Validation of Senofilcon A With New UV / HEV Filter
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Validation of senofilcon A with new UV / HEV Filter
Protocol CR-6470
Version: 2.0
Date: 14 September 2021
Investigational Products: senofilcon A with new UV / HEV Filter
Keywords: Sphere platform, Test lens: senofilcon A with new UV / HEV blocker, Control 
lens: senofilcon A without new UV / HEV blocker (ACUVUE OASYS 1-Day), daily wear, 
daily disposable, dispensing, Revitalens, logMAR visual acuity, biomicroscopy, fit 
acceptance, CLUE vision, situational visual performance (indoors and digital devices), CLUE 
handling, CLUE comfort.
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the 
Declaration of Helsinki,3 and all applicable regulatory requirements.
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document.
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 7 
SPONSOR NAME AND ADDRESS....................................................................................... 7 
MEDICAL MONITOR............................................................................................................. 7 
AUTHORIZED SIGNATURES............................................................................................... 8 
CHANGE HISTORY................................................................................................................ 9 
SYNOPSIS.............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 16 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 18 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 18 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives................................................................................................................. 18 
2.2. 
Endpoints.................................................................................................................. 19 
2.3. 
Hypotheses ............................................................................................................... 20 
3. 
TARGETED STUDY POPULATION........................................................................... 21 
3.1. 
General Characteristics ............................................................................................ 21 
3.2. 
Inclusion Criteria...................................................................................................... 21 
3.3. 
Exclusion Criteria..................................................................................................... 22 
3.4. 
Enrollment Strategy.................................................................................................. 23 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 23 
4.1. 
Description of Study Design .................................................................................... 23 
4.2. 
Study Design Rationale............................................................................................ 24 
4.3. 
Enrollment Target and Study Duration.................................................................... 24 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 24 
5.1. 
Test Article Allocation............................................................................................. 24 
5.2. 
Masking.................................................................................................................... 25 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 25 
6. 
STUDY INTERVENTION............................................................................................. 26 
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6.1. 
Identity of Test Articles............................................................................................ 26 
6.2. 
Ancillary Supplies/Products..................................................................................... 27 
6.3. 
Administration of Test Articles................................................................................ 27 
6.4. 
Packaging and Labeling ........................................................................................... 27 
6.5. 
Storage Conditions................................................................................................... 28 
6.6. 
Collection and Storage of Samples .......................................................................... 28 
6.7. 
Accountability of Test Articles ................................................................................ 28 
7. 
STUDY EVALUATIONS.............................................................................................. 29 
7.1. 
Time and Event Schedule......................................................................................... 29 
7.2. 
Detailed Study Procedures ....................................................................................... 30 
VISIT 1 ........................................................................................................................... 30 
VISIT 2 ........................................................................................................................... 36 
FINAL EVALUATION.................................................................................................. 38 
7.3. 
Unscheduled Visits................................................................................................... 39 
7.4. 
Laboratory Procedures ............................................................................................. 41 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 41 
8.1. 
Completion Criteria.................................................................................................. 41 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 41 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 42 
9.1. 
Systemic Medications .............................................................................................. 42 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 44 
11. 
STUDY TERMINATION ........................................................................................... 45 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 46 
13. 
ADVERSE EVENTS................................................................................................... 47 
13.1. 
Definitions and Classifications............................................................................. 47 
13.2. 
Assessing Adverse Events.................................................................................... 50 
13.2.1. 
Causality Assessment.................................................................................... 50 
13.2.2. 
Severity Assessment...................................................................................... 50 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 51 
13.4. 
Reporting Adverse Events.................................................................................... 52 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 52 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
53 
13.5. 
Event of Special Interest....................................................................................... 53 
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13.6. 
Reporting of Pregnancy........................................................................................ 54 
14. 
STATISTICAL METHODS........................................................................................ 54 
14.1. 
General Considerations......................................................................................... 54 
14.2. 
Sample Size Justification...................................................................................... 54 
14.3. 
Analysis Populations ............................................................................................ 58 
14.4. 
Level of Statistical Significance........................................................................... 59 
14.5. 
Primary Analyses.................................................................................................. 59 
14.6. 
Secondary Analyses.............................................................................................. 62 
14.7. 
Other Exploratory Analysis.................................................................................. 63 
14.8. 
Interim Analysis ................................................................................................... 63 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 63 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 64 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 64 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 64 
15.2. 
Subject Record...................................................................................................... 64 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 65 
16. 
DATA MANAGEMENT............................................................................................. 65 
16.1. 
Access to Source Data/Document ........................................................................ 65 
16.2. 
Confidentiality of Information.............................................................................. 65 
16.3. 
Data Quality Assurance........................................................................................ 65 
16.4. 
Data Monitoring Committee (DMC).................................................................... 66 
17. 
CLINICAL MONITORING........................................................................................ 66 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 66 
18.1. 
Study-Specific Design Considerations ................................................................. 66 
18.2. 
Investigator Responsibility................................................................................... 67 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 67 
18.4. 
Informed Consent ................................................................................................. 68 
18.5. 
Privacy of Personal Data ...................................................................................... 68 
19. 
STUDY RECORD RETENTION................................................................................ 70 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 70 
21. 
PUBLICATION........................................................................................................... 71 
22. 
REFERENCES ............................................................................................................ 71 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 73 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 84 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 85 
APPENDIX D:
.................................... 114 
 Limbal & Conjunctival (Bulbar) Redness........................................................... 115 
 Expanded Sodium Fluorescein Corneal Staining................................................ 122 
 Lens Fitting Characteristics................................................................................. 129 
 Subject Reported Ocular Symptoms/Problems................................................... 135 
Front and Back Surface Lens Deposit Grading Procedure ................................. 137 
 Determination of Distance Spherocylindrical Refractive Error.......................... 142 
 Biomicroscopy Scale........................................................................................... 148 
 Keratometry Procedure ....................................................................................... 154 
 Distance and Near Snellen Visual Acuity Evaluation......................................... 156 
 Distance LogMAR Visual Acuity Measurement Procedure............................... 161 
 Patient Reported Outcomes................................................................................. 165 
 White Light Lens Surface Wettability ................................................................ 167 
 Visual Acuity Chart Luminance and Room Illumination Testing ...................... 169 
APPENDIX E: IRIS COLOR SCALE ................................................................................. 178 
APPENDIX F: STARTING LENS POWER GUIDANCE.................................................. 179 
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION .............................. 180 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 192 
 
LIST OF TABLES
Table 1: Enrollment Strategy Overall..................................................................................... 23 
Table 2: Duration of Study Visits........................................................................................... 24 
Table 3: Test Articles.............................................................................................................. 26 
Table 4: Ancillary Supplies .................................................................................................... 27 
Table 5: Time and Events ....................................................................................................... 29 
Table 6: Disallowed systemic medications............................................................................. 43 
Table 7: Disallowed systemic antihistamines......................................................................... 44 
Table 8: Examples of major and minor protocol deviations................................................... 44 
Table 9: Descriptive Summary and Adjusted Means of LogMAR Visual Acuity and CLUE 
Scores from 
, 
 and 
 (Interim) ....................................................... 55 
Table 10: Descriptive Summary and Adjusted Proportion Estimates for Two Situational Visual 
Performance Items at 2-week Follow-up from
 and 
 (Interim).................. 55 
Table 11: Sample Size Estimation for the Primary Endpoints ............................................... 58 
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Table 12: Power Estimation for the Secondary Endpoints..................................................... 58 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 15 
 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Validation of senofilcon A with new UV / HEV Filter
Protocol Number: CR-6470
Version: 2.0
Date: 14 September 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155:2020,1 ICH 
guidelines2, and the Declaration of Helsinki.3
Author / Study 
Responsible Clinician
See Electronic Signature Report 
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Biostatistical Review
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety Officer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
 
