Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
Evaluation of Multifocal Contact Lens Designs with and without an HEV-Blocker on Visual 
Function  
 
Protocol CR-6391 
 
Version: 4.0 
                            
Date: 12 January 2022 
 
 
Investigational Products: JJV Investigational Multifocal Contact Lens with and without HEV-
Blocker 
Control: ACUVUE® OASYS Multifocal Contact Lens 
 
Keywords: JJV Investigational Multifocal, ACUVUE® OASYS Multifocal Contact Lens, 
HEV Blocker, Presbyopia, Randomized, senofilcon A (C3), senofilcon A, Daily Wear 
 
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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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6
SPONSOR NAME AND ADDRESS ....................................................................................... 6
MEDICAL MONITOR ............................................................................................................. 6
AUTHORIZED SIGNATURES ............................................................................................... 7
CHANGE HISTORY................................................................................................................ 9
SYNOPSIS .............................................................................................................................. 10
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 16
1.
INTRODUCTION AND BACKGROUND ................................................................... 18
1.1.
Name and Descriptions of Investigational Products............................................. 18
1.2.
Intended Use of Investigational Products ............................................................. 18
1.3.
Summary of Findings from Nonclinical Studies .................................................. 18
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...................................................................................................................... 19
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 20
2.1.
Objectives ............................................................................................................. 20
2.2.
Endpoints .............................................................................................................. 20
2.3.
Hypotheses............................................................................................................ 21
3.
TARGETED STUDY POPULATION ........................................................................... 22
3.1.
General Characteristics ......................................................................................... 22
3.2.
Inclusion Criteria .................................................................................................. 22
3.3.
Exclusion Criteria ................................................................................................. 23
3.4.
Enrollment Strategy .............................................................................................. 24
4.
STUDY DESIGN AND RATIONALE .......................................................................... 24
4.1.
Description of Study Design................................................................................. 24
4.2.
Study Design Rationale ........................................................................................ 25
4.3.
Enrollment Target and Study Duration ................................................................ 25
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 25
5.1.
Test Article Allocation ......................................................................................... 25
5.2.
Masking ................................................................................................................ 26
5.3.
Procedures for Maintaining and Breaking the Masking ....................................... 26
6.
STUDY INTERVENTION ............................................................................................. 27
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
6.1.
Identity of Test Articles ........................................................................................ 27
6.2.
Ancillary Supplies/Products ................................................................................. 28
6.3.
Administration of Test Articles ............................................................................ 28
6.4.
Packaging and Labeling ........................................................................................ 28
6.5.
Storage Conditions ............................................................................................... 28
6.6.
Collection and Storage of Samples ....................................................................... 29
6.7.
Accountability of Test Articles ............................................................................. 29
7.
STUDY EVALUATIONS .............................................................................................. 30
7.1.
Time and Event Schedule ..................................................................................... 30
7.2.
Detailed Study Procedures .................................................................................... 31
VISIT 1 ........................................................................................................................... 31
VISIT 2 ........................................................................................................................... 36
FINAL EVALUATION .................................................................................................. 39
7.3.
Unscheduled Visits ............................................................................................... 40
7.4.
Laboratory Procedures .......................................................................................... 41
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 42
8.1.
Completion Criteria .............................................................................................. 42
8.2.
Withdrawal/Discontinuation from the Study ........................................................ 42
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 43
9.1.
Systemic Medications ........................................................................................... 43
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 .................................................................................... 49
13.2.1.
Causality Assessment .................................................................................... 49
13.2.2.
Severity Assessment ...................................................................................... 50
13.3.
Documentation and Follow-Up of Adverse Events .............................................. 50
13.4.
Reporting Adverse Events .................................................................................... 51
13.4.1.
Reporting Adverse Events to Sponsor .......................................................... 52
13.4.2.
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
52
13.5.
Event of Special Interest ....................................................................................... 53
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
13.6.
Reporting of Pregnancy ........................................................................................ 53
14.
STATISTICAL METHODS ........................................................................................ 53
14.1.
General Considerations ......................................................................................... 53
14.2.
Sample Size Justification ...................................................................................... 54
14.3.
Analysis Populations ............................................................................................ 54
14.4.
Level of Statistical Significance ........................................................................... 55
14.5.
Primary Analysis .................................................................................................. 55
14.6.
Secondary Analysis .............................................................................................. 57
14.7.
Other Exploratory Analysis .................................................................................. 59
14.8.
Interim Analysis ................................................................................................... 60
14.9.
Procedure for Handling Missing Data and Drop-Outs ......................................... 60
14.10.
Procedure for Reporting Deviations from Statistical Plan ................................... 60
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 60
15.1.
Electronic Case Report Form/Data Collection ..................................................... 60
15.2.
Subject Record ...................................................................................................... 61
15.3.
Trial Registration on ClinicalTrials.gov ............................................................... 61
16.
DATA MANAGEMENT............................................................................................. 62
16.1.
Access to Source Data/Document ........................................................................ 62
16.2.
Confidentiality of Information.............................................................................. 62
16.3.
Data Quality Assurance ........................................................................................ 62
16.4.
Data Monitoring Committee (DMC) .................................................................... 62
17.
CLINICAL MONITORING ........................................................................................ 63
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 63
18.1.
Study-Specific Design Considerations ................................................................. 63
18.2.
Investigator Responsibility ................................................................................... 63
18.3.
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 63
18.4.
Informed Consent ................................................................................................. 65
18.5.
Privacy of Personal Data ...................................................................................... 65
19.
STUDY RECORD RETENTION................................................................................ 66
20.
FINANCIAL CONSIDERATIONS ............................................................................ 67
21.
PUBLICATION ........................................................................................................... 67
22.
REFERENCES ............................................................................................................ 67
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 69
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 70
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 71
APPENDIX D: 
 .................................... 100
 DETERMINATION OF NEAR ADDITION .................................................... 101
 LENS FITTING CHARACTERISTICS ............................................................ 107
 SUBJECT REPORTED OCULAR SYMPTOMS ............................................. 113
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTION
............................................................................................................................................... 115
 BIOMICROSCOPY SCALE ............................................................................. 121
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ..... 127
APPENDIX E:  OCULAR DOMINANCE .......................................................................... 132
APPENDIX F:  IRIS COLOR SCALE ................................................................................. 133
APPENDIX G:  TEST AND CONTROL LENS FITTING GUIDE .................................... 135
APPENDIX H:  PSYCHOPHYSICAL TESTING ............................................................... 136
APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION ................................ 142
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 154
 
LIST OF TABLES 
Table 1:  Detailed Randomization Plan for all Study Visits ................................................... 25
Table 2: Test Articles .............................................................................................................. 27
Table 3: Ancillary Supplies .................................................................................................... 28
Table 4: Time and Events ....................................................................................................... 30
Table 5: Disallowed systemic medications ............................................................................. 43
Table 6: Disallowed systemic antihistamines ......................................................................... 44
Table 7: Examples of major and minor protocol deviations ................................................... 45
Table 8: 
 Descriptive Summaries by Endpoint and Lens Type: 40-65 years ........... 54
Table 9: Sample Size and Power Estimates by Endpoint ....................................................... 54
 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 15
 
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Study Endpoints 
Primary endpoints: disability glare, halo size (mm), and 
starburst size (mm). 
 
Secondary endpoints: two-point thresholds with and without 
403 nm filter; heterochromatic contrast threshold and glare 
discomfort. 
  
Primary and secondary endpoints will be measured with 
natural, binocular viewing conditions. 
 
Other endpoints: Subjective ratings of glare discomfort, halo 
and starburst intensity and color perception. 
Study Design 
This is a single-masked, bilateral, controlled, randomized, 2x2 
crossover, non-dispensing clinical trial.  There will be two 
study visits.  Eligible subjects will be randomized and fit into 
one study lens per visit based on the randomization schedule.  
There will be a 7±3 days washout between the study visits.  
Additional details of the procedures done at each study visit 
are located at the end of the synopsis in the flowchart (Figure 
1). 
Sample Size 
A total of approximately 35 eligible subjects will be enrolled 
with 25 targeted to complete the study. 
Study Duration 
The study will last approximately 6-7 months.   
 
