Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Protocol CR-6388
Version: 3.0
Date: 07 April 2021
Investigational Products: Alcon DAILIES® Aqua Comfort Plus® (nelfilcon A), Alcon 
DAILIES TOTAL1® (delfilcon A), CooperVision® clariti® 1 day (somofilcon A),
CooperVision® MyDay® (stenfilcon A), Johnson & Johnson 1-Day ACUVUE® Moist
(etafilcon A), and Johnson and Johnson ACUVUE OASYS®1-Day with HydraLuxe™ 
Technology (senofilcon A) are daily disposable marketed and FDA approved contact lenses 
which will be worn in daily disposable modality
Keywords: Alcon DAILIES® Aqua Comfort Plus® (nelfilcon A), Alcon DAILIES 
TOTAL1® (delfilcon A), CooperVision® clariti® 1 day (somofilcon A), CooperVision®
MyDay® (stenfilcon A), Johnson & Johnson 1-Day ACUVUE® Moist (etafilcon A), and 
Johnson and Johnson ACUVUE OASYS®1-Day with HydraLuxe™ Technology (senofilcon 
A), habitual lens, daily disposable, daily wear, dispensing, symptomatic, CLDEQ-8, CLUE
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, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 18 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 19 
1.1. 
Name and Descriptions of Investigational Products ................................................ 19 
1.2. 
Intended Use of Investigational Products................................................................. 19 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 19 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 19 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...20 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 21 
2.1. 
Objectives................................................................................................................. 21 
2.2. 
Endpoints.................................................................................................................. 22 
2.3. 
Hypotheses ............................................................................................................... 24 
3. 
TARGETED STUDY POPULATION........................................................................... 27 
3.1. 
General Characteristics ............................................................................................ 27 
3.2. 
Inclusion Criteria...................................................................................................... 27 
3.3. 
Exclusion Criteria..................................................................................................... 28 
3.4. 
Enrollment Strategy.................................................................................................. 29 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 29 
4.1. 
Description of Study Design .................................................................................... 29 
4.2. 
Study Design Rationale............................................................................................ 29 
4.3. 
Enrollment Target and Study Duration.................................................................... 30 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 30 
5.1. 
Test Article Allocation............................................................................................. 30 
5.2. 
Masking.................................................................................................................... 31 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 31 
6. 
STUDY INTERVENTION............................................................................................. 31 
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6.1. 
Identity of Test Articles............................................................................................ 31 
6.2. 
Ancillary Supplies/Products..................................................................................... 32 
6.3. 
Administration of Test Articles................................................................................ 33 
6.4. 
Packaging and Labeling ........................................................................................... 33 
6.5. 
Storage Conditions................................................................................................... 34 
6.6. 
Collection and Storage of Samples .......................................................................... 34 
6.7. 
Accountability of Test Articles ................................................................................ 34 
7. 
STUDY EVALUATIONS.............................................................................................. 35 
7.1. 
Time and Event Schedule......................................................................................... 35 
7.2. 
Detailed Study Procedures ....................................................................................... 38 
VISIT 1........................................................................................................................... 39 
VISIT 2 (14 ± 2 days following Visit 1) ....................................................................... 45 
VISIT 2 (14 ± 2 days following Visit 1) ....................................................................... 46 
VISIT 3 (14 ± 2 days following Visit 3) ....................................................................... 51 
FINAL EVALUATION (ARM 1 & ARM 2)................................................................. 52 
7.3. 
Unscheduled Visits................................................................................................... 53 
7.4. 
Laboratory Procedures ............................................................................................. 54 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 54 
8.1. 
Completion Criteria.................................................................................................. 54 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 54 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 55 
9.1. 
Systemic Medications .............................................................................................. 55 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 57 
11. 
STUDY TERMINATION ........................................................................................... 58 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 58 
13. 
ADVERSE EVENTS................................................................................................... 60 
13.1. 
Definitions and Classifications............................................................................. 60 
13.2. 
Assessing Adverse Events.................................................................................... 62 
13.2.1. 
Causality Assessment.................................................................................... 62 
13.2.2. 
Severity Assessment...................................................................................... 63 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 63 
13.4. 
Reporting Adverse Events.................................................................................... 64 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 65 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
………………………………………………………………………………65 
13.5. 
Event of Special Interest....................................................................................... 66 
13.6. 
Reporting of Pregnancy........................................................................................ 66 
14. 
STATISTICAL METHODS........................................................................................ 66 
14.1. 
General Considerations......................................................................................... 66 
14.2. 
Sample Size Justification...................................................................................... 66 
14.3. 
Analysis Populations ............................................................................................ 69 
14.4. 
Level of Statistical Significance........................................................................... 69 
14.5. 
Primary Analysis .................................................................................................. 69 
14.6. 
Secondary Analysis .............................................................................................. 70 
14.7. 
Other Exploratory Analysis.................................................................................. 72 
14.8. 
Interim Analysis ................................................................................................... 75 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 75 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 75 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 75 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 75 
15.2. 
Subject Record...................................................................................................... 76 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 76 
16. 
DATA MANAGEMENT............................................................................................. 76 
16.1. 
Access to Source Data/Document ........................................................................ 76 
16.2. 
