Evaluation of Prototype Lenses With Experimental UV/HEV Blocker
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of Prototype Lenses with Experimental UV/HEV Blocker 
Protocol CR-6437
Version: 1.0
Date: 18 March 2021
Investigational Products: senofilcon A with and without a new ultraviolet (UV) / high energy 
visible (HEV) light blocker
Keywords: Sphere R&D platform, ACUVUE OASYS 1-DAY, senofilcon A (C3), UV/HEV-
blocker, daily wear, daily disposable, dispensing, CLUE vision, CLUE comfort, CLUE 
handling, subjective performance 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements.  
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ...................................................................................................................................17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION ........................................................................... 20 
3.1. 
General Characteristics ............................................................................................ 20 
3.2. 
Inclusion Criteria ...................................................................................................... 20 
3.3. 
Exclusion Criteria ..................................................................................................... 21 
3.4. 
Enrollment Strategy.................................................................................................. 22 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 23 
4.1. 
Description of Study Design .................................................................................... 23 
4.2. 
Study Design Rationale ............................................................................................ 23 
4.3. 
Enrollment Target and Study Duration .................................................................... 23 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 24 
5.1. 
Test Article Allocation ............................................................................................. 24 
5.2. 
Masking .................................................................................................................... 25 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 25 
6. 
STUDY INTERVENTION ............................................................................................. 25 
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6.1. 
Identity of Test Articles............................................................................................ 25 
6.2. 
Ancillary Supplies/Products ..................................................................................... 26 
6.3. 
Administration of Test Articles ................................................................................ 27 
6.4. 
Packaging and Labeling ........................................................................................... 27 
6.5. 
Storage Conditions ................................................................................................... 27 
6.6. 
Collection and Storage of Samples .......................................................................... 27 
6.7. 
Accountability of Test Articles ................................................................................ 28 
7. 
STUDY EVALUATIONS .............................................................................................. 28 
7.1. 
Time and Event Schedule ......................................................................................... 28 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2 ........................................................................................................................... 34 
VISIT 3 ........................................................................................................................... 39 
FINAL EVALUATION .................................................................................................. 40 
7.3. 
Unscheduled Visits ................................................................................................... 41 
7.4. 
Laboratory Procedures ............................................................................................. 43 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 43 
8.1. 
Completion Criteria .................................................................................................. 43 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 43 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 44 
9.1. 
Systemic Medications .............................................................................................. 44 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 46 
11. 
STUDY TERMINATION ........................................................................................... 47 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 48 
13. 
ADVERSE EVENTS ................................................................................................... 49 
13.1. Definitions and Classifications................................................................................. 49 
13.2. Assessing Adverse Events ........................................................................................ 52 
13.2.1. 
Causality Assessment .................................................................................... 52 
13.2.2. 
Severity Assessment ...................................................................................... 52 
13.3. Documentation and Follow-Up of Adverse Events ................................................. 53 
13.4. Reporting Adverse Events ........................................................................................ 54 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 54 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
........................................................................................................................55 
13.5. Event of Special Interest .......................................................................................... 55 
13.6. Reporting of Pregnancy ............................................................................................ 56 
14. 
STATISTICAL METHODS ........................................................................................ 56 
14.1. General Considerations ............................................................................................ 56 
14.2. Sample Size Justification ......................................................................................... 56 
14.3. Analysis Populations ................................................................................................ 60 
14.4. Level of Statistical Significance ............................................................................... 60 
14.5. Primary Analysis ...................................................................................................... 60 
14.6. Secondary Analysis .................................................................................................. 61 
14.7. Other Exploratory Analysis ...................................................................................... 61 
14.8. Interim Analysis ....................................................................................................... 64 
14.9. Procedure for Handling Missing Data and Drop-Outs ............................................. 64 
14.10. Procedure for Reporting Deviations from Statistical Plan ....................................... 64 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 64 
15.1. Electronic Case Report Form/Data Collection ......................................................... 64 
15.2. Subject Record ......................................................................................................... 65 
15.3. Trial Registration on ClinicalTrials.gov................................................................... 66 
16. 
DATA MANAGEMENT............................................................................................. 66 
16.1. Access to Source Data/Document ............................................................................ 66 
16.2. Confidentiality of Information ................................................................................. 66 
16.3. Data Quality Assurance ............................................................................................ 66 
16.4. Data Monitoring Committee (DMC)........................................................................ 67 
17. 
CLINICAL MONITORING ........................................................................................ 67 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 67 
18.1. Study-Specific Design Considerations ..................................................................... 67 
18.2. Investigator Responsibility ....................................................................................... 67 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) .............. 68 
18.4. Informed Consent ..................................................................................................... 69 
18.5. Privacy of Personal Data .......................................................................................... 69 
19. 
STUDY RECORD RETENTION................................................................................ 70 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 71 
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21. 
PUBLICATION ........................................................................................................... 71 
22. 
REFERENCES ............................................................................................................ 72 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 74 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 96 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 97 
APPENDIX D: 
 .................................... 126 
Limbal and Conjunctival (Bulbar) Redness ........................................................ 127 
Expanded Sodium Fluorescein Corneal Staining ................................................ 134 
 Lens Fitting Characteristics ................................................................................. 141 
 Subject Reported Ocular Symptoms/Problems ................................................... 147 
 Front and Back Surface Lens Deposit Grading Procedure ................................. 149 
 Determination of Distance Spherocylindrical Refractions .................................. 154 
 Biomicroscopy Scale ........................................................................................... 160 
 Distance and Near Visual Acuity Evaluation ...................................................... 166 
 Patient Reported Outcomes ................................................................................. 171 
 White Light Lens Surface Wettability ................................................................ 173 
APPENDIX E: IRIS COLOR ............................................................................................... 175 
APPENDIX F: STARTING LENS POWER ........................................................................ 177 
APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION .............................. 179 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 191 
LIST OF TABLES
Table 1: Enrollment Strategy Overall ..................................................................................... 22 
Table 2: Duration of Study Visits ........................................................................................... 23 
Table 3: Test Articles .............................................................................................................. 25 
Table 4: Ancillary Supplies .................................................................................................... 26 
Table 5: Time and Events ....................................................................................................... 28 
Table 6: Unscheduled Visit Procedures .................................................................................. 41 
Table 7: Disallowed systemic medications ............................................................................. 45 
Table 8: Disallowed systemic antihistamines ......................................................................... 46 
Table 9:  Examples of major and minor protocol deviations .................................................. 46 
Table 12: Sample Size Estimates ............................................................................................ 59 
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SYNOPSIS 
Protocol Title
Evaluation of Prototype Lenses with Experimental UV/HEV 
Blocker
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase
Clinical trial phase: Confirmatory
Design control phase: Confirmatory phase 3 
Trial Registration
This study will be registered on ClinicalTrials.gov. 
Test Article(s)
Investigational Product:  
x
senofilcon A C3 containing a new UV/HEV blocker
with propylene glycol (PG) hydration 
Approved Product:
x
Production ACUVUE OASYS 1-Day (senofilcon A 
C3) 
Wear and Replacement 
Schedules
Wear Schedule: daily disposable 
Replacement Schedule: daily
Objectives 
The purpose of this investigation is to evaluate the 
short-term, clinical performance of prototype contact lenses 
with experimental UV/HEV-blocker produced on a 
commercial manufacturing line.  Subjective responses will 
comprise the primary and secondary endpoints. 
Study Endpoints 
Primary endpoint: 
1. CLUE overall comfort score at 2-week follow-up  
Secondary endpoints:  
1. CLUE overall quality of vision score at 2-week 
follow-up  
2. CLUE overall handling score at 2-week follow-up  
Other observations: preferences to habitual lens, preference 
between Test and Control lenses, purchase intent, outdoor 
performance, indoor performance, driving performance, 
digital performance, cosmetic acceptance.
Study Design 
This is a bilateral, 2-week dispensing, randomized, 
controlled, subject-masked, 2×2 crossover study.  Each 
subject will be bilaterally fitted with a Test or Control lens in
random fashion for a wear period of two weeks each. There 
will be a total of 3 visits:
1. Visit 1: Screening, baseline evaluation and lens fit #1 
2. Visit 2: 2-week follow-up, lens fit #2 
3. Visit 3: 2-week follow-up, Final evaluation 
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See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1) 
Sample Size
Approximately 230 subjects in total (enrolling a115 to start 
with the Test lens and a115 to start with the Control lens)
will be targeted to be enrolled in this study, with the aim to
complete approximately 200 subjects (a100 in each of the 2 
lens wear sequences).
Study Duration 
Subject enrollment will last 8 weeks per site. Once enrolled, 
subjects will be in the study for approximately 4 weeks, 
making the entire study approximately 12 weeks in duration. 
Anticipated Study 
Population 
Subjects will be male and female of any race and ethnicity, 
age 18 through 39, habitual wearers of spherical silicone 
hydrogel contact lenses within the power range of -1.00 
through -6.00 D. Subjects will be targeted in a 7:3 ratio 
based on habitual lens wear (7 habitual daily disposable 
wearers versus 3 habitual daily wear reusable wearers).
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria after Screening
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Be between 18 and 39 (inclusive) years of age at the 
time of screening.
4. By self-report, habitually wear spherical silicone 
hydrogel soft contact lenses in both eyes in a daily 
reusable or daily disposable wear modality (i.e. not 
extended wear modality). Habitual wear is defined as 
a minimum of 6 hours of wear per day, for a minimum 
of 5 days per week during the past 30 days. 
5. Have a habitual contact lens prescription that is
current within the prior 6 months, and they must have 
worn that prescription for at least 2 weeks prior to 
entering the study.  
Inclusion Criteria following Baseline Evaluation
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6. The subject’s vertex corrected spherical equivalent 
distance refraction must be in the range of -1.00 
through -6.00 D (except -5.00 D) in both eyes. 
7. The subject’s refractive cylinder must be 1.00 D or 
less.
8. The subject must have best corrected visual acuity of 
20/25 or better in each eye.
Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study: 
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any ocular or systemic allergies or diseases that 
may interfere with contact lens wear. 
3. Have any autoimmune disease or use of medication, 
which may interfere with contact lens wear.  Habitual 
medications used by successful soft contact lens 
wearers are considered acceptable.
4. Have any previous, or planned, ocular or interocular 
surgery (e.g., radial keratotomy, PRK, LASIK, etc.). 
5. Be currently wearing lenses in a monovision, multi-
focal, toric, or extended wear modality. 
