Evaluating Soft Contact Lens Prototypes for Myopia Control
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
Johnson & Johnson Vision Care, Inc. 
 
Clinical Study Protocol 
 
 
Evaluating Soft Contact Lens Prototypes for Myopia Control 
 
Protocol CR-5959 
 
Version: 3.0, Amendment 2 
 
Date: 11 September 2018 
 
Investigational Products:  
Test Lenses: Daily disposable soft contact lenses made in senofilcon A material with three 
different types of optical designs for myopia control. 
• EMO-114 
• EMO-116 
• EMO-118 
Control Lens:   
• EMO-117 
 
Key Words: Myopia control, Soft contact lens, Dispensing, Daily Wear, Daily disposable, 
Senofilcon A, Axial length, Cycloplegic auto refraction, Pediatric population 
 
 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc.  Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
 
 
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TABLE OF CONTENTS 
 
PROTOCOL TITLE, NUMBER, VERSION ............................................................................7 
SPONSOR NAME AND ADDRESS ........................................................................................7 
MEDICAL MONITOR ..............................................................................................................7 
AUTHORIZED SIGNATURES ................................................................................................8 
CHANGE HISTORY.................................................................................................................9 
SYNOPSIS ...............................................................................................................................11 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .....................22 
1.     INTRODUCTION AND BACKGROUND .....................................................................24 
1.1. 
Name and Descriptions of Investigational Products ..................................................24 
1.2. 
Intended Use of Investigational Products ...................................................................24 
1.3. 
Summary of Findings from Nonclinical Studies ........................................................25 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .....................................25 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study .............................................................................................................26 
2.     STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ........................................27 
2.1. 
Objectives ...................................................................................................................27 
2.2. 
Endpoints ....................................................................................................................27 
2.3. 
Hypotheses .................................................................................................................28 
3.     TARGETED STUDY POPULATION .............................................................................29 
3.1. 
General Characteristics ...............................................................................................29 
3.2. 
Inclusion Criteria ........................................................................................................29 
3.3. 
Exclusion Criteria .......................................................................................................29 
3.4. 
Enrollment Strategy ....................................................................................................30 
4.     STUDY DESIGN AND RATIONALE ............................................................................31 
4.1. 
Description of Study Design ......................................................................................31 
4.2. 
Study Design Rationale ..............................................................................................31 
4.3. 
Enrollment Target and Study Duration ......................................................................32 
5.     TEST ARTICLE ALLOCATION AND MASKING .......................................................33 
5.1. 
Test Article Allocation ...............................................................................................33 
5.2. 
Masking ......................................................................................................................33 
5.3. 
Procedures for Maintaining and Breaking the Masking .............................................34 
6.     STUDY INTERVENTION ..............................................................................................34 
6.1. 
Identity of Test Articles ..............................................................................................34 
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6.2. 
Ancillary Supplies/Products .......................................................................................35 
6.3. 
Administration of Test Articles ..................................................................................35 
6.4. 
Packaging and Labeling .............................................................................................36 
6.5. 
Storage Conditions .....................................................................................................36 
6.6. 
Collection and Storage of Samples ............................................................................36 
6.7. 
Accountability of Test Articles ..................................................................................36 
7.     STUDY EVALUATIONS ................................................................................................38 
7.1. 
Time and Event Schedule ...........................................................................................38 
7.2. 
Detailed Study Procedures .........................................................................................41 
VISIT 1 – Screening and Baseline ...................................................................................41 
VISIT 2 – Study Lens Fitting and Dispensing .................................................................47 
VISIT 3 – 1-week Follow-up ...........................................................................................54 
VISIT 4 – 1-month Follow-up..........................................................................................58 
VISIT 5 – 3-month Follow-up..........................................................................................58 
VISIT 6 – 6-month Follow-up..........................................................................................58 
VISIT 7 – 12-month Follow-up (Optional) ......................................................................67 
I/R TRAINING VISIT .....................................................................................................68 
BACKUP SPECTACLE LENS DISPENSING ...............................................................70 
FINAL EVALUATION ...................................................................................................71 
MANAGING SUBJECTS THROUGH STUDY TERMINATION ................................71 
7.3. 
Unscheduled Visits .....................................................................................................72 
7.4. 
Laboratory Procedures ...............................................................................................74 
8.     SUBJECTS COMPLETION/WITHDRAWAL ...............................................................74 
8.1. 
Completion Criteria ....................................................................................................74 
8.2. 
Withdrawal/Discontinuation from the Study .............................................................74 
9.        PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .................75 
10.     DEVIATIONS FROM THE PROTOCOL .....................................................................77 
11.     STUDY TERMINATION ..............................................................................................77 
12.     PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .................78 
13.     ADVERSE EVENTS ......................................................................................................79 
13.1. Definitions and Classifications ...................................................................................79 
13.2. Assessing Adverse Events ..........................................................................................81 
13.2.1. Causality Assessment ...........................................................................................82 
13.2.2. Severity Assessment .............................................................................................82 
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13.3. Documentation and Follow-Up of Adverse Events ...................................................82 
13.4. Reporting Adverse Events ..........................................................................................84 
13.4.1. Reporting Adverse Events to Sponsor ..................................................................84 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities .85 
13.5. Event of Special Interest .............................................................................................85 
13.5.1. Specific Requirements for Recording and Diagnosing Possible Microbial Keratitis
.............................................................................................................................85 
13.5.2. Loss of Best Sphero-cylindrical Corrected Visual Acuity without Physical Cause
.............................................................................................................................87 
13.6. Reporting of Pregnancy ..............................................................................................87 
14.     STATISTICAL METHODS ...........................................................................................88 
14.1. General Considerations ..............................................................................................88 
14.2. Sample Size Justification ............................................................................................88 
14.3. Analysis Populations ..................................................................................................89 
14.4. Level of Statistical Significance .................................................................................89 
14.5. Primary Analysis ........................................................................................................89 
14.6. Secondary Analysis ....................................................................................................90 
14.7. Other Analyses ...........................................................................................................90 
14.8. Interim Analysis .........................................................................................................91 
14.9. Procedure for Handling Missing Data and Drop-Outs ...............................................91 
14.10. Procedure for Reporting Deviations from Statistical Plan .........................................91 
15.      DATA HANDLING AND RECORD KEEPING/ARCHIVING ..................................92 
15.1. Electronic Case Report Form/Data Collection ...........................................................92 
15.2. Subject Record ...........................................................................................................92 
16.     DATA MANAGEMENT ...............................................................................................93 
16.1. Access to Source Data/Document ..............................................................................93 
16.2. Confidentiality of Information ...................................................................................93 
16.3. Data Quality Assurance ..............................................................................................93 
17.     MONITORING ...............................................................................................................94 
18.     ETHICAL AND REGULATORY ASPECTS ...............................................................94 
18.1. Study-Specific Design Considerations .......................................................................94 
18.2. Investigator Responsibility .........................................................................................94 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) ................94 
18.4. Informed Consent .......................................................................................................96 
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18.5. Privacy of Personal Data ............................................................................................96 
19.     STUDY RECORD RETENTION ..................................................................................97 
20.     FINANCIAL CONSIDERATIONS ...............................................................................98 
21.     PUBLICATION ..............................................................................................................98 
22.     REFERENCES ...............................................................................................................98 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ....101 
APPENDIX B: PARENT/PATIENT INSTRUCTION GUIDE............................................106 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ........................................107 
APPENDIX D: 
 .....................................108 
 LENS FITTING CHARACTERISTICS ..............................................................109 
 SUBJECT REPORTED OCULAR SYMPTOMS PROBLEMS .........................116 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................118 
 CONJUNCTIVAL STAINING............................................................................125 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ..........................129 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 134 
 PATIENT REPORTED OUTCOMES.................................................................138 
 ADMINISTRATION OF CYLCLOPLEGIA ......................................................140 
 ANTERIOR CHAMBER ANGLE GRADING SCALE .....................................143 
 COVER-UNCOVER TEST .................................................................................146 
 ISO BIOMICROSCOPY SCALE ........................................................................149 
 MEASURING AXIAL LENGTH & OCULAR BIOMETRICS WITH THE 
LENSTAR 900.......................................................................................................................157 
 
MEASURING 
PUPIL 
DIAMETER 
WITH 
NEUROPTICS 
VIP-200 
PUPILLOMETER..................................................................................................................163 
SPECIMEN COLLECTION PROCEDURES FOR CORNEAL CULTURE .....167 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING ...............................................................................................................................170 
WAM-5500 ON-AXIS AUTO REFRACTION MEASUREMENT ...................175 
 CORNEAL INFILTRATE ASSESSMENT ........................................................179 
 DIAGNOSIS OF MICROBIAL KERATITIS ...................................................185 
MEASURING AXIAL LENGTH & OTHER OCULAR BIOMETRICS WITH IOL MASTER 
WORK AID ...........................................................................................................................190 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .........................195 
 
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LISTING OF TABLES  
 
Table 1: Test Articles .............................................................................................................. 34 
Table 2: Ancillary Supplies/Products used in this study ........................................................ 35 
Table 3: Time and Events ....................................................................................................... 38 
 
LISTING OF FIGURES 
 
Figure 1: Study Flowchart ...................................................................................................... 18 
  