Confidentiality of Information.............................................................................. 76 
16.3. 
Data Quality Assurance........................................................................................ 77 
16.4. 
Data Monitoring Committee (DMC).................................................................... 77 
17. 
CLINICAL MONITORING........................................................................................ 78 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 78 
18.1. 
Study-Specific Design Considerations ................................................................. 78 
18.2. 
Investigator Responsibility................................................................................... 78 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 79 
18.4. 
Informed Consent ................................................................................................. 80 
18.5. 
Privacy of Personal Data ...................................................................................... 80 
19. 
STUDY RECORD RETENTION................................................................................ 81 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 82 
21. 
PUBLICATION........................................................................................................... 82 
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22. 
REFERENCES ............................................................................................................ 82 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)..... 84 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 96 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)......................................... 97 
APPENDIX D:
.................................... 136 
 LENS FITTING CHARACTERISTICS............................................................ 137 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS....................... 143 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
............................................................................................................................................... 145 
 BIOMICROSCOPY SCALE ............................................................................. 151 
 KERATOMETRY PROCEDURE..................................................................... 157 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION..... 159 
 PATIENT REPORTED OUTCOMES .............................................................. 164 
 LENS INSERTION AND REMOVAL ............................................................. 166 
APPENDIX E:
 GUIDELINES FOR COVID-19 RISK MITIGATION ............ 169 
APPENDIX F: PRE-SCREENING TELEPHONE SCRIPT WITH QUESTIONS............. 181 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 186 
 
LIST OF TABLES
Table 1: Test Articles.............................................................................................................. 31 
Table 2: Ancillary Supplies .................................................................................................... 33 
Table 3: Time and Events ....................................................................................................... 35 
Table 4: Disallowed systemic medications............................................................................. 56 
Table 5: Disallowed systemic antihistamines......................................................................... 56 
Table 6: Examples of major and minor protocol deviations................................................... 57 
Table 7 :  Historical Descriptive Statistics by  Study and Lens Type for CLDEQ-8 Scores.. 67 
Table 8 : Historical Descriptive Statistics by Study and Lens Type for CLUE Comfort Scores
................................................................................................................................................. 67 
Table 9 : Sample Size Calculation and Power Analysis required to Test Primary Hypothesis 
for CLUE Comfort and Secondary hypothesis for CLDEQ8-scores for different Scenarios of 
Effect Sizes ............................................................................................................................. 68 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 17 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Protocol Number: CR-6388
Version: 3.0
Date: 07 April 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155,1 ICH guidelines,2
and the Declaration of Helsinki.3
Author/ Study 
Responsible 
Clinician
See Electronic Signature Report
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Biostatistics
Reviewer
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Medical Safety 
Officer
See Electronic Signature Report
DATE
Fellow Reviewer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
DATE
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Johnson & Johnson Vision Care, Inc.
SYNOPSIS  
Protocol Title
Evaluation of Dryness in a Silicone Hydrogel Daily 
Disposable Contact Lens
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Marketing claims, Phase 4
Trial Registration
This study will be registered on ClinicalTrials.gov based on 
the following: this study utilized a marketed product
Test Article(s)
Test: Johnson and Johnson ACUVUE OASYS®1-Day with 
HydraLuxe™ Technology (Senofilcon A) (AO1D)
Control: Subject’s habitual lens, including:
-
Alcon DAILIES® Aqua Comfort Plus® (nelfilcon A)
(DACP)
-
Alcon DAILIES TOTAL1® (delfilcon A) (DT1)
-
CooperVision® clariti® 1 day (somofilcon A)
(Clariti)
-
CooperVision® MyDay® (stenfilcon A), (MyDay)
-
Johnson & Johnson 1-Day ACUVUE® Moist 
(etafilcon A) (Moist)
Wear and Replacement 
Schedules
Wear Schedule: Daily
Replacement Schedule: Daily
Objectives 
Primary Objective: 
The primary objective of this study is to demonstrate that 
AO1D is non-inferior to habitual lenses with respect to 
subjective comfort from baseline to 2-week follow-up in a 
population of symptomatic daily disposable contact lens 
wearers.
Secondary Objectives:
The secondary objectives of this study are to demonstrate that 
AO1D is non-inferior with respect to (1) change in contact 
lens related dry eye symptoms from baseline to 2-week 
follow-up, (2) subjects’ habitual lenses with respect to contact 
lens related dry eye symptoms and (3) subjective comfort at 
2-week follow-up in a population of symptomatic daily 
disposable contact lens wearers. 
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Study Endpoints
Primary Endpoint: 
1. Change in the CLUE comfort score from baseline at 
2-week follow-up
Secondary Endpoints:
1. Change in the CLDEQ-8 total score from baseline at 
2-week follow-up
2. CLDEQ-8 total score at 2-week follow-up
3. CLUE comfort score at 2-week follow-up
Tertiary Endpoints
1. CLDEQ-8 Individual Questions:
x
During a typical day in the past 2 weeks, how often did 
your eyes feel discomfort while wearing your contact 
lenses?
x
When your eyes felt discomfort with your contact 
lenses, how intense was this feeling of discomfort (on 
a scale of 1-5) at the end of your wearing time?
x
During a typical day in the past 2 weeks, how often did 
your eyes feel dry?
x
When your eyes felt dry, how intense was this feeling 
of dryness (on a scale of 1-5) at the end of your 
wearing time?
