Evaluation of Acuvue Oasys 1-Day Contact Lenses in New Wearers
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Evaluation of Acuvue Oasys 1-Day contact lenses in new wearers  
 
Protocol CR-6565  
 
Version: 2.0  
                            
Date: 12 March 2024   
 
 
Investigational Products: ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY  
 
Keywords: R&D Sphere, New Wearer, senofilcon A marketed product (ACUVUE OASYS® 1-DAY with 
HydraLuxe™ TECHNOLOGY), Daily Wear, Daily Disposable, dispensing, Eye-Cept preservative free rewetting 
drops, refraction, Insertion and Removal training, neophytes, confidence survey, motivation survey, CLUE 
comfort, CLUE vision, CLUE handling. 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
 
This clinical trial will be conducted in compliance with ISO 14155:2020 Clinical investigation of medical 
devices for human subjects – Good clinical practice1, and the Declaration of Helsinki.2  
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, released or published 
without written approval from Johnson & Johnson Vision Care, Inc. The information may not be disclosed to 
others except to the extent necessary to obtain Institutional Review Board/Independent Ethics Committee 
approval and informed consent, or as required by International, Federal and State Laws, as applicable. Persons to 
whom this information is disclosed must be informed that this information is privileged and confidential and that 
it should not be further disclosed without the written permission of Johnson & Johnson Vision Care, Inc. Any 
supplemental information that may be added to this document is also confidential and proprietary to Johnson & 
Johnson Vision Care, Inc. and must be kept in confidence in the same manner as the contents of this document. 
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE.................................................................................... 6 
SPONSOR NAME AND ADDRESS ..................................................................................................................... 6 
MEDICAL MONITOR .......................................................................................................................................... 6 
AUTHORIZED SIGNATURES ............................................................................................................................. 7 
CHANGE HISTORY ............................................................................................................................................. 8 
SYNOPSIS ............................................................................................................................................................. 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS .......................... 13 
1. 
INTRODUCTION AND BACKGROUND ................................................................................................ 14 
1.1. 
Name and Descriptions of Investigational Products ........................................................................... 14 
1.2. 
Intended Use of Investigational Products............................................................................................ 14 
1.3. 
Summary of Findings from Nonclinical Studies ................................................................................. 14 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .............................................................. 14 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study .......... 14 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ................................................................... 15 
2.1. 
Objectives ........................................................................................................................................... 15 
2.2. 
Endpoints ............................................................................................................................................ 15 
2.3. 
Hypotheses .......................................................................................................................................... 16 
3. 
TARGETED STUDY POPULATION ....................................................................................................... 16 
3.1. 
General Characteristics ....................................................................................................................... 16 
3.2. 
Inclusion Criteria ................................................................................................................................ 16 
3.3. 
Exclusion Criteria ............................................................................................................................... 17 
3.4. 
Enrollment Strategy ............................................................................................................................ 17 
4. 
STUDY DESIGN AND RATIONALE ...................................................................................................... 17 
4.1. 
Description of Study Design ............................................................................................................... 17 
4.2. 
Study Design Rationale ....................................................................................................................... 17 
4.3. 
Enrollment Target and Study Duration ............................................................................................... 18 
5. 
TEST ARTICLE ALLOCATION AND MASKING ................................................................................. 18 
5.1. 
Test Article Allocation ........................................................................................................................ 18 
5.2. 
Masking .............................................................................................................................................. 18 
5.3. 
Procedures for Maintaining and Breaking the Masking ...................................................................... 18 
6. 
STUDY INTERVENTION ......................................................................................................................... 18 
6.1. 
Identity of Test Articles ...................................................................................................................... 18 
6.2. 
Ancillary Supplies/Products ................................................................................................................ 19 
6.3. 
Administration of Test Articles ........................................................................................................... 19 
6.4. 
Packaging and Labeling ...................................................................................................................... 19 
6.5. 
Storage Conditions .............................................................................................................................. 20 
6.6. 
Collection and Storage of Samples ..................................................................................................... 20 
6.7. 
Accountability of Test Articles ........................................................................................................... 20 
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7. 
STUDY EVALUATIONS .......................................................................................................................... 20 
7.1. 
Time and Event Schedule ................................................................................................................... 20 
7.2. 
Detailed Study Procedures .................................................................................................................. 22 
VISIT 1 ....................................................................................................................................................... 22 
VISIT 2 ....................................................................................................................................................... 30 
VISIT 3 ....................................................................................................................................................... 33 
FINAL EVALUATION .............................................................................................................................. 34 
7.3. 
Unscheduled Visits ............................................................................................................................. 35 
7.4. 
Laboratory Procedures ........................................................................................................................ 36 
8. 
SUBJECTS COMPLETION/WITHDRAWAL .......................................................................................... 36 
8.1. 
Completion Criteria ............................................................................................................................ 36 
8.2. 
Withdrawal/Discontinuation from the Study ...................................................................................... 36 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .............................................. 37 
9.1. 
Systemic Medications ......................................................................................................................... 37 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................................................. 37 
11. 
STUDY TERMINATION........................................................................................................................... 38 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............................................. 39 
13. 
ADVERSE EVENTS .................................................................................................................................. 40 
13.1. 
Definitions and Classifications ........................................................................................................... 40 
13.2. 
Assessing Adverse Events .................................................................................................................. 41 
13.2.1. 
Causality Assessment............................................................................................................. 42 
13.2.2. 
Severity Assessment .............................................................................................................. 42 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................................................ 42 
13.4. 
Reporting Adverse Events .................................................................................................................. 43 
13.4.1. 
Reporting Adverse Events to Sponsor ................................................................................... 43 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities ................... 44 
13.5. 
Event of Special Interest ..................................................................................................................... 44 
13.6. 
Reporting of Pregnancy ...................................................................................................................... 44 
14. 
STATISTICAL METHODS ....................................................................................................................... 44 
14.1. 
General Considerations ....................................................................................................................... 44 
14.2. 
Sample Size Justification .................................................................................................................... 45 
14.3. 
Analysis Populations ........................................................................................................................... 45 
14.4. 
Level of Statistical Significance.......................................................................................................... 45 
14.5. 
Primary Analysis ................................................................................................................................. 45 
14.6. 
Secondary Analysis ............................................................................................................................. 45 
14.7. 
Exploratory Analysis .......................................................................................................................... 45 
14.8. 
Interim Analysis .................................................................................................................................. 46 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................................................ 46 
14.10. Procedure for Reporting Deviations from Statistical Plan .................................................................. 46 
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Table 3: Time and Events ..................................................................................................................................... 21 
Table 4: Disallowed systemic medications ........................................................................................................... 37 
Table 5: Examples of major and minor protocol deviations ................................................................................. 38 
 