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below.  Subjects will be 
P\RSLF ZLWK UHIUDFWLYH DVWLJPDWLVP RI  ' DQG DGDSWHG
soft contact lens wearers.  In addition, an attempt will be made 
to recruit an even distribution in the following ADD groups:  
+0.75 to +1.25 D, +1.50 to +1.75 D and +2.00 to +2.50 D.  
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
 
Inclusion Criteria following Screening: 
  
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and receive 
a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol. 
3. The subject must be at least 40 and not more than 70 
years of age at the time of screening. 
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision. 
5. The subject must be an adapted soft contact lens wearer 
in both eyes (i.e., worn lenses a minimum of 2 days per 
week for at least 8 hours per wear day, for at least 1 
month of duration). 
6. The subject must already be wearing a presbyopic 
contact lens correction (e.g., reading spectacles over 
contact lenses, multifocal or monovision contact lenses, 
etc.) or if not respond positively to at least one symptom 
on the “Presbyopic Symptoms Questionnaire”.  
 
Inclusion Criteria at Baseline Evaluation: 
 
7. The subject must have normal color perception as 
evidenced by reading 17 out of the first 21 Ishihara plates 
correctly. 
8. The subject’s distance spherical equivalent of their 
refraction must be in the range of -1.00 D to -4.00 D. 
9. The subject’s refractive cylinder must be  ' in each 
eye. 
10. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D in each eye. 
11. The subject must have best corrected distance visual 
acuity of 20/20-3 or better in each eye. 
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Clinical Study Protocol 
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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 following Screening: 
 
1. Currently pregnant or lactating. 
2. Any systemic disease (e.g., Sjögren’s Syndrome), 
allergies, infectious disease (e.g., hepatitis, tuberculosis), 
contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g., rheumatoid arthritis), or other 
diseases, by self-report, which are known to interfere 
with contact lens wear and/or participation in the study. 
3. Use of any of the following oral medications within 1 
week prior to enrollment: oral retinoids, oral tetracyclines, 
oral 
phenothiazines, 
anticholinergics, 
oral/inhaled 
steroids, oral phosphodiesterase type 5 inhibitors, 
interferon 
alfa, 
antimycobacterial 
antibiotics, 
and 
nitroimidazole antibiotics.  See section 9.1 for additional 
details regarding excluded systemic medications.  
4. Any current use of ocular medication with the exception 
of rewetting drops. 
5. Any known hypersensitivity or allergic reaction to single 
use preservative free rewetting drops or sodium 
fluorescein. 
6. Any previous or planned (during the course of the study) 
ocular surgery (e.g., radial keratotomy, PRK, LASIK  
dacryocystorhinostomy, cataract surgery, retinal surgery, 
peripheral iridotomy/iridectomy, etc.). 
7. Participation in any contact lens or lens care product 
clinical trial within 7 days prior to study enrollment. 
8. Employee or immediate family member of an employee 
of clinical site (e.g., Investigator, Coordinator, 
Technician). 
9. Any active or ongoing ocular or systemic allergies that 
may interfere with contact lens wear.   
10. A history of amblyopia, strabismus or binocular vision 
abnormality. 
11. History of herpetic keratitis. 
12. History of optic nerve or retinal disease or trauma. 
13. Abnormal color vison. 
 
 
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Clinical Study Protocol 
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Exclusion Criteria at Baseline Evaluation: 
 
14. Any other ocular abnormalities that are known to 
interfere with contact lens wear and/or participation in 
the study. This may include, but not be limited to 
entropion, ectropion, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, or corneal distortion  
15. Any grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the FDA scale. 
16. Any current ocular infection or inflammation. 
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear.  
See Section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
The addition of the HEV-Blocker may provide benefits 
beyond the benefits of the correction of only ametropia.  The 
test procedures will evaluate objective test methods in an 
optical bench set-up to quantify some of these potential 
benefits.  See Figure 1 in the synopsis and Section 7.2 in the 
protocol for the additional details on the procedures. 
Microbiology or Other 
Laboratory Testing 
None. 
Study Termination 
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, will result in stopping further dispensing 
investigational product.  In the event of a UADE or SAE, the 
Sponsor 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 
Non-preserved rewetting drops and optical bench test 
methods.  
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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Clinical Study Protocol 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
Add 
 
 
Near addition; the additional power required for near vision correction  
ADE  
 
Adverse Device Effect 
ADHD  
 
Attention Deficit Hyperactivity Disorder 
AE 
 
 
Adverse Event/Adverse Experience 
AO1DfA 
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY for 
ASTIGMATISM 
AOfA 
ACUVUE OASYS® 2-WEEK for ASTIGMATISM 
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 
ESD 
 
 
Eyelid Stabilized Design 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
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 
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Clinical Study Protocol 
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QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity  
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
1. INTRODUCTION AND BACKGROUND 
Filters have long been used in ophthalmic devices, with sunglasses probably the best-known 
example.  Sunglasses help to minimize the deleterious effects of intense light.  Intense light 
can lead to discomfort as well as degrade visual performance.  Using light filters can help to 
improve the discomfort associated with intense light as well as improve the visual 
performance. 
 
Johnson & Johnson currently has two multifocal contact lenses on the market.  Multifocal 
contact lenses correct refractive errors through the use of simultaneous vision, where the 
distance, intermediate and near corrections are placed in front of the pupil at one time.  This 
type of correction can reduce image contrast and create visual artifacts, thus reducing visual 
performance.  Given the vision compromise created by simultaneous vision, the additional 
detrimental impact of intense light can further compound the problem. 
 
The purpose of this study is to investigate the potential visual benefits of using a High Energy 
Visible (HEV) light blocker in multifocal contact lenses and evaluate its impact on 
performance.  An investigational multifocal contact lens with an HEV blocker will be 
compared to a multifocal lens without an HEV blocker.     
1.1. Name and Descriptions of Investigational Products  
Investigational Products:  JJV Investigational Multifocal Contact Lens with HEV blocker (Test 
Lens) 
JJV Investigational Multifocal Contact Lens without HEV-Blocker (Control Lens) 
1.2. Intended Use of Investigational Products 
All lenses in this study are intended to correct spherical refractive error and presbyopia.  The 
study is non-dispensing and all of the study lenses will be worn as a daily disposable lens, with 
the lenses being discarded after a wear at the clinical site.  The lenses will be fit in a randomized 
fashion.  After fitting, the subject will undergo a number of vision assessments.  The sequence 
will then be repeated with the other study lens type. 
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding the JJV 
investigational lenses used in this study refer to the latest version of the CR-6391 Investigator 
Brochure.   
1.4. Summary of Known Risks and Benefits to Human Subjects 
Anticipated risks and adverse reactions with this lens are similar to those with other soft daily 
wear contact lenses.  A listing of examples of adverse reactions is found in the Section 13 of 
this protocol.  The investigator should follow normal clinical guidelines regarding examination 
and care of subjects who participate in this trial.  Refer to study lens package insert for 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
The lenses displayed good clinical vision performance with binocular, high luminance, high 
contrast logMAR visual acuity of -0.132, -0.066 and 0.072 at distance, intermediate and near 
respectively.  There were four adverse of events during the study.  Three of the four were non-
ocular adverse events.  Two of those not related to the study lenses and one (headache) was 
related to the Control Contact lens.  There was one ocular adverse event (non-significant 
infiltrative event) that was possibly related to the test lens.   
For information about the control product refer to study lens package insert for additional 
details (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)  and the 
Investigational Brochure (IB) for the Investigational product. 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Characterize the effects of an HEV-blocker on several measures of visual function in a 
presbyopic population and to compare the results to a lens without an HEV-Blocker 
(ACUVUE® OASYS Multifocal). 
 
Primary Objective 
The primary objective is to evaluate the impact an HEV blocker used in a multifocal contact 
lens has on artifacts potentially caused by intense light with respect to glare disability 
threshold, starbursts and halos. 
 
Secondary Objective  
The secondary objective is to assess the impact an HEV blocker has on the deleterious effects 
of scatter, measured as two-point thresholds measured with and without a 403 nm filter, 
heterochromatic contrast threshold and glare discomfort. 
 
