Evaluation of Marketed Soft Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of marketed soft contact lenses  
Protocol CR-6483
Version: 3.0
Date: 09 February 2022
Investigational Products:  None
Keywords:  Sphere platform, Study 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 14155:2020,0
the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),0 the 
Declaration of Helsinki,0 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. 
CR-6483, v 3.0
 
Page 1 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 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 ............................................................................................................... 16 
3. 
TARGETED STUDY POPULATION ........................................................................... 16 
3.1. 
General Characteristics ............................................................................................ 16 
3.2. 
Inclusion Criteria ...................................................................................................... 17 
3.3. 
Exclusion Criteria ..................................................................................................... 17 
3.4. 
Enrollment Strategy.................................................................................................. 18 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 19 
4.1. 
Description of Study Design .................................................................................... 19 
4.2. 
Study Design Rationale ............................................................................................ 19 
4.3. 
Enrollment Target and Study Duration .................................................................... 19 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 20 
5.1. 
Test Article Allocation ............................................................................................. 20 
5.2. 
Masking .................................................................................................................... 20 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 20 
6. 
STUDY INTERVENTION ............................................................................................. 21 
CR-6483, v 3.0
 
Page 2 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.1. 
Identity of Test Articles............................................................................................ 21 
6.2. 
Ancillary Supplies/Products ..................................................................................... 21 
6.3. 
Administration of Test Articles ................................................................................ 22 
6.4. 
Packaging and Labeling ........................................................................................... 22 
6.5. 
Storage Conditions ................................................................................................... 22 
6.6. 
Collection and Storage of Samples .......................................................................... 22 
6.7. 
Accountability of Test Articles ................................................................................ 22 
7. 
STUDY EVALUATIONS .............................................................................................. 23 
7.1. 
Time and Event Schedule ......................................................................................... 23 
7.2. 
Detailed Study Procedures ....................................................................................... 24 
VISIT 1 ........................................................................................................................... 24 
VISIT 2 ........................................................................................................................... 30 
FINAL EVALUATION .................................................................................................. 32 
7.3. 
Unscheduled Visits ................................................................................................... 32 
7.4. 
Laboratory Procedures ............................................................................................. 34 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 34 
8.1. 
Completion Criteria .................................................................................................. 34 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 34 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 35 
9.1. 
Systemic Medications .............................................................................................. 36 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 37 
11. 
STUDY TERMINATION ........................................................................................... 38 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 39 
13. 
ADVERSE EVENTS ................................................................................................... 40 
13.1. 
Definitions and Classifications ............................................................................. 40 
13.2. 
Assessing Adverse Events .................................................................................... 42 
13.2.1. 
Causality Assessment .................................................................................... 43 
13.2.2. 
Severity Assessment ...................................................................................... 43 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 44 
13.4. 
Reporting Adverse Events .................................................................................... 45 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 45 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
46 
13.5. 
Event of Special Interest ....................................................................................... 46 
CR-6483, v 3.0
 
Page 3 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
13.6. 
Reporting of Pregnancy ........................................................................................ 46 
14. 
STATISTICAL METHODS ........................................................................................ 47 
14.1. 
General Considerations ......................................................................................... 47 
14.2. 
Sample Size Justification ...................................................................................... 47 
14.3. 
Analysis Populations ............................................................................................ 47 
14.4. 
Level of Statistical Significance ........................................................................... 47 
14.5. 
Primary Analyses .................................................................................................. 47 
14.6. 
Secondary Analyses .............................................................................................. 48 
14.7. 
Other Exploratory Analysis .................................................................................. 48 
14.8. 
Interim Analysis ................................................................................................... 48 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 48 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 48 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 48 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 48 
15.2. 
Trial Registration on ClinicalTrials.gov ............................................................... 49 
16. 
DATA MANAGEMENT............................................................................................. 49 
16.1. 
Access to Source Data/Document ........................................................................ 49 
16.2. 
Confidentiality of Information.............................................................................. 49 
16.3. 
Data Quality Assurance ........................................................................................ 50 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 50 
17. 
CLINICAL MONITORING ........................................................................................ 50 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 51 
18.1. 
Study-Specific Design Considerations ................................................................. 51 
18.2. 
Investigator Responsibility ................................................................................... 51 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 51 
18.4. 
Informed Consent ................................................................................................. 52 
18.5. 
Privacy of Personal Data ...................................................................................... 53 
19. 
STUDY RECORD RETENTION................................................................................ 54 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 55 
21. 
PUBLICATION ........................................................................................................... 55 
22. 
REFERENCES ............................................................................................................ 55 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 57 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 76 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 77 
CR-6483, v 3.0
 
