The Effects of Contact Lenses With UV/HEV-Filter on Visual Function
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol  
Johnson & Johnson Vision 
 
 
 
 
 
The Effects of Contact Lenses With UV/HEV-Filter on Visual Function 
Protocol CR-6480 
Version: 5.0 
 
Date: 12 June 2023 
 
Investigational Products: senofilcon A with new ultraviolet (UV) and high energy visible 
(HEV) light filter 
 
Keywords: Sphere R&D platform, Presbyopia R&D Platform, Astigmatism R&D Platform, 
ACUVUE OASYS MAX 1-Day, ACUVUE OASYS MAX 1-Day Multifocal, ACUVUE 
OASYS 1-DAY, ACUVUE OASYS Multifocal, ACUVUE OASYS 1-Day 
for Astigmatism, senofilcon A, UV/HEV-filter, daily wear, daily disposable, non-dispensing, 
psychometric evaluation, visual range, brightness perception, motion detection. 
 
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 Declaration 
of Helsinki,2 and all applicable regulatory requirements. 
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY ................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS 
................................................................................................................................................. 16 
1. 
INTRODUCTION AND BACKGROUND.................................................................... 18 
1.1. 
Name and Descriptions of Investigational Products ................................................ 25 
1.2. 
Intended Use of Investigational Products ................................................................. 25 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 25 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 25 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study… ............................................................................................................................... 25 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 26 
2.1. 
Objectives ................................................................................................................. 26 
2.2. 
Endpoints .................................................................................................................. 26 
2.3. 
Hypotheses ............................................................................................................... 27 
3. 
TARGETED STUDY POPULATION ........................................................................... 28 
3.1. 
General Characteristics ............................................................................................ 28 
3.2. 
Inclusion Criteria ...................................................................................................... 28 
3.3. 
Exclusion Criteria ..................................................................................................... 29 
3.4. 
Enrollment Strategy .................................................................................................. 30 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 30 
4.1. 
Description of Study Design .................................................................................... 30 
4.2. 
Study Design Rationale ............................................................................................ 31 
4.3. 
Enrollment Target and Study Duration .................................................................... 31 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 32 
5.1. 
Test Article Allocation ............................................................................................. 32 
5.2. 
Masking .................................................................................................................... 32 
5.3. 
Procedures for Maintaining and Breaking the Masking. .......................................... 32 
6. 
STUDY INTERVENTION ............................................................................................. 33 
6.1. 
Identity of Test Articles ............................................................................................ 33 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 35 
6.3. 
Administration of Test Articles ................................................................................ 35 
6.4. 
Packaging and Labeling ........................................................................................... 35 
6.5. 
Storage Conditions ................................................................................................... 36 
6.6. 
Collection and Storage of Samples .......................................................................... 36 
6.7. 
Accountability of Test Articles ................................................................................ 36 
7. 
STUDY EVALUATIONS .............................................................................................. 37 
7.1. 
Time and Event Schedule ......................................................................................... 37 
7.2. 
Detailed Study Procedures ....................................................................................... 38 
VISIT 1 .............................................................................................................................38 
VISIT 2… .........................................................................................................................49 
FINAL EVALUATION .................................................................................................. 57 
7.3. 
Unscheduled Visits ................................................................................................... 57 
7.4. 
Laboratory Procedures ............................................................................................. 59 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 59 
8.1. 
Completion Criteria .................................................................................................. 59 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 59 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 60 
9.1. 
Systemic Medications .............................................................................................. 60 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 62 
11. 
STUDY TERMINATION ........................................................................................... 62 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 63 
13. 
ADVERSE EVENTS ................................................................................................... 64 
13.1. Definitions and Classifications................................................................................. 64 
13.2. Assessing Adverse Events ........................................................................................ 67 
13.2.1. 
Causality Assessment .................................................................................... 67 
13.2.2. 
Severity Assessment ...................................................................................... 67 
13.3. Documentation and Follow-Up of Adverse Events ................................................. 68 
13.4. Reporting Adverse Events ........................................................................................ 69 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 69 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
………………………………………………………………………………70 
13.5.   Event of Special Interest .......................................................................................... 70 
13.6.   Reporting of Pregnancy ............................................................................................ 71 
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14. 
STATISTICAL METHODS ........................................................................................ 71 
14.1. General Considerations ............................................................................................ 71 
14.2. Sample Size Justification ......................................................................................... 71 
14.3. Analysis Populations ................................................................................................ 72 
14.4. Level of Statistical Significance ............................................................................... 72 
14.5. Primary Analyses ..................................................................................................... 72 
14.6. Secondary Analyses ................................................................................................. 73 
14.7. Other Exploratory Analysis ...................................................................................... 74 
14.8. Interim Analysis ....................................................................................................... 75 
14.9. Procedure for Handling Missing Data and Drop-Outs ............................................. 75 
14.10. Procedure for Reporting Deviations from Statistical Plan ....................................... 75 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 75 
15.1. Electronic Case Report Form/Data Collection ......................................................... 75 
15.2. Subject Record ......................................................................................................... 76 
15.3. Trial Registration on ClinicalTrials.gov................................................................... 76 
16. 
DATA MANAGEMENT ............................................................................................. 77 
16.1. Access to Source Data/Document ............................................................................ 77 
16.2. Confidentiality of Information ................................................................................. 77 
16.3. Data Quality Assurance ............................................................................................ 77 
16.4. Data Monitoring Committee (DMC) ........................................................................ 77 
17. 
CLINICAL MONITORING ........................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................. 78 
18.1. Study-Specific Design Considerations ..................................................................... 78 
18.2. Investigator Responsibility ....................................................................................... 78 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) .............. 78 
18.4. Informed Consent ..................................................................................................... 80 
18.5. Privacy of Personal Data .......................................................................................... 80 
19. 
STUDY RECORD RETENTION ................................................................................ 81 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION ........................................................................................................... 82 
22. 
REFERENCES ............................................................................................................ 82 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 84 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 85 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 86 
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APPENDIX D: 
 ..................................... 164 
 DETERMINATION OF NEAR ADDITION ..................................................... 165 
 LENS FITTING CHARACTERISTICS ............................................................. 171 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ........................ 177 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE 
ERROR ................................................................................................................................. 179 
 BIOMICROSCOPY SCALE .............................................................................. 185 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ...... 191 
 TORIC FIT EVALUATION ............................................................................... 196 
APPENDIX E: EYE DOMINANCY .................................................................................... 201 
APPENDIX F: IRIS COLOR SCALE .................................................................................. 202 
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION .............................. 204 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 216 
 
LIST OF TABLES 
Table 1: Test Articles .............................................................................................................. 33 
Table 2: Control Articles ........................................................................................................ 34 
Table 3: Ancillary Supplies .................................................................................................... 35 
Table 4: Sample Labels ........................................................................................................... 36 
Table 5: Time and Events:  Phase 1 and Phase 2 .................................................................... 37 
Table 6: Disallowed systemic medications ............................................................................. 61 
Table 7: Disallowed systemic antihistamines ......................................................................... 61 
Table 8: Examples of major and minor protocol deviations ................................................... 62 
 
LIST OF FIGURES 
Figure 1: Study Flowchart: Phase 1 ........................................................................................ 14 
Figure 2: Study Flowchart: Phase 2 ........................................................................................ 15 
Figure 3:  Visual range illustration ......................................................................................... 19 
Figure 4:  Energy of blue haze versus sunlight ....................................................................... 19 
Figure 5:  Wavelength versus relative energy of D6500 illuminant ....................................... 20 
Figure 6:  Schematic of visual range set up ............................................................................ 20 
Figure 7:  Visual range set up emulates natural scene ............................................................ 21 
Figure 8:  Relative Energy of Various Light Sources ............................................................. 22 
Figure 9:  Motion threshold versus stimulus eccentricity ....................................................... 24 
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5.0 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Updated endpoints in 
Section 2.2. 
 
Updated hypotheses in 
Section 2.3 
 
 
 
 
Updated statistical  
Sections 14.2, 14.5, 14.6, 
and 14.7 
 
 
 
Updated Phase 2 sample 
size in Section 4.3 to 
match synopsis. 
 
Updated Section 6.1 
CLIFT test article 
quantities to reflect 
updated sample size. 
Based on decision 
from platform leads 
based on sample size 
calculations from 
Phase 1. 
Based on decision 
from platform leads 
based on sample size 
calculations from 
Phase 1. 
 
Based on decision 
from platform leads 
based on sample size 
calculations from 
Phase 1. 
 
Accuracy 
 
 
 