6. Have participated in a contact lens or lens care 
product clinical trial within 14 days prior to study 
enrollment  
7. Be an employee (e.g., Investigator, Coordinator, 
Technician) or immediate family member of an 
employee 
(including 
partner, 
child, 
parent, 
grandparent, grandchild or sibling of the employee or 
their spouse) of the clinical site.
8. Have a history of binocular vision abnormality or 
strabismus.
9. Have any infectious disease (e.g., hepatitis, 
tuberculosis) or contagious immunosuppressive 
diseases (e.g., HIV) by self-report.
Exclusion Criteria following Baseline Evaluation
The subject must not: 
10. Have any Grade 3 or greater slit lamp findings (e.g., 
edema, corneal neovascularization, corneal staining, 
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tarsal abnormalities, conjunctival injection) on the 
FDA classification scale, any previous history or 
signs of a contact lens-related corneal inflammatory 
event (e.g., past peripheral ulcer or round peripheral 
scar), or any other ocular abnormality that may 
contraindicate contact lens wear.
11. Have any ocular infection.
12. Have any corneal distortion resulting from previous 
hard or rigid gas permeable contact lens wear.
13. Have entropion, ectropion, extrusions, chalazia, 
recurrent styes, glaucoma, history of recurrent 
corneal erosions, or aphakia.
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear from 24 hours 
prior to receiving the study product through the study period 
of a28 days. Habitual medications taken by successful soft 
contact lens wearers are generally considered acceptable (see 
Section 9.1 for details regarding disallowed systemic 
medications). Note that habitual medications should be taken 
throughout the study period.
Measurements and 
Procedures
Subjective questionnaires (CLUE and MRD/GSI) will
comprise the primary and secondary outcome measures with 
physiological responses being monitored. 
Microbiology or Other 
Laboratory Testing 
None 
Study Termination 
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Preservative free rewetting drops/artificial tears or saline.  
ACUVUE RevitaLens will be used to transport any 
problematic lenses back to the Sponsor.
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 AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
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PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
The range of high energy visible (HEV) light is roughly defined in the literature, with 
references stating 380-500 nm5, 400-500 nm6 and others stating 430-510 nm.7  This region of 
the electromagnetic spectrum has special meaning to the eye. It is light that we can see, but 
yet can have negative and positive effects on the eye. At the shorter wavelength end of the 
range, around 435r20 nm,8 the light has enough energy to cause premature damage to the 
retinal pigment epithelium and has being linked to macular degeneration.  The shorter 
wavelengths are also scattered more than longer wavelengths (Rayleigh scattering), which 
create the blue sky and “blue haze” that we see when looking at distant objects.  At the longer 
wavelength end of the range, around 480r20 nm,9 the light is responsible for regulating our 
circadian rhythms and pupillary light reflexes. 
Ophthalmic devices that block the shorter HEV wavelengths while transmitting the longer 
wavelengths might experience an immediate visual improvement through better chromatic 
contrast, while benefitting in the long-term through enhanced retinal protection.  This study 
will investigate, for the first time, the prototype Test lenses manufactured on a commercial 
line.
1.1.
Name and Descriptions of Investigational Products  
This study will test a senofilcon A (C3) design prototype with new UV/HEV blocker against 
a commercially available marketed product ACUVUE OASYS® Brand Contact Lenses 1-Day 
with HydraLuxe™ Technology (AO1D).  Further details about the test articles are found in 
section 6 of this protocol.  Note that the new UV/HEV blocker was previously identified as 
Theia I.
1.2.
Intended Use of Investigational Products
The intended use of the investigative product is for correcting myopia and for improving the 
visual experience by improving contrast.  During the study, each test article will be worn 
bilaterally in daily wear, daily disposable modality for at least 6 hours per day and 5 days per 
week for approximately two weeks. The subject will wear both test articles in a cross-over 
study design. 
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding senofilcon A 
(C3) – based lens with new UV/HEV blocker, 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 
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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 (C3) with 
new UV/HEV-blocker, refer to the latest version of the Investigator’s Brochure.10
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
The package insert for the AO1D Control lens can be found in the appendices.  Prior clinical 
data of the new UV/HEV-blocker is summarized in the Investigator’s Brochure. 
The literature is absent of any articles pertaining to soft contact lenses containing 
HEV-blocker. Articles that pertain to “blue-blocking” spectacles and intraocular lenses do 
exist with a sampling shown here: 
1. Mainster MA. Violet and blue light blocking intraocular lenses: photoprotection 
versus photoreception. British Journal of Ophthalmology. 2006;90(6):784-792. 
2. Braunstein RE. A Blue-Blocking Intraocular Lens Should Be Used in Cataract Surgery. 
Archives of Ophthalmology. 2005;123(4):547. 
3. Glazer-Hockstein C, Dunaief JL. Could Blue Light–Blocking Lenses Decrease the Risk 
of Age-Related Macular Degeneration? Retina. 2006;26(1):1-4. 
4. Kimberly B, James R P. AMBER LENSES TO BLOCK BLUE LIGHT AND 
IMPROVE SLEEP: A RANDOMIZED TRIAL. Chronobiology International. 
2009;26(8):1602-1612. 
5. Hayashi K. Visual function in patients with yellow tinted intraocular lenses compared 
with vision in patients with non-tinted intraocular lenses. British Journal of 
Ophthalmology. 2006;90(8):1019-1023. 
6. Schmoll C, Khan A, Aspinall P, et al. New light for old eyes: comparing melanopsin-
mediated non-visual benefits of blue-light and UV-blocking intraocular lenses. British 
Journal of Ophthalmology. 2013;98(1):124-128. 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The purpose of this investigation is to evaluate the short-term, clinical performance of
prototype contact lenses with experimental UV/HEV-blocker produced on a commercial 
manufacturing line.  Subjective responses will comprise the primary and secondary endpoints.
The results may be used to support marketing claims or help understand market readiness of 
the Test lens.  
Primary Objective(s)
The primary objective is to evaluate the clinical performance of the senofilcon A material, with 
and without a UV/HEV filter, when both are manufactured on commercial production lines. 
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2.2.
Endpoints 
Primary Endpoint: 
1. CLUE overall quality of vision score at 2-week follow-up  
Secondary Endpoints:  
1. CLUE overall comfort score at 2-week follow-up  
2. CLUE overall handling score at 2-week follow-up  
Subjective over quality of vision, overall comfort and handling scores will be assessed using 
Contact Lens User Experience (CLUE) questionnaire.11 CLUE is a validated patient-reported 
outcomes questionnaire to assess patient-experience attributes of soft, disposable contact 
lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the 
US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 
20), where higher scores indicate a more favorable/positive response. A 5-point increase in an 
average CLUE score translates into 10% shift in the distribution of scores for population of 
soft disposable contact lens wearers. 
Other Exploratory Endpoints:  
Items evaluating visual clarity: 
x
Clarity of vision indoors in bright light (MIS00623)  
x
Clarity of vision indoors in dim light (MIS00624)  
x
Clarity of vision in bright sunlight (MIS00612)  
x
Clarity of distance vision (i.e. looking at things that are more than 5 feet away, such 
as street signs) (P3_0006_p10)  
Items evaluating driving performance: 
x
Ability to see comfortably while driving at night (MIS01980)  
x
Ability to see comfortably while driving during the day (MIS01981)  
x
My vision was clear enough to allow me to drive at night (V056_1)  
x
With these lenses, I felt very confident to drive at night (V086_2)  
Items evaluating digital device performance: 
x
Reduction in the feeling of tired eyes from using a computer or other digital device 
(MIS02001)  
x
Ability to see comfortably while using a computer or other digital device (MIS01982)  
Preference items:
x
Overall opinion (PREf6_1_1) 
x
Overall comfort (PREf6_2_1) 
x
Overall vision (PREf6_3_1) 
x
Comfort throughout the day (PREf6_5_1) 
x
Comfort at the end of the day (PREf6_6_1) 
x
Comfort from activity to activity (PREf6_7_1) 
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x
Clarity of vision from activity to activity (PREf6_8_1) 
x
Overall preference while using computer screens & digital devices (PREf6_4_1) 
All other exploratory endpoints (items) are evaluated using Likert scales. The response set for 
preference items include: Strongly prefer the first set of study lenses, Slightly prefer the first 
set of study lenses, No preference, Slightly prefer the second set of study lenses, and Strongly 
prefer the second set of study lenses. Study lens preference will be derived based on subject’s 
responses and the sequence of lens wear.
2.3.
Hypotheses
Primary Hypothesis 
1. Test lens will be non-inferior to the Control lens at the 2-week follow-up evaluation 
with respect to CLUE Vision. A non-inferiority margin of –5 points will be used.  
Secondary Hypotheses
1. Test lens will be non-inferior to the Control lens at the 2-week follow-up evaluation 
with respect to CLUE comfort. A non-inferiority margin of -5 points will be used.   
2. Test lens will be non-inferior to the Control lens at the 2-week follow-up evaluation 
with respect to CLUE Handling. A non-inferiority margin of 5 points will be used.   
All primary and secondary hypotheses must be met to satisfy the objective of the study. Other 
exploratory endpoints will be assessed in support of the primary and secondary endpoints; 
other exploratory hypotheses will be evaluated only when all primary and secondary 
hypotheses are met.
Other Exploratory Hypotheses
1. The Test lens will be superior to the Control lens with respect to the proportion of 
subjects with “Excellent” response to the statement “Clarity of vision indoors in bright 
light” at the 2-week follow-up visit.  
2. The Test lens will be superior to the Control lens with respect to the proportion of 
subjects with higher ratings to the following individual CLUE or MRD items at the 2-
week follow-up evaluation:
1) Clarity of distance vision (i.e. looking at things that are more than 5 feet away, such 
as street signs). (P3_0006_p10) 
2) Clarity of vision in bright sunlight. (MIS00612) 
3) Ability to see comfortably while driving at night (MIS01980) 
4) Ability to see comfortably while driving during the day (MIS01981) 
5) Clarity of vision indoors in bright light. (MIS00623) 
6) Reduction in the feeling of tired eyes from using a computer or other digital device. 
(MIS02001) 
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7) Ability to see comfortably while using a computer or other digital device. 
(MIS01982) 
8) My vision was clear enough to allow me to drive at night (V056_1) 
9) With these lenses, I felt very confident to drive at night (V086_2) 
10)  Clarity of vision indoors in dim light (MIS00624) 
3. The Test lens will be superior to the Control lens with respect to the following 
preference questions at the 2-week follow-up evaluation:
1) Overall opinion (PREf6_1_1) 
2) Overall comfort (PREf6_2_1) 
3) Overall vision (PREf6_3_1) 
4) Comfort throughout the day (PREf6_5_1) 
5) Comfort at the end of the day (PREf6_6_1) 
6) Comfort from activity to activity (PREf6_7_1) 
7) Clarity of vision from activity to activity (PREf6_8_1) 
8) Overall preference while using computer screens & digital devices (PREf6_4_1) 
Study lens preferences to habitual lens, study lens purchase intent, acceptable lens fit rates, 
surface characteristics, biomicroscopy findings, and other characteristics of both study lenses 
will be descriptively summarized with tables and/or graphs.   