Page 4 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 ...................................... 80 
 Lens Fitting Characteristics ................................................................................... 81 
 Subject Reported Ocular Symptoms/Problems ..................................................... 87 
 Front and Back Surface Lens Deposit Grading Procedure ................................... 89 
 Determination of Distance Spherocylindrical Refractive Error ............................ 94 
 Biomicroscopy Scale ........................................................................................... 100 
 Distance and Near Snellen Visual Acuity Evaluation ......................................... 106 
 Patient Reported Outcomes ................................................................................. 111 
 White Light Lens Surface Wettability ................................................................ 113 
APPENDIX E: IRIS COLOR SCALE ................................................................................. 115 
APPENDIX F: STARTING LENS POWER GUIDANCE .................................................. 116 
APPENDIX G: Guidelines for COVID-19 Risk Mitigation................................................. 117 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 129 
LIST OF TABLES
Table 1: Planned Enrollment by Strata and Site ..................................................................... 18 
Table 2: Duration of Study Visits ........................................................................................... 19 
Table 3: Test Articles .............................................................................................................. 21 
Table 4: Ancillary Supplies .................................................................................................... 21 
Table 5: Time and Events ....................................................................................................... 24 
Table 6: Disallowed systemic medications ............................................................................. 36 
Table 7: Disallowed systemic antihistamines ......................................................................... 37 
Table 8: Examples of major and minor protocol deviations ................................................... 38 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 13 
CR-6483, v 3.0
 
Page 5 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Evaluation of marketed soft contact lenses  
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase
Clinical trial phase: Feasibility
Design control phase: Post-market benchmark
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor 
Test Article(s)
Investigational Products: none
Approved Products: Dailies Total 1
Wear 
and 
Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily
Objectives 
Primary Objectives: This study is being conducted to evaluate 
the clinical performance of a marketed product.
Study Endpoints 
Primary endpoint(s): CLUE overall comfort and vision. 
Other observations: Subjective responses concentrated on 
other aspects of vision, comfort, and/or handling. 
Study Design 
This is a bilateral, 2-week dispensing, non-randomized, 
controlled, single-masked, single-arm study.  Each subject 
will be bilaterally fitted with the study lens.  
There will be a total of 2 visits:
1. Visit 1: Screening, baseline evaluation and lens fitting. 
2. Visit 2: Follow-up evaluation and final evaluation.  
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (
Figure 1).
Sample Size
Up to 80 subjects will be enrolled to complete approximately 
70.
Study Duration 
Once enrolled, each subject will be in the study for 2 weeks.  
The enrollment period is 2 weeks, making the entire study 
duration approximately 4 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.
CR-6483, v 3.0
 
Page 9 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
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. 
CR-6483, v 3.0
 
Page 10 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any 
ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, 
allergies, 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 
CR-6483, v 3.0
 
Page 11 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
recurrent corneal erosions, aphakia, moderate or above 
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.
CR-6483, v 3.0
 
Page 12 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 
CR-6483, v 3.0
 
Page 14 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
UADE  
 
Unanticipated Adverse Device Effect
UV 
 
 
Ultraviolet radiation
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
1.
INTRODUCTION AND BACKGROUND
This study will investigate the clinical performance of a marketed contact lens.
1.1.
Name and Descriptions of Investigational Products  
Dailies Total 1 (DT1) is a marketed product.  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, the 
study articles 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
Not Applicable – Marketed product only. 
1.4.
Summary of Known Risks and Benefits to Human Subjects
The risks of wearing soft contact lenses are well known. Benefits to the subjects include the 
correction of their refractive error.
For the most comprehensive risk and benefit information regarding DT1, refer to the latest 
version of the package insert of the marketed product.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
The package insert for the DT1 Study lens can be found in the appendices.  Prior clinical data 
of the investigational lens is summarized in the Investigator’s Brochure. 
Articles that pertain to the DT1 lenses 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.
CR-6483, v 3.0
 