2. CLUE Comfort Individual Questions: 
x
These contact lenses were very comfortable (C001_2)
x
I could wear these contact lenses comfortably for as 
long as I wanted to (C008_1)
x
These lenses were very comfortable at the end of the 
day (C020_2)
x
My eyes felt very dry at the end of the day (C021_2)
x
My eyes felt dry all day (C022_1)
x
My eyes felt dry at the end of the day (C023_1)
x
I have experienced dry eyes (C041_1)
x
The comfort of these lenses decreased throughout the 
day (C061_1)
3. CLUE Vision Individual Questions:
x
I had very good vision at the end of the day (V004_2)
x
I experienced fluctuations in the quality of my vision 
(V009_1)
x
I was very satisfied with the quality of my vision in 
dim lighting (V013_2)
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x
I was satisfied with the quality of my vision at night 
(V014_1)
x
I was very satisfied with the clarity of distant objects 
(V034_2)
x
I was satisfied with the clarity of near objects 
(V035_1) 
x
I was very satisfied by the clarity of my vision at the 
end of the day (V037_2)
x
My vision with these lenses was exceptional (V124_3)
4. MRD Questions:
x
These lenses help to reduce the feeling of dryness at 
the end of the day (MIS01977)
x
I would recommend them to people who experience 
dryness with their own contact lenses (P3_0021_p10)
x
Have you been able to use these lenses for 8 hours or 
more with digital devices? (MIS01978)
Please think about your experience with your current contact 
lenses / the study contact lenses. Please indicate how you 
would rate the contact lenses on each of the following 
characteristics.
x
Not making your eyes feel dry throughout the day 
(P3_0006_p38)
x
Keeping your eyes from feeling dry at the end of the 
day (P3_0006_p39)
Please indicate how often, if ever, you experienced the 
following sensations when you wore your current contact 
lenses/ the study contact lenses.
x
Burning (P3_0023_p01)
x
Dryness (P3_0023_p02)
x
Grittiness (P3_0023_p03)
5. Preference Questions:
x
Thinking about the last two lenses you tried, which 
lens did you prefer overall? (PREF1)
x
Overall Comfort (PREF10_3)
x
Comfort at the end of the day (PREF10_5)
x
Overall vision (PREF10_7)
x
Keeping your eyes from feeling dry (PREF10_14)
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Other Endpoints:
Average Wear Time / Comfortable Wear Time 
Safety Endpoints:  Adverse events, lens fitting characteristics, 
slit lamp findings, entrance/exit visual acuity, subject reported 
ocular symptoms
Study Design
This is a multi-site, randomized, bilateral, dispensing, parallel 
design study with two arms (ARM 1 and ARM 2). Subjects 
may be pre-screened for contact lens related dryness 
symptoms via phone or email prior to entrance to the study.
Subjects in ARM 1 will be fitted into AO1D and followed up 
after 2 weeks of wear. Subject will be masked to the identity 
of the lens assigned. There will be 2 visits as follows:
x
Pre-screen questions via phone or email
x
Visit 1: Screening, baseline evaluation, fitting AO1D
x
Visit 2: 2-week follow up and final evaluation
Subjects in ARM 2 will be first fitted into their habitual lenses 
and dispensed for 2 weeks. At the follow-up visit, subjects will 
be fitted into AO1D and followed up after 2 weeks of wear.
Subjects will not be masked to their habitual lens (open label), 
but they will be masked to the identity of AO1D during the 
second period of wear. There will be 3 visits as follows:
x
Pre-screen questions via phone or email
x
Visit 1: Screening, baseline evaluation, fitting habitual 
lens
x
Visit 2: 2-week habitual lens follow up; fitting AO1D 
x
Visit 3: 2-week AO1D follow up and final evaluation
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations.
Sample Size
Approximately 112 potential subjects will be enrolled via.
pre-screening, and approximately 80 subjects (40 per arm) are 
targeted to complete the study.
Study Duration
The study will last approximately 4 months and include
approximately a 3-month enrollment period.
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Johnson & Johnson Vision Care, Inc.
Anticipated Study 
Population
Subjects, ages 18-59 that are current daily disposable 
spherical soft contact lens wearers are to be enrolled in this 
clinical study. Across sites, approximately 112 potential
subjects will be enrolled via pre-screening, and approximately 
80 subjects (40 per arm) are targeted to complete the study.
Subjects will be pre-screened via phone or email to determine 
symptomatology and targeted for enrollment with a 
questionnaire to identify contact lens related dry eye 
symptoms. Upon enrollment, eligible subjects will have a 
CLDEQ-8 score of 15 or greater. Subjects who habitually use 
ACUVUE OASYS®1-Day will not be eligible.
Recruitment will aim to enroll subjects evenly by habitual lens 
type by site.  Considering subject availability and regional 
differences as potential barriers to the exact proportion of 20% 
per lens type by site, the maximum for each habitual lens type 
will be capped at 40% per lens type by site.
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Eligibility Criteria -
Inclusion
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study:
Inclusion Criteria after Screening:
1. The subject must 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. Between 18 and 59 (inclusive) years of age at the time of
screening.