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Approximately 115 subjects will be targeted to start with the Test lens and approximately 115
will be targeted to start with the Control lens.  Within each of these two starting groups, the 
intent is to complete 100 (200 total subjects).  Enrolled subjects will be habitual wearers of 
silicone hydrogel spherical contact lenses.  All subjects will be the age of t18 and <40.  
Subjects will wear the study contact lenses approximately two weeks each on a daily wear 
(DW) daily disposable (DD) basis for a total study duration of approximately 28 days (4 weeks) 
per subject.  
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
Inclusion Criteria after Screening
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between 18 and 39 (inclusive) years of age at the time of screening. 
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4. By self-report, habitually wear spherical silicone hydrogel soft contact lenses in both 
eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear 
modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a 
minimum of 5 days per week during the past 30 days. 
5. Have a habitual contact lens prescription that is current within the prior 6 months, and 
they must have worn that prescription for at least 2 weeks prior to entering the study.  
Inclusion Criteria following Baseline Evaluation 
6. The subject’s vertex corrected spherical equivalent distance refraction must be in the 
range of -1.00 through -6.00 D (except -5.00 D) in both eyes. 
7. The subject’s refractive cylinder must be 1.00 D or less. 
8. The subject must have best corrected visual acuity of 20/25 or better in each eye. 
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any ocular or systemic allergies or diseases that may interfere with contact lens 
wear. 
3. Have any autoimmune disease or use of medication, which may interfere with contact 
lens wear.  Habitual medications used by successful soft contact lens wearers are 
considered acceptable.
4. Have any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, 
PRK, LASIK, etc.).
5. Be currently wearing lenses in a monovision, multi-focal, toric, or extended wear 
modality.
6. Have participated in a contact lens or lens care product clinical trial within 14 days 
prior to study enrollment  
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family 
member of an employee (including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site.
8. Have a history of binocular vision abnormality or strabismus. 
9. Have any infectious disease (e.g., hepatitis, tuberculosis) or contagious 
immunosuppressive diseases (e.g., HIV) by self-report. 
Exclusion Criteria following Baseline Evaluation 
The subject must not: 
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3
13-15 day follow-up for the study lens, subjective responses, 
preference between study lenses, VA, fitting characteristics, surface 
characteristics, physiology, Final Evaluation. 
1.0 hours 
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Use of the test articles will be randomized using a lens fitting schedule supplied by the study 
biostatistician. The clinical site will follow the lens fitting schedule provided and will complete 
enrollment according to the randomization list and will not pre-select or pre-assign subjects. 
Randomly-permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. A computer-generated randomization scheme will be used to randomly assign subjects, 
in blocks of 2, to one of the two possible lens wear sequences (Test/Control or Control/Test). 
The randomization will be stratified by site and type of habitual lens wear (daily disposable 
and daily wear reusable). The ratio of habitual wearers of daily disposable lenses to habitual 
wearers of daily wear reusable lenses is 7:3 within each study site (7 habitual wearers of daily 
disposable lenses versus 3 habitual wearers of daily wear reusable lenses).  See Table 1. The 
random scheme will be generated using the PROC PLAN procedure from Statistical Analysis 
System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, NC)12.
Randomization will be performed at visit 1. The following must have occurred prior to 
randomization: 
ͻ
Informed consent must have been obtained.  
ͻ
The subject must have met all eligibility criteria.
ͻ
The subject’s screening and baseline information must have been collected.
The following steps should be followed to maintain randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule to obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
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6.3.
Administration of Test Articles
Test articles will be dispensed to subject meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the Investigator and/or the Sponsor.
6.4.
Packaging and Labeling
The test articles will be packaged in blisters as the primary packaging. The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with plastic bags as the secondary packaging form. The sample 
study label is shown below. The sample study label is shown below. The information 
represented on the label below is sample information only and is not representative of the actual 
study lens information. 
Primary Packaging
Secondary Packaging
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
Subjects will dispose of their worn lenses on a daily basis.  When possible, any lens or test 
article associated with an Adverse Events and/or a Product Quality Complaint must be retained 
and stored in a glass vial with moderate RevitaLens solution pending directions from the 
sponsor for potential return back to JJVC. 
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For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation 
Additional subjects will be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
x
Disallowed medications for this study include: medications that may interfere with 
contact lens wear (see section 9.1).  Habitual medications used by successful soft 
contact lens wearers are considered acceptable.
x
Concomitant therapies that are disallowed include: NA
9.1.
Systemic Medications
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film.  
A summary of disallowed systemic medications is shown in Table 7. Subjects with a history 
of taking these medications will be allowed to enroll only if:
x
The medications have been taken on a continual, routine basis for at least 6 months,
and
x
The subject has demonstrated successful contact lens wear during this time.
Or:
x
The subject was taking the medication on a temporary basis and ceased taking that 
medication at least 2 weeks prior to signing the informed consent (this is considered 
sufficient time for the medication to have left the body prior to enrollment).
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The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
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x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.” 
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that: 
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1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury 
x
Permanent or persistent impairment of a body structure or a body function 
x
Hospitalization or prolongation of patient hospitalization 
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x
Chronic disease 
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
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x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA 
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
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other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x
Seriousness/Classifications (see definition in section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in section 0). 
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown. 
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
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x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x
Any referral to another health care provider if needed. 
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
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Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
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subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.5. Event of Special Interest
None
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13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS
14.1. General Considerations
A general description of the statistical methods to be implemented in this clinical trial is 
outlined below. More details will be included in the stand-alone Statistical Analysis Plan 
(SAP). The SAP will be developed and finalized prior to database lock. 
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC)13.  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.
14.2. Sample Size Justification
This study is designed and powered to demonstrate non-inferiority of the Test lens compared 
to the Control lens with respect to CLUE overall quality of vision, CLUE overall comfort and 
handling at the 2-week follow-up evaluation. Sample size was calculated for these primary and 
secondary endpoints to achieve a minimum statistical power of 80% with a 2-sided type I error 
of 0.05 based on historical data from 
. The same type of Test and Control lenses were 
investigated in 
 with the same 2×2 crossover design; Test lenses in 
 were 
made from the pilot line while Test lenses in the current study are produced from the 
manufacturing line. Table 10 below presents the descriptive statistics of CLUE scores at the 2-
week follow-up evaluation observed from 
14
In addition to the primary and secondary endpoints mentioned above, sample size was also 
calculated to see what is the required number of subjects for achieving a statistical power of 
approximately 80% to demonstrate superiority of the Test lens compared to the Control lens 
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Sample size for CLUE overall quality of vision was calculated using a linear mixed model-
based power analysis method assuming no difference between the Test and Control lenses.15
An unstructured (UN) covariance matrix, which was used to model the covariance between 
measurements on the same subjects across study periods, was estimated from the analysis of 
 historical data.14 Parameters in the UN covariance matrix were freely estimated for 
the two habitual lens groups. For sample size calculation CLUE vision scores were analyzed 
using a linear mixed model with lens as a fixed effect and the estimated UN covariance matrix 
and tested for non-inferiority using a non-inferiority margin of -5 points. Below is the variance-
covariance matrix used in the sample size calculation for CLUE overall quality of vision.  
Habitual daily disposable lens wearers: ቂ210.12
55.2899
55.2899
367.06 ቃ
Habitual daily reusable lens wearers: ቂ276.46
125.78
125.78
118.44ቃ
CLUE Overall Comfort   
Sample size for CLUE overall comfort was calculated using a linear mixed model-based power 
analysis method16 assuming no difference between Test and Control. An unstructured (UN) 
covariance matrix, which was used to model the covariance between measurements on the 
same subjects across study periods, was estimated from the analysis of 
 historical 
data.14 Parameters in the UN covariance matrix were freely estimated for different habitual 
lens groups. For sample size calculation CLUE comfort scores were analyzed using a linear 
mixed model with lens as a fixed effect and the estimated UN covariance matrix and tested for 
non-inferiority using a non-inferiority margin of -5 points. Below is the variance-covariance 
matrix used in the sample size calculation for CLUE comfort. 
Habitual daily disposable lens wearers: ቂ351.71
െ19.9976
െ19.9976
487.88 ቃ
Habitual daily reusable lens wearers: ቂ384.67
230.69
230.69
442.74ቃ
CLUE Overall Handling  
Sample size for CLUE overall handling was calculated using a linear mixed model-based 
power analysis method16 assuming no difference between the Test and Control lenses. A 
unstructured (UN) covariance matrix, which was used to model the covariance between 
measurements on the same subjects across study periods, was estimated from the analysis of 
 historical data. Parameters in the UN covariance matrix were freely estimated for 
different habitual lens groups. For sample size calculation CLUE handling scores were 
analyzed using a linear mixed model with lens as a fixed effect and the estimated UN 
covariance matrix and tested for non-inferiority using a non-inferiority margin of -5 points. 
Below is the variance-covariance matrix used in the sample size calculation for CLUE overall 
handling.  
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Habitual daily disposable lens wearers: ቂ255.02
95.4223
95.4223
418.37 ቃ
Habitual reusable lens wearers: ቂ425.78
201.18
201.18
261.21ቃ
Clarity of vision indoors in bright light 
Clarity of vision indoors in bright light will be evaluated at 2-week follow-up using a 5-point 
Likert scale (1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor) with a “Not Applicable” 
response option. Responses to clarity of vision indoors in bright light will be converted into a 
binary variable for the purpose of analysis (Excellent = 1 and others = 0) and “Not Applicable” 
will not be included in the analysis. Indicated by historical data from 
, the correlation 
between measurements from different periods within the same subject was about 0.45 and the 
proportion of subjects with an “Excellent” response was about 0.55 and 0.45 for the Test and 
Control lenses, respectively. Assumptions for correlation and proportions were made based on 
these observations and a total of 2000 replicating trials were simulated. The simulated binary 
data were analyzed using a generalized linear mixed model with a logit link function and tested 
for statistical superiority. Sample size was estimated for a minimum statistical power of 80%. 