Page 15 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
4. 0RQWpVဨ0LFy5REHUWHWDO2QဨH\HRSWLFDOTXDOLW\RIGDLO\GLVSRVDEOHFRQWDFWOHQVHV
for different wearing times." Ophthalmic and Physiological Optics 33.5 (2013): 581-
591.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective: 
This study is being conducted to evaluate the clinical performance of a marketed product. 
2.2.
Endpoints 
Primary Endpoints: 
x
CLUE overall comfort 
x
CLUE overall vision 
Subjective overall comfort and vision will be assessed using Contact Lens User Experience 
(CLUE) questionnaire at the two-week follow-up. CLUE is a validated patient-reported 
outcomes questionnaire to assess patient-experience attributes of soft, disposable contact 
lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the 
US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal 
distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response. A 5-point increase in an average CLUE score translates into 10% 
shift in the distribution of scores for population of soft disposable contact lens wearers.5
Other Exploratory Endpoint(s):
Subjective responses concentrated on other aspects of vision, comfort, and/or handling. 
2.3.
Hypotheses
No statistical hypotheses will be tested. All study endpoints will be summarized by descriptive 
statistics.   
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Approximately 80 subjects will be enrolled targeting 70 to complete.  Enrolled subjects will 
be habitual wearers of silicone hydrogel spherical contact lenses worn as daily wear reusable 
or daily disposable.  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.  
CR-6483, v 3.0
 
Page 16 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 
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 following Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, allergies, 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. 
CR-6483, v 3.0
 
Page 17 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Use of the study article will be non-randomized.  All subjects will receive the same study lens 
on both eyes. 
The following must have occurred prior to lens fitting: 
ͻ
Informed consent must have been obtained. 
ͻ
The subject must have met all eligibility criteria.
ͻ
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps should be followed: 
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. All subjects will be assigned to the same study lenses in this 
single arm study. Subjects will be unaware of the identity of the study lenses.  Investigators 
and clinical site personnel involved in the data collection will not be masked as to the identity 
of the study lenses.  
5.3.
Procedures for Maintaining and Breaking the Masking
The identity of the study lenses will be masked to the subjects by over labeling the blister pack 
of the study lens. The label will contain the study number, lot number, sphere power, expiration 
date and the randomization codes.  
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the sponsor must be informed as soon as possible. The date, time, 
and reason for the unmasking must be documented in the subject record. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued will be replaced. 
CR-6483, v 3.0
 
Page 20 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6.3.
Administration of Test Articles
Study articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study.  Lost or damaged test articles may be
replaced at the discretion of the investigator and/or the sponsor.  
6.4.
Packaging and Labeling
The study articles will be packaged in blisters as the primary packaging. The study article will 
be over-labeled to mask the identity of the lens.  The study articles will be in plastic bags as 
the secondary packaging form.  The sample study label is shown below. The information 
represented on the label below is sample information only and is not representative of the actual 
study lens information. 
Primary Packaging
Secondary Packaging
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. 
CR-6483, v 3.0
 
Page 22 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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. 
7.
STUDY EVALUATIONS 
7.1.
Time and Event Schedule
CR-6483, v 3.0
 
Page 23 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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
CR-6483, v 3.0
 
Page 35 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety,
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
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. 
CR-6483, v 3.0
 
Page 39 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.
CR-6483, v 3.0
 
Page 40 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 
CR-6483, v 3.0
 
Page 41 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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: 
CR-6483, v 3.0
 
Page 42 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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. 
CR-6483, v 3.0
 
Page 43 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 
CR-6483, v 3.0
 
Page 44 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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: 
CR-6483, v 3.0
 
Page 45 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.5. 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. 
CR-6483, v 3.0
 
Page 46 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
14. STATISTICAL METHODS
14.1. General Considerations
Statistical analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software Version
9.4 or higher (SAS Institute, Cary, NC).6 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
14.2. Sample Size Justification
The target is to enroll approximately 80 eligible subjects with 70 subjects to complete the 
study. There is no statistical hypothesis to be tested. Targeting 70 subjects to complete the 
study will be sufficient to evaluate descriptive summaries of the primary endpoints and other 
observations. The data collected from this clinical trial will be utilized for sample size 
calculations for future clinical trials.
14.3. Analysis Populations 
Safety Population: 
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
Per-Protocol Population:  
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file. 
14.4. Level of Statistical Significance
Not applicable. No statistical testing will be performed.
14.5. Primary Analyses
Descriptive summary statistics (e.g., mean, median, and standard deviation) will be calculated 
for each primary endpoint by timepoint (baseline and follow-up). No statistical hypothesis will 
be tested on the primary endpoints. 
CR-6483, v 3.0
 