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CHANGE HISTORY 
Version
Originator
Description of Change(s) and 
Section Number(s) Affected
Justification 
for Change
Date
1.0
New Protocol
NA
07 Sep 2021
2.0
Update Section 7.2, Step 1.8: 
remove GSI Background 
questionnaire
Questionnaire 
is not being 
used
14 Sep 2021
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SYNOPSIS  
Protocol Title
Validation of senofilcon A with new UV / HEV Filter
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: confirmatory
Design control phase: Confirmatory phase, phase 3
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
Sponsor
Test Article(s)
Investigational Products: senofilcon A with new UV / HEV 
filter
Approved Products: senofilcon A without new UV / HEV 
filter (ACUVUE OASYS 1-Day)
Wear and Replacement 
Schedules
Wear Schedule: daily wear
Replacement Schedule: daily disposable
Objectives 
This study is being conducted to validate that the Test lens 
meets the customer requirements.
Primary Objectives: The Test lens will meet the safety and 
efficacy requirements of the Design Validation Requirements.
Secondary Objectives: The Test lens will meet the Market 
Preference Requirements.
Study Endpoints
Primary endpoint(s): logMAR acuity, biomicroscopy, fit 
acceptance, CLUE vision
Secondary endpoint(s): CLUE handling, CLUE comfort, 
situational visual performance –
digital devices, and 
situational visual performance - indoors
Study Design
This is a bilateral, dispensing, randomized, controlled, 
subject-masked, 2-arm parallel study. Each subject will be 
bilaterally fitted with one of the two study articles during the 
course of the study.
There will be a total of 2 visits:
1. Visit 1: Screening, baseline evaluation and lens fit #1
2. Visit 2: Follow-up to lens fit #1. 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).
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Sample Size
Approximately 320 subjects in total (enrolling a160 in the 
Test lens group and 160 in the Control lens group with the aim 
to complete approximately 286 subjects (a143 in each of the 
2 lens groups).
Study Duration
Subject enrollment will last 4 weeks per site. Once enrolled, 
subjects will be in the study for approximately 2 weeks, 
making the entire study approximately 6 weeks in duration.
Anticipated Study 
Population
Subjects will be male and female of any race and ethnicity, 
age 18 through 39, habitual wearers of spherical silicone 
hydrogel contact lenses within the power range of -1.00 
through -6.00 D. Subjects will be targeted in a 7:3 ratio based 
on habitual lens wear (7 habitual daily disposable wearers 
versus 3 habitual daily wear reusable wearers) within each 
lens group.
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Eligibility Criteria -
Inclusion
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria after Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form.
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the 
time of screening.
4. By self-report, habitually wear spherical silicone 
hydrogel soft contact lenses in both eyes in a daily 
reusable 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. 
Inclusion Criteria at Baseline Evaluation
6. The subject’s vertex corrected spherical equivalent 
distance refraction must be in the range of -1.00
through -6.00 D in both eyes.
7. The subject’s refractive cylinder must be 1.00 D or 
less.
8. The subject must have best corrected visual acuity of 
20/25 or better in each eye.
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Eligibility Criteria –
Exclusion
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
Exclusion Criteria after Screening:
The subject must not:
1. Be currently pregnant or lactating.
2. Have any ocular or systemic allergies or diseases that 
may interfere with contact lens wear. 
3. Have any autoimmune disease or use of medication, 
which may interfere with contact lens wear.  Habitual 
medications used by successful soft contact lens 
wearers are considered acceptable.
4. Have any previous, or planned, ocular or interocular 
surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
5. Be currently wearing lenses in a monovision, multi-
focal, toric, or extended wear modality.
6. Have participated in a contact lens or lens care 
product clinical trial within 14 days prior to study 
enrollment
7. 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.
8. Have a history of binocular vision abnormality or 
strabismus.
9. Have any infectious disease (e.g., hepatitis, 
tuberculosis) or contagious immunosuppressive 
diseases (e.g., HIV) by self-report.
Exclusion Criteria at Baseline Evaluation
The subject must not:
10. Have any Grade 3 or greater slit lamp findings (e.g., 
edema, corneal neovascularization, corneal staining, 
tarsal abnormalities, conjunctival injection) on the 
FDA classification scale, any previous history or 
signs of a contact lens-related corneal inflammatory 
event (e.g., past peripheral ulcer or round peripheral 
scar), or any other ocular abnormality that may 
contraindicate contact lens wear.
11. Have any ocular infection.
12. Have any corneal distortion resulting from previous 
hard or rigid gas permeable contact lens wear.
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13. Have entropion, ectropion, extrusions, chalazia, 
recurrent styes, glaucoma, history of recurrent corneal 
erosions, or aphakia.
Disallowed 
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear from 24 hours 
prior to receiving the study product through the study period 
of a14 days. Habitual medications taken by successful soft 
contact lens wearers are generally considered acceptable.  
Note that habitual medications should be taken throughout the 
study period.
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
LogMAR visual acuity, biomicroscopy, fit acceptance, 
GSI/MRD and CLUE questionnaire items.
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
Preservative free rewetting drops/artificial tears or saline.  
ACUVUE RevitaLens will be used to transport any 
problematic lenses back to the Sponsor.
logMAR visual 
acuity charts.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
286-320 Subjects
x
Available powers:  -1.00 to -6.00 in 0.25 D steps
x
Habitual wearers of spherical silicone soft contact lenses worn as daily wear
x
CL Rx current within prior 6 months, and worn for at least 2 weeks
x
t 18 and < 40 years of age. 
Informed Consent
Eligibility Criteria
Baseline Information
¾ Baseline questionnaires
¾ Habitual lens type, modality
¾ Keratometry
¾ Iris color
¾ Subjective refraction
¾ Physiology
Test Group
Trial Period 1
¾ Subjects will be randomly assigned, and fit, a Test or 
Control lens on both eyes
¾ Modify powers to obtain a 0.00 D spherical over-refraction
10-Minute Evaluation
¾ Symptoms
¾ Fitting characteristics, VA
¾ For further testing, the lenses must provide:
¾ Appropriate fitting characteristics on both eyes
¾ 20/30 or better vision in both eyes
¾ Investigator approval
Follow-up 1
(13-15 Days)
¾ Compliance
¾ Patient reported outcomes (Questionnaires), Preference to Habitual
¾ logMAR acuity
¾ Surface characteristics, physiology
Control Group
Trial Period 1
¾ Subjects will be randomly assigned, and fit, a Test or 
Control lens on both eyes
¾ Modify powers to obtain a 0.00 D spherical over-refraction
143-160 Subjects
143-160 Subjects
Final Evaluation
¾ Keratometry
¾ Subjective refraction
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
COVID-19
Coronavirus Disease 2019
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HEV
High Energy Visible light
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICH
International Council for Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LogMAR
Logarithm of Minimal Angle of Resolution
OD
Right Eye
OS
Left Eye
OU
Both Eyes
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
QA
Quality Assurance
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
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SD
Standard Deviation
UADE
Unanticipated Adverse Device Effect
UV
Ultraviolet radiation
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND 
The range of high energy visible (HEV) light is roughly defined in the literature, with 
references stating 380-500 nm5, 400-500 nm6 and others stating 430-510 nm.7 This region of 
the electromagnetic spectrum has special meaning to the eye. It is light that we can see, but
yet can have negative and positive effects on the eye. At the shorter wavelength end of the 
range, around 435r20 nm,8 the light has enough energy to cause premature damage to the 
retinal pigment epithelium and has being linked to macular degeneration.
The shorter 
wavelengths are also scattered more than longer wavelengths (Rayleigh scattering), which 
create the blue sky and “blue haze” that we see when looking at distant objects. At the longer 
wavelength end of the range, around 480r20 nm,9 the light is responsible for regulating our 
circadian rhythms and pupillary light reflexes.
Ophthalmic devices that block the shorter HEV wavelengths while transmitting the longer 
wavelengths might experience an immediate visual improvement through better chromatic 
contrast, while benefitting in the long-term through enhanced retinal protection. This study 
will investigate the clinical performance of the prototype Test lenses against an otherwise 
similar Control.
1.1.
Name and Descriptions of Investigational Products  
This study will evaluate a senofilcon A design prototype with new UV/HEV blocker against a 
commercially available marketed product ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxe™ Technology (AO1D).  Further details about the test articles are found in 
section  of this protocol.  Note that the new UV/HEV blocker was previously identified as 
Theia I.
1.2.
Intended Use of Investigational Products 
The intended use of the investigative product is for correcting myopia and for improving the 
visual experience by improving contrast. During the study, each test article will be worn 
bilaterally in daily wear, daily disposable modality for at least 6 hours per day and 5 days per 
week for approximately two weeks. The subject will wear both test articles in a cross-over 
study design.
1.3.
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding senofilcon A 
with new UV / HEV filter, refer to the latest version of the Investigator’s Brochure.
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1.4.
Summary of Known Risks and Benefits to Human Subjects 
The risks of wearing soft contact lenses are well known and are described in the Investigator’s 
Brochure and Informed Consent.
The material safety testing/lens release criteria was 
determined based on the Risk Assessment. Benefits to the subjects include the correction of 
their refractive error with the potential of improved contrast in HEV environments.
For the most comprehensive risk and benefit information regarding senofilcon A with new UV 
/ HEV filter, refer to the latest version of the Investigator's Brochure.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The package insert for the AO1D Control lens can be found in the appendices.  Prior clinical 
data of the new UV/HEV-blocker is summarized in the Investigator’s Brochure.
The literature is absent of any articles pertaining to soft contact lenses containing 
HEV-blocker. Articles that pertain to “blue-blocking” spectacles and intraocular lenses do 
exist with a sampling shown here:
1. Mainster, Martin A. "Violet and blue light blocking intraocular lenses: 
photoprotection versus photoreception." British journal of ophthalmology. 90.6
(2006): 784-792.
2. Braunstein, Richard E., and Janet R. Sparrow. "A blue-blocking intraocular lens 
should be used in cataract surgery." Archives of ophthalmology 123.4 (2005): 547-
549.
3. Glazer-Hockstein, Carolyn, and Joshua L. Dunaief. "Could blue light–blocking lenses
decrease the risk of age-related macular degeneration?" (2006): 1-4.
4. Kimberly, Burkhart, and Phelps James R. "Amber lenses to block blue light and 
improve sleep: a randomized trial." Chronobiology international 26.8 (2009): 1602-
1612.
5. Hayashi, Ken, and Hideyuki Hayashi. "Visual function in patients with yellow tinted 
intraocular lenses compared with vision in patients with non-tinted intraocular 
lenses." British journal of ophthalmology 90.8 (2006): 1019-1023.
6. Schmoll, Conrad, et al. "New light for old eyes: comparing melanopsin-mediated 
non-visual benefits of blue-light and UV-blocking intraocular lenses." British Journal 
of Ophthalmology (2013): bjophthalmol-2013.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
This study is being conducted to validate that the Test lens meets the customer requirements 
prior to launch.  Senofilcon A with a new HEV / UV filter (Test) and without a new UV / HEV 
filter (Control) will be evaluated on several safety and efficacy measures.
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Primary Objective(s)
The primary objective is to demonstrate that the Test lens meets all of the safety and efficacy 
requirements of the Design Validation Requirements as defined by 
Secondary Objective(s)
The secondary objective is to demonstrate that the Test lens meets all of the Market Preferences 
as defined in 
2.2.
Endpoints  
Primary Endpoint(s):  The following endpoints are defined in 
Primary Safety Endpoints:
Biomicroscopy 
Biomicroscopy (slit lamp findings) will be assessed for each subject eye across all study visits 
(including scheduled and unscheduled visits). FDA Slit Lamp Classification Scale will be used 
to grade the findings. The percentage of eyes with clinically significant slit lamp findings (i.e.,
Grade 3 or higher, or significant corneal infiltrates) will be analyzed.
Lens Fit Acceptance
Lens fitting will be assessed at dispensing and follow-up visits for each subject eye. The 
percentage of eyes with unacceptable lens fitting will be analyzed.
Primary Efficacy Endpoints:
Distance Monocular LogMAR Visual Acuity (VA)
Distance monocular logMAR VA will be assessed for each subject eye at the two-week follow-
up evaluation using ETDRS charts at 4 meters under high luminance high contrast (HLHC)
condition.
CLUE Overall Quality of Vision