Overall preference while using computer screens & digital devices
Responses to overall preference while using computer screens & digital devices will be 
collapsed into three categories for the purpose of analysis (Prefer Test, No Preference, and 
Prefer Control). Indicated by historical data from 
, the percentage of subjects 
preferring Test lens was assumed to be 0.4, the percentage of subjects preferring Control lens 
was assumed to be 0.2, the percentage of subjects with no preference was assumed to be 0.4. 
A total of 2000 replicating trials were simulated. The simulated multinomial data were 
analyzed using a generalized linear regression model with a generalized logit link function and 
tested for statistical superiority (preference ratio of preferring Test to Control). Sample size 
was estimated for a minimum statistical power of 80%.  
Table 10: Sample Size Estimates
Endpoint
Hypothesis
Sample size
Power
Primary
CLUE Vision
Non-inferiority
100
91.3%
Secondary
CLUE Handling  
Non-inferiority
160
90.5%
CLUE Comfort
Non-inferiority
200
81.4%
Exploratory  
Clarity of vision indoors in 
bright light
Superiority 
200
79.2% 
Overall preference while 
using computer screens & 
digital devices
Superiority 
150
81.2% 
As indicated in Table 12 above, the sample size chosen for this study was primarily driven by 
the secondary endpoint of CLUE overall comfort in order to achieve a statistical power of at 
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least 80% for the primary and secondary endpoints. The plan is to enroll approximately 230 
eligible subjects with a target of 200 to complete the study. During the enrollment period, the 
subject dropout rate will be closely monitored, if an unexpectedly high dropout rate is 
observed, then the targeted total enrollment number may be increased accordingly to ensure 
that a minimum of 200 subjects complete the study. With 200 subjects to complete this study 
was also powered (a statistical power of approximately 80% or above) to demonstrate 
superiority of the Test lens compared to the Control lens with respect to clarity of vision in 
doors in bright light (proportion of subjects with “Excellent” response) and overall preference 
while using computer screens & digital devices at the 2-week follow-up evaluation. 
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article.  At least one observation should be recorded. 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population).  Justification of excluding subjects with protocol deviations in 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 study 
or deviation from protocol.  At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with a two-sided type I error rate of 5%. 
The primary and secondary hypotheses will be tested with a type I error of 5% individually. 
All primary and secondary hypotheses need to be met in order to analyze other exploratory
hypotheses and each exploratory hypothesis will be tested individually at the two-sided type I 
error rate of 5%.
14.5. Primary Analysis 
The primary endpoint is CLUE overall quality of vision. Non-inferiority of Test compared to 
Control with respect to CLUE vision will be assessed on the Per-protocol population (PP).  
CLUE Overall Quality of Vision
CLUE vision scores will be analyzed using a linear mixed model to compare the Test and 
Control lenses at the 2-week follow-up evaluation. The model will include baseline CLUE 
vision scores, lens type, lens sequence, and period as fixed effects and site as a random effect 
(G-side). Other subject characteristics such as age, gender, race, iris category, and subject 
group based on habitual lens wear (habitual daily disposable and habitual daily wear reusable) 
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will be included as fixed covariates when appropriate. The covariance of residuals between 
measurement from different periods within the same subject (R-side) will be modeled using 
Unstructured (UN) covariance structure. If the model does not converge, then other covariance 
structures, such as compound Symmetry (CS) covariance structure, will be considered. 
Heterogeneous residuals covariance structures across habitual lens groups will be considered 
when appropriate. A log-likelihood ratio test will be used to test for the homogeneity between 
the residual covariance structures. The Kenward and Roger method (Kenward & Roger, 
1997)17 will be used for the denominator degree of freedom.  
Hypothesis Testing 
The null and alternative hypotheses for testing non-inferiority of the Test lens relative to the 
Control lens with respect to CLUE vision scores are as follows: 
ܪ଴: ߤ்െ ߤ஼൑െ5
ܪ஺: ߤ்െ ߤ஼ > െ5
Where, ߤ்represents the mean CLUE vision score for the Test lens and ߤ௖represents the mean 
CLUE vision score for the Control lens. Non-inferiority will be declared if the lower bound of 
the 2-sided 95% confidence interval of the difference (Test – Control) is greater than -5. If
non-inferiority of the Test lens over Control lens is met, then superiority will be assessed on 
the ITT population. If the lower bound is greater than 0, then superiority of the Test lens over 
the Control lens will be established.
14.6. Secondary Analysis  
The secondary endpoints include CLUE overall comfort and CLUE overall handling. The non-
inferiority analysis on CLUE comfort and handling will be conducted on the PP population.  
CLUE Overall Comfort
CLUE overall comfort scores will be analyzed using the same model as the primary endpoint 
of CLUE vision and tested in the same manner.  
CLUE Overall Handling 
CLUE overall handling scores will be analyzed using the same model as the primary endpoint 
of CLUE vision and tested in the same manner.  
14.7. Other Exploratory Analysis  
The following other exploratory endpoints will be assessed in support of primary and 
secondary endpoints and will be conducted on the ITT population. Exploratory hypotheses will 
be assessed only when all primary and secondary hypotheses are met. 
Clarity of Vision Indoors in Bright Light 
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To test superiority of the Test lens compared to the Control with respect to the proportion of 
subjects with “Excellent” response to the statement “clarity of vision indoors in bright light”, 
responses will be converted into a binary variable for the purpose of analysis (Excellent = 1 
and others = 0) and “Not applicable” response will not be considered in the analysis. The 
dichotomized item responses will be analyzed using a generalized linear mixed model with a 
binomial distribution and the logit as the link function. The model will include lens type, 
sequence, and period as fixed effects and site as a random effect (G-side). Other subject 
characteristics such as age, gender, race, subject group based on habitual lens wear, and iris 
category will be included as fixed covariates when appropriate. The covariance of residuals 
between measurements from different periods within the same subject (R-side) will be
modeled using Unstructured (UN) covariance structure. If the model does not converge, then 
other covariance structures, such as compound Symmetry (CS) covariance structure, will be 
considered. Heterogeneous residuals covariance structures across habitual lens groups will be 
considered when appropriate. A log-likelihood ratio test will be used to test for the 
homogeneity between the residual covariance structures.
Hypothesis Testing 
The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens with respect to clarity of vision indoors at bright light are as follows: 
ܪ଴: ܱܴ൑1.0
ܪ஺: ܱܴ> 1.0
Where OR represents the odds ratio of having “Excellent” rating for the Test lens compared to 
the Control at the 2-week follow-up. Superiority will be declared if the lower bound of the 2-
sided 95% confidence interval is above 1.0. 
Individual CLUE or MRD questions: 
1) Clarity of distance vision (i.e. looking at things that are more than 5 feet away, such as 
street signs). (P3_0006_p10) 
2) Clarity of vision in bright sunlight. (MIS00612) 
3) Ability to see comfortably while driving at night (MIS01980) 
4) Ability to see comfortably while driving during the day (MIS01981) 
5) Clarity of vision indoors in bright light. (MIS00623) 
6) Reduction in the feeling of tired eyes from using a computer or other digital device. 
(MIS02001) 
7) Ability to see comfortably while using a computer or other digital device. (MIS01982)
8) My vision was clear enough to allow me to drive at night (V056_1) 
9) With these lenses, I felt very confident to drive at night (V086_2) 
10)  Clarity of vision indoors in dim light (MIS00624) 
All individual CLUE and MRD items are assessed using 5-point Likert scales. “Not 
applicable” responses will not be considered in the analysis. Item responses will be reverse 
coded as needed so that higher values indicate more positive/favorable ratings for study lenses. 
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To compare the proportion of subjects with higher ratings for the Test lens to the proportion 
of subjects with higher ratings for the Control lens, the outcome variable will be derived by 
comparing the within-subject ratings for Test and Control: (1) if the rating of the Test is higher 
than the rating of the Control (Test – Control > 0), then the derived nominal outcome variable 
will be “Higher rating for Test”; (2) if the rating of the Control is higher than the rating of the 
Test (Test – Control < 0), then the derived outcome will be “Higher rating for Control”; and
(3) if ratings for Test and Control are the same (Test – Control = 0), then the derived outcome 
will be “Same Rating”. The derived outcome will be analyzed using a generalized linear mixed
model with a multinomial distribution and the generalized logit as the link function. The 
analysis model will include lens sequence as a fixed effect and site as a random effect (G-
sided). Other subject characteristics such as gender, race, subject group based on habitual lens 
wear, and iris category will be included as fixed covariates when appropriate.  
Hypothesis Testing 
The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens with respect to the proportion of subjects with higher ratings are as follows: 
ܪ଴: ܴܲ൑1.0
ܪ஺: ܴܲ> 1.0
Where PR represents the proportion ratio of higher rating for Test to higher rating for Control 
at the 2-week follow-up evaluation. Superiority will be declared if the lower bound of the 2-
sided 95% confidence interval is above 1.0.  
Preference Questions:
1) Overall opinion (PREf6_1_1) 
2) Overall comfort (PREf6_2_1) 
3) Overall vision (PREf6_3_1) 
4) Comfort throughout the day (PREf6_5_1) 
5) Comfort at the end of the day (PREf6_6_1) 
6) Comfort from activity to activity (PREf6_7_1) 
7) Clarity of vision from activity to activity (PREf6_8_1) 
8) Overall preference while using computer screens & digital devices (PREf6_4_1) 
Responses to preference items will be collapsed into three categories for the purpose of 
analysis (Prefer Test, No Preference, and Prefer Control). The collapsed item responses will 
be analyzed using a generalized linear mixed model with a multinomial distribution and the 
generalized logit as the link function. The analysis model will include lens sequence as a fixed 
effect and site as a random effect (G-sided). Other subject characteristics such as gender, race, 
subject group based on habitual lens wear, and iris category will be included as fixed covariates 
when appropriate.  
Hypothesis Testing 
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The null and alternative hypotheses for testing superiority of the Test lens relative to the 
Control lens with respect to subjective preference are as follows: 
ܪ଴: ܴܲ൑1.0
ܪ஺: ܴܲ> 1.0
Where PR represents the preference ratio of preferring the Test lens to preferring the Control 
lens (proportion of subjects preferring Test to proportion of subjects preferring Control) at the 
2-week follow-up. Superiority will be declared if the lower bound of the 2-sided 95% 
confidence interval is above 1.0.
Study lens preferences to habitual lens, study lens purchase intent, acceptable lens fit rates, 
surface characteristics, biomicroscopy findings, and other characteristics of both study lenses 
will be descriptively summarized with tables and/or graphs. Post-hoc analyses may be 
conducted at the discretion of the study responsible clinician.  
