 47 
13.3. Documentation and Follow-Up of Adverse Events .................................................. 48 
13.4. Reporting Adverse Events......................................................................................... 49 
13.4.1.Reporting Adverse Events to Sponsor..................................................................... 49 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
.......................................................................................................................... 50 
13.5. Events of Special Interest.......................................................................................... 50 
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13.6. Reporting of Pregnancy............................................................................................. 51 
14. STATISTICAL METHODS............................................................................................. 51 
14.1. General Considerations ............................................................................................. 51 
14.2. Sample Size Justification........................................................................................... 51 
14.3. Analysis Populations ................................................................................................. 53 
14.4. Level of Statistical Significance................................................................................ 53 
14.5. Primary Analysis ....................................................................................................... 53 
14.6. Secondary Analysis ................................................................................................... 54 
14.7. Other Analyses .......................................................................................................... 55 
14.8. Interim Analysis ........................................................................................................ 56 
14.9. Procedure for Handling Missing Data and Drop-Outs.............................................. 56 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ............................... 56 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING..................................... 56 
15.1. Electronic Case Report Form/Data Collection.......................................................... 56 
15.2. Subject Record .......................................................................................................... 57 
15.3. ClinicalTrials.gov...................................................................................................... 57 
16. DATA MANAGEMENT.................................................................................................. 57 
16.1. Access to Source Data/Document ............................................................................. 57 
16.2. Confidentiality of Information .................................................................................. 57 
16.3. Data Quality Assurance............................................................................................. 58 
16.4. Data Monitoring Committee (DMC)......................................................................... 58 
17. CLINICAL MONITORING............................................................................................. 58 
18. ETHICAL AND REGULATORY ASPECTS.................................................................. 59 
18.1. Study-Specific Design Considerations...................................................................... 59 
18.2. Investigator Responsibility........................................................................................ 59 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)............... 59 
18.4. Informed Consent...................................................................................................... 60 
18.5. Privacy of Personal Data ........................................................................................... 61 
19. STUDY RECORD RETENTION..................................................................................... 62 
20. FINANCIAL CONSIDERATIONS ................................................................................. 63 
21. PUBLICATION................................................................................................................ 63 
22. REFERENCES ................................................................................................................. 63 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) AND 
CONTACT LENS CHECKLIST SPECIFICATIONS........................................................... 66 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 67 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 68 
APPENDIX D: 
...................................... 69 
 Lens Fitting Characteristics.................................................................................. 70 
 Subject Reported Ocular Symptoms/Problems.................................................... 76 
 Determination of Distance Spherocylindrical Refractive Error........................... 78 
 Distance and Near Snellen Visual Acuity Evaluation.......................................... 84 
 Distance LogMAR Visual Acuity Measurement Procedure................................ 89 
 Cover-Uncover Test............................................................................................. 93 
 ISO Biomicroscopy Scale .................................................................................... 96 
 Measuring Pupil Diameter with NeurOptics VIP-200 Pupillometer and NeurOptics 
VIP®-300 Pupillometer......................................................................................................... 105 
Visual Acuity Chart Luminance and Room Illumination Testing ..................... 112 
APPENDIX E: 
 GUIDELINES FOR COVID-19 RISK MITIGATION ............ 121 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE........................ 133 
LISTING OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 15 
LISTING OF TABLES 
Table 1: Test Articles.............................................................................................................. 27 
Table 2: Ancillary Supplies .................................................................................................... 28 
Table 3: Time and Events ....................................................................................................... 30 
Table 4: Potential Disallowed Systemic Medications ............................................................ 40 
Table 5: Examples of major and minor protocol deviations................................................... 41 
Table 6: Descriptive Summary of Monocular LogMAR Visual Acuity Post Lens-Fitting from 
– Per Protocol Subjects ........................................................................................... 52 
Table 7: Sample Size and Power for the Primary and Secondary Endpoints......................... 52 
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PROTOCOL TITLE, NUMBER, VERSION 
Title: Evaluating visual acuity and initial fit performance of two soft contact lenses
Protocol Number: CR-6441
Version: 2.0
Date: 06 May 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155,1 ICH guidelines,2
and the Declaration of Helsinki.3
Author/Study 
Responsible Clinician
See Electronic Signature Report
DATE
Clinical Operations 
See Electronic Signature Report
Manager
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety Officer
See Electronic Signature Report
DATE
Reviewer –
See Electronic Signature Report
Fellow
DATE
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Reviewer –
See Electronic Signature Report
Biostatistician
DATE
Approver
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
 
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SYNOPSIS  
Protocol Title
Evaluating visual acuity and initial fit performance of two soft contact 
lenses
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: confirmatory
Design control phase: confirmatory phase, phase 3
Trial Registration
The study will be registered on clinicaltrial.gov by the Sponsor.
Test Article(s)
Investigational Products:
x
Test: EMO-200
x
Control: EMO-118
Both lenses are Daily disposable soft contact lenses (SCL) made in 
senofilcon A material.
Wear and 
Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily disposable 
This is a non-dispensing study. Subjects will wear both test articles
during one visit. The order of contact lens type received will be 
randomized.
Objectives 
To compare visual acuity and lens fit performance of EMO-200 with 
EMO-118 lens.
Primary Objective:
To demonstrate that visual acuity of EMO-200 lens is non-inferior to 
EMO-118 lens.
Secondary Objective: 
To demonstrate that lens fit performance of EMO-200 lens is non-
inferior to EMO-118 lens.
Study Endpoints
Primary endpoint:
x
Monocular distance (4 m) logMAR visual acuity under bright 
lighting conditions with a high luminance, high contrast chart 
(bright HLHC), measured per 
 and 
Secondary endpoints:
x
Lens fit acceptance, measured per 
Other endpoints:
x
Monocular distance (4 m) logMAR visual acuity under dim
lighting conditions with a low luminance, high contrast chart 
(dim LLHC), measured per 
 and 
x
Monocular distance (4 m) logMAR visual acuity under bright 
lighting conditions with a high luminance, low contrast chart 
(bright HLLC), measured per 
and
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x
Lens centration and movement characteristics, measured per 
x
Slit lamp findings, measured per 
x
Subject reported ocular symptoms, measured per 
x
Pupil diameter (mm), measured per 
Study Design
This is a multi-center, randomized, controlled, double-masked, 2x2 
cross-over, non-dispensing study. Each subject will be bilaterally fitted 
with one of the two test articles in each of the two periods during a single 
visit, which includes:
Visit 1: Subject screening, baseline evaluation, randomization, lens fit 
#1 and #2, and final evaluation 
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 67 subjects will be enrolled in the study with a minimum 
of 56 subjects targeted to complete the study.