Accuracy 
 
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SYNOPSIS 
 
Protocol Title 
The Effects of Contact Lenses With UV/HEV-Filter on Visual 
Function 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Clinical trial phase: Feasibility 
Design control phase: 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor. 
Test Article(s) 
Investigational Products: senofilcon A-based contact lens 
(toric) with new UV/HEV filter 
Approved Products: ACUVUE OASYS MAX 1-Day 
(sphere, multifocal), ACUVUE OASYS 1-Day (sphere, 
toric), ACUVUE OASYS Multifocal 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily 
Objectives 
The objectives of this study are to objectively measure 
potential benefits of a new UV/HEV filter using 
psychophysical testing techniques. 
Study Endpoints 
Primary endpoint(s): visual range 
Secondary endpoint(s): brightness perception, motion 
detection 
Other observations: Ocular physiology. 
Study Design 
This is a 2-phase, single-site, non-dispensing, randomized, 
controlled, double-masked, 2x2 crossover study. There will be 
2 subject groups (sphere wearers and multifocal wearers) in 
Phase 1 and 3 subject groups (sphere wearers, multifocal 
wearers, and toric wearers) in Phase 2. Each subject will be 
bilaterally fitted with one of the two test articles in each of the 
two periods within each study phase. 
There will be a total of 2 visits in each phase of the study: 
1. Visit 1: Screening, baseline evaluation, lens fit #1 and 
psychophysical evaluation 
2. Visit 2: Baseline evaluation, lens fit #2, psychophysical 
evaluation, and final evaluation. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
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Sample Size 
Phase 1 will pilot the procedures and will enroll approximately 
24 subjects, with a target of at least 20 to complete (∼10 
spherical wearers and ∼10 multifocal wearers). Data from 
Phase 1 will be used for sample size estimation for Phase 2. 
Subjects in Phase 1 will not participate in Phase 2. 
Phase 2 will execute the same procedures as Phase 1 with a 
different sample size. Phase 2 sample size will be calculated 
based on data collected from Phase 1. The total sample size 
for Phase 2 will be approximately 135 subjects (45 per subject 
group to enroll and 40 to complete) due to resources and study 
timing. 
Study Duration 
There are two study visits in each phase that will last 
approximately 2.5-3 hours each and will be separated by 1-14 
days. 
• The study enrollment period for Phase 1 will be 
approximately 2 weeks, making the duration of Phase 1 
approximately 4 weeks. 
• Up to 2 weeks will be allotted for statistical analyses. 
• The study enrollment period for Phase 2 will be 
approximately 12 weeks, making the duration of Phase 2 
approximately 14 weeks. 
• The total study duration is expected to last about 20 weeks. 
Anticipated Study 
Population 
All subjects will be healthy adult male and female volunteers 
of any race and ethnicity that satisfy the inclusion criteria. All 
subjects must habitually wear one of three soft contact lenses 
within the power ranges available for this study: 
1. Spherical 
2. Multifocal 
3. Toric (astigmatism) 
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Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol. 
3. Be between 18 and 70 (inclusive) years of age at the time 
of screening. 
4. By self-report, habitually wear soft contact lenses (sphere, 
multifocal, toric) in both eyes in a daily reusable or daily 
disposable wear modality (i.e. not extended wear 
modality). Habitual wear is defined as a minimum of 6 
hours of wear per day, for a minimum of 5 days per week 
during the past 30 days. 
Inclusion Criteria at Baseline Evaluation 
5. If applicable, those subjects receiving the spherical lenses 
will need a vertex-corrected distance refraction within the 
range of -1.00 through -6.00 DS 
6. If applicable, those subjects receiving the multifocal 
lenses will need a vertex-corrected distance refraction 
within the range of -1.00 through -6.00 DS 
7. If applicable, those subjects receiving the toric lenses will 
need a vertex-corrected distance refraction within the 
range of -1.50 through -4.00 DS, -0.625 through 
-1.625 DC, and cylinder axes: 80/90/100, 170/180/10 
8. The best corrected, monocular, distance visual acuity must 
be 20/25 or better in each eye. 
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Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any 
ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication that the 
investigator believes might contraindicate or interfere with 
contact lens wear, or otherwise compromise study 
endpoints, including infectious disease (e.g., hepatitis, 
tuberculosis), contagious immunosuppressive disease 
(e.g., 
Human 
Immunodeficiency 
Virus 
[HIV]), 
autoimmune disease (e.g. rheumatoid arthritis, Sjögren’s 
syndrome), or history of serious mental illness or seizures. 
See section 9.1 for additional details regarding excluded 
systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, 
SoftPerm) within the past 6 months. 
5. Be currently wearing lenses in an extended wear modality. 
6. Have participated in a contact lens or lens care product 
clinical trial within 14 days prior to study enrollment. 
7. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an employee 
(including partner, child, parent, grandparent, grandchild 
or sibling of the employee or their spouse) of the clinical 
site. 
8. (Phase 2 only): Have participated in Phase 1 of the study. 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities that the investigator believes might 
contraindicate contact lens wear or may otherwise 
compromise study endpoints (including entropion, 
ectropion, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, aphakia, moderate or above 
corneal distortion, herpetic keratitis). 
10. Have a history of strabismus or amblyopia. 
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11. Have fluctuations in vision due to clinically significant dry 
eye or other ocular conditions. 
12. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, 
PRK, LASIK, iridotomy, retinal laser photocoagulation, 
etc.). 
Disallowed 
Medications/Interventions 
No ocular medications. 
See section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
The new UV/HEV-filter has the potential to provide visual 
benefits that go beyond the correction of ametropia. To 
evaluate some of these benefits, various laboratory equipment 
will be used to measure visual range, brightness perception, 
and motion detection in accordance with published literature 
and established psychometric and psychophysical principles. 
Microbiology or Other 
Laboratory Testing 
None 
Study Termination 
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled. 
Ancillary Supplies/ Study- 
Specific Materials 
Optical device for measuring visual range; light track for 
motion detection, projected optics for measuring brightness 
perception. 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File. 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
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 
BSCVA 
Best Spectacle Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CLUE 
Contact Lens User Experience 
COM 
Clinical Operations Manager 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
 
 
D 
Diopter 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
ESD 
Eyelid Stabilized Design 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HEV 
High Energy Visible 
HIPAA 
Health Insurance Portability and Accountability Act 
HIV 
Human Immunodeficiency Virus 
IB 
Investigator’s Brochure 
ICH 
The International Council for Harmonization 
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 
LRE 
Log-Relative Energy 
OD 
Right Eye 
OS 
Left Eye 
OU 
Both Eyes 
PIG 
Patient Instruction Guide 
PQC 
Product Quality Complaint 
PRK 
Photorefractive Keratectomy 
PRO 
Patient Reported Outcome 
QA 
Quality Assurance 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SAP 
Statistical Analysis Plan 
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SAS 
Statistical Analysis System 
SD 
Standard Deviation 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
UGA 
University of Georgia 
UV 
Ultraviolet 
VA 
Visual Acuity 
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1. INTRODUCTION AND BACKGROUND 
A. Visibility (a.k.a. visual range, contrast sensitivity function under emulated blue 
haze) 
Bennett in 1930 defined “visibility” as “the clearness with which objects in the atmosphere 
stand out from their surroundings.” In Wooten and Hammond (2012) the authors provided a 
detailed overview of the atmospherics optics and visual issues that are involved. A few basic 
ideas were explored: 
 
A.1. Rayleigh’s and Mie’s scatter equations 
Essentially, short-wave (SW) visible light (blue appearing) scatters significantly more than 
other wavelengths. Hence, a clear sky is blue, correlating with the predominance of SW energy 
that is scattered into our eyes. Note that violet wavelengths are scattered more than blue, yet 
we perceive a blue sky and not a violet sky. This is because the sun emits more blue light than 
violet, and our eyes are more sensitive to blue than to violet. When particle diameter is greater 
than about 0.1λ, Rayleigh’s theory does not explain the scattering. Larger particles scatter more 
and show a more complex spatial pattern and wavelength dependency (smaller particles 
converge on Rayleigh’s theory, larger, like fog droplets, simpler geometrical optics). 
 
A.2. Haze aerosols 
Pure air, consisting of only gas molecules, is so rare as to be only of theoretical interest. Ground 
fog is unusual, but not rare. Between these two extremes exists a range of conditions called 
aerosols that constitute the overwhelmingly predominant set of factors that largely determine 
the quality of vision in the atmosphere. The wavelength dependency of haze aerosols was first 
presented by Middleton (1952): βsc = cλ-υ. This formula, combined with extensive observations, 
show that scatter in haze aerosols varies from slightly blue to very blue. 
 
A.3. Visual range 
Aside from the optical and neural aspects of the human observer, scatter in the aerosol haze is 
the primary determinant of visual discrimination and range in the outdoors. As we look out 
over the landscape from an elevated location or from an airplane, we notice that the more and 
more distant elements of the scene become lighter in tone, until sometimes the most distant 
objects are indiscernible from the horizon. Frequently, the scene seems tinged with a distinctly 
blue hue. Artists call this phenomenon “aerial prospective” and use it as a depth cue in 
paintings. Atmospheric physicists call it air light. It is this air light that forms a SW dominant 
veiling illuminance over visual objects in the distance. 
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Figure 3: Visual range illustration 
 
 
Figure 4: Energy of blue haze versus sunlight 
 
 
A.4. Targets and backgrounds (air light): 
Non-image forming air light acts as a background or veiling luminance with respect to targets 
seen through it. Furthermore, the background luminance increases and becomes increasingly 
short-wave dominant (blue haze) as the viewing distance increases. The luminance of a target, 
on the other hand, decreases and becomes increasingly short-wave deficient as the viewing 
distance increases. 
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Figure 5: Wavelength versus relative energy of D6500 illuminant 
 
 
A short-wave absorbing filter would have a quantitatively different effect on the 
luminance of a background and a target. A SW filter would improve contrast for a target in an 
aerosol haze by attenuating the air light luminance (background) more than the target 
luminance 
 
A.5 The conceptual design of the visibility apparatus: 
In the proposed study, the plan is to use a system that is based on the systems that previously 
used and published, testing the ideas expounded in the Visibility Hypothesis (Hammond et al., 
2012, Fletcher et al., 2014). 
 
Figure 6: Schematic of visual range set up. 
 
Contrast sensitivity is measured using a series of sine-wave gratings on glass (back illuminated 
with broad-band light). Blue Haze is brought in from a different optical channel and imposed 
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between the eye and the grating target. At the plane of the eye, it can be made to exactly mimic 
the optics of a natural scene. 
 
Figure 7: Visual range set up emulates natural scene 
 
 
 
A.6. Details of the method 
The determination of contrast sensitivity requires an apparatus that provides for the careful, 
calibrated variation of sine-wave gratings with respect to spatial frequency and contrast. In 
most vision experiments, these features are achieved with a CRT oscilloscope or computer 
monitor (or even less precisely, with wall charts like the CSV-1000), which allows relatively 
simple electronic control of both spatial frequency and contrast. However, absolute energy and 
the spectral energy distributions of the available phosphors are not appropriate for the 
experiments that we would like to conduct. The need for brighter light in some of the 
assessments rules out oscilloscopic displays because of their relatively low energy. Also, as 
noted, we need broad-band light that is close in spectral energy to natural phases of daylight. 
This can be achieved with a combination of integrating spheres and laser light sources; it cannot 
be done with CRTs. The challenge for our proposal is how to generate and control sine-wave 
gratings in a way that allows a wide range of control of the spectral energy distributions. CRTs, 
computer monitors, wall charts, etc., will not work. Consequently, the previously validated 
apparatus used in other clinical studies, such as 
 can be adapted for testing visual 
range under simulated haze conditions, as shown in Figure 7 above. 
 
To measure visual range, participants will view a highly calibrated 0.5 cycles per mm grating, 
which when placed in the apparatus with the participant at the appropriate test distance 
produces contrast at 8 cycles per degree of visual angle. Participants will view the grating first 
with no simulated haze interposed. The researcher will gradually introduce haze that increases 
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The lack of SW energy in Tungsten-Halogen would have minimized any direct filtering effects 
in Kelley’s study. 
 
Details of the method 
The evaluation will involve simple tests of stimulus brightness based on brightness matching: 
in essence, the investigators will set the scene at a moderate brightness and the subject will 
adjust the standard (now the dependent outcome) to match. A projector with a high-intensity 
xenon source will be used to project natural scenes for binocular viewing. A total of five scenes 
will be selected that vary in their short- mid- and long-wave composition. Participants will 
adjust a neutral density wedge that controls the intensity of a light stimulus presented next to 
the natural scene. The log-relative energy at which the standard and scene match to the observer 
will be recorded. 
 