Exploratory Objectives 
The exploratory endpoints include subjective response to the visual artifacts and color 
perception.  
2.2. Endpoints  
Primary Endpoints 
Glare Disability Threshold (change in log relative energy level) (GD) 
GD threshold will be evaluated by exposing subjects to various intensities of a white light 
annulus (~10-deg inner diameter; 12-degree outer diameter), which surrounds a mid-wave 
(580 nm), central grating target. GD will be quantified by the log relative energy level 
necessary to obscure the central target. 
 
Starburst diameter (mm) 
Starburst diameter will be quantified by the horizontal spread of the spokes emerging from the 
center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with 
reverse threading) will be used to spread two posts out from a central mid-point. The posts 
attach to a custom-designed ruler that indicates the lateral spread of the starburst.  
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
Halos (mm) 
Halos will be quantified by the diameter (mm) of outer edges of the halo of the white light 
point-like stimulus and is measured using the same micrometer as for starbursts. 
 
Secondary Endpoints  
 
Two-point threshold (mm) 
To create the two-point threshold stimulus, a single point-source like stimulus will be spread 
into two distinct points of light, using a custom-built, collapsible light baffle. The two-point 
threshold will be quantified as the minimum distance (mm) at which a participant can detect 
two distinct points of light, separated by a small black space.  
 
Glare Discomfort (change in squint in mm) (GDC) 
GDC will be evaluated by calculating the change in height of the palpebral fissure measured  
while the participant views the mid-wave central grating target, compared to the maximal 
squint during a 5-second photostress exposure induced by a solid, 10-degree broadband field, 
which completely obscures the target (~10-deg diameter). Both eyes will be recorded and 
averaged, to produce an average palpebral fissure height before and during the photostress 
exposure. 
 
Heterochromic Contrast Threshold (HCT) 
Using the same optical bench set-up described in GD above, to measure HCT, participants will 
view the mid-wave (580 nm) grating target presented on presented on a short-wave (460 nm) 
“sky-light background.” The intensity of the background will be adjusted, until the participant 
is no longer able to resolve the grating target. The log-relative energy of the background needed 
to obscure the central target will be recorded as HCT.   
 
Exploratory Endpoints 
 
Color perception testing 
A custom-built device will be used to measure color perception. Participants will view a 
stimulus that consists of broadband light that is passed through integrating spheres, coated with 
an ultra-diffuse reflective material. The experimenters will then adjust a set of Wratten filters 
until the subject perceives a perfect, untinted white. CIE coordinates (x,y; u’,v’; total 
illuminance; total irradiance) will be recorded.   
 
Subjective discomfort while viewing halos, starbursts and the photostressor will be assessed. 
Subjective discomfort will be measured using a single Likert-type question following exposure 
to the photostressor and after viewing halo and starburst stimuli.  
2.3. Hypotheses 
Primary Hypotheses 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
1. Glare disability thresholds measured using the optical bench will be significantly higher 
in the Test lens compared to the Control lens.  
2. Halo sizes (mm) measured with the custom halometer device will be significantly 
smaller in the Test lens compared to the Control lens.  
3. Starburst size (mm), as measured with the halometer,  will be significantly smaller in 
the Test lens compared to the Control lens.   
 
 
Secondary Hypotheses 
 
1. Two-point thresholds (mm) measured using the light shield and baffle device will be 
significantly lower in the Test lens compared to the Control lens with the 403 nm filter.  
 
2. Two-point thresholds (mm) measured using the light shield and baffle device will be 
significantly lower in the Test lens compared to the Control lens without the 403 nm 
filter.  
 
3. The Test lens will have a significantly lower change in squint response (mm) compared 
to the Control lens with respect to glare discomfort as measured on an optical bench. 
 
4. Heterochromatic contrast thresholds measured using the optical bench will be 
significantly higher in the Test lens compared to the Control lens.  
 
 
Exploratory Hypotheses  
 
1. Color appearance (x, y, u’, v’) measured using the custom colorimeter device will not 
differ between the Test lens and the Control lens.  
 
2. The photostressor, halo and starburst stimuli will be perceived as significantly less 
intense / uncomfortable in the Test lens, compared to the Control lens.  
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female volunteers with presbyopia will be screened as per criteria outlined 
below.  Subjects will be adapted soft contact lens wearers and be myopic with no or low levels 
RI DVWLJPDWLVP  75 D).  In addition, an attempt will be made to recruit an even distribution 
of subjects in the following ADD groups: +0.75D to +1.25 D, +1.50D to +1.75 D and +2.00D 
to +2.50 D. 
 
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
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Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between at least 40 and not more than 70 years of age at the time of screening. 
4. Possess a wearable pair of spectacles that provide correction for distance vision 
5. Be an adapted soft contact lens wearer in both eyes (i.e., worn lenses a minimum of 2 
days per week for at least 8 hours per wear day, for 1 month of more duration). 
6. Be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact 
lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at 
least one symptom on the “Presbyopic Symptoms Questionnaire”. 
 
Inclusion Criteria at Baseline Evaluation 
7. The subject must have normal color perception as evidenced by reading 17 out of the 
first 21 Ishihara plates correctly. 
8. The subject’s distance spherical equivalent of their refraction must be in the range of -
1.00 D to -4.00 D. 
9. The VXEMHFW¶V UHIUDFWLYH F\OLQGHU PXVW EH  ' LQ HDFK H\H 
10. The subject’s ADD power must be in the range of +0.75 D to +2.50 D in each eye. 
11. The subject must have best corrected distance visual acuity of 20/20-3 or better in each 
eye. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Any systemic disease (e.g., Sjögren’s Syndrome), allergies, infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which 
are known to interfere with contact lens wear and/or participation in the study. 
3. Use of any of the following oral medications within 1 week prior to enrollment: oral 
retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, oral/inhaled steroids, 
oral phosphodiesterase type 5 inhibitors, interferon alfa, antimycobacterial antibiotics, 
and nitroimidazole antibiotics.  See Section 9.1 for additional details regarding 
excluded systemic medications. 
4. Any current use of ocular medication with the exception of rewetting drops. 
5. Any known hypersensitivity or allergic reaction to single use preservative free 
rewetting drops or sodium fluorescein. 
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6. Any previous or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK  dacryocystorhinostomy, cataract surgery, retinal surgery, 
peripheral iridotomy/iridectomy, etc.). 
7. Participation in any contact lens or lens care product clinical trial within 7 days prior 
to study enrollment. 
8. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
9. Any active or ongoing ocular or systemic allergies that may interfere with contact lens 
wear. 
10. History of herpetic keratitis.  
 
11. A history of amblyopia, strabismus or binocular vision abnormality. 
12. History of optic nerve or retinal disease or trauma 
13. Abnormal color vison. 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not have: 
14. Any other ocular abnormalities that are known to interfere with contact lens wear 
and/or participation in the study. This may include, but not be limited to entropion, 
ectropion,  chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or 
corneal distortion  
15. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale. 
16. Any current ocular infection or inflammation. 
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.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a single-site, 2-visit, single-masked (partial), bilateral, controlled, 2x2 crossover, 
randomized, non-dispensing clinical trial.  There will be two study visits. Approximately 35 
subjects will be enrolled with a target of 25 subjects to complete. If a subject meets all 
eligibility criteria, then the subject will be randomized at Visit 1 into one of two lens wear 
sequences using a 2x2 crossover design. The subjects will be fit into the study lenses at each 
visit per the randomization scheme. There will be a 7±3 days washout between study visits. 
Subjects will not wear the study lenses outside the study visit.  Additional details of the 
procedures done at each study visit are contained in Section 7.2. 
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4.2. Study Design Rationale 
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×2 bilateral crossover design was considered to 
be the optimal design since the study period is relatively short, the design can be cost effective, 
and more efficient comparisons between treatments can be made compared to a parallel, 
between-subjects design. In a crossover design, fewer subjects are required to achieve the same 
pre-specified statistical power. Each subject will act as their own control to reduce the 
influence of potential confounding factors such as age, gender and vision correction. A 7±3 
days washout period between study lens wear will be implemented to help reduce any potential 
bias. 
4.3. Enrollment Target and Study Duration 
A total of approximately 35 eligible subjects will be enrolled with 25  targeted to complete the 
study. The study will last approximately 6-7 months. 
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
A computer-generated randomization scheme will be used to randomly assign subjects to one 
of the 2 possible contact lens wear sequences in a bilateral fashion using a 2x2 crossover design 
with a block of size 2. The randomization scheme will be generated using the PROC PLAN 
procedure from Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS 
Institute, Cary, NC)6. Please see below for details regarding the randomization by study period. 
 