LIST OF FIGURES 
Figure 1: Study Flowchart .................................................................................................................................... 12 
 
 
 
 
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SYNOPSIS  
Protocol Title 
Evaluation of Acuvue Oasys 1-Day contact lenses in new wearers  
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Clinical trial phase: 
Post Market 
Design control phase: 
Post-Marketing, Phase 4 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
Test Article: 
Approved Product: ACUVUE OASYS® 1-DAY with HydraLuxe™ 
TECHNOLOGY (AO1D) 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear (DW) 
Replacement Schedule: Daily disposable (DD) 
Objectives  
Primary Objective: The primary objective of this study is to estimate the 
incidence rate (percentage) of eyes with clinically significant slit-lamp 
findings (Grade 3 or 4) related to the study lens after approximately 2-weeks 
of lens wear.  
 
Exploratory Objectives:  The other objectives are to measure commitment 
to lens wear in neophyte subjects after approximately two weeks of wearing 
experience, measure Insertion & Removal (I&R) skills, evaluate new wearer 
confidence and motivation for lens wear, and assess lens performance (CLUE 
vision, comfort & handling scores). 
Study Endpoints 
Primary Endpoints: 
1. Incidence (percentage) of eyes with Grade 3 or 4 slit lamp findings 
related to the study lenses after 2-week of lens wear.  
 
Exploratory Endpoints: 
• 
Commitment to lens wear: Do you want to continue to wear 
contact lenses after this study? (Yes or No) 
• 
Reason for discontinuation (if applicable). 
• 
Time for lens insertion OU 
• 
Time for lens removal OU  
• 
New wearer confidence level 
• 
New wearer motivation level  
• 
Lens performance (CLUE vision, comfort, handling scores)  
Study Design 
This is a multi-site, bilateral, dispensing, non-randomized, uncontrolled, 
unmasked, single arm study. Each subject will be fitted with the study lenses 
and dispensed for approximately 14 days of wear. 
 
There will be a total of 3 visits: 
Visit 1: Screening, baseline evaluation and lens fitting. Dispense for 7 ± 1 
days. 
Visit 2: Follow up #1; Dispense an additional supply for 7 ± 1 days. 
Visit 3: Follow up #2; Final evaluation.   
 
See the flow chart at the end of the synopsis table for the schematic of the 
study visits and procedures of main observations ( Figure 1). 
Sample Size 
Approximately 40 neophyte subjects will be enrolled into the study. It is 
anticipated that approximately 30 subjects will complete the study.  
Study Duration 
The study enrollment period is approximately 8 weeks. Once enrolled, 
subjects will be in the study for about 2 weeks, making the total study duration 
about 10 weeks from the first subject first visit (FSFV) to last subject last visit 
(LSLV).  
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Anticipated Study Population 
Healthy pediatric and adult subjects, ages 13 to 39 (inclusive), of any race or 
ethnicity that have never trialed or placed lenses on eye (neophytes), that meet 
the eligibility criteria for the study.  
Eligibility Criteria - Inclusion 
Potential subjects must satisfy all of the following criteria to be enrolled in the 
study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the Statement of Informed Consent and 
receive a fully executed copy of the form. (For subjects aged 18 and 
older) 
2. Read (or be read to) and sign the Children’s Assent (Information and 
Assent Form) and receive a fully executed copy of the form. (For 
subjects aged 13 to 17)  
3. Have parents or legal guardians who must read, understand, and sign 
the Statement of Informed Consent (Parental Permission Form and 
Authorization to Use and Disclose Medical Information). (For 
subjects aged 13 to 17)  
4. Appear able and willing to adhere to the instructions set forth in this 
clinical protocol.  
5. Be between 13 and 39 (inclusive) years of age at the time of 
screening. 
6. By self-report, having never worn any type of contact lenses and 
never attempted to insert contact lenses. 
7. Have a pair of prescription glasses on hand that corrects distance 
vision, if determined to be required by the investigator.  
 
Inclusion Criteria at Baseline Evaluation 
8. The magnitude of the cylindrical component of the subject’s vertex-
corrected distance refraction must be ≤ 0.75 DC in each eye. 
9. Subject must have a vertex corrected distance sphero-cylindrical 
refraction in the range such that appropriate spherical lens powers 
are available for correction in both eyes. The spherical lens powers 
available in this study are:  
a. 
-1.00 to -6.00 (in 0.25D steps) 
10. Best corrected monocular distance visual acuity must be 20/20-3 or 
better in each eye. 
Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will be excluded 
from participating in the study: 
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating.  
2. Be currently using any ocular medications or have any ocular 
infection of any type. 
3. By self-report, have any ocular or systemic disease, allergies, or 
infection, or use medications that the investigator believes might 
contraindicate or interfere with contact lens wear, or otherwise 
compromise the study endpoints. See section 9.1 for additional 
details regarding systemic medications. 
4. Have previously participated in a contact lens, contact lens primary 
package, or lens care related clinical trial. 
5. Be an employee (e.g., Investigator, Coordinator, Technician) or 
immediate family member of an employee (including partner, child, 
parent, grandparent, grandchild, or sibling of the employee or their 
spouse) of the clinical site.  
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Exclusion Criteria at Baseline Evaluation 
The subject must not: 
6. Have clinically significant (grade 3 or higher on the FDA grading 
scale) slit lamp findings or other corneal, eyelid, or ocular disease or 
abnormalities that the investigator believes might contraindicate 
contact lens wear or may otherwise compromise study endpoints 
(including significant blepharitis, entropion, ectropion, ptosis, 
chalazia, recurrent styes, pterygium, significant dry eye disease, 
history of recurrent corneal erosions, aphakia, corneal distortion, 
herpetic keratitis). 
7. Have a history of strabismus or amblyopia.  
8. Have fluctuations in vision due to clinically significant dry eye or 
other ocular or systemic conditions. 
9. Have had or have planned (within the study period) any ocular or 
intraocular surgery or procedures (e.g., PRK, LASIK, IPL, 
blepharoplasty, etc.) 
Disallowed 
Medications/Interventions  
See section 9.1 for details regarding disallowed systemic medications. 
Measurements and 
Procedures 
The key procedures associated with this study will be: 
• 
Refraction 
• 
Evaluation and grading of ocular physiology using a slit lamp 
biomicroscope. 
• 
Contact lens I&R training. 
• 
I&R skills measurement (e.g., time to insertion). 
• 
Contact lens fitting. 
• 
Evaluation of subjective comfort, vision and handling using the CLUE 
questionnaire. 
• 
Evaluation of subject’s confidence and motivation for lens wear 
(survey). 
Microbiology or Other 
Laboratory Testing 
None. 
Study Termination 
The occurrence of an Unanticipated Adverse Device Effect (UADE) or 
Serious Adverse Event (SAE) for which a causal relationship to a test article 
cannot be ruled out, could result in stopping further dispensing of the 
marketed product. In the event of a UADE or SAE, the Sponsor Medical 
Monitor may review 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 
BioTrue Multipurpose contact lens solution, LacriPure, Eye-Cept, or another 
preservative free rewetting drop. Sodium Fluorescein.    
 
