Clinical Performance of Senofilcon A Investigational Lens
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical performance of senofilcon A investigational lens 
Protocol CR-6481
Version: 3.0
                           
Date: 17 March 2022
Investigational Products: senofilcon A prototype lens
Keywords:  Sphere platform, Test lens: senofilcon A prototype, Control lens: delefilcon A
(Dailies Total 1), daily wear, daily disposable, dispensing, Revitalens, subjective performance. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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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
............................................................................................................................................ 14 
1. 
INTRODUCTION AND BACKGROUND.................................................................. 15 
1.1. 
Name and Descriptions of Investigational Products............................................... 15 
1.2. 
Intended Use of Investigational Products............................................................... 15 
1.3. 
Summary of Findings from Nonclinical Studies .................................................... 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .................................. 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ..................................... 16 
2.1. 
Objectives ............................................................................................................. 16 
2.2. 
Endpoints .............................................................................................................. 16 
2.3. 
Hypotheses ............................................................................................................ 17 
3. 
TARGETED STUDY POPULATION......................................................................... 18 
3.1. 
General Characteristics.......................................................................................... 18 
3.2. 
Inclusion Criteria................................................................................................... 18 
3.3. 
Exclusion Criteria.................................................................................................. 19 
3.4. 
Enrollment Strategy............................................................................................... 20 
4. 
STUDY DESIGN AND RATIONALE........................................................................ 21 
4.1. 
Description of Study Design.................................................................................. 21 
4.2. 
Study Design Rationale......................................................................................... 21 
4.3. 
Enrollment Target and Study Duration .................................................................. 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING.................................................... 22 
5.1. 
Test Article Allocation.......................................................................................... 22 
5.2. 
Masking ................................................................................................................ 22 
5.3. 
Procedures for Maintaining and Breaking the Masking.......................................... 23 
6. 
STUDY INTERVENTION.......................................................................................... 23 
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6.1. 
Identity of Test Articles......................................................................................... 23 
6.2. 
Ancillary Supplies/Products .................................................................................. 24 
6.3. 
Administration of Test Articles ............................................................................. 24 
6.4. 
Packaging and Labeling ........................................................................................ 24 
6.5. 
Storage Conditions................................................................................................ 25 
6.6. 
Collection and Storage of Samples ........................................................................ 25 
6.7. 
Accountability of Test Articles.............................................................................. 25 
7. 
STUDY EVALUATIONS........................................................................................... 26 
7.1. 
Time and Event Schedule...................................................................................... 26 
7.2. 
Detailed Study Procedures..................................................................................... 27 
VISIT 1 ....................................................................................................................... 27 
VISIT 2 ....................................................................................................................... 32 
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.......................................................... 37 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 37 
9.1. 
Systemic Medications............................................................................................ 38 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................ 39 
11. 
STUDY TERMINATION......................................................................................... 40 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 41 
13. 
ADVERSE EVENTS................................................................................................ 42 
13.1. 
Definitions and Classifications........................................................................... 42 
13.2. 
Assessing Adverse Events ................................................................................. 44 
13.2.1. 
Causality Assessment ................................................................................. 45 
13.2.2. 
Severity Assessment ................................................................................... 45 
13.3. 
Documentation and Follow-Up of Adverse Events............................................. 46 
13.4. 
Reporting Adverse Events ................................................................................. 47 
13.4.1. 
Reporting Adverse Events to Sponsor......................................................... 47 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
48 
13.5. 
Event of Special Interest .................................................................................... 48 
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13.6. 
Reporting of Pregnancy ..................................................................................... 48 
14. 
STATISTICAL METHODS..................................................................................... 49 
14.1. 
General Considerations...................................................................................... 49 
14.2. 
Sample Size Justification ................................................................................... 49 
14.3. 
Analysis Populations ......................................................................................... 52 
14.4. 
Level of Statistical Significance......................................................................... 52 
14.5. 
Primary Analyses............................................................................................... 53 
14.6. 
Secondary Analyses........................................................................................... 53 
14.7. 
Other Exploratory Analysis................................................................................ 54 
14.8. 
Interim Analysis ................................................................................................ 54 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................ 54 
14.10. 
Procedure for Reporting Deviations from Statistical Plan................................... 54 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................... 55 
15.1. 
Electronic Case Report Form/Data Collection.................................................... 55 
15.2. 
Subject Record .................................................................................................. 55 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................. 56 
16. 
DATA MANAGEMENT.......................................................................................... 56 
16.1. 
Access to Source Data/Document ...................................................................... 56 
16.2. 
Confidentiality of Information ........................................................................... 56 
16.3. 
Data Quality Assurance ..................................................................................... 56 
16.4. 
Data Monitoring Committee (DMC).................................................................. 57 
17. 
CLINICAL MONITORING ..................................................................................... 57 
18. 
ETHICAL AND REGULATORY ASPECTS........................................................... 57 
18.1. 
Study-Specific Design Considerations ............................................................... 57 