14.8. Interim Analysis  
An interim analysis will be conducted after 50% of the subjects (about 100 subjects) complete 
2-week follow-up evaluation in the second study period. The interim analysis will consist of 
descriptive summaries for questionnaire data. The results will be reviewed with historical data 
with Test lenses from the pilot line before the design validation study is initiated. The results 
will be communicated to the project team. 
14.9. Procedure for Handling Missing Data and Drop-Outs
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 20 imputations. 
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using the 
Bioclinica EDC system. An authorized data originator will enter study data into the eCRFs 
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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 ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
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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. 
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16.4. Data Monitoring Committee (DMC) 
Not Applicable 
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
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x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 141551
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 States18 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. 
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All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
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Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This is a multicenter study. The participating institution and Principal Investigations for this 
study agree that, should this study results be published, the first publication of the results of 
this study shall be made in conjunction with the presentation of a joint, multicenter publication 
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of the study results with the investigators and the institutions from all appropriate sites 
contributing data, analyses and comments. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human 
Subjects — Good Clinical Practice. Available at 
https://www.iso.org/standard/45557.html 
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-
GCP). Available at 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving 
Human Subjects. Available at https://www.wma.net/policies-post/wma-
declaration-of-helsinki-ethical-principles-for-medical-research-involving-
human-subjects/
4. United States (US) Code of Federal Regulations (CFR). . Available at 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Gallas J, Eisner M. Eye protection from sunlight damage. Comprehensive 
Series in Photosciences. 2001;3:427-455. 
6. Kim H, Kim HS, Jung CH, Yoon I. Monitor Calibration Approach to 
Reducing High Energy Visible Light from White Light-Emitting Diode. 
Science & Engineering Research Support Society. 2015;87:151-154. 
7. Rai V, Dayan N, B. M-K. A Comparative eEvaluation of Photo-toxic Effect of 
Frationated Melanin and Chlorpromazine Hydrochloride on Human (Dermal 
Fibroblasts and Epidermal Keratinocytes) and Mouse Cell Line/s (fibroblast 
Balb/c 3T3). Toxicology in Vitro.25(2):538-544. 
8. Smick K. Blue Light Hazard: New Knowledge, New Approaches to 
Maintaining Ocular Health. Report of a roundtable sponsored by Essilor of 
America;2013. 
9. Panda S. Illumination of the Melanopsis Signaling Pathway. Science & 
Engineering Research Support Society. 2005;307(5709):600-604. 
10. Buch J.  Investigator Brochure 
 (VIS-CSIB-006348) Evaluation of 
Prototype Lenses with Experimental UV/HEV Blocker. December 03, 2019 
11. Wirth RJ, Edwards MC, Henderson M, Henderson T, Olivares G, Houts CR. 
Development of the Contact Lens User Experience: CLUE Scales. Optometry 
and vision science : official publication of the American Academy of 
Optometry. 2016;93(8):801-808. 
12. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS 
Institute Inc.
13. (NCT02402127) Lubricity Post Wear – Competitive Lens Pilot. 2016 
14. Buch J.  Clinical Study Report 
 (VIS-CSRP-006381) Evaluation of 
Prototype Lenses with Experimental UV/HEV Blocker. February 08, 2021 
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15. Stroup W. Generalized Mixed Models:  Modern Concepts, Methods and 
Applications. Boca Raton CRC Press; 2013  
16. Stroup WW. Mixed model procedures to assess power, precision, and sample 
sizes. . Alexandria, VA.: American Statistical Association; 1999.
17. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from 
Restricted Maximum Likelihood. Biometrics. 1997;53(3):983–997. 
18. 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)
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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 1-Day with HydraLuxe™ 
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DESCRIPTION
ACUVUE OASYS® Brand Contact Lenses 1-Day and ACUVUE OASYS® 
Brand Contact Lenses 1-Day for ASTIGMATISM are soft (hydrophilic) 
contact lenses made with HydraLuxe™ Technology. They are available as 
spherical or toric lenses respectively. 
These lenses are made of a silicone hydrogel material containing an internal 
wetting agent, visibility tint, and UV absorbing monomer and are tinted blue 
using Reactive Blue Dye #4 to make the lenses more visible for handling.
A benzotriazole UV absorbing monomer is used to block UV radiation. The 
transmittance characteristics for these lenses are less than 1% in the UVB 
range of 280 nm to 315 nm and less than 10% in the UVA range of 316 nm 
to 380 nm for the entire power range.
Lens Properties:
The physical/optical properties of the lens are:
• Speciﬁ c Gravity (calculated):
0.98 - 1.12
• Refractive Index:
1.42
• Light Transmission: 
85% minimum
• Surface Character:
Hydrophilic
• Water Content:
38%
• Oxygen Permeability:
VALUE
METHOD
122 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, non-
edge corrected)
103 x 10-11 (cm2/sec) 
(ml O2/ml x mm Hg) at 35°C
Fatt (boundary corrected, edge 
corrected)
Lens Parameters:
• Diameter Range:
12.0 mm to 15.0 mm
• Center Thickness:
varies with power
• Base Curve Range:
7.85 mm to 10.00 mm
• Spherical Power Range:
-20.00D to +20.00D
• Cylinder Power Range:
-0.25D to -10.00D
• Axis Range:
2.5° to 180°
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AVAILABLE LENS PARAMETERS
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology are 
hemispherical shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.085 mm to 0.221 mm (varies with power)
Base Curve:
8.5 mm, 9.0 mm
Powers:
-0.50D to -6.00D (in 0.25D increments)
-6.50D to -12.00D (in 0.50D increments)
+0.50D to +6.00D (in 0.25D increments)
+6.50D to +8.00D (in 0.50D increments)
ACUVUE OASYS® Brand 1-Day with HydraLuxe™ Technology for 
ASTIGMATISM are hemitoric shells of the following dimensions:
Diameter:
14.3 mm
Center Thickness:
0.075 mm to 0.172 mm (varies with power)
Base Curve:
8.5 mm
Powers:
+0.00D to -6.00D (in 0.25D increments)
Cylinders: -0.75D, -1.25D, -1.75D, -2.25D*
Axis: 10° to 180° in 10° increments
*-2.25D cylinder is availble in 10°, 20°, 70°, 80°, 90°, 100°, 110°, 
160°, 170°, 180° axes only.
+0.25D to +4.00D (in 0.25D increments)
-6.50D to -9.00D (in 0.50D increments)
Cylinders: -0.75D, -1.25D, -1.75D
Axis: 10°, 20°, 70°, 80°, 90°, 100°, 110°, 160°, 
170°, 180°
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TRANSMITTANCE CURVES
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology (senoﬁ lcon A) 
Visibility Tinted with UV Blocker vs. 24 yr. old human cornea and 25 yr. old 
human crystalline lens. 
……. 
ACUVUE OASYS®  
1-Day with 
HydraLuxe™ 
Technology 
(senoﬁ lcon A)*
_____
24 YR. OLD HUMAN 
CORNEA1
- - - - - 
25 YR. OLD HUMAN 
CRYSTALLINE LENS2
* The data was obtained from measurements taken through the central 3-5 mm portion for 
the thinnest marketed lens (-9.00D lens, 0.075 mm center thickness).
1Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p. 58, ﬁ gure 2-21
2Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, Florida, 
1986, p. 19, ﬁ gure 5 
WARNING: UV absorbing contact lenses are NOT substitutes for 
protective UV absorbing eyewear, such as UV absorbing goggles 
or sunglasses because they do not completely cover the eye and 
surrounding area. The patient should continue to use UV absorbing 
eyewear as directed.
ACTIONS
In its hydrated state, the contact lens, when placed on the cornea, acts as 
a refracting medium to focus light rays onto the retina.
The transmittance characteristics for these lenses are less than 1% in the 
UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 
316 nm to 380 nm for the entire power range.
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NOTE:  Long-term exposure to UV radiation is one of the risk 
factors associated with cataracts.  Exposure is based on a number 
of factors such as environmental conditions (altitude, geography, 
cloud cover) and personal factors (extent and nature of outdoor 
activities).  UV-Blocking contact lenses help provide protection 
against harmful UV radiation. However, clinical studies have not 
been done to demonstrate that wearing UV-Blocking contact 
lenses reduces the risk of developing cataracts or other eye 
disorders. The Eye Care Professional should be consulted for more 
information.
INDICATIONS (USES)
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ 
Technology are indicated for daily disposable wear for the optical 
correction of refractive ametropia (myopia and hyperopia) in phakic or 
aphakic persons with non-diseased eyes who may have 1.00D or less of 
astigmatism.
ACUVUE OASYS® Brand Contact Lenses 1-Day with HydraLuxe™ Tech-
nology for ASTIGMATISM are indicated for daily disposable wear for the 
optical correction of refractive ametropia (myopia and hyperopia) in phakic 
or aphakic persons with non-diseased eyes who may have 0.50D to 3.00D 
of astigmatism.
These lenses contain a UV Blocker to help protect against transmission of 
harmful UV radiation to the cornea and into the eye.
CONTRAINDICATIONS (REASONS NOT TO USE) 
DO NOT USE these contact lenses when any of the following 
conditions exist:
• Acute or subacute inﬂ ammation or infection of the anterior chamber 
of the eye.
• Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva, or eyelids.
• Severe insufﬁ ciency of lacrimal secretion (dry eye).
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• Corneal hypoesthesia (reduced corneal sensitivity).
• Any systemic disease that may affect the eye or be exaggerated by 
wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced 
or exaggerated by wearing contact lenses or use of contact lens 
solutions.
• Ocular irritation due to allergic reactions which may be caused by 
use of contact lens solutions (i.e., rewetting drops) that contain 
chemicals or preservatives (such as mercury, Thimerosal, etc.) to 
which some people may develop an allergic response.
• Any active corneal infection (bacterial, fungal, protozoal, or viral).
• If eyes become red or irritated.
WARNINGS
Patients should be advised of the following warnings pertaining to 
contact lens wear:
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF THE PATIENT EXPE-
RIENCES:
• Eye Discomfort,
• Excessive Tearing,
• Vision Changes,
• Loss of Vision,
• Eye Redness,
• Or Other Eye Problems, 
THE PATIENT SHOULD BE INSTRUCTED TO IMMEDIATELY RE-
MOVE THE LENSES AND PROMPTLY CONTACT THE EYE CARE 
PROFESSIONAL.
• When prescribed for daily wear, patients should be instructed not 
to wear lenses while sleeping. Clinical studies have shown that 
the risk of serious adverse reactions is increased when lenses are 
worn overnight, and that the risk of ulcerative keratitis is greater for 
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extended wear contact lens users than for daily wear users.3
• Studies have shown that contact lens wearers who are smokers 
have a higher incidence of adverse reactions than nonsmokers.