C. Motion perception (a.k.a. peripheral glare displacement threshold) 
There are many definitions of motion perception, but some distinctions should be made up 
front. In past studies we have measured temporal vision (like CFF or the temporal contrast 
sensitivity function) but this is not motion per se. Motion implies movement across space and 
typically includes both speed/velocity and direction. In a real-world setting, motion perception 
also includes input from not just visual but also vestibular and proprioceptive inputs. Most 
basic motion experiments tend to keep stimulus exposure (duration) and head position constant 
while varying the velocity (isochronal thresholds). 
 
The underlying biology of motion perception is well-known and distinct. Retinal ganglion cells 
that act as motion detectors have been identified, as well as the primary visual pathways 
(primarily magnocellular) and extrastriate cortical areas specialized for motion (like V5). This 
biology itself could likely be influenced by tinted contact lenses. For example, the wavelength 
content of stimuli have been used to bias information transmission down the magno vs the 
parvocellular pathways. The magnocellular system (unlike parvocellular neurons) does not 
respond to stimuli varying only in hue. This is the scientific justification behind used colored 
filters (like Irlen filters) for disorders that reflect parvo-magno imbalances (like dyslexia and 
schizophrenia; although the state of the evidence for using these kinds of filters is pretty 
controversial; Miyasaka et al., 2019). 
 
Leibowitz et al. (1972) performed the study that was both foundational and is likely the best 
option for beginning studies in this area. Liebowitz first showed that much of the variance in 
peripheral motion perception is caused by optical factors. The basic result is shown below: 
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Figure 9: Motion threshold versus stimulus eccentricity 
 
 
As shown in the figure, whereas motion thresholds change for all subjects with eccentricity, 
the worsening was much greater for subjects whose refractive condition was not corrected. The 
testing scheme that Leibowitz used can be used in this study to emphasize different optical 
factors (he tested mostly blur) while measuring small changes in isochronal thresholds. 
 
Details of the method 
Leibowitz used only three male graduate students. While a subject maintained monocular 
fixation with his dominant eye, thresholds for motion perception were determined for the 
temporal visual field for a one-second exposures at eccentric angles ranging from 0° to 80° in 
10° steps. The stimulus was a white (high reflectance, 80%) square, 1.3 cm on a side, with 
luminance 4.3 mlam, viewed against a black (low reflectance, less than one percent) back- 
ground at a distance of 78.7 cm. Subjects report whether the stimuli moved to the left of right 
(forced choice, with thresholds defined psychometrically). In our application, we will select 
points that are in the area of the curve most affected by optical correction (40-80 degrees, 
randomly presented). A xenon source will be channeled through a fiber optic light guide 
affixed to an automated, motor-driven positioning slide that moves left and right on fixed 
increments. Participants will view a centrally located fixation point. The fiber optic test light 
will be presented in the periphery. Participants will judge which direction the test light moved 
from its starting point, either to the left (towards the fixation point) or to the right (away from 
the fixation point). The essential idea is that the poorer optics results in more aberrated the 
light, the less the subject will be able to correctly indicate the direction of motion. The distance 
necessary for a participant to reliably detect that movement has occurred will be recorded. 
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1.1. Name and Descriptions of Investigational Products 
This study will test three (3) senofilcon A designs (two of which are commercially available: 
ACUVUE OASYS MAX 1-Day and ACUVUE OASYS MAX 1-Day Multifocal) that each 
contain a new UV/HEV filter against three (3) commercially available products that don’t 
contain the new UV/HEV-filter (ACUVUE OASYS 1-Day, ACUVUE OASYS 
Multifocal, and ACUVUE OASYS 1-Day for Astigmatism). Further details about the test 
articles are found in Section 6 of this protocol. 
 
1.2. Intended Use of Investigational Products 
The intended use of the investigative product is for correcting myopia and for improving the 
visual experience by improving contrast in an HEV environment. During the study, each test 
article will be worn bilaterally in daily wear, daily disposable modality for 2.5-3 hours. The 
subject will wear both test articles in a cross-over study design. 
 
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding senofilcon A 
lens with new UV/HEV filter, refer to the latest version of the Investigator’s Brochure.10 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The risks of wearing soft contact lenses are well known and are described in the Investigator’s 
Brochure and Informed Consent. The material safety testing/lens release criteria was 
determined based on the Risk Assessment. Benefits to the subjects include the correction of 
their refractive error with the potential of improved contrast in HEV environments. 
 
For the most comprehensive risk and benefit information regarding the senofilcon A with new 
UV/HEV-filter, refer to the latest version of the Investigator’s Brochure or the package insert 
of the marketed products. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
1. Bennet, MG, 1930. The physical conditions controlling visibility through the 
atmosphere. Quar. J. Roy. Meteorol. Soc. 56, 1–29. 
2. Bovier, E.R., Renzi, L. and Hammond, B.R. (2014). A double-blind, placebo- 
controlled study on the effects of lutein and zeaxanthin on neural processing speed and 
efficiency. PLoS ONE 9(9): e108178. doi:10.1371/journal.pone.0108178. 
3. Fletcher, L. M., Engles, M., & Hammond Jr, B. R. (2014). Visibility through 
atmospheric haze and its relation to macular pigment. Optometry and  Vision  Science, 
91(9), 1089-1096. 
4. Gregory, R. L. (2015). Eye and brain: The psychology of seeing. Princeton university 
press. 
5. Hammond, B.R., Warner, R.M. and Fuld, K. (1995). The relationship between blood 
pressure and sensitivity to flicker. Journal of Psychophysiology, 9(3), 212-220. 
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6. Hammond Jr, B. R., Wooten, B. R., Engles, M., & Wong, J. C. (2012). The influence 
of filtering by the macular carotenoids on contrast sensitivity measured under simulated 
blue haze conditions. Vision research, 63, 58-62. 
7. Hammond,   B.   R.   (2012).   The   visual   effects   of   intraocular    colored    filters. 
Scientifica, 2012. 
8. Kelly, S. A. (1990). Effect of yellow-tinted lenses on brightness. JOSA A, 7(10), 1905- 
1911. 
9. Leibowitz, H. W., Johnson, C. A., & Isabelle, E. (1972). Peripheral motion detection 
and refractive error. Science, 177(4055), 1207-1208. 
10. Middleton, WEK, 1952. Vision through the Atmosphere, University of Toronto Press, 
Toronto, ON, 
11. Miyasaka, J. D. S., Vieira, R. V. G., Novalo-Goto, E. S., Montagna, E., & Wajnsztejn, 
R. (2019). Irlen syndrome: systematic review and level of evidence analysis. Arquivos 
de neuro-psiquiatria, 77(3), 194-207. 
12. Renzi, L., Bovier. E and Hammond, B.R. (2013). A role for the macular carotenoids in 
visual motor response. Nutritional Neuroscience. 16(6), 262-268. 
13. Wooten, B. R., & Hammond, B. R. (2002). Macular pigment: influences on visual 
acuity and visibility. Progress in retinal and eye research, 21(2), 225-240. 
 
Additional information about the toric Test lens can be found in the Investigator Brochure. 
Additional information about the other Test lenses and the Control lenses can be found in their 
Package Insert (Appendix C). 
 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
 
2.1. Objectives 
The purpose of this investigation is to evaluate the short-term, clinical psychophysical 
performance of contact lenses with a new UV/HEV-filter.  
 
Primary Objective(s) 
The primary objective of Phase 1 study is to collect clinical data to estimate the required Phase 
2 sample size for achieving the primary objective with adequate statistical power given the 
prespecified primary hypotheses testing. 
 
The primary objective of the Phase 2 study is to objectively measure potential benefits of a 
new UV/HEV filter using psychophysical testing techniques. 
 
The results from this study may be used to support marketing claims or help understand market 
readiness of the Test lenses that contain the UV/HEV filter. 
 
 
2.2. Endpoints 
The investigational lens has the potential to improve how far the subject can see through blue 
atmospheric haze (visual range), improve how well they can perceive motion, and positively 
influence how bright an image appears compared to the control lens. In this study, the 
investigators will evaluate these parameters using controlled laboratory systems. 
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Primary Endpoints for Sphere and Multifocal wearers: 
 
1. Visual Range (tested binocularly at 8 cycles per degree). Visual range is defined as the 
log relative energy of simulated haze needed to obscure an otherwise high contrast 
grating target. Better visual range is indicated by a higher log-relative energy (LRE) of 
simulated haze (more haze) to obscure an otherwise highly visible target. 
 
Secondary Endpoints: 
 
1. For Spherical wearers - Motion Detection (tested binocularly). Motion detection is 
defined as the distance needed (in mm) to determine that a test light has moved from a 
standard position. Better motion detection is indicated by a smaller distance needed to 
detect that movement has occurred. 
 
2. For Multifocal wearers - Brightness Perception Score (tested binocularly). Brightness 
perception is defined as the log- relative energy needed to match a standard stimulus to 
a natural scene, across 10 different projected scenes. The perception of brighter image 
is indicated by a higher log-relative energy (LRE) needed to match the initially dim 
standard to the target. The top 5 scenes will be averaged for each subject. 
 
 
Exploratory Endpoints: 
 
1. For Spherical wearers – brightness perception 
2. For Multifocal wearers – motion detection 
3. For Toric wearers – visual range, motion detection, and brightness perception 
4. Biomicroscopy (all contact lens wearers) 
 
2.2. Hypotheses 
Phase 1 
No Hypotheses will be tested in Phase 1. Data obtained from Phase 1 will be used to calculate 
the sample size required for yielding adequate statistical power in testing the planned primary 
hypotheses in Phase 2. See Section 14.8 for further details. 
 
Primary Hypotheses - Phase 2 
 
The statistical hypotheses to meet the primary study objective of Phase 2 will be defined on 
the basis of the Phase 1 clinical results to make the adequate efficacy assumptions to power 
the Phase 2 of the study appropriately.  
 
1. Subjects wearing the Test lens will have statistically significantly improved visual 
range than the Control lens among spherical wearers.  
 
2. Subjects wearing the Test lens will have statistically significantly improved visual 
range than the Control lens among multifocal wearers.  
 
 
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Secondary Hypotheses - Phase 2 
 
1. Subjects wearing the Test lens will have statistically significantly improved motion 
detection than the Control lens among spherical wearers.  
 
2. Subjects wearing the Test lens will perceive an image statistically significantly brighter 
than the Control lens among multifocal wearers.  
 
 
Exploratory Hypotheses - Phase 2 
 
1. Subjects wearing the Test lens will have statistically significantly improved visual 
range than the Control lens among Toric wearers.  
 
2. Subjects wearing the Test lens will perceive an image statistically significantly brighter 
than the Control lens among Toric wearers.  
    