Subjective overall quality of vision will be assessed using Contact Lens User Experience 
(CLUE) questionnaire.10 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.
Secondary Endpoint(s):  The following endpoints are defined in 
Secondary Efficacy Endpoints:
CLUE Overall Handling
Overall handling will be assessed using Contact Lens User Experience (CLUE) questionnaire.
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CLUE Overall Comfort 
Overall comfort will be assessed using Contact Lens User Experience (CLUE) questionnaire.
Situational Visual Performance – Indoors
Situation visual performance – indoors will be assessed using the individual item “Clarity of 
vision indoors in bright light” (
). This item uses a 5-point Likert response scale, 1: 
Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor.
Situational Visual Performance – Digital Devices
Situation visual performance – digital devices will be assessed using the individual item 
“Overall preference while using computer screens & digital devices” (
). The 
response set for this preference item include: Strongly prefer my habitual lenses, Slightly prefer 
my habitual lenses, No preference, Slightly prefer the study lenses, and Strongly prefer the 
study lenses.  
2.3.
Hypotheses 
All the following primary hypotheses must be met for the objectives of this study to be 
satisfied:
Primary Hypotheses
Safety
1. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to the proportion of eyes with clinically significant slit lamp findings across 
all study visits. A non-inferiority margin of 5% will be used.
2. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to the proportion of eyes with unacceptable lens fitting at dispensing and 
follow up visit. A non-inferiority margin of 10% will be used.
Efficacy
1. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to monocular high luminance, high contrast distance visual acuity at the 
follow-up visit. A non-inferiority margin of 0.05 logMAR will be used.
2. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to overall CLUE vision score at the follow up visit. A non-inferiority margin 
of -5 points on the CLUE scale will be used.
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Secondary Hypotheses
Efficacy
1. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to overall CLUE handling score at the follow-up visit. A non-inferiority 
margin of -5 points on the CLUE scale will be used.
2. The JJVCI investigational contact lens is non-inferior to the control lens with 
respect to overall CLUE comfort score at the follow-up visit. A non-inferiority 
margin of -5 points on the CLUE scale will be used.
3. The JJVCI Investigational contact lens will be non-inferior to the Control lens with 
respect to the proportion of subjects with Excellent responses to the statement 
“Clarity of Vision indoors in bright light (
)” at the follow-up visit. A 
non-inferiority margin of 0.67 for odds ratio will be used.
4. The JJVCI Investigational contact lens will be superior to the Control habitual lens 
with respect to overall preference while using computer screens & digital devices 
at the follow up visit.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
Approximately 160 subjects will be targeted to the Test Group and approximately 160 will be 
targeted to the Control Group.  Within each lens group, the intent is to complete 143 (286 total 
subjects).  Enrolled subjects will be habitual wearers of silicone hydrogel spherical contact 
lenses.  All subjects will be the age of t18 and <40.  Subjects will wear the study contact lenses 
approximately two weeks each on a daily wear (DW) daily disposable (DD) basis for a total 
study duration of approximately 14 days (2 weeks) per subject.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
The subject must:
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both 
eyes in a daily reusable 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. 
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Inclusion Criteria following Baseline Evaluation
6. The subject’s vertex corrected spherical equivalent distance refraction must be in the 
range of -1.00 through -6.00 D in both eyes.
7. The subject’s refractive cylinder must be 1.00 D or less.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:
Exclusion Criteria after Screening:
The subject must not:
1. Be currently pregnant or lactating.
2. Have any ocular or systemic allergies or diseases that may interfere with contact lens 
wear. 
3. Have any autoimmune disease or use of medication, which may interfere with contact 
lens wear.  Habitual medications used by successful soft contact lens wearers are 
considered acceptable.
4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, 
PRK, LASIK, etc.).
5. Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear 
modality.
6. Have participated in a contact lens or lens care product clinical trial within 14 days 
prior to study enrollment
7. 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.
8. Have a history of binocular vision abnormality or strabismus.
9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious 
immunosuppressive diseases (e.g., HIV) by self-report.
Exclusion Criteria at Baseline Evaluation
The subject must not:
10. Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on 
the FDA classification scale, any previous history or signs of a contact lens-related 
corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or 
any other ocular abnormality that may contraindicate contact lens wear.
11. Have any ocular infection.
12. Have any corneal distortion resulting from previous hard or rigid gas permeable 
contact lens wear.
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13. Have entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, or aphakia.
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
The overall goal is to enroll approximately 320 eligible subjects and complete 286 that are 
evenly distributed between the Test Group and the Control Group (Table 1).
Table 1: Enrollment Strategy Overall
Overall Enrollment
Strata
Test Group
Control Group
Total
Randomized
Overall
143-160
143-160
286-320
Habitual Daily 
Disposable
~112
~112
~224
Habitual Daily Wear 
Reusable
~48
~48
~96
Completed
Overall
143
143
286
Habitual Daily 
Disposable
a100
a100
a200
Habitual Daily Wear 
Reusable
a43
a43
a86
Approximately 16 sites are expected to enroll approximately 20 subjects each with 
approximately 10 subject wearing the Test lens and approximately 10 wearing the Control lens 
during the study. Habitual wearers of daily disposable lenses will be preferentially targeted in 
a 7:3 ratio over habitual wearers of daily wear reusable lenses in each lens group within each 
site (i.e., 7 habitual wearers of daily disposable lenses versus 3 habitual wearers of daily wear 
reusable lenses). 
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This study is a controlled, randomized, subject-masked, 2-arm parallel, 2-week dispensing, 
bilateral evaluation where the study lenses are worn for a minimum of 5 days per week and 6 
hours per day.  At study closure, participants will have no further access to the Test lenses.
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
then they will be randomized and fit with either the Test or Control lenses in both eyes; 
otherwise, a subject will be deemed ineligible for this study. If the subject is dispensed study 
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lenses at the initial visit, a follow-up visit will be conducted. The follow-up visit will occur 
approximately 2 weeks after the initial visit. Unscheduled visits may occur during the study.
4.2.
Study Design Rationale 
The purpose of this study is to evaluate the performance of a new UV/HEV-filter in a 2-arm 
parallel design. In this parallel design, subjects are randomized to one of the two study arms 
and after randomization each participant will stay in their assigned treatment arm for the 
duration of the study. Randomization eliminates the selection bias and balances both the known
and unknown confounding factors that may affect the study outcomes.
4.3.
Enrollment Target and Study Duration 
This study will have an enrollment target of 320 subjects, with a target of at least 286 to
complete. The study will be conducted at up to 16 clinical sites, where the enrollment target 
for each site will be approximately 20 subjects. A subject will be considered enrolled upon 
signing of the informed consent form. 
There will be 2 visits in total per subject; total study duration including the enrollment period 
is expected to be approximately 6 weeks. Subjects who are discontinued prior to the final 
evaluation may be replaced at the discretion of the study sponsor. The investigation will end 
at the time that the study data is hard locked.
Table 2: Duration of Study Visits
Visit
Description
| Duration
1
Informed consent, eligibility criteria, baseline data, trial fitting 1, 
dispense lenses. Study lenses to be worn 13-15 days to first follow-
up visit.
2.0 hours
3
13-15 day follow-up for the study lens, subjective responses, 
preference to habitual lenses, VA, fitting characteristics, surface 
characteristics, physiology, Final Evaluation.
1.0 hours
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
Use of the test articles will be randomized using a lens fitting schedule supplied by the study 
biostatistician. The clinical site will follow the lens fitting schedule provided and will complete
enrollment according to the randomization list and will not pre-select or pre-assign subjects.
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. A computer-generated randomization scheme will be used to randomly assign subjects, 
in blocks of 2, to one of the two lens groups (Test or Control). The randomization will be 
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stratified by site and type of habitual lens wear (daily disposable and daily wear reusable). The 
ratio of habitual wearers of daily disposable lenses to habitual wearers of daily wear reusable 
lenses is 7:3 within each study site (7 habitual wearers of daily disposable lenses versus 3 
habitual wearers of daily wear reusable lenses).  See Table 1. The random scheme will be 
generated using the PROC PLAN procedure from Statistical Analysis System (SAS) Software 
Version 9.4 or higher (SAS Institute, Cary, NC).11
Randomization will be performed at visit 1. The following must have occurred prior to
randomization:
•
Informed consent must have been obtained.
•
The subject must have met all eligibility criteria.
•
The subject’s screening and baseline information must have been collected.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens
fitting schedule to obtain the test article assignment for that subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule.
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section.
5.2.
Masking 
This is a single-masked trial. The investigators may be aware of the study lenses based on a
slight difference in lens color (the Test lenses will be slightly more turquoise in color than the 
Control lens). 
Masking will be used to reduce potential bias. Subjects will be unaware of the identity of the 
investigational product. Investigators and clinical site personnel involved in the data collection 
will not be masked as to the identity of the investigational product.
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. 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before 
the mask is broken.
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Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the sponsor must be informed as soon as possible. The date, time, 
and reason for the unmasking must be documented in the subject record. The investigator is 
also advised not to reveal the study treatment assignment to the clinical site or sponsor 
personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued will be replaced.
6.
STUDY INTERVENTION 
6.1.
Identity of Test Articles  
The following contact lenses will be used in this study:
Table 3: Test Articles
Control
Test
Manufacturer
JJVC
JJVC
Name
AV OASYS 1-DAY
TRP-200
Hydration
PG
PG
Material
senofilcon A
senofilcon A
Packaging Form
Sterile blister pack
Sterile blister pack
Nominal Water Content (%)
38
38
Nominal Dk (edge corrected)
103
103
Nominal Modulus
101
101
Inversion Indicator
123
123
Nominal Base Curve/Diameter @ 22°C 
(mm)
8.5 / 14.3
8.5 / 14.3
Nominal Center Thickness @ -3.00 D 
(mm)
0.085
0.085
Nominal Powers (D)
-1.00 to -6.00 in 0.25 
steps
-1.00 to -6.00 in 0.25 
steps
New UV/HEV-Filter
NA
Yes
At least 1080 lenses per SKU per study lens will be made available based on the following 
factors: sample size, bilateral wear, daily replacement, 2-week duration, safety margin of 2X, 
and US distribution model for the range of lenses -1.00 through -6.00 DS.
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6.2.
Ancillary Supplies/Products 
The following solutions will be used in this study.  Note that RevitaLens will be used 
primarily to transport potential problematic lenses back to the Sponsor.
Table 4: Ancillary Supplies
Solution
Solution 
Name/Description
Acuvue RevitaLens 
Multipurpose Solution
Single use
Eye-Cept®
Rewetting
Drops
LacriPure
Saline
Solution
ScleralFil
Preservative
Free Saline
Solution
Manufacturer
Johnson & Johnson 
Vision
Optics
Laboratory
Menicon
Bausch & 
Lomb
Preservative
alexidine 
dihydrochloride 
0.00016% and 
polyquaternium-1
0.0003%
None
None
None
Lens cases and fluorescein strips (either 0.6 mg or 1.0 mg) will be supplied for use as needed.
6.3.
Administration of Test Articles 
Test 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 Test articles will be packaged in blisters as the primary packaging. The Test article will 
be over-labeled to mask the identity of the lens. The Test articles will be in plastic bags as the 
secondary packaging form. The sample study label is shown below:
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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. 
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 
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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.
 