Table 1:  Detailed Randomization Plan for all Study Visits 
Sequence 
Period 1 (Visit 1)  
Period 2 (Visit 2)  
1 
Test  
Control  
2 
Control  
Test 
 
The study site must follow the randomization scheme provided and complete enrollment 
according to the randomization list and not pre-select or assign subjects.  
 
The randomized assignment of subjects will be performed at the first visit prior to the first 
fitting. The following must have occurred prior to randomization: 
 
x Informed consent has been obtained 
x Subject meets all the inclusion/exclusion criteria 
x Subject history and baseline information has 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. 
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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 (partial) study. It is impossible to totally mask the subjects as the lenses 
with the HEV blocker will have a different color, however subjects will not be informed of the 
differences in optical designs or any details regarding the intended performance of the HEV 
blocker.  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. 
 
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 may be replaced. 
5.3. Procedures for Maintaining and Breaking the Masking 
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. 
 
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/randomization scheme 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 
randomization scheme. 
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. 
 
 
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6.6. Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
6.7. Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records.  
 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes: 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC. 
 
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
Reference 
: Site Instructions for Test Article Receipt and Test Article 
Accountability for additional information. 
 
 
 
 
 
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8. 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 completed all visits through the final visit 2.   
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. 
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 any study visits  
x Subject not compliant with study lens wear schedule  
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.  
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Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x Lens replacements that occur due to drops/fall-outs. 
x Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e., tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x Who received the complaint? 
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. 
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x Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to Form Control No. 
 
for test article return instructions). 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”  
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
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. 
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Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of > 2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
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 
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x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1 
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
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. 
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x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g., 
concomitant treatment, concomitant disease(s), is inconclusive. The relationship in 
time is reasonable. Therefore, the causal relationship cannot be excluded. 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g., 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g., it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
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.). 
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x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form (
) 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
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, 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
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 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analyses will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4  or higher (SAS Institute, Cary, NC).6  Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis.  Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
 
Summaries will be presented by study lens type, Test (Investigational Multifocal Contact Lens-
MF (HEV) and Control (Investigational Multifocal Contact Lens-MF) and will be performed 
separately by completion status (Safety Population, Per-Protocol Population and Intent-to-
Treat Population, when appropriate). 
 
All primary and secondary analyses will be performed on the Intent-to-Treat Population (see 
Section 14.3 for additional details).  
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Clinical Study Protocol 
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All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
All subjects regardless of actual treatment and subsequent withdrawal from study or deviation 
from protocol.  At least one observation should be recorded.    
14.4. Level of Statistical Significance 
Primary and secondary hypotheses will be test with a two-sided type I error rate of 5%. All 
primary and secondary hypotheses must be met in order to test any exploratory hypotheses 
14.5. Primary Analysis  
  
Starbursts (mm) and Halos (mm) 
Starbursts and Halos will be analyzed separately using a linear mixed model. Sequence of lens 
wear, period and lens type will be included as fixed effects. ADD Power, gender, race and 
dominant eye (Left or Right) may be included in the model as covariates when appropriate. 
Residual errors between measurements within the same subject across study periods will be 
modeled using an unstructured covariance structure (UN). The Kenward and Roger Method 
will be used for the denominator degrees of freedom. Comparisons between the study lenses 
will be carried out using two-sided 95% CIs for the least-square mean (LSM) difference (Test 
minus Control).  Superiority will be declared if the upper limit of the 95% confidence interval 
is below 0.  
 
The model will be constructed as follows:  
We denote ݕ௜௝௞௟ as the Starburst (or Halo) measurement for the lth subject in the assigned to 
the kth lens sequence during the jth period for the ith study lens (Test or Control). 
 
The Model was as follows: 
 
ݕ௜௝௞௟= ߤ଴+  ߚଵܮ݁݊ݏ௜௝௞+ ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞ + ߝ௜௝௞௟ 
 
x ߤ଴: overall intercept; 
x ܮ݁݊ݏ௜௝௞: Lens indicator; ܮ݁݊ݏ௜௝௞=1 for Test and 0 otherwise;  
x ܲ݁ݎ݅݋݀௝  : effect of the ݆th period; period=1 if analysis period=1 and 0 otherwise 
x ߝ௝௞௟: random error associated with the ݆th period for the lth subject for the ith 
treatmentassigned to the kth lens sequence   
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x 
ቂߝଵ௞௟
ߝଶ௞௟ቃܰቆቂ
ቃ ቈߪଵଵ
ଶ
ߪଵଶ
ߪଶଵ
ߪଶଶ
ଶ቉ቇ
 
 
Hypothesis Testing 
The null and alternative hypotheses are as follows and will be conducted separately for both 
starbursts and halos :  
 
ܪைߤ்௘௦௧െߤ஼௢௡௧௥௢௟൒ 
ܪ஺ߤ்௘௦௧െߤ஼௢௡௧௥௢௟	  
 
where ߤ்௘௦௧െߤ஼௢௡௧௥௢௟is the population mean difference between the Test and the Control 
lenses. If the upper limit of the 95% confidence limit is below 0 then the results favor the Test 
lens. If the lower limit of the 95% confidence limit is above 0 then the results favor the Control 
lens. 
 
GD Threshold (change in log relative energy level) 
GD Threshold will be analyzed using a linear mixed model. Sequence of lens wear, period and 
lens type will be included as fixed effects. ADD Power, gender, race and dominant eye (Left 
or Right) may be included in the model as covariates when appropriate. Residual errors 
between measurements within the same subject across study periods will be modeled using an 
unstructured covariance structure (UN). The Kenward and Roger Method will be used for the 
denominator degrees of freedom. Comparisons between the study lenses will be carried out 
using two-sided 95% CIs for the least-square mean (LSM) difference (Test minus Control).  
Superiority will be declared if the upper limit of the 95% confidence interval is below 0.  
 
The model will be constructed as follows:  
We denote ݕ௜௝௞௟ as the GD threshold for the lth subject in the assigned to the kth lens sequence 
during the jth period for the ith study lens (Test or Control). 
 
The Model was as follows: 
 
ݕ௜௝௞௟= ߤ଴+  ߚଵܮ݁݊ݏ௜௝௞+ ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞ + ߝ௜௝௞௟ 
 
x ߤ଴: overall intercept; 
x ܮ݁݊ݏ௜௝௞: Lens indicator; ܮ݁݊ݏ௜௝௞=1 for Test and 0 otherwise;  
x ܲ݁ݎ݅݋݀௝  : effect of the ݆th period; period=1 if analysis period=1 and 0 otherwise 
x ߝ௝௞௟: random error associated with the ݆th period for the lth subject for the ith 
treatmentassigned to the kth lens sequence   
x 
ቂߝଵ௞௟
ߝଶ௞௟ቃܰቆቂ
ቃ ቈߪଵଵ
ଶ
ߪଵଶ
ߪଶଵ
ߪଶଶ
ଶ቉ቇ
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Hypothesis Testing 
The null and alternative hypotheses for glare disability are as follows:  
 
ܪைߤ்௘௦௧െߤ஼௢௡௧௥௢௟൑ 
ܪ஺ߤ்௘௦௧െߤ஼௢௡௧௥௢௟
  
 
where ߤ்௘௦௧െߤ஼௢௡௧௥௢௟is the population mean difference between the Test and the Control 
lenses. If the upper limit of the 95% confidence limit is below 0 then the results favor the 
Control lens. If the lower limit of the 95% confidence limit is above 0 then the results favor 
the Test lens. 
 
Note: 
Prior to fitting any linear models for any endpoints, the distribution of each endpoint will be 
assessed to ensure the assumption of normality is fulfilled, this will be evaluated using the 
Shapiro-Wilks test for each study lens separately under the UNIVARIATE PROCEDURE in 
SAS Version 9.4. If an endpoint is concluded to follow a non-normal distribution, then a 
generalized linear model will be fit instead of the proposed linear models. If this occurs, the 
distribution that best fits the data will be chosen for the model and associated endpoint.   
 