4. Be a daily disposable current soft contact lens wearer in 
both eyes with a minimum of 6 days/week wear time over the 
last 1 month by self-report.
5. Have a CLDEQ-8 score of 15 or greater with the habitual 
lens.
6. Subjects must possess a pair of spectacles for distance 
correction.
7. Subject’s habitual lens must be the following lens types: 
Alcon DAILIES® Aqua Comfort Plus®, Alcon DAILIES 
TOTAL1®, CooperVision® clariti® 1 day, CooperVision®
MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist
Inclusion Criteria after Baseline
8. The subject’s vertex corrected spherical distance refraction 
must be in the range of -1.00 D to -6.00 D (inclusive) in each 
eye.
9. The magnitude of subject’s vertex corrected refractive 
cylinder must be less than 1.00 diopter in each eye.
10. Have spherical best corrected visual acuity of 20/25 or 
better in each eye.
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Eligibility Criteria –
Exclusion
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:
Exclusion Criteria after Screening:
1. Subject’s habitual lens is ACUVUE OASYS®1-Day.
2. Currently pregnant or lactating, by self-report.
3. Any ocular or systemic allergies, disease or use of
medication which may interfere with contact lens wear (at the
discretion of the investigator).
4. Any active ocular abnormalities/conditions that may
interfere with contact lens wear (at the discretion of the
investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a
contagious immunosuppressive disease (e.g. HIV), by self-
report.
6. Any corneal distortion resulting from previous hard or rigid 
gas permeable contact lens wear.
7. Habitual contact lens wear modality as extended wear (≥1 
night per month of extended wear).
8. Habitual contact lens is rigid gas permeable, toric,
monovision or multi-focal
9. Any previous, or planned (during the course of the study)
ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
10. Participation in any contact lens or lens care product
clinical trial within 2 weeks prior to study enrollment.
11. Employee or employee’s immediate family member of
clinical site (e.g., Investigator, Coordinator, Technician).
12. Current habitual use of Restasis, Xiidra, ocular steroids, or 
any medication (Rx or over the counter (OTC)) that may
interfere with contact lens wear (at the discretion of the
investigator).
Exclusion Criteria after Baseline
13. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact lens 
wear and/or participation in the study. This may include, but 
not be limited to entropion, ectropion, extrusions, chalazia,
recurrent styes, glaucoma, history of recurrent corneal
erosions, aphakia, or corneal distortion.
14. Any Grade 3 or greater biomicroscopy findings (this
includes, 
corneal 
edema, 
corneal 
staining, 
corneal
vascularization, conjunctival injection, tarsal abnormalities,
bulbar injection) on the FDA classification scale 
Disallowed 
Medications/Interventions 
Current habitual use of Restasis, Xiidra, ocular steroids, or any 
medication (Rx or over the counter (OTC)) that may interfere 
with contact lens wear (at the discretion of the investigator)
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Measurements and
Procedures
PRO questionnaires (comfort, vision, and dryness), lens fit 
assessment, and safety parameters (slit lamp findings, 
entrance/exit visual acuity).  
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
Non-preserved saline, sodium fluorescein
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
Visit 1 
Informed consent
Habitual lens 
Questionnaires
Refraction
Biomicroscopy
Eligibility
Pre-screening questions
Approximately 112 daily disposable soft spherical contact lens wearers
Age 18-59; Dioptric range: -1.00D to -6.00D, CLDEQ-8 ≥15
RANDOMIZE
ARM 1
ARM 2 
Visit 1 (cont’d)
Lens fitting (Test)
Over refract
Fit assessment
Visual acuity
Dispense
Visit 1 (cont’d)
Lens fitting (Control)
Over refract
Fit assessment
Visual acuity
Dispense
Visit 2 (Control)
Adverse event / medication review
Questionnaires
Visual acuity
Fit assessment
Visit 2 (Control)
Adverse event / medication review
Questionnaires
Visual acuity
Lens fitting (Test)
Fit assessment
Biomicroscopy
Dispense
Final Evaluation
Biomicroscopy
Refraction
Visual Acuity
Visit 3
Adverse event / medication review
Questionnaires
Fit assessment
Visual acuity
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COMMONLY USED ABBREVIATIONS, ACRONYMS 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
1.
INTRODUCTION AND BACKGROUND 
Dryness and discomfort are frequent complaints of contact lens wearers. Modern contact lens 
products, such as ACUVUE OASYS®1-Day may provide relief to subjects who experience 
symptoms of dryness related to contact lens wear. This study will evaluate contact lens related 
dry eye symptoms and subjective comfort in ACUVUE OASYS® 1-Day and subject’s habitual
daily disposable contact lenses.
1.1.
Name and Descriptions of Investigational Products  
This study will evaluate the commercially available marketed products (ACUVUE OASYS® 
Brand Contact Lenses 1-Day with HydraLuxe™ Technology). Further details about the test 
articles are found in Section 6 of this protocol.
1.2.
Intended Use of Investigational Products 
The intended use of the investigative product is for correcting myopia. During the study, each 
test article will be worn bilaterally in daily wear, daily disposable modality for at least 8 hours 
per day for approximately two weeks.