Study Duration
The total duration of the study (anticipated first subject first visit and last 
subject last visit) is maximal 10 weeks, including up to 10 weeks of
enrollment period.
Anticipated Study 
Population
Healthy male and female children between 7 and 12 years of age 
(inclusive) 
with
non-vertex 
corrected
best 
sphere 
refraction 
between -0.75 D and -4.50 D (inclusive), with 1.00 D or less astigmatism
in each eye. Potential subjects can be spectacle lens wearers, current soft 
lens wearers, or symptomatic myopes (e.g., with complaints of blurry 
vision) currently without correction. There are no restrictions as to 
race/ethnicity of the subject.
Eligibility Criteria –
Inclusion
Potential subjects must satisfy all of the following criteria to be enrolled 
in the study:
Inclusion Criteria following Screening:
The subject must:
1. The subject’s parents or legal guardians must read, understand, and 
sign the STATEMENT OF INFORMED CONSENT (Parental 
Permission Form and Authorization to Use and Disclose Medical 
Information). The subject must read (or be read to) and sign the 
CHILDREN’S ASSENT (Information and Assent Form) and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. Between 7 and 12 (inclusive) years of age at the time of screening.
4. Have normal eyes (i.e., no ocular medications or infections of any
type).
Inclusion Criteria following Baseline Evaluation:
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5. Have non-vertex corrected subjective spherical distance refraction 
in the range of -0.75 D to -4.50 D (inclusive) in each eye.
6. Have refractive cylinder in the range of 0.00 D to -1.00 D
(inclusive) in each eye with any degree of axis, by subjective 
sphero-cylindrical refraction. 
7. Have sphero-cylindrical best-corrected visual acuity of 0.04 
logMAR (20/20-2) or better in each eye, and the difference of 
sphero-cylindrical best-corrected visual acuity between the two 
eyes is less than 0.20 logMAR (2 lines).
8. Have < 1.50 D difference in subjective best-sphere refraction 
between the two eyes.
Eligibility Criteria –
Exclusion
Potential subjects who meet any of the following criteria will be 
excluded from participating in the study:
Exclusion Criteria following Screening:
The subject must not:
1. Currently pregnant or lactating.
2. Have any systemic disease (e.g., Sjögren’s Syndrome), allergies, 
infectious disease (e.g., hepatitis, tuberculosis), contagious 
immunosuppressive diseases (e.g., HIV), autoimmune disease 
(e.g., rheumatoid arthritis), any underlying medical condition that 
makes subjects at risk of severe COVID complications, or other 
diseases, by parent of legal guardian’s 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. See section 9 for additional details regarding excluded
systemic medications. 
4. Any current use of ocular medication (occasional use of re-wetting 
drops is allowed).
5. Any previous or planned (during the course of the study) ocular 
surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Participation in any contact lens or lens care product clinical trial 
within 30 days prior to study enrollment.
7. Current or recent (within 60 days from enrollment) wear of 
orthokeratology lenses.
8. Current or recent (within 30 days from enrollment) rigid lens 
wearers.
9. Immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician).
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10. Children who are wards of the State or any other agency,
institution, or entity.
Exclusion Criteria following Baseline:
11. Any ocular allergies, infections or other ocular abnormalities that 
are known to interfere with contact lens wear and/or participation 
in the study. This may include, but not be limited to entropion,
ectropion, extrusions, chalazia, recurrent styes, ocular 
hypertension, glaucoma, history of recurrent corneal erosions, 
aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, 
keratoconus suspect, and pellucid marginal degeneration.
12. Grade 3 or greater palpebral conjunctival observations or any other 
Grade 2 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, conjunctival injection) on the 
ISO 11980 classification scale.
13. Any previous history or signs of a contact lens-related corneal 
inflammatory event (e.g., past peripheral ulcer or round peripheral 
scar), or any other ocular abnormality that may contraindicate 
contact lens wear or subjects’ participation in the study.
14. Any central corneal scar.
15. Any corneal distortion resulting from ocular diseases or previous 
hard or rigid gas permeable contact lens wear.
16. Binocular vision abnormality, intermittent strabismus or 
strabismus.
17. Pupil diameter under bright illumination is less than 2 mm in 
either eye.
Disallowed 
Medications/Intervent
ions
Disallowed medications for this study include:
Any medication and therapies that would normally contraindicate 
contact lens wear or have ocular side effects that would affect vision 
assessment.
Concomitant therapies that are disallowed include:
1. Contact lens corneal reshaping/CRT/orthokeratology
2. Any vision training/vision therapy/orthoptics/patching
3. Any therapies that the investigator feels would be contraindicated 
in contact lens wear or would affect vision assessment.
See section 9.1 for details regarding disallowed systemic medications.
Measurements and 
Procedures
x ETDRS logMAR distance visual acuity under dim LLHC, bright 
HLLC and bright HLHC conditions (OD, OS)
x Subjective lens fit assessment (OD, OS)
x Pupil diameter (OD, OS) 
x Subject’s reported ocular symptoms (OD, OS)
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x Slit lamp examination per the ISO 11980 grading scale (OD, OS)
Microbiology or 
Other Laboratory 
Testing 
None.
Study Termination
The occurrence of an Unanticipated Adverse Device Effect (UADE) or 
Serious Adverse Event (SAE) for which a causal relationship to a test 
article cannot be ruled out, will result in stopping further fitting
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
• Precision Vision® distance (4-meter) high (Charts 1 – 4) and low 
(Chart 1 and 2) contrast ETDRS logMAR visual acuity charts.
• Precision Vision® LED Illuminator Cabinet
• Precision Vision® large mesopic filter for ETDRS Illuminator Cabinet
• Sekonic light meter
• Eye-Cept® Rewetting Drops by Optics® Laboratories
• Fluorescein GloStrips® 0.6 mg or equivalent
Principal
Investigator(s) and 
Study
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and institutions is kept 
separately from the Study Protocol and is included in the study Trial 
Master File.
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Figure 1: Study Flowchart
Potential Subjects Identified Based On:
Age: 7 - 12 yrs (inclusive) 
Ethnicity: any
Best sphere refraction: -0.75D to -4.50D
Cylinder: 1.00D or lower
General Population
Visit 1 
Trial fitting #2
Repeat all procedures under Trial fitting #1
Final Evaluation
Visit 1
Screening, Baseline
x Subjective sphero-cylindrical refraction with BSCVA (OD, OS)
x
Subjective best-sphere refraction with VA (OD, OS)
x
Cover test
x
Slit lamp examination
x
Corneal distortion
x
Pupil diameter
Randomization
Visit 1 
Trial fitting #1
x
Lens fit assessment
x
Over lens Snellen VA
x
Over refraction
Power modification?