 
 
 
 
 
 
 
 
 
7.
STUDY EVALUATIONS  
7.1.
Time and Event Schedule 
Table 5: Time and Events
Visit Information
Visit 1
Screening, Baseline, 
Treatment 1
Visit 2
2-week FU
Treatment 1
Visit 2
Final Evaluation
Time Point
14 days after Visit 1
(+/- 1 day)
14 days after Visit 1
(+/- 1 day)
Estimated Visit Duration
2.0 hours
45 min
15 min
Statement of Informed 
Consent
x
Demographics
x
Medical 
History/Concomitant 
Medications
x
x
Habitual Contact Lens 
Information
x
Inclusion/Exclusion Criteria
x
Study Questionnaires 
Baseline
x
Entrance Visual Acuity
x
x
Slit Lamp Biomicroscopy
x
x
x (if applicable)
Expanded Conjunctival 
Redness
x
x
x (if applicable)
Expanded Corneal Staining
x
x
x (if applicable)
Keratometry
x
x
Iris Color
x
Subjective Spherocylindrical 
Refraction
x
x
Lens Selection
x
Lens Insertion & Settling
x
Visual Acuity and Over 
Refraction
x
Lens Power Modification (if 
applicable)
x
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Visit Information
Visit 1
Screening, Baseline, 
Treatment 1
Visit 2
2-week FU
Treatment 1
Visit 2
Final Evaluation
Time Point
14 days after Visit 1
(+/- 1 day)
14 days after Visit 1
(+/- 1 day)
Estimated Visit Duration
2.0 hours
45 min
15 min
Subject Reported Ocular 
Symptoms
x
x
Lens Fit Assessment
x
x
Lens Wettability
x
x
Surface characteristics
x
Lens dispensing information 
and criteria
x
Patient instructions
x
Study Questionnaires FU
x
logMAR Acuity
x
Exit Acuity
x
x
Final Evaluation
x
7.2.
Detailed Study Procedures 
VISIT 1
The subjects must enter the visit wearing their habitual contact lenses.
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of 
Informed Consent
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study. The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form.
Note: The subject must be provided a signed 
copy of this document.
1.2
Demographics
Record the subject’s year of birth, age, 
gender, race and ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Record the subject’s medical history and 
concomitant medications.
1.4
Habitual Lenses
Record the subject’s habitual lens type,
parameters, lens care solution, wear modality
and approximate prescription date.
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Visit 1: Screening
Step
Procedure
Details
1.5
Habitual Wear Time
Record the average wearing time and 
comfortable wearing time.
1.6
SCL Rx 
Confirmation
The investigator confirms:
1. The subject is wearing a SCL Rx that 
has been confirmed current (up-to-
date) within the prior 6 months.
2. The subject has worn the up-to-date 
SCL Rx for at least 2 weeks.
1.7
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
completed as part of Final Evaluation.
Visit 1: Baseline
Step
Procedure
Details
1.8
Baseline 
Questionnaire
The subject will respond to the following 
Baseline Questionnaires based on their 
habitual lenses:
1. CLUE Baseline
1.9
Entrance Visual 
Acuity
Record the distance Snellen visual acuity 
(OD, OS, and OU) to the nearest letter with
their habitual contact lens correction in place.
Subjects must read the smallest line until at 
least 50% of the letters are read incorrectly.
1.10
Remove Habitual 
Lens
The subject’s habitual lenses will be removed 
and stored in their own lens case. If they 
forgot to bring their lens case, one will be 
provided to them.
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Visit 1: Baseline
Step
Procedure
Details
1.11
Slit Lamp 
Biomicroscopy  
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.
If any of these slit lamp findings are grade 3 
or higher (FDA scale), the subject may not 
continue at this time, but may return up to 
one additional time to determine eligibility. If 
discontinued a final examination must be 
completed.
Limbal and Bulbar Conjunctival Hyperemia 
findings (
) and Corneal Staining 
Assessment (
) will also be 
collected for internal purposes.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
1.12
Keratometry
Record the keratometry readings OD and OS 
in diopters. This can come from any 
appropriate instrument so long as the same 
instrument is used at the Final Evaluation.
1.13
Iris Color
The investigator will record the subject’s iris 
color based on the scale provided.
1.14
Subjective Sphero-
cylindrical 
Refraction
Complete subjective spherocylindrical 
refraction and record the resultant distance 
visual acuity (OD, OS, and OU) to the nearest 
letter.
1.15
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible.
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms do not need to be 
completed as part of Final Evaluation.
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.16
Lens Selection
Assign the study lens based on the 
randomization scheme provided by the 
biostatistician.  
Select the contact lens power based on the
spherical equivalent from the subjective 
sphero-cylindrical refraction.
Record the test condition.
1.17
Lens Insertion
The Investigator or the subject inserts the 
study lenses. Record the time of lens 
insertion.
Check for lens damage under the slit lamp 
before proceeding with lens settling. 
Replace damaged lenses if applicable.
Ensure the subject is given a Patient 
Instruction Guide.
1.18
Lens Settling 
Allow the study lenses to settle for a 
minimum of 5 minutes.
1.19
Subjective Best 
Sphere Over 
Refraction
Perform subjective best sphere refraction 
over the study lenses with a phoropter (adopt 
the maximum plus to maximum visual acuity 
(MPMVA) approach and record the best 
corrected distance visual acuity to the nearest 
letter (OD and OS).
1.20
Lens Power 
Modification (if 
applicable)
Adjust the lens power if the subject’s best 
sphere over-refraction is not plano. 
For each power modification, select the 
adjusted fitting lens power as appropriate and 
repeat steps 1.17 through 1.19.
One power modification is allowed. 
1.21
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.22
General Lens Fit 
Assessment
Evaluate lens centration, movement on blink, 
and push-up test for each eye.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement.
x
edge lift.
x
excessive movement in primary and 
up gaze.
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and push-up test.
Note: if lens fit is unacceptable for either eye, 
the subject will be discontinued from the 
study.
1.23
White Light Lens 
Surface Wettability
Record the white light lens wettability of both 
lenses.
1.24
Visual Acuity
Record the distance visual acuity with the 
contact lenses (OD, OS, and OU) to the 
nearest letter. Smaller lines must be shown 
until the subject incorrectly identifies at least 
50% of the letters.
1.25
Continuance
For the subject to continue in the study, they 
must meet all three of the following criteria:
x
Visual acuity is 20/30 or better OD 
and OS.
x
The lens fit is acceptable OD and OS.
x
Investigator approval.
If the Investigator does not approve the 
dispensing of the first study lens, then the 
study is terminated for that subject.
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Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.26
Dispense
The lenses will be dispensed for 13-15 days
1. The subjects should wear their lenses 
similar to the inclusion criteria: t6 hours 
per day, t5 days per week.
2. The lenses will be worn as daily wear 
daily disposable only.
3. All subjects will be provided a bottle of 
ACUVUE RevitaLens to return any 
problematic lenses to the investigational 
site.
4. Rewetting drops are permitted if needed.
5. A patient instruction booklet will be 
provided.
Note 1: Ensure that the subject has enough 
lenses to last them to their next scheduled 
visit with no extras.  In the event a lens is lost 
or damaged, and the subject has run out of 
lenses, the subject will return to the 
investigator site for replacement.
Note 2: The subject’s habitual contact lenses 
cannot be worn at any time during the study.
Note 3: Remind the subjects to bring back 
any unworn lenses to the next visit.
Note 4: Remind the subject to bring a 
habitual form of correction to next visit.
1.27
Schedule next visit
Schedule the follow-up visit to occur in 14 ±
1 days (counting the day of this visit as day 0, 
the subject may return on day 13 through 15).
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VISIT 2
The follow-up will occur 13-15 days after Visit 1. The subjects must enter the visit wearing 
their study contact lenses.
Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
2.1
Adverse Events and 
Concomitant 
Medications Review
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
2.2
Wearing Time
Record the average wearing time and 
comfortable wearing time.
2.3
Compliance
Confirm compliance with the prescribed wear 
schedule.
2.4
Return unworn 
lenses
Collect any unworn study lenses from the 
subject.
2.5
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.6
Follow-Up
Questionnaire
Subjects will respond to the following 
questionnaires:
1. CLUE Follow-up
2. GSI Product Performance
3. Lens preference to habitual
2.7
Distance ETDRS 
LogMAR Visual 
Acuity
Measure monocular distance high luminance 
high contrast (HLHC) visual acuity using 
ETDRS charts at 4 meters. 
Measure each eye once using the charts shown 
in the table below:
Condition
HLHC
Room 
illumination
> 400 lux
Chart 
luminance
120 - 200 cd/m2
Eye
OD
OS
Charts
HC-1
HC-2
Recorded letter-by-letter results into EDC.
2.8
Visual Acuity
Record the distance Snellen visual acuity with 
the contact lenses (OD, OS, and OU) to the 
nearest letter.  Subjects must read the smallest 
line until at least 50% of the letters are read 
incorrectly.
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Visit 2: Treatment 1 Follow-Up 1
Step
Procedure
Details
2.9
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement.
x
edge lift.
x
excessive movement in primary and 
up gaze.
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and push-up test.
Note: if lens fit is unacceptable subject will 
be discontinued from the study.
2.10
Wettability 
Characteristics
Record the white light lens wettability of both 
lenses.
2.11
Surface Deposits
Record any front and back surface lens 
deposits.
2.12
Lens Removal
Both lenses will be removed and discarded.
2.13
Slit Lamp 
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings. If no slit lamp 
finding is noted on the EDC form it is 
considered as a zero “0” grade for all 
observations listed. 
Note: If the subject has Grade 3 or 4 slit 
lamp findings on the FDA scale, then they 
must be followed as an adverse event.  
Adverse events must be reported to the JJVC 
monitors immediately.
Limbal and Bulbar Conjunctival Hyperemia 
findings (
) and Corneal Staining 
Assessment (
) will be emphasized 
using a more detailed scale.
After the slit lamp examination, at the 
discretion of the Investigator, rinse the 
subject’s eyes thoroughly with rewetting 
drops or saline.
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FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study.
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason.
F.2
Keratometry
Record the keratometry readings OD and OS 
in diopters. This can come from any 
appropriate instrument so long as the same 
instrument was used at the Baseline
Evaluation.
F.3
Exit Refraction 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter and record the 
best-corrected distance visual acuity (OD, OS
and OU) to the nearest letter. 
Note: This step is not necessary if the subject 
was exited due to screen failure.
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Final Evaluation
Step
Procedure
Details
F.4
Exit Slit Lamp 
Biomicroscopy (for 
subjects that are 
discontinued early)
FDA Slit Lamp Classification Scale will be 
used to grade the findings. If no slit lamp 
finding is noted on the EDC form it is 
considered as a zero “0” grade for all 
observations listed. 
Note: If the subject has Grade 3 or 4 slit 
lamp findings on the FDA scale, then they 
must be followed as an adverse event.  
Adverse events must be reported to the JJVC 
monitors immediately.
Limbal and Bulbar Conjunctival Hyperemia 
findings
 and Corneal Staining 
Assessment 
 will be emphasized 
using a more detailed scale.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. This step is not 
necessary if the subject was exited due to 
screen failure.
Note: This step is not necessary if the subject 
was exited due to screen failure, or if 
biomicroscopy was performed as part of the 
final follow-up visit procedures (i.e., 
immediately prior to the final evaluation).
7.3.
Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected, as appropriate:
x
Chief complaint prompting the visit. If the reason is an adverse event, the applicable 
eCRF for the adverse event must be completed and subject record completed as 
appropriate.
x
Date and time of the visit and all procedures completed at the unscheduled visit.
x
Review of adverse event and concomitant medications.
x
Documentation of any test article dispensed or collected from the subject, if applicable.
x
Slit lamp findings (using the Slit Lamp Classification Scale).
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified.
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Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider. 
The following information will be collected during an unscheduled visit.
Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for 
reasons for the unscheduled visit.
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
U.4
Entrance VA (if 
applicable)
Record the entrance distance visual acuity 
(OD, OS) to the nearest letter. 
U.5
Subjective Sphero-
cylindrical 
Refraction (if 
applicable)
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.  If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled.
Limbal and Bulbar Conjunctival Hyperemia 
findings (
) and Corneal Staining 
Assessment (
) will be emphasized 
using a more detailed scale.
After the slit lamp examination, at the 
discretion of the Investigator, rinse the 
subject’s eyes thoroughly with rewetting 
drops or saline.
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Unscheduled Visit
Step
Procedure
Details
U.7
Dispensing (if 
applicable)
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the
dispensing instructions given in the detailed 
study procedures.
U.8
Exit Visual Acuity 
(if applicable)
Record the subject’s exit distance visual 
acuity (OD, OS) to the nearest letter. 
Note: If the only reason for the unscheduled visit is that the subject requires additional test 
articles, only the dispensing information needs to be recorded.
7.4.
Laboratory Procedures  
Not Applicable.
8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
x
provided informed consent.
x
they are eligible.
x
have not withdrawn/discontinued from the study for any reason described in section 
8.2.
x
completed all visits through the final visit 3.
x
If all visits were completed but an additional visit is considered necessary for subject 
care, follow the requirements for unscheduled visits in section 7.3.
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent.
x
Subject not compliant to protocol such as study lens wear time or habitual lens wear 
while enrolled in the study.
x
Subject lost to follow-up.
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear.
x
Subjects who have experienced a Corneal Infiltrative Event (CIE).
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment).
x
Subject missed a study visit.
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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
9.1.
Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. 
A summary of disallowed systemic medications is shown in Table 6. Subjects with a history 
of taking these medications will be allowed to enroll only if:
x
The medications have been taken on a continual, routine basis for at least 6 months,
and
x
The subject has demonstrated successful contact lens wear during this time.
Or:
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x
The subject was taking the medication on a temporary basis and ceased taking that 
medication at least 2 weeks prior to signing the informed consent (this is considered 
sufficient time for the medication to have left the body prior to enrollment).
Subjects with a history of taking medications listed in Table 6 on a long-term, routine basis for 