Supply the subject a bottle of contact lens solution for rinsing purposes, if 
necessary. 
Principal Investigator(s) and 
Study Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and institutions is kept 
separately from the Study Protocol and is included in the study Trial Master 
File. 
 
This study will utilize approximately 5 clinical sites.  
 
 
 
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Figure 1: Study Flowchart 
 
 
 
Visit 1: Screening 
Statement of Informed Consent, Childrens Assent (if applicable) 
Demographics 
Medical History & Concomitant Medications 
Eligibility after Screening 
Visit 1: Baseline Evaluation 
Subject Reported Ocular Symptoms 
Baseline confidence & motivation questionnaire 
Baseline (entrance) visual acuity 
Spherocylindrical Refraction and Distance VA 
Slit Lamp Biomicroscopy 
Eligibility at Baseline 
Visit 1: Lens Fitting 
Lens power selection 
I&R training (staff trains the subject) 
I&R learning session (timed) 
Lens fit assessment 
Spherical over-refraction, Modification (if applicable) 
Subject Reported Ocular Symptoms 
Patient reported outcomes (Post fit questionnaire) 
Patient education and instructions 
Dispense 7± 1 days 
Final Evaluation 
    Commitment to lens wear questionnaire 
Visit 2: Follow up #1 
Wear compliance 
Subject Reported Ocular Symptoms 
Confidence & Motivation Questionnaire  
Patient reported outcomes (Post fit questionnaire) 
Removal of lenses (timed) 
Slit Lamp Biomicroscopy 
Insertion of lenses (timed) 
Lens fit assessment 
Continuance & Dispense 7± 1 days 
Visit 3: Follow up #2 
Wear compliance 
Subject Reported Ocular Symptoms 
Confidence & Motivation Questionnaire 
Patient reported outcomes (Post fit questionnaire) 
Removal of lenses, re-insertion of lenses (timed) 
Lens fit assessment 
Slit Lamp Biomicroscopy 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS 
ADE 
 
 
Adverse Device Effect 
ADHD  
 
Attention Deficit Hyperactivity Disorder 
AE 
 
 
Adverse Event/Adverse Experience 
AO1D 
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY  
BSCVA  
              Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COM 
 
 
Clinical Operations Manager 
CRA 
 
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO 
 
 
Contract Research Organization 
 
 
 
 
D 
 
 
Diopter 
DMC 
 
 
Data Monitoring Committee 
eCRF 
 
 
Electronic Case Report Form 
EDC 
 
 
Electronic Data Capture 
FDA 
 
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice 
HIPAA  
              Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
HL 
 
 
Hand Length 
HVID 
 
 
Horizontal Visible Iris Diameter 
IB 
 
 
Investigator’s Brochure 
ICH 
 
 
The International Council for Harmonization 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
I&R 
 
 
Insertion and Removal 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC 
 
 
Johnson & Johnson Vision Care, Inc. 
LASIK  
 
Laser-Assisted in Situ Keratomileusis 
OD 
 
 
Right Eye 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
MPMVA 
 
Maximum Plus to Maximum Visual Acuity 
PAH 
 
 
Palpebral aperture height  
PIG 
 
 
Patient Instruction Guide 
PQC 
 
 
Product Quality Complaint 
PRK 
 
 
Photorefractive Keratectomy 
PRO 
 
 
Patient Reported Outcome 
PW 
 
 
Palm Width 
QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
UADE  
 
Unanticipated Adverse Device Effect 
USADE  
              Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
 
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1. 
INTRODUCTION AND BACKGROUND 
1.1. 
Name and Descriptions of Investigational Products  
This study will use the commercially available spherical ACUVUE OASYS® 1-DAY with HydraLuxe™ 
TECHNOLOGY (AO1D) contact lenses. Further details about the Test article are found in section 6 of this 
protocol. 
1.2. 
Intended Use of Investigational Products 
The intended use of the study lenses is for correcting myopia. There will be one treatment in this study. During 
the study, subjects will wear AO1D lenses bilaterally in daily wear, daily disposable modality over the course of 
approximately two weeks. Since the primary objective of this study is to estimate the incidence rate (percentage) 
of eyes with clinically significant slit-lamp findings (Grade 3 or 4) related to the study lens after approximately 
2-weeks of lens wear, subjects will not be required to adhere to any specific minimum lens wear requirements, 
however, they will be instructed to only wear the lenses during waking hours and educated on typical wear time 
(e.g., maximum 14-16 hours per day). 
1.3. 
Summary of Findings from Nonclinical Studies 
Not Applicable – Marketed product only. 
1.4. 
Summary of Known Risks and Benefits to Human Subjects 
The following risks/adverse events and clinical benefits can be associated with wearing soft contact lenses in 
general: 
• 
The eyes may burn, sting and/or itch. 
• 
There may be a feeling of something in the eye (foreign body, scratched area). 
• 
There may be the potential for some temporary impairment due to peripheral infiltrates, peripheral 
corneal ulcers, and corneal erosion. 
• 
There may be the potential for other physiological observations, such as local or generalized edema, 
• 
corneal neovascularization, corneal staining, injection, tarsal abnormalities, iritis and conjunctivitis, 
some of which are clinically acceptable in low amounts. 
• 
There may be excessive watering, unusual eye secretions, or redness of the eye. 
• 
Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or dry eyes may also 
occur. 
• 
Soft contact lenses, like spectacle lenses, provide correction of refractive error. 
 
For the most comprehensive risk and benefit information regarding study lenses refer to the package insert of 
the marketed product (Appendix C).  
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
Recent review of the literature points to several factors that may contribute to new wearer dropout. Sulley et al 
found that the main reasons for discontinuation were problems with vision (41%), discomfort (36%), and 
handling problems (25%)4.  
 