 
 
3. TARGETED STUDY POPULATION 
 
3.1. General Characteristics 
This study will enroll healthy adult subjects of any gender, race, and ethnicity that satisfy the 
eligibility criteria. 
 
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
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2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between 18 and 70 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or 
daily disposable wear modality (i.e. not extended wear modality). Habitual wear is 
defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week 
during the past 30 days. 
 
Inclusion Criteria at Baseline Evaluation 
5. If applicable, those subjects receiving the spherical lenses will need a vertex-corrected 
distance refraction within the range of -1.00 through -6.00 DS 
6. If applicable, those subjects receiving the multifocal lenses will need a vertex-corrected 
distance refraction within the range of -1.00 through -6.00 DS 
7. If applicable, those subjects receiving the toric lenses will need a vertex-corrected 
distance refraction within the range of -1.50 through -4.00 DS, -0.625 through 
-1.625 DC, and cylinder axes: 80/90/100, 170/180/10 
8. The best corrected, monocular, distance visual acuity must be 20/25 or better in each 
eye 
 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be currently using any ocular medications or have any ocular infection of any type. 
3. By self-report, have any ocular or systemic disease, allergies, infection, or use of 
medication that the investigator believes might contraindicate or interfere with contact 
lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human 
Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, 
Sjögren’s syndrome), or history of serious mental illness or seizures. See section 9.1 
for additional details regarding excluded systemic medications. 
4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or 
hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months. 
5. Be currently wearing lenses in an extended wear modality. 
6. Have participated in a contact lens or lens care product clinical trial within 14 prior to 
study enrollment. 
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family 
member of an employee (including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site. 
8. (Phase 2 only): Have participated in Phase 1 of the study. 
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Exclusion Criteria at Baseline Evaluation 
The subject must not: 
9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp 
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or abnormalities that the investigator 
believes might contraindicate contact lens wear or may otherwise compromise study 
endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history 
of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic 
keratitis). 
10. Have a history of strabismus or amblyopia. 
11. Have fluctuations in vision due to clinically significant dry eye or other ocular 
conditions. 
12. Have had or have planned (within the study period) any ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 
 
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 
The study is a 2-phase, single-site, non-dispensing, controlled, randomized, double-masked, 
2x2 crossover (2 study lenses x 2 wearing periods) design where one of the study lenses will 
be worn bilaterally for 2.5-3 hours on Visit 1 and the other study lens worn bilaterally for  2.5- 
3 hours on Visit 2. At study closure, participants will have no further access to the study lenses. 
 
It is important that the subjects wear the same type of lens on both eyes (i.e., both eyes wear 
spherical, both eyes wear multifocal, or both eyes wear toric). All lenses will be fit for distance 
vision OD and OS according to the fitting guides located in the appendices, which largely 
follow the Fitting Guide of the control lenses. 
 
Non-presbyopes (age 18 through 39) may wear either a spherical lens or a toric lens on both 
eyes. The Fitting Guide for spherical products extends to 1.00 D of refractive cylinder, while 
the Fitting Guide for toric products starts at 0.75 D of refractive cylinder. The investigator will 
therefore use her / his experience in deciding whether the subject will be best fit in a spherical 
or toric lens on each eye. If fitting the toric lens, the refractive cylinder power should be suitable 
to be fit with either the 0.75 D or 1.25 D cylinder lens. 
 
Presbyopes (age 40-70) will be fit with a multifocal lens on both eyes. Note that the multifocal 
lenses, particularly the higher ADD powers, are likely to over-refract needing more minus. 
This is normal and will not follow the same 0.00 D over-refraction requirement as the spherical 
and toric designs. 
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4.2. Study Design Rationale 
The purpose of this study is to evaluate the performance of a new UV/HEV-filter in a 2x2 
crossover design for three different subject groups (i.e., sphere wears, multifocal wears, and 
toric wears). Crossover designs are a well-established study design in which subjects are 
exposed to multiple treatments during different time periods. This design is cost effective and 
more efficient since it eliminates part of the inter-subject variability from the treatment 
comparisons. Subjects will be randomized into the two lens wear sequences: Test/Control or 
Control/Test. Randomization eliminates selection bias and balances both the known and 
unknown confounding factors that may affect the study outcomes. A potential limitation of 
crossover design is the carry-over effect from the previous treatment. The 2 study periods 
(visits) will be separated by 1-14 days and the wearing time of 2.5-3 hours in each period is 
considered effectively short to minimize the presence of the carry-over effect in the 
psychometric tests of interest. Rest period between trials within a single measurement type and 
between different measurement types is incorporated to eliminate the impact of any previous 
testing. 
 
• Within a single measurement type (e.g., visual range), a minimum of 30-seconds will 
be taken between trials. 
• Between measurement types (e.g., when switching from visual range to measuring 
brightness perception), a 5-minute break will be taken. 
• Participants will be given a 15-minute break after every 45 minutes of visual function 
testing. 
 
4.3. Enrollment Target and Study Duration 
Phase 1 
Phase 1 will have an enrollment target of 24 subjects, with a target of at least 20 to complete. 
Approximately 10 subjects will wear spherical soft contact lenses and approximately 10 subjects 
will wear multifocal soft contact lenses. The study will be conducted at a single clinical site. 
A subject will be considered enrolled upon signing the informed consent form. 
 
There will be 2 visits in total per subject separated by 1-14 days. The enrollment period is 2 
weeks making the duration of Phase 1 approximately 4 weeks. If subjects discontinue prior to 
the final evaluation, then additional subjects may be enrolled at the discretion of the study 
sponsor to maintain sample size requirements. 
 
Phase 2 
Phase 1 results are used to estimate the number of subjects required for Phase 2. However, the 
total sample size for Phase 2 will be approximately 135 subjects due to resources and study 
timing. The study will be conducted at a single clinical site. A subject will be considered enrolled 
upon signing the informed consent form. Phase 1 subjects will not be Phase 2 subjects. 
 
There will be 2 visits in total per subject separated by 1-14 days. The enrollment period is 12 
weeks making the duration of Phase 2 approximately 14 weeks. If subjects discontinue prior 
to the final evaluation, then additional subjects may be enrolled at the discretion of the study 
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sponsor to maintain sample size requirements. The investigation will end at the time that the 
study data is hard locked. 
 
5. TEST ARTICLE ALLOCATION AND MASKING 
 
5.1. Test Article Allocation 
This is a two phase, 2x2 crossover study within each phase. Both study lenses will be worn in 
a bilateral and randomized fashion. Randomly-permuted block randomization will be used to 
avoid bias in the assignment of subjects to treatment and to enhance the validity of statistical 
comparisons across treatment groups. A computer-generated randomization scheme will be 
used to randomly assign subjects to one of the two possible lens wear sequences (Test/Control 
or Control/Test) within each study phase. The randomization will be stratified by subject group 
within each phase. The random scheme will be generated by the unmasked biostatistician using 
the PROC PLAN procedure in Statistical Analysis System (SAS) Software Version 9.4 or 
higher (SAS Institute, Cary, NC).5 
 
Randomization will be performed at Visit 1. The following must have occurred prior to 
randomization: 
 
• Informed consent must have been obtained. 
• The subject must have met all eligibility criteria. 
• The subject’s screening and baseline information must have been collected. 
5.2. Masking 
This is a double-masked study. Subjects will be unaware of the identity of the investigational 
product. The investigator conducting the psychophysical testing will also not be informed. 
Instead, lens type will be identified by code only, and the link between the code and the lens 
type will not be revealed to the investigator conducting the psychophysical testing until after 
the database has been locked. The clinician fitting the lenses will not be masked as to the 
identity of the investigational products and may be able to tell the difference between the Test 
and Control lenses based on color differences between the lenses. 
 
5.3. Procedures for Maintaining and Breaking the Masking 
Every attempt will be made to keep the clinical trial personnel involved in the study (e.g. data 
management, study lead biostatistician and clinical operations) unaware of the identity of the 
assigned study lenses. The identity of the study lenses will be masked by having the blister 
packs labeled with the study number, lot number, sphere power, expiration date and the 
randomization codes. Only the unmasked biostatistician generating the lens fitting schedule 
will have access to the decode information that allows matching of the randomization codes to 
the test articles. The medical monitor will also have access to the decode information in case 
breaking the mask is necessary for the urgent medical treatment of a subject. 
 
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 
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• Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
• Collect all unused test article(s) from the subject. 
• Make arrangements for subject care, if needed, due to their study participation 
Additional subjects will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
• Concomitant medications will be documented during screening and updated during the 
study. Disallowed medications for this study include: Any ocular medication. 
medications that may interfere with contact lens wear (see section 9.1). Habitual 
medications used by successful soft contact lens wearers are generally considered 
acceptable. 
• Concomitant therapies that are disallowed include: NA 
9.1. Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. 
 
A summary of disallowed systemic medications is shown in Table 7. Subjects with a history of 
taking these medications will be allowed to enroll only if: 
 
• The medications have been taken on a continual, routine basis for at least 6 months, 
and 
• The subject has demonstrated successful contact lens wear during this time. 
Or:  
• The subject was taking the medication on a temporary basis and ceased taking that 
medication at least 2 weeks prior to signing the informed consent (this is considered 
sufficient time for the medication to have left the body prior to enrollment). 
 
Subjects with a history of taking medications listed in Table 6 on a long-term, routine basis 
for less than 6 months will not be allowed to participate in the study. 
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suspended. Upon review and consultation with IRB, and JJVC Safety Review committee, the 
study may be terminated. 
 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or any 
SAE where the relationship to study agent cannot be ruled out, may result in stopping further 
dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask the 
treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify 
the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use. 
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• Damage deemed by clinicians or clinical staff to be caused by handling by the user, and 
not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where there 
is no deficiency alleged by the subject. 
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Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred. 
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
 
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
• Who received the complaint. 
• Study number. 
• Clinical site information (contact name, site ID, telephone number). 
• Lot number(s). 
• Unique Subject Identifier(s). 
• Indication of who first observed complaint (site personnel or subject). 
• OD/OS indication, along with whether the lens was inserted. 
• Any related AE number if applicable. 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
• Eye Care Provider objective (slit lamp) findings if applicable. 
• Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
 
 
 
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 and whether 
anticipated or unanticipated.” 
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Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
 
• Death 
• Serious deterioration in the health of the subject that resulted in any of the following: 
• Life-threatening illness or injury 
• Permanent or persistent impairment of a body structure or a body function 
• Hospitalization or prolongation of patient hospitalization 
• Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• Chronic disease 
• Fetal distress, fetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• Limbal cell Damage leading to Conjunctivalization 
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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: 
 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time. However, the Investigator may choose to prescribe treatment as a precautionary 
measure. 
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
 
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.1 
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the 
test 
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article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
 
• Seriousness/Classifications (see definition in section 13.1). 
• Causality or Relatedness – i.e., the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
• Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in section 
13.2.2). 
• Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
• Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
 
• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
• Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
• Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
• Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
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• Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
• Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
• Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure. Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF. 
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship. 
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
 
• Adverse event (diagnosis not symptom). 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
• Date the clinical site was notified. 
• Date and time of onset. 
• Date and time of resolution. 
• Adverse event classification, severity, and relationship to test articles, as applicable. 
• Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
• Any referral to another health care provider if needed. 
• Outcome, ocular damage (if any). 
• Likely etiology. 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
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Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or been 
satisfactorily resolved. If further treatment beyond licensure is required, the patient will be 
referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain information 
requested by the Sponsor in addition to that information reported on the eCRF. All subjects 
experiencing a serious/significant adverse event must be followed up and all outcomes must be 
reported. 
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When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
 
• Notify the Sponsor immediately. 
• Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
• Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
• Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines. 
 