less than 6 months will not be allowed to participate in the study.
Table 6: Disallowed systemic medications
Class of Drug
Common Indication(s)
Common Examples
Estrogens (not
including
contraceptive 
medication)
Menopause, osteoporosis, vaginitis
Vagifem, 
Estrace, 
Climara, 
Vivelle-Dot, Premarin, Minivelle, 
etc.
Anticholinergics
Irritable 
bowel 
syndrome, 
Parkinson’s disease, peptic ulcer, 
cystitis, nasal congestion, cold 
symptoms, 
overactive 
bladder, 
COPD
Bentyl, 
Spiriva, 
Atrovent, 
Hyosyne, Levsin, Symax Fastab, 
Symax SL, Homax SL, Cogentin, 
Transderm Scop, etc.
Beta-blockers
Hypertension, angina, heart attack, 
migraine, 
artrial 
fibrillation, 
andrenal cancer, essential tumor, 
glaucoma
Toprol XL, Lopressor, Tenormin, 
Propranolol, Timoptic, Trandate, 
Inderal LA, etc.
Psychotropics
Antipsychotic 
(schizophrenia, 
mania), 
antidepression, 
antiobsessive, antianxiety, mood 
stabilizer, stimulants (ADHD)
Zoloft, Celexa, Prozac, Lexapro, 
Effexor, 
Cymbalta, 
Ativan, 
Xanax, Desyrel, Wellbutrin, etc.
Vitamin A 
analogs
Cystic acne
Isotretinoin
Examples of disallowed systemic antihistamines are given in 
Table 7. Subjects with a history of taking systemic antihistamines will be allowed to enroll 
only if:
x
They have taken antihistamines continuously for at least 2 weeks, and 
x
They have demonstrated successful wear while taking the medication
Or:
x
They stopped taking the medication for at least 2 weeks prior to enrollment.
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Table 7: Disallowed systemic antihistamines
Class of Drug
Common Indication(s)
Common Examples
Antihistamines
Allergic rhinitis, sedation, hives, 
allergic conjunctivitis, skin allergy, 
itching, motion sickness
Hydroxyzine, 
Promethagan, 
Phenadoz, 
Vistaril, 
Claritin, 
Zyrtec, Astepro, Astelin, Optivar, 
Allegra, Benedryl, etc.
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations
that contradict the information contained in the Informed Consent/Assent forms will be
considered Major Deviations.
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. 
Protocol waivers are prohibited.
Table 8 lists examples of deviations that will constitute major and minor protocol deviations
for this study. 
Table 8: Examples of major and minor protocol deviations
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Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended 2 days or more 
than out of visit window 
defined in study procedures
Visit attended 1 day or fewer 
out of visit window defined 
in study procedures
Unanswered PRO questions
For questionnaires where 
data is related to a primary or 
secondary endpoint,
2 or 
more PRO questions are 
unanswered (i.e., left blank).
For questionnaires where 
data is related to a primary or 
secondary endpoint, 1 or 
fewer PRO questions are 
unanswered (i.e., left blank).
For questionnaires where 
data where data is not related 
to a primary or secondary 
endpoint, any PRO questions 
are unanswered (i.e., left 
blank).
Insufficient wear of study 
lenses 
Subject does not wear study 
lenses for at least 6 hours on 
at least 5 days of a study lens 
wear period.
NA
In the case of a major protocol deviation, the decision of whether or not the subject will be 
excluded from the Per-Protocol analysis population will be made at the time of cohort 
review.
11. STUDY TERMINATION 
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC Safety Management 
Team , the study may be terminated. This potential stopping rule is established based on our 
trial involving approximately 200 subjects wearing the investigational soft contact lens for up 
to 3 years with an assumed MK rate that is below 0.2% per patient-year. The rate of 0.2% per 
patient year is the established rate for extended wear lenses in adults, which was requested by 
the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA response to a 
pre-IDE submission. To be conservative, 200 independent patient years were used in the 
calculation. The probability of observing 2 cases or more incidents of MK is 0.061, and 3 cases 
or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient year). 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
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the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
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.  
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Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
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 
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.0
An AE includes any condition (including a pre-existing condition) that:
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1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
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:
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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
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.0
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.
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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:
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:
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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.
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.
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Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
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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:
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
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13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock.
All data summaries and statistical analyses will be performed using the SAS software Version
9.4 or higher (SAS Institute, Cary, NC).11 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the efficacy 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
14.2. Sample Size Justification 
This study is designed and powered to demonstrate non-inferiority of the Test lens compared 
to the Control lens with respect to the primary endpoints: slit lamp findings, fit acceptance, 
distance monocular logMAR VA, and CLUE overall quality of vision. Sample size was 
estimated to achieve a minimum statistical power of 80% for logMAR VA and CLUE vision 
with a 2-sided type I error of 0.05 each, and a minimum statistical power of 80% for slit lamp 
findings and lens fit acceptance with the 95% central posterior credible interval. For 
information purpose, power was estimated for the secondary endpoints using the sample size 
determined by the primary endpoints.
Sample size/power estimation was based on historical hard-lock data from 
 and 
 and the interim read data from 
. The same type of Test and Control lenses were 
investigated in 
 and 
 with a 2×2 crossover design. Test lenses in 
were made from the pilot line while Test lenses in 
 and the current study are produced 
from the manufacturing line. 
 is a 6×6 crossover study with 6 different types of lenses. 
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For sample size estimation, the logMAR VA data for the Theia lens and ACUVUE OASYS 1-
Day lens in 
 were used to make assumptions for the Test and Control lenses in the 
current study, respectively. Only the first period data from these studies were used in the 
sample size estimation. There were no grade 3 or higher slit lamp findings or unacceptable lens 
fit observed in 
. No unacceptable lens fit and only one Grade 3 slit lamp findings 
(conjunctival injection) for one subject eye with the Test lens at an unscheduled visit was 
observed in 
 interim data. Table 9 and Table 10 below present the descriptive statistics 
and adjusted means/proportions of logMAR VA, CLUE scores, and individual situational 
visual performance items for indoors and digital devices observed from these studies.Error! R
eference source not found.
Table 9: Descriptive Summary and Adjusted Means of LogMAR Visual Acuity and CLUE 
Scores from 
, 
 and 
 (Interim)
Study 
Endpoint
Timepoint
Test 
Mean(SD)
Control 
Mean(SD)
Test 
Adjusted 
Mean
Control 
Adjusted 
Mean
LogMAR
VA (High 
Contrast 
Dim)
1-Week 
FU
-0.01(0.046)
0.023(0.020) 
-0.02
0.03
(Interim)
CLUE 
Vision 
2-Week 
FU
71.3(20.36)
68.5(20.65)
73.6
69.1
CLUE 
Comfort 
2-Week 
FU
71.4(22.22)
67.1(23.18)
73.4
69.8
CLUE 
Handling
2-Week 
FU
70.3 (21.38)
69.5 (21.66)
68.9
70.7
SD = standard deviation, FU = follow-up
Table 10: Descriptive Summary and Adjusted Proportion Estimates for Two Situational 
Visual Performance Items at 2-week Follow-up from 
 and 
 (Interim)
Study 
Item
Lens 
Number of 
Subjects
Proportion of
“Excellent” 
Rating
Adjusted 
Proportion of
“Excellent” 
Rating
(Interim)
Clarity of 
vision 
indoors in 
bright light 
Test 
146
60%
63%
Control 
141
45%
47%
Study  
Item
Lens 
Prefer Habitual 
Lens
No Preference
Prefer Study Lens
Unadjusted
Adjusted
Unadjusted
Adjusted
Unadjusted
Adjusted
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Study 
Item
Lens 
Number of 
Subjects
Proportion of
“Excellent” 
Rating
Adjusted 
Proportion of
“Excellent” 
Rating
(Interim)
Overall 
preference 
while 
using 
computer 
screens & 
digital 
devices
Test 
24
(16%)
19
(13%)
54
(37%)
56
(38%)
69
(47%)
72
(49%)
Monocular Distance logMAR Visual Acuity
The sample size estimation for monocular distance logMAR visual acuity was calculated using 
a linear mixed model-based power analysis method.12 The model included lens as a fixed 
effect. An unstructured (UN) covariance matrix was used to model the residual errors between 
measurements within the same subject across eyes. It was assumed there was no difference 
between the Test and Control lenses since the two lenses have not been evaluated for logMAR 
VA performance in the same study previously. Sample size estimation was carried out using 
an approximation of the power of an F-test derived from the non-centrality parameter 
calculated from the observed F statistic of the linear mixed model. Below is the variance-
covariance matrix used in the sample size calculation based on historical data from
Period 1 for monocular logMAR visual acuity. 
The UN covariance matrix: ቂ0.002492
0.000689
0.000689
0.000736ቃ
CLUE Overall Quality of Vision
Sample size for CLUE overall quality of vision was calculated using a two independent sample 
t test in PROC Power assuming the Test lens is 2 points higher than the Control lens and a 
common standard deviation of 21. A non-inferiority margin of -5 points was used since this is 
considered to be no more than a 10% shift in the population distribution of CLUE scores.
Lens Fit Acceptance
Unacceptable lens fitting is a binary response as ܻ= 1 if a subject eye has an unacceptable 
fitting and ܻ= 0 otherwise. From the historical data there was no unacceptable lens fitting for 
both study lenses. Assuming no difference between study lenses and a correlation of 0.70
between left and right eyes within the same subject, a total of 2000 replicating trials were 
simulated with an unacceptable fitting rate of 5% (worse-case scenario). Given the rare event 
binary outcome of fit acceptance, each replicated sample was analyzed using a Bayesian beta-
binomial model with correlated binary data.13 Sample size was estimated to achieve a minimal 
statistical power of 80% with a non-inferiority margin of 10% (Test – Control) based on the 
simulated data. For each simulated trial, the lower bound of the 95% central posterior credible 
interval constructed for the percentage difference was compared to the 10% margin. With the 
proposed sample size, there was at least 80% of the estimated 95% credible intervals with 
upper bound being below 10%. 
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Biomicroscopy (Slit Lamp Findings)
Slit lamp findings (SLF) are converted to a binary response as ܻ= 1 if a subject eye has a
clinically significant SLF and ܻ= 0 otherwise for analysis purpose. From the historical data 
there was no or extremely low rate for clinically significant SLF for the study lenses. Assuming 
no difference between study lenses and a correlation of 0.70 between left and right eyes within 
the same subject, a total of 2000 replicating trials were simulated with clinically significant 
SLF rate of 2% (worse-case scenario). Given the rare event binary outcome of slit lamp 
findings, each replicated sample was analyzed using a Bayesian beta-binomial model with 
correlated binary data (Diniza et al; 2010). Sample size was estimated to achieve a minimal 
statistical power of 80% with a non-inferiority margin of 5% (Test – Control) based on the 
simulated data. For each simulated trial, the lower bound of the 95% central posterior credible 
interval constructed for the percentage difference was compared to the 5% margin. With the 
proposed sample size, there was at least 80% of the estimated 95% credible intervals with 
upper bound being below 5%. 
CLUE Overall Comfort 
Power for CLUE overall comfort was estimated using a two independent sample t test in PROC 
Power assuming the Test lens is 2 points higher than the Control lens and a common standard 
deviation of 23. A non-inferiority margin of -5 points was used since this is considered to be 
no more than a 10% shift in the population distribution of CLUE scores.
CLUE Overall Handling
Power for CLUE overall handling was estimated using PROC Power for a two independent 
sample t test assuming the Test lens is 2 points lower than the Control lens and a common 
standard deviation of 21. A non-inferiority margin of -5 points was used since this is considered 
to be no more than a 10% shift in the population distribution of CLUE scores.
Clarity of Vision Indoors in Bright Light
Clarity of vision indoors in bright light will be evaluated at 2-week follow-up using a 5-point 
Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) with a “Not Applicable” 
response option. Responses to clarity of vision indoors in bright light will be converted into a 
binary variable for the purpose of analysis (Excellent = 1 and others = 0) and “Not Applicable” 
will not be included in the analysis. Based on historical data from 
 and 
(Interim), it was assumed the percentage of subjects with an “Excellent” rating was 60% and 
50% for the Test and Control lenses, respectively. Power was calculated using PROC POWER 
for Pearson chi-square test for two proportions. The non-inferiority odds ratio margin of 0.67 
was used, which corresponds to no more than a 10% difference between the Test and Control 
lenses.
Overall Preference While Using Computer Screens & Digital Devices
Responses to overall preference while using computer screens & digital devices in the Test 
lens group will be collapsed into three categories for the purpose of analysis (Prefer Test Lens, 
No Preference, and Prefer Habitual Lens). Based on historical data from 
 and 
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(Interim) for period 1, it was assumed that the percentage of subjects preferring Test lens 
was 0.4, the percentage of subjects preferring Habitual lens was 0.2, and the percentage of 
subjects with no preference was 0.4. A total of 2000 replicating trials were simulated. To 
estimate statistical power, the simulated multinomial data were analyzed using a generalized 
linear regression model with a generalized logit link function and tested for statistical 
superiority (preference ratio of preferring Test to Habitual). 
Table 11 below summarizes the required number of completed subjects to achieve a minimum 
of 80% statistical power for the primary endpoints. Table 12 shows the statistical power for 
the secondary endpoints based on the sample size determined by the primary endpoints. 
Table 11: Sample Size Estimation for the Primary Endpoints
Endpoint
Hypothesis 
Testing
Sample Size
Power
Monocular Distance LogMAR VA
Non-inferiority
16
84%
CLUE Vision
Non-inferiority
286
80%
Lens Fit Acceptance 
Non-inferiority
140
83%
Slit Lamp Findings
Non-inferiority
240
83%
Table 12: Power Estimation for the Secondary Endpoints
Endpoint
Hypothesis 
Testing
Sample Size
Power
CLUE Comfort
Non-inferiority
286
73%