 
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SYNOPSIS 
 
Protocol Title 
Evaluating Soft Contact Lens Prototypes for Myopia Control 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Development phase, Phase 1   
Trial Registration The study will be registered on clinicaltrial.gov by the Sponsor based on 
the following:   
This is an interventional clinical trial for evaluating safety and 
effectiveness of novel soft contact lenses for controlling myopia 
progression in pediatric populations. 
Test Article(s) 
Daily disposable soft contact lenses (SCL) made in senofilcon A material 
with four different types of optical designs. 
Test Lenses:  
• EMO-114 
• EMO-116 
• EMO-118 
Control Lens:   
• EMO-117 
Wear and 
Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily disposable  
Subjects will be randomly assigned to receive one of the four test articles.  
Objectives  
The objective of the study is to evaluate the safety and effectiveness of 
three soft contact lens prototypes for controlling myopia progression by 
comparing to a control soft contact lens.   
Study Endpoints 
Primary endpoints: 
1. Change of Axial Length (AL) at 6-month from baseline 
2. Change of Spherical Equivalent Cycloplegic Auto Refraction 
(SECAR) at 6-month from baseline 
Secondary endpoint: 
• Serious and significant ocular adverse events 
Other observations: 
1. Non-significant AEs and non-ocular AEs 
2. Slit lamp findings per the ISO 11980 grading scale 
3. Subject-reported ocular symptoms 
4. Corneal radius of curvature measured by an autorefractor 
5. Over-the-lens near visual acuity 
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6. Subjective best-sphere over-refraction 
7. Number of power modification per each prescription update 
8. Number of prescription update during the study 
9. Lens fit characteristics  
10. Distance logMAR visual acuity under High Luminance High 
Contrast (HLHC) conditions 
11. Subjective vision, comfort, and handling scores based on the 
Pediatric Contact Lens User Experience (pCLUE) questionnaire. 
12. Lens wear time compliance 
13. Number of visits for contact lens insertion/removal training 
Study Design 
This is a multi-site, prospective, randomized, controlled, double-masked, 
four-arm-parallel-group, dispensing study.   
Each subject will be bilaterally fitted with one of the four types of test 
articles and wear lenses of the assigned lens type during the entire course 
of the study. Test articles will be worn a minimum 8 hours per day and 5 
days per week (subjects will be encouraged to wear study contact lenses 
10 hours or more per day and 7 days per week) in a daily disposable 
modality for a minimum of 6 months and up to 1 year*.  
There will be a total of 7 scheduled visits.  
Visit 1: Screening, baseline evaluation,  
Visit 2: Baseline, randomization, lens fit and dispensing 
Visit 3: 1-week follow-up 
Visit 4: 1-month follow-up 
Visit 5: 3-month follow-up 
Visit 6: 6-month follow-up 
Visit 7: 1-year follow-up (optional) 
* The study will complete after all subjects have completed the 6-month 
follow-up (Visit 6). Considering the extensive enrollment period (e.g., 
approximately 8 months), while waiting for the last enrolled subjects to 
complete the 6-months follow-up, the study allows subjects enrolled at the 
beginning of the enrollment period to continue wearing study lenses for up 
to 1 year and complete the 1-year follow-up (Visit 7) before completing 
the final evaluation and exiting the study. 
See the flow chart at the end of the synopsis table for the schematic of the 
study visits and procedures of main observations (Figure 1). 
Sample Size 
Approximately 240 subjects will be enrolled in the study with a minimum 
of 160 subjects (40/arm) targeted to complete the 6-month follow-up.  
Study Duration 
The total duration of the study is estimated to be about 18 months, 
including approximately 8 months of enrollment period.  
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Anticipated 
Study Population 
Healthy male and female children between 7 and 12 years of age 
(inclusive) with best sphere refraction between -0.75D and -4.50D 
(inclusive), 1.00D or less astigmatism. Potential subjects can be spectacle 
lens wearers, current soft lens wearers, or symptomatic myopes (e.g., with 
complaints of blurry vision) but currently with no correction. Study sites 
will aim to enroll at least 50% of subjects in the age group of 7 – 9 years 
as well as subjects with 0.50D or more myopia progression in the past 12 
months (documented or by self-report) to their best effort.  
Eligibility 
Criteria 
Potential subjects must satisfy all following criteria to be enrolled in the 
study:  
Inclusion Criteria after Screening: 
1. The subject must read (or be read to), understand, and sign the 
Statement of Information and Assent and receive a fully executed 
copy of the form. 
2. The subject’s parent(s) or legal guardian(s) must read, understand 
and sign the Statement of Informed Consent and receive a fully 
executed copy of the form. 
3. Appear able and willing to adhere to the instructions set forth in 
this clinical protocol. 
4. Between 7 and 12 years of age (inclusive). 
5. Have normal eyes (ie, no ocular medications or infections of any 
type). 
Inclusion Criteria after Baseline 1: 
6. Distance subjective best-sphere refraction must be 
between -0.75D and -4.50D (inclusive) in each eye. 
7. Cylindrical refraction must be 1.00D or less in each eye, by 
subjective sphero-cylindrical refraction.  
8. Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 
0.8 in decimal convention or 0.10 logMAR) or better in each eye. 
Inclusion Criteria after Baseline 2: 
9. Cycloplegic objective sphero-cylindrical refraction (by auto 
refraction) must be between -0.75D and -4.50D in sphere and is 
1.00D or less in cylinder in each eye (based on the average of 5 
repeated sphero-cylindrical refraction measures). 
10. The difference in spherical equivalent power between the two 
eyes must be less than 1.50D (based on the average of 5 repeated 
sphero-cylindrical refraction measures). 
Potential subjects who meet any of the following criteria will be 
excluded from participating in the study: 
Exclusion Criteria after Screening: 
1. Currently pregnant or lactating. 
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2. Any systemic allergies, infectious disease (e.g., hepatitis, 
tuberculosis), autoimmune disease (e.g., rheumatoid arthritis), or 
other systemic diseases (e.g., diabetes), by the parent or legal 
guardian’s report, which are known to interfere with contact lens 
wear and/or participation in the study. 
3. Use of systemic medications (e.g., chronic steroid use) that are 
known to interfere with contact lens wear.  
4. Any current use of ocular topical medication.  
5. Any previous or planned ocular or intraocular surgery, including 
refractive surgery. 
6. Participation in any contact lens or lens care product clinical trial 
within 30 days prior to study enrollment. 
7. Participation in any prior myopia control clinical study in the test 
group. 
8. Current or recent (within 30 days from enrollment) rigid lens 
wearers.  
9. History of orthokeratology treatment or use of other ophthalmic 
devices (e.g., bifocal, multifocal contact or spectacle lenses) or 
drugs (e.g., atropine or pirenzepine) for the purpose of controlling 
myopia progression.  
10. Any known hypersensitivity or allergic reaction to EyeCept® (or 
sponsor approved equivalent) Rewetting Drop Solution. 
11. Relatives of employee of investigational clinic (e.g., Investigator, 
Coordinator, Technician). 
Exclusion Criteria after Baseline: 
12. Any ocular allergies, infections or other ocular abnormalities that 
are known to interfere with contact lens wear and/or participation 
in the study. This may include, but not be limited to, aphakia, 
uveitis, ocular hypertension, glaucoma, severe 
keratoconjunctivitis sicca, history of recurrent corneal erosions, 
keratoconus, keratoconus suspect, pellucid marginal 
degeneration, entropion, ectropion, extrusions, chalazia, and 
recurrent styes.  
13. Grade 3 or greater palpebral conjunctival observations or any 
other Grade 2 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, conjunctival injection) on 
the ISO 11980 classification scale. 
14. Any previous history or signs of a contact lens-related corneal 
inflammatory event (e.g., past peripheral ulcer or round 
peripheral scar), or any other ocular abnormality that may 
contraindicate contact lens wear. 
15. Any central corneal scar 
16. Any corneal distortion resulting from ocular diseases or previous 
hard or rigid gas permeable contact lens wear. 
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17. Binocular vision abnormality, intermittent strabismus or 
strabismus. 
18. Anterior chamber angle is Grade 2 or narrower in either eye. 
19. IOP is 21 mmHg or higher in either eye. 
Disallowed 
Medications/ 
Interventions  
Disallowed medications for this study included the following: 
1. Any chronic (3 months or more) or seasonal (30 days or more) use of 
topical ophthalmic medication except for artificial tears or contact 
lens rewetting drops. This includes but is not be limited to, topical 
ophthalmic anti-histamine, topical ophthalmic mast cell stabilizers, 
topical ophthalmic antibiotics, topical ophthalmic vasoconstricting 
agents, and topical decongestants, including nasal decongestants 
(naphazoline, tetrahydrozoline, and phenylephrine), etc.  
Short-term use of above listed topical ophthalmic medication may be 
allowed, but must be completed at least 7 days prior to any scheduled 
study visit. 
2. Any outside the study use of topical agents with anti-muscarinic 
properties for more than 3 consecutive days (i.e., other than for 
diagnostic use), or repeated single use of these agents for more than 3 
doses within the last 6 months. This includes but is not limited to 
atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate and 
homatropine. Occasional use of these agents (i.e., three doses or less 
during the last 6 months) must be completed 21 days prior any 
scheduled study visit.   
3. Any chronic use of oral agents with anti-muscarinic properties. This 
includes, but is not limited to  
1) Any GI anti-spasmodic medicine containing atropine, 
hyoscyamine, and dicyclomine 
2) Over-the-counter cold & allergy preparations and sleeping agents 
that contain first generation anti-histamines (diphenhydramine, 
chlorpheniramine) 
3) Tricyclic anti-depressant (amitriptyline, imipramine, 
nortriptyline) 
4) Anti-psychotics agents (chlorpromazine, thioridazine) 
5) Anti-nausea/anti-cough medication containing promethazine, 
prochlorperazine, meclizine and scopolamine 
6) Anti-anxiety agent (hydroxyzine) 
7) Ipratropium bromide  
Short-term use of above listed oral agents with anti-muscarinic 
properties may be allowed but must be completed at least 7 days prior 
to any scheduled study visit. 
4. Any chronic use of human growth hormone products containing 
somatropin, eg, Genotropin, Nutropin, Saizen, etc. Short-term use of 
these medications may be allowed but must be completed at least 30 
days prior to any scheduled study visit. 
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5. Any chronic use of oral beta-blocker. Short-term use of oral beta-
blockers may be allowed but must be completed at least 7 days prior 
to any scheduled study visit.  
6. Any chronic use of anti-psychotic and neurological. This includes but 
is not limited to,  
1) ADHD medications containing methylphenidates, amphetamines 
and its derivatives (Ritalin, Concerta, Adderall, and Strattera, etc.) 
2) Anti-psychotic agents phenothiazines (chlorpromazine, 
thioridazine)  
Short-term use of above listed medications may be allowed, but must 
be completed at least 30 days prior to any scheduled study visit. 
7. Any chronic use of sulfa drugs. This includes but is not limited to 
1) Sulfamethoxazole containing products, such as Bactrim, Septra 
2) Carbonic anhydrase inhibitors such as dorzolamide and 
acetazolamide 
3) Sulfasalazine 
4) Topiramate 
5) Thiazides diuretics such as hydrochlorothiazide & chlorthalidone 
Short-term use of above listed medications may be allowed, but must 
be completed at least 7 days prior to any scheduled study visit. 
8. Any medications that has known ocular side effects. 
 