13.5. Event of Special Interest 
None 
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13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
 
14. STATISTICAL METHODS 
 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. 
 
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).5 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 separately for each phase and lens type (Test and Control) and 
will be performed separately by completion status (Safety Population, Per-Protocol Population 
and Intent-to-Treat Population, when appropriate). 
 
14.2. Sample Size Justification 
Sample size for Phase 1 was not determined on the basis of statistical considerations because 
it is primarily for the collecting clinical data to calculate the required sample size for Phase 2. 
Sample size requirements for Phase 2 were based on assumptions derived from the analysis of 
selected data collected in Phase 1. It was calculated that the total sample size of 120 subjects 
to complete (40 per group) the study provides at least 90% power to test each primary and 
secondary hypothesis. The sample size and power calculations were performed using a paired 
sample t-test approach (exact method) in PASS (NCSS, 2021).6   
A gate-keeping approach will be used to control the study-wise Type I error rate at the one-
sided 0.025 level and adjust for multiplicity due to multiple efficacy endpoints of interest in 
combination of Bonferroni adjustment. The null hypothesis for the primary efficacy endpoints 
has to be rejected at one-sided alpha level of 0.025 first, in order to propagate the full alpha to 
the secondary family of hypothesis tests. The Bonferroni approach will apply then to testing 
the secondary efficacy endpoints. 
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The sample size estimates for primary endpoints were calculated using 1-sided Type I error 
rate of 0.025 for each endpoint. The sample size estimates for the two secondary endpoints 
were adjusted using a Bonferroni adjustment and calculated using a one-sided Type I error rate 
of 0.0125 (i.e., one-sided 0.025/2).  
 
While no Toric wearers were enrolled in Phase 1, it is anticipated that the multifocal group 
would require the largest sample due to simultaneous optics of the multifocal lens and the 
intraocular scattering that naturally occurs with age, which can both compromise and reduce 
the quality of vision. Hence it is expected that the sample size required to test endpoints for 
Toric wearers would be no more than the sample size required for Multifocal wearers. As these 
endpoints did not have data from Phase 1, all hypotheses for the Toric wearers will be 
exploratory endpoints.  
 
Table 9 displays the statistical power and associated sample sizes estimates derived for the 
primary and secondary endpoints for Sphere and Multifocal groups, given the assumed 
treatment effect sizes. Based on the table below, it is planned that Phase 2 will enroll 
approximately 135 subjects (45 subjects per group) with the target of  120 subjects (40 subjects 
per group) to complete the study, assuming approximately a 10% drop-out rate.  
 
Table 9: Assumptions for Power and Sample Size Calculations for The Primary and Secondary 
Endpoints  
Endpoint 
Type 
Endpoint 
(Subject 
Group) 
Standard 
Deviation of 
Paired 
Differences 
Effect Size 
Alpha 
Power 
Sample 
Size Per 
Group 
Primary 
 
Visual Range 
(Sphere)  
0.10 
1.83 
0.05 
0.94 
6 
Visual Range 
(Multifocal) 
0.23 
0.52 
0.05 
0.90 
41 
Secondary 
Motion 
Detection 
(Sphere)  
1.16 
0.99 
0.03 
0.92 
16 
Brightness 
Perception 
(Multifocal) 
0.20 
0.70 
0.03 
0.91 
29 
 
14.3. Analysis Populations 
Safety Population: 
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article.  
 
Per-Protocol (PP) Population:  
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file. 
 
Intent-To-Treat (ITT Population): 
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol.  
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14.4. Level of Statistical Significance 
Although the Test and Control lenses are senofilcon A based lenses with and without the new 
UV/HEV filter, respectively, the study lenses assigned to each subject group will be different 
with different optical designs specifically for vision correction of the sphere, multifocal, and 
toric (astigmatism) lens wearers. Therefore, the planned hypotheses in Phase 2 will be tested 
separately for each subject group without Type I error adjustment across the three subject 
groups, due to different optical designs of the study lenses for different groups. The primary 
hypothesis for each subject group will be tested using a one-sided Type I error rate of 0.025. 
The secondary hypotheses will be tested only when the primary hypothesis is met for the same 
subject group. For secondary hypotheses, the Type I error rate will be adjusted using the 
Bonferroni approach for the two secondary hypotheses and each secondary hypothesis will be 
tested using the Bonferroni adjusted one-sided Type I error rate 0.0125 (i.e., one-sided 
0.025/2).   
 
14.5. Primary Analyses  
Phase 1 
There is no planned hypothesis testing in Phase 1. Data collected during Phase 1 of the study 
will be used to power Phase 2 for testing superiority of test lens relative to control lens with 
respect to the primary endpoint within each subject group. See section 14.8 for details 
regarding the interim analysis of the Phase 1 data. 
 
Phase 2 
Visual Range 
The visual range metric will be analyzed separately for two of the three subject groups (i.e., 
Spherical wearers and Multifocal wearers) using a linear mixed model. The analysis will be 
conducted on the ITT population. An appropriate distribution from the exponential family 
(e.g., normal or lognormal) will be considered for the linear mixed modeling based on the 
distribution of the endpoint. The model will include lens type, lens sequence, and period as 
fixed effects. Other baseline and subject characteristics such as age, gender, race, and iris color 
will be included as fixed covariates when appropriate. An unstructured (UN) covariance matrix 
will be used to model the residual errors among within-subject repeated measures (R-side). If 
the model fails to converge, a Compound Symmetric (CS) matrix may be considered. The 
Kenward and Roger method7 will be used for the denominator degree of freedom. 
 
Hypothesis Testing 
The null and alternative hypotheses for testing superiority of the Test relative to the Control 
with respect to mean visual range within each subject group (Spherical wearers and Multifocal 
wearers) are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶 ≤ 0 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶>  0 
 
Where 𝜇𝜇𝑇𝑇 and 𝜇𝜇𝐶𝐶 represent mean visual range (i.e., LRE of simulated haze) for the Test and 
Control lenses, respectively. The one-sided confidence interval for the least-squares (LS) mean 
difference (Test – Control) and associated p-value will be calculated to test the primary 
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hypothesis for visual range. Superiority of the Test lens relative to the Control will be declared 
if the lower confidence limit is greater than 0. 
 
If a significant sequence effect will be observed, only the period 1 data will be analyzed. 
 
14.6. Secondary Analyses 
Phase 2 
Motion Detection 
The motion detection metric will be analyzed for the Spherical wearer subject group only using 
a linear mixed model. The analysis will be conducted on the ITT population. The model will 
include lens type, lens sequence, and period as fixed effects. Other baseline and subject 
characteristics such as age, gender, race, and iris color will be included as fixed covariates when 
appropriate. An UN covariance matrix will be used to model the residual errors among 
observations within the same subject at the two study periods (R-side). If the model fails to 
converge, a CS matrix may be considered. The Kenward and Roger method7 will be used for 
the denominator degree of freedom. 
 
Hypothesis Testing 
The null and alternative hypotheses for testing superiority of the Test relative to the Control 
with respect to mean motion detection within the Spherical wearer subject group are as follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶 ≥ 0 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶<  0 
 
where 𝜇𝜇𝑇𝑇 and 𝜇𝜇𝐶𝐶 represent mean motion detection (i.e., distance needed to detect that 
movement) for the Test and Control lenses, respectively. The one-sided adjusted confidence 
interval for the LS mean difference (Test – Control) and associated p-value will be calculated 
to test statistical superiority. Superiority of the Test lens relative to the Control will be declared 
if the adjusted upper confidence limit is less than 0. 
 
Brightness Perception 
The brightness perception (LRE) will be analyzed for the Multifocal wearers  subject group 
only using a linear mixed model. The analysis will be conducted on the ITT population. The 
model will include lens type, lens sequence, period, and natural scene as fixed effects. Other 
subject characteristics such as age, gender, race, and iris color will be included as fixed 
covariates when appropriate. An UN covariance matrix will be used to model the residual errors 
of within-subject repeated measures (R-side). If the model fails to converge, a CS matrix may 
be considered. The Kenward and Roger method7 will be used for the denominator degree of 
freedom. 
 
The null and alternative hypotheses for testing superiority of the Test relative to the Control 
with respect to mean brightness perception within the Multifocal wearers subject group are as 
follows: 
 
𝐻𝐻0: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶 ≤ 0 
𝐻𝐻𝐴𝐴: 𝜇𝜇𝑇𝑇− 𝜇𝜇𝐶𝐶> 0 
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where 𝜇𝜇𝑇𝑇 and 𝜇𝜇𝐶𝐶 represent mean brightness perception (i.e., LRE) for the Test and Control 
lenses, respectively. The one-sided adjusted confidence interval for the LS mean difference 
(Test – Control) and associated p-value will be calculated to test statistical superiority. 
Superiority of the Test lens relative to the Control will be declared if the adjusted lower 
confidence limit is larger than 0. 
 
If a significant sequence effect was observed, only the period 1 data will be analyzed for the 
corresponding endpoint. 
 
14.7. Other Exploratory Analysis 
For Toric wearers, visual range, and brightness perception will be analyzed and tested in the same manner 
as described for primary and secondary endpoints.  
 
All other exploratory endpoints will be descriptively summarized  
 
Other exploratory analysis may be conducted at the discretion of the study responsible 
clinician. 
 
14.8. Interim Analysis 
This is a two-phase study. Approximately 20 subjects will be targeted to complete Phase 1. An 
interim analysis will be performed using data collected from Phase 1 to estimate the required 
sample size for Phase 2 to achieve at least 80% power for testing the primary hypothesis within 
each subject group. The total sample size for Phase 2 will be approximately 150 subjects 
maximum, combining statistical with resources and study timing considerations.  
The IA will be conducted at completion of Phase 1. The analyses and statistical power 
calculation for the determination of the Phase 2 sample size will be conducted by the study 
unmasked biostatistician. No other team members, nor investigators or subjects will know the 
Phase 1 results or the Phase 1 lens assignment. 
 