18.2. 
Investigator Responsibility................................................................................. 57 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB)........... 58 
18.4. 
Informed Consent .............................................................................................. 59 
18.5. 
Privacy of Personal Data.................................................................................... 59 
19. 
STUDY RECORD RETENTION ............................................................................. 60 
20. 
FINANCIAL CONSIDERATIONS.......................................................................... 61 
21. 
PUBLICATION ....................................................................................................... 61 
22. 
REFERENCES......................................................................................................... 62 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)...... 63 
APPENDIX B: PATIENT INSTRUCTION GUIDE............................................................ 82 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)........................................ 83 
APPENDIX D: 
...................................... 86 
 Lens Fitting Characteristics ................................................................................ 87 
 Subject Reported Ocular Symptoms/Problems.................................................... 93 
 Front and Back Surface Lens Deposit Grading Procedure................................... 95 
 Determination of Distance Spherocylindrical Refractive Error.......................... 100 
 Biomicroscopy Scale........................................................................................ 106 
 Distance and Near Snellen Visual Acuity Evaluation........................................ 112 
 Patient Reported Outcomes .............................................................................. 117 
 White Light Lens Surface Wettability............................................................... 119 
APPENDIX E: IRIS COLOR SCALE............................................................................... 121 
APPENDIX F: STARTING LENS POWER GUIDANCE................................................. 122 
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION.............................. 123 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE........................ 135 
LIST OF TABLES
Table 1: Enrollment Strategy Overall .................................................................................. 20 
Table 2: Duration of Study Visits ........................................................................................ 21 
Table 3: Test Articles .......................................................................................................... 23 
Table 4: Ancillary Supplies ................................................................................................. 24 
Table 5: Time and Events.................................................................................................... 26 
Table 6: Disallowed systemic medications........................................................................... 38 
Table 7: Disallowed systemic antihistamines....................................................................... 39 
Table 8: Examples of major and minor protocol deviations.................................................. 40 
Table 9: Descriptive Summary for the Primary and Secondary Endpoints at 2-week Follow-up 
from Historical and Interim Data......................................................................................... 49 
Table 10: Sample Size Estimation for the Primary and Secondary Endpoints....................... 51 
LIST OF FIGURES
Figure 1: Study Flowchart ................................................................................................... 13 
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SYNOPSIS 
Protocol Title
Clinical performance of senofilcon A investigational lens 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Claims
Design control phase: Phase 3 
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s)
Investigational Products: senofilcon A prototype as the Test 
lens
Approved Products: Dailies Total 1 as the Control lens
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable 
Objectives 
Primary Objectives: This study is being conducted to evaluate 
the clinical performance of an investigational soft contact lens 
against the clinical performance of a marketed product.
Study Endpoints
Primary endpoint(s): Subjective responses concentrated on 
comfort towards the end of the day. 
Secondary endpoint(s): Subjective responses concentrated on
digital device use, night driving, and all day comfort. 
Other observations: Subjective responses concentrated on 
other aspects of vision, comfort, and/or handling.
Study Design
This study is a controlled, randomized, subject-masked, 2-arm 
parallel, 2-week dispensing, bilateral evaluation where the 
study lenses are worn for a minimum of 5 days per week and 
6 hours per day.
There will be a total of 2 visits:
1. Visit 1: Screening, baseline evaluation and lens 
fitting.
2. Visit 2: Follow-up evaluation, 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
Up to 360 subjects will be enrolled to complete approximately 
330 (approximately 165 in each arm).
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Study Duration
Once enrolled, each subject will be in the study for 2 weeks.  
The enrollment period is 4 weeks per site, making the entire 
study duration approximately 6 weeks.
Anticipated Study 
Population 
The study will enroll habitual wearers of spherical silicone 
hydrogel contact lenses, daily wear reusable and daily 
disposable.  Subjects may be of any race or ethnicity that meet 
the eligibility criteria.
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria after Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form.
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time 
of screening.
4. By self-report, habitually wear spherical soft silicone 
hydrogel contact lenses in both eyes in a daily wear or 
daily disposable wear modality (i.e. not extended wear
modality). Habitual wear is defined as a minimum of 6 
hours of wear per day, for a minimum of 5 days per week 
during the past 30 days.
5. Have a habitual contact lens prescription that is current 
within the prior 6 months, and they must have worn that 
prescription for at least 2 weeks prior to entering the study. 
6. Possess a wearable pair of spectacles that provide 
correction for distance vision.
Inclusion Criteria at Baseline Evaluation
7. The spherical equivalent of the subject’s vertex-corrected 
distance refraction must be between -1.00 and -6.00 DS 
(inclusive) in each eye.
8. The magnitude of the cylindrical component of the 
subject’s vertex-corrected distance refraction must be 
between 0.00 and 1.00 DC (inclusive) in each eye.
9. The best corrected, monocular, distance visual acuity 
must be 20/25or better in each eye.
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Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
Exclusion Criteria after 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, infection, or use of medication that the 
investigator believes might contraindicate or interfere 
with contact lens wear, or otherwise compromise study 
endpoints, including infectious disease (e.g., hepatitis, 
tuberculosis), contagious immunosuppressive disease 
(e.g., Human Immunodeficiency Virus [HIV]), 
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s 
syndrome), or history of serious mental illness or 
seizures. See section 9.1 for additional details regarding 
excluded systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g. 
SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact 
lenses.
6. Be currently wearing lenses in an extended wear 
modality.
7. Have participated in a contact lens or lens care product 
clinical trial within 30 days prior to study enrollment.
8. 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:
9. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities that the investigator believes might 
contraindicate contact lens wear or may otherwise 
compromise study endpoints (including entropion, 
ectropion, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, aphakia, moderate or above 
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corneal distortion, herpetic keratitis). (Specify method of 
determination if needed).
10. Have a history of strabismus or amblyopia.
11. Have fluctuations in vision due to clinically significant 
dry eye or other ocular conditions. 
12. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, 
PRK, LASIK, iridotomy, retinal laser photocoagulation, 
etc.).
Disallowed 
Medications/Interventions  
No ocular medications.
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
Subjects will respond to a GSI/MRD questionnaire.
Microbiology or Other 
Laboratory Testing
None 
Study Termination
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
RevitaLens, preservative-free artificial tears.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
ADE 
 