Concomitant therapies that are disallowed include:  
1. Contact lens corneal reshaping/CRT/orthokeratology 
2. Any vision training/vision therapy/orthoptics/patching 
3. Use of reading spectacles or progressive addition lenses  
4. Any therapies that the investigator felt would be contraindicated 
in contact lens wear. 
Measurements 
and Procedures 
• Axial length (by LENSTAR LS 900, or a similar device (e.g., 
IOLMaster) in Asian sites upon approval of the sponsor) 
• Cycloplegic auto refraction (by an open-field auto refractor) 
• Slit lamp examination per the ISO 11980 grading scale 
• Subjective ocular symptom questionnaires  
• Landolt C logMAR visual acuity under the high luminance high 
contrast conditions (OD, OS, OU) 
• Subjective lens fit assessment 
• Subjective assessment of vision, comfort and lens handling 
Microbiology or 
Other Laboratory 
Testing  
Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature. 
Study 
Termination 
The occurrence of one or more Unanticipated Adverse Device Effect 
(UADE), or any Serious Adverse Event (SAE) where relationship to study 
agent cannot be ruled out, will result in stopping further dispensing 
investigational product.  In the event of a UADE or SAE, the Sponsor 
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Medical Monitor may unmask the treatment regimen of subject(s) and may 
discuss this with the Principal Investigator before any further subjects are 
enrolled. 
Ancillary 
Supplies/ Study-
Specific 
Materials 
Topical anesthetics (e.g., 0.5% proparacaine or equivalent approved in 
local markets) 
Cycloplegia agent (1% cyclopentolate) 
Precision Vision Landolt C 4-meter, high contrast, logMAR visual acuity 
charts (2210, 2210A and 2210B) 
Precision Vision Landolt C 40-cm, high contrast, logMAR visual acuity 
charts 
There will be no contact lens care solutions, e.g., disinfecting or storage 
used/provided in the study. 
Principal 
Investigator and 
Study Sites 
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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Flowchart, continued 
Visit 2 – Trial Lens Fitting
6.   Record lens information
7.   Lens insertion 
8.   Lens settling
9.   Subjective lens fit assessment
10. Over the lens distance VA (OD, OS, OU)
11. Subjective best-sphere over-refraction with distance VA (OD, OS, OU)
12. Lens power adjustment?
Visit 2 – Trial Lens Fitting, continued
13. Near LOE Landolt C HLHC logMAR VA, without over refraction (OD, OS, OU)
14. Distance LOE Landolt C HLHC logMAR VA, without over refraction (OD, OS, OU)
15. I/R training 
16. Exit distance VA (OD, OS, OU)
Visit 2: Lens Fitting
Visit 2 – Baseline
1. Medical history and concomitant medications review
2. Subject symptom form
3. Entrance distance VA (OD, OS, OU)
4. Slit lamp biomicroscopy (ISO 11980 scale), including conjunctival staining
5. Subjective best sphere refraction, with distance & near VA (OD, OS, OU)
No
I/R training successful?
17. Continuance (lens dispensing criteria)
18. Trial Lens Dispensing; Schedule Visit 3
Yes
No
I/R Training Visit
• 
Entrance distance VA
• 
Slit lamp
• 
I/R training
• 
Exit distance VA
• 
Lens dispensing, if I/R 
training successful
Yes
Randomization
 
 
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Flowchart, continued 
Visit 3 – Entrance Information
1. pCLUE
2. Subject symptom form
3. Medical history and concomitant medication review
4. Lens wear  time and compliance
8. Lens power adjustment?
YES, record 
lens information
NO
Visit 3: 1-week Follow-up
Visit 3 – Study lens follow up
5. LOE distance VA (OD, OS, OU)
6. Subjective lens fit assessment
7. Subjective best-sphere over-refraction, with distance VA (OD, OS, OU)
Visit 3 – Study lens follow up, continued
9.   Near LOE HLHC Landolt C logMAR VA, without over refraction (OD, OS, OU, under HLHC)
10. Distance LOE HLHC Landolt C logMAR VA, without over refraction (OD, OS, OU)
11. Remove and discard the study contact lenses 
12. Axial length (non-cycloplegic)
13. Slit lamp biomicroscopy, with conjunctival staining
14. Exit distance VA (OD, OS, OU)
15. CL checklist
16. Continuance (lens dispensing criteria)
17. Lens dispensing; Schedule visit 4
Visit 4: 1-month Follow-up 
Repeat Visit 3
Visit 5: 3-month Follow-up 
Repeat Visit 3
 
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required for Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IOP 
Intraocular Pressure 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
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PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
 
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1. INTRODUCTION AND BACKGROUND 
Based on the literature reports and past experiences of developing soft contact lenses for 
controlling myopia progression at Johnson & Johnson Vision Care (JJVC),5-10 it is 
hypothesized that introducing more “plus” power in the optical design of the lens that covers 
larger retinal area is likely to result in larger myopia control treatment effect. However, this 
approach may also lead to negative impact on vision. In order to balance between maximizing 
myopia control efficacy and minimizing visual impact, a series of new optical designs for 
myopia control are proposed. These prototypes were evaluated in pilot studies for their visual 
performances
 in adult subjects. 11-13 Lens prototypes were 
also evaluated for their potential for controlling myopia progression via “in-vitro” modeling. 
The results of these studies indicated that two prototype designs (EMO-114 and EMO-118) 
provided satisfactory visual, comfort and fit performances14,15 and are suitable to be further 
evaluated for their myopia control efficacy in a longitudinal clinical trial.   
 
The purpose of the current study is to evaluate the safety and effectiveness of two new lens 
prototypes (EMO-114 and EMO-118) for controlling myopia progression. Also included in the 
study is a third investigational lens (EMO-116) that has an optical design simulating that of 
the MiSight lens (CooperVision, Inc.). The MiSight lens is CE-marked and indicated for 
myopia control in patients of 8-18 years of age.6,16   
1.1. Name and Descriptions of Investigational Products  
This study will test three investigational lenses (EMO-114, -116, and -118) for their myopia 
control effect against a marketed control lens. Two of the investigational lenses (Test1: EMO-
114 and Test 2: EMO-118) are new lens prototypes designed for myopia control purpose. The 
third investigational lens (Test 3: EMO-116) has an optical design simulating the CE-marked 
MiSight lens and is included in the study serving as the positive control lens. An FDA-cleared, 
non-marketed lens (Control: EMO-117) is included in the study to serve as the negative control 
lens. All four study lenses are made in senofilcon A material and will be worn in the daily 
disposable modality.  Further details about the test articles are found in Section 6 of this 
protocol. 
1.2. Intended Use of Investigational Products 
The intended use of the three investigational soft contact lenses (Test: EMO-114, -116, and -
118) is for correcting myopia and controlling the progression of myopia. The fourth 
investigational lens (Control: EMO-117) is for correcting myopia only and is not intended for 
controlling myopia progression. During this study, each subject will wear one of the four types 
of contact lenses. All four types of contact lenses will be worn bilaterally in the daily wear, 
daily disposable modality for at least 8 hours per day, 5 days per week (subjects will be 
encouraged to wear study contact lenses 10 hours or more per day and 7 days per week) for a 
minimum of 6 months and up to 1 year.  
 
 
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1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding the 
investigational lenses refer to the latest version of the Investigator's Brochure for EMO Design 
Family Lenses.17  
1.4. Summary of Known Risks and Benefits to Human Subjects 
The benefit of controlling myopia progression is considered to be substantial18 as the 
prevalence and incidence of myopia has been increasing substantially over the past few 
decades.19-21 In addition, significant health risks have been associated with myopia, including 
glaucoma, cataract, retinal detachment and myopic macular degeneration. Therefore, it can be 
considered most advantageous to control the progression of myopia and start treatment at an 
early age when myopia is at a low level. Based on theoretical predication, it is estimated that 
an effect of reducing myopia progression by 33% and 50% will result in a reduction in risk 
population (defined as the percentage of myopes being 5.00 D or higher) by 73% and over 
90%, respectively.22  
 
The risks associated with the wear of contact lenses for myopia control includes 1) contact lens 
risks in general population; 2) contact lens risks in pediatric population; and 3) risks 
specifically associated with EMO family of lenses, such as potential sub-optimal visual 
performances and long-term physiological and/or neurological impact.  
 
