Visual Performance of Soft Contact Lenses With Myopia Control Optics
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
Visual Performance of Soft Contact Lenses with Myopia Control Optics 
Protocol CR-6457  
Version: 4.0  
Date: 29 March 2022  
Investigational Products:  
Run-in: 
•
1 Day Acuvue Moist
Test: 
•
EMO-114
•
EMO-118
Control: 
•
MiSight 1 Day
Keywords: myopia, senofilcon A, etafilcon A, omafilcon A, daily wear, daily replacement, 
logMAR distance visual acuity, logMAR near visual acuity, patient-reported outcomes 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 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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Clinical Study Protocol 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 7 
SPONSOR NAME AND ADDRESS ....................................................................................... 7 
MEDICAL MONITOR ............................................................................................................. 7 
AUTHORIZED SIGNATURES ............................................................................................... 8 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS .............................................................................................................................. 11 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 19 
1.
INTRODUCTION AND BACKGROUND ................................................................... 21 
Name and Descriptions of Investigational Products ................................................ 21 
Intended Use of Investigational Products................................................................. 21 
Summary of Findings from Nonclinical Studies ...................................................... 22 
Summary of Known Risks and Benefits to Human Subjects ................................... 22 
 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 23 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 23 
Objectives ................................................................................................................. 23 
Endpoints .................................................................................................................. 24 
Hypotheses ............................................................................................................... 24 
3.
TARGETED STUDY POPULATION ........................................................................... 25 
General Characteristics ............................................................................................ 25 
Inclusion Criteria ...................................................................................................... 25 
Exclusion Criteria ..................................................................................................... 26 
Enrollment Strategy.................................................................................................. 27 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 27 
Description of Study Design .................................................................................... 27 
Study Design Rationale ............................................................................................ 27 
Enrollment Target and Study Duration .................................................................... 28 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 28 
Test Article Allocation ............................................................................................. 28 
Masking .................................................................................................................... 29 
Procedures for Maintaining and Breaking the Masking........................................... 29 
6.
STUDY INTERVENTION ............................................................................................. 29 
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Identity of Test Articles............................................................................................ 29 
Ancillary Supplies/Products ..................................................................................... 30 
Administration of Test Articles ................................................................................ 31 
Packaging and Labeling ........................................................................................... 31 
Storage Conditions ................................................................................................... 32 
Collection and Storage of Samples .......................................................................... 32 
Accountability of Test Articles ................................................................................ 32 
7.
STUDY EVALUATIONS .............................................................................................. 33 
Time and Event Schedule ......................................................................................... 33 
Detailed Study Procedures ....................................................................................... 35 
VISIT 1 ........................................................................................................................... 35 
VISIT 2 ........................................................................................................................... 43 
VISIT 3 ........................................................................................................................... 52 
VISIT 4 ........................................................................................................................... 53 
VISIT 5 ........................................................................................................................... 53 
FINAL EVALUATION .................................................................................................. 57 
Unscheduled Visits ................................................................................................... 58 
Laboratory Procedures ............................................................................................. 61 
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 61 
Completion Criteria .................................................................................................. 61 
Withdrawal/Discontinuation from the Study ........................................................... 62 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 62 
Systemic Medications .............................................................................................. 63 
10.
DEVIATIONS FROM THE PROTOCOL .................................................................. 64 
11.
STUDY TERMINATION ........................................................................................... 65 
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 66 
13.
ADVERSE EVENTS ................................................................................................... 67 
Definitions and Classifications ............................................................................. 67 
Assessing Adverse Events .................................................................................... 70 
13.2.1. 
Causality Assessment .................................................................................... 71 
13.2.2. 
Severity Assessment ...................................................................................... 71 
Documentation and Follow-Up of Adverse Events .............................................. 71 
Reporting Adverse Events .................................................................................... 73 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 73 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
74 
Event of Special Interest ....................................................................................... 74 
13.5.1. 
Specific Requirements for Recording and Diagnosing Possible Microbial 
Keratitis 74 
13.5.2. 
Loss of Best Sphero-cylindrical Corrected Visual Acuity without Physical 
Cause 
76 
Reporting of Pregnancy ........................................................................................ 76 
14.
STATISTICAL METHODS ........................................................................................ 76 
General Considerations ......................................................................................... 76 
Sample Size Justification ...................................................................................... 77 
Analysis Populations ............................................................................................ 78 
Level of Statistical Significance ........................................................................... 79 
Primary Analysis .................................................................................................. 79 
Secondary Analysis .............................................................................................. 80 
Other Exploratory Analysis .................................................................................. 80 
Interim Analysis ................................................................................................... 80 
Procedure for Handling Missing Data and Drop-Outs ......................................... 80 
Procedure for Reporting Deviations from Statistical Plan ................................... 81 
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 81 
Electronic Case Report Form/Data Collection ..................................................... 81 
Subject Record ...................................................................................................... 81 
Trial Registration on ClinicalTrials.gov ............................................................... 82 
16.
DATA MANAGEMENT............................................................................................. 82 
Access to Source Data/Document ........................................................................ 82 
Confidentiality of Information.............................................................................. 82 
Data Quality Assurance ........................................................................................ 82 
Data Monitoring Committee (DMC) .................................................................... 83 
17.
CLINICAL MONITORING ........................................................................................ 83 
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 83 
Study-Specific Design Considerations ................................................................. 83 
Investigator Responsibility ................................................................................... 84 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 84 
Informed Consent ................................................................................................. 85 
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Privacy of Personal Data ...................................................................................... 86 
19.
STUDY RECORD RETENTION................................................................................ 87 
20.
FINANCIAL CONSIDERATIONS ............................................................................ 87 
21.
PUBLICATION ........................................................................................................... 88 
22.
REFERENCES ............................................................................................................ 88 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 90 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 101 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 102 
APPENDIX D: 
 .................................... 139 
, Near LogMAR Visual Acuity Measurement Procedure .................................... 140 
, Lens Fitting Characteristics ................................................................................ 143 
, Subject Reported Ocular Symptoms/Problems .................................................. 149 
, Front and Back Surface Lens Deposit Grading Procedure ................................ 151 
, Determination of Distance Spherocylindrical Refractions ................................. 156 
, Distance and Near Snellen Visual Acuity Evaluation ........................................ 162 
, Distance LogMAR Visual Acuity Measurement Procedure .............................. 167 
, Patient Reported Outcomes ................................................................................ 171 
, White Light Lens Surface Wettability ............................................................... 173 
, Cover-Uncover Test ........................................................................................... 175 
, ISO Biomicroscopy Scale .................................................................................. 178 
, Visual Acuity Chart Luminance and Room Illumination Testing ..................... 187 
APPENDIX E: Fitting Guide 1-Day Acuvue® Moist Brand Contact Lenses ....................... 196 
APPENDIX F: Fitting Guide MiSight® 1 day ...................................................................... 225 
APPENDIX G: CR-6457 Lens Power Modification Guide ................................................. 233 
APPENDIX H: COVID-19 risk mitigation guidelines ......................................................... 236 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 248 
LIST OF TABLES 
Table 1: Test Articles .............................................................................................................. 30 
Table 2: Ancillary Supplies .................................................................................................... 31 
Table 3: Time and Events ....................................................................................................... 33 
Table 4: Disallowed systemic medications ............................................................................. 63 
Table 5: Disallowed systemic antihistamines ......................................................................... 64 
Table 6: Examples of major and minor protocol deviations ................................................... 65 
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Table 7: Descriptive Summaries of Binocular LogMAR Visual Acuity at 1-week Follow-up 
from 
 – Per Protocol Subjects ................................................................................... 77 
Table 8: Power Analysis for the Primary Hypothesis ............................................................. 78 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 18 
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Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
sponsor because this study is in the confirmatory clinical trial 
phase. 
 