This study will measure commitment to lens wear in a healthy neophyte population. Eligible subjects will be 
trained and fitted into a commercially available daily disposable contact lens brand (AO1D), known for its 
acceptable clinical performance. After approximately two weeks of wear experience, subjects will be 
interviewed about their commitment to lens wear. Subjects may drop out of the study prematurely, and if so, the 
reason for dropping out will be documented.  
 
For the most comprehensive information regarding study lenses refer to the package insert of the marketed 
product (Appendix C).  
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2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. 
Objectives  
Primary Objective: The primary objective of this study is to estimate the incidence rate (percentage) of eyes 
with clinically significant slit-lamp findings (Grade 3 or 4) related to the study lens after approximately 2-weeks 
of lens wear.  
 
Exploratory Objectives:  The other objectives are to measure commitment to lens wear in neophyte subjects 
after approximately two weeks of wearing experience, measure Insertion & Removal (I&R) skills, evaluate new 
wearer confidence and motivation for lens wear, and assess lens performance (CLUE vision, comfort & handling 
scores). 
2.2. 
Endpoints  
Primary Endpoint: 
 
1. Percentage of eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear: 
Slit Lamp Findings (Grade 3 or higher) will be assessed for each subject eye at all study visits (scheduled 
and unscheduled). However, the primary endpoint will be the percentage of eyes with Grade 3 or higher 
SLFs related to study lens wear, after approximately 2 weeks of lens wear. SLFs will be evaluated and 
classified using the FDA Grading scale rating from 0 to 4, where Grade 0 represents the absence of 
findings and 1 to 4 representing successively worse findings (i.e., Grade 1=trace, Grade 2= mild, Grade 
3=moderate and Grade 4= severe). 
 
Other Exploratory Endpoints: 
 
1. Commitment to lens wear: Do you want to continue to wear contact lenses after this study? (Response 
set: Yes, No) 
 
2. Reasons for Discontinuation (if applicable): Which of the following is the main reason why you want 
to stop wearing contact lenses? (Response set: They were uncomfortable to wear, My eyes were too dry 
to wear them, I didn’t like my vision with contacts, They were too difficult to put on and take off, They 
were more trouble than it’s worth, I’m concerned about the cost, and Other reason [free text]) 
 
3. Insertion Time:  
Insertion time is quantified as the total time (in minutes and seconds) it takes for the subject to insert 
both lenses (OU). Insertion time will be collected at the initial fitting, after approximately 1-week of 
wear, and after approximately 2-weeks of wear. The insertion time is a continuous endpoint.   
 
4. Removal Time:  
Removal time is quantified as the total time (in minutes and seconds) it takes for the subject to remove 
their lenses (OU) at three different time points – at the initial fitting, after approximately 1-week of wear, 
and after approximately 2-weeks of wear. The removal time is a continuous endpoint.  
 
5. Confidence:  
New wearer confidence (for lens wear) will be assessed at baseline (prior to lens fitting), post fitting, 
after approximately 1-week of wear, and after approximately 2-weeks of wear using the individual 
questionnaire item: How confident do you feel in your ability to successfully put on contact lenses? 
(Response Set: Not confident, A little confident, Somewhat confident, Confident, Highly confident). 
(Response Set: No confidence/Little Confidence/Some Confidence/Confident/High Confidence). New 
wearer confidence is an ordinal categorical endpoint.  
 
6. Motivation:  
New wearer motivation (for lens wear) will be assessed at baseline (prior to lens fitting), post lens 
fitting, after approximately 1-week of wear, and after approximately 2-weeks of wear using the 
individual questionnaire item: How motivated are you to wear contact lenses? (Response Set: I am not 
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motivated, /I am a little motivated, /I am somewhat motivated, /I am motivated, /I am highly motivated).  
New wearer motivation is an ordinal categorical endpoint.   
 
7. CLUE Vision, Comfort, and Handling scores will be collected at the initial fitting, after approximately 
1-week of wear, and after approximately 2 weeks of wear. The CLUE vision, comfort and handling 
scores are continuous endpoints.  
 
Subjective comfort, vision, handling scores will be assessed using the Contact Lens Use Experience 
(CLUE™)5 questionnaire after approximately 30 minutes of lens wear (post initial fitting), and after 
approximately 1 and 2 weeks of wear. CLUE is a validated patient-reported outcomes questionnaire to 
assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and 
packaging) in a contact-lens wearing population in the US. Derived CLUE™ scores using Item Response 
Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher 
scores indicate a more favorable/positive response with a range of 0-120. A 5-point increase in an 
average CLUE™ score translates into 10% shift in the distribution of scores for population of soft contact 
lens wearers. 
2.3. 
Hypotheses 
Not applicable. All study endpoints will be summarized descriptively. 
3. 
TARGETED STUDY POPULATION 
3.1. 
General Characteristics  
Subjects will be healthy male and female volunteers of any race and ethnicity that meet the inclusion and exclusion 
criteria. Subjects who are eligible to be enrolled will be between the ages of 13 and 39 years old. Subjects younger 
than 18 years old are considered minors and will be required to be accompanied by a parent or a legal guardian. 
Appropriate Informed Consent forms and Children’s Assent forms will be presented, and ample time will be 
provided for the subjects and their parent or legal guardian to ask questions and make an informed decision.  
3.2. 
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the 
form (For subjects aged 18 and older) 
2. Read (or be read to) and sign the Children’s Assent (Information and Assent Form) and receive a fully 
executed copy of the form. (For subjects aged 13 to 17)  
3. Have parents or legal guardians who must read, understand, and sign the Statement of Informed Consent  
(Parental Permission Form and Authorization to Use and Disclose Medical Information). (For subjects 
aged 13 to 17)  
4. Appear able and willing to adhere to the instructions set forth in this clinical protocol.  
5. Be between 13 and 39 (inclusive) years of age at the time of screening. 
6. By self-report, having never worn any type of contact lenses and never attempted to insert contact lenses. 
7. Have a pair of prescription glasses on hand that corrects distance vision, if determined to be required by 
the investigator.  
 