Information about how the sample size calculation for Phase 2 will be conducted is located in 
Section 14.2. Subject accountability and demographics, and the primary and secondary 
endpoints data collected from Phase 1 will also be descriptive summarized for the interim 
analysis. 
 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing values will not be imputed. The count of missing values will be included in the 
summary tables and listings. 
 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
 
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15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured first on a paper case report form (CRF) to be stored on 
the study site, so that the investigator conducting the psychophysical testing may perform 
necessary calculations. After calculations are performed, the data will be captured on electronic 
case report forms (eCRFs) using the Clario EDC system. An authorized data originator will 
enter study data into the eCRFs using the EDC system. Data collected on equipment that is not 
captured in EDC will be formatted to the specification of the JJVC database manager and sent 
to JJVC for analysis. 
 
External data sources for this study include: Not Applicable 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study  
 
procedures for each visit. Only specifically delegated staff can enter data on a CRF. Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
 
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
 
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Adverse event notes must be reviewed and initialed by the Investigator. 
 
15.3. Trial Registration on ClinicalTrials.gov 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
 
16. DATA MANAGEMENT 
 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the  
 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub- 
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
 
16.4. Data Monitoring Committee (DMC) 
Not applicable 
 
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17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
• Ensuring the rights and wellbeing of subjects are protected. 
• Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
 
• Ensuring that the clinical site has sufficient test article and supplies. 
• Clarifying questions regarding the study. 
• Resolving study issues or problems that may arise. 
• Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
 
18. ETHICAL AND REGULATORY ASPECTS 
 
18.1. Study-Specific Design Considerations 
Potential subjects 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, and applicable regulatory 
requirements. GCP is an international ethical and scientific quality standard for designing, 
conducting, recording, and reporting studies that involve the participation of human subjects. 
Compliance with this standard provides public assurance that the rights, safety, and well-being 
of study subjects are protected, consistent with the principles of the Declaration of Helsinki 
64th WMA General Assembly 20132 and that the clinical study data are credible. The 
Investigator must maintain clinical study files in accordance applicable regulatory 
requirements. 
 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol. 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information). 
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• Sponsor-approved subject recruitment materials. 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
• Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be  
 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
 
• Protocol revisions 
• Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
• If applicable, new or revised subject recruitment materials approved by the Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure revisions 
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of 
the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• Any other requirements of the IEC/IRB 
 
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
 
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
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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,2 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) in the 
United States8 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. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
 
• processed fairly and lawfully. 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
• adequate, relevant, and not excessive in relation to said purposes. 
• accurate and, where necessary, kept current. 
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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 ISO 14155:2020,1 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 the ISO 14155:20201 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
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• Continuing an ineligible subject in the study. 
• Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
• Query resolution. 
• Case Report Form signature. 
• Completion of any follow-up action items. 
 
21. PUBLICATION 
This is a single-site study. The participating institution and Principal Investigator for this study 
agree that, should this study results be published, the first publication of the results of this study 
shall be made in conjunction with the presentation of a joint, single-center publication of the 
study results with the investigators and the institutions contributing data, analyses and 
comments. 
 
22. REFERENCES 
1. 
ISO 14155:2020: Clinical investigation of medical devices for human subjects — Good 
clinical practice,  Available at: https://www.iso.org/standard/71690.html 
2. 
Declaration of Helsinki – Ethical principles for Medical Research Involving Human Subjects,       
Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-
medical-research-involving-human-subjects/  
3. 
United States (US) Code of Federal Regulations (CFR).  Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 
4. 
Buch J.Clinical Study Protocol 
 Role of glare and spectral  
filtering on contrast sensitivity: A pilot study. November 02, 2022  
5. 
SAS Institute Inc. 2014. SAS/STAT® 13.2 User’s Guide. Cary, NC: SAS Institute Inc. 
6. 
PASS. Power Analysis and Sample Size Software. Kaysville, Utah, USA: NCSS, LLC; 2021. 
7. 
Kenward MG RJ. Small Sample Inference for Fixed Effects from Restricted Maximum 
Likelihood. Biometrics. 1997;53(3):983. 
8. 
Health Information Portability and Accountability Act (HIPAA),  Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
Not Applicable. 
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APPENDIX B: PATIENT INSTRUCTION GUIDE 
The Patient Instruction Guide (PIG) will be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
ACUVUE® OASYS MAX 1-Day 
ACUVUE® OASYS MAX 1-Day MULTIFOCAL 
ACUVUE® OASYS 1-Day with HydraLuxe® Technology 
ACUVUE® OASYS 1-Day with HydraLuxe® Technology for ASTIGMATISM 
ACUVUE® OASYS MULTIFOCAL with PUPIL OPTIMIZED DESIGN 
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PACKAGE INSERT & FITTING INSTRUCTION GUIDE 
 
 
 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses 
ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses 
senofilcon A Soft (hydrophilic) Contact Lenses 
for Daily Disposable Wear 
 
 
 
 
 
 
 
 
 
 
CAUTION: U.S. Federal law restricts this device to sale by or 
on the order of a licensed practitioner. 
IMPORTANT: Please read carefully and keep this information for future use. 
This Package Insert and Fitting Guide is intended for the Eye Care Professional, but should be 
made available to patients upon request. 
The Eye Care Professional should provide the patient with the appropriate instructions that 
pertain to the patient’s prescribed lenses. Copies are available for download at www.acuvue.com. 
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LOW 
“Low” near ADD 
MID 
“Medium” near ADD 
HGH 
“High” near ADD 
Visit www.acuvue.com/guides for additional information about symbols. 
 
 
 
 
 
 
 
  
DESCRIPTION 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses are soft (hydrophilic) contact lenses available as spherical 
and multifocal lenses. 
 
These lenses are made of a silicone hydrogel material (senofilcon A) containing an internal wetting agent 
and are tinted using Reactive Blue Dye #247 to make lenses more visible for handling. 
 
A benzotriazole ultraviolet (UV) absorbing monomer is used to block UV radiation (280 nm – 380 nm) in 
combination with a novel fused tricyclic chromophore that also blocks UV radiation and partially filters 
high energy visible radiation (HEV)* in the range of 380 nm to 450 nm. The light transmittance 
characteristics for these lenses are less than 1% in the UVB range of 280 nm to 315 nm and 10% in the 
UVA range of 315 nm to 380 nm. The thinnest lenses transmit ≤ 45% of the radiation in the range from 
380 nm to 450 nm. Please see HEV filtering NOTE in the ACTIONS section below. 
 
Lens Properties: 
The physical/optical properties of the lens are: 
 
• 
Specific Gravity (calculated): 
0.98 – 1.12 
• 
Refractive Index: 
1.42 
• 
Visible Light Transmittance: 
≥78% 
• 
HEV Light Transmittance*: 
≤ 45% 
• 
Surface Character: 
Hydrophilic 
• 
Water Content: 
38% 
• 
Oxygen Permeability (Dk): 
VALUE 
METHOD 
103 x 10-11 (cm2/sec) 
(ml O2/mL x mm Hg) @ 35°C 
Fatt (boundary corrected, edge 
corrected) 
 
Lens Parameter Ranges: 
• 
Diameter (DIA): 
12.0 mm to 15.0 mm 
• 
Center Thickness: 
varies with power 
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• 
Base Curve (BC): 
7.85 mm to 10.00 mm 
• 
Spherical Power (D): 
-20.00D to +20.00D 
• 
Multifocal ADD Power: 
+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 MAX 1-Day Contact Lenses (senofilcon A) are hemispherical shells of the 
following dimensions: 
Diameter (DIA): 
14.3 mm 
Center Thickness: 
0.085 mm to 0.221 mm (varies with power) 
Base Curve (BC): 
8.5 mm, 9.0 mm 
Powers (D): 
-12.00D to +8.00D 
 
 
The ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses (senofilcon A) are hemispherical 
shells of the following dimensions: 
Diameter (DIA): 
14.3 mm 
Center Thickness: 
0.070 mm to 0.191 mm (varies with power) 
Base Curve (BC): 
8.4 mm 
Powers (D): 
-9.00D to +6.00D 
ADD Powers (D): 
+1.25D (LOW), +1.75D (MID), +2.50D (HGH) 
 
 
  
TRANSMITTANCE CURVE 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses (senofilcon A) vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
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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. 
 
*NOTE: Filtering of HEV light by contact lenses has not been demonstrated to confer any health 
benefit to the user, including but not limited to retinal protection, protection from cataract 
progression, reduced eye strain, improved contrast, improved acuity, reduced glare, improved low 
light vision, or improved circadian rhythm/sleep cycle. The Eye Care Professional should be consulted 
for more information. 
 
  
INDICATIONS (USES) 
 
ACUVUE® OASYS MAX 1-Day Contact Lenses (senofilcon A) are indicated for daily disposable wear for the 
correction of vision in people with non-diseased eyes who are nearsighted (myopic) or farsighted 
(hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity. 
ACUVUE® OASYS MAX 1-Day MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily 
disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and 
may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that 
does not interfere with visual acuity. 
The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is 
required. Lenses should be discarded upon removal. 
 
 
  
CONTRAINDICATIONS (REASONS NOT TO 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 
• 
Ocular irritation due to allergic reactions which may be caused by use of contact lens 
solutions (i.e. rewetting drops) that contain chemicals or preservatives (such as mercury or 
Thimerosal, etc.) to which some people may develop an allergic response 
• 
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by 
wearing contact lenses 
• 
Any active corneal infection (bacterial, fungal, protozoal, or viral) 
• 
If eyes become red or irritated 
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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. 
 
• 
Patients should be instructed not to wear their lenses while sleeping. Clinical studies have 
shown that the risk of serious adverse reactions is increased when lenses are worn 
overnight, and that the risk of ulcerative keratitis is greater for extended wear contact lens 
users than for daily wear users.4 
• 
Studies have shown that contact lens wearers who are smokers have a higher incidence of 
adverse reactions than nonsmokers. 
• 
Problems with contact lenses or lens care products could result in serious injury to the eye. 
Patients should be cautioned that proper use and care of contact lenses and lens care 
products are essential for the safe use of these products. 
• 
The overall risk of ulcerative keratitis may be reduced by carefully following directions for 
lens care. 
4New 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. 
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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 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. 
• 
Fluorescein, a yellow dye, should not be used while the lenses are on the eyes unless 
otherwise indicated. The lenses absorb this dye and become discolored. Whenever 
fluorescein is used in eyes, the eyes should be flushed with a sterile saline solution that is 
recommended for in-eye use. 
• 
Eye Care Professionals should instruct the patient to remove lenses immediately if the eyes 
become red or irritated. 
Eye Care Professionals should carefully instruct patients about the following care regimen 
and safety precautions: 
 
Handling Precautions: 
• 
Before leaving the Eye Care Professional's office, the patient should be able to promptly 
remove lenses or should have someone else available who can remove the lenses for him or 
her. 
• 
DO NOT use if the sterile blister package is opened or damaged. 
• 
Always wash, rinse, and dry hands before handling lenses. It is best to put on lenses before 
putting on makeup. 
• 
DO NOT touch contact lenses with fingers or hands if the hands are not free of foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
• 
Carefully follow the handling, insertion, removal, and wearing instructions in the "Patient 
Instruction Guide" for ACUVUE® OASYS MAX 1-Day Contact Lenses and those prescribed by 
the Eye Care Professional. 
• 
Always handle lenses carefully and avoid dropping them. 
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• 
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. 
 