 
Adverse Device Effect
ADHD  
 
Attention Deficit Hyperactivity Disorder
AE 
 
 
Adverse Event/Adverse Experience
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations
CLUE  
 
Contact Lens User Experience
COM  
 
Clinical Operations Manager
CRA 
 
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO 
 
 
Contract Research Organization
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC 
 
 
Electronic Data Capture
ETDRS  
 
Early Treatment Diabetic Retinopathy Study 
FDA 
 
 
Food and Drug Administration
GCP 
 
 
Good Clinical Practice
HEV 
 
 
High Energy Visible light
HIPAA  
 
Health Insurance Portability and Accountability Act
HIV 
 
 
Human Immunodeficiency Virus
IB 
 
 
Investigator’s Brochure
ICH 
 
 
The International Council for Harmonization
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization
ITT 
 
 
Intent-to-Treat
JJVC 
 
 
Johnson & Johnson Vision Care, Inc.
LASIK  
 
Laser-Assisted in Situ Keratomileusis
LogMAR 
 
Logarithm of Minimal Angle of Resolution
OD 
 
 
Right Eye
OS 
 
 
Left Eye
OU 
 
 
Both Eyes
PIG 
 
 
Patient Instruction Guide
PQC 
 
 
Product Quality Complaint
PRK 
 
 
Photorefractive Keratectomy
PRO 
 
 
Patient Reported Outcome
QA 
 
 
Quality Assurance
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation
UADE  
 