Yes
x
LLHC, HLLC, HLHC ETDRS VA (OD, OS)
x
Visual experience
x
Subject reported ocular symptom
No
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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
AL
Axial Length
BCVA
Best Corrected Visual Acuity
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CI
Confidence Interval
CLWT
Cumulative Lens Wear Time
CRO
Contract Research Organization
CT
Center Thickness
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
LSM
Least-square mean
MedDRA©
Medical Dictionary for Regulatory Activities
MK
Microbial Keratitis
MOP
Manual of Procedures
MPMVA
Maximum Plus to Maximum Visual Acuity
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
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OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
PI
Principal Investigator
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SECAR
Spherical Equivalent Cycloplegic Auto Refraction
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
 
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1.
INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision Care (JJVC) has developed a soft contact lens prototype 
(EMO-118) for the purpose of controlling myopia progression in pediatric populations. A six-
month dispensing clinical trial (
) was conducted, which indicated that EMO-118 lens 
was efficacious in slowing myopia progression in children between 7 and 12 years of age after
6 months of wear. 5 The EMO-118 lens is further evaluated in a longer-term, pivotal study 
(
) for the purpose of demonstrating the safety and efficacy of the lens meeting specific 
requirements from heath authorities. 
 study is currently on-going.
The EMO-200 lens is a “re-design” of EMO-118 for supporting market launch. Both EMO-
118 and EMO-200 lenses have the same geometry and optical design, and are in the same 
senofilcon A material. The “re-design” was driven by upgrades to the lens design system to 
enable metrology of the complex optics on the lens plastic molds. In other words, the EMO-118 
lens design was “re-generated” using the upgraded lens design system and was given a new 
lens design code of EMO-200. As documented in
, the two lens designs are 
equivalent. Based on the thorough comparison between the EMO-118 and EMO-200 lenses
with considerations of equivalency of lens design, product specifications, test methods, raw 
materials, and/or manufacturing process, it is determined that it is prudent to confirm the 
clinical performance of the EMO-200 lens in a sample of pediatric patients that the lens is 
intended to be used.
The purpose of the study is to demonstrate that the redesigned EMO-200 lens is non-inferior 
to the EMO-118 with regards to visual performance and lens fit acceptance. These two 
endpoints are selected as surrogate assessments of the optics introduced to the eye that drives 
myopia control.
1.1.
Name and Descriptions of Investigational Products  
The two investigative lenses of the study are EMO-200 (Test lens) and EMO-118 (Control 
lens). Both the Test and Control lenses are made of the same materials using the same 
manufacturing process as the ACUVUE OASYS® Brand Contact Lenses with HydraLuxe™ 
Technology (cleared by FDA under K042275). Both lenses have the same optical design 
intended for controlling the progression of myopia through introducing relative plus powers to 
the lens, and both lenses have the same diameter and base curve. As specified in the technical 
report (
), the two lens designs are equivalent. 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 soft contact lenses (Test: EMO-200, Control: EMO-
118) is for correcting myopia and slowing axial elongation and myopia progression in children.
Both lenses are intended to be worn in daily disposable modality. During this study, each
subject will wear both test articles once within one study visit (one lens type in each of the two 
periods). Each lens type will be worn by the subject binocular for up to 2 hours. This is a non-
dispensing study; no study lenses will be dispensed to the subjects to take home to wear.
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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
investigational lens refer to the latest version of the Investigator's Brochure for EMO Design 
Family Lenses.6
1.4.
Summary of Known Risks and Benefits to Human Subjects 
The benefit of controlling myopia progression is considered to be substantial7as the prevalence 
of myopia has been increasing over the past few decades.8-10Because myopia increases the risk 
of diseases such as cataract, glaucoma, peripheral retinal degeneration, retinal detachment, and 
myopic macular degeneration,11 myopia is likely to become a leading cause of permanent 
sight-loss.12-14 Research has shown that early onset of myopia and moderate amount of myopia 
at young age are risk factors for future high degrees of myopia,15 while “slowing myopia by 1 
diopter should reduce the likelihood of a patient developing myopic macular degeneration by 
40%”.16 As such, 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.17
The risks associated with the wear of contact lenses for myopia control include 1) contact lens 
risks in the general population; 2) contact lens risks in a pediatric population; and 3) risks 
specifically associated with EMO family of lenses, such as potential sub-optimal visual 
performance and long-term physiological and/or neurological impact. 
Assessments regarding contact lens risks in general and in the pediatric population concluded 
that the risks associated with the EMO investigational lenses are expected to be the same as 
those normally attributed to the wear of soft hydrophilic contact lenses on a daily wear basis. 
The daily disposable modality of the investigational lenses further reduces risks associated 
with lens care and the use of care products (e.g., 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. In addition, the most recent review of the
safety of contact lens wear in children concluded that “the incidence of corneal infiltrative 
events in children is no higher than in adults, and in the youngest age range of 8 to 11 years, it 
may be markedly lower”.18 In addition, in all JJVC-sponsored prospective, pediatric soft 
contact lens trials for myopia control to date, which involves 920 patient-years of daily 
disposable soft contact lens wear in children (aged 7 – 15 years at baseline), there have been 
no serious or significant ocular adverse events (AE) reported.5,19 The rates of contact lens 
related non-significant ocular AEs were found to be consistent with those reported in the 
literature and are similar to, if not less than, the rate for adults, supporting the conclusion that 
children can safely wear daily disposable soft contact lenses. 
Due to the unique optical design of the EMO lenses, 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 (e.g., blurry vision or 
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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 visual acuity and
refraction over the study lens. There has been no evidence in the literature suggesting any long-
term physiological or neurological risks associated with children being exposed to chronic 
myopic defocus (e.g., due to under correction) or to multi-focal optical interventions. For
example, there have been no reports of loss of best corrected visual acuity in published 
pediatric clinical trials utilizing various methods for myopia control purposes or in any prior 
JJVC conducted myopia control trials.5,20-26 Because the current study is a non-dispensing
study and the maximum lens exposure time for each subject is 4 hours in total, contact lens 
risks in pediatric population and potential long-term physiological/neurological impact are not 
applicable.