CLUE Handling
Non-inferiority
286
23%
Situational Visual Performance –
Indoor (Clarity of Vision Indoors in 
Bright Light)
Non-inferiority
286
93%
Situational Visual Performance –
Digital Devices (Overall Preference 
While Using Computer Screens & 
Digital Devices)
Superiority
143 for Test 
Lens Group
88%
As indicated in Table 11 above, the sample size chosen for this study was primarily driven by 
the primary endpoint of CLUE overall quality of vision in order to achieve a statistical power 
of at least 80% for all primary endpoints. The plan is to enroll approximately 320 eligible 
subjects with a target of 286 to complete the study (143 per arm).
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.
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Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analyses  
Primary Efficacy Analyses:
Primary efficacy analyses will be conducted on the Per-Protocol (PP) population. Sensitivity 
analysis may be considered on the Intent-to-Treat (ITT) population with no missing data 
imputation.
CLUE Overall Quality of Vision
CLUE vision scores will be analyzed using a linear mixed model to compare the Test and 
Control lenses at the 2-week follow-up evaluation. The model will include baseline CLUE 
vision score and lens type as fixed effects and clinical site as a random effect (G-side). Other 
subject characteristics such as age, gender, iris category (dark iris and light iris), and habitual
lens type (habitual daily disposable and habitual daily wear reusable) will be included when 
appropriate. The Kenward and Roger method will be used for the denominator degree of 
freedom.14
Hypothesis Testing
The null and alternative hypotheses for testing non-inferiority of the Test lens relative to the 
Control lens with respect to CLUE vision scores are as follows: 
ܪ଴: ߤ்− ߤ஼≤−5
ܪ஺: ߤ்− ߤ஼ > −5
Where, ߤ்represents the mean CLUE vision score for the Test lens and ߤ௖represents the mean 
CLUE vision score for the Control lens. Non-inferiority will be declared if the lower bound of 
the 2-sided 95% confidence interval of the difference (Test – Control) is greater than -5. If
non-inferiority of the Test lens over Control lens is met, then superiority will be assessed. If 
the lower bound is greater than 0, then superiority of the Test lens over the Control lens will 
be established.
Monocular Distance logMAR Visual Acuity
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Monocular distance logMAR VA under bright HLHC will be analyzed using a linear mixed 
model. The model will include lens type as a fixed effect. Other subject characteristics such as 
age, gender, iris category, and habitual lens type will be included when appropriate. Site will 
be included in the model as a random effect (G-side). The covariance of residuals between 
measurements within the same subject across eyes (R-side random effect) will be modeled 
using Unstructured (UN) covariance structure. If the model does not converge, then compound 
Symmetry (CS) covariance structure will be considered. The Kenward and Roger method will 
be used for the denominator degree of freedom.14
Hypothesis Testing
The null and alternative hypotheses for testing non-inferiority of the Test lens relative to the 
Control lens with respect to logMAR visual acuity are as follows: 
ܪ଴: ߤ்− ߤ஼≥0.05
ܪ஺: ߤ்− ߤ஼ < 0.05
Where, ߤ்represents the mean logMAR VA score for the Test lens and ߤ௖represents the mean 
logMAR VA score for the Control lens. Non-inferiority will be declared if the upper bound of 
the 2-sided 95% confidence interval of the difference (Test – Control) is less than 0.05. If non-
inferiority of the Test lens over Control lens is met, then superiority will be assessed. If the 
upper bound is less than 0, then superiority of the Test lens over the Control lens will be 
established.
Primary Safety Analyses:
Primary safety analysis will be conducted on the safety population based on treatments actually 
received by subjects.
Lens Fit Acceptance
Lens fit acceptance will be analyzed using a Bayesian beta-binomial model with correlated 
binary data.13
The Model:
Let ܻଵand ܻଶdenote the binary outcomes of lens fit acceptance (Yes/No) in left and right eyes, 
respectively, across dispensing and follow-up visits when wearing a study lens. Considering 
the correlation, ߩ, between ܻଵand ܻଶ, the distribution of the sum ܻ = ܻଵ + ܻଶis obtained by 
the mixture of two variables. One of them follow a binomial distribution ܤ݅݊(2, ݌) with mixing 
probability (1 − ߩ) and the other one follows a modified Bernoulli distribution, ܯܤ݁ݎ݊(݌),
taking value 0 and 2 rather than conventional 0 and 1, with mixing probability ߩ:
ܲ(ܻ =  ݕ| ݌, ߩ) = (1 − ߩ)ܤ݅݊(2, ݌)ܫ஺ଵ +   ߩܯܤ݁ݎ݊(݌)ܫ஺ଶ ,
where ܫ஺ଵ = {0, 1, 2}, ܫ஺ଶ= {0, 2} and ݌is the probability of success (i.e., acceptable lens 
fitting).
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To overcome the complexity of the mixture likelihood a latent variable ܼ௜, i = 1, 2 is introduced 
in the model to indicate in which component of the model the observation ݕ௜, i=1, 2, belongs 
to, that is,
ܼ௜= ൜1, if the observation belong to the MBern(p),
0, if the observation belong to the Bin(2, p)  
The joint distribution of the augmented data (ܻ௜, ܼ௜), ݅= 1, 2, is given by
P(Y = y୧, Z = z୧| p, ρ)
=  ρ୸౟p୷౟୸౟/ଶ(1 −p)(ଶି୷౟)୸౟/ଶ(1 −ρ)ଵି୸౟൬2
y୧൰p୷౟(ଵି୸౟)(1 −p)(ଶି୷౟)(ଵି୸౟)
The probability p links to the regression variables through a logit transformation as follow:
logit (p) =  β଴+ βଵlens
It is assumed that β଴, βଵ and ߩto be independent with a non-informative prior N(0, 1000) for
β଴ and βଵ, and beta(0.5, 0.5) for ߩ. The Metropolis sampler algorithm as implemented in the 
SAS/STAT MCMC Procedure11 will be used to estimate the posterior distributions of the 
parameters (β଴, βଵ, ߩ). Inferences will be made based on a posterior credible interval for the 
relevant parameters.
Bayesian Estimation and Statistical Evaluation of Hypothesis:
Non-inferiority of the Test lens relative to the Control lens with respect to lens fit acceptance 
will be evaluated using Bayesian statistics. The null and alternative hypotheses for evaluating 
non-inferiority of the Test lens relative to the Control lens with respect to les fit acceptance are 
as follows: 
ܪ଴: ݌୘− ݌େ≥0.1
ܪ஺: ݌୘− ݌େ< 0.1,
where ݌୘and ݌େare the probability of event (i.e., unacceptable lens fitting) for Test lens and 
Control lens, respectively. Based on Bayesian posterior probability distribution of the 
proportion difference (݌்− ݌஼), non-inferiority is interpreted as 95% probability of Test 
being no worse than Control by 10% (i.e., ݌୘− ݌େ< 0.1) with respect to unacceptable lens 
fitting rate. If the upper bound of the 95% central posterior credible interval is below 0.1, it 
can be concluded that there is 95% probability that the Test lens is non-inferior to the Control 
lens based on the observed sample. 
In the case of all eyes have an acceptable lens fit (i.e., zero unacceptable lens fit), a Bayesian 
hierarchical model accounting for zero event problem will be considered.15 Details of this 
model will be provided in the stand-along SAP.
Biomicroscopy (Slit Lamp Findings) 
Biomicroscopy will be analyzed using the same Bayesian beta-binomial model as described 
for lens fit acceptance. The proportion of eyes with clinically significant slit lamp findings (i.e., 
Grade 3 or higher, or significant corneal infiltrates) across study visits will be modeled.
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Bayesian Estimation and Statistical Evaluation of Hypothesis:
Non-inferiority of the Test lens relative to the Control lens with respect to slit lamp findings
will be evaluated using Bayesian statistics. The null and alternative hypotheses for evaluating 
non-inferiority of the Test lens relative to the Control lens are as follows: 
ܪ଴: ݌୘− ݌େ≥0.05
ܪ஺: ݌୘− ݌େ< 0.05,
where ݌୘and ݌େare the probability of clinically significant slit lamp findings across study 
visits for Test and Control, respectively. Based on Bayesian posterior probability distribution 
of the proportion difference (݌்− ݌஼), non-inferiority is interpreted as 95% probability of 
Test being no worse than Control by 5% (i.e., ݌୘− ݌େ< 0.05). If the upper bound of the 95% 
central posterior credible interval is below 0.05, it can be concluded that there is 95% 
probability that the Test lens is non-inferior to the Control lens based on the observed sample. 
In the case of zero clinically significant SLF, a Bayesian hierarchical model accounting for
zero event problem will be considered.15
14.6. Secondary Analyses  
Secondary Efficacy Analyses:
Secondary efficacy analyses will be conducted on the Per-Protocol (PP) population.
CLUE Overall Comfort and Overall Handling
CLUE overall comfort and handling will be analyzed using the same statistical method 
described for CLUE overall quality of vision. 
Situational Visual Performance – Indoors
Situation visual performance – indoors will be assessed using the individual item “Clarity of 
vision indoors in bright light” (
). Item responses will be converted into a binary 
variable for the purpose of analysis (Excellent = 1 and others = 0) and “Not applicable” 
response will not be considered in the analysis. The dichotomized item responses will be 
analyzed using a generalized linear mixed model with a binomial distribution and the logit as 
the link function. The model will include lens type as a fixed effect and site as a (G-side) 
random effect. Other subject characteristics such as age, gender, iris category, habitual lens 
type will be included when appropriate.
Hypothesis Testing
The null and alternative hypotheses for testing non-inferiority of the Test lens relative to the 
Control lens with respect to clarity of vision indoors at bright light are as follows: 
ܪ଴: ܱܴ≤0.67
ܪ஺: ܱܴ> 0.67
Where OR represents the odds ratio of having “Excellent” rating for the Test lens compared to 
the Control at the 2-week follow-up. Non-inferiority will be declared if the lower bound of the 
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2-sided 95% confidence interval is above 0.67. If non-inferiority of the Test lens over Control 
lens is met, then superiority will be assessed. If the lower bound is above 1.0, then superiority 
of the Test lens over the Control lens can be concluded.
Situational Visual Performance – Digital Devices
Situation visual performance – digital devices will be assessed using the preference item 
“Overall preference while using computer screens & digital devices”
among the 
Test lens group. Item responses will be collapsed into three categories for the purpose of 
analysis (Prefer Test Lens, No Preference, and Prefer Habitual Lens). The collapsed item 
responses will be analyzed using a generalized linear mixed model with a multinomial 
distribution and the generalized logit as the link function. The analysis model will include site 
as a random effect (G-sided), and gender, habitual lens type, and iris category will be included 
as fixed covariates when appropriate.
Hypothesis Testing
The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens are as follows: 
ܪ଴: ܴܲ≤1.0
ܪ஺: ܴܲ> 1.0
Where PR represents the preference ratio of Test lens to Habitual lens (proportion of subjects 
preferring Test to proportion of subjects preferring Habitual lens) at the 2-week follow-up.
Superiority will be declared if the lower bound of the 2-sided 95% confidence interval is above 
1.0.
14.7. Other Exploratory Analysis  
Not applicable
14.8. Interim Analysis  
Not applicable
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data on the primary efficacy analyses, sensitivity 
analysis may be conducted on the ITT population using multiple imputation methods if the 
proportion of subject dropout is greater than the 15%. The SAS/STAT procedures PROC MI 
and PROC MIANALYZE will be utilized with a parametric regression method used to make 
at least 20 imputations.
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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 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2020.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
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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.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
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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.
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.
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18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
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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 Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
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compliance with the Health Information Portability and Accountability Act (HIPAA) and other
applicable personal data protection and security laws and regulations.16,17 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.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
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19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
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.
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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.
Gallas J, Eisner M. Eye protection from sunlight damage. In. Comprehensive Series 
in Photosciences: Elsevier; 2001:437-455.
6.
Kim H, Kim H-S, Jung C-H, Yoon I. Monitor Calibration Approach to Reducing 
HighEnergy Visible Light from White Light-Emitting Diode. 2015/04/15, 2015.
7.
Rai V, Dayan N, Michniak-Kohn B. A comparative evaluation of photo-toxic effect 
of fractionated melanin and chlorpromazine hydrochloride on human (dermal 
fibroblasts and epidermal keratinocytes) and mouse cell line/s (fibroblast Balb/c 3T3). 
Toxicology in Vitro. 2011;25(2):538-544.
8.
Smick K, et al. Blue light hazard: New knowledge, new approaches to maintaining 
ocular health.: Report of a roundtable sponsored by Essilor of America;2013.
9.
Panda S. Illumination of the Melanopsin Signaling Pathway. Science. 
2005;307(5709):600-604.
10.
Wirth RJ, Edwards MC, Henderson M, Henderson T, Olivares G, Houts CR. 
Development of the Contact Lens User Experience: CLUE Scales. Optometry and 
vision science : official publication of the American Academy of Optometry. 
2016;93(8):801-808.
11.
SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute 
Inc.
12.
Stroup W, ed Mixed model procedures to assess power, precision, and sample size in 
the design of experiments. Baltimore, MD: Proc Biopharmaceutical Section Am Stat 
Assoc; 1999.
13.
Diniz CAR, Tutia MH, Leite JG. Bayesian analysis of a correlated binomial model. 
Brazilian Journal of Probability and Statistics. 2010;24(1).
14.
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53(3):983.
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15.
Chen Z, McGee M. A Bayesian Approach to Zero-Numerator Problems Using 
Hierarchical Models. Journal of Data Science. 2021;6(2):261-268.
16.
Health Information Portability and Accountability Act (HIPAA). Available at 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
17.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at http://data.europa.eu/eli/reg/2017/745/2017-
05-05
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-Day ACUVUE OASYS® with HydraLuxe™
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IMPORTANT:  Please read carefully and keep this 
information for future use.
This Package Insert and Fitting Guide is intended for the 
Eye Care Professional, but should be made available to 
patients upon request. 
The Eye Care Professional should provide the patient 
with the appropriate instructions that pertain to the 
patient’s prescribed lenses. Copies are available for 
download at www.acuvue.com.
senoﬁ lcon A Soft (hydrophilic) Contact Lenses
Visibility Tinted with UV Blocker
for Daily Disposable Wear
CAUTION: U.S. Federal law restricts this device to 
sale by or on the order of a licensed practitioner.
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology
ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxeTM Technology for ASTIGMATISM
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VCT-0007 (13)
 