Unanticipated Adverse Device Effect
UV 
 
 
Ultraviolet radiation
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
This study will investigate the clinical performance of an investigational Test lens against a
marketed Control lens. 
1.1.
Name and Descriptions of Investigational Products 
This study will evaluate a senofilcon A-based prototype against a commercially available 
marketed product Dailies Total 1 (DT1).  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 investigative product is for correcting myopia. During the study, one 
of the study articles per subject will be worn bilaterally in a daily wear, daily disposable
modality for at least 6 hours per day and 5 days per week for approximately two weeks.
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 senofilcon A-
based investigational lens, refer to the latest version of the Investigator’s Brochure.
1.4.
Summary of Known Risks and Benefits to Human Subjects
The risks of wearing soft contact lenses are well known and are described in the Investigator’s 
Brochure and Informed Consent.  The material safety testing/lens release criteria was 
determined based on the Risk Assessment. Benefits to the subjects include the correction of 
their refractive error.
For the most comprehensive risk and benefit information regarding senofilcon A-based 
investigational lens, refer to the latest version of the Investigator's Brochure.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
The package insert for the DT1 Control lens can be found in the appendices.  Prior clinical 
data of the investigational lens is summarized in the Investigator’s Brochure.
The literature is absent of any articles pertaining to the investigational lens.  Articles that 
pertain to the DT1 lenses do exist with a sampling shown here:
1.
Wolffsohn, James, et al. "The influence of end of day silicone hydrogel daily disposable 
contact lens fit on ocular comfort, physiology and lens wettability." Contact Lens and 
Anterior Eye 38.5 (2015): 339-344. 
2.
Dumbleton, Kathryn A., et al. "A multi-country assessment of compliance with daily 
disposable contact lens wear." Contact Lens and Anterior Eye 36.6 (2013): 304-312. 
3.
Jayasree, Stephy VK, et al. "Quantification of water content in contact lenses combining 
terahertz imaging and optical coherence tomography." 2021 46th International 
Conference on Infrared, Millimeter and Terahertz Waves (IRMMW-THz). IEEE.
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4.
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different wearing times." Ophthalmic and Physiological Optics 33.5 (2013): 581-591. 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective(s)
This study is being conducted to evaluate the clinical performance of an investigational soft 
contact lens against the clinical performance of a marketed product.
2.2.
Endpoints 
Primary Endpoint(s): 
1. End of day comfort
x
Subjects will respond to the question, “Comfort at the End of the Day” 
 