Test Article(s) 
Investigational Products:  
Daily disposable soft contact lenses (SCL) made in senofilcon 
A material with the same parameters but differing optical 
designs 
• EMO-118 (Test 1) 
• EMO-114 (Test 2) 
 
Approved Products:    
• MiSight® 1 day, a SCL made in omafilcon A material 
approved by the US-FDA for slowing the progression 
of myopia in children (Control) 
• 1-Day Acuvue® Moist Brand Contact Lenses  
manufactured in etafilcon A material (Run-in period) 
 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily disposable 
 
Objectives  
Primary Objective 
The primary objective is to evaluate the logMAR visual 
performance of soft contact lenses featuring myopia control 
optical designs. 
 
Exploratory Objectives 
The exploratory objectives of the study are to assess:  
• logMAR visual performance at 4 m under varying 
luminance and contrast conditions 
• logMAR visual performance at 40 cm under high  and 
low contrast conditions   
• Patient-reported outcomes at fitting and follow-up 
• Assess safety through adverse events, slit lamp 
findings, and subject-reported ocular symptoms 
• Number of power modifications and over-refraction 
with first trial lens at fitting  
• Over-refraction at follow-up 
• Lens fitting characteristics 
 
Study Endpoints 
Primary endpoint(s):  
• Binocular distance (4 m) high luminance high contrast 
(HLHC) logMAR visual acuity, measured per 
 
 
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Primary safety endpoint: 
• Number (n, %) of subjects and eyes with contact lens 
related (i.e., related and possibly related) serious and 
significant ocular adverse events (AEs), including best 
corrected logMAR loss ≥ 0.20 logMAR (10 letters). 
 
Other exploratory endpoints: 
• Monocular HLHC logMAR visual acuity at 4 m 
• Binocular high luminance low contrast (HLLC) 
logMAR visual acuity at 4 m 
• Monocular HLLC logMAR visual acuity at 4 m 
• Binocular low luminance high contrast (LLHC) 
logMAR visual acuity at 4 m 
• Monocular LLHC logMAR visual acuity at 4 m 
• Binocular HLHC logMAR visual acuity at 40 cm 
• Binocular HLLC logMAR visual acuity at 40 cm 
• Subjective vision, comfort, and ease of handling 
• Non-significant AEs and non-ocular AEs 
• Slit lamp findings per the ISO 11980 grading scale 
• Subject-reported ocular symptoms 
• Number of contact lens insertion attempts per eye at 
fitting 
• Subjective best sphere over-refraction with the first 
trial lens 
• Subjective best sphere over-refraction at follow-up 
• Number of power modifications at fitting 
• Lens fitting characteristics 
 
Study Design 
This is a multi-site, bilateral, dispensing, randomized, 
controlled, single-masked, 3x3 crossover study with a run-in 
period. Following the run-in period, each subject will be 
bilaterally fitted with one of the three study contact lenses test 
articles in each of the three periods.  
 
There will be a total of 5 planned visits: 
Visit 1: Screening, baseline evaluation, run-in lens fit and 
application/removal training  
Visit 2: Run-in follow-up and treatment #1 fit  
Visit 3: Treatment #1 follow-up and Treatment #2 fit  
Visit 4: Treatment #2 follow-up and Treatment #3 fit  
Visit 5: Treatment #3 follow-up and study exit  
 
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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 
The goal is to enroll approximately 75 eligible subjects and 
complete 50. Up to 6 sites are expected to enroll 
approximately 15 subjects each.  
Study Duration 
There will be 5 visits in total per subject (not including 
application and removal training). Total study duration 
including the enrollment period is expected to be 
approximately 4 months, with an expected enrollment period 
of 2 months.  
Anticipated Study 
Population 
Healthy male and female subjects between 7 and 17 years old 
with best sphere refraction from -1.00 to -4.50 D (inclusive) 
and 0.75 D or less astigmatism will be recruited. The goal is 
to have the number of 7-12 year old subjects approximately 
equal to the number of 13-17 year old subjects. 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 regarding race/ethnicity of the subjects.  
 
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. 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. Have parents or legal guardians who must read, 
understand, 
and 
sign 
the 
STATEMENT 
OF 
INFORMED CONSENT (Parental Permission Form 
and Authorization to Use and Disclose Medical 
Information).  
3. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol. 
4. Be between 7 and 17 (inclusive) years of age at the 
time of screening. 
5. By self-report, habitually wear soft contact lenses or 
be a current non-contact lens wearer interested in soft 
lens wear.  
 
Inclusion Criteria following Baseline Evaluation 
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6. The non-vertex corrected best sphere distance 
refraction must be between -1.00 D and -4.50 D 
(inclusive) in each eye. 
7. The magnitude of the cylindrical component of the 
subject’s vertex-corrected distance refraction must be 
less than or equal to 0.75 D (inclusive) in each eye with 
any degree of axis. 
8. The distance visual acuity with best sphere distance 
correction must be 20/25 or better in each eye. 
9. Have ≤ 1.50 D difference in subjective best-sphere 
refraction between the two eyes. 
10. Have 20/40 or better vision in each eye with wearable 
spectacles or uncorrected. 
 