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable – marketed product only.
1.4.
Summary of Known Risks and Benefits to Human Subjects 
The following risks/adverse events can be associated with wearing soft contact lenses in
general:
• The eyes may burn, sting and/or itch.
• There may be a feeling of something in the eye (foreign body, scratched area).
• There may be the potential for some temporary impairment due to peripheral
infiltrates, peripheral corneal ulcers and corneal erosion.
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• There may be the potential for other physiological observations, such as local or
generalized edema, corneal neovascularization, corneal staining, injection, tarsal
abnormalities, iritis and conjunctivitis, some of which are clinically acceptable in
low amounts.
• There may be excessive watering, unusual eye secretions, or redness of the eye.
• Poor visual acuity, blurred vision, rainbows or halos around objects, photophobia, or
dry eyes may also occur if the lenses are worn continuously or for too long a time.
There is no direct benefit to the subject for participating in the study, although they will be
able to try marketed contact lenses and may find improvement in symptoms of dryness and 
discomfort related to contact lens wear.
For the most comprehensive clinical information regarding marketed lenses: Alcon 
DAILIES® Aqua Comfort Plus® (nelfilcon A), Alcon DAILIES TOTAL1® (delfilcon A),
CooperVision® clariti® 1 day (somofilcon A), CooperVision® MyDay® (stenfilcon A), 
Johnson & Johnson 1-Day ACUVUE® Moist (etafilcon A), and Johnson and Johnson 
ACUVUE OASYS®1-Day with HydraLuxe™ Technology (senofilcon A), refer to the latest 
version of the associated package insert (APPENDIX C: PACKAGE INSERTS).
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Symptoms of dryness related to contact lens wear will be evaluated for study inclusion by the 
Contact Lens Dry Eye Questionnaire (CLDEQ-8). The CLDEQ-8 is a validated outcome 
measure for soft contact lenses wearers to evaluate the status of and change in overall opinion 
of soft contact lenses, as seen in Figure 2.7 It has been highly correlated with habitual baseline 
status and change in overall opinion when subjects are refit with contact lenses.5 A CLDEQ-
8 score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical 
management of their CL- related symptoms.6 A three point change in CLDEQ-8 scores has 
also been shown to be clinically important.6 For this study, to ensure that symptomatic subjects 
are being recruited, the inclusion criteria will have a CLDEQ cut off of ≥15.
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Figure 2: CLDEQ-8 by Overall Opinion of Habitual Lenses7
For the most comprehensive clinical information regarding marketed lenses: Alcon 
DAILIES® Aqua Comfort Plus® (nelfilcon A), Alcon DAILIES TOTAL1® (delfilcon A), 
CooperVision® clariti® 1 day (somofilcon A), CooperVision® MyDay® (stenfilcon A), 
Johnson & Johnson 1-Day ACUVUE® Moist (etafilcon A), and Johnson and Johnson 
ACUVUE OASYS®1-Day with HydraLuxe™ Technology (senofilcon A), refer to the latest 
version of the associated package insert. (APPENDIX C: PACKAGE INSERTS).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
The primary objective of this study is to demonstrate that AO1D is non-inferior to habitual 
lenses with respect to the change in contact lens subjective comfort from baseline to 2-week 
follow-up in a population of symptomatic daily disposable contact lens wearers.
The secondary objectives of this study are to demonstrate that AO1D is non-inferior with 
respect to the (1) change in contact lens related dry eye symptoms, (2) to subjects’ habitual 
lenses with respect to contact lens related dry eye symptoms and (3) subjective comfort at 2-
week follow-up in a population of symptomatic daily disposable contact lens wearers.
This study is conducted with the primary intent to support the market claims on the AO1D.
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2.2.
Endpoints  
Primary Endpoint
x
Change in CLUE Comfort score from baseline to 2-week follow-up
Subjective overall vision and comfort scores will be assessed using Contact Lens User 
Experience (CLUE) questionnaire.8 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.9 A 5-point increase in an average 
CLUE score translates into 10% shift in the distribution of scores for population of soft 
disposable contact lens wearers.
Secondary Endpoints
x
Change in CLDEQ-8 total score from baseline to 2-week follow-up
x
CLDEQ-8 total score at 2-week follow-up
x
CLUE Comfort score at 2-week follow-up
The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been 
highly correlated with habitual baseline status and change in overall opinion when subjects are 
refit with contact lenses.5 A CLDEQ-8 total score of ≥12 is proposed to identify contact lens 
wearers who could benefit from clinical management of their contact lens related symptoms. 
A three points change in CLDEQ-8 total scores has also been shown to be clinically important.6
This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. 
Tertiary Endpoints
1. CLDEQ-8 Questions: CLDEQ-8 individual questions will be analyzed only if primary 
and/or secondary endpoints are met.
x
During a typical day in the past 2 weeks, how often did your eyes feel discomfort while 
wearing your contact lenses?
x
When your eyes felt discomfort with your contact lenses, how intense was this feeling 
of discomfort (on a scale of 1-5) at the end of your wearing time?
x
During a typical day in the past 2 weeks, how often did your eyes feel dry?
x
When your eyes felt dry, how intense was this feeling of dryness (on a scale of 1-5) at 
the end of your wearing time?