14.6. Secondary Analysis  
Light Scattering with and without 403nm filer and Glare Discomfort (mm)   
Light scattering with and without a 403nm filter and glare discomfort will be analyzed 
separately using a linear mixed model. Sequence of lens wear, period and lens type will be 
included as fixed effects. ADD Power, gender, race and dominant eye (Left or Right) may be 
included in the model as covariates when appropriate. Residual errors between measurements 
within the same subject across study periods will be modeled using an unstructured covariance 
structure (UN). The Kenward and Roger Method will be used for the denominator degrees of 
freedom. Comparisons between the study lenses will be carried out using two-sided 95% CIs 
for the least-square mean (LSM) difference (Test minus Control).  Superiority will be declared 
if the upper limit of the 95% confidence interval is below 0.  
 
The model will be constructed as follows:  
We denote ݕ௜௝௞௟ as the Light scattering (with or without 403nm filter) measurement for the lth 
subject in the assigned to the kth lens sequence during the jth period for the ith study lens (Test 
or Control). 
 
The Model was as follows: 
 
ݕ௜௝௞௟= ߤ଴+  ߚଵܮ݁݊ݏ௜௝௞+ ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞ + ߝ௜௝௞௟ 
 
x ߤ଴: overall intercept; 
x ܮ݁݊ݏ௜௝௞: Lens indicator; ܮ݁݊ݏ௜௝௞=1 for Test and 0 otherwise;  
x ܲ݁ݎ݅݋݀௝  : effect of the ݆th period; period=1 if analysis period=1 and 0 otherwise 
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Clinical Study Protocol 
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x ߝ௝௞௟: random error associated with the ݆th period for the lth subject for the ith 
treatmentassigned to the kth lens sequence   
x 
ቂߝଵ௞௟
ߝଶ௞௟ቃܰቆቂ
ቃ ቈߪଵଵ
ଶ
ߪଵଶ
ߪଶଵ
ߪଶଶ
ଶ቉ቇ
 
Hypothesis Testing 
The null and alternative hypotheses are as follows and will be conducted separately for both 
starbursts and halos :  
 
ܪைߤ்௘௦௧െߤ஼௢௡௧௥௢௟൒ 
ܪ஺ߤ்௘௦௧െߤ஼௢௡௧௥௢௟	  
 
where ߤ்௘௦௧െߤ஼௢௡௧௥௢௟is the population mean difference between the Test and the Control 
lenses. If the upper limit of the 95% confidence limit is below 0 then the results favor the Test 
lens. If the lower limit of the 95% confidence limit is above 0 then the results favor the Control 
lens. 
 
Heterochromatic Contrast Threshold (HCT) 
HCT will be analyzed using a linear mixed model. Sequence of lens wear, period and lens type 
will be included as fixed effects. ADD Power, gender, race and dominant eye (Left or Right) 
may be included in the model as covariates when appropriate. Residual errors between 
measurements within the same subject across study periods will be modeled using an 
unstructured covariance structure (UN). The Kenward and Roger Method will be used for the 
denominator degrees of freedom. Comparisons between the study lenses will be carried out 
using two-sided 95% CIs for the least-square mean (LSM) difference (Test minus Control).  
Superiority will be declared if the upper limit of the 95% confidence interval is below 0.  
 
The model will be constructed as follows:  
We denote ݕ௜௝௞௟ as the HCT measurement for the lth subject in the assigned to the kth lens 
sequence during the jth period for the ith study lens (Test or Control). 
 
The Model was as follows: 
 
ݕ௜௝௞௟= ߤ଴+  ߚଵܮ݁݊ݏ௜௝௞+ ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞ + ߝ௜௝௞௟ 
 
x ߤ଴: overall intercept; 
x ܮ݁݊ݏ௜௝௞: Lens indicator; ܮ݁݊ݏ௜௝௞=1 for Test and 0 otherwise;  
x ܲ݁ݎ݅݋݀௝  : effect of the ݆th period; period=1 if analysis period=1 and 0 otherwise 
x ߝ௝௞௟: random error associated with the ݆th period for the lth subject for the ith 
treatmentassigned to the kth lens sequence   
x 
ቂߝଵ௞௟
ߝଶ௞௟ቃܰቆቂ
ቃ ቈߪଵଵ
ଶ
ߪଵଶ
ߪଶଵ
ߪଶଶ
ଶ቉ቇ
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Hypothesis Testing 
The null and alternative hypotheses for HCT are as follows:  
 
ܪைߤ்௘௦௧െߤ஼௢௡௧௥௢௟൑ 
ܪ஺ߤ்௘௦௧െߤ஼௢௡௧௥௢௟
  
 
where ߤ்௘௦௧െߤ஼௢௡௧௥௢௟is the population mean difference between the Test and the Control 
lenses. If the upper limit of the 95% confidence limit is below 0 then the results favor the 
Control lens. If the lower limit of the 95% confidence limit is above 0 then the results favor 
the Test lens. 
 
14.7. Other Exploratory Analysis  
Color Appearance (white point) 
The four chromaticity coordinates (ݔݔ, ݕݕ, ݑݑƍ DQG ݒݒƍ IURP WKH FRORU DSSHDUDQFH WHVW ZLOO
be analyzed using a linear mixed model. Sequence of lens wear, period and lens type will be 
included as fixed effects. ADD Power, gender, race and dominant eye (Left or Right) may be 
included in the model as covariates when appropriate. Residual errors between measurements 
within the same subject across study periods will be modeled using an unstructured covariance 
structure (UN). The Kenward and Roger Method will be used for the denominator degrees of 
freedom. Comparisons between the study lenses will be carried out using two-sided 95% CIs 
for the least-square mean (LSM) difference (Test minus Control).  Superiority will be declared 
if the upper limit of the 95% confidence interval is below 0.  
 
The model will be constructed as follows:  
We denote ݕ௜௝௞௟ as the Light scattering (with or without 403nm filter) measurement for the lth 
subject in the assigned to the kth lens sequence during the jth period for the ith study lens (Test 
or Control). 
 
The Model was as follows: 
 
ݕ௜௝௞௟= ߤ଴+  ߚଵܮ݁݊ݏ௜௝௞+ ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞ + ߝ௜௝௞௟ 
 
x ߤ଴: overall intercept; 
x ܮ݁݊ݏ௜௝௞: Lens indicator; ܮ݁݊ݏ௜௝௞=1 for Test and 0 otherwise;  
x ܲ݁ݎ݅݋݀௝  : effect of the ݆th period; period=1 if analysis period=1 and 0 otherwise 
x ߝ௝௞௟: random error associated with the ݆th period for the lth subject for the ith 
treatmentassigned to the kth lens sequence   
x 
ቂߝଵ௞௟
ߝଶ௞௟ቃܰቆቂ
ቃ ቈߪଵଵ
ଶ
ߪଵଶ
ߪଶଵ
ߪଶଶ
ଶ቉ቇ
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Hypothesis Testing 
The null and alternative hypotheses for the significance testing between the Test lens and the 
Control lens with respects to each chromaticity coordinate for color appearance are presented 
below: 
 
ܪைߤ்௘௦௧െߤ஼௢௡௧௥௢௟  
ܪ஺ߤ்௘௦௧െߤ஼௢௡௧௥௢௟് 
where ߤ்௘௦௧െߤ஼௢௡௧௥௢௟ the population mean difference between the Test and the Control 
lenses. Statistical differences will be concluded if 0 is not contained within the 95% confidence 
interval. 
14.8. Interim Analysis 
Not applicable. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations. 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
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 
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Johnson & Johnson Vision Care, Inc. 
 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x subject identification 
x eligibility 
x study identification 
x study discussion 
x provision of and date of informed consent 
x visit dates 
x results of safety and efficacy parameters as required by the protocol 
x a record of all adverse events 
x follow-up of adverse events 
x medical history and concomitant medication 
x test article receipt/dispensing/return records 
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 based on the following: The study is 
determined not to be an early feasibility study.  
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16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable 
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Clinical Study Protocol 
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17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
x Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x Ensuring the rights and wellbeing of subjects are protected. 
x Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test article and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is / fully 
able to understand the risks, benefits, and potential adverse events of the study and provide 
their consent voluntarily. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6(R2) 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
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. 
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x Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x Investigator’s Brochure (or equivalent information). 
x Sponsor-approved subject recruitment materials. 
x Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x Protocol revisions 
x Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x If applicable, new or revised subject recruitment materials approved by the Sponsor 
x Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x Investigator’s Brochure revisions  
x Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
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. 
 