Given the infrequency of adverse events in soft contact lens wearing children and the non-
serious nature of the vast majority of these events versus the potential benefit from slowing the 
progression of myopia, it is proposed that the benefits of slowing myopia progression outweigh 
the risks associated with daily disposable soft contact lens wear in children. This assessment 
is supported by Gifford et al., who compared the absolute lifetime risk of vision impairment 
from myopia to the childhood and lifetime risks of contact lens wear for myopia control. The 
authors concluded that “The comparative lifetime risks of contact lens wear commenced at age 
8 for myopia control are less than the lifetime risks of vision impairment with myopia more 
than 6D or axial length more than 26 mm. When only childhood CL wear is considered, the 
risk comparison is clearly skewed towards the positive impact of CL wear, especially in daily 
disposable wear.”27
For the most comprehensive risk and benefit information regarding the EMO lenses refer to
the latest version of the Investigator's Brochure for EMO Design Family Lenses.6
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 of 
contact lens safety and myopia control with soft contact lenses. Potential applicable literature
was identified through a literature search on PubMed.org dated since 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 EMO Design Family Lenses.6
To date, there have been five clinical studies involving the EMO-118 lens
 were both non-dispensing 
pilot studies with a primary objective of evaluating the visual performances of EMO lens 
design prototypes with
 being conducted in an adult population and 
 in a 
pediatric population.
 was a non-dispensing study including pediatric and your adult 
subjects for assessing the accommodative response with multiple designs of EMO lenses
including EMO-118.
(on-going) were myopia control clinical trials in 
7-12 years old children with the EMO-118 lens dispensed for wear for 6-month and at a
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minimum, 3 years, respectively. For detailed information regarding prior clinical data refer to 
the latest version of the Investigator's Brochure for EMO Design Family Lenses.6
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
To compare visual acuity and lens fit performance of EMO-200 with EMO-118 lens.
Primary Objective:
To demonstrate that visual acuity of EMO-200 lens is non-inferior to EMO-118 lens.
Secondary Objective: 
To demonstrate that lens fit performance of EMO-200 lens is non-inferior to EMO-118 lens.
2.2.
Endpoints  
Primary endpoint:
x
Monocular distance (4 m) logMAR visual acuity under bright lighting conditions with 
a high luminance, high contrast chart (bright HLHC), measured per 
Monocular distance logMAR visual acuity under bright HLHC conditions will be collected 
post-lens fitting for each subject eye using the Precision Vision 4-meter high contrast 
ETDRS charts. One measurement per eye (OD and OS) will be collected. See Sections 7.2
and Appendix D for details regarding primary endpoint data collection.
Secondary endpoints:
x
Lens fit acceptance, measured per 
Lens fit acceptance will be assessed post lens fitting for each subject eye. Acceptable fit is 
a binary response where Y=1 if lens fit is deemed acceptable by the investigator and Y=0 
otherwise. An unacceptable fit is deemed by one of the following criteria: 
x
limbal exposure at primary gaze or with extreme eye movement;
x
edge lift;
x
excessive movement in primary and up gaze; or 
x
insufficient movement in all three of the following conditions: primary gaze, up 
gaze, and Josephson push up.
See Sections 7.2 and Appendix D for details regarding secondary endpoint data collection.
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Disclose Medical Information). The subject must read (or be read to) and sign the 
CHILDREN’S ASSENT (Information and Assent Form) and receive a fully executed copy 
of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 7 and 12 (inclusive) years of age at the time of screening.
4. Have normal eyes (i.e., no ocular medications or infections of any type).
Inclusion Criteria following Baseline Evaluation:
5. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D 
to -4.50 D (inclusive) in each eye.
6. Have refractive cylinder in the range of 0.00 D to -1.00 D (inclusive) in each eye with any 
degree of axis, by subjective sphero-cylindrical refraction. 
7. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (20/20-2) or better 
in each eye, and the difference of sphero-cylindrical best-corrected visual acuity between 
the two eyes is less than 0.20 logMAR (2 lines).
8. Have < 1.50 D difference in subjective best-sphere refraction between the two eyes.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating
in the study:
Exclusion Criteria following Screening:
The subject must not:
1. Currently pregnant or lactating.
2. Have any systemic disease (e.g., Sjögren’s Syndrome), allergies, infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune 
disease (e.g., rheumatoid arthritis), any underlying medical condition that makes subjects 
at risk of severe COVID complications, or other diseases, by parent of legal guardian’s 
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. See section 9 for additional details 
regarding excluded systemic medications. 
4. Any current use of ocular medication (occasional use of re-wetting drops is allowed).
5. Any previous or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK, etc.).
6. Participation in any contact lens or lens care product clinical trial within 30 days prior to 
study enrollment.
7. Current or recent (within 60 days from enrollment) wear of orthokeratology lenses.
8. Current or recent (within 30 days from enrollment) rigid lens wearers.
9. Immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, 
Technician).
10. Children who are wards of the State or any other agency, institution, or entity.
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Exclusion Criteria following Baseline:
11. Any ocular allergies, infections or other ocular abnormalities that are known to interfere 
with contact lens wear and/or participation in the study. This may include, but not be 
limited to entropion, ectropion, extrusions, chalazia, recurrent styes, ocular hypertension,
glaucoma, 
history 
of 
recurrent 
corneal 
erosions, 
aphakia, 
uveitis,
severe 
keratoconjunctivitis sicca, keratoconus, keratoconus suspect, and pellucid marginal 
degeneration.
12. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit 
lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival 
injection) on the ISO 11980 classification scale.
13. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., 
past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may 
contraindicate contact lens wear or subjects’ participation in the study.
14. Any central corneal scar.
15. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas 
permeable contact lens wear.
16. Binocular vision abnormality, intermittent strabismus or strabismus.
17. Pupil diameter under bright illumination is less than 2 mm in either eye.
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or other 
sources (e.g., media and school) utilizing Independent Ethics Committee (IEC) or Institutional 
Review Board (IRB) approved materials. 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This is a multi-center, randomized, controlled, double-masked, 2x2 cross-over, non-dispensing
study. Each subject will be bilaterally fitted with one of the two test articles in each of the two
periods during a single visit, which includes:
Visit 1: Subject screening, baseline evaluation, randomization, lens fit #1 and #2, and final 
evaluation
If a subject meets all edibility criteria, then they will be randomized to one of two lens wear 
sequences. Subjects will be fitted in a bilateral fashion in their first study lens per the 
randomization scheme. Study assessments will be performed on the first lens. After undergoing 
all assessments, the first study lens will be removed, and subjects will have a 15-minute 
washout period prior to be fit with their second lens per the randomization schedule. Study 
assessments will be conducted while wearing the 2nd study lens and final evaluations will be 
performed.