Page 47 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
14.6. Secondary Analyses  
Not applicable 
14.7. Other Exploratory Analysis  
All other observations will be summarized descriptively by timepoint.
14.8. Interim Analysis  
An interim analysis will be performed after approximately 90% of the subjects (about 63 
subjects) complete the study. The interim analysis will consist of subject accountability, 
demographics, and descriptive summaries for questionnaire data. The results will be reviewed 
to gain insights of the DT1 lens performance before the competitive claim study is initiated. 
The results will be communicated to the project team.
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using the 
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 
CR-6483, v 3.0
 
Page 48 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 ISO14155:2020.0Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.2. 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 
CR-6483, v 3.0
 
Page 49 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
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. 
CR-6483, v 3.0
 
Page 50 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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),0 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20130and 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)0, 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. 
CR-6483, v 3.0
 
Page 51 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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
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 Helsinki0current ICH GCP0Error! Reference source not 
found. and ISO 14155:20200 guidelines, applicable regulatory requirements, and Sponsor Policy.
CR-6483, v 3.0
 
Page 52 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.7,8 Appropriate measures 
will be employed to safeguard these data, to maintain the confidentiality of the person’s related 
health and medical information, to properly inform the concerned persons about the collection 
and processing of their personal data, to grant them reasonable access to their personal data 
and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
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. 
CR-6483, v 3.0
 
Page 53 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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 guidelines0, 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 GCP0 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
CR-6483, v 3.0
 
Page 54 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This is a multicenter study. The participating institution and Principal Investigations for this 
study agree that, should this study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint, multicenter publication 
of the study results with the investigators and the institutions from all appropriate sites 
contributing data, analyses and comments. 
22. REFERENCES
1. 
ISO 14155:2020: 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. 
Wirth RJ, Edwards MC, Henderson M, Henderson T, Olivares G, Houts CR. 
Development of the Contact Lens User Experience: CLUE Scales. Optom Vis Sci. 
2016;93(8):801-808. 
CR-6483, v 3.0
 
Page 55 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
6. 
 SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS 
Institute Inc.  
7.
Health Information Portability and Accountability Act (HIPAA). Available at 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
8. 
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 
CR-6483, v 3.0
 
Page 56 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
CR-6483, v 3.0
 
Page 57 of 129
JJVC CONFIDENTIAL

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
1
CR-6483, v 3.0
 
Page 58 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
2
CR-6483, v 3.0
 
Page 59 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
3
CR-6483, v 3.0
 
Page 60 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
4
CR-6483, v 3.0
 
Page 61 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
5
CR-6483, v 3.0
) 
Page 62 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
6
CR-6483, v 3.0
 
Page 63 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
7
CR-6483, v 3.0
 
Page 64 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
8
CR-6483, v 3.0
 
Page 65 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
9
CR-6483, v 3.0
 
Page 66 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
10
CR-6483, v 3.0
 
Page 67 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
11
CR-6483, v 3.0
 
Page 68 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
12
CR-6483, v 3.0
 
Page 69 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
13
CR-6483, v 3.0
 
Page 70 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
14
CR-6483, v 3.0
 
Page 71 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
15
CR-6483, v 3.0
 
Page 72 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
16
CR-6483, v 3.0
 
Page 73 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
17
CR-6483, v 3.0
 
Page 74 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

35263(&,),&$7,2
)LQDO
3URWRFRO-RKQVRQ	-RKQVRQ9LVLRQ&DUH,QF&RQILGHQWLDO
18
CR-6483, v 3.0
 
Page 75 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately. 
CR-6483, v 3.0
 
Page 76 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
DAILIES TOTAL 1
CR-6483, v 3.0
 
Page 77 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS
CR-6483, v 3.0
 
Page 81 of 129
JJVC CONFIDENTIAL

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 1 of 5
CR-6483, v 3.0
 
Page 82 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 2 of 5
CR-6483, v 3.0
 
Page 83 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 3 of 5
CR-6483, v 3.0
 
Page 84 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 4 of 5
CR-6483, v 3.0
 