Inclusion Criteria at Baseline Evaluation 
8. The magnitude of the cylindrical component of the subject’s vertex-corrected distance refraction must 
be ≤ 0.75 DC in each eye. 
9. Subject must have a vertex corrected distance sphero-cylindrical refraction in the range such that 
appropriate spherical lens powers are available for correction in both eyes. The spherical lens powers 
available in this study are:  
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a. 
-1.00 to -6.00 (in 0.25D steps) 
10. Best corrected monocular distance visual acuity must be 20/20-3 or better in each eye. 
3.3. 
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating.  
2. Be currently using any ocular medications or have any ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, allergies, or infection, or use medications that the 
investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise 
the study endpoints. See section  9.1 for additional details regarding systemic medications. 
4. Have previously participated in a contact lens, contact lens package, or lens care related clinical trial. 
5. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an 
employee (including partner, child, parent, grandparent, grandchild, or sibling of the employee or their 
spouse) of the clinical site.  
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
6. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings or other 
corneal, eyelid, or ocular disease or abnormalities that the investigator believes might contraindicate 
contact lens wear or may otherwise compromise study endpoints (including significant blepharitis, 
entropion, ectropion, ptosis, chalazia, recurrent styes, pterygium, significant dry eye disease, history of 
recurrent corneal erosions, aphakia, corneal distortion, herpetic keratitis). 
7. Have a history of strabismus or amblyopia.  
8. Have fluctuations in vision due to clinically significant dry eye or other ocular or systemic conditions.  
9. Have had or have planned (within the study period) any ocular or intraocular surgery or procedures (e.g., 
PRK, LASIK, IPL, blepharoplasty, etc.) 
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. Potential study subjects should 
preferably have a recent history of a comprehensive eye exam, at the investigator’s discretion.  
4. 
STUDY DESIGN AND RATIONALE 
4.1. 
Description of Study Design 
This is a 3-visit, multi-site, bilateral, dispensing, non-randomized, uncontrolled, unmasked, single arm study. 
Subjects will be fitted bilaterally with the same study lenses (one treatment) and dispensed for approximately 2 
weeks of wear (two 1-week wear periods). At Visit 1, subjects will be fitted into the study lenses and dispensed 
for approximately 1 week. At Visit 2 (Follow up #1), additional lenses will be dispensed for another 1-week 
wearing period. Visit 3 will be the final follow up (#2) and final (exit) evaluation.  
 
At the conclusion of the study, subjects will not have access to the study lenses but will be advised to continue 
care with their eye care provider (ECP) and discuss contact lens options with them directly. 
4.2. 
Study Design Rationale 
Single arm study designs are well-established study designs in which subjects are exposed to a single treatment 
for the duration of the study. This design is cost effective and efficient when the performance of the treatment is 
known, and the primary objective of the study is not efficacy related. This design was selected because it most 
closely simulates real world contact lens fitting experience for subjects, providing an opportunity to measure 
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JJVC reserves the right to terminate the study at any time for any reason. Additionally, the IEC/IRB reserves the 
right to terminate the study if an unreasonable risk is determined. The study can be terminated by the Principal 
Investigator at the individual clinical site due to specific clinical observations, if in their opinion, after a discussion 
with JJVC, it is determined that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is determined that an adverse 
event presents an unreasonable risk, the investigation, or that part of the investigation presenting the risk, will be 
terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify the IEC/IRB and 
Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of test 
articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, clinical research 
associates (CRA), clinical operations managers (COM), medical monitors, and site personnel, etc. The following 
are not considered product quality complaints: 
• 
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient Reported Outcomes 
(PRO).” 
• 
Clinical test articles that are stored improperly or damaged after receipt at the investigational site. 
• 
Lens replacements that occur due to drops/fall-outs. 
• 
Damage deemed by clinicians or clinical staff to be caused by handling by the user, and not indicative 
of a quality deficiency (i.e., tears, rips, etc.), only in situations where there is no deficiency alleged by 
the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be recorded in the 
EDC system, which will trigger an automatic email notification to the appropriate COM/CRA and Clinical QA 
representative. In cases where the EDC system in use is not configured to send automatic notifications or when 
an EDC system is not used, the COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC 
has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect additional information 
which will include:  
• 
Date the complaint was received/recorded in the EDC System (Date of Sponsor Awareness). 
• 
Who received the complaint. 
• 
Study number. 
• 
Clinical site information (contact name, site ID, telephone number). 
• 
Lot number(s). 
• 
Unique Subject Identifier(s). 
• 
Indication of who first observed complaint (site personnel or subject). 
• 
OD/OS indication, along with whether the lens was inserted. 
• 
Any related AE number if applicable. 
• 
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, resolution of 
symptoms, etc.). 
• 
Eye Care Provider objective (slit lamp) findings if applicable. 
• 
Confirmation of product availability for return (and tracking information, if available), or rationale if 
product is not available for return 
 
 
 
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Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel to determine if it is 
an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint results in an AE/SAE, the COM/CRA, or 
trained site personnel will follow section 13 of this protocol. If the AE/SAE was potentially the result of a product 
quality related deficiency, these procedures also apply and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the PQC forms will be 
marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be documented. 
13. ADVERSE EVENTS 
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 and whether anticipated or unanticipated.”  
NOTE: This definition includes events related to the investigational medical device or the comparator, 
and to the procedures involved. For users or other persons, this definition is restricted to events related to 
investigational medical devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study but appeared or reappeared following initiation of the study. 
2. Was present prior to the study but worsened during the study. This would include any condition resulting 
from concomitant illnesses, reactions to concomitant medications, or progression of disease states. 
NOTE: Pregnancy must be documented as an adverse event and must be reported to the clinical monitor 
and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
• 
Death 
• 
Serious deterioration in the health of the subject that resulted in any of the following: 
• 
Life-threatening illness or injury 
• 
Permanent or persistent impairment of a body structure or a body function 
• 
Hospitalization or prolongation of patient hospitalization 
• 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 
a body structure or a body function. 
• 
Chronic disease 
• 
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not limited to: 
• 
Microbial Keratitis (MK) 
• 
Iritis (including cells in the anterior chamber) 
• 
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or greater 
• 
Central Corneal Opacity 
• 
Central Corneal Neovascularization 
• 
Uveitis 
• 
Endophthalmitis 
• 
Hypopyon 
• 
Hyphemia 
• 
Penetration of Bowman’s Membrane 
• 
Persistent Epithelial Defect 
• 
Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant discontinuation (temporary 
or permanent) of the contact lens wear. 
 