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At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA)4 and 
other applicable personal data protection and security laws and regulations. Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the 
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
 
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. 
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These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x processed fairly and lawfully. 
x collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x adequate, relevant, and not excessive in relation to said purposes. 
x accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
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. 
 
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If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
x Continuing an ineligible subject in the study. 
x Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x Query resolution. 
x Case Report Form signature. 
x Completion of any follow-up action items. 
21. PUBLICATION 
There is no plan to publish this outcome of this investigation. 
22. REFERENCES 
1. ISO 14155:2011: 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. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html    
6. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute Inc.  
7. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A comparison of two approaches for 
selecting covariance structures in the analysis of repeated measurements. Communications in 
Statistics - Simulation and Computation. 1998;27(3):591-604. 
8. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53(3):983. 
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9. 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) 
Not Applicable. 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
A Patient Instruction Guide (PIG) will be provided separately. 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
 
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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 
patient instructions that pertain to the patient’s 
prescribed lenses.
ACUVUE® OASYS MULTIFOCAL (senofilcon A) Contact Lens 
Soft (hydrophilic) Contact Lenses Visibility Tinted with UV 
Blocker for Daily & Extended Wear 
CAUTION: US Federal law restricts this device to sale 
by or on the order of a licensed practitioner
ACUVUE® OASYS MULTIFOCAL Contact Lenses with PUPIL 
OPTIMIZED DESIGN
PACKAGE INSERT & FITTING INSTRUCTION GUIDE
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• Light Transmittance: ≥89% minimum
• Surface Character: Hydrophilic
• Water Content: 38%
• Oxygen Permeability (Dk):
VALUE
METHOD
103 x 10-11 (cm2/sec) (ml 
O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edgse 
corrected)
122 x 10-11 (cm2/sec) (ml 
O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non- edge 
corrected)
Lens Parameters Ranges:
The ACUVUE® OASYS MULTIFOCAL (senofilcon A) Soft 
Contact Lenses are hemispherical or hemitoric shells of the 
following dimensions:
• Diameter (DIA) :
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve (BC):
7.85 mm to 10.00 mm
• Spherical Power (D):
-20.00D to +20.00D
• Multifocal ADD Power Range:
+0.25D to +4.00D
Each lens is supplied in a foil-sealed plastic package containing 
borate buffered saline solution with methyl ether cellulose.
AVAILABLE LENS PARAMETERS
The ACUVUE® OASYS MULTIFOCAL (senofilcon A) Soft 
Contact Lenses are hemispherical shells of the following 
dimensions:
Diameter:
14.3 mm
Center Thickness:
Minus Lens - varies with power (e.g. 
-4.00D: 0.070 mm)
Plus Lens - varies with power (e.g. +4.00D: 
0.168
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Base Curve:
8.4 mm
Powers:
-9.00D to +6.00D (in 0.25D increments)
ADD Powers:
+1.25 (LOW), +1.75 (MID), +2.50 (HGH)
 