Assessment regarding contact lens risks in general and in the pediatric population concluded 
that the risks associated with the EMO investigational lenses are expected to be the same as 
those normally attributed to the wear of soft hydrophilic contact lenses on a daily wear basis. 
The daily disposable modality of the investigational lenses further reduces risks associated 
with lens care and the use of care products (eg, cleaning, disinfecting, rinsing and storage, etc.). 
Anticipated adverse reactions with these lenses are the same as any other soft contact lens as 
listed in this study protocol Section 13.1. In addition, the most recent review on the safety of 
contact lens wear in children concluded that “the incidence of corneal infiltrative events in 
children is no higher than in adults, and in the youngest age range of 8 to 11 years, it may be 
markedly lower”.23 
 
Due to the unique optical design of the EMO lenses, visual performance of these lenses may 
not be equivalent to that of lenses with a conventional spherical lens design. To manage the 
risk, special attention will be paid to visual acuity, visual complaints (eg, blurry vision or visual 
artifacts such as ghosting or haloes, etc.), and subjective visual acceptance while fitting the 
study lenses. In addition, the study lens power may be modified based on the refraction over 
the study lens and visual acuity. Finally, specific criteria regarding visual acuity and subjective 
vision acceptance will be imposed for lens dispensing. The study lenses will not be dispensed 
and the subject will be discontinued from the study if these vision criteria are not met. Finally, 
there has been no evidence in the literature suggesting any long-term physiological or 
neurological risks associated with children being exposed to chronic myopic defocus (e.g., due 
to under correction) or to multi-focal type optical interventions.  
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2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
The objective of the study is to evaluate the safety and effectiveness of three soft contact lens 
prototypes for controlling myopia progression by comparing to a control soft contact lens. 
 
Primary Objective:  
The primary objective of the study is to evaluate the performance of three soft contact lens 
prototypes for slowing myopia progression in children age 7 to 12 years old (inclusive) after 
6-month of lens wear by comparing to a control soft contact lens.  
 
Secondary Objective:  
The secondary objective of the study is to evaluate the safety of three new soft contact lens 
prototypes.  The evaluation of the safety of the test articles will be based on monitoring adverse 
events, slit lamp findings and subject reported ocular symptoms throughout the study.  
 
Other Objectives: 
Other exploratory objectives include: 
1. Assessing visual acuity with the study lenses; 
2. Assessing lens fit characteristics;  
3. Assessing lens wear time compliance; 
4. Assessing subject’s responses regarding lens vision, comfort and handling 
performances.  
 
In addition, the performance of the three Test lenses (EMO-114, -116, and -118) for myopia 
control may be evaluated and compared with the Control lens (EMO-117) for one year of lens 
wear, if applicable. Summary statistical analyses will be performed on safety and efficacy 
parameters of available 1-year data.  
2.2. Endpoints  
Primary Endpoints 
There are two co-primary endpoints in this study: 
1. Change of axial length (AL) from baseline at 6 months;  
Axial length (in the unit of mm) will be measured using LENSTAR LS 900 
manufactured by Haag-Streit, or a similar device (e.g., IOLMaster) in selected Asian 
sites upon approval of the sponsor.  
2. Change of spherical equivalent of cycloplegic auto refraction (SECAR) from baseline 
at 6 months    
SECAR (in the unit of D) will be computed from the sphero-cylindrical refraction 
measured by a commercially available autorefraction such as WAM-5500 
manufactured by Grand Seiko.  
 
Secondary Endpoints 
• Serious and significant ocular Adverse Events (AEs) 
 
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Other Endpoints: 
1. Non-significant AEs and non-ocular AEs 
2. Slit lamp findings per the ISO 11980 grading scale 
3. Subject-reported ocular symptoms 
4. Corneal radius of curvature measured by an autorefractor 
5. Over-the-lens near visual acuity 
6. Subjective best-sphere over-refraction 
7. Number of power modification per each prescription update 
8. Number of prescription update during the study 
9. Lens fit characteristics  
10. Distance logMAR visual acuity under High Luminance High Contrast (HLHC) 
conditions 
11. Subjective vision, comfort, and handling scores based on the Pediatric Contact Lens 
User Experience (pCLUE) questionnaire. 
pCLUE is a subjective questionnaire that is currently being developed specific for 
pediatric populations based on the existing CLUE™ questionnaire for the adult 
population. CLUE™ is a validated patient reported outcomes (PRO) questionnaire to 
assess patient-experience attributes of soft contact lenses (comfort, vision, handling, 
and packaging) in a contact-lens wearing population in the US, ages 18-65.33 
12. Lens wear time compliance 
13. Number of visits for contact lens insertion/removal training 
 
In addition, the following observations will be recorded or monitored throughout the study:  
1. Subject’s demographics 
2. Subject’s disposition, number and reasons for discontinuation 
3. Number and reasons for unscheduled visits 
4. Lens accountability, including reasons for lens dispensing or replacement  
5. Protocol deviations 
6. Product quality complaints 
2.3. Hypotheses 
Primary Hypotheses: 
After approximately 6 months of lens wear, at least one of the three Test lenses (EMO-114, -
116, and -118) will be efficacious in slowing the progression of myopia compared to the 
Control lens (EMO-117) such that: 
1. 
the change of axial length (AL) of the eye from baseline will be statistically 
significantly less for the Test lens compared with the Control lens. 
2. 
the change of Spherical Equivalent of Cycloplegic Auto Refraction (SECAR) of the 
eye from baseline will be statistically significantly less in magnitude with the Test 
lens compared with the Control lens. 
 
Both conditions regarding the performance of the Test lens must be met in order to meet the 
primary objective.  
 
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Secondary Hypothesis: 
Secondary endpoint and all other safety endpoints will be summarized descriptively. No 
secondary endpoint hypothesis testing will be performed. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female children between 7 and 12 years of age (inclusive) with best sphere 
refraction between -0.75D and -4.50D (inclusive), 1.00D or less astigmatism. Potential subjects 
can be spectacle lens wearers, current soft lens wearers, or symptomatic myopes (e.g., with 
complaints of blurry vision) but currently with no correction. Each study site will aim to enroll 
at least 50% of subjects in the age group of 7 – 9 years as well as subjects with 0.50D or more 
myopia progression in the past 12 months (documented or by self-report) to their best effort. 
There are no restrictions as to gender or race/ethnicity.  
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
  
Inclusion Criteria after Screening: 
1. The subject must read (or be read to), understand, and sign the Statement of Information 
and Assent and receive a fully executed copy of the form. 
2. The subject’s parent(s) or legal guardian(s) must read, understand and sign the Statement 
of Informed Consent and receive a fully executed copy of the form. 
3. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
4. Between 7 and 12 years of age (inclusive). 
5. Have normal eyes (i.e., no ocular medications or infections of any type). 
 
Inclusion Criteria after Baseline 1: 
6. Distance subjective best-sphere refraction must be between -0.75D and -4.50D 
(inclusive) in each eye. 
7. Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical 
refraction.  
8. Have sphero-cylindrical best-corrected visual acuity of 20/25 (ie, 0.8 in decimal 
convention or 0.10 logMAR) or better in each eye. 
 
Inclusion Criteria after Baseline 2: 
9. Cycloplegic objective sphero-cylindrical refraction (by auto refraction) must be 
between -0.75D and -4.50D in sphere and is 1.00D or less in cylinder in each eye (based 
on the average of 5 repeated sphero-cylindrical refraction measures). 
10. The difference in spherical equivalent power between the two eyes must be less than 
1.50D (based on the average of 5 repeated sphero-cylindrical refraction measures). 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
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Exclusion Criteria after Screening: 
1. Currently pregnant or lactating. 
2. Any systemic allergies, infectious disease (e.g., hepatitis, tuberculosis), autoimmune 
disease (e.g., rheumatoid arthritis), or other systemic diseases (e.g., diabetes), by the 
parent or legal guardian’s report, which are known to interfere with contact lens wear 
and/or participation in the study. 
3. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with 
contact lens wear.  
4. Any current use of ocular topical medication.  
5. Any previous or planned ocular or intraocular surgery, including refractive surgery. 
6. Participation in any contact lens or lens care product clinical trial within 30 days prior to 
study enrollment. 
7. Participation in any prior myopia control clinical study in the test group. 
8. Current or recent (within 30 days from enrollment) rigid lens wearers.  
9. History of orthokeratology treatment or use of other ophthalmic devices (e.g., bifocal, 
multifocal contact or spectacle lenses) or drugs (e.g., atropine or pirenzepine) for the 
purpose of controlling myopia progression.  
10. Any known hypersensitivity or allergic reaction to EyeCept® (or sponsor approved 
equivalent) Rewetting Drop Solution. 
11. Relatives of employee of investigational clinic (e.g., Investigator, Coordinator, 
Technician). 
 
Exclusion Criteria after Baseline: 
12. Any ocular allergies, infections or other ocular abnormalities that are known to interfere 
with contact lens wear and/or participation in the study. This may include, but not be 
limited to, aphakia, uveitis, ocular hypertension, glaucoma, severe keratoconjunctivitis 
sicca, history of recurrent corneal erosions, keratoconus, keratoconus suspect, pellucid 
marginal degeneration, entropion, ectropion, extrusions, chalazia, and recurrent styes.  
13. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 or greater slit 
lamp findings (e.g., edema, corneal neovascularization, corneal staining, conjunctival 
injection) on the ISO 11980 classification scale. 
14. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., 
past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may 
contraindicate contact lens wear. 
15. Any central corneal scar 
16. Any corneal distortion resulting from ocular diseases or previous hard or rigid gas 
permeable contact lens wear. 
17. Binocular vision abnormality, intermittent strabismus or strabismus. 
18. Anterior chamber angle is Grade 2 or narrower in either eye. 
19. IOP is 21 mmHg or higher in either eye. 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
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4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a multi-site, prospective, randomized, controlled, double-masked, four-arm-parallel-
group, dispensing study.   
 