2. CLUE Comfort Questions: CLUE comfort questions will be analyzed only if primary 
and/or secondary endpoints are met.
x
These contact lenses were very comfortable (C001_2)
x
I could wear these contact lenses comfortably for as long as I wanted to (C008_1)
x
These lenses were very comfortable at the end of the day (C020_2)
x
My eyes felt very dry at the end of the day (C021_2)
x
My eyes felt dry all day (C022_1)
x
My eyes felt dry at the end of the day (C023_1)
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x
I have experienced dry eyes (C041_1)
x
The comfort of these lenses decreased throughout the day (C061_1)
3. CLUE Vision Questions:
x
I had very good vision at the end of the day (V004_2)
x
I experienced fluctuations in the quality of my vision (V009_1)
x
I was very satisfied with the quality of my vision in dim lighting (V013_2)
x
I was satisfied with the quality of my vision at night (V014_1)
x
I was very satisfied with the clarity of distant objects (V034_2)
x
I was satisfied with the clarity of near objects (V035_1) 
x
I was very satisfied by the clarity of my vision at the end of the day (V037_2)
x
My vision with these lenses was exceptional (V124_3)
4. MRD Questions:
x
These lenses help to reduce the feeling of dryness at the end of the day (MIS01977)
x
I would recommend them to people who experience dryness with their own contact 
lenses (P3_0021_p10)
x
Have you been able to use these lenses for 8 hours or more with digital devices? 
(MIS01978)
Please think about your experience with your current contact lenses/ the study contact lenses.
Please indicate how you would rate the contact lenses on each of the following characteristics.
x
Not making your eyes feel dry throughout the day (P3_0006_p38)
x
Keeping your eyes from feeling dry at the end of the day (P3_0006_p39)
Please indicate how often, if ever, you experienced the following sensations when you wore 
your current contact lenses/ the study contact lenses.
x
Burning (P3_0023_p01)
x
Dryness (P3_0023_p02)
x
Grittiness (P3_0023_p03)
5. Preference Questions:
x
Thinking about the last two lenses you tried, which lens did you prefer overall? 
(PREF1)
x
Overall Comfort (PREF10_3)
x
Comfort at the end of the day (PREF10_5)
x
Overall vision (PREF10_7)
x
Keeping your eyes from feeling dry (PREF10_14)
Other Endpoints:
Average Wear Time / Comfortable Wear Time 
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7. Subject’s habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort 
Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision®
MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist.
Inclusion Criteria after Baseline:
8. The subject’s vertex corrected spherical distance refraction must be in the range of -1.00 D 
to -6.00 D (inclusive) in each eye.
9. The magnitude of subject’s vertex corrected refractive cylinder must be less than 1.00 
diopter in each eye.
11. Have spherical 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:
1. Subject’s habitual lens is ACUVUE OASYS®1-Day.
2. Currently pregnant or lactating, by self-report.
3. Any ocular or systemic allergies, disease or use of medication which may interfere with 
contact lens wear (at the discretion of the investigator).
4. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the 
discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive 
disease (e.g. HIV), by self-report.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Habitual contact lens wear modality as extended wear (≥1 night per month of extended 
wear).
8. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
9.. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK, etc.).
10. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to 
study enrollment.
11. Employee or employee’s immediate family member of clinical site (e.g., Investigator, 
Coordinator, Technician).
12. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the 
counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator).
Exclusion Criteria after Baseline:
13. Any ocular allergies, infections or other ocular abnormalities that are known to interfere 
with contact lens wear and/or participation in the study. This may include, but not be limited 
to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent 
corneal erosions, aphakia, or corneal distortion.
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14. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal 
staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection)
on the FDA classification scale 
3.4.
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. Subjects will be pre-screened via phone or e-mail to determine symptomatology and 
targeted for enrollment with a CLDEQ-8 questionnaire score of 15 or greater. Recruited
subjects will be habitual contact lens wearers of 5 difference lenses; Alcon DAILIES® Aqua 
Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision®
MyDay®, or Johnson & Johnson 1-Day ACUVUE® Moist. Further details about allocation 
between habitual lens types within clinical sites is located in Section 4.3.
4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms 
(ARM 1 and ARM 2). Subjects will be pre-screened for contact lens related dryness symptoms
via phone or email prior to enter the study.
Subjects in ARM 1 will be fitted into AO1D and followed up after 2 weeks of wear. Subjects
will be masked to the identity of the lens assigned. There will be 2 visits as follows:
x
Pre-screen questions via. phone or email
x
Visit 1: Screening, baseline evaluation, fitting AO1D
x
Visit 2: 2-week follow up and final evaluation
Subjects in ARM 2 will be first fitted into their habitual lenses and dispensed for 2 weeks. At 
the follow-up visit, subject will be fitted into AO1D and followed up after 2 weeks of where. 
Subjects will not be masked to their habitual lens (open label), but they will be masked to the 
identity of AO1D during the second period of wear. There will be 3 visits as follows:
x
Pre-screen questions via phone or email
x
Visit 1: Screening, baseline evaluation, fitting habitual lens
x
Visit 2: 2-week habitual lens follow up; fitting AO1D 
x
Visit 3: 2-week AO1D follow up and final evaluation
.