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. Be currently pregnant or lactating. 
2. Be diabetic. 
3. Be currently using any ocular medications. Lubricants 
(artificial tears) eyedrops are allowed.   
4. Have any current ocular infection of any type.  
5. Have 
any 
systemic 
disease 
(e.g., 
Sjogren’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, a history of serious mental 
illness or seizures, or other diseases, by parent or legal 
guardian’s self-report, which are known to interfere 
with contact lens wear and/or participation in the 
study.  
6. Use of systemic medication (e.g., chronic steroid use) 
that are known to interfere with contact lens wear 
and/or participation in the study. See section 9.1 for 
additional details regarding excluded systemic 
medications.  
7. Have habitually worn rigid gas permeable (RGP) 
lenses, orthokeratology lenses, or hybrid lenses (e.g. 
SynergEyes, SoftPerm) within the past 30 days. 
8. Be currently wearing lenses in an extended wear 
modality.  
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9. Be currently wearing soft contact lenses for 
astigmatism in either eye.  
10. Have participated in a contact lens or lens care product 
clinical trial within 7 days prior to study enrollment. 
11. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an 
employee 
(including 
partner, 
child, 
parent, 
grandparent, grandchild or sibling of the employee or 
their spouse) of the clinical site. 
12. Children who are wards of the State or any other 
agency, institution, or entity.  
 
Exclusion Criteria following Baseline Evaluation 
 
The subject must not: 
13. Have 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 is not limited to, entropion, ectropion, 
chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, aphakia, moderate or above 
corneal distortion, herpetic keratitis. 
14. Have grade 3 or greater palpebral conjunctival 
observations or any other grade 2 slit lamp findings on 
the ISO 11980 classification scale. 
15. Have strabismus (intermittent or constant) or 
amblyopia. 
16. Have a history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer 
or round peripheral scar). 
17. Have any central corneal scar. 
18. Have a pupil diameter under bright illumination of less 
than 2 mm in either eye.  
 
Disallowed 
Medications/Interventions  
See section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
Primary endpoint: logMAR Visual Acuity at distance (4 m)  
Microbiology or Other 
Laboratory Testing 
None 
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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 dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled. 
 
See section 11 for additional study-specific stopping rules. 
 
Ancillary Supplies/ Study-
Specific Materials 
The following supplies may be provided to the clinical sites as 
needed:  
• Lens cases  
• Fluorescein strips (either 0.6 mg or 1.0 mg)  
• Precision Vision distance (4 m) high and low contrast 
ETDRS logMAR visual acuity charts 
• Precision Vision near (40 cm) high and low contrast 
ETDRS logMAR visual acuity charts  
• Precision Vision LED Illuminator Cabinet 
• Precision Vision large mesopic filter for ETDRS 
Illuminator Cabinet 
• Sekonic light meter 
 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File. 
 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE  
 
Adverse Device Effect 
ADHD  
 
Attention Deficit Hyperactivity Disorder 
AE 
 
 
Adverse Event/Adverse Experience 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COM  
 
Clinical Operations Manager 
COVID-19 
 
Coronavirus Disease 2019 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICH 
 
 
International Council for Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LASIK 
 
Laser-Assisted in Situ Keratomileusis 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
OD 
 
 
Right Eye 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRK  
 
Photorefractive Keratectomy 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
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UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
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1. INTRODUCTION AND BACKGROUND 
The MiSight® 1 day is the only current soft contact lens with a US-FDA indication to slow the 
progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at 
the initiation of treatment. Johnson and Johnson Vision Care (JJVC) has developed a series of 
soft contact lens prototypes with novel optical designs that aim to maximize myopia control 
efficacy while minimizing potential visual impact. The EMO-118 design was efficacious in 
slowing refractive error progression and axial elongation in children between 7 and 12 years 
of age after 6 months of wear (
) and is being confirmed in a longer-term myopia 
control clinical trial (
). The EMO-114 design was efficacious in slowing axial 
elongation and performed similarly to EMO-116, a dual focus myopia control design, but did 
not demonstrate a statistically significant reduction in refractive error progression at 6 months 
(
).5,6 EMO-114 did, however, minimize the potential visual impact and provided 
objective and subjective visual performance that approached a control lens with conventional 
optics. This study will assess the visual performance of these EMO-118 and EMO-114 in 
neophyte and habitual soft contact lens wearers compared to a marketed control indicated to 
slow the progression of myopia.  
 Name and Descriptions of Investigational Products  
One commercially available marketed product with conventional optics (1-DAY ACUVUE® 
MOIST) will be used during the study run-in period for neophyte and existing soft contact lens 
wearers.  
 
This study will test two senofilcon A-C3 design prototypes with varying myopia control optical 
designs (Test 1 and Test 2) and one commercially available marketed product for myopia 
control (Control). Both Test lenses are senofilcon A-C3 prototypes and use the same 
manufacturing process as the ACUVUE OASYS® Brand Contact Lenses with HydraLuxe™ 
Technology (AO1D; cleared by FDA under K042275). The Test lenses have a smaller lens 
diameter and a steeper base curve compared to the AO1D to facilitate lens application while 
maintaining a well-centered fit in children. While both Test lenses have myopia control optical 
designs, the EMO-114 lens has a larger optical zone, no central myopic defocus dot and 
reduced dioptric power within the myopia control zones. The Control lens is manufactured in 
omafilcon A material and features two concentric zones to create myopic defocus.  
 
Further details about the test articles are found in section 6 of this protocol. For detailed 
information regarding the investigational products, refer to the latest version of the 
Investigator's Brochure for EMO Design Family Lenses and the package insert of the marketed 
products.7 
 Intended Use of Investigational Products 
The intended use of the investigational products is for correcting myopia and slowing the 
progression of myopia in children. For this study, however, slowing the progression of myopia 
is not a study endpoint and the duration of test article wear may not produce a lasting effect. 
During the study, each test article will be worn bilaterally in daily wear, daily disposable 
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modality for at least 8 hours per day. The subject will wear each investigational product for 
one wearing period. 
 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 EMO-114 
and EMO-118 refer to the latest version of the Investigator's Brochure for EMO Design  
Family Lenses.7 
 Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the investigational lenses during this study will be the 
correction of refractive error. While the Test and Control lenses feature myopia control optical 
designs, the duration of wear during the study is may not be sufficient to produce a lasting 
reduction in a subject’s axial length and myopia control efficacy is not an endpoint of this 
study. Other potential benefits are that soft contact lenses (conventional and myopia control) 
have shown better subjective performance versus glasses regarding appearance, satisfaction, 
social self-perception, and willingness to try new activities.8    
 
The anticipated risks associated with the use of the investigational lenses are considered to be 
the same as those for any other soft contact lens worn in the same modality (i.e. daily 
disposable wear) and within the same population.  
 