. 
o
Response set: Very Satisfied, Satisfied, Neither Satisfied nor Dissatisfied, 
Dissatisfied, and Very Dissatisfied.
Secondary Endpoint(s): 
1. Digital device use
x
Subjects will respond to the question, “Reduction in the feeling of tired eyes from 
using a computer or other digital device” 
o
Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor.
2. Comfort throughout the day  
x
Subjects will respond to the question, “I could wear these contact lenses 
comfortably for as long as I wanted to” 
o
Response set: Strongly Disagree, Disagree, Neither Agree Nor Disagree, Agree, 
and Strongly Agree.
3. Comfortable vision while night driving  
x
Subjects will respond to the question, “Ability to see comfortably while driving at 
night” 
o
Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor.
Other Exploratory Endpoint(s):
Other exploratory endpoints including subjective questions regarding comfort, vision, 
handling, and preferences, such as:
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1. Clarity of distance vision
x
Subjects will respond to the question, “Clarity of distance vision (i.e. looking at 
things that are more than 5 feet away, such as street signs)” 
. 
o
Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor.
2. Vision clarity throughout the day
x
Subjects will respond to the question, “I was very satisfied by the clarity of my 
vision throughout the day”
3. Didn’t have to think about the lenses
x
Subjects will respond to the question, “I didn't have to think about my lenses until 
I was ready to take them out” 
o
Response set: Agree Strongly, Agree Somewhat, Neither Agree Nor 
Disagree, Disagree Somewhat, and Disagree Strongly.
4. Ability to see comfortably using digital devices
x
Subjects will respond to the question, “Ability to see comfortably while using a
computer or other digital device” 
o
Response set: Not Applicable, Excellent, Very Good, Good, Fair, and Poor.
5. Tired eyes
x
Subjects will respond to the question, “My eyes felt tired” 
6. Eye fatigue
x
Subjects will respond to the question, “Eye fatigue” 
Response set: Always, Frequently, Occasionally, Rarely, Never, and Don't Know.
7. Vision at the end of the day
x
Subjects will respond to the question, “I had very good vision at the end of the day” 
8. Vision in dim lighting
x
Subjects will respond to the question, “I was satisfied with the quality of my vision 
in dim lighting” 
9. Dry eyes at the end of the day
x
Subjects will respond to the question, “I have experienced dry eyes at the end of 
the day” 
Response set for CLUE items: Strongly Disagree, Disagree, Neither Agree Nor Disagree, 
Agree, and Strongly Agree. 
 also has a “Not Applicable” response option. 
2.3.
Hypotheses
The primary hypothesis must be met for the objective of this study to be satisfied:
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Primary Hypothesis 
1. After approximately two weeks of wear, the Test lens will have superior performance 
to the Control lens with respect to end of day comfort. 
The primary hypothesis must be met in order to begin testing any secondary hypotheses.
Secondary Hypotheses
1. After approximately two weeks of wear, the Test lens will have superior performance 
to the Control lens with respect to digital device use. 
2. After approximately two weeks of wear, the Test lens will have superior performance 
to the Control lens with respect to comfort throughout the day.  
3. After approximately two weeks of wear, the Test lens will have superior performance 
to the Control lens with respect to comfortable vision while night driving.
Exploratory Hypotheses
There will be no exploratory hypotheses. All exploratory endpoints will be descriptively 
summarized.
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Approximately 180 subjects will be targeted to the Test Group and approximately 180 will be 
targeted to the Control Group.  Within each lens group, the intent is to complete 165 (330 total
subjects).  Enrolled subjects will be habitual wearers of silicone hydrogel spherical contact 
lenses.  All subjects will be the age of t18 and <40.  Subjects will wear the study contact lenses 
approximately two weeks each on a daily wear (DW) daily disposable (DD) basis for a total 
study duration of approximately 14 days (2 weeks) per subject.  
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  
Inclusion Criteria after Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both 
eyes in a daily wear or daily disposable wear modality (i.e. not extended wear 
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modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a 
minimum of 5 days per week during the past 30 days.
5. Have a habitual contact lens prescription that is current within the prior 6 months, and 
they must have worn that prescription for at least 2 weeks prior to entering the study. 
6. Possess a wearable pair of spectacles that provide correction for distance vision. 
Inclusion Criteria at Baseline Evaluation
7. The spherical equivalent of the subject’s vertex-corrected distance refraction must be 
between -1.00 and -6.00 DS (inclusive) in each eye.
8. The magnitude of the cylindrical component of the subject’s vertex-corrected distance 
refraction must be between 0.00 and 1.00 DC (inclusive) in each eye.
9. The best corrected, monocular, distance visual acuity must be 20/25 or better in each 
eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:
Exclusion Criteria after 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, infection, or use of 
medication that the investigator believes might contraindicate or interfere with 
contact lens wear, or otherwise compromise study endpoints, including infectious 
disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., 
Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid 
arthritis, Sjögren’s syndrome), or history of serious mental illness or seizures. See 
section 9.1for additional details regarding excluded systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or 
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
5. Be currently wearing monovision or multifocal contact lenses.
6. Be currently wearing lenses in an extended wear modality.
7. Have participated in a contact lens or lens care product clinical trial within 14 days 
prior to study enrollment.
8. 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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5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Use of the test articles will be randomized using a lens fitting schedule supplied by the study 
biostatistician. The clinical site will follow the lens fitting schedule provided and will complete 
enrollment according to the randomization list and will not pre-select or pre-assign subjects.
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. A computer-generated randomization scheme will be used to randomly assign
subjects to one of the two lens groups (Test or Control). The randomization will be stratified 
by site and type of habitual lens wear (daily disposable and daily wear reusable). The ratio of 
habitual wearers of daily disposable lenses to habitual wearers of daily wear reusable lenses 
is 7:3 within each study site (7 habitual wearers of daily disposable lenses versus 3 habitual 
wearers of daily wear reusable lenses). See Table 1. The random scheme will be generated 
using the PROC PLAN procedure from Statistical Analysis System (SAS) Software Version 
9.4 or higher (SAS Institute, Cary, NC).5  
Randomization will be performed at Visit 1. The following must have occurred prior to
randomization: 
•
Informed consent must have been obtained.  
•
The subject must have met all eligibility criteria. 
•
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule to obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2.
Masking
This is a single-masked trial. Subjects will be unaware of the identity of the investigational 
product.  The investigators may be aware of the study lenses based on a slight difference in 
lens color (the Test lenses will be slightly more turquoise in color than the Control lens). 
Investigators and clinical site personnel involved in the data collection will not be masked as 
to the identity of the investigational product.
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6.5.
Storage Conditions
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples
No samples will be collected as part of the study procedures.
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC.
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study
monitor immediately. 
Reference 
Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information.
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8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent. 
x
Subject not compliant to protocol such as study lens wear time or habitual lens wear 
while enrolled in the study.
x
Subject lost to follow-up. 
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear. 
x
Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x
Subject missed a study visit. 
x
Subject not compliant with study lens wear schedule (i.e. wears study lenses less than 
at least 6 hours per day for at least 5 days a week over the 2 week wear period)
x
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:
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
x
Disallowed medications for this study include: medications that may interfere with 
contact lens wear (see section 9.1).  Habitual medications used by successful soft 
contact lens wearers are considered acceptable.
x
Concomitant therapies that are disallowed include: NA