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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) 
• 
Contact Lens-induced Acute Red Eye (CLARE) 
• 
Any Temporary Loss of > 2 Lines of BCVA 
• 
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 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic and usually do not 
warrant discontinuation of contact lens wear but may cause a reduction in wear time.  However, the Investigator 
may choose to prescribe treatment 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: This definition includes adverse events resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device.1 
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, the test article, if that effect, problem, or 
death was not previously identified in nature, severity, or 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, or related - see definition 
in section 13.2.1). 
• 
Adverse Event Severity – Adverse event severity is used to assess the degree of intensity of the adverse 
event (mild, moderate, or severe - see definition in 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, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the test article. The 
test article relationship for each adverse event should be determined by the investigator using these explanations: 
• 
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) begin when the subjects are exposed 
to the test article, study treatment or study procedure.  Adverse events reported before the use of test article, start 
of study treatment, or study procedures will be recorded as medical history. However, if the condition deteriorates 
at any time during the study, it will be recorded and reported as an AE. Untoward medical events reported after 
the subject’s exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the subject record and 
in the eCRFs and complete the Adverse Event eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All Adverse Events including 
local and systemic reactions not meeting the criteria for “serious adverse events” shall be captured on the 
appropriate case report form or electronic data system. All adverse events occurring while the subject is enrolled 
in the study must be documented appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. All adverse events 
will be followed in accordance with applicable licensing requirements. Such documentation will include the 
following: 
• 
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. 
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• 
Date and time of resolution. 
• 
Adverse event classification, severity, and relationship to test articles, as applicable. 
• 
Treatment regimen instituted (where appropriate), including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
• 
Any referral to another health care provider if needed. 
• 
Outcome, ocular damage (if any). 
• 
Likely etiology. 
• 
Best corrected visual acuity at the discovery of the event and upon conclusion of the event, if the AE is 
related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or study procedures 
(whether related to the visual system or not), an AE review form 
 must be completed. Additional 
dated and initialed entries should be made at follow-up evaluations. Separate forms must be completed for each 
eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment eCRF. Where 
necessary, a culture of the corneal lesion will be collected to determine if the infection is microbial in nature. If 
cultures are collected, the date of culture collection and laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration of the event at each 
level of intensity to be performed. Adverse events characterized as intermittent require documentation of the onset 
and duration of each episode. Changes in the assessment of relationship to the Test Article shall also be clearly 
documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within licensure, until all signs 
and symptoms have returned to pre-treatment status, stabilized, or been satisfactorily resolved. If further treatment 
beyond licensure is required, the patient will be referred to the appropriate health care provider. The Investigator 
will use his/her clinical judgment as to whether a subject reporting with an adverse event will continue in the 
study. If a subject is discontinued from the study, it will be the responsibility of the Investigator to record the 
reason for discontinuation. The Investigator will also document the adverse event appropriately and complete the 
Adverse Event eCRF. Any subjects with ongoing adverse events related to the test article, study treatment or 
study procedures, as of the final study visit date, should be followed to resolution of the adverse event or until 
referral to an appropriate health care provider, as recommended by the Investigator. Non-ocular adverse events 
that are not related to the test article, study treatment, or study procedures may be recorded as “ongoing” without 
further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone as soon as possible 
and no later than 24 hours from discovery for any serious /significant adverse events, and 2 days from discovery 
for any non-significant adverse event. In addition, a written report will be submitted by the Principal Investigator 
to the IEC/IRB according to their requirements (section 13.4.2). The report will comment whether the adverse 
event was considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring during the study period 
as soon as possible by e-mail or telephone, but no later than 24 hours following discovery of the event. The 
Investigator is obligated to pursue and obtain information requested by the Sponsor in addition to that information 
reported on the eCRF. All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
 
In the event of a serious/significant adverse event, the Investigator must: 
• 
Notify the Sponsor immediately. 
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• 
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. 
 
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 
None. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the event is recorded as 
an Adverse Event. Once discontinued, pregnant participants and their fetuses will not be monitored for study 
related purposes. Pregnant participants are not discontinued from contact lens or solution related studies for safety 
concerns, but due to general concerns relating to pregnancy and contact lens use. Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to systemic 
hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical analysis will be undertaken by the study biostatistician. A general description of the statistical methods 
to be implemented in this clinical trial is outlined below. 
 
All data summaries and statistical analyses will be performed using the SAS software Version 9.4 or higher (SAS 
Institute, Cary, NC6. 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 
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(n, mean, standard deviation [SD], median, minimum and maximum). Frequency count and percentage of subjects 
or eyes within each category will be provided for categorical data. 
14.2. Sample Size Justification 
This study was not designed or powered to test any statistical hypotheses, as there was no available data for these 
endpoints and population. The sample size of 40 subjects to enroll with approximately 30 to complete was based 
on clinical considerations and operational feasibility to gain more understanding about the new wearers contact 
lens experience. 
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article. 
 
Per-Protocol Population:  
All subjects who successfully complete all visits and do not substantially deviate from the protocol as determined 
by the trial cohort review committee prior to database hard lock. Justification for the exclusion of subjects with 
protocol deviations from the per-protocol population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
Intention-to-treat population will include all assigned subjects. 
14.4. Level of Statistical Significance 
Not applicable, there is no planned hypothesis testing for any study endpoints. 
14.5. Primary Analysis 
The primary analyses will be conducted on the safety population. The primary endpoint will be summarized using 
counts and percentages. The primary endpoints will be evaluated using the following clinical findings:  
Incidence (percentage) of eyes with Grade 3 or 4 slit lamp findings related to the study lenses after 2-
week of lens wear.  
14.6. Secondary Analysis  
Not applicable. 
 
14.7. Exploratory Analysis 
The exploratory analyses will be conducted on the Intention-to-Treat population. 
 
The following endpoints will be collected and analyzed separately for each timepoint:  
1. Commitment to lens wear: Do you want to continue to wear contact lenses after this study? 
2. Reasons for Discontinuation (if applicable): Which of the following is the main reason why you want to 
stop wearing contact lenses? 
3. Insertion Time OU (at the initial fitting, after approximately 1-week of wear, and after approximately 
2-weeks of wear). 
4.  Removal time OU (at the initial fitting, after approximately 1-week of wear, and after approximately 
2-weeks of wear). 
5. Confidence (baseline, post fitting, after approximately 1-week of wear, and after approximately 2-weeks 
of wear).  
6. Motivation (baseline, post fitting, after approximately 1-week of wear, and after approximately 2-weeks 
of wear). 
7. Lens performance (CLUE vision, comfort, and handling scores) at fitting, after approximately 1-week 
of wear, and after approximately 2-weeks of wear. 
 