While the target population for this study is children (<18 years), not adults, clinical research 
has generally supported that younger children can successfully  and safely wear soft contact 
lenses .9-12 While contact lens wear is less common in children than adults, studies assessing 
adverse event rates have concluded that the adverse event rates in children are similar to 
established rates among adults wearing soft contact lenses .9,10 A thorough review of the risks 
and benefits of myopia control concluded that the incidence of corneal infiltrative events and 
microbial keratitis in children 12 years of age and younger is no higher than that observed in 
adults, and may be lower.9 Furthermore, all investigational lenses used in this study will be 
used in a daily wear, daily disposable modality, which reduces lens care burden and avoids 
potential contamination from the storage case, a known risk factor for microbial keratitis.13,14   
 
Another known risk is that the optical design of myopia control soft contact lenses may not 
provide equivalent vision quality to a conventional spherical lens design. While minimal 
difference has been measured between optical designs using high contrast visual acuity, 
reductions in low contrast and/or low luminance conditions have been reported.15 While the 
visual experience with a soft myopia control contact lens may be different, children using 
MiSight 1 Day have subjectively rated their overall vision similarly to a parallel control group 
using single vision spectacles after 12 and 24 months of wear .8 To manage this risk, the 
protocol is designed to ensure that each subject meets a minimum visual acuity and reports 
acceptable subjective vision prior to study contact lens dispense.  
 
No additional risks associated with participation in this investigation are anticipated. 
 
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• Over-refraction at follow-up 
• Lens fitting characteristics 
 Endpoints  
Primary efficacy endpoint:  
• Binocular distance (4 m) high luminance high contrast (HLHC) logMAR visual acuity, 
measured per 
 
 
Primary safety endpoint: 
• Number (n, %) of subjects and eyes with contact lens related (i.e., related and 
possibly related) serious and significant ocular adverse events (AEs), including best 
corrected logMAR loss ≥ 0.20 logMAR (10 letters). 
 
Other exploratory endpoints: 
• Monocular HLHC logMAR visual acuity at 4 m 
• Binocular high luminance low contrast (HLLC) logMAR visual acuity at 4 m 
• Monocular HLLC logMAR visual acuity at 4 m 
• Binocular low luminance high contrast (LLHC) logMAR visual acuity at 4 m 
• Monocular LLHC logMAR visual acuity at 4 m 
• Binocular HLHC logMAR visual acuity at 40 cm 
• Binocular HLLC logMAR visual acuity at 40 cm 
• Subjective vision, comfort, and ease of handling 
• Non-significant AEs and non-ocular AEs 
• Slit lamp findings per the ISO 11980 grading scale 
• Subject-reported ocular symptoms 
• Number of contact lens insertion attempts per eye at fitting 
• Subjective best sphere over-refraction with the first trial lens 
• Subjective best sphere over-refraction at follow-up 
• Number of power modifications at fitting  
• Lens fitting characteristics 
 Hypotheses 
The primary hypothesis must be met to satisfy the objective of the study. 
 
Primary Hypothesis 
 
1. The distance (4 m) binocular high luminance high contrast visual acuity (in logMAR) 
with EMO-118 will be non-inferior to that of MiSight at follow-up visit. A non-
inferiority margin of 0.05 logMAR will be used. 
 
 
 
 
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Other Exploratory Hypotheses  
 
1. The distance (4 m) binocular high luminance high contrast visual acuity (in logMAR) 
with EMO-114 will be superior to that of EMO-118 at follow-up visit.  
2. The distance (4 m) binocular high luminance high contrast visual acuity (in logMAR) 
with EMO-114 will be superior to that of MiSight at follow-up visit. 
3. TARGETED STUDY POPULATION 
 General Characteristics  
Healthy male and female subjects between 7 and 17 years old with best sphere refraction from 
-1.00 to -4.50 D (inclusive) and 0.75 D or less astigmatism will be recruited. The goal is to 
have the number of 7-12 year old subjects approximately equal to the number of 13-17 year 
old subjects, which will be stratified per site. 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 regarding race/ethnicity of the subjects.  
 Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. 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. Have parents or legal guardians who must read, understand, and sign the STATEMENT 
OF INFORMED CONSENT (Parental Permission Form and Authorization to Use and 
Disclose Medical Information).  
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
4. Be between 7 and 17 (inclusive) years of age at the time of screening. 
5. By self-report, habitually wear soft contact lenses or be a current non-contact lens 
wearer interested in soft lens wear.  
 
Inclusion Criteria following Baseline Evaluation 
6. The non-vertex corrected best sphere distance refraction must be between -1.00 D and 
-4.50 D (inclusive) in each eye. 
7. The magnitude of the cylindrical component of the subject’s vertex-corrected distance 
refraction must be less than or equal to 0.75 D (inclusive) in each eye with any degree 
of axis. 
8. The distance visual acuity with best sphere distance correction must be 20/25 or better 
in each eye. 
9. Have ≤ 1.50 D difference in subjective best-sphere refraction between the two eyes. 
10. Have 20/40 or better vision in each eye with wearable spectacles or uncorrected. 
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 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. Be currently pregnant or lactating. 
2. Be diabetic. 
3. Be currently using any ocular medications. Lubricants (artificial tears) eyedrops are 
allowed.   
4. Have any current ocular infection of any type.  
5. Have any systemic disease (e.g., Sjogren’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, a history of serious mental 
illness or seizures, or other diseases, by parent or legal guardian’s self-report, which 
are known to interfere with contact lens wear and/or participation in the study.  
6. Use of systemic medication (e.g., chronic steroid use) that are known to interfere with 
contact lens wear and/or participation in the study. See section 9.1 for additional details 
regarding excluded systemic medications.  
7. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or 
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 30 days. 
8. Be currently wearing lenses in an extended wear modality.  
9. Be currently wearing soft contact lenses for astigmatism in either eye.  
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior 
to study enrollment. 
11. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family 
member of an employee (including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site. 
12. Children who are wards of the State or any other agency, institution, or entity.  
 
Exclusion Criteria following Baseline Evaluation 
 
The subject must not: 
13. Have 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 
is not limited to, entropion, ectropion, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic 
keratitis. 
14. Have grade 3 or greater palpebral conjunctival observations or any other grade 2 slit 
lamp findings on the ISO 11980 classification scale. 
15. Have strabismus (intermittent or constant) or amblyopia. 
16. Have a history or signs of a contact lens-related corneal inflammatory event (e.g., past 
peripheral ulcer or round peripheral scar). 
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17. Have any central corneal scar. 
18. Have a pupil diameter under bright illumination of less than 2 mm in either eye.  
 Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
 
The goal is to enroll approximately 75 eligible subjects and complete 50. Up to 6 sites are 
expected to enroll approximately 15 subjects each. The preferred ratio for the number of 
subjects in the two age groups (7 -12 years and 13- 17 years) is 1:1 within each site. 
4. STUDY DESIGN AND RATIONALE 
 Description of Study Design 
This is a multi-center, randomized, subject-masked, bilateral, 3x3 crossover dispensing study 
including a run-in period. Once the subjects complete the run-in period, they will be 
randomized to one of six lens wear sequences. Subjects will be bilaterally fitted with one of 
the three test articles in each of the three study periods. Investigational lenses should be worn 
for a minimum of 10 days and 8 hours per day. Subjects will not have access to the test articles 
at study closure. 
 