• Problems with contact lenses or lens care products could result in 
serious injury to the eye. Patients should be cautioned that proper 
use and care of contact lenses and lens care products are essential 
for the safe use of these products.
• The overall risk of ulcerative keratitis may be reduced by carefully 
following directions for lens care.
3 New England Journal of Medicine, September 21, 1989; 321 (12), pp. 773-783
Speciﬁ c Instructions for Use and Warnings:
• Water Activity
Instructions for Use
Do not expose contact lenses to water while wearing them.
WARNING:
Water can harbor microorganisms that can lead to severe infection, 
vision loss or blindness. If lenses have been submersed in water 
when participating in water sports or swimming in pools, hot tubs, 
lakes, or oceans, the patient should be instructed to discard them 
and replace them with a new pair. The Eye Care Professional should 
be consulted for recommendations regarding wearing lenses during 
any activity involving water.
PRECAUTIONS
Special Precautions for Eye Care Professionals:
• Due to the small number of patients enrolled in clinical investiga-
tion of lenses, all refractive powers, design conﬁ gurations, or lens 
parameters available in the lens material are not evaluated in signif-
icant numbers. Consequently, when selecting an appropriate lens 
design and parameters, the Eye Care Professional should consider 
all characteristics of the lens that can affect lens performance and 
ocular health, including oxygen permeability, wettability, central and 
peripheral thickness, and optic zone diameter.
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• The potential impact of these factors on the patient’s ocular health 
should be carefully weighed against the patient’s need for refractive 
correction; therefore, the continuing ocular health of the patient and 
lens performance on the eye should be carefully monitored by the 
prescribing Eye Care Professional.
• Patients who wear these lenses to correct presbyopia using mono-
vision may not achieve the best corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual and 
should be considered when selecting the most appropriate type of 
lens for each patient.
• Fluorescein, a yellow dye, should not be used while the lenses are 
on the eyes. The lenses absorb this dye and become discolored. 
Whenever ﬂ uorescein is used in eyes, the eyes should be ﬂ ushed 
with a sterile saline solution that is recommended for in-eye use.
• Eye Care Professionals should instruct the patient to remove the 
lenses immediately if the eyes become red or irritated. 
Eye Care Professionals should carefully instruct patients about the 
following care regimen and safety precautions.
Handling Precautions:
• Before leaving the Eye Care Professional’s ofﬁ ce, the patient should 
be able to promptly remove the lenses or should have someone 
else available who can remove the lenses for him or her. 
• DO NOT use if the sterile blister package is opened or damaged. 
• Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorants, or sprays in the 
eyes or on the lenses. It is best to put on lenses before putting on 
makeup. Water-based cosmetics are less likely to damage lenses 
than oil-based products. 
• DO NOT touch contact lenses with the ﬁ ngers or hands if the 
hands are not free of foreign materials, as microscopic scratches 
of the lenses may occur, causing distorted vision and/or injury to 
the eye.
• Carefully follow the handling, insertion, removal, and wearing 
instructions in the “Patient Instruction Guide” for the prescribed 
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wearing schedule and those prescribed by the Eye Care 
Professional.
• Always handle lenses carefully and avoid dropping them.
• Never use tweezers or other tools to remove lenses from the lens 
container unless speciﬁ cally indicated for that use. Slide the lens up 
the side of the bowl until it is free of the container. 
• Do not touch the lens with ﬁ ngernails. 
Lens Wearing Precautions:
• If the lens sticks (stops moving) on the eye, follow the recom-
mended directions in “Care for a Sticking (Non-Moving) Lens." The 
lens should move freely on the eye for the continued health of the 
eye. If non-movement of the lens continues, the patient should be 
instructed to immediately consult his or her Eye Care Professional.
• Never wear lenses beyond the period recommended by the Eye 
Care Professional.
• The patient should be advised to never allow anyone else to wear 
their lenses. They have been prescribed to ﬁ t their eyes and to 
correct their vision to the degree necessary. Sharing lenses greatly 
increases the chance of eye infections.
• If aerosol products, such as hair spray, are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
• Avoid all harmful or irritating vapors and fumes while wearing 
lenses. 
• Always discard lenses worn as prescribed by the Eye Care 
Professional. 
Lens Care Precautions:  
• The patient should be informed that no cleaning or disinfection is 
needed when lenses are worn for daily disposable wear.  Patients 
should always dispose of lenses when removed and have spare 
lenses or spectacles available.
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Other Topics to Discuss with Patients:
• Always contact the Eye Care Professional before using any medi-
cine in the eyes. 
• Certain medications, such as antihistamines, decongestants, 
diuretics, muscle relaxants, tranquilizers, and those for motion 
sickness may cause dryness of the eye, increased lens awareness, 
or blurred vision. Should such conditions exist, proper remedial 
measures should be prescribed. Depending on the severity, this 
could include the use of lubricating drops that are indicated for use 
with soft contact lenses or the temporary discontinuance of contact 
lens wear while such medication is being used. 
• Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
• As with any contact lens, follow-up visits are necessary to assure 
the continuing health of the patient’s eyes. The patient should be 
instructed as to a recommended follow-up schedule. 
Who Should Know That the Patient is Wearing Contact Lenses?
• Patients should inform all doctors (Health Care Professionals) about 
being a contact lens wearer. 
• Patients should always inform their employer of being a contact 
lens wearer. Some jobs may require use of eye protection equip-
ment or may require that the patient not wear contact lenses. 
ADVERSE REACTIONS
The patient should be informed that the following problems may 
occur when wearing contact lenses:
• The eye may burn, sting, and/or itch.
• There may be less comfort than when the lens was ﬁ rst placed on 
the eye.
• There may be a feeling of something in the eye (foreign body, 
scratched area).
• There may be the potential for some temporary impairment due to 
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peripheral inﬁ ltrates, peripheral corneal ulcers, or corneal erosion. 
There may be the potential for other physiological observations, 
such as local or generalized edema, corneal neovascularization, 
corneal staining, injection, tarsal abnormalities, iritis, and conjuncti-
vitis; some of which are clinically acceptable in low amounts.
• There may be excessive watering, unusual eye secretions, or 
redness of the eye.
• Poor visual acuity, blurred vision, rainbows, or halos around 
objects, photophobia, or dry eyes may also occur if the lenses are 
worn continuously or for too long a time.
The patient should be instructed to conduct a simple 3-part self-examina-
tion at least once a day. They should ask themselves:
• How do the lenses feel on my eyes?
• How do my eyes look?
• Have I noticed a change in my vision? 
If the patient reports any problems, he or she should be instructed to 
IMMEDIATELY REMOVE THE LENS. If the problem or discomfort stops, 
the patient should discard the lens and place a new fresh lens on the eye.
If after inserting the new lens, the problem continues, the patient should be 
directed to IMMEDIATELY REMOVE THE LENS AND CONTACT HIS OR 
HER EYE CARE PROFESSIONAL.
The patient should be instructed NOT to use a new lens as self-treatment 
for the problem.
The patient should be advised that when any of the above symptoms oc-
cur, a serious condition such as infection, corneal ulcer, neovascularization, 
or iritis may be present. He or she should be instructed to seek immediate 
professional identiﬁ cation of the problem and prompt treatment to avoid 
serious eye damage.
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GENERAL FITTING GUIDELINES
A. Patient Selection
Patients selected to wear these lenses should be chosen based on: 
• Motivation to wear lenses 
• Ability to follow instructions regarding lens wear care
• General health 
• Ability to adequately handle and care for the lenses 
• Ability to understand the risk and beneﬁ ts of lens wear
Patients who do not meet the above criteria should not be provided with 
contact lenses. 
B. Pre-ﬁ tting Examination
Initial evaluation of the patient should begin with a thorough case history 
to determine if there are any contraindications to contact lens wear. During 
the case history, the patient’s visual needs and expectations should be 
determined as well as an assessment of their overall ocular, physical, and 
mental health. 
Preceding the initial selection of trial contact lenses, a comprehensive 
ocular evaluation should be performed that includes, but is not limited to, 
the measurement of distance and near visual acuity, distance and near 
refractive prescription (including determining the preferred reading distance 
for presbyopes), keratometry, and biomicroscopic evaluation. 
Based on this evaluation, if it is determined that the patient is eligible to 
wear these lenses, the Eye Care Professional should proceed to the lens 
ﬁ tting instructions as outlined below. 
C. Initial Power Determination
A spectacle refraction should be performed to establish the patient’s 
baseline refractive status and to guide in the selection of the appropriate 
lens power. Remember to compensate for vertex distance if the refraction 
is greater than ±4.00D.
D. Base Curve Selection (Trial Lens Fitting)
The following trial lenses should be selected for patients regardless of kera-
tometry readings. However, corneal curvature measurements should be 
performed to establish the patient’s baseline ocular status. 
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• ACUVUE OASYS® 1-Day: 8.5 mm/14.3 mm
• ACUVUE OASYS® 1-Day for ASTIGMATISM: 8.5 mm/14.3 mm
The trial lens should be placed on each of the patient's eyes and evaluated 
after the patient has adjusted to the lenses.  
1. Criteria of a Properly Fit Lens 
A properly ﬁ t lens will center and completely cover the cornea (i.e., no 
limbal exposure), have sufﬁ cient movement to provide tear exchange 
under the contact lens with the blink, and be comfortable. The lens 
should move freely when manipulated digitally with the lower lid, and 
then return to its properly centered position when released.
2. Criteria of a Flat Fitting Lens 
A ﬂ at ﬁ tting lens may exhibit one or more of the following characteris-
tics: decentration, incomplete corneal coverage (i.e., limbal exposure), 
excessive movement with the blink, and/or edge standoff. If the lens is 
judged to be ﬂ at ﬁ tting, it should not be dispensed to the patient.
3. Criteria of a Steep Fitting Lens 
A steep ﬁ tting lens may exhibit one or more of the following charac-
teristics: insufﬁ cient movement with the blink, conjunctival indentation, 
and resistance when pushing the lens up digitally with the lower lid. 
If the lens is judged to be steep ﬁ tting, it should not be dispensed to 
the patient.
If the initial trial base curve is judged to be ﬂ at or steep ﬁ tting, the alternate 
base curve, if available, should be trial ﬁ t and evaluated after the patient 
has adjusted to the lens. The lens should move freely when manipulated 
digitally with the lower lid, and then return to a properly centered position 
when released. If resistance is encountered when pushing the lens up, the 
lens is ﬁ tting tightly and should not be dispensed to the patient.