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In addition, the relationship between endpoints (i.e., CLUE™ scores, insertion time (OU), and removal time (OU)  
and human factors will also be investigated both graphically (e.g., via scatterplots) and through a correlation 
analysis, at fitting and 1-week follow-up. 
Anatomical human factors will include palpebral aperture height (PAH), horizontal visible iris diameter (HVID), 
hand length, palm width, hand dominance and while non-anatomical human factors will include motivation, 
confidence, and demographics (e.g., gender, age). 
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.  
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no known reasons for 
which it is planned to deviate from these analysis methods. If for any reason a change is made, the change will be 
documented in the study report along with a justification for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the Sitero EDC system. An 
authorized data originator will enter study data into the eCRFs using the EDC system. Data collected on 
equipment that is not captured in EDC will be formatted to the specification of the JJVC database manager and 
sent to JJVC for analysis. Data generated from post hoc measurements (e.g., Compositional characteristics of 
contact lens lipid uptake, Measured tear film protective capability, Measured contact lens surface dehydration 
rate, etc.) will be collected on specific Microsoft Office Excel format worksheets at the clinical site and at the 
completion of the analysis transferred to JJVC biostatistician for data analysis in such format. 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study procedures for 
each visit. Only specifically delegated staff can enter data on a CRF.  Once completed, the eCRFs will be reviewed 
for accuracy and completeness and signed by the Investigator. The sponsor or sponsor’s representatives will be 
authorized to gain access to the subject recordation for the purposes of monitoring and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and complete data 
collection. Data will be transmitted from the clinical site to a secure central database as forms are completed or 
updated, ensuring information accuracy, security, and confidentiality. After the final database lock, the 
Investigator will be provided with Individual Patient Profiles (IPP) including the full audit trail on electronic 
media in PDF format for all of the study data. The IPP must be retained in the study files as a certified copy of 
the source data for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
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 
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• 
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 
 
The subject record is the eCRF or an external record. The author of an entry in the subject record must be 
identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.  
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and regulatory 
inspection(s) by providing direct access to source data/documents. Should the clinical site be contacted for an 
audit by an IEC/IRB or regulatory authority, JJVC must be contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific data or other 
pertinent information is confidential and remains the property of JJVC. The 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. To allow the use of the information derived 
from this clinical study, the Investigator understands that he/she has an obligation to provide complete test results 
and all data developed during this study to the Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of qualified investigators 
and appropriate clinical sites and review of protocol procedures with the Principal Investigator. The Principal 
Investigator, in turn, must ensure that all Sub-Investigators and clinical site personnel are familiar with the 
protocol and all study-specific procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the start of the study. 
The Sponsor will review case report forms for accuracy and completeness remotely during the conduct of the 
study, during monitoring visits, and after transmission to data management. Any data discrepancies will be 
resolved with the Investigator or designee, as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced during the study 
and to access compliance with applicable regulations pertaining to the conduct of clinical trials. The clinical sites 
will provide direct access to study-related source data/documents and reports for the purpose of monitoring and 
auditing by JJVC and for inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable. 
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17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the Investigator’s designated 
clinical site personnel. The monitor’s responsibilities will include: 
• 
Ensuring that the investigation is being conducted according to the protocol, any subsequent versions, 
and regulatory requirements are maintained. 
• 
Ensuring the rights and wellbeing of subjects are protected. 
• 
Ensuring adequate resources, including facilities, laboratories, equipment, and qualified clinical site 
personnel. 
• 
Ensuring that protocol deviations are documented with corrective action plans, as applicable. 
• 
Ensuring that the clinical site has sufficient test article and supplies. 
• 
Clarifying questions regarding the study. 
• 
Resolving study issues or problems that may arise. 
• 
Reviewing of study records and source documentation verification in accordance with the monitoring 
plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects and their parents/legal guardians will be fully informed of the risks and requirements of the 
study and, during the study, subjects and their parents/legal guardians will be given any new information that may 
affect their decision to continue participation. Subjects and their parents/legal guardians will be told that their 
consent to participate in the study is voluntary and may be withdrawn at any time with no reason given and 
without penalty or loss of benefits to which they would otherwise be entitled. Subjects will only be enrolled if the 
subject is / subject’s parents/legal guardians are fully able to understand the risks, benefits, and potential adverse 
events of the study and provide their consent voluntarily, and the subject provides their assent voluntarily. 
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, according to ISO 14155:2020,1 and applicable regulatory 
requirements. GCP is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this standard provides 
public assurance that the rights, safety, and well-being of study subjects are protected, consistent with the 
principles of the Declaration of Helsinki 64th WMA General Assembly 20132 and that the clinical study data are 
credible. The Investigator must maintain clinical study files in accordance with 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. 
• 
Sponsor-approved informed consent form (and any other written materials to be provided to the subjects) 
• 
Investigator’s Brochure (or equivalent information). 
• 
Sponsor-approved subject recruitment materials. 
• 
Information on compensation for study-related injuries or payment to subjects for participation in the 
study. 
• 
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not required, as 
documented by IEC/IRB). 
• 
Information regarding funding, name of the Sponsor, institutional affiliations, other potential conflicts 
of interest, and incentives for subjects. 
• 
Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
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This study will be undertaken only after IEC/IRB has given full approval of the final protocol, the informed 
consent form, applicable recruiting materials, and subject compensation programs, and the Sponsor has received 
a copy of this approval. This approval letter must be dated and must clearly identify the documents being 
approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following documents to the IEC/IRB 
for their review and approval, where appropriate: 
• 
Protocol revisions 
• 
Revision(s) to informed consent form and any other written materials to be provided to subjects 
• 
If applicable, new or revised subject recruitment materials approved by the Sponsor 
• 
Revisions to compensation for study-related injuries or payment to subjects for participation in the study 
• 
Investigator’s Brochure revisions  
• 
Summaries of the status of the study (at least annually or at intervals stipulated in guidelines of the 
IEC/IRB) 
• 
Reports of adverse events that are serious, unanticipated, and associated with the test articles, according 
to the IRB’s requirements 
• 
New information that may adversely affect the safety of the subjects or the conduct of the study 
• 
Major protocol deviations as required by the IEC/IRB 
• 
Report of deaths of subjects under the Investigator's care 
• 
Notification if a new Investigator is responsible for the study at the clinical site 
• 
Any other requirements of the IEC/IRB 
 
For protocol revisions that increase subject risk, the revisions and applicable informed consent form revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request should be documented 
in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about the study 
completion. Documentation of this notification must be retained at the clinical site and a copy provided to the 
CRO or Sponsor as applicable. 
18.4. Informed Consent 
For subjects aged 18 or older 
Each subject or their representative, must give written consent according to local requirements after the nature of 
the study has been fully explained. The consent form must be signed before performance of any study-related 
activity. The consent form that is used must be approved by both the Sponsor and by the reviewing IEC/IRB. The 
informed consent is in accordance with principles that originated in the Declaration of Helsinki,3 current ICH 
GCP2 and ISO 14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site personnel must explain 
to potential subject the aims, methods, reasonably anticipated benefits, and potential hazards of the study, and 
any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may 
withdraw consent to participate at any time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity to ask questions. 
After this explanation and before entry into the study, consent should be appropriately recorded by means of the 
subject's dated signature. After having obtained the consent, a copy of the informed consent form must be given 
to the subject. 
 