Lens Wearing Precautions: 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions in “Care for 
a Sticking (Non-Moving) Lens”. The lens should move freely on the eye for the continued 
health of the eye. If non-movement of the lens continues, the patient should be instructed 
to immediately consult his or her Eye Care Professional. 
• 
Never wear lenses beyond the period recommended by the Eye Care Professional. 
• 
The patient should be advised to never allow anyone else to wear their lenses. 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. 
• 
Ask the Eye Care Professional about wearing lenses during sporting activities. 
• 
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. 
 
Lens Care Precautions: 
• 
The patient should be informed that no cleaning or disinfection is needed when lenses are 
worn for daily disposable wear. Patients should always dispose of lenses when removed and 
have spare lenses or spectacles available. 
 
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. Depending on the severity, this could include the use of lubricating drops that 
are indicated for use with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• 
Oral contraceptive users could develop visual changes or changes in lens tolerance when 
using contact lenses. Patients should be cautioned accordingly. 
• 
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. 
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• 
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 corneal ulcers, or corneal erosion. There may be the potential for other 
physiological observations, such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjunctivitis; some of which are 
clinically acceptable in low amounts. 
• 
There may be excessive watering, unusual eye secretions or redness of the eye. 
• 
Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or dry 
eyes may also occur if the lenses are worn continuously or for too long a time. 
The patient should be instructed to conduct a simple 3-part self-examination at least once a day. They 
should ask themselves: 
 
• 
How do the lenses feel on my eyes? 
• 
How do my eyes look? 
• 
Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to IMMEDIATELY REMOVE THE LENS. 
If the problem or discomfort stops, the patient should discard the lens and place a new fresh lens on the 
eye. 
 
If after inserting the new lens, the problem continues, the patient should be directed to IMMEDIATELY 
REMOVE THE LENS AND CONTACT HIS OR HER EYE CARE PROFESSIONAL. 
 
The patient should be advised that when any of the above symptoms occur, a serious condition such as 
infection, corneal ulcer, neovascularization, or iritis may be present. He or she should be instructed to 
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seek immediate professional 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. 
 
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 
necessary. 
 
D. Base Curve Selection (Trial Lens Fitting) 
 
The following trial lenses should be selected for patients regardless of keratometry readings. However, 
corneal curvature measurements should be performed to establish the patient’s baseline ocular status. 
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For the Spherical or Multifocal ACUVUE® OASYS MAX 1-Day Contact Lenses, the initial lens should be 
selected from the currently available base curves. 
 
The trial lens should be placed on each of the patient’s eyes and evaluated after the patient has 
adjusted to the lenses. 
 
1. Criteria of a Properly Fit Lens 
 
A properly 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 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 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 lower lid, and then return to a properly centered position when released. If 
resistance is encountered when pushing the lens up, the lens is fitting tightly and should not be 
dispensed to the patient. 
 
E. Final Lens Power 
 
A spherical over-refraction should be performed to determine the final lens power after the lens fit is 
judged acceptable. The spherical over-refraction should be combined with the trial lens power to 
determine the final lens prescription. The patient should experience good visual acuity with the correct 
lens power unless there is excessive residual astigmatism. 
 
Example 1: 
Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
-0.25D 
Final lens power: 
-2.25D 
 
Example 2: 
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Diagnostic lens: 
-2.00D 
Spherical over-refraction: 
+0.25D 
Final lens power: 
-1.75D 
If vision is acceptable, perform a slit lamp examination to assess adequate fit (centration and 
movement). If fit is acceptable, dispense the lenses instructing the patient to return in one week for 
reassessment (see dispensing and follow up information in PATIENT MANAGEMENT). 
 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download from 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 MAX 1-Day Multifocal Contact Lenses. 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 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 ≥ ±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. 
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Method 2 (preferred): Determine which eye will accept the added power with the least 
reduction in vision while both eyes are open. Place a hand-held trial lens equal to +1.00D in 
front of one eye and then the other while the distance refractive error correction is in place for 
both eyes. Determine whether the patient functions best with the +1.00D lens over the right or 
left eye, which is the non-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. Remember to compensate for vertex distance if the refraction is ≥ ±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. 
 
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 an 
ACUVUE® OASYS MAX 1-Day 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. 
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• 
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 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 from www.acuvue.com. 
 
  
MONOVISION FITTING GUIDELINES 
 
 
A. Patient Selection 
Monovision Needs Assessment 
For a good prognosis the patient should have adequately corrected distance and near visual acuity in 
each eye. The amblyopic patient with significant amounts of uncorrected astigmatism (greater than 
1.00D) in one eye may not be a good candidate for monovision correction with these lenses. 
 
Occupational and environmental visual demands should be considered. If the patient requires critical 
vision (visual acuity and stereopsis), it should be determined by trial whether this patient can function 
adequately with monovision correction. Monovision contact lens wear may not be optimal for activities 
such as: 
 
(1) visually demanding situations such as operating potentially dangerous machinery or 
performing other potentially hazardous activities; and 
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(2) driving automobiles (e.g., driving at night). Patients who cannot pass their state driver’s 
license requirements with monovision correction should be advised to not drive with this 
correction, OR may require that additional over-correction be prescribed. 
 
Patient Education 
 
All patients do not function equally well with monovision correction. Patients may not perform as well 
for certain tasks with this correction as they have with spectacles (multifocal, bifocal, trifocal, readers, 
progressives). Each patient should understand that monovision, as well as other presbyopic alternatives, 
can create a vision compromise that may reduce visual acuity and depth perception for distance and 
near tasks. Therefore, caution should be exercised. During the fitting process, it is necessary for the 
patient to realize the disadvantages as well as the advantages of clear near vision, and straight ahead 
and upward gaze that monovision contact lenses provide. 
 
B. Eye Selection 
 
Generally, the non-dominant eye is corrected for near vision. The following two methods for eye 
dominance can be used. 
 
1. Ocular Preference Determination Methods 
 
Method 1: 
Determine which eye is the “sighting eye.” Have the patient point to an object at 
the far end of the room. Cover one eye. If the patient is still pointing directly at 
the object, the eye being used is the dominant (sighting) eye. 
 
Method 2: 
Determine which eye will accept the added power with the least reduction in 
vision. Place a hand-held trial lens equal to the spectacle near ADD in front of 
one eye and then the other while the distance refractive error correction is in 
place for both eyes. Determine whether the patient functions best with the near 
ADD lens over the right or left eye 
Other methods include the “Refractive Error Method” and the “Visual Demands Method.” 
 
2. Refractive Error Method 
 
For anisometropic correction, it is generally best to fit the more hyperopic (less myopic) eye for 
distance and the more myopic (less hyperopic) eye for near. 
 
3. Visual Demands Method 
 
Consider the patient’s occupation during the eye selection process to determine the critical 
vision requirements. If a patient’s gaze for near tasks is usually in one direction, correct the eye 
on that side for near. 
 
Example: 
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A secretary who places copy to the left side of the desk will function best with the near lens on 
the left eye. 
 
C. Special Fitting Characteristics 
 
1. Unilateral Vision Correction Requirement 
 
There are circumstances where only one contact lens is required. As an example, an emmetropic 
patient would only require a near lens whereas a bilateral myope would require corrective 
lenses on both eyes. 
 
Example: 
 
A presbyopic emmetropic patient who requires a +1.75D ADD would have a +1.75D lens on the 
near eye and the other eye left without correction. 
 
A presbyopic patient requiring a +1.50D ADD who is -2.50D myopic in the right eye and -1.50D 
myopic in the left eye may have the right eye corrected for distance and the left uncorrected for 
near. 
 
2. Near ADD Determination 
 
Always prescribe the lens power for the near eye that provides optimal near acuity at the 
midpoint of the patient’s habitual reading distance. However, when more than one power 
provides optimal reading performance, prescribe the least plus (most minus) of the powers. 
 
3. Trial Lens Fitting 
 
A trial fitting is performed in the office to allow the patient to experience monovision correction. 
Lenses are fit according to the “General Fitting Guidelines” for base curve selection described in 
this guide. 
 
Case history and standard clinical evaluation procedure should be used to determine the 
prognosis. Determine the distance correction and the near correction. Next determine the near 
ADD. With trial lenses of the proper power in place, observe the reaction to this mode of 
correction. 
 
Allow the lenses to settle for about 20 minutes with the correct power lenses in place. Walk 
across the room and have the patient look at you. Assess the patient’s reaction to distance 
vision under these circumstances. Then have the patient look at familiar near objects such as a 
watch face or fingernails. Again assess the reaction. As the patient continues to look around the 
room at both near and distance objects, observe the reactions. Only after these vision tests are 
completed should the patient be asked to read print. Evaluate the patient’s reaction to large 
print (e.g., typewritten copy) at first and then graduate to news print and finally smaller type 
sizes. 
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After the patient’s performance under the above conditions is completed, tests of visual acuity 
and reading ability under conditions of moderately dim illumination should be attempted. 
 
An initial unfavorable response in the office, while indicative of a guarded prognosis, should not 
immediately rule out a more extensive trial under the usual conditions in which a patient 
functions. 
 
4. Adaptation 
 
Visually demanding situations should be avoided during the initial wearing period. A patient may 
at first experience some mild blurred vision, dizziness, headaches and a feeling of slight 
imbalance. You should explain the adaptation 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 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. 
 
5. Other Suggestions 
 
The success of the monovision technique may be further improved by having your patient follow 
the suggestions below: 
 
Have a third contact lens (distance power) to use when critical distance viewing is needed. 
 
Have a third contact lens (near power) to use when critical near viewing is needed. 
 
Having supplemental spectacles to wear over the monovision contact lenses for specific 
visual tasks may improve the success of monovision correction. This is particularly applicable 
for those patients who cannot meet their state driver’s license requirements with a 
monovision correction. 
 