Each subject will be bilaterally fitted with one of the four types of test articles and wear lenses 
of the assigned lens type during the entire course of the study. Test articles will be worn a 
minimum 8 hours per day and 5 days per week (subjects will be encouraged to wear study 
contact lenses 10 hours or more per day and 7 days per week) in a daily disposable modality 
for a minimum of 6 months and up to 1 year*.  
 
There will be a total of 7 scheduled visits.  
Visit 1: Screening and baseline evaluation 
Visit 2: Baseline, randomization, lens fit and dispensing 
Visit 3: 1-week follow-up 
Visit 4: 1-month follow-up 
Visit 5: 3-month follow-up 
Visit 6: 6-month follow-up 
Visit 7: 1-year follow-up (optional)* 
 
* The study will complete after all subjects have completed the 6-month follow-up (Visit 6). 
Considering the extensive enrollment period (e.g., approximately 8 months), while waiting for 
the last enrolled subjects to complete the 6-months follow-up, the study allows subjects 
enrolled at the beginning of the enrollment period to continue wearing study lenses for up to 1 
year and complete the 1-year follow-up (Visit 7) before completing the final evaluation and 
exiting the study.  
 
Study participants will have no access to test articles at study closure.  
4.2. Study Design Rationale 
The study is designed as a study for proof of concept that soft contact lenses with novel optical 
designs have the potential for controlling myopia progression. A total of three investigational 
soft contact lenses will be evaluated for their safety and effectiveness of controlling myopia 
progression in children of 7 to 12 years of age by comparing to an FDA-cleared, non-marketed 
control contact lens. 
 
Among the three Test lenses, two are of novel optical designs for myopia control (EMO-114 
and EMO-118). The third Test lens (EMO-116) with an optical design simulating the MiSight 
lens (CE-marked for the myopia control indication, not marketed in the US, Canada or China) 
is included in the study to serve as a reference (positive control) for evaluating the myopia 
control efficacy of the two novel lens design prototypes (EMO-114 and EMO-118).    
    
The Control lens (EMO-117) used in this study is an FDA-cleared, non-marketed soft contact 
lens with conventional, single-vision spherical optical design. This lens is selected as the 
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placebo control for evaluating the optical impact of the three Test lenses on myopia 
progression.    
 
All four types of test articles are identical in all aspects (lens material, diameter, base curve, 
modality, and manufacturing process) except for different optical designs.  
 
Since evaluating myopia progression of a subject and the lens effect of controlling myopia 
progression is longitudinal in nature, a bilateral dispensing, parallel-group study design is 
required. The designs of the four test articles allow the study to be conducted as a randomized, 
placebo-controlled, double-masked trial, which is considered to be the gold-standard for a 
clinical trial. Such clinical trial design and the selection of a soft contact lens as the control are 
recommended by the expert panel during the FDA workshop to inform the premarket 
evaluation of contact lenses designed to control myopia progression (Silver Spring, MD, 
September 30, 2016). 
 
For the purpose of minimizing potential seasonal effect on a subject’s rate of myopia 
progression, the complete evaluation of the effectiveness of a Test lens typically requires at 
least 1 year of lens wear. The study, however, is designed to have a minimum of 6 months of 
lens wear follow-up and evaluates the myopia control effect of Test lenses at 6 months instead 
of 1 year. The reason for selecting the 6-month study duration is that based on clinical trials 
reported in the literature and conducted by JJVC on evaluating lenses for myopia control,5-10 
it appears that the treatment effect, if any, is largest within the first 6 months treatment, and 
the effect appears to diminish over time. Therefore, as a first study for proof of concept of 
EMO lens design prototypes, a 6-month treatment period is expected to be sufficient to identify 
lenses that have potential myopia control effect.      
4.3. Enrollment Target and Study Duration 
Approximately 240 subjects will be enrolled in the study with a minimum of 160 subjects 
(40/arm) targeted to complete the 6-month follow-up. The point of enrollment is defined as the 
execution of the informed consent and assent at Visit 1.  
 
Approximately 6-8 multi-national clinical sites, including sites in the US, Canada and China 
will participate in the study. Each site is expected to enroll approximately 30 to 40 subjects 
with 20 to 32 subjects (approximately 5 to 8 subjects per arm, per site) targeted to complete 
the study.  
 
The duration of study enrollment will be approximately 8 months, unless otherwise approved 
by the Sponsor. 
 
Eligible subjects will be randomly assigned to one of the four study arms and complete up to 
six scheduled visits. Details of the visit schedule are provided in Sections 4.1 and 7.1 of the 
current study protocol.  
 
The total duration of the study is estimated to be 18 months, including approximately 8 months 
of enrollment period.  
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5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using parallel design with 4 
lens types. Using a computer-generated randomization scheme provided by the study 
biostatistician, each subject will randomly be assigned to one of four study arms with a 1:1:1:1 
ratio.  Randomization will be first stratified by site. At each site, the study sample will be 
further stratified based on age (7 – 9 years and 10 – 12 years) and best-sphere refraction at 
baseline (lower than -2.00D myopia vs. -2.00D or more myopia). Each study site will aim to 
enroll at least 50% of subjects in the age group of 7 – 9 years.  
 
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 block will contain four different lenses.  
 
The clinical site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. 
 
Randomization must be performed at Visit 2. The following must have occurred prior to 
randomization:  
• Informed consent and assent have been obtained from participant’s parent/legal 
guardian and the participant  
• It has been determined that the subject meets all the inclusion / exclusion criteria  
• Subject history and baseline information has been collected  
 
When the trial fitting assessment is ready to be conducted, the following steps should be 
followed:  
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme to obtain the study test article assignment for that subject prior 
to dispensing.  
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme.  
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that were opened, whether dispensed or not, must be recorded on the 
Test Article Accountability Log in the “Lenses Dispensed” section.  
5.2. Masking 
This study will be double-masked. Both subjects and investigators (including clinical site 
personnel involved in the data collection) will be masked to the identity of the investigational 
product during the study.  Every attempt will be made to keep the other clinical trial personnel 
involved in the study (e.g. Data management, Biostatistician and Clinical Operations) unaware 
of the identity of the study lenses.  The identity of the study lenses will be masked by over 
labeling the blister packs with a label containing the study number, lot number, sphere power, 
expiration date and the randomization codes. Only the personnel involved in the over labeling 
and the Statistician generating the randomization scheme will have access to the decode 
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6.4. Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. The test article will be 
labeled as investigational lenses with the identity of the lens masked to the 
subject/Investigators. The test articles will be in cartons, in arrays of six blisters, as the 
secondary packaging form. The sample study label is shown below: 
 
                                                    
 
 
6.5. Storage Conditions  
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6. Collection and Storage of Samples 
Where necessary, a culture of the corneal lesion will be collected to determine if the infection 
is microbial in nature. Refer Section 13.5.1 for determination of corneal culture and 
 
for specimen collection procedures for corneal culture.    
 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC. 
6.7. Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records.  
 
Test article must be kept in a locked storage cabinet or room, 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.   
 
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7.2. Detailed Study Procedures 
VISIT 1 – Screening and Baseline 
Potential subjects who currently wear myopia correcting lenses (spectacles or soft contact 
lenses) should report to the visit wearing their spectacle lenses. 
 
It is preferred, but not required that on an individual basis, each subject reports to baseline, 6-
and 12-month (if applicable) visits at approximately the same time frame of the day, eg, 
morning, noon, early or late afternoon. 
 
Instructions for breaking Visit 1 into two sections (as needed):  
 
Due to the length of Visit 1, it is foreseeable that some subjects may not be able to complete 
all procedures within one visit. In such cases, subjects will complete Visit 1 procedures up to 
1.16 (pupil diameter) without being cyclopleged. If Visit 1 is to be completed on two separate 
days, the subject’s exit visual acuity must be collected at the end of the first part of the Visit 1, 
before the subject exits the visit. 
 
The subject may return on a different day (up to 21 days from the initial visit) to complete the 
rest of procedures in Visit 1 including all procedures under the sections of “Questionnaires” 
and “Cycloplegia and Endpoint Data Collection” below. 
 
When the subject returns to complete the rest of the procedures of visit 1, the following 
information will be collected prior to performing any other testing procedures:  
• Visit date,  
• Review of medical history and concomitant medications/therapies  
• Entrance visual acuity  
• Slit lamp biomicroscopy  
 
Results of procedures under the second part of Visit 1 will be recorded in Visit 1 EDC. 
 
Note: verify and document device accuracy 
 and appropriate room and 
acuity chart lighting levels 
 before the visit. 
 
 
 
 
 
 
 
 
 
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VISIT 4 – 1-month Follow-up 
The Subject must report to the visit wearing the test article. 
 
It is preferred, but not required that on an individual basis, each subject reports to the visit at 
approximately the same time frame as the baseline visit. 
 
Repeat all procedures listed under Visit 3, 1-week follow-up visit.  
 
Dispense the study contact lenses for a wearing period of 2 months (up to 90 lenses per eye). 
 
Instruct the subject to fill out the lens wear and activity diary every month till the next visit.  If 
paper diary is provided, instruct the subject to bring the diary to the next visit.  
 
Schedule the subject for Visit 5 (3-month follow-up, 91 ± 7 days from Visit 2). 
 
Note: verify and document device accuracy 
 and appropriate room and 
acuity chart lighting levels 
 before the visit. 
 
VISIT 5 – 3-month Follow-up 
The Subject must report to the visit wearing the test article. 
 