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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, 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:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
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x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form Control No.
for test article return instructions). 
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: 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. 
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Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal 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:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
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x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
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:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
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:
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x
Seriousness/Classifications (see definition in section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 13.2.2). 
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown. 
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
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13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure. Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.). 
x
Date the clinical site was notified. 
x
Date and time of onset. 
x
Date and time of resolution. 
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x
Any referral to another health care provider if needed. 
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
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 
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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.
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:
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x
Notify the Sponsor immediately. 
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according to
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.
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hypothesis is rejected. According to the truncated Hochberg procedure with a truncation 
fraction of ݂=
ଵ
ଶ, the larger p-value obtained from these two secondary tests will be compared 
to the endpoint-specific alpha level 0.0375, and the smaller p-value will be compared to the 
endpoint-specific alpha level 0.025.  
x
If the secondary test with the larger p-value is successful and the one with the smaller 
p-value is not successful, then alpha of 0.025 passes to the last secondary endpoint 
(comfortable vision while night driving).  
x
If the secondary test with the smaller p-value is successful and the one with the larger 
p-value is not successful, then alpha of 0.0125 passes to the last secondary endpoint. 
x
If both secondary tests are successful, the unused alpha available for testing the last 
secondary endpoint will be 0.05.  
x
If both secondary endpoints fail to show superiority, the last secondary endpoint cannot 
be tested. 
14.5. Primary Analyses
The primary analysis will be conducted on the Intent-to-Treat (ITT) population with observed 
cases (use only available datapoints and no imputation for missing data). 
End of Day Comfort
End of Day Comfort will be measured using the individual item “Comfort at the End of the 
Day” at 2-week follow-up. Item responses will be converted into a binary variable for the 
purpose of analysis (Very Satisfied or Satisfied = 1 and others = 0). The dichotomized item 
responses will be analyzed using a generalized linear mixed model with a binomial distribution 
and the logit as the link function. The model will include lens type as a fixed effect and site as 
a (G-side) random effect. Other subject characteristics such as age, gender, race, iris category,
habitual lens type will be included as fixed effects when appropriate.  
Hypothesis Testing
The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens with respect to end of day comfort are as follows: 
ܪ଴:  ܱܴ൑1
ܪ஺: ܱܴ> 1
Where OR represents the odds ratio of having “Very Satisfied” or “Satisfied” rating for the 
Test lens compared to the Control at the 2-week follow-up. Comparisons between Test and
Control will be carried out using the 95% confidence interval (CI) constructed for the odds 
ratio (Test over Control). Superiority will be declared if the lower bound of the 2-sided 95% 
confidence interval is above 1.  
14.6. Secondary Analyses  
Secondary analyses will be conducted on the Intent-to-Treat (ITT) population with observed 
cases (use only available datapoints and no imputation for missing data). 
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All secondary endpoints will be analyzed separately using the same model as described for the 
primary endpoint. Item responses will be converted into binary variables as follows: Excellent 
or Very Good = 1 and others = 0 for digital device use (“Reduction in the feeling of tired eyes 
from using a computer or other digital device”) and comfortable vision while night driving 
(“Ability to see comfortably while driving at night”), and Strongly Agree or Agree = 1 and 
others = 0 for comfort throughout the day (“I could wear these contact lenses comfortably for 
as long as I wanted to”). 
According to the testing strategy presented in section 14, if the primary hypothesis is met, the 
secondary endpoints will be tested as follows:
x
for the first two secondary endpoints (digital device use and comfort throughout the 
day), comparisons between Test and Control will be carried out using the 
corresponding adjusted two-sided CI (96.25% CI for alpha = 0.0375 or 97.5% CI for 
alpha = 0.025), depending on the relative magnitude of the obtained nominal p-values,
constructed for the odds ratio (Test over Control) separately for each endpoint; 
x
for the last secondary endpoint (comfortable vision while night driving), a two-sided 
95% CI (alpha = 0.05), 97.5% CI (alpha = 0.025), or 98.75% CI (alpha = 0.0125) will 
be estimated for odds ratio and the confidence level will be determined based on the 
success of the previously tested secondary endpoints. 
Superiority will be declared if the lower bound of the corresponding CI is above 1. 
14.7. Other Exploratory Analysis  
All other exploratory endpoints will be descriptively summarized. A future planned post-hoc 
meta-analysis may be conducted using these endpoints.
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 on the primary and secondary analyses,
sensitivity analysis may be conducted on the ITT population using multiple imputation 
methods if the proportion of subject dropout is greater than 15%. The SAS/STAT procedures 
PROC MI and PROC MIANALYZE will be utilized with a parametric regression method used 
to make at least 20 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 
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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 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be
formatted to the specification of the JJVC database manager and sent to JJVC for analysis. 
External data sources for this study include: Not Applicable.
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
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x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. 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. 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.
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Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC)
Not applicable
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide
their consent 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, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
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and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
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x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent
Each subject 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.
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) and other
applicable personal data protection and security laws and regulations.12,13 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 
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about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
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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:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This is a multicenter study. The participating institution and Principal Investigations for this 
study agree that, should this study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint, multicenter publication 
of the study results with the investigators and the institutions from all appropriate sites 
contributing data, analyses and comments.
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22. REFERENCES
1. 
ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. Available at https://www.iso.org/standard/45557.html
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. 
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. 
United States (US) Code of Federal Regulations (CFR). . Available at 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. 
 SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute Inc.  
6. 
Buch J. Clinical Study Report
Evaluation of Prototype 
Lenses with Experimental UV/HEV Blocker  
7. 
Buch J. Clinical Study Report
Vision Evaluation of 
Contact Lenses with new UV/HEV Filter  December 08, 2021.
8. 
Buch J. Clinical Study Reports
Evaluation of Prototype 
Lenses with Experimental UV/HEV  November 11, 2021.
9. 
Buch J. Clinical Study Report 
 