E. Final Lens Power (Spherical)
A spherical over-refraction should be performed to determine the ﬁ nal lens 
power after the lens ﬁ t is judged acceptable. The spherical over-refraction 
should be combined with the trial lens power to determine the ﬁ nal lens 
prescription. The patient should experience good visual acuity with the 
correct lens power unless there 
ve residual astigmatism.
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Example 1
Diagnostic lens:
-2.00D
Spherical over-refraction: 
-0.25D
Final lens power: 
-2.25D
Example 2
Diagnostic lens:
-2.00D
Spherical over-refraction: 
+0.25D
Final lens power: 
-1.75D
If vision is acceptable, perform a slit lamp examination to assess adequate 
ﬁ t (centration and movement). If the ﬁ t is acceptable, dispense the lenses 
and instruct the patient to return in one week for reassessment (see 
dispensing and follow up information in PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
TORIC FITTING GUIDELINES
Although most aspects of the ﬁ tting procedure are identical for all types 
of soft contact lenses, including toric lenses, there are some additional 
steps and/or rules to follow to assure the proper ﬁ t of toric lenses.
The only new steps you must follow in prescribing ACUVUE OASYS® 
1-Day for ASTIGMATISM are that you must determine the stability, 
repeatability, and drift angle of the lens axis so that you can prescribe the 
correct lens axis for the patient.
A. How to Determine Lens Cylinder and Axis Orientation 
1. Locate the Orientation Marks
To help determine the proper orientation of the toric lens, you’ll 
ﬁ nd two primary marks approximately 1 mm from the lens edge 
representing the vertical position on opposite ends of the lens at 
6 and 12 o’clock (Fig. 1). Because of the lens’ ballasting system, 
either mark can represent the vertical position – there is no “top” 
and “bottom” as in a prism-ballasted lens. You don’t need to view 
both marks to assess orientation; simply look for the 6 o’clock 
mark as you would with a prism-ballasted lens.
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Figure 1
You’ll need a slit lamp biomicroscope with a 1 to 2 mm 
parallelepiped beam to highlight the marks when the lens is ﬁ tted 
to the eye. There are a number of techniques you can use to 
improve the visibility of the 6 o’clock mark. Using a parallelepiped 
beam and medium magniﬁ cation (10x or 15x), slowly pan 
down the lens, looking just below the direct illumination at the 
retroilluminated area. Backlighting the mark this way should make 
it more visible. Sometimes manipulating the lower lid may be 
necessary to uncover the mark.
2. Observe Lens Rotation and Stability
Observe the position and stability of the “bottom” mark. It usually 
stabilizes at the 6 o’clock position. If it does, calculation of the 
lens power will be straightforward. The 6 o’clock position is not a 
“must”; however, the absolute requirement is that the axis position 
be stable and repeatable.
The mark may stabilize somewhat left or right (drift) of the vertical 
meridian and still enable you to ﬁ t a toric lens for that eye, as 
long as the lens always returns to the same “drift axis” position 
after settling. The deviation can be compensated for in the ﬁ nal 
prescription. Your objective is to ensure that whatever position the 
initial lens assumes near 6 o’clock, this position must be stable 
and repeatable. With full eye movement or heavy blink, you may 
see the marks swing away, but they must return quickly to the 
original stable position. If the lens does not return quickly, you may 
need to select a different lens.
3. Assessing Rotation
Imagine the eye as a clock dial and every hour represents a 
30° interval. If the orientation mark of the initial lens stabilizes 
somewhat left or right of the vertical position, the ﬁ nal lens will 
orient on the eye with the same deviation. You can use an axis 
reticule in the slit lamp or use a line-scribed lens in a spectacle trial 
frame to measure or estimate the “drift angle” of the cylinder axis.
To compensate for this “drift”, measure or estimate the “drift”, then 
add or subtract it from the refractive axis to determine the correct 
cylinder axis. Use the LARS (Left Add, Right Subtract) method to 
determine which direction to compensate.
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B. Final Lens Power 
When the diagnostic lens has its axis aligned in the same meridian 
as the patient’s refractive axis, a spherocylindrical over-refraction may 
be performed and visual acuity determined. However, in the case 
of crossed axes, such as when the diagnostic lens axis is different 
from the spectacle cylinder axis, it is not advisable to perform a full 
spherocylindrical over-refraction because of the difﬁ culty in computing 
the resultant power. A spherical over-refraction without cylinder 
refraction may be performed. 
If the required cylinder correction falls between two available cylinder 
powers, it is recommended to prescribe the lower cylinder power 
lens. See below for instructions on how to determine the ﬁ nal lens 
power.
1. For the Sphere
If sphere alone or combined sphere and cylinder Rx > ±4.00D, 
compensate for vertex distance. If sphere alone or combined 
sphere and cylinder Rx ≤ ±4.00D, vertex compensation is not 
necessary.
2. For the Cylinder
Adjust the axis by the drift angle using the LARS method. Choose 
a cylinder that is ≤ 0.50D from the refractive cylinder.
3. Case Examples
Example 1
Manifest (spectacle) refraction:
O.D. -2.50D / -1.25D x 180° 20/20
O.S. -2.00D / -1.00D x 180° 20/20
Choose a diagnostic lens for each eye with axis 180°. Place 
the lens on each eye and allow a minimum of 3 minutes for it to 
equilibrate, based on the patient’s initial response to the lens. If the 
lens has not yet stabilized, recheck until stable.
Check the orientation of the axis mark. If the bottom axis mark 
is in the 6 o’clock position on both eyes, choose the appropriate 
cylinder as listed previously. If the lens has not yet stabilized, 
recheck until stable.
Here is the Rx Prescribed:
O.D. -2.50D / -1.25D x 180°
O.S. -2.00D / -0.75D x 180°
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Example 2
Manifest (spectacle) refraction:
O.D. -3.00D / -1.00D x 90° 20/20
O.S. -4.75D / -2.00D x 90° 20/20
Choose diagnostic lenses of -3.00D / -0.75D x 90° for the right 
eye and -4.50D / -1.75D x 90° for the left eye, the nearest lenses 
available to the spherical power, cylinder power, and axis needed. 
For the left eye, since the manifest refraction called for -4.75D, 
compensating for vertex distance the sphere is reduced by 0.25D 
to -4.50D. The cylinder power will be -1.75D. Place the lens on 
each eye and allow a minimum of 3 minutes for it to equilibrate, 
based on the patient's initial response to the lens. If the lens has 
not yet stabilized, recheck until stable. 
Right Eye
The orientation mark on the right lens rotates left from the 6 
o’clock position by 10° and remains stable in this position. 
Compensation for this rotation should be done as follows: 
Compensate the 10° axis drift by adding it to the manifest 
refraction axis.
Here is the Rx Prescribed:
O.D. -3.00D / -0.75D x 100°
Left Eye
The orientation mark on the left lens rotates right from the 6 
o’clock position by 10° and remains stable in this position. 
Compensate for the 10° axis drift by subtracting it from the 
manifest refraction axis. 
Here is the Rx Prescribed: 
O.S. -4.50D / -1.75D x 80°
If vision is acceptable, perform a slit lamp examination to assess 
adequate ﬁ t (centration and movement). If ﬁ t is acceptable, 
dispense the lenses instructing the patient to return in one week 
for reassessment (see dispensing and follow-up information in 
PATIENT MANAGEMENT).
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
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MONOVISION FITTING GUIDELINES
A. Patient Selection
1. Monovision Needs Assessment
For a good prognosis, the patient should have adequately 
corrected distance and near visual acuity in each eye. The 
amblyopic patient or the patient with signiﬁ cant astigmatism 
(greater than 1.00D) in one eye may not be a good candidate for 
monovision correction with these lenses.
Occupational and environmental visual demands should be 
considered. If the patient requires critical vision (visual acuity and 
stereopsis), it should be determined by trial whether this patient 
can function adequately with monovision correction. Monovision 
contact lens wear may not be optimal for activities such as:
• visually demanding situations such as operating potentially 
dangerous machinery or performing other potentially hazardous 
activities; and
• driving automobiles (e.g., driving at night). Patients who cannot 
meet state driver's licensing requirements with monovision 
correction should be advised to not drive with this correction, 
OR may require that additional over-correction be prescribed.
2. Patient Education
All patients do not function equally well with monovision correc-
tion. Patients may not perform as well for certain tasks with this 
correction as they have with spectacles (multifocal, bifocal, trifocal, 
readers, progressives). Each patient should understand that 
monovision, as well as other presbyopic alternatives, can create 
a vision compromise that may reduce visual acuity and depth 
perception for distance and near tasks. Therefore, caution should 
be exercised when the patient is wearing the correction for the ﬁ rst 
time until they are familiar with the vision provided in visually chal-
lenging environments (e.g., reading a menu in a dim restaurant, 
driving at night in rainy/foggy conditions, etc.). During the ﬁ tting 
process, it is necessary for the patient to realize the disadvantages 
as well as the advantages of clear near vision and straight ahead 
and upward gaze that monovision contact lenses provide.
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B. Eye Selection
1. Ocular Preference Determination Methods
Generally, the non-dominant eye is corrected for near vision. The 
following two methods for eye dominance can be used.
Method 1:  Determine which eye is the “sighting eye.” Have the 
patient point to an object at the far end of the room. 
Cover one eye. If the patient is still pointing directly at the 
object, the eye being used is the dominant (sighting) eye.
Method 2:  Determine which eye will accept the added power with 
the least reduction in vision. Place a hand-held trial lens 
equal to the spectacle near ADD in front of one eye 
and then the other while the distance refractive error 
correction is in place for both eyes. Determine whether 
the patient functions best with the near ADD lens over 
the right or left eye.
2. Other Eye Selection Methods
Other methods include the "Refractive Error Method" and the 
"Visual Demands Method."
Refractive Error Method
For anisometropic correction, it is generally best to ﬁ t the more 
hyperopic (less myopic) eye for distance and the more myopic 
(less hyperopic) eye for near.
Visual Demands Method
Consider the patient’s occupation during the eye selection process 
to determine the critical vision requirements. If a patient’s gaze for 
near tasks is usually in one direction, correct the eye on that side 
for near.
Example: A secretary who places copy to the left side of the desk 
will function best with the near lens on the left eye.
C. Special Fitting Characteristics
1. Unilateral Vision Correction
There are circumstances where only one contact lens is required. 
As an example, an emmetropic patient would only require a near 
lens, whereas a bilateral myope would require corrective lenses on 
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both eyes.
Examples: 
A presbyopic emmetropic patient who requires a +1.75D ADD 
would have a +1.75D lens on the near eye and the other eye left 
without correction. 
A presbyopic patient requiring a +1.50D ADD who is -2.50D 
myopic in the right eye and -1.50D myopic in the left eye may 
have the right eye corrected for distance and the left uncorrected 
for near.