It is preferred, but not required that on an individual basis, each subject reports to the visit at 
approximately the same time frame as the baseline visit. 
 
Repeat all procedures listed under Visit 3, 1-week follow-up visit.  
 
Dispense the study contact lenses for a wearing period of 3 months (up to 120 lenses per eye). 
 
Instruct the subject to fill out the lens wear and activity diary every month till the next visit.  If 
paper diary is provided, instruct the subject to bring the diary to the next visit.  
Schedule the subject for Visit 6 (6-month follow up, 182 ± 14 days from Visit 2). 
 
Note: verify and document device accuracy 
 and appropriate room and 
acuity chart lighting levels 
 before the visit. 
 
VISIT 6 – 6-month Follow-up 
The Subject must report to the visit wearing the test article. 
 
It is preferred, but not required that on an individual basis, each subject reports to the visit at 
approximately the same time frame as the baseline visit. 
 
 
 
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Instructions for breaking Visit 6 into two sections (as needed):  
 
Due to the length of the visit, it is foreseeable that some subjects may not be able to complete 
all procedures within one visit. In such cases, subjects will complete the visit on two separate 
days. The two parts of the visit should be performed within 7 days, and the second half of the 
visit shall be completed within the originally specified visit window. 
 
During the first part of the visit, the subject will complete all procedures before step 6.26, the 
section of “Cycloplegia and Endpoint Data Collection”. The subject’s exit visual acuity must 
be collected at the end of the first part of the visit before the subject exits the visit.  
 
When the subject returns to complete the rest of the procedures of the visit, the following 
information will be collected prior to performing any other testing procedures:  
• Visit date,  
• Review of medical history and concomitant medications/therapies  
• Entrance visual acuity  
• Slit lamp biomicroscopy  
 
Results of procedures performed during the second part of the visit will be recorded in EDC 
of the corresponding visit. Subjects shall continue wearing the assigned test articles during the 
break of the two parts of the visit. 
 
Instructions for managing subjects presenting to Visit 6 while the study is in the process of 
being terminated:  
 
Until the clinical site receives the written notification from the sponsor that the study is 
terminated without the subject completing the 1-year follow-up, all active subjects shall 
complete the 6-month follow-up visit (Visit 6) with their lens prescription updated (if 
applicable), additional study lenses dispensed and Visit 7 (1-year follow-up visit) scheduled. 
 
In the event that the study is terminated, the subject will complete Visit 6 without lens 
modification and dispensing. The subject will complete final evaluation before exiting the 
study. 
 
Note: verify and document device accuracy 
 and appropriate room and 
acuity chart lighting levels 
 before the visit. 
 
 
 
 
 
 
 
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• Subject death during the study period 
• Subject withdrawal of consent 
• Subject not compliant to protocol, including significant non-compliant to lens wear 
time schedule, e.g., the subject is found to have lens wear time that is less than 6 hours 
per day or less than 5 days per week for two consecutive follow-up visits (e.g., at both 
Visits 4 and 5, Visits 5 and 6, or Visits 6 and 7) 
• Subject lost to follow-up  
• Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant) 
• Subject develops significant or serious adverse events causing discontinuation of study 
lens wear for more than 3 consecutive weeks during the first 6-month dispensing period   
• 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 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 
 
An additional subject may be enrolled if a subject discontinues from the study during the study 
enrollment period.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.  
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 the following: 
1. Any chronic (3 months or more) or seasonal (30 days or more) use of topical 
ophthalmic medication except for artificial tears or contact lens rewetting drops. This 
includes but is not be limited to, topical ophthalmic anti-histamine, topical 
ophthalmic mast cell stabilizers, topical ophthalmic antibiotics, topical ophthalmic 
vasoconstricting agents, and topical decongestants, including nasal decongestants 
(naphazoline, tetrahydrozoline, and phenylephrine), etc.  
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Short-term use of above listed topical ophthalmic medication may be allowed, but 
must be completed at least 7 days prior to the study or scheduled follow-up visits 
during the study. 
2. Any outside the study use of topical agents with anti-muscarinic properties for more 
than 3 consecutive days (i.e., other than for diagnostic use), or repeated single use of 
these agents for more than 3 doses within the last 6 months. This includes but is not 
limited to atropine, scopolamine, pirenzepine, tropicamide, cyclopentolate and 
homatropine. Occasional use of these agents (i.e., three doses or less during the last 6 
months) must be completed 21 days prior to the study or any scheduled follow-up 
visit during the study.   
3. Any chronic use of oral agents with anti-muscarinic properties. This includes, but is 
not limited to  
1) Any GI anti-spasmodic medicine containing atropine, hyoscyamine, and 
dicyclomine 
2) Over-the-counter cold & allergy preparations and sleeping agents that contain 
first generation anti-histamines (diphenhydramine, chlorpheniramine) 
3) Tricyclic anti-depressant (amitriptyline, imipramine, nortriptyline)  
4) Anti-psychotics agents (chlorpromazine, thioridazine) 
5) Anti-nausea/ anti-cough medication containing promethazine, 
prochlorperazine, meclizine and scopolamine 
6) Anti-anxiety agent (hydroxyzine) 
7) Ipratropium bromide  
Short-term use of above listed oral agents with anti-muscarinic properties may be 
allowed but must be completed at least 7 days prior to the study or scheduled follow-
up visits during the study. 
4. Any chronic use of human growth hormone products containing somatropin, e.g., 
Genotropin, Nutropin, Saizen, etc. Short-term use of these medications may be 
allowed but must be completed at least 30 days prior to the study or scheduled 
follow-up visits during the study. 
5. Any chronic use of oral beta-blocker. Short-term use of oral beta-blockers may be 
allowed but must be completed at least 7 days prior to the study or scheduled follow-
up visits during the study.  
6. Any chronic use of anti-psychotic and neurological. This includes but is not limited 
to,  
1) ADHD medications containing methylphenidates, amphetamines & its 
derivatives (Ritalin, Concerta, Adderall, and Strattera, etc.) 
2) Anti-psychotic agents phenothiazines (chlorpromazine, thioridazine)  
Short-term use of above listed medications may be allowed, but must be completed at 
least 30 days prior to the study or scheduled follow-up visits during the study. 
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7. Any chronic use of sulfa drugs. This includes but is not limited to 
1) Sulfamethoxazole containing products, such as Bactrim, Septra 
2) Carbonic anhydrase inhibitors such as dorzolamide and acetazolamide 
3) Sulfasalazine 
4) Topiramate 
5) Thiazides diuretics such as hydrochlorothiazide & chlorthalidone 
Short-term use of above listed medications may be allowed, but must be completed at 
least 7 days prior to the study or scheduled follow-up visits during the study. 
8. Any medications that has known ocular side effects. 
 
Concomitant therapies that are disallowed include:  
1. Contact lens corneal reshaping/CRT/orthokeratology 
2. Any vision training/vision therapy/orthoptics/patching 
3. Use of reading spectacles or progressive addition lenses  
4. Any therapies that the investigator felt would be contraindicated in contact lens wear. 
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
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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.   
 
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 or not the lens was inserted 
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• 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 applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1  
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event 
 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
• Results in death 
• Is life threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
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• Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body) 
• Is a congenital anomaly/birth defect, or 
• Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function).   
 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered an SAE when, based upon appropriate medical 
judgment, they may jeopardize the patient or subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in the above definition. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• 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 – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
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Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1  
 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly.  Elements of categorization will include: 
• 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; 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; severe for all events - see definition in 
Section 13.2.2).   
• Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
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• Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
• 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 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.   
 
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Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  
Such documentation will include the following: 
• 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, 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 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF 
.  Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature.  If cultures are collected, the date of culture 
collection and laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether or not a subject reporting with an adverse event will continue in the 
study.  If a subject is discontinued from the study, it will be the responsibility of the Investigator 
to record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
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not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event.  In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2).  The report will comment whether or not the adverse event 
was considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received.  The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
• 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.  
13.5. 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 
event34: 
1. Central (6 mm) or paracentral (8 mm) location; 
2. Penetration of Bowman’s membrane; 
3. Infiltrate> 2mm 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 
. 
 
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 1mm 
• 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).31 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. 
 
All cases of symptomatic corneal infiltrates shall be reported to DMC. The DMC will serve as 
an independent committee to adjudicate whether the event should be classified as infectious or 
non-infectious by majority vote. 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. 35 
• Definite MK: one or more central (6 mm) or paracentral (8 mm) corneal stromal 
infiltrates greater than 2mm 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 
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• Probable MK: same definition as that of definite MK but failing to meet all of the 
specified criteria, e.g., the size of the lesion was less than 2mm, the pain was minimal, 
or there was less than Grade 2 anterior chamber reaction, no mucopurulent discharge, 
or negative corneal culture. 
• 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 
During the course of the study, 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), the 
subject will cease wearing the study lenses and 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. 36 
 
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 pathology 37-39) 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 (Sections 11 
and 13.1). 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the course of the study will be 
discontinued after the event is recorded as an Adverse Event.  Once discontinued, pregnant 
participants and their fetuses will not be monitored for study related purposes.  At the 
Investigator’s discretion, the study participant may be followed by the Investigator through 
delivery. However, this data will not be collected as part of the clinical study database.  
Pregnant participants are not discontinued from contact lens or solution related studies for 
safety concerns, but due to general concerns relating to pregnancy and contact lens use.  
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or 
visual acuity that occur secondary to systemic hormonal changes, and not due to unforeseen 
health risks to the mother or fetus. 
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14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the Sponsor. A general description of the statistical 
methods to be implemented in this clinical trial is outlined below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each subject/eye 
will be used when available for summarization and statistical analysis.  Unscheduled visits will 
be summarized separately and will be excluded from the statistical analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
 
All statistical analysis will be conducted on the per-protocol population defined in section 14.3. 
14.2. Sample Size Justification 
This is a pilot study for assessing the investigational test articles. As such, the sample size was 
not determined based on any power analysis with regard to the primary endpoint. The collected 
data will be used to design future trials. Below sample size calculation is for reference only.   
 