At Visit 1 if subjects meet all eligibility criteria, then they will be fitted with the run-in lens. 
Application and removal training must be completed and the other requirements met before 
lenses are dispensed, either at V1 or at a subsequent unscheduled visit. The visit window for 
visit 2 will be calculated from the date of the run-in contact lens dispense.  
 
At Visit 2, after undergoing all the assessments for the run-in lens follow-up, the run-in lens 
will be removed, and subjects will be randomized to one of six lens wear sequences. Subjects 
will be fitted in a bilateral fashion in their first study lens per the randomization scheme. 
Follow-up evaluation on the first lens will be after approximately 2 weeks of lens wear. After 
undergoing all follow-up assessments, the study lens will be removed, and subjects will be fit 
with the next lens per the randomization schedule.  
 
This process will be repeated until the subjects have worn all three test articles.  
 Study Design Rationale 
This study is to evaluate logMAR visual performance of three soft contact lenses featuring 
myopia control optical designs using a 3×3 crossover design. Crossover designs are well-
established and expose subjects to multiple treatments during different time periods. This 
design is cost effective and efficient since it eliminates between-subject variability from the 
treatment comparisons. A limitation of crossover design is the potential for carryover effects 
between treatments. Since the primary endpoint of logMAR visual acuity is an objective 
measure, a carryover effect is less concerning. All subjects will begin with a run-in period 
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using a single vision contact lens design to allow both new and existing contact lens wearers 
to enter the study and acclimate to a similar contact lens design.  
 
 Enrollment Target and Study Duration 
Approximately 75 subjects will be enrolled in the study with a minimum of 50 subjects targeted 
to complete the study. The study will be conducted at up to six clinical sites, where the 
enrollment target for each site will be approximately 15 subjects with a minimum of 10 subjects 
completing the study. The point of study enrollment is defined as the execution of the informed 
consent and assent at Visit 1. Subjects will be stratified at each site by age so that the number 
of children from 7-12 years old is approximately equal to those 13-17 years old.  
 
 
There will be 5 visits in total per subject (not including application and removal training). Total 
study duration including the enrollment period is expected to be approximately 4 months, with 
an expected enrollment period of 2 months. Subjects who are discontinued prior to the final 
evaluation will not be replaced. The investigation will end at the time that the study data is 
hard locked. 
5. TEST ARTICLE ALLOCATION AND MASKING 
 Test Article Allocation  
The three study lenses (Test1, Test2, and Control) will be worn in a bilateral and random 
fashion using a 3×3 crossover design with 3 lens types and 3 periods. Use of the test articles 
will be randomized using a lens fitting schedule supplied by the study biostatistician. The 
clinical site will follow the lens fitting schedule provided and will complete enrollment 
according to the randomization list and will not pre-select or pre-assign subjects. 
 
Randomly-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 subject will begin with a run-in period using a single vision contact lens design 
(run-in lens: 1 Day Acuvue Moist) and then will be randomly assigned to one of six unique 
sequences 
of 
the 
three 
lens 
types 
(Test1/Test2/Control, 
Test1/Control 
/Test2, 
Test2/Test1/Control, Test2/Control /Test1, Control/Test1/Test2, Control/Test2/Test1) using a 
3×3 Williams design which is balanced for first-order carryover effects. Each block will 
contain these six different lens trial sequences.20 The randomization will be stratified by site 
and age (7 – 12 years old and 13- 17 years old). The preferred ratio for the number of subjects 
in the two age groups is 1:1 within each site. 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).21 
 
Randomization will be performed at visit 1. The following must have occurred prior to 
randomization: 
• Informed consent must have been obtained.  
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• 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 should 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. 
 Masking 
This is a single-masked study with the subjects being masked. The subjects will not be told 
any information regarding the optical designs of the lenses beyond that they are intended to 
correct for their refractive error and feature myopia control optics. The investigators cannot be 
completely masked to the identity of the investigational lenses because there will be more than 
one fitting guide used and the fitting guide is specific to the lens design.  
 Procedures for Maintaining and Breaking the Masking 
The identity of the study lenses will be masked by having the blister packs labeled with the 
study number, lot number, sphere power, expiration date and the randomization codes. The 
medical monitor will have access to the decode information in case breaking the mask is 
necessary for the urgent medical treatment of a subject. 
 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the sponsor must be informed as soon as possible. The date, time, 
and reason for the unmasking must be documented in the subject record. The investigator is 
also advised not to reveal the study treatment assignment to the clinical site or sponsor 
personnel.  
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued will not be replaced. 
 
6. STUDY INTERVENTION 
 Identity of Test Articles  
The following contact lenses will be used in this study: 
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Primary Packaging 
Secondary Packaging 
 
 Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
 Collection and Storage of Samples 
No samples will be collected as part of the study procedures. 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. 
 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, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC. 
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 Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
• Subject withdrawal of consent. 
• Subject not compliant to protocol (e.g., refusing any protocol specified procedure) 
• Subject lost to follow-up. 
• Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
• Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear  
• Subjects who have experienced a Corneal Infiltrative Event (CIE). 
• Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
• Subject not compliant with study lens wear schedule  
• Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
 
For discontinued subjects, the Investigator will: 
• Complete the current visit (scheduled or unscheduled). 
• Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
• Record the spherocylindrical refraction with best corrected distance visual acuity. 
• Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2 
• Collect all unused test article(s) from the subject. 
• Make arrangements for subject care, if needed, due to their study participation 
 
Additional subjects will not 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:  
1. Any medication or therapy that would normally contraindicate contact lens wear or 
have ocular side effects that would affect vision assessment. 
2. Topical atropine or other medications that may temporarily impact pupil size 
 
Concomitant therapies that are disallowed include:  
1. Orthokeratology 
2. Vision therapy/orthoptics/patching 
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further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• 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.   
 
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Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
• Who received the complaint. 
• Study number. 
• Clinical site information (contact name, site ID, telephone number). 
• Lot number(s). 
• Unique Subject Identifier(s). 
• Indication of who first observed complaint (site personnel or subject). 
• OD/OS indication, along with whether the lens was inserted. 
• Any related AE number if applicable. 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
• Eye Care Provider objective (slit lamp) findings if applicable. 
• 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.   
 