Study participants will have no access to test articles at study closure. 
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4.2.
Study Design Rationale 
This study is designed as a confirmatory clinical trial to demonstrate that visual acuity and fit 
acceptance of the EMO-200 lens is non-inferior to those of the EMO-118 lens using a 2×2
crossover design. Crossover designs are a well-established study design in which subjects are 
exposed to multiple treatments during different time periods. This design is cost effective and 
more efficient since it eliminates between-subject variability from the treatment comparisons. 
Subjects will be randomized into the two lens wear sequences: Test/Control or Control/Test. 
Randomization removes potential for systematic error or bias and balances both the known and 
unknown confounding factors that may affect the study outcomes. A potential limitation of 
crossover design is the carry-over effect from the previous treatment. A washout period of 15 
minutes with the subjects wearing their habitual correction before proceeding to Treatment 2 
Lens Fitting is considered to minimize the presence of any carry-over effect.
Both EMO-200 and EMO-118 lenses have the same optical design intended for myopia control 
in pediatric populations. They have the same diameter and base cure and are made in the same 
material. The EMO-200 lens is manufactured in Ireland for supporting commercialization. It 
is considered a “re-design” of the EMO-118 lens driven by upgrades to the lens design system 
to enable metrology of the complex optics on the lens plastic molds. Comparing lenses made 
under the code name of EMO-200 with those made under the code name of EMO-118, 
thorough assessments from aspects of lens design, product specifications, test methods, raw 
materials, and manufacturing process, suggest no reason to believe that the clinical 
performance of the two lenses would be different. The effectiveness of the optical design in 
myopia correction and slowing axial elongation and refraction change of the eye has been 
demonstrated in 
 with the EMO-118 lens. Any deviation in the EMO-200 lens from 
the intended optical and/or mechanical designs, which may lead to the lens potentially being 
less effective, will be manifested as differences in the lens visual performance and or fit 
performance, compared to the EMO-118 lens. As such, monocular distance visual acuity and 
lens fit acceptance of the EMO-200 lens are selected to be the primary and secondary endpoints 
of this investigation as surrogates in place of assessment of the lens long-term myopia control 
effect. In addition, subject reported ocular symptoms with the study lenses will be collected. 
4.3.
Enrollment Target and Study Duration 
Approximately 67 subjects will be enrolled in the study with a minimum of 56 subjects targeted 
to complete the study. The point of study enrollment is defined as the execution of the informed 
consent and assent at Visit 1.
Approximately 4 – 6 clinical sites in the United States will participate in the study. Each site 
is expected to screen (enroll) up to 17 subjects with a minimum 10 subjects completing the 
study. Subjects will be enrolled among participating clinical sites to ensure the target number 
of completed subjects is met.
The total duration of the study enrollment will be approximately 10 weeks, unless otherwise 
approved by the Sponsor.
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There will be one scheduled visit in this study. Eligible subjects will be bilaterally fitted with 
both test articles within one visit. The total duration of the study is expected to be 12 weeks 
(including the enrollment period).
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using a 2x2 crossover design 
with 2 lens types and 2 periods. Two lens types will be fit at one study visit. Using a computer-
generated randomization scheme provided by the study biostatistician, each subject will 
randomly be assigned to one of two unique sequences of the two lens types (Test/Control, or 
Control/Test).
Permuted block randomization will be used to avoid bias in the assignment of subjects to 
treatment, and to enhance the validity of statistical comparisons across treatment groups. Each 
block will contain two different lens trial sequences. The randomization scheme will be 
generated using the PROC PLAN procedure in Statistical Analysis System (SAS) Software 
Version 9.4 or higher (SAS Institute, Cary, NC, USA).32
The clinical site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects.
Randomization shall be performed at Visit 1. The following must have occurred prior to 
randomization: 
•
Informed consent must have been obtained.
•
The subject must have met all eligibility criteria.
•
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps shall be followed to maintain randomization 
codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule to obtain the test article assignment for that subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule.
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section.
5.2.
Masking 
Masking will be used to reduce potential bias. This is a double-masked study where subjects, 
investigators and clinical site personnel involved in the data collection will be masked to the 
identity of the assigned study lenses.
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6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. The test article will be 
over-labeled to mask the subject and investigators to the identity of the lens. The test articles 
will be in plastic bags as the secondary packaging form. The sample study label is shown 
below:
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to 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 articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting;
2. The number and reason for unplanned replacements.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
 
 
 
 
 
 
 
 
 
 
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8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent.
x
Subject not compliant to protocol (e.g., refusing any protocol specified procedure)
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 during the visit) from the subject and discard them, 
unless otherwise stated in section 7.2.
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include:
Any medication and therapies that would normally contraindicate contact lens wear or have 
ocular side effects that would affect vision assessment.
Concomitant therapies that are disallowed include:
1. Contact lens corneal reshaping/CRT/orthokeratology
2. Any vision training/vision therapy/orthoptics/patching
3. Any therapies that the investigator feels would be contraindicated in contact lens wear or 
would affect vision assessment.
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Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
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 apply and will be executed in parallel.  
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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: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications,
or progression of disease states.
Note: 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 adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
o
Life-threatening illness or injury
o
Permanent or persistent impairment of a body structure or a body function
o
Hospitalization or prolongation of patient hospitalization
o
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
o
Chronic disease
o
Foetal distress, foetal death or a congenital physical or mental impairment of 
birth defect.
Per ISO 11980, Serious adverse events are those events that result in, or have potential to cause, 
either permanent impairment of an ocular function or damage to an ocular structure, and may 
necessitate medical or surgical intervention.
Serious adverse events may include any hazardous, sight-threatening conditions occurring 
after exposure to test article, including but not limited to the following.
a) A presumed infectious ulcer (defined as a progressive erosion of the corneal tissue). 