Using the POWER procedure in SAS 9.4, below is the summary of different statistical powers 
based on the different assumptions of the true difference in each of the primary endpoint at the 
given sample size (40 per arm). The estimated standard deviation is from the change at 6 
months for the test group of the historical study 
 The power analysis was conducted 
controlling 2-sided type I error of 0.05.  
 
Assuming the true difference in change of axial length (AL) from baseline at 6 months is 
between 0.05mm to 0.12mm, the table below demonstrates the table below demonstrates the 
power analysis for the given sample size (40 per arm). 
 
Difference (Test-Control)  
Estimated Standard 
Deviation 
# of subjects per arm 
Power 
0.05 
0.10 
40 
0.60 
0.08 
0.10 
40 
0.94 
0.10 
0.10 
40 
0.99 
0.12 
0.10 
40 
0.99 
 
Assuming the true difference in change of spherical equivalent of cycloplegic auto refraction 
(SECAR) from baseline at 6 months (in magnitude) is between 0.10D to 0.25D, the table below 
demonstrates the power analysis for the given sample size (40 per arm).  
 
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Difference (Test-Control)  
Estimated Standard 
Deviation 
# of subjects per arm 
Power 
0.10 
0.32 
40 
0.03 
0.15 
0.32 
40 
0.54 
0.20 
0.32 
40 
0.79 
0.25 
0.32 
40 
0.93 
14.3. Analysis Populations 
Safety Population: 
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who have successfully completed the initial screening and baseline visit (Visit 1), 
the study lens fitting and dispensing visit (Visit 2), and the 6-month follow up visit (Visit 6), 
and did not substantially deviate from the protocol as determined by the trial cohort review 
committee prior to database hard lock (Per-Protocol Population). Justification of excluding 
subjects with protocol deviations in the per-protocol population set will be documented in a 
memo to file. 
 
Intent-to-Treat (ITT) Population: 
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
The two primary endpoints, changes of axial length (AL) and cycloplegic auto refraction 
(SECAR) from baseline at 6 months follow-up, will be analyzed separately using a linear 
mixed model for longitudinal data. Each model will include treatment group, time period (in 
weeks) and treatment group by time interaction as fixed effect factors; and site, subject nested 
in site, and eye nested in subject as random effect factors when appropriate. Other baseline 
characteristics known of importance such as age, gender, refractive error at baseline, axial 
length at baseline, pupil size, parental history of myopia and other factors will be included as 
fixed covariates when appropriate. The covariance between residual errors from the same 
subject/eye across lens wearing time periods will be selected based on the finite-sample 
corrected Akaike’s Information Criterion.41 Covariance structures considered may include: 
Homogeneous Compound Symmetry (CS), first-order autoregressive (AR(1)) and 
Unstructured covariance structure (UN).  For AR (1) structure, site, subject nested in site and 
eye nested in subject will be included in each model as random effects. For the remaining 
structures, only site and subject will be included as random effects. The covariance structure 
that returns the lowest Akaike Information Criteria Corrected (AICC) will be selected as the 
structure that best fit the data. Heterogeneous residuals covariance structures (R-side) across 
treatment groups will be considered when appropriate. The log-likelihood ratio test will be 
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used to test for the homogeneity between the residual covariance structures. The Kenward and 
Roger method will be used for the denominator degree of freedom.42 
 
The null and alternative hypotheses for superiority for each test lens relative to the control are 
as follows for AL and SECAR: 
𝐻𝐻0: ∆ 𝐴𝐴𝐴𝐴≥0; 𝐻𝐻𝐴𝐴: ∆ 𝐴𝐴𝐴𝐴< 0; 
 
𝐻𝐻0: ∆ 𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆≥0; 𝐻𝐻𝐴𝐴: ∆ 𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆< 0, 
 
where ∆ 𝐴𝐴𝐴𝐴 and ∆ 𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆𝑆 are the mean differences (Test minus Control) in change from baseline 
of AL and SECAR at 6 months follow-up respectively.   
 
For each primary endpoint, the comparison between the treatment groups at 6-Month time 
period will be conducted using a t-test on least-square means from the final model. The 
corresponding CI of least-square mean (LSM) difference (i.e. LSM change from baseline of 
test group minus LSM change from baseline for control group) will be calculated with 95% 
confidence to test the primary hypothesis.  
 
Superiority of the test lens relative to the control lens in reducing change from baseline in axial 
length at 6-Month will be claimed if the corresponding upper confidence limits of the LSM 
differences is smaller than 0.  
 
Superiority of the test lens relative to the control lens in reducing the magnitude of change 
from baseline in cycloplegic auto refraction at 6-Month will be claimed if the corresponding 
lower confidence limits of the LSM differences is greater than 0. 
14.6. Secondary Analysis 
Secondary endpoint – serious and significant ocular adverse events will be summarized 
descriptively using all available data from the entire study, including data from unscheduled 
visits.  
14.7. Other Analyses 
If the primary objective of the study is met, additional analysis may be performed to compare 
among three Test lenses, including comparisons between Test 1 and Test 2 vs. Test 3 lenses. 
 
In addition, the performance of the three Test lenses (EMO-114, -116, and -118) for myopia 
control may be evaluated and compared with the Control lens (EMO-117) after 1-year of lens 
wear, if data are available.  
 
Summary statistical analysis will be provided for the following other observations for the entire 
study, including 1-year data, if available: 
1. Non-significant AEs and non-ocular AEs 
2. Slit lamp findings per the ISO 11980 grading scale 
3. Subject-reported ocular symptoms 
4. Corneal radius of curvature measured by an autorefractor 
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5. Over-the-lens near visual acuity 
6. Subjective best-sphere over-refraction 
7. Number of power modification per each prescription update 
8. Number of prescription update during the study 
9. Lens fit characteristics  
10. Distance logMAR visual acuity under High Luminance High Contrast (HLHC) 
conditions 
11. Subjective vision, comfort, and handling scores based on the Pediatric Contact Lens 
User Experience (pCLUE) questionnaire. 
12. Lens wear time compliance, including weighted average of daily lens wear time (in 
hours), average number of lens wear days per week, and a composite lens wear time 
compliance score (%) relative to protocol specified minimum and recommended lens 
wear time requirements, per each dispensing period and for the entire study 
13. Number of visits for contact lens insertion/removal training 
14. Subject’s demographics 
15. Subject’s disposition, number and reasons for discontinuation 
16. Number and reasons for unscheduled visits 
17. Lens accountability, including reasons for lens dispensing or replacement  
18. Protocol deviations 
19. Product quality complaints 
 
Further exploratory analysis will be considered at discretion of the Study Responsible 
Clinician. 
14.8. Interim Analysis 
Not applicable. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations. 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
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15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted to 
the specification of the JJVC database manager and sent to JJVC for analysis.  
 
External Date Sources for this study include: Not Applicable.  
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy and 
completeness and signed by the Investigator.  The sponsor or sponsor’s representatives will be 
authorized to gain access to the subject recordation for the purposes of monitoring and auditing 
the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2011.1  
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
• 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 
• 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 
 
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The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC.  The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
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17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, 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 
18.1. Study-Specific Design Considerations 
Potential subjects and their parents/legal guardians will be fully informed of the risks and 
requirements of the study and, during the study, subjects and their parents/legal guardians will 
be given any new information that may affect their decision to continue participation.  Subjects 
and their parents/legal guardians will be told that their consent/assent to participate in the study 
is voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled.  Only subjects whose parents are 
fully able to understand the risks, benefits, and potential adverse events of the study, and 
provide their consent voluntarily, and subjects who provides their assent will be enrolled. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol and, if applicable, amendments 
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• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information) and amendments 
• 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, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval 
letter must be dated and must clearly identify the documents being approved. 
 
During the study the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
• Protocol amendments 
• 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 amendments or new edition(s) 
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of 
the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• Any other requirements of the IEC/IRB 
 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
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At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject must give written assent and their parents (legal guardians) must give written 
consent according to local requirements after the nature of the study has been fully explained. 
The consent and assent forms must be signed before performance of any study-related activity. 
The consent and assent forms that are used must be approved by both the Sponsor and by the 
reviewing IEC/IRB. The informed consent and assent are in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO141551 GCP guidelines, 
applicable regulatory requirements, and Sponsor policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential 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, respectively, and the opportunity to ask 
questions. After this explanation and before entry into the study, assent and consent should be 
appropriately recorded by means of the subject's and parent/legal guardian’s dated signatures. 
After having obtained the consent and assent, a copy of the informed consent and assent forms 
must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States,43 the Personal Information Protection and Electronic Documents Act (PIPEDA) 
in Canada,44 and other applicable personal data protection and security laws and regulations.  
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
• processed fairly and lawfully 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
• adequate, relevant, and not excessive in relation to said purposes 
• accurate and, where necessary, kept current 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/ISO 14155 GCP guidance1,2  and all study documents as 
specified by the applicable regulatory requirement(s). The Investigator/Institution will take 
measures to prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least 2 years after the last approval of a marketing 
application in an ICH region and until there are no pending or contemplated marketing 
applications in an ICH region or until at least 2 years have elapsed since the formal 
discontinuation of clinical development of the investigational product. These documents will 
be retained for a longer period if required by the applicable regulatory requirements or 
instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
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 
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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  
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor based on the following: 
 