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SYMBOLS KEY
The following symbols may appear on the label or carton:
Date of Manufacture
Manufactured by or in
Consult Instructions for Use
CAUTION: U.S. Federal law restricts this device 
to sale by or on the order of a licensed practitioner
Use By Date (expiration date)
Diameter
DIA
Base Curve
BC
Diopter (lens power)
D
Batch Code
LOT
Sterile Using Steam or Dry Heat
STERILE
UV-Blocking
Fee Paid for Waste Management
Quality System Certification Symbol
123
Lens Orientation Correct
123
Lens Orientation Incorrect (Lens Inside Out)
 
CYL
AXIS
Cylinder
Axis
Single-Use
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
-0.25D to -10.00D
• Axis Range:
.5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®  
1-Day with 
HydraLuxe™ 
Technology 
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area. The patient should continue to use UV absorbing 
eyewear as directed.
ACTIONS
In its hydrated state, the contact lens, when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina.
The transmittance characteristics for these lenses are less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire 
nge.
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) 
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NOTE:  Long-term exposure to UV radiation is one of the risk 
factors associated with cataracts.  Exposure is based on a number 
of factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of outdoor 
activities).  UV-Blocking contact lenses help provide protection 
against harmful UV radiation. However, clinical studies have not 
been done to demonstrate that wearing UV-Blocking contact 
lenses reduces the risk of developing cataracts or other eye 
disorders. The Eye Care Professional should be consulted for more 
information.
INDICATIONS (USES)
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism.
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ Tech-
nology for ASTIGMATISM are indicated for daily disposable wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism.
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these contact lenses when any of the following 
conditions exist:
• Acute or subacute inﬂ ammation or infection of the anterior chamber 
of the eye.
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids.
• Severe insufﬁ ciency of lacrimal secretion (dry eye).
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• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious adverse reactions is increased when lenses are 
worn overnight, and that t
 ulcerative keratitis is greater for 
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extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products.
• The overall risk of ulcerative keratitis may be reduced by carefully 
following directions for lens care.
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783
Speciﬁ c Instructions for Use and Warnings:
• Water Activity
Instructions for Use
Do not expose contact lenses to water while wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, 
vision loss or blindness. If lenses have been submersed in water 
when participating in water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient should be instructed to discard them 
and replace them with a new pair. The Eye Care Professional should 
be consulted for recommendations regarding wearing lenses during 
any activity involving water.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investiga-
tion of lenses, all refractive powers, design conﬁ gurations, or lens 
parameters available in the lens material are not evaluated in signif-
icant numbers. Consequently, when selecting an appropriate lens 
design and parameters, the Eye Care Professional should consider 
all characteristics of the lens that can affect lens performance and 
ocular health, including oxygen permeability, wettability, central and 
peripheral thickness, and optic zone diameter.
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• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handlin
on, removal, and wearing 
instructions in the “Patient 
n Guide” for the prescribed 
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wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
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Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potentia
e temporary impairment due to 
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peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
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GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be selected for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses.  
1. Criteria of a Properly Fit Lens 
A properly ﬁ t lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufﬁ cient movement to provide tear exchange 
under the contact lens with the blink, and be comfortable. The lens 
should move freely when manipulated digitally with the lower lid, and 
then return to its properly centered position when released.
2. Criteria of a Flat Fitting Lens 
A ﬂ at ﬁ tting lens may exhibit one or more of the following characteris-
tics: decentration, incomplete corneal coverage (i.e., limbal exposure), 
excessive movement with the blink, and/or edge standoff. If the lens is 
judged to be ﬂ at ﬁ tting, it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens 
A steep ﬁ tting lens may exhibit one or more of the following charac-
teristics: insufﬁ cient movement with the blink, conjunctival indentation, 
and resistance when pushing the lens up digitally with the lower lid. 
If the lens is judged to be steep ﬁ tting, it should not be dispensed to 
the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t and evaluated after the patient 
has adjusted to the lens. The lens should move freely when manipulated 
digitally with the lower lid, and then return to a properly centered position 
when released. If resistance is encountered when pushing the lens up, the 
lens is ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should e
e good visual acuity with the 
correct lens power unless there is
ve residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll 
ﬁ nd two primary marks approximately 1 mm from the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, 
either mark can represent the vertical position – there is no “top” 
and “bottom” as in a prism-ballasted lens. You don’t need to view 
both marks to assess orientation; simply look for the 6 o’clock 
mark as you would with a prism-ballasted lens.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
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B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately 
corrected distance and near visual acuity in each eye. The 
amblyopic patient or the patient with signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateral 
uld require corrective lenses on 
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s performance under the above conditions 
is completed, tests of vis
and reading ability under 
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conditions of moderately dim illumination should be attempted.
An initial unfavorable response in the ofﬁ ce, while indicative of 
a guarded prognosis, should not immediately rule out a more 
extensive trial under the usual conditions in which a patient 
functions.
4. Adaptation
Visually demanding situations should be avoided during the 
initial wearing period. A patient may at ﬁ rst experience some 
mild blurred vision, dizziness, headaches, and a feeling of slight 
imbalance. You should explain the adaptational symptoms to 
the patient. These symptoms may last for a brief minute or for 
several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation.
To help in the adaptation process, the patient can be advised to 
ﬁ rst use the lenses in a comfortable familiar environment such as 
in the home.
Some patients feel that automobile driving performance may not 
be optimal during the adaptation process. This is particularly true 
when driving at night. Before driving a motor vehicle, it may be 
recommended that the patient be a passenger ﬁ rst to make sure 
that their vision is satisfactory for operating an automobile. During 
the ﬁ rst several weeks of wear (when adaptation is occurring), it 
may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the 
patient should be able to drive under other conditions with caution.
D. Other Suggestions
The success of the monovision technique may be further improved by 
having the patient follow the suggestions below:
• Have a third contact lens (distance power) to use when critical 
distance viewing is needed.
• Have a third contact lens (near power) to use when critical near 
viewing is needed.
• Having supplemental spectacles to wear over the monovision 
contact lenses for speciﬁ c visual tasks may improve the success 
of monovision correction. This is particularly applicable for those 
patients who cannot meet state driver's licensing requirements 
with monovision correction.
• Make use of proper illu
 when carrying out visual tasks.
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Monovision ﬁ tting success can be improved by the following 
suggestions:
• Reverse the distance and near eyes if a patient is having trouble 
adapting.
• Reﬁ ne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients.
• Emphasize the beneﬁ ts of clear near vision and straight ahead 
and upward gaze with monovision.
The decision to ﬁ t a patient with monovision correction is most 
appropriately left to the Eye Care Professional in conjunction with the 
patient after carefully considering the patient’s needs.
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
PATIENT MANAGEMENT
Dispensing Visit
Each sterile lens is supplied in a foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
from the container, peel back the foil seal, place a ﬁ nger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of 
the container.
• Evaluate the physical ﬁ t and visual acuity of the lens on each eye.
• Teach the patient how to apply and remove his or her lenses.
• Explain daily disposable lens wear and schedule a follow-up 
examination.
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com.
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES.
Follow-Up Examinations
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of speciﬁ c problems, if any, and a 
ith the patient of the wear 
schedule, daily disposable modalit
oper lens handling procedures. 
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Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
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VCT-0007 (13) 
 