Validation of senofilcon 
A with new UV/HEV Filter  January 12, 2022.
10. 
Dmitrienko A, Tamhane AC, Wiens BL. General Multistage Gatekeeping Procedures. 
Biometrical Journal. 2008;50(5):667-677. 
11. 
Dmitrienko A, Kordzakhia G, Tamhane AC. Multistage and Mixture Parallel 
Gatekeeping Procedures in Clinical Trials. Journal of Biopharmaceutical Statistics. 
2011;21(4):726-747. 
12. 
Health Information Portability and Accountability Act (HIPAA). Available at 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
13. 
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at http://data.europa.eu/eli/reg/2017/745/2017-
05-05
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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17
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18
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately.
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Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
DAILIES TOTAL1  
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Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS
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Title:                          Lens Fitting Characteristics
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Revision Number:  6
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Title:                          Lens Fitting Characteristics
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Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS  
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Title:                          Subject Reported Ocular Symptoms/Problems
Document Type:  
Document Number:
Revision Number:  4 
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Johnson & Johnson Vision Care, Inc.
FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE  
CR-6481, v 3.0
 
 
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
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Revision Number:  4
Page 2 of 4
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
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Revision Number:  4
Page 3 of 4
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
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Revision Number:  4
Page 4 of 4
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Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
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Revision Number:  5 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
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Revision Number:  5 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
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Revision Number:  5 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
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Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE  
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Title:     
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  10 
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Title:     
 
Biomicroscopy Scale
Document Type:
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Revision Number:  10 
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Title:     
 
Biomicroscopy Scale
Document Type:
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Revision Number:  10 
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Title:     
 
Biomicroscopy Scale
Document Type:
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Revision Number:  10 
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Title:     
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  10 
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Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION  
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES 
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Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
3
Page 1 of 1
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Johnson & Johnson Vision Care, Inc.
WHITE LIGHT LENS SURFACE WETTABILITY  
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Johnson & Johnson Vision Care, Inc.
APPENDIX F: STARTING LENS POWER GUIDANCE
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Johnson & Johnson Vision Care, Inc.
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION
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Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6481 Clinical performance of senofilcon A investigational lens 
Version and Date: 3.0 17 March 2022
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in the Appendix G 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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