For subjects aged 13 to 17 
 
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 
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signed before performance of any study-related activity. The consent and assent forms that are used must be 
approved by both the Sponsor and by the reviewing IEC/IRB. The informed consent and assent are in accordance 
with principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 14155:20201 guidelines,  
applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site personnel must explain 
to potential subject and the parent (legal guardian) the aims, methods, reasonably anticipated benefits, and 
potential hazards of the study, and any discomfort it may entail. Subjects and their parents (legal guardians) will 
be informed that their participation is voluntary and that they may withdraw consent to participate at any time.  
 
The subject and parent (legal guardian) will be given sufficient time to read the Information and Assent form and 
the informed consent form (Parental Permission Form and Authorization to Use and Disclose Medical 
Information), respectively, and the opportunity to ask questions. After this explanation and before entry into the 
study, assent and consent should be appropriately recorded by means of the subject's and parent/legal guardian’s 
dated signatures. After having obtained the consent and assent, a copy of the informed consent and assent forms 
must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to the Study Subject, 
and personal data related to Principal Investigator and any clinical site personnel (e.g., name, clinic address and 
phone number, curriculum vitae) is subject to compliance with the Health Information Portability and 
Accountability Act (HIPAA) in the United States7 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 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, except for 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their investigation 
related activities that, as part of the investigation will have access to the CRFs and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be limited to those data 
that are necessary to investigate the efficacy, safety, quality, and utility of the investigational product(s) used in 
this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality and compliance 
with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
• 
processed fairly and lawfully. 
• 
collected for specified, explicit, and legitimate purposes and not further processed in a way incompatible 
with these purposes. 
• 
adequate, relevant, and not excessive in relation to said purposes. 
• 
accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating subject before 
collection of data. Such consent should also address the transfer of the data to other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the right to request 
rectification of any data that are not correct or complete. Reasonable steps should be taken to respond to such a 
request, taking into consideration the nature of the request, the conditions of the study, and the applicable laws 
and regulations. 
 
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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 ISO 14155:2020,1 guidelines, 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 
ISO 14155:2020,1 and all study documents as specified by the applicable regulatory requirement(s). The 
Investigator/Institution will take measures to prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a marketing application 
in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or until 
at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational 
product. These documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the responsibility of keeping 
the study records, custody must be transferred to a person who will accept the responsibility. The Sponsor must 
be notified in writing of the name and address of the new custodian. Under no circumstance shall the Investigator 
relocate or dispose of any study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any documentation 
relating to this study, the Investigator must permit access to such reports. If the Investigator has a question 
regarding retention of study records, he/she should contact JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research Agreement. The 
Research Agreement will be signed by the Principal Investigator and a JJVC management representative prior to 
study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations such as: 
• 
Continuing an ineligible subject in the study. 
• 
Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have been completed, such 
as: 
• 
Query resolution. 
• 
Case Report Form signature. 
• 
Completion of any follow-up action items. 
21. PUBLICATION 
There is no plan to publish the outcome of this investigation. 
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — Good Clinical 
Practice. Available at: https://www.iso.org/standard/71690.html 
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2. Declaration of Helsinki - Ethical principles for Medical Research Involving Human Subjects. 
Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-subjects/  
3. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
4. Sulley A, et. al., Retention rates in new contact lens wearers. Eye & Contact Lens 2018. 
5. Wirth RJ, Edwards MC, Henderson M, Henderson T, Oliveres G, Houts CR. Development of the 
contact lens user experience: CLUE scales. Optometry and Vision Science. 2016;93(8):801-8. 
https://pubmed.ncbi.nlm.nih.gov/27383257/ 
6. SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC SAS Institute Inc; 2014. 
7. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A patient instruction guide (PIG) will be provided separately 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY (AO1D) 
 
 
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APPENDIX D: 
  
• 
LENS FITTING CHARACTERISTICS 
• 
 SUBJECT REPORTED OCULAR SYMPTOMS 
• 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 
• 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE ERROR 
• 
 BIOMICROSCOPY SCALE 
• 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
• 
 PATIENT REPORTED OUTCOMES 
• 
 WHITE LIGHT LENS SURFACE WETTABILITY 
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 LENS FITTING CHARACTERISTICS  
 
 
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Title:                          Lens Fitting Characteristics 
Document Type:       
 
Document Number:  
 
Revision Number:  6 
f 5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
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 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 
 
 
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Title:                           Front and Back Surface Lens Deposit Grading Procedure 
Document Type:       
 
Document Number:  
 
Revision Number:  4 
f 4 
 
 
 
 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE ERROR 
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error 
Document Type:        
 
Document Number:  
 
Revision Number:  5 
f 5 
 
  
 
 
 
 
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 BIOMICROSCOPY SCALE 
 
 
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 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation 
Document Type:       
 
Document Number:  
 
Revision Number:  5 
f 4 
 
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Document Type:       
 
Document Number:  
 
Revision Number:  5 
f 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
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 WHITE LIGHT LENS SURFACE WETTABILITY 
 
 
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APPENDIX E: WORK AID: INSERTION AND REMOVAL TRAINING GUIDE 
 
 
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APPENDIX F: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6565 Evaluation of Acuvue Oasys 1-Day contact lenses in new wearers  
 
Version and Date: 2.0 12 March 2024 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155:2020,1 the Declaration of Helsinki,2 United States (US) 
Code of Federal Regulations (CFR),3 and the pertinent individual country laws/regulations and to comply with 
its obligations, subject to ethical and safety considerations. I, as the Principal Investigator, am responsible for 
ensuring that all clinical site personnel, including Sub-Investigators, adhere to all 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. 
 
All clinical site personnel involved in the conduct of this study have completed Human Subjects Protection 
Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about their 
obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this study without 
written authorization. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, (COVID-19 
Work Instruction in the Appendix of this protocol). I agree to conduct this study in compliance with local, state, 
governmental guidance for COVID-19 risks. 
 
 
Principal 
Investigator: 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
Institution/Site: 
 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
 
Institution/Site Address 
 
 
 
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