Signs may include irregular focal infiltrates (> 1 mm); active lesions with raised edges; 
significant diffuse infiltration; anterior corneal to mid-stromal involvement; erosion 
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with overlying staining; conjunctival and lid edema; anterior chamber reaction (iritis); 
severe bulbar and limbal redness. Symptoms associated with a presumed infectious 
ulcer (microbial keratitis) may include pain of rapid onset; severe redness; purulent or 
mucopurulent discharge; tearing; photophobia. For the purposes of reporting, a corneal 
ulcer which has any of the following characteristics should be considered in this 
category:
1) central or paracentral location;
2) penetration of Bowman̓s membrane;
3) infiltrate > 2 mm diameter;
4) associated with iritis Ӌ grade 2;
5) associated with any increase in intraocular pressure;
6) culture positive for microorganisms;
7) increasing size or severity at subsequent visits.
b) Any central or paracentral corneal event (such as vascularization) that results in 
permanent opacification.
c) Any serious adverse ophthalmic events including hypopyon and hyphema.
d) Any neovascularization within the central 6 mm of the cornea.
e) The loss of two or more lines of visual acuity that fail to resolve.
f)
All cases of iritis.
Diagnoses and conditions that are considered Ocular Serious Adverse Events that may occur 
during this study 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 – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear or require medical treatment
to maintain normal ocular health.
Per ISO 11980, significant but non-serious adverse events should include, but not be limited 
to:
–
peripheral non-progressive non-infectious ulcers;
–
all symptomatic corneal infiltrative events;
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–
all cases of corneal staining greater than or equal to grade 3;
–
a temporary loss of two or more lines of best corrected visual acuity (for greater than 
or equal to 2 weeks);
–
cases greater than or equal to grade 2 neovascularization;
–
any ocular event that necessitates temporary lens discontinuation of greater than or 
equal to 2 weeks.
Diagnoses and conditions that are considered Ocular Significant Adverse Events that may 
occur during the study include, but not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
In addition to above identified serious and significant adverse events, below are examples of 
other diagnoses and conditions that may occur during the study. The classification of these 
adverse events should be based on the above-specified definitions.
x
Non-significant Infiltrative Event (NSIE), if it is < Grade 2, non-symptomatic, and does 
not require medication
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
Note 1: 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: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is 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 
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degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or 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, or severe - see definition in 
section 13.1).
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, or other.
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely.
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g.
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
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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) begin 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 and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), 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, if the AE is related to the visual system.
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Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
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 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 
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subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.
13.5. Events of Special Interest 
None identified.
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13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. 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 
This section is a general outline of the statistical methods that will be implemented in this 
clinical trial. More details will be included in the stand-alone Statistical Analysis Plan (SAP). 
The standalone SAP will be finalized and signed prior the database lock and unmasking. 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software version 
9.4 or higher (SAS Institute, Cary, NC, USA).32 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.
14.2. Sample Size Justification 
This study was designed and powered to demonstrate non-inferiority of the Test lens (EMO-
200) compared to the Control lens (EMO-118) with respect to monocular distance logMAR 
visual acuity under bright HLHC and lens fit acceptance after 10-minute lens settling period. 
The ample size was calculated for both the primary and secondary endpoints to achieve a 
minimum statistical power of 80% using a 2-sided type I error of α=0.05 based on historical 
data from 
 was a 2×2 crossover study with two study lenses (EMO-116 
and EMO-118). In 
 all eyes had acceptable lens fit. Table 6 below presents the 
descriptive statistics of monocular logMAR visual acuity under bright HLHC at fitting 
observed from 
.
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Lens Fit 
Acceptance
Non-inferiority (-10%)
56
81%
As indicated in Table 7 above, the sample size chosen for this study was primarily driven by 
lens fit acceptance in order to achieve a statistical power of at least 80% for both primary and 
secondary endpoints. The plan is to enroll approximately 67 subjects with a target of 56 to 
complete the study. 
14.3. Analysis Populations 
The following analysis populations will be defined and used in the analysis and presentation 
of the data.
All Enrolled:
All Enrolled Population includes all subjects with recorded data in the electronic Case Report 
Form (eCRF) database.
Intent-To-Treat (ITT):
Intent-to-treat will include all the subjects who were randomized to study treatment. Subjects 
will be analyzed as per randomized treatment. At least one observation should be recorded.
Subjects with major protocol deviations, including, but not limited to non-compliant to 
protocol specified lens wear time requirements, ineligible subjects who were inadvertently 
randomized and primary endpoint measurements collected without or with non-valid device 
verifications, etc., will be included in the ITT analyses.
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation for safety endpoints should be recorded 
(e.g., ocular symptom, slit-lamp finding, etc.) on or after treatment start date. Subjects will be 
analyzed as per treatment received.
Per Protocol (PP)
All subjects who have completed the study and did not substantially deviate from the protocol 
as determined by the trial cohort review committee prior to database hard lock. Justification of 
excluding subjects with protocol deviations in the per-protocol population set will be 
documented in a memo to file. See Section 10 for definition and examples of major deviations.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5.  Primary Analysis 
Non-inferiority of Test compared to Control with respect to the primary endpoint of monocular 
logMAR visual acuity will be assessed on the Per-protocol population (PP). 
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Monocular Distance logMAR Visual Acuity (VA)
Monocular distance logMAR VA under bright HLHC will be analyzed using a linear mixed 
model to compare the Test and Control lenses after a 10-minute lens setting period. The model 
will include lens type, lens sequence, and period as fixed effects. Other subject characteristics 
such as age, gender and race will be included as fixed covariates when appropriate. Site and 
subject will be included in the model as random effects (G-side). The covariance of residuals 
between measurements on the same eye across periods within the same subject (R-side) will 
be modeled using Unstructured (UN) covariance structure. If the model does not converge, 
then other covariance structures, such as compound Symmetry (CS) covariance structure, will 
be considered. The Kenward and Roger method (Kenward & Roger, 1997)35 will be used for 
the denominator degree of freedom. 
Hypothesis Testing
The null and alternative hypotheses for testing non-inferiority of the Test lens relative to the 
Control lens with respect to logMAR visual acuity are as follows: 
ܪ଴: ߤ்− ߤ஼≥0.05
ܪ஺: ߤ்− ߤ஼ < 0.05
Where, ߤ்represents the mean logMAR VA score for the Test lens and ߤ௖represents the mean 
logMAR VA score for the Control lens. Non-inferiority will be declared if the upper bound of 
the 2-sided 95% confidence interval of the difference (Test – Control) is less than 0.05.
14.6. Secondary Analysis 
Non-inferiority of Test compared to Control with respect to the secondary endpoint of lens fit 
acceptance will be assessed on the safety population. 