TRANSMITTANCE CURVE
ACUVUE® OASYS MULTIFOCAL (senofilcon A) Soft Contact 
Lenses vs. 24 yr. old human cornea vs. 25 yr. old human 
crystalline lens.
…….
ACUVUE® OASYS 
MULTIFOCAL 
(senofilcon A) Contact 
Lenses*
_____
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 (-1.00D 
lens, 0.070 mm center thickness).
1 Lerman, S., Radiant Energy and the Eye, MacMillan, New 
York, 1980, p.58, figure 2-21.
2 Waxler, M. Hitchins, V.M., Optical Radiation and Visual Health, 
CRC Press, Boca Raton, Florida, 1986, p.19, figure 5.
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ACTIONS
In its hydrated state, the contact lens, when placed on the 
cornea, acts as a refracting medium to focus light rays on the 
retina.
When hydrated and placed on the cornea for therapeutic use, 
the contact lens acts as a bandage to protect the cornea.
These lenses contain a UV Blocker to help protect against 
transmission of harmful UV radiation to the cornea and into the 
eye.  The light transmittance characteristics are less than 1% in 
the UVB range of 280 nm to 315 nm and less than 10% in the 
UVA range of 315 nm to 380 nm for the entire power range.
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.
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 MULTIFOCAL (senofilcon A) Contact Lenses 
are indicated for the correction of vision in presbyopic people 
with non-diseased eyes who
ither presbyopic or are 
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presbyopic and are also nearsighted (myopic) or farsighted 
(hyperopic) and may have 0.75D or less of astigmatism. 
Eye Care Professionals may prescribe the lenses either for 
single use, disposable wear or frequent/planned replacement 
wear with cleaning, disinfection and scheduled replacement 
(see “Replacement Schedule”). When prescribed for single 
use disposable wear, no cleaning or disinfection is required. 
Lenses should be discarded upon removal. When prescribed 
for frequent/planned replacement wear, the lenses may be 
disinfected using a chemical disinfection system only. 
These lenses are intended for daily wear for up to 14 days 
(2 weeks) and extended wear for up to 6 nights/7 days 
of continuous wear. It is recommended that the contact 
lens wearer ﬁrst be evaluated on a daily wear schedule. If 
successful, then a gradual introduction of extended wear 
can be followed as determined by the prescribing Eye Care 
Professional. 
These lenses are also indicated for therapeutic use as a 
bandage lens for the following acute and chronic ocular 
conditions:
• For corneal protection in lid and corneal abnormalities 
such as entropion, trichiasis, tarsal scars, and recurrent 
corneal erosion. In addition, they are indicated for 
protection where sutures or ocular structure malformation, 
degeneration or paralysis may result in the need to protect 
the cornea from exposure or repeated irritation.
• For corneal pain relief in conditions such as bullous 
keratopathy, epithelial erosion and abrasion, ﬁlamentary 
keratitis, and post-keratoplasty.
• For use as a barrier during the healing process of epithelial 
defects such as chronic epithelial defects, corneal ulcer, 
neurotrophic and neuroparalytic keratitis, and chemical 
burns.
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• For post-surgical conditions where bandage lens use is 
indicated such as post refractive surgery, lamellar grafts, 
corneal ﬂaps, and additional ocular surgical conditions.
• For structural stability and protection in piggy back lens 
ﬁtting where the cornea and associated surfaces are too 
irregular to allow for corneal rigid gas permeable (RGP) 
lenses to be ﬁt. In addition, the use of the lens can prevent 
irritation and abrasions in conditions where there are 
elevation differences in the host/graph junction or scar 
tissue.
Lenses prescribed for therapeutic use may be worn for daily or 
extended wearing periods.
CONTRAINDICATIONS (REASONS NOT TO USE)
When prescribing contact lens wear for REFRACTIVE 
AMETROPIA USE, DO NOT USE these lenses when any of the 
following conditions exist:
• Acute or subacute inflammation or infection of the anterior 
chamber of the eye.
• Any eye disease, injury or abnormality that affects the 
cornea, conjunctiva or eyelids.
• Severe insufficiency of lacrimal secretion (dry eye).
• 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., cleaning and 
disinfecting solutions, rewetting drops, etc.) that contain 
chemicals or preservatives (such as mercury, Thimerosal, 
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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.
For THERAPEUTIC USE, the Eye Care Professional may 
prescribe these lenses to aid in the healing process of certain 
ocular conditions, which may include those cited above.
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 EXPERIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness, or
• Other Eye Problems,
THE PATIENT SHOULD BE INSTRUCTED TO 
IMMEDIATELY REMOVE THE LENSES AND PROMPTLY 
CONTACT THE EYE CARE PROFESSIONAL.
• When prescribed for daily wear, patients should be 
instructed not to wear their lenses while sleeping. Clinical 
studies have shown that when lenses are worn overnight, 
the risk of ulcerative keratitis is greater than among those 
who do not wear them overnight.3
• Studies have shown that contact lens wearers who are 
smokers have a higher incidence of adverse reactions 
than nonsmokers.
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• 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, including lens cases, 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, including 
cleaning the lens case.
3 New England Journal of Medicine, September 21, 1989; 321 
(12), pp. 773-783
Specific Instructions for Use and Warnings:
• Water Activity
Instruction 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.
• Soaking and Storing Your Lenses
Instruction for Use
Use only fresh multi-purpose (contact lens disinfecting) 
solution each time the lenses are soaked (stored).
WARNING:
Do not reuse or “top off” old solution left in the lens 
case since solution reuse reduces effective lens 
disinfection and could lead to severe infection, vision 
loss, or blindness.  
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“Topping-Off” is the addition of fresh solution to 
solution that has been sitting in the case.
• Discard Date on Multi-Purpose Solution Bottle
Instructions for Use
– Discard any remaining solution after the recommended 
time period indicated on the bottle of multi-purpose 
solution used for disinfecting and soaking the contact 
lenses.
– The discard date refers to the time that the patient can 
safely use the contact lens care product after the bottle 
has been opened. It is not the same as the expiration 
date, which is the last date that the product is still effective 
before it is opened. 
WARNING:
Using multi-purpose solution beyond the discard date 
could result in contamination of the solution and can 
lead to severe infection, vision loss, or blindness.
– To avoid contamination, DO NOT touch tip of 
container to any surface. Replace cap after using.
– To avoid contaminating the solution, DO NOT 
transfer to other bottles or containers.
• Rub and Rinse Time
Instruction for Use
To adequately disinfect the lenses, the patient should rub and 
rinse the lenses according to the recommended lens rubbing 
and rinsing times in the labeling of the multi-purpose solution. 
WARNING:
– Rub and rinse lenses for the recommended amount 
of time to help prevent serious eye infections.
– Never use water, saline solution, or rewetting drops 
to disinfect the lenses. These solutions will not 
disinfect the lenses. Not using the recommended 
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disinfectant can lead to severe infection, vision loss, 
or blindness.
• Lens Case Care
Instructions for Use
– Empty and clean contact lens cases with digital rubbing 
using fresh, sterile disinfecting solutions/contact lens 
cleaner. Never use water. Cleaning should be followed by 
rinsing with fresh, sterile disinfecting solutions (never use 
water) and wiping the lens cases with fresh, clean tissue 
is recommended. Never air-dry or recap the lens case lids 
after use without any additional cleaning methods. If air 
drying, be sure that no residual solution remains in the case 
before allowing it to air-dry.
– Replace the lens case according to the directions provided 
by the Eye Care Professional or the manufacturer’s labeling 
that accompanies the case. 
– Contact lens cases can be a source of bacterial growth.
WARNING:
Do not store lenses or rinse lens cases with water 
or any non-sterile solution. Only fresh multi-purpose 
solution should be used to prevent contamination of 
the lenses or lens case. Use of non-sterile solution 
can lead to severe infection, vision loss, or blindness.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical 
investigation of lenses, all refractive powers, design 
configurations or lens parameters available in the lens 
material are not evaluated in significant numbers. 
Consequently, when selecting an appropriate lens design 
and parameters, the Eye Care Professional should 
consider all characteristics of the lens that can affect 
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lens performance and ocular health, including oxygen 
permeability, wettability, central and peripheral thickness 
and optic zone diameter.
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 monovision or multifocal correction 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. 
• Eye Care Professionals should instruct the patient to 
remove lenses immediately if the eyes become red or 
irritated.
• Eye Care Professionals should instruct the patient to 
always have a functional pair of spectacles with a current 
prescription available to use if the patient becomes unable 
to wear contact lenses, or in circumstances where contact 
lens wear is not advised.
Eye Care Professionals should carefully instruct patients 
about the following care regimen and safety precautions:
Handling Precautions:
• DO NOT use if the sterile blister package is opened or 
damaged. 
• Always wash, rinse, and dry hands before handling lenses. 
It is best to put on lenses before putting on makeup. 
• Carefully follow the handling, insertion, removal, cleaning, 
disinfecting, storing and wearing instructions in the Patient 
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Instruction Guide for these lenses and those prescribed by 
the Eye Care Professional.
• Never use tweezers or other tools to remove lenses from 
the lens container. Slide the lens up the side of the bowl 
until it is free of the container.
• Close supervision is necessary for the Therapeutic use of 
these lenses. Ocular medications used during treatment 
with a bandage lens should be closely monitored by the 
Eye Care Professional. In certain ocular conditions, only 
the Eye Care Professional will insert and remove the 
lenses. In these cases, patients should be instructed not 
to handle the lenses themselves.
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the 
recommended directions in "Care for Sticking (Non-
Moving) Lenses". 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. 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. 
• The patient should be advised to never rinse the lenses 
in water from the tap. Tap water contains many impurities 
that can contaminate or damage the lenses and may lead 
to eye infection or injury.
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Lens Care Precautions:
• Different solutions cannot always be used together and 
not all solutions are safe for use with all lenses. Use only 
recommended solutions.
• Do not change solution without consulting with the Eye 
Care Professional. 
• Never use solutions recommended for conventional hard 
contact lenses only.
• Always use fresh, unexpired lens care solutions and 
lenses, and always follow directions in the package inserts 
for the use of contact lens solutions.
• Sterile unpreserved solutions, when used, should be 
discarded after the time specified in the directions. 
• Do not use saliva or anything other than the 
recommended solutions for lubricating or wetting lenses. 
• Always keep the lenses completely immersed in the 
recommended storage solution when the lenses are not 
being worn (stored). Prolonged periods of drying (e.g., 
exposing the lens to air for 30 minutes or more) will reduce 
the ability of the lens surface to return to a wettable state. 
If the lens surface does become dried out, discard the 
lens and use a new one.
Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using 
any medicine 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. 
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• Oral contraceptive users could develop visual changes 
or changes in lens tolerance when using contact lenses. 
Patients should be cautioned accordingly. 
• Do not change lens type (e.g. brand name, etc.) or 
parameters (e.g. diameter, base curve, lens power, etc.) 
without consulting the Eye Care Professional. 
• Instruct patients to always confirm the lens parameters 
printed on the multi-pack and on the individual lens 
package match their prescription. If there is a mismatch 
the patient should not use the product.
• 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 equipment 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 first 
placed on the eye.
• There may be a feeling of something in the eye (foreign 
body, scratched area).
• There may be the potential for some temporary 
impairment due to peripheral infiltrates, peripheral 
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identification of the problem and prompt treatment to avoid 
serious eye damage.
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 benefits of lens wear
Patients who do not meet the above criteria should not be 
provided with contact lenses.
B. Pre-fitting 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 appropriate lens fitting instruction 
outlined below.
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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 the patient 
regardless of keratometry readings. However, corneal 
curvature measurements should be performed to establish the 
patient’s baseline ocular status.
• ACUVUE® OASYS MULTIFOCAL (senofilcon A) Soft 
Contact Lens: 8.4 mm/14.3 mm
The trial lenses 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 fit lens will center and completely cover the 
cornea (i.e., no limbal exposure), have sufficient 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 flat fitting lens may exhibit one or more of the following 
characteristics: decentration, incomplete corneal coverage 
(i.e., limbal exposure), excessive movement with the blink 
and/or edge standoff. If the lens is judged to be flat fitting, 
it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens
A steep fitting lens may exhibit one or more of the following 
characteristics: insufficient movement with the blink, 
conjunctival indentation, and resistance when pushing the 
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lens up digitally with the lower lid. If the lens is judged to be 
steep fitting, it should not be dispensed to the patient.
If the initial trial base curve is judged to be flat or steep fitting, 
the alternate base curve, if available, should be trial fit 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. 
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.
MULTIFOCAL FITTING GUIDELINES
A. Presbyopic Needs Assessment & Patient Education
Multifocal contact lenses may produce compromise to vision 
under certain circumstances and the patient should understand 
that they might not find their vision acceptable in specific 
situations (i.e., reading a menu in a dim restaurant, driving at 
night in rainy/foggy conditions, etc.). Therefore, caution should 
be exercised when the patient is wearing the correction for the 
first time until they are familiar with the vision provided in visually 
challenging environments. Occupational and environmental 
visual demands should be considered. If the patient requires 
critical visual acuity and stereopsis, it should be determined 
by trial whether this patient can function adequately with the 
ACUVUE® OASYS MULTIFOCAL (senofilcon A) Soft Contact 
Lens. Wear may not be optimal for such activities as:
1. Visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially 
hazardous activities; and
2. Driving automobiles (e.g., driving at night). Patients who 
cannot pass their state driver’s license requirements with 
these lenses should be advised to not drive with this 
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correction, OR may require that additional over-correction 
be prescribed.
These lenses are not recommended for patients who 
have –1.00D or greater of refractive cylinder as this level 
of uncorrected cylinder may lead to additional visual 
compromise. 
These lenses are available in the following ADD powers:
• Lens “LOW” =“low” near ADD lens (Max +1.25 ADD)
• Lens “MID” = “medium” near ADD lens (Max +1.75 ADD)
• Lens “HGH” = “high” near ADD lens (Max +2.50 ADD)
B. 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. 
Determine the spherical equivalent distance prescription for a 
multifocal patient. Determine the eye dominance using one of 
the methods below:
 