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the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
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The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day for ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, lot 
 and expiration date
CR-6470, v 2.0
) 
 
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
©Johnson & Johnson Vision Care Companies 2016
In Canada: Johnson & Johnson Vision Care, division of Johnson & Johnson, Inc. 
In USA: Johnson & Johnson Vision Care, Inc.
Printed in USA.
Revision date: 09/16
Revision number: AO-03-16-13
ACUVUE OASYS® and HydraLuxe™ are Trademarks of 
the Johnson & Joh
n Care Companies
20401080
CR-6470, v 2.0
-
 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX D: 
 
 
Limbal & Conjunctival (Bulbar) Redness
Expanded Sodium Fluorescein Corneal Staining
 Lens Fitting Characteristics
 Subject Reported Ocular Symptoms/Problems
Front and Back Surface Lens Deposit Grading Procedure
 Determination of Distance Spherocylindrical Refractive Error 
 Biomicroscopy Scale
Keratometry Procedure
 Distance and Near Snellen Visual Acuity Evaluation
Distance LogMAR Visual Acuity Measurement Procedure
 Patient Reported Outcomes 
White Light Lens Surface Wettability
Visual Acuity Chart Luminance and Room Illumination Testing
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
CR-6470, v 2.0
 
 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
  
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
CR-6470, v 2.0
 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
  
          
 
 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
 
 
 
 
 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 1 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 2 of 5
        
       
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 3 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 4 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:  
Revision Number:  5
Page 5 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS  
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Title:                         Subject Reported Ocular Symptoms/Problems
Document Type:  
Document Number:  
Revision Number:  3
Page 1 of 1
  
  
            
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE  
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 3 of 4
  
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Title:                        Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR  
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Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 1 of 5
       
  
       
       
       
        
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Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 2 of 5
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Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 3 of 5
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Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 4 of 5
       
       
       
       
       
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Title:                       Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5
Page 5 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE  
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Title:    
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  9 
Page 1 of 5
 
 
  
 
 
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Title:    
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  9 
Page 2 of 5
   
  
  
 
 
 
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Page 150 of 192
JJVC CONFIDENTIAL

Title:    
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  9 
Page 3 of 5
 
 
   
CR-6470, v 2.0
 
 
Page 151 of 192
JJVC CONFIDENTIAL

Title:    
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  9 
Page 4 of 5
  
 
 
 
                 
CR-6470, v 2.0
 
 
Page 152 of 192
JJVC CONFIDENTIAL

Title:    
 
Biomicroscopy Scale
Document Type:
Document Number:
 
 
 
 
 
 
Revision Number:  9 
Page 5 of 5
   
  
 
 
 
 
 
 
  
  
 
 
 
CR-6470, v 2.0
 
 
Page 153 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 KERATOMETRY PROCEDURE  
CR-6470, v 2.0
 
 
Page 154 of 192
JJVC CONFIDENTIAL

Page 1 of 1 
Keratometry Procedure
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
CR-6470, v 2.0
 
 
Page 155 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION  
CR-6470, v 2.0
 
 
Page 156 of 192
JJVC CONFIDENTIAL

Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 1 of 4
  
CR-6470, v 2.0
 
 
Page 157 of 192
JJVC CONFIDENTIAL

Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 2 of 4
CR-6470, v 2.0
 
 
Page 158 of 192
JJVC CONFIDENTIAL

Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 3 of 4
CR-6470, v 2.0
 
 
Page 159 of 192
JJVC CONFIDENTIAL

Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:  
Revision Number:  4
Page 4 of 4
CR-6470, v 2.0
 
 
Page 160 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE  
CR-6470, v 2.0
 
 
Page 161 of 192
JJVC CONFIDENTIAL

Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 1 of 3 
 
  
CR-6470, v 2.0
 
 
Page 162 of 192
JJVC CONFIDENTIAL

Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 2 of 3 
 
 
CR-6470, v 2.0
 
 
Page 163 of 192
JJVC CONFIDENTIAL

Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 3 of 3 
 
 
CR-6470, v 2.0
 
 
Page 164 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PATIENT REPORTED OUTCOMES  
CR-6470, v 2.0
 
 
Page 165 of 192
JJVC CONFIDENTIAL

Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
2
Page 1 of 1
  
                       
CR-6470, v 2.0
 
 
Page 166 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 WHITE LIGHT LENS SURFACE WETTABILITY  
CR-6470, v 2.0
 
 
Page 167 of 192
JJVC CONFIDENTIAL

 
Page 1 of 1 
 
 White Light Lens Surface Wettability   
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 
  
 
   
 
 
 
  
 
 
  
  
  
 
 
  
 
 
 
 
 
     
 
 
CR-6470, v 2.0
 
 
Page 168 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING  
CR-6470, v 2.0
 
 
Page 169 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 170 of 192
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 171 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 172 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 173 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 174 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 175 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 176 of 192
JJVC CONFIDENTIAL

Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
Document Number:
Revision Number:  4 
CR-6470, v 2.0
 
 
Page 177 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
 
CR-6470, v 2.0
 
 
Page 178 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: STARTING LENS POWER GUIDANCE 
CR-6470, v 2.0
 
 
Page 179 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
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Page 180 of 192
JJVC CONFIDENTIAL

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Page 182 of 192
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Page 191 of 192
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6470 Validation of senofilcon A with new UV / HEV Filter
Version and Date: 2.0 14 September 2021
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-6470, v 2.0
 
 
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JJVC CONFIDENTIAL