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 
 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: 
a) Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
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b) 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. 
c) 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: 
• Death 
• 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 Fetal distress, fetal 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 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 Bowman’s membrane; 
3) infiltrate > 2 mm diameter; 
4) associated with iritis ≥ 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. 
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f) All cases of iritis. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• 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: 
a) peripheral non-progressive non-infectious ulcers; 
b) all symptomatic corneal infiltrative events; 
c) all cases of corneal staining greater than or equal to grade 3; 
d) a temporary loss of two or more lines of best corrected visual acuity (for greater than 
or equal to 2 weeks); 
a) cases greater than or equal to grade 2 neovascularization;  
b) 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: 
a) Contact Lens Induced Peripheral Ulcer (CLPU) 
b) Significant Infiltrative Events (SIE) 
c) Superior Epithelial Arcuate Lesions (SEALs) 
d) Other grade 3 or higher corneal findings, such as abrasions or edema 
e) Non-contact lens related corneal events - e.g., Epidemic Keratoconjunctivitis (EKC) 
f) Asymptomatic Corneal Scar 
 
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. 
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a) Non-significant Infiltrative Event (NSIE), if it is < Grade 2, non-symptomatic, and 
does not require medication 
b) Contact Lens Papillary Conjunctivitis (CLPC) 
c) Superficial Punctate Keratitis (SPK) 
d) Conjunctivitis: Bacterial, Viral, Allergic 
e) Blepharitis 
f) Meibomianitis 
g) Contact Dermatitis 
h) Localized Allergic Reactions 
 
 
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) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
 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: 
• Seriousness/Classifications (see definition in section 13.1). 
• 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). 
• 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 
section13.2.2). 
• Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
• Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
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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: 
• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
• 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. 
• 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. 
• 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: 
• Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
• Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
• Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
 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. 
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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: 
• Adverse event (diagnosis not symptom). 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
• Date the clinical site was notified. 
• Date and time of onset. 
• Date and time of resolution. 
• Adverse event classification, severity, and relationship to test articles, as applicable. 
• Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
• Any referral to another health care provider if needed. 
• Outcome, ocular damage (if any). 
• Likely etiology. 
• 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. 
 
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 
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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. 
 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 
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: 
• Notify the Sponsor immediately. 
• 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. 
• 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. 
• Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
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Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
 Event of Special Interest 
13.5.1. Specific Requirements for Recording and Diagnosing Possible Microbial Keratitis 
The signs of a presumed infectious ulcer (defined as progressive erosion of the corneal 
tissue) may include irregular focal infiltrates (>1 mm); active lesions with raised edges; 
significant diffuse infiltration; anterior corneal to mid-stromal involvement; erosion 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, MK) may include pain of rapid onset; severe redness; purulent or mucopurulent 
discharge; tearing; photophobia. For the purpose of reporting, per the ISO 11980, a presumed 
corneal ulcer which has any of the following characteristics should be reported as a serious 
adverse event:48 
 
1) Central (6 mm) or paracentral (8 mm) location; 
2) Penetration of Bowman’s membrane; 
3) Infiltrate> 2 mm diameter 
4) Associated with iritis ≥ Grade 2; 
5) Associated with any increase in intraocular pressure; 
6) Culture positive for microorganisms 
7) Increasing size of severity at subsequent visits. 
 
In the event of any case of possible microbial keratitis (e.g., presence of an infiltrative lesion), 
the investigators shall provide complete descriptions of the event. A comprehensive 
description of diagnostic procedures is provided in 
.  
 
The investigator shall record the following in the CRF:  
• Presence and severity of pain;  
• Presence and type of discharge; 
• Presence of lid edema; 
• Presence of chemosis; 
• Pattern and grading of redness (bulbar/limbal); 
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• Characterization of infiltrates (size, shape, location, depth) on the Infiltrate Assessment 
Form; 
• Characterization of the epithelial defect (size/depth); 
• Involvement of surrounding cornea;  
• Endothelial involvement; 
• Grading of anterior chamber cell and flare 
The investigator shall record the diagnosis and specific treatment on the Adverse Event Form. 
Where necessary, a culture of the corneal lesion will be collected to determine if the infection 
is microbial in nature. For example, if an overlying epithelial defect is present and any one of 
the conditions listed below is present when the infiltrate is first evaluated, the infiltrate must 
be cultured.  
• Diameter greater than 1 mm 
• Location within the central (6 mm) optical zone 
• Purulent discharge 
• Pain 
• Photophobia 
• Iris/Anterior chamber inflammation 
 
Any corneal lesions meeting the criteria set forth above must be cultured as outlined in the 
Premarket Notification (510[k]) Guidance Document for Daily Wear Contact Lenses 
(Revised May 1994).22 Cultures will be collected with the Sponsor approved culture kits and 
sent to a study designated laboratory for analysis. The results will be communicated to the 
Investigator and the Sponsor. See 
 for specific procedures that should be followed 
for culturing of possible cases of infectious keratitis. 
 
For other infiltrative events that do not meet the criteria as specified above, the investigators 
may culture the lesion when deemed appropriate. If cultures are collected, a source document 
note should be completed specifying the date of culture collection and laboratory utilized. An 
eCRF documenting this should be completed. 
 
The following definitions will be used to classify whether the case is definite MK, probable 
MK, probably not MK, definitely not MK, or MK unrelated to contact lens wear.23 
• Definite MK: one or more central (6 mm) or paracentral (8 mm) corneal stromal 
infiltrates greater than 2 mm in size with pain rated more than mild, and one of the 
following: 
o anterior chamber reaction (iritis) Grade 2 or higher 
o mucopurulent discharge 
o positive corneal culture 
• Probable MK: One or more corneal stromal infiltrates greater than 1 mm, with 
overlying epithelial defect, with pain more than mild, and at least one of the following 
additional criteria: 
o anterior chamber reaction; 
o mucopurulent discharge; 
o positive corneal culture; 
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o aggressive treatment consistent with standard of care for MK in North America 
(choice of medication, high frequency dosing of long duration to resolution). 
• Probably not MK: not meeting any of the above specified MK definitions. 
• Definitely not MK: not meeting any of the above specified MK definitions and with 
significant evidence that suggests non-infectious etiology (e.g., reduction in severity 
without pharmacologic treatment). 
• MK unrelated to contact lens wear: cases such as Herpes simplex keratitis or 
Staphylococcal marginal keratitis, where, in the judgment of the panel, the etiology is 
unrelated to the wear of contact lenses. 
13.5.2. Loss of Best Sphero-cylindrical Corrected Visual Acuity without Physical Cause 
At the final study visit, if it is found that best sphero-cylindrical corrected visual acuity 
(BSCVA) of a subject is less than 20/25 (0.1 logMAR) in either eye and is more than 1.5 
lines worse than that was measured at baseline without any physical cause (confirmed 
through up to 3 repeated independent measures to rule out potential measurement errors or 
variations), an adverse event will be filed. The subject will be followed until the best 
corrected visual acuity is no more than 1.5 lines worse than baseline or is stabilized before 
being discontinued from the study. A decrease of more than 1.5 lines of BSCVA is 
considered a significant change. This criterion is established based on the 95% limits of 
agreement of repeated measures of visual acuity in children.24 It is not anticipated that 
development of amblyopia (defined as a reduction of BSCVA to 20/30 or worse or a two-line 
difference between the two eyes, in the absence of pathology25-27) will occur while wearing 
the investigational soft contact lens. Upon identifying the first confirmed case of amblyopia 
during the course of the study, the event will be investigated and followed according to 
procedures specified for an Unanticipated Adverse Device Effect (section 11 and 
section 13.1). 
 