Page 85 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  6
Page 5 of 5
CR-6483, v 3.0
 
Page 86 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
CR-6483, v 3.0
 
Page 87 of 129
JJVC CONFIDENTIAL

7LWOH6XEMHFW5HSRUWHG2FXODU6\PSWRPV3UREOHPV
'RFXPHQW7\SH

'RFXPHQW1XPEHU

5HYLVLRQ1XPEHU
3DJHRI





CR-6483, v 3.0
 
Page 88 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE  
CR-6483, v 3.0
 
Page 89 of 129
JJVC CONFIDENTIAL

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
CR-6483, v 3.0
 
Page 90 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
CR-6483, v 3.0
 
Page 91 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 3 of 4
CR-6483, v 3.0
 
Page 92 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
CR-6483, v 3.0
 
Page 93 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
CR-6483, v 3.0
 
Page 94 of 129
JJVC CONFIDENTIAL

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 1 of 5
CR-6483, v 3.0
 
Page 95 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 2 of 5
CR-6483, v 3.0
 
Page 96 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 3 of 5
CR-6483, v 3.0
 
Page 97 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 4 of 5
CR-6483, v 3.0
 
Page 98 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE  
CR-6483, v 3.0
 
Page 100 of 129
JJVC CONFIDENTIAL

7LWOH

%LRPLFURVFRS\6FDOH
'RFXPHQW7\SH

'RFXPHQW1XPEHU






5HYLVLRQ1XPEHU

CR-6483, v 3.0
 
Page 101 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH

%LRPLFURVFRS\6FDOH
'RFXPHQW7\SH

'RFXPHQW1XPEHU






5HYLVLRQ1XPEHU

3DJHRI


CR-6483, v 3.0
 
Page 102 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH

%LRPLFURVFRS\6FDOH
'RFXPHQW7\SH

'RFXPHQW1XPEHU






5HYLVLRQ1XPEHU
3DJHRI

CR-6483, v 3.0
 
Page 103 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH

%LRPLFURVFRS\6FDOH
'RFXPHQW7\SH

'RFXPHQW1XPEHU






5HYLVLRQ1XPEHU

CR-6483, v 3.0
 
Page 104 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH

%LRPLFURVFRS\6FDOH
'RFXPHQW7\SH

'RFXPHQW1XPEHU






5HYLVLRQ1XPEHU
3DJHRI

CR-6483, v 3.0
 
Page 105 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION
CR-6483, v 3.0
 
Page 106 of 129
JJVC CONFIDENTIAL

7LWOH'LVWDQFHDQG1HDU6QHOOHQ9LVXDO$FXLW\(YDOXDWLRQ
'RFXPHQW7\SH

'RFXPHQW1XPEHU

5HYLVLRQ1XPEHU
3DJHRI
CR-6483, v 3.0
 
Page 108 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH'LVWDQFHDQG1HDU6QHOOHQ9LVXDO$FXLW\(YDOXDWLRQ
'RFXPHQW7\SH

'RFXPHQW1XPEHU

5HYLVLRQ1XPEHU
3DJHRI






















CR-6483, v 3.0
 
Page 109 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

7LWOH'LVWDQFHDQG1HDU6QHOOHQ9LVXDO$FXLW\(YDOXDWLRQ
'RFXPHQW7\SH

'RFXPHQW1XPEHU

5HYLVLRQ1XPEHU
3DJHRI



































CR-6483, v 3.0
 
Page 110 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 PATIENT REPORTED OUTCOMES 
CR-6483, v 3.0
 
Page 111 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
WHITE LIGHT LENS SURFACE WETTABILITY
CR-6483, v 3.0
 
Page 113 of 129
JJVC CONFIDENTIAL

Title:
White Light Lens Surface Wettability
Document Type:
Document Number:
Revision Number:
2
Page 1 of 1
CR-6483, v 3.0
 
Page 114 of 129
JJVC CONFIDENTIAL
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: IRIS COLOR SCALE
CR-6483, v 3.0
 
Page 115 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: STARTING LENS POWER GUIDANCE
CR-6483, v 3.0
 
Page 116 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION
CR-6483, v 3.0
 
Page 117 of 129
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6483 Evaluation of marketed soft contact lenses 
Version and Date: 3.0 09 February 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
CR-6483, v 3.0
 
Page 129 of 129
JJVC CONFIDENTIAL