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 (preferred): Determine which eye will not accept 
added power. Place a +1.00 hand-held trial lens in front 
of one eye and then the other with the distance refractive 
error correction is in place for both eyes while the patient 
is viewing the distance visual acuity chart. The eye that the 
patient notices the greatest reduction in vision while having 
the plus over it is determined to be the dominant eye.
C. Select the Initial Trial Lens
1. For each eye, select the trial lens distance power that 
is closest to the patient’s distance spherical equivalent. 
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Remember to compensate for vertex distance if the 
refraction is greater than ±4.00D.
2. Select the near power of the lens based on the patients 
ADD range as follows: 
• ADD: +0.75 to +1.25 use a “LOW” near ADD lens on 
each eye 
• ADD: +1.50 to +1.75 use a “MID” near ADD lens on 
each eye
• ADD: +2.00 to +2.50 use a “MID” near ADD on the 
dominant eye and a “HGH” near ADD lens on the non-
dominant eye
3. Allow the lenses to settle for a minimum 10 minutes.
4. Assess distance and near vision binocularly and 
monocularly.
5. Demonstrate the vision under various lighting conditions 
(normal and decreased illumination) and at distance, 
intermediate and near. 
6. Make adjustments in power as necessary based on the 
distance over-refraction.  The use of hand held trial lenses 
is recommended.  Check the impact on distance and near 
vision.
7. If vision is still unacceptable, make adjustments in power 
as necessary (see “Multifocal Troubleshooting” 
below). If distance and near vision are acceptable, 
perform a slit lamp examination to assess adequate fit 
(centration and movement). If fit is acceptable, dispense 
the lenses instructing the patient to return in one week for 
reassessment (see PATIENT MANAGEMENT section).
D. Multifocal Troubleshooting
Unacceptable Near Vision:
If it has been determined that no change is required based 
on the over-refraction then add +0.25 D to the spherical 
power of the non-dominant eye. 
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Unacceptable Distance Vision:
If it has been determined that no change is required based 
on the over-refraction then make the changes as listed 
below:
• If the patient is wearing two “LOW” ADD lenses, change 
the dominant eye to a ACUVUE® OASYS (senofilcon A) 
Soft Contact Lens sphere lens with a power equal to the 
spherical equivalent distance prescription.
• If the patient is wearing two “MID” ADD lenses, change 
the ADD power in the dominant eye to the “LOW” ADD 
power.
• If the patient is wearing a “MID” ADD lens in the dominant 
eye and a “HGH” ADD lens in the non-dominant eye, 
change the non-dominant eye to a “MID” ADD lens and 
add +0.25D to the distance power.
Once the changes have been made for the troubleshooting 
repeat steps 3-6 in section C above (“Select the Initial 
Trial Lens”) to assess if the vision is acceptable.
E. Adaptation
Visually demanding situations should be avoided during 
the initial wearing period. A patient may at first 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 first 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 
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passenger first to make sure that their vision is satisfactory
for operating an automobile. During the first 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.
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
• PROVIDE THE PATIENT WITH A COPY OF THE PATIENT
INSTRUCTION GUIDE FOR THESE LENSES. REVIEW
THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED
WEARING AND REPLACEMENT SCHEDULE (DAILY
DISPOSABLE, EXTENDED WEAR, OR FREQUENT
REPLACEMENT).
• Recommend an appropriate cleaning and disinfecting
system and provide the patient with instructions regarding
proper lens care. Chemical or hydrogen peroxide
disinfection is recommended.
• Schedule a follow-up examination.
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.
For Daily Wear:
Patients tend to over wear the lenses initially. The Eye Care
Professional should emphasize the importance of adhering
to the initial maximum wearing schedule. Maximum wearing
time should be determined by the Eye Care Professional
based upon the patient’s physiological eye condition, because
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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
For Extended Wear:
It is recommended that the contact lens wearer ﬁrst be 
evaluated on a daily wear schedule. If successful, then a 
gradual introduction of extended wear can be followed as 
determined by the prescribing Eye Care Professional.
These lenses are intended for extended wear up to 6 nights/7 
days of continuous wear. Not all patients can achieve the 
maximum wear time.
For Therapeutic Lens Wear:
Close supervision by the Eye Care Professional is necessary. 
These lenses can be worn for extended wear for up to 6 
nights/7 days of continuous wear. The Eye Care Professional 
should determine the appropriate wearing time and provide 
speciﬁc instructions to the patient regarding lens care, 
insertion, and removal.
REPLACEMENT SCHEDULE
For Lenses Prescribed for Frequent Replacement:
When prescribed for daily wear (frequent replacement), it is 
recommended that the lenses be discarded and replaced with 
a new lens every 2 weeks. However, the Eye Care Professional 
is encouraged to determine an appropriate replacement 
schedule based upon the response of the patient.
For Lenses Prescribed for Single Use Disposable Wear:
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These lenses are indicated for single use disposable wear and 
should be discarded upon removal.
LENS CARE DIRECTIONS
For Lenses Prescribed for Frequent Replacement Wear:
The Eye Care Professional should review with the patient, lens 
care directions for cleaning, disinfecting and storing, including 
both basic lens care information and specific instructions on 
the lens care regimen recommended for the patient.
For Lenses Prescribed for Single Use Disposable Wear:
The Eye Care Professional should review with the patient that 
no cleaning or disinfection is needed with disposable lenses. 
Patients should always dispose of lenses when they are 
removed and have replacement lenses or spectacles available. 
Care for a Sticking (Non-Moving) Lens
During removal, if the lens sticks to the eye, 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 contact 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
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Each 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 MULTIFOCAL : base curve, power,
diameter, ADD, lot number, and expiration date
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions
observed in patients wearing these lenses or experienced with
the 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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Clinical Study Protocol 
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 DETERMINATION OF NEAR ADDITION 
 
 
 
 
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Clinical Study Protocol 
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 LENS FITTING CHARACTERISTICS 
 
 
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Clinical Study Protocol 
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 SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
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Clinical Study Protocol 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTION 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
BIOMICROSCOPY SCALE 
 
 
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 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
 
 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX E:  OCULAR DOMINANCE 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX F:  IRIS COLOR SCALE 
 
 
 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX G:  TEST AND CONTROL LENS FITTING GUIDE 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX H:  PSYCHOPHYSICAL TESTING  
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Johnson & Johnson Vision Care, Inc. 
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Johnson & Johnson Vision Care, Inc. 
 
APPENDIX I: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6391 Evaluation of Multifocal Contact Lens Designs with and without 
an HEV-Blocker on Visual Function 
 
Version and Date: 4.0 12 January 2022 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the Declaration 
of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual 
country laws/regulations and to comply with its obligations, subject to ethical and safety considerations. 
The Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion. 
 
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix I of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
Principal 
Investigator: 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
Institution/Site:  
 
 
 
 
Institution/Site Name 
 
 
 
 
 
 
Institution/Site Address 
 
 
 
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