 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 
 General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock. 
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 Level of Statistical Significance 
The planned primary analysis for this study will be conducted with a two-sided type I error 
rate of 5%. Each exploratory analysis will be conducted with a two-sided type I error rate of 
5%. 
 Primary Analysis  
Primary Efficacy Endpoint 
 
Binocular Distance (4m) logMAR Visual Acuity (VA) 
Non-inferiority of the EMO-118 compared to the MiSight lens with respect to the primary 
endpoint of distance binocular HLHC logMAR visual acuity will be assessed on the Per-
protocol population (PP).  
 
The distance binocular logMAR VA under HLHC will be analyzed using a linear mixed model 
at the follow-up evaluation. The model will include lens type, lens sequence, period, and first-
order carryover as fixed effects and interaction between lens type and period will be evaluate. 
Other subject characteristics such as age, gender and race will be included as fixed covariates 
when appropriate. Site will be included in the model as a random effect (G-side). The 
covariance of residuals between measurements from different periods within the same subject 
(R-side) will be modeled using Unstructured (UN) covariance structure. If the model does not 
converge, the compound Symmetry (CS) covariance structure will be considered. The 
Kenward and Roger method will be used for the denominator degree of freedom.28  
 
Hypothesis Testing 
The null and alternative hypotheses for testing non-inferiority of the EMO-118 lens relative to 
the MiSight lens with respect to logMAR visual acuity are as follows:  
 
𝐻𝐻0:  𝜇𝜇𝐸𝐸𝐸𝐸𝐸𝐸118 − 𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀ℎ𝑡𝑡≥0.05 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝐸𝐸𝐸𝐸𝐸𝐸118 − 𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀ℎ𝑡𝑡< 0.05 
 
Where, 𝜇𝜇𝐸𝐸𝐸𝐸𝐸𝐸118 represents the mean logMAR VA score for the EMO-118 lens and 𝜇𝜇𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀𝑀ℎ𝑡𝑡 
represents the mean logMAR VA score for the MiSight lens. Non-inferiority will be declared 
if the upper bound of the 2-sided 95% confidence interval (CI) of the mean difference (EMO-
118 – MiSight) is less than 0.05. 
 
Primary Safety Endpoint 
Primary safety endpoint will be evaluated by tabulations of contact lens related (i.e., related 
and possibly related) serious and significant ocular adverse events and will be summarized by 
treatment across all visits. The tables will present the number and percentage of eyes and 
subjects by diagnosis and sorted by decreasing frequency based on the total number of reports.  
 
Additionally, all ocular and non-ocular adverse events will be summarized by seriousness (i.e., 
ocular AEs by serious, significant and all other ocular AEs, and non-ocular AEs by serious and 
non-serious), relatedness, severity and diagnosis. A listing of all adverse events including all 
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information of an event (e.g., diagnosis, duration, treatment and resolution status) will be 
provided.  
 
 Secondary Analysis  
Not applicable. 
 
 Other Exploratory Analysis 
Exploratory hypotheses on distance binocular HLHC logMAR VA will be assessed using the 
same model as the primary analysis. Comparisons between EMO-114 and the other two study 
lenses will be conducted based on the 2-sided 95% CIs constructed for the mean differences 
between EMO-114 and EMO-118 (EMO-114 – EMO-118) and between EMO-114 and 
MiSight (EMO-114 – MiSight). Superiority of EMO-114 lens relative to EMO-118 lens will 
be declared if the upper bound of the 95% CI for the mean difference is less than 0. Superiority 
of EMO-114 lens relative to MiSight lens will be declared if the upper bound of the 
corresponding 95% CI is less than 0. 
  
Patient-reported outcome (PRO) items will be used to measure subjective vision, comfort, and 
ease of handling, with descriptive summaries tabulated by lens type. Exploratory analysis will 
be conducted to evaluate the psychometric properties of these PRO measures.   
 
Descriptive data summaries will be tabulated by lens type for all other exploratory endpoints. 
A by-subject listing of all adverse events (ocular and non-ocular AEs) will be provided. 
 
As supplementary analyses to support the primary analysis, two sensitivity analyses may be 
considered. (1) If non-inferiority for the primary endpoint is met with subjects in the per-
protocol population, a sensitivity analysis using ITT population may be considered. (2) To 
evaluate the impact of missing data, a sensitivity analysis using ITT population with missing 
data imputed may be conducted using multiple imputation methods if the proportion of subject 
dropout is greater than the 15%. The SAS/STAT procedures PROC MI and PROC 
MIANALYZE will be utilized with a parametric regression method using the fully conditional 
method (FCS) to make at least 50 imputations.21 
 
 Interim Analysis  
Not applicable. 
 Procedure for Handling Missing Data and Drop-Outs 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. Missing or spurious values will not be imputed. The count of missing values will be 
included in the summary tables and listings.  
 
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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 
 Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. 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 on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2011.1 
 Subject Record 
At a minimum, subject record should be available for the following:  
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
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• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• 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. 
 
 Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor because this study is in the 
confirmatory clinical trial phase. 
16. DATA MANAGEMENT 
 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. 
 Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
 Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
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Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from 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. 
 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. 
• 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 
 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. Subjects will only be enrolled if the 
subject’s parents/legal guardians are fully able to understand the risks, benefits, and potential 
adverse events of the study and provide their consent voluntarily, and, the subject provides 
their assent voluntarily. 
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 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(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
 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): 
• Final protocol. 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information). 
• Sponsor-approved subject recruitment materials. 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
• Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
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) 
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• 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. 
 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 
originated in the Declaration of Helsinki,3 current ICH GCP2 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. 
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 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 States29  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: 
• 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. 
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19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
• Continuing an ineligible subject in the study. 
• 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: 
• Query resolution. 
• Case Report Form signature. 
• Completion of any follow-up action items. 
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21. PUBLICATION 
There is no plan to publish this outcome of this investigation. 
22. REFERENCES 
 
1. 
ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at https://www.iso.org/standard/45557.html 
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available 
at 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. 
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. 
Available 
at 
https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
4. 
United States (US) Code of Federal Regulations (CFR). . Available at 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. 
Cheng X.  Clinical Study Report 
 Evaluating Soft 
Contact Lens Prototypes for Myopia Control. October 25, 2019 
6. 
Cheng X.  Clinical Study Protocol 
 Evaluating a soft 
contact lens for myopia control. August 07, 2020 
7. 
Cheng X.  Investigator Brochure 
 EMO Design Family Lenses. May 2021 
8. 
Pomeda AR, Pérez-Sánchez B, Cañadas Suárez MdP, Prieto Garrido FL, Gutiérrez-
Ortega R, Villa-Collar C. MiSight Assessment Study Spain. Eye & Contact Lens: 
Science & Clinical Practice. 2018;44:S99-S104. 
9. 
Bullimore M. The Safety of Soft Contact Lenses in Children. Optom Vis Sci. 
2017;94(6):638-646. 
10. 
Chalmers RL, McNally JJ, Chamberlain P, Keay L. Adverse event rates in the 
retrospective cohort study of safety of paediatric soft contact lens wear: the ReCSS 
study. Ophthalmic and Physiological Optics. 2020;41(1):84-92. 
11. 
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 Ophthalmologica. 2019;98(3). 
12. 
Walline JJ, Jones LA, Rah MJ, et al. Contact Lenses in Pediatrics (CLIP) Study: Chair 
Time and Ocular Health. Optometry and Vision Science. 2007;84(9):896-902. 
13. 
Chalmers RL, Hickson-Curran SB, Keay L, Gleason WJ, Albright R. Rates of Adverse 
Events With Hydrogel and Silicone Hydrogel Daily Disposable Lenses in a Large 
Postmarket Surveillance Registry: The TEMPO Registry. Investigative Ophthalmology 
& Visual Science. 2015;56(1):654-663. 
14. 
Stapleton F, Edwards K, Keay L, et al. Risk Factors for Moderate and Severe Microbial 
Keratitis in Daily Wear Contact Lens Users. Ophthalmology. 2012;119(8):1516-1521. 
15. 
Richdale K, Cox I, Kollbaum P, et al. CLEAR – Contact lens optics. Contact Lens and 
Anterior Eye. 2021;44(2):220-239. 
16. 
Cheng X.  Clinical Study Report 
 Evaluation of Visual 
Performances of Soft Contact Lens Prototypes for Myopia Control. December 08, 2017 
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17. 
Cheng X.  Clinical Study Protocol 
 Evaluating 
Accommodative Responses of Soft Contact Lenses for Myopia Control. March 27, 2018 
18. 
Nixon A.  Clinical Study Report 
 Evaluation of Vision 
and Fit Performance of a Soft Contact Lens for Myopia Control. May 29, 2020 
19. 
Cheng X.  Clinical Study Protocol 
 Evaluating visual 
acuity and initial fit performance of two soft contact lenses. May 06, 2021 
20. 
Williams EJ. Experimental Designs Balanced for the Estimation of Residual Effects of 
Treatments. Australian Journal of Chemistry. 1949;2(2):149. 
21. 
SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute Inc.  
22. 
FDA Premarket Notification [510(k)] Guidance Document for Daily Wear Contact 
Lens [May 1994].  
23. 
Bullimore MA, Sinnott LT, Jones-Jordan LA. The Risk of Microbial Keratitis With 
Overnight 
Corneal 
Reshaping 
Lenses. 
Optometry 
and 
Vision 
Science. 
2013;90(9):937-944. 
24. 
Manny RE, Hussein M, Gwiazda J, Marsh-Tootle W. Repeatability of ETDRS Visual 
Acuity in Children. Investigative Opthalmology & Visual Science. 2003;44(8):3294. 
25. 
Attebo K, Mitchell P, Cumming R, Smith W, Jolly N, Sparkes R. Prevalence and causes 
of amblyopia in an adult population. Ophthalmology. 1998;105(1):154-159. 
26. 
Chua B, Mitchell P. Consequences of amblyopia on education, occupation, and long 
term vision loss. Br J Ophthalmol. 2004;88(9):1119-1121. 
27. 
Scheiman M, Wick B. Clinical Management of Binocular Vision- Heterophoric, 
Accommodative, & Eye Movement Disorders, 4th edn (Wolter Kluwer 
Health/Lippincott, Williams & Wilkins). 2008;34(6):678-679. 
28. 
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53(3):983. 
29. 
Health Information Portability and Accountability 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) 
 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
This will be provided separately 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-Day Acuvue® Moist Brand Contact Lenses 
 
 
 
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PACKAGE INSERT (APPROVED PRODUCT) 
MiSight® 1 day  
 
 
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APPENDIX D: 
 
 
• 
 Near LogMAR Visual Acuity Measurement Procedure 
• 
 Lens Fitting Characteristics   
• 
 Subject Reported Ocular Symptoms/Problems  
• 
 Front and Back Surface Lens Deposit Grading Procedure 
• 
 Determination of Distance Spherocylindrical Refractions  
• 
 Distance and Near Snellen Visual Acuity Evaluation  
• 
 Distance LogMAR Visual Acuity Measurement Procedure 
• 
 Patient Reported Outcomes 
• 
 White Light Lens Surface Wettability 
• 
 Cover-Uncover Test 
• 
ISO Biomicroscopy Scale  
• 
 Visual Acuity Chart Luminance and Room Illumination Testing  
 
 
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          Lens Fitting Characteristics 
Document Type:       
 
Document Number:  
 
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Page 4 of 5 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
 
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WHITE LIGHT LENS SURFACE WETTABILITY 
 
 
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Document Number:  
 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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APPENDIX E: FITTING GUIDE 1-DAY ACUVUE® MOIST BRAND CONTACT 
LENSES 
 
 
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APPENDIX F: FITTING GUIDE MISIGHT® 1 DAY 
 
 
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APPENDIX G: CR-6457 LENS POWER MODIFICATION GUIDE 
 
 
 
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APPENDIX H: COVID-19 RISK MITIGATION GUIDELINES 
 
 
 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6457 Visual Performance of Soft Contact Lenses with Myopia 
Control Optics 
Version and Date: 4.0 29 March 2022 
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155:2020,1 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 H 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 
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