4.2.
Study Design Rationale 
This study is a parallel design with two arms (ARM 1 and ARM 2). Subjects in the ARM 1
will receive the over labeled AO1D to wear bilaterally for about 2-weeks, while subject in 
ARM 2 will first receive the open labeled habitual lens to wear bilateral for approximately 2-
weeks during the first wear period, then receive the over labeled AO1D in a bilateral fashion 
for approximately 2-weeks during the second wear period. This design will allow comparison 
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of the Test lens against subjects’ habitual lenses in both between the two study arms and within 
the ARM 2.The primary endpoints will compare the two study arms  in a parallel design setting 
The secondary endpoints within ARM 2 are to compare subject’s habitual lenses and AO1D 
lenses.
This study design allows efficient comparison of the Test lens compared to subjects’ 
habitual lens with minimal sample size, as well as allows subjects to experience both lens types 
in efficient comparison.
4.3.
Enrollment Target and Study Duration 
Approximately 112 potential subjects will be targeted to be enrolled via pre-screening, and 
approximately 80 subjects (40 per arm) are targeted to complete the study. Subjects will be 
considered enrolled in the study upon execution of informed consent. 
Recruitment will aim to enroll subjects evenly by habitual lens type by site.  Considering 
subject availability and regional differences as potential barriers to the exact proportion of 20% 
per lens type by site, the maximum for each habitual lens type will be capped at 40% per lens 
type by site. This will need to be monitored by the clinical site and clinical operations.
Depending on the study arm, there are 2 to 3 planned study visits and the study will last 
approximately 4 months, including approximately a 4-month enrollment period.  Subjects who 
are discontinued prior to the final evaluation may be replaced at the discretion of the study 
sponsor.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
This will be a randomized 2-arm study. This study is parallel design with 2 arms such that the 
first arm (refer as “ARM 1”) is designed with 1 lens (the AO1D) while the second arm (refer 
as “ARM 2”) is designed with 2 lenses wearing (habitual lens and AO1D) respectively.
Subjects in the ARM 1 will receive the AO1D in a bilateral fashion for approximately 2 weeks, 
while the subjects in ARM 2 will first receive the open labeled habitual lens to wear bilaterally 
for approximately 2 weeks during the first wear period and then receive the AO1D to wear 
bilaterally for approximately 2 weeks during the second wear period. 
Subjects will be randomly assigned to either ARM 1 or ARM 2 based on a computer-generated 
randomization schedule prepared before the study initiation. The randomization scheme will 
be generated using the PROC PLAN procedure from Statistical Analysis System (SAS) 
Software Version 9.4 or higher (SAS Institute, Cary, NC)10 provided by the study 
biostatistician. 
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization:
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6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions.
6.6.
Collection and Storage of Samples 
No samples will be collected as part of the study procedures.
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC.
6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning 
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles per JJVC instruction.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
 
 
 
 
 
 
 
 
 
 
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x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit.
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled).
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity.
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
An additional subject will be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: Restasis, Xiidra, ocular steroids, or any 
medication (Rx or OTC) that may interfere with contact lens wear at the discretion of the 
investigator.
Concomitant therapies that are disallowed include: N/A 
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 4. 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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Insufficient wear of study 
lenses 
Subject does not wear study
lenses for at least 6 hours on 
at least 5 days of a study lens 
wear period.
Subject does not wear study 
lenses for at least 1 hour prior 
to attending a follow-up 
visit.
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
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.
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x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
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.
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13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
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
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x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
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.”
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Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in section 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. 
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concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.).
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.
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x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
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.
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13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
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The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below. More details will be included in the stand-alone Statistical Analysis Plan (SAP). The 
SAP will be developed and finalized prior to database lock.
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).11 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the 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) and will be summarized by  lens type and ARM (ARM1- AO1D and ARM2 –
Subjects’ Habitual Lenses and AO1D) Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
14.2. Sample Size Justification 
This study was design and powered to demonstrate non-inferiority of the change from baseline 
(CFB: 2-Week Follow-up minus baseline) of the Test lens relative to subjects’ habitual CLUE 
comfort scores, a margin of -5 points will be used to test the hypothesis. Additionally, a power 
analysis for the change from baseline (CFB: 2-week follow-up minus baseline) of the Test lens
compared to subjects’ habitual lens with respect to CLDEQ-8 total scores was also provided. 
Table 7  and Table 8 below displays the descriptive statistics for the CLDEQ-8 total scores and 
CLUE comfort scores, respectively observed from the historical data including 
, 
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and 
considering the following 5 habitual lens types: Johnson & Johnson 1-
Day ACUVUE® Moist, Alcon DAILIES® Aqua Comfort Plus®, Alcon DAILIES 
TOTAL1®, Clariti 1-Day and MyDay. Subjects included in Table 7 had a CLDEQ-8 score of 
15 or higher at screening. 