Make use of proper illumination when carrying out visual tasks. 
Monovision fitting success can be improved with the following suggestions: 
 
Reverse the distance and near eyes if a patient is having trouble adapting. 
 
Refine the lens powers if there is trouble with adaptation. Accurate lens power is critical for 
presbyopic patients. 
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 
Emphasize the benefits of clear near vision and straight-ahead and upward gaze with 
monovision. 
The decision to fit a patient with monovision correction is most appropriately left to the Eye Care 
Professional in conjunction with the patient after carefully considering the patient’s needs. 
 
All patients should be supplied with a copy of the PATIENT INSTRUCTION GUIDE for these lenses. 
Copies are available for download from www.acuvue.com. 
 
  
PATIENT MANAGEMENT 
 
 
• 
Follow the accepted standard of care in fitting and following up with your patient. 
• 
Schedule the appropriate follow-up examination. 
• 
Preferably, at the follow-up visits, lenses should have been worn for at least six hours. 
• 
Provide the patient with a copy of the PATIENT INSTRUCTION GUIDE for these lenses, which 
can be found at www.acuvue.com. REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT 
HE OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING AND REPLACEMENT 
SCHEDULE (DAILY DISPOSABLE). 
 
  
WEARING SCHEDULE 
 
 
The wearing schedule should be determined by the Eye Care Professional. Regular checkups, as 
determined by the Eye Care Professional, are also extremely important. 
 
Patients tend to 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 
individual response to contact lenses varies. 
 
The maximum suggested wearing time for these lenses is: 
 
Day 
Hours 
1 
6-8 
2 
8-10 
3 
10-12 
4 
12-14 
5 and after 
all waking hours 
 
 
  
REPLACEMENT SCHEDULE 
 
 
These lenses are indicated for daily disposable wear and should be discarded upon removal. 
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LENS CARE DIRECTIONS 
 
 
When lenses are dispensed, the Eye Care Professional should provide the patient with appropriate and 
adequate warnings and instructions for daily disposable lens wear. 
 
The Eye Care Professional should review with patients that no cleaning or disinfection is needed with 
disposable lenses. Patients should always dispose of lenses when they are removed and have spare 
lenses or spectacles available. 
 
Basic Instructions: 
• 
Always wash, rinse, and dry hands before handling contact lenses. 
• 
Do not use saliva or anything other than the recommended solutions for lubricating or rewetting 
lenses. Do not put lenses in the mouth. 
• 
Eye Care Professionals may recommend a lubricating/rewetting solution which can be used to 
wet (lubricate) lenses while they are being worn to make them more comfortable. 
 
Care for a Sticking (Non-Moving) Lens 
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 consult the Eye Care Professional. 
 
 
 
 
 
 
 
  
EMERGENCIES 
 
 
The patient should be informed that if chemicals of any kind (household products, gardening solutions, 
laboratory chemicals, etc.) are splashed into the eyes, the patient should: FLUSH EYES IMMEDIATELY 
WITH TAP WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL OR VISIT A HOSPITAL 
EMERGENCY ROOM WITHOUT DELAY. 
 
  
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 
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Tel: 1-800-843-2020 
www.acuvue.com 
 
Revision Date: 02/2022 
Revision Number: AO-01-22-03 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
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 TORIC FIT EVALUATION 
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Document Number:  
 
Revision Number: 7 
 
 
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Clinical Study Protocol Johnson 
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APPENDIX F: IRIS COLOR SCALE 
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Clinical Study Protocol Johnson 
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APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION 
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Clinical Study Protocol Johnson 
& Johnson Vision Care, Inc. 
Guidelines for COVID-19 Risk Mitigation 
Title: 
 
 
Document Type: 
 
 
Document Number: 
 
Revision Number: 5 
 
 
 
1.0 
PURPOSE 
 
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19 pandemic. 
 
2.0 
SCOPE 
 
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as 
appropriate. 
 
NOTE: Re-opening of sites outside of the US will be evaluated on a country by country basis subject to 
local health authority guidance. 
 
3.0 
DEFINITIONS 
 
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements. 
 
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is the 
leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry 
take a leading role in patient care with respect to eye and vision care, as well as general health and well-
being. As primary health care providers, Doctor of Optometry have extensive, ongoing training to 
examine, diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that 
manifest in the eye. The American Optometric Association is a federation of state, student, and armed 
forces optometric associations. Through these affiliations, the AOA serves members consisting of 
optometrists, students of optometry, paraoptometric assistants and technicians. The AOA and its affiliates 
work to provide the public with quality vision and eye care. 
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia. 
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID- 
19). 
Clinical Study: Voluntary research studies conducted in people and designed to answer specific 
questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using 
existing treatments. May also be called clinical trials, studies, research, trials, or protocols. 
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator. 
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial. 
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures 
(SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. 
 
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety. 
 
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life 
cycle. 
 
4.0 
GUIDANCE FOR STUDY DOCUMENTS 
 
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, 
safety and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be 
at risk, study intervention will be discontinued, and study follow-up will be conducted as outlined in the 
protocol. 
 
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel: 
 
Additional Risks Related to the COVID-19 Pandemic: 
• 
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures. 
• 
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator 
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms. 
• 
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits. 
• 
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including 
an unscheduled visit, up to discontinuation from the study, as appropriate. 
 
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution. 
 
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks: 
 
4.1.1 
Informed Consent: 
 
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document: 
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STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC 
 
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from 
the Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
 
During this study, all appropriate measures will be taken to minimize risks including the use of personal 
protective equipment such as masks and gloves, as well as proper sanitization. This is in conformance to 
guidance from the CDC, local health departments, and the state and county in which the study doctor’s office is 
located. However, these measures may not completely eliminate the risks associated with contracting COVID-19. 
 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff. 
 
4.1.2 
COVID-19 Risk Control Checklist (Attachment-B): 
 
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal Investigator 
will review/sign the study specific checklist prior to the Site Initiation Meeting. 
 
 
4.1.3 
Protocol Compliance Investigator(s) Signature Page: 
 
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
4.1.4 
Study Site Initiation Training Slides: 
 
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients, 
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment. 
 
5.0 
GUIDANCE FOR REMOTE SUBJECT VISITS 
 
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions. Possible disruption of the study as a result of COVID-19 control measures may lead to delays in 
scheduled follow-up visits. 
 
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible. Discussions with the subject during remote 
assessments may include: 
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The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will 
be communicated to the sites and to the health authorities according to local guidance. 
 
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s 
responsible medical monitor to discuss initial plans for study intervention and follow-up. The medical 
monitor will notify the Safety Management Team of any subject(s) that have reported “COVID-19”, 
“Asymptomatic COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report. 
 
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits. 
 
Monitoring Visits 
 
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with 
increased frequency to address the source data verification backlog. 
 
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, 
all parties involved in this clinical trial should communicate relevant information in a timely manner so 
that all relevant parties remain sufficiently informed. 
 
6.1.1 
Study Site Initiation: 
 
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable. 
Study site training will be documented utilizing Site Initiation Report 
 
per Study Site Initiation 
 
 
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, etc. 
as applicable for the location of the study site. 
 
6.1.2 
Interim Monitoring Visits (if applicable): 
 
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.). 
 
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan 
 
 
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site. 
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Document Number: 
 
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6.1.3 
Study Site Closure: 
 
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.). 
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Attachment A: Study Site Correspondence 
 
XXXX XX, 2020 
 
 
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>> 
 
 
Dear <<Principal Investigator>> and Study Team, 
 
Coronavirus (COVID-19) has impacted several communities and business activities over the past several 
months. While we work toward the successful conduct of clinical studies, our commitment continues to be the 
safety of patients, healthcare professionals, and to our communities. 
 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
 
Protocol: 
 
• 
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section. 
 
Protocol Signature Page: 
 
• 
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation. 
 
Informed Consent: 
 
• 
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document. 
 
COVID-19 Risk Control Checklist for Clinical Studies: 
 
• 
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic. 
 
We want to encourage the need for open lines of communication about potential challenges you may foresee as 
the result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your 
respective Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study 
Managers). 
 
Thank you for your continued engagement, collaboration, and dedication to your study subjects during 
this challenging time. 
 
 
Please file this letter in your site file study correspondence. 
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RESOURCE LINKS 
 
US Resource Links 
 
• 
OSHA Training 
https://www.osha.gov/SLTC/covid-19/controlprevention.html 
 
Personal Protective Equipment (PPE) Training 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html 
 
• 
I&R Training 
ACUVUE® LensAssist: https://www.acuvue.com/lensassist 
 
• 
Clinic Preparedness Guides 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness.html 
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4= 
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-
preparedness- guide 
 
• 
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses 
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic- 
lenses.pdf 
 
OUS Resource Links 
 
• 
Updates on local regulations in Hong Kong 
https://www.coronavirus.gov hk/eng/index.html 
 
• 
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma 
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical- 
services-letter-17-june-2020.pdf 
 
• 
NHS Optical Letter 
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april- 
2020.pdf 
 
• 
The College of Optometrists primary eye care COVID-19 guidance: Red phase 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance- 
for-optometrists.html 
 
• 
The College of Optometrists COVID-19: College updates 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for- 
optometrists.html#CollegeGuidelines 
 
• 
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf 
• 
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public- 
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance- 
outpatient-ambulatory-care-settings html 
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Guidelines for COVID-19 Risk Mitigation 
Title: 
 
 
Document Type: 
 
 
Document Number: 
 
Revision Number: 5 
 
 
• 
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of 
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf 
• 
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health: 
https://www.health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals- 
including-aged-care-providers-pathology-providers-and-health-care-managers 
 
• 
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection- 
principles-for-covid-19.pdf 
• 
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need- to-
know/covid-19-clinical-advice/infection-control-guidelines-and-advice/ 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6480 The Effects of Contact Lenses With UV/HEV-Filter on 
Visual Function 
 
Version and Date: 5.0 12 June 2023 
I have read and understand the protocol specified above and agree on its content. 
 
I agree to conduct this study according to ISO 14155:2020,1 the Declaration of Helsinki,2 
United States (US) Code of Federal Regulations (CFR),3 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety 
considerations. The Principal Investigator is responsible for ensuring that all clinical site 
personnel, including Sub-Investigators adhere to all GCP guidelines regarding clinical trials 
during and after study completion. 
 
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct 
this study in compliance with local, state, governmental guidance for COVID-19 risks. 
 
Principal 
Investigator: 
  
  
Signature 
Date 
Name and Professional Position (Printed) 
Institution/Site:    
Institution/Site Name 
Institution/Site Address 
 
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