2. Near ADD Determination
Always prescribe the lens power for the near eye that provides 
optimal near acuity at the midpoint of the patient’s habitual reading 
distance. However, when more than one power provides optimal 
reading performance, prescribe the least plus (most minus) of the 
powers.
3. Trial Lens Fitting
A trial ﬁ tting is performed in the ofﬁ ce to allow the patient to 
experience monovision correction. Lenses are ﬁ t according to 
the GENERAL FITTING GUIDELINES for base curve selection 
described in this Package Insert.
Case history and standard clinical evaluation procedure should 
be used to determine the prognosis. Determine the distance 
correction and the near correction. Next determine the near ADD. 
With trial lenses of the proper power in place, observe the reaction 
to this mode of correction.
Allow the lenses to settle for about 20 minutes with the correct 
power lenses in place. Walk across the room and have the patient 
look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near 
objects such as a watch face or ﬁ ngernails. Again assess the 
reaction. As the patient continues to look around the room at both 
near and distance objects, observe the reactions. Only after these 
vision tests are completed should the patient be asked to read 
print. Evaluate the patient’s reaction to large print (e.g., typewritten 
copy) at ﬁ rst and then graduate to newsprint and ﬁ nally smaller 
type sizes.
After the patient’s performance under the above conditions 
is completed, tests of visual acuity and reading ability under 
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conditions of moderately dim illumination should be attempted.
An initial unfavorable response in the ofﬁ ce, while indicative of 
a guarded prognosis, should not immediately rule out a more 
extensive trial under the usual conditions in which a patient 
functions.
4. Adaptation
Visually demanding situations should be avoided during the 
initial wearing period. A patient may at ﬁ rst experience some 
mild blurred vision, dizziness, headaches, and a feeling of slight 
imbalance. You should explain the adaptational symptoms to 
the patient. These symptoms may last for a brief minute or for 
several weeks. The longer these symptoms persist, the poorer the 
prognosis for successful adaptation.
To help in the adaptation process, the patient can be advised to 
ﬁ rst use the lenses in a comfortable familiar environment such as 
in the home.
Some patients feel that automobile driving performance may not 
be optimal during the adaptation process. This is particularly true 
when driving at night. Before driving a motor vehicle, it may be 
recommended that the patient be a passenger ﬁ rst to make sure 
that their vision is satisfactory for operating an automobile. During 
the ﬁ rst several weeks of wear (when adaptation is occurring), it 
may be advisable for the patient to only drive during optimal driving 
conditions. After adaptation and success with these activities, the 
patient should be able to drive under other conditions with caution.
D. Other Suggestions
The success of the monovision technique may be further improved by 
having the patient follow the suggestions below:
• Have a third contact lens (distance power) to use when critical 
distance viewing is needed.
• Have a third contact lens (near power) to use when critical near 
viewing is needed.
• Having supplemental spectacles to wear over the monovision 
contact lenses for speciﬁ c visual tasks may improve the success 
of monovision correction. This is particularly applicable for those 
patients who cannot meet state driver's licensing requirements 
with monovision correction.
• Make use of proper illumination when carrying out visual tasks.
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Monovision ﬁ tting success can be improved by the following 
suggestions:
• Reverse the distance and near eyes if a patient is having trouble 
adapting.
• Reﬁ ne the lens powers if there is trouble with adaptation. 
Accurate lens power is critical for presbyopic patients.
• Emphasize the beneﬁ ts of clear near vision and straight ahead 
and upward gaze with monovision.
The decision to ﬁ t a patient with monovision correction is most 
appropriately left to the Eye Care Professional in conjunction with the 
patient after carefully considering the patient’s needs.
All patients should be supplied with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available for 
download at www.acuvue.com.
PATIENT MANAGEMENT
Dispensing Visit
Each sterile lens is supplied in a foil-sealed plastic package containing 
buffered saline solution with methyl ether cellulose. To remove the lens 
from the container, peel back the foil seal, place a ﬁ nger on the lens, and 
slide the lens up the side of the bowl of the lens package until it is free of 
the container.
• Evaluate the physical ﬁ t and visual acuity of the lens on each eye.
• Teach the patient how to apply and remove his or her lenses.
• Explain daily disposable lens wear and schedule a follow-up 
examination.
• Provide the patient with a copy of the PATIENT 
INSTRUCTION GUIDE for these lenses. Copies are available 
for download at www.acuvue.com.
REVIEW THESE INSTRUCTIONS WITH THE PATIENT SO THAT HE 
OR SHE CLEARLY UNDERSTANDS THE PRESCRIBED WEARING 
AND REPLACEMENT SCHEDULES.
Follow-Up Examinations
Follow-up care (necessary to ensure continued successful contact lens 
wear) should include routine periodic progress examinations, management 
of speciﬁ c problems, if any, and a review with the patient of the wear 
schedule, daily disposable modality  and proper lens handling procedures. 
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Recommended Follow-up Examination Schedule (complications 
and speciﬁ c problems should be managed on an individual patient 
basis):
1. One week from the initial lens dispensing to patient
2. One month post-dispensing
3. Every three to six months thereafter 
NOTE: Preferably, at the follow-up visits, lenses should be worn for at least 
six hours.
Recommended Procedures for Follow-up Visits:
1. Solicit and record patient’s symptoms, if any.
2. Measure visual acuity monocularly and binocularly at distance and 
near with the contact lenses.
3. Perform an over-refraction at distance and near to check for residual 
refractive error.
4. With the biomicroscope, judge the lens ﬁ tting characteristics (as 
described in the GENERAL FITTING GUIDELINES) and evaluate 
the lens surface for deposits and damage.
5. Following lens removal, examine the cornea and conjunctiva with 
the biomicroscope and ﬂ uorescein (unless contraindicated).
• The presence of vertical corneal striae in the posterior central 
cornea and/or corneal neovascularization is indicative of 
excessive corneal edema.
• The presence of corneal staining and/or limbal-conjunctival 
hyperemia can be indicative of an unclean lens, a reaction to 
solution preservatives, excessive lens wear and/or a poorly 
ﬁ tting lens.
• Papillary conjunctival changes may be indicative of an unclean 
and/or damaged lens.
6. Periodically perform keratometry and spectacle refractions. The 
values should be recorded and compared to the baseline meas-
urements.
If any observations are abnormal, use professional judgment to 
alleviate the problem and restore the eye to optimal conditions. If 
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the criteria for successful ﬁ t are not satisﬁ ed during any follow-up 
examinations, repeat the patient’s trial ﬁ tting procedure and reﬁ t 
the patient.
WEARING SCHEDULE
The wearing schedule should be determined by the Eye Care Professional.  
Regular checkups, as determined by the Eye Care Professional, are also 
extremely important.
Patients tend to overwear the lenses initially. The Eye Care Professional 
should emphasize the importance of adhering to the initial maximum wear-
ing schedule.  Maximum wearing time should be determined by the Eye 
Care Professional based upon the patient’s physiological eye condition, 
because individual response to contact lenses varies.
The maximum suggested wearing time for these lenses is:
Day
Hours
1
6-8
2
8-10
3
10-12
4
12-14
5 and after
all waking hours
REPLACEMENT SCHEDULE
These lenses are indicated for daily disposable wear and should be 
discarded upon removal.
LENS CARE DIRECTIONS
When lenses are prescribed for daily disposable wear, the Eye Care 
Professional should provide the patient with appropriate and adequate 
warnings and instructions for daily disposable lens wear at the time they 
are dispensed. 
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The Eye Care Professional should review with patients that no cleaning 
or disinfection is needed with daily disposable lenses. Patients should 
always dispose of lenses when they are removed and have spare lenses or 
spectacles available.
Basic Instructions
• Always wash, rinse, and dry hands before handling contact lenses.
• Do not use saliva or anything other than the recommended solutions 
for lubricating or rewetting lenses. Do not put lenses in the mouth.
• Eye Care Professionals may recommend a lubricating/rewetting 
solution which can be used to wet (lubricate) lenses while they are 
being worn to make them more comfortable. 
Care for a Sticking (Non-Moving) Lens
If the lens sticks (stops moving), the patient should be instructed to apply 
a few drops of the recommended lubricating or rewetting solution directly 
to the eye and wait until the lens begins to move freely on the eye before 
removing it. If non-movement of the lens continues after a few minutes, the 
patient should immediately consult the Eye Care Professional.
EMERGENCIES
The patient should be informed that if chemicals of any kind (household 
products, gardening solutions, laboratory chemicals, etc.) are splashed 
into the eyes, the patient should: FLUSH EYES IMMEDIATELY WITH TAP 
WATER AND IMMEDIATELY CONTACT THE EYE CARE PROFESSIONAL 
OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
HOW SUPPLIED
Each UV-blocking sterile lens is supplied in a foil-sealed plastic package 
containing buffered saline solution with methyl ether cellulose. The plastic 
package is marked with the following: 
• ACUVUE OASYS® 1-Day: base curve, power, diameter, lot number, 
and expiration date
• ACUVUE OASYS® 1-Day for ASTIGMATISM: base curve, power, 
diameter, cylinder, axis, lot number, and expiration date
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REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing these lenses or experienced with these lenses should be 
reported to:
Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Jacksonville, FL 32256
USA
Tel: 1-800-843-2020
www.acuvue.com
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Clinical Study Protocol
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 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
Page 3 of 6 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 6 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
Page 5 of 6 
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Title:                          Limbal & Conjunctival (Bulbar) Redness
Document Type:  
Document Number:
Revision Number:  5 
Page 6 of 6 
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EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 6 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 6 
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Title:                          Expanded Sodium Fluorescein Corneal Staining
Document Type:  
Document Number:
Revision Number:  5 
Page 6 of 6 
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LENS FITTING CHARACTERISTICS
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 5 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  5 
Page 5 of 5 
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Clinical Study Protocol
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
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FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE
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Title:                           Front and Back Surface Lens Deposit Grading Procedure
Document Type:  
Document Number:
Revision Number:  4 
Page 4 of 4 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
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Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 5 
  
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 BIOMICROSCOPY SCALE
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  4 
Page 2 of 4 
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PATIENT REPORTED OUTCOMES
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WHITE LIGHT LENS SURFACE WETTABILITY
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APPENDIX E: IRIS COLOR
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APPENDIX F: STARTING LENS POWER
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Clinical Study Protocol
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APPENDIX G: GUIDELINES FOR COVID-19 RISK MITIGATION
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6437 Evaluation of Prototype Lenses with Experimental 
UV/HEV Blocker
Version and Date: 1.0 18 March 2021 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix G of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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