Let ܻଵand ܻଶdenote the binary outcomes of lens fit acceptance (Yes/No) in left and right eyes, 
respectively, when wearing a study lens. Considering the correlation, ߩ, between ܻଵand ܻଶ, the 
distribution of the sum ܻ = ܻଵ + ܻଶis obtained by the mixture of two variables. One of them 
follow a binomial distribution ܤ݅݊(2, ݌) with mixing probability (1 − ߩ) and the other one 
follows a modified Bernoulli distribution, ܯܤ݁ݎ݊(݌), taking value 0 and 2 rather than 
conventional 0 and 1, with mixing probability ߩ:
ܲ(ܻ =  ݕ| ݌, ߩ) = (1 − ߩ)ܤ݅݊(2, ݌)ܫ஺ଵ +   ߩܯܤ݁ݎ݊(݌)ܫ஺ଶ ,
where ܫ஺ଵ = {0, 1, 2}, ܫ஺ଶ= {0, 2} and ݌is the probability of success (i.e., acceptable lens 
fitting).
To overcome the complexity of the mixture likelihood a latent variable ܼ௜, i = 1, 2 is introduced 
in the model to indicate in which component of the model the observation ݕ௜, i=1, 2, belongs 
to, that is,
ܼ௜= ൜1, if the observation belong to the MBern(p),
0, if the observation belong to the Bin(2, p)  
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The joint distribution of the augmented data (ܻ௜, ܼ௜), ݅= 1, 2, is given by
P(Y = y୧, Z = z୧| p, ρ)
=  ρ୸౟p୷౟୸౟/ଶ(1 −p)(ଶି୷౟)୸౟/ଶ(1 −ρ)ଵି୸౟൬2
y୧൰p୷౟(ଵି୸౟)(1 −p)(ଶି୷౟)(ଵି୸౟)
The probability p links to the regression covariates through a logit transformation as follow:
logit (p) =  β଴+ βଵlens +  δ + ߛ
It is assumed that β଴, βଵ and ρ to be independent with a non-informative prior N(0,1000) for 
β଴ and βଵ, and beta(0.5,0.5) for ρ. δ and ߛare the subject-specific and site-specific random 
effects, respectively. We assume random subject effects are independent and identically 
distributed as  δ ~ N(0, ߪ௦௨௕௝
ଶ
) and random site effects are independent and identically 
distributed as  ߛ~ N(0, ߪ௦௜௧௘
ଶ
). For the variances of random subject and site effects, an 
independent non-informative conjugate prior inverse-gamma(0.001, 0.001) will be used. The 
Metropolis sampler algorithm as implemented in the SAS/STAT MCMC Procedure (SAS 
Institute Inc., 2015)36 will be used to estimate the posterior distributions of the parameters (β଴,
βଵ, ρ). Inferences will be made based on a posterior credible interval for the relevant 
parameters.
Hypothesis Testing
The null and alternative hypotheses for testing non-inferiority of Test relative to Control are as 
follows:
H଴: p୘− pେ≤−0.1
Hଵ: p୘− pେ> −0.1,
where p୘and pେare the probability of success (i.e., acceptable lens fitting) for Test lens and 
Control lens, respectively. Non-inferiority will be declared if the posterior probability p(݌்−
 ݌஼> −0.1|data) ≥.975.
In the case of all eyes have an acceptable lens fit (i.e., zero unacceptable lens fit), a Bayesian 
hierarchical model accounting for zero event problem will be considered (Chen & McGee,
2008).37 Details of this model will be provided in the stand-along SAP.
14.7. Other Analyses 
Summary statistical analysis will be provided for the following other observations:
Other endpoints:
x
Monocular distance (4 m) logMAR visual acuity under dim lighting conditions with a 
low luminance, high contrast chart (dim LLHC), measured per 
x
Monocular distance (4 m) logMAR visual acuity under bright lighting conditions with 
a high luminance, low contrast chart (bright HLLC), measured per
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x
Lens centration and movement characteristics, measured per 
x
Slit lamp findings, measured per 
x
Subject reported ocular symptoms, measured per 
x
Pupil diameter (mm)
Further exploratory analysis will be considered if necessary, at discretion of the Study
Responsible Clinician.
14.8. Interim Analysis 
There will not be an interim analysis performed on this study. 
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.
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.
External Data Sources for this study include: Not applicable.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data into the eCRF.  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 record 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 
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Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. ClinicalTrials.gov  
The study will be registered on clinicaltrial.gov by the Sponsor.
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 
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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.
16.4. Data Monitoring Committee (DMC) 
Not applicable.
17. CLINICAL 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:
•
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained.
•
Ensuring the rights and wellbeing of subjects are protected.
•
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
•
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable.
•
Ensuring that the clinical site has sufficient test article and supplies.
•
Clarifying questions regarding the study.
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•
Resolving study issues or problems that may arise.
•
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 their parents/legal guardians will be fully informed of the risks and 
requirements of the study and, during the study, subjects and their parents/legal guardians will
be given any new information that may affect their decision to continue participation. Subjects
and their parents/legal guardians 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 whose parents are fully 
able to understand the risks, benefits, and potential adverse events of the study, and provide 
their consent voluntarily, and subjects who provide their assent 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(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
1. Final protocol.
2. Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
3. Investigator’s Brochure (or equivalent information).
4. Sponsor-approved subject recruitment materials.
5. Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
6. Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB).
7. Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects.
8. Any other documents that the IEC/IRB requests to fulfill its obligation.
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This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
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:
•
Protocol revisions
•
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
•
If applicable, new or revised subject recruitment materials approved by the Sponsor
•
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
•
Investigator’s Brochure revisions
•
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
•
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
•
New information that may adversely affect the safety of the subjects or the conduct of 
the study
•
Major protocol deviations as required by the IEC/IRB
•
Report of deaths of subjects under the Investigator's care
•
Notification if a new Investigator is responsible for the study at the clinical site
•
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject must give written assent and their parents (legal guardians) must give written 
consent according to local requirements after the nature of the study has been fully explained. 
The consent and assent forms must be signed before performance of any study-related activity. 
The consent and assent forms that are used must be approved by both the Sponsor and by the 
reviewing IEC/IRB. The informed consent and assent are in accordance with principles that 
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originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable 
regulatory requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject and the parent (legal guardian) the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study, and any discomfort it may 
entail. Subjects and their parents (legal guardians) will be informed that their participation is 
voluntary and that they may withdraw consent to participate at any time. 
The subject and parent (legal guardian) will be given sufficient time to read the Information 
and Assent form and the informed consent form (Parental Permission Form and Authorization 
to Use and Disclose Medical Information), respectively, and the opportunity to ask questions. 
After this explanation and before entry into the study, assent and consent should be 
appropriately recorded by means of the subject's and parent/legal guardian’s dated signatures.
After having obtained the consent and assent, a copy of the informed consent and assent forms
must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States,38 and other applicable personal data protection and security laws and 
regulations. Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
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•
processed fairly and lawfully.