This is an interventional clinical trial for evaluating safety and effectiveness of novel soft 
contact lenses for controlling myopia progression in pediatric populations. 
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects - Godd 
Clinical Practice. Available at: https://www.iso.org/standard/45557.html In. 
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html In. 
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/index.html 
In. 
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR. In. 
5. Aller TA, Liu M, Wildsoet CF. Myopia Control with Bifocal Contact Lenses: A 
Randomized Clinical Trial. Optom Vis Sci. 2016;93(4):344-352. 
6. Anstice NS, Phillips JR. Effect of dual-focus soft contact lens wear on axial myopia 
progression in children. Ophthalmology. 2011;118(6):1152-1161. 
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7. Cheng X, Xu J, Chehab K, Exford J, Brennan N. Soft Contact Lenses with Positive 
Spherical Aberration for Myopia Control. Optom Vis Sci. 2016;93(4):353-366. 
8. Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact 
(DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year 
randomised clinical trial. Br J Ophthalmol. 2014;98(1):40-45. 
9. Sankaridurg P, Holden B, Smith E, 3rd, et al. Decrease in rate of myopia progression 
with a contact lens designed to reduce relative peripheral hyperopia: one-year results. 
Invest Ophthalmol Vis Sci. 2011;52(13):9362-9367. 
10. Walline JJ, Greiner KL, McVey ME, Jones-Jordan LA. Multifocal contact lens myopia 
control. Optom Vis Sci. 2013;90(11):1207-1214. 
11. Cheng X. Clinical Protocol 
 
Evaluation of Vision, Comfort, 
Handling and Fit Performances of Soft Contact Lenses for Myopia Control.  January 30, 
2017. 
12. Cheng X. Clinical Protocol 
Evaluation of Vision, Comfort, 
Handling and Fit Performances of Soft Contact Lenses for Myopia Control.  June 16, 
2017. 
13. Cheng X. Clinical Protocol
 Evaluation of Visual 
Performances of Soft Contact Lens Prototypes for Myopia Control.  TBD. 
14. Cheng X. Clinical Report 
 Evaluation of Vision, Comfort, 
Handling and Fit Performances of Soft Contact Lenses for Myopia Control.  TBD. 
15. Cheng X. Clinical Report 
 Evaluation of Visual 
Performances of Soft Contact Lens Prototypes for Myopia Control.  TBD. 
16. Kollbaum PS, Jansen ME, Tan J, Meyer DM, Rickert ME. Vision performance with a 
contact lens designed to slow myopia progression. Optom Vis Sci. 2013;90(3):205-214. 
17. Cheng X. Investigator's Brochure: EMO Design Family Lenses.  October 11, 2017. 
18. Vitale S, Sperduto RD, Ferris FL, 3rd. Increased prevalence of myopia in the United 
States between 1971-1972 and 1999-2004. Arch Ophthalmol. 2009;127(12):1632-1639. 
19. Lin LL, Shih YF, Hsiao CK, Chen CJ, Lee LA, Hung PT. Epidemiologic study of the 
prevalence and severity of myopia among schoolchildren in Taiwan in 2000. J Formos 
Med Assoc. 2001;100(10):684-691. 
20. Lin LL, Shih YF, Hsiao CK, Chen CJ. Prevalence of myopia in Taiwanese 
schoolchildren: 1983 to 2000. Ann Acad Med Singapore. 2004;33(1):27-33. 
21. Xu L, Wang Y, Li Y, Cui T, Li J, Jonas JB. Causes of blindness and visual impairment 
in urban and rural areas in Beijing: the Beijing Eye Study. Ophthalmology. 
2006;113(7):1134 e1131-1111. 
22. Brennan NA. Predicted Reduction in High Myopia for Various Degrees of Myopia 
Control. Annual Clinical Conference of the British Contact Lens Association; 2012. 
23. Bullimore MA. The Safety of Soft Contact Lenses in Children. Optom Vis Sci. 2017. 
24. Cheng X. Clinical Report 
 Controlling Myopia Progression with Spherical 
Aberration in Soft Contact Lenses.  April 25, 2013. 
25. Cheng X. Clinical Report 
 Controlling Myopia Progression with Spherical 
Aberration in Soft Contact Lenses.  April 29, 2013. 
26. Cheng X. Clinical Report 
 Controlling Myopia Progression with Soft 
Contact Lenses.  April 27, 2013. 
27. Cheng X. Clinical Report 
 Controlling Myopia Progression with Soft 
Contact Lenses.  April 30, 2013. 
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28. Cheng X. Clinical Report 
 Controlling Myopia Progression with Soft 
Contact Lenses.  April 28, 2013. 
29. Cheng X. Clinical Report 
 Controlling Myopia Progression 
through Optical Intervention.  May 21, 2017. 
30. Cheng X. Investigator's Brochure: RMY-100 Lens.  October 10, 2017. 
31. FDA Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lens 
[May 1994]. 
32. FDA Information Sheets: Significant Risk and Nonsignificant Risk Medical Device 
Studies [October, 1995]. In. 
33. Wirth RJ, Edwards MC, Henderson M, Henderson T, Olivares G, Houts CR. 
Development of the Contact Lens User Experience: CLUE Scales. Optom Vis Sci. 
2016;93(8):801-808. 
34. BS EN ISO 11980:2012: Ophthalmic optics - Contact lenses and contact lens care 
products - Guidance for clinical investigations In: BSI Standards Limited  
35. Bullimore MA, Sinnott LT, Jones-Jordan LA. The risk of microbial keratitis with 
overnight corneal reshaping lenses. Optometry and vision science : official publication of 
the American Academy of Optometry. 2013;90(9):937-944. 
36. Manny RE, Hussein M, Gwiazda J, Marsh-Tootle W, Group CS. Repeatability of 
ETDRS visual acuity in children. Investigative ophthalmology & visual science. 
2003;44(8):3294-3300. 
37. 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. 
38. Chua B, Mitchell P. Consequences of amblyopia on education, occupation, and long 
term vision loss. The British journal of ophthalmology. 2004;88(9):1119-1121. 
39. Scheiman M, Wick B. Clinical Management of Binocular Vision: Heterophoric, 
Accommodative, and Eye Movement Disorders. Wolters Kluwer Health/Lippincott 
Williams & Wilkins; 2008. 
40. Cheng X. Clinical Protocol 
 Controlling Myopia 
Progression through Optical Intervention.  July 26, 2015. 
41. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated Measures. 
Communications in Statistics—Simulation and Computation. 1998(27):591–604. 
42. Kenward MGaR, J. H. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997(53):983–997. 
43. Health Information Portabiltiy and Accountabiltiy Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html. In. 
44. Canada Personal Information Protection and Electronic Documents Act (PIPEDA). 
Available at: http://laws-lois.justice.gc.ca/eng/acts/P-8.6/. In. 
  
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
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PRO SPECIFICATION
n 2 Final  2017-11-01
Protocol 5959                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATION
n 2 Final  2017-11-01
Protocol 5959                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATION
n 2 Final  2017-11-01
Protocol 5959                 Johnson & Johnson Vision Care, Inc.                  Confidential
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n 2 Final  2017-11-01
Protocol 5959                 Johnson & Johnson Vision Care, Inc.                  Confidential
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APPENDIX B: PARENT/PATIENT INSTRUCTION GUIDE  
A parent/patient instruction guide, contact lens insertion and removal instructions, insertion 
and removal instructional video, and a study pamphlet will be provided separately to study 
participant’s and their parent’s. 
 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Not Applicable 
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 LENS FITTING CHARACTERISTICS 
 
 
 
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SUBJECT REPORTED OCULAR SYMPTOMS PROBLEMS  
 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
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 CONJUNCTIVAL STAINING  
 
 
 
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
 
 
 
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 1 of 3 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 2 of 3 
 
 
 
 
 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
 
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 ADMINISTRATION OF CYLCLOPLEGIA 
 
 
 
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ANTERIOR CHAMBER ANGLE GRADING SCALE 
 
 
 
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COVER-UNCOVER TEST  
 
 
 
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ISO BIOMICROSCOPY SCALE 
 
 
 
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 MEASURING AXIAL LENGTH & OCULAR BIOMETRICS WITH THE 
LENSTAR 900  
 
 
 
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 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 
PUPILLOMETER 
 
 
 
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SPECIMEN COLLECTION PROCEDURES FOR CORNEAL CULTURE  
 
 
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
 
Document Number:  
 
Revision Number: 3 
 
Page 1 of 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
 
Document Number:  
 
Revision Number: 3 
 
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Title: 
Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type: 
 
Document Number:  
 
Revision Number: 3 
 
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WAM-5500 ON-AXIS AUTO REFRACTION MEASUREMENT 
 
 
 
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Title: 
WAM‐5500 On‐axis Auto Refraction Measurement 
Document Type: 
 
Document Number:  
 
Revision Number: 3 
 
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CORNEAL INFILTRATE ASSESSMENT 
 
 
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DIAGNOSIS OF MICROBIAL KERATITIS 
 
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MEASURING AXIAL LENGTH & OTHER OCULAR BIOMETRICS WITH IOL 
MASTER WORK AID 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
 
Protocol Number and Title:  
CR- 5959 Evaluating Soft Contact Lens Prototypes for Myopia Control 
 
Version and Date: Version: 3.0, Amendment 2, Date: 11-Sep-2018 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 ISO 14155,1 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 ICH11 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
 
Principal 
Investigator: 
 
 
  
 
Signature 
 
 
 Date 
 
Name and Professional Position (Printed) 
  
 
Institution/Site: 
 
  
 
Institution/Site Name 
 
 
  
 
Institution/Site Address 
  
 
 
 
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