•
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes.
•
adequate, relevant, and not excessive in relation to said purposes.
•
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP,2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
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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 is a multicenter study. The participating institution and Principal Investigations for this
study agree that, should this study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint, multicenter publication 
of the study results with the investigators and the institutions from all appropriate sites
contributing data, analyses and comments.
22. REFERENCES 
1.
ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects -
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2.
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). 
Available at: https://www.ich.org/page/efficacy-guidelines.
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.
United
States (US)
Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.
5.
Cheng X. Clinical Report 
 Evaluating Soft Contact Lens 
Prototypes for Myopia Control. October 25, 2019.
6.
Cheng X. Investigator's Brochure: EMO Design Family Lenses. Version 3. April, 
2021.
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7.
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.
8.
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.
9.
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.
10.
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):e1-11.
11.
Ikuno Y. Overview of the Complications of High Myopia. Retina. 2017;37(12):2347-
2351.
12.
Tsai ASH, Wong CW, Lim L, et al. PEDIATRIC RETINAL DETACHMENT IN AN 
ASIAN POPULATION WITH HIGH PREVALENCE OF MYOPIA: Clinical 
Characteristics, Surgical Outcomes, and Prognostic Factors. Retina. 2019;39(9):1751-
1760.
13.
Jones D, Luensmann D. The prevalence and impact of high myopia. Eye Contact Lens.
2012;38(3):188-196.
14.
Tideman JW, Snabel MC, Tedja MS, et al. Association of Axial Length With Risk of 
Uncorrectable Visual Impairment for Europeans With Myopia. JAMA ophthalmology. 
2016;134(12):1355-1363.
15.
Chua SY, Sabanayagam C, Cheung YB, et al. Age of onset of myopia predicts risk of 
high myopia in later childhood in myopic Singapore children. Ophthalmic Physiol Opt. 
2016;36(4):388-394.
16.
Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis 
Sci. 2019;96(6):463-465.
17.
Gifford KL, Richdale K, Kang P, et al. IMI - Clinical Management Guidelines Report. 
Invest Ophthalmol Vis Sci. 2019;60(3):M184-M203.
18.
Bullimore MA. The Safety of Soft Contact Lenses in Children. Optom Vis Sci. 
2017;94(6):638-646.
19.
Cheng X, Brennan NA, Toubouti Y, Greenaway NL. Safety of soft contact lenses in 
children: retrospective review of six randomized controlled trials of myopia control. 
Acta Ophthalmol. 2019.
20.
Cheng X. Clinical Report 
 Controlling Myopia 
Progression with Spherical Aberration in Soft Contact Lenses. April 25, 2013.
21.
Cheng X. Clinical Report 
Controlling Myopia 
Progression with Spherical Aberration in Soft Contact Lenses. April 29, 2013.
22.
Cheng X. Clinical Report 
 Controlling Myopia 
Progression with Soft Contact Lenses. April 27, 2013.
23.
Cheng X. Clinical Report 
 Controlling Myopia 
Progression with Soft Contact Lenses. April 30, 2013.
24.
Cheng X. Clinical Report
 Controlling Myopia 
Progression with Soft Contact Lenses. April 28, 2013.
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25.
Cheng X. Clinical Report 
 Controlling Myopia 
Progression through Optical Intervention. May 21, 2017.
26.
Cheng X. Investigator's Brochure: 
October 10, 2017.
27.
Gifford KL. Childhood and lifetime risk comparison of myopia control with contact 
lenses. Cont Lens Anterior Eye. 2020;43(1):26-32.
28.
Cheng X. Clinical Protocol 
 Evaluating Accommodative
Responses of Soft Contact Lenses for Myopia Control. March 27, 2018.
29.
Cheng X. Clinical Protocol 
 Evaluating a soft contact 
lens for myopia control. 2019.
30.
Cheng X. Clinical Report 
 Evaluation of Visual 
Performances of Soft Contact Lens Prototypes for Myopia Control. December 8, 2017.
31.
Nixon A. Clinical Report 
 Evaluation of Vision and Fit 
Performance of a Soft Contact Lens for Myopia Control. May 29, 2020.
32.
SAS® 9.4 Statements: Reference. Third ed. Cary, NC: SAS Institute Inc; 2014.
33.
Stroup WW. Mixed model procedures to assess power, precision, and sample sizes.
Alexandria, VA: American Statistical Association; 1999.
34.
Diniza CAR, Tutiab MH, Leitea JG. Bayesian analysis of a correlated binomial model. 
Brazilian Journal of Probability and Statistics. 2010;24(1):68-77.
35.
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997(53):983–997.
36.
SAS/STAT® 14.1 User’s Guide. Cary, NC: SAS Institute Inc; 2015.
37.
Chen Z, McGee M. A Bayesian Approach to Zero-Numerator Problems Using 
Hierarchical Models. Journal of Data Science. 2008(6):261-268.
38.
Health Information Portabiltiy and Accountabiltiy Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html.
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
AND CONTACT LENS CHECKLIST SPECIFICATIONS 
Not Applicable.
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
This will be provided separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Not Applicable.
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APPENDIX D: 
 
 
x
Lens Fitting Characteristics 
x
 Subject Reported Ocular Symptoms/Problems 
x
 Determination of Distance Spherocylindrical Refractive Error  
x
Distance and Near Snellen Visual Acuity Evaluation  
x
 Distance LogMAR Visual Acuity Measurement Procedure 
x
 Cover-Uncover Test 
x
, ISO Biomicroscopy Scale
x
 Measuring Pupil Diameter with NeurOptics VIP-200 Pupillometer and 
NeurOptics VIP®-300 Pupillometer 
x
 Visual Acuity Chart Luminance and Room Illumination Testing 
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 LENS FITTING CHARACTERISTICS 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
 
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DETERMINATION 
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 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION   
 
 
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DISTANCE 
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 COVER-UNCOVER TEST 
 
 
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 ISO BIOMICROSCOPY SCALE 
 
 
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 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 
PUPILLOMETER AND NEUROPTICS VIP®-300 PUPILLOMETER 
 
 
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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APPENDIX E: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR- 6441 Evaluating visual acuity and initial fit performance of 
two soft contact lenses
Version and Date: 2.0, 06 May 2021
I have read and understand the protocol specified above and agree on its content.
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2
the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion.
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct 
this study in compliance with local, state, governmental guidance for COVID-19 risks.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
CR-6441, v 2.0
 
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JJVC CONFIDENTIAL