Table 7 : Historical Descriptive Statistics by  Study and Lens Type for CLDEQ-8 Scores
Study
N
Mean (SD)
AO1D 2-week
Habitual Baseline 
Difference 
Overall 
24
12.8 (6.35)
20.3 (4.39)
-7.5 (7.17)
11
12.5 (4.37)
19.3 (3.13)
-6.8 (4.77)
5
13.4 (6.27)
18.2 (4.32)
-4.8 (8.04)
8
12.9 (9.06)
22.9 (5.11)
-10.0 (9.30)
Table 8 : Historical Descriptive Statistics by Study and Lens Type for CLUE Comfort Scores
Study
N
Mean (SD)
AO1D 2-week
Habitual Baseline 
Difference 
Overall 
24
52.6 (18.78)
37.9 (18.12) 
14.72 (25.21)
11
55.0 (16.18)
38.1 (16.47)
16.9 (20.38)
5
52.0 (19.38)
54.8 (21.88)
-2.8 (36.80)
8
49.7 (23.48) 
27.1 (8.93)
22.6 (20.60)
Table 9 displays the sample size estimates for the primary endpoint of CLUE Comfort score,
and the secondary endpoint of CLDEQ8- Scores for different scenarios of effect sizes.
CLDEQ-8 power analysis was provided for informational purposes. All Sample size 
calculations were performed with 80% power and 2-sided alpha=0.05. With respect to 
CLDEQ-8 Scores, for ARM1 a standard deviation of 7.17 was utilized (See Table 7 ), while 
a standard deviation of 5.0 was utilized for ARM2 in each calculation for the various effect 
sizes. The different effect sizes for CLDEQ-8 scores were based on the historical effect sizes 
provided in Table 7.  Historically, on average AO1D improved CLEQ8-scores about 7 points 
after 2-weeks of wear. The power analysis for CLDEQ8-scores is displayed in Table 9 below. 
With respect to CLUE comfort scores, for ARM1 a standard deviation of 25.21 was used (See 
Table 8) while, a standard deviation of 18.12 was utilized for ARM2 in the calculation for each 
scenario. Due to the varying effect sizes displayed in Table 8 above, effect sizes of 3, 5 and 9
were utilized as a more conservative estimate for the sample size calculation since there was a 
high a difference observed between AO1D and subjects’ habitual lenses with respect to CLUE 
Comfort (22.6 points) in
.
Sample size and power calculations for each endpoint and scenario were calculated using a 2-
sided Satterthwaite t-test assuming unequal variances using the POWER11 procedure in SAS 
Version 9.49.
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14.3. Analysis Populations 
Safety Population:
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from the per-protocol 
population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from the 
study or deviation from the protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
The study hypotheses will be tested using the following gatekeeping strategy; If the primary 
hypothesis is met, then the secondary hypotheses will be tested. If  the primary and secondary 
hypotheses are met, all tertiary hypotheses will be evaluated for both between the study arms 
and within the second arm. If the primary and secondary hypotheses regarding CLUE comfort 
are met, then the tertiary hypotheses relevant to this endpoint will be evaluated for both 
between the study arms and within the second arm.  If only the primary hypothesis for CLUE 
comfort is met then, then associated tertiary hypotheses relevant to this endpoint will only be 
evaluated between study arms. If both secondary hypotheses regarding CLDEQ8-Scores are 
met, then the tertiary hypotheses relevant to this endpoint will be evaluated for between the 
study arms only and within the second arm. If only 1 of the secondary hypotheses regarding 
CLDEQ8-scores is met, then the associated tertiary hypotheses relevant to this endpoint will 
be evaluated between study arms.
14.5. Primary Analysis  
The primary endpoint is the change in CLUE comfort score from baseline to 2-week follow-
up. The data from the ARM 1 (Test) will be compared to the first period of the ARM 2 (Control, 
habitual lens). The primary analyses will be conducted on the Per-Protocol (PP) population. A 
sensitivity analysis will be conducted on the Intent-to-Treat (ITT) population. Non-inferiority 
will be assessed on PP population, while superiority will be assessed on ITT population. 
Change in CLUE Scores:
The CLUE comfort scores will be analyzed using a linear mixed model to assess the difference 
between the Test and Control (subjects’ habitual lens) lenses. The regression model will 
include ARM (ARM1 – Test, and ARM 2 – Habitual Lens), time (Baseline and Follow-up
evaluation) and ARM by time interaction as fixed effect factors. Baseline characteristics such 
as age and gender may be included as fixed effect covariates in the model when appropriate. 
Investigational site will be included as a random effect (G-side). An Unstructured (UN) or 
compound symmetric (CS) covariance or heterogenous compound symmetry (CSH) structures 
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will be used to model the residual errors between measurements within the same subject across 
time (R-side). The log-likelihood ratio test will be used to assess homogeneity between the 
residual covariance structure across ARM. The Kenward and Roger method9 will be used to 
calculate the denominator degree of freedom. 
Hypothesis Testing:
The null and alternative hypotheses for non-inferiority of the Test relative to Control are as
follows:
ܪϸ≤
ܪܣϸ!,
where ϸ is the difference between lens types (Test minus Control) in mean change from 
baseline at 2-week follow-up. Non-inferiority of the Test lens relative to the Control lens will 
be based on the LSM difference in the score change from baseline at 2-week follow-up and its 
corresponding 95% confidence interval from the final model. The lower bound of the 95% CI 
will be compared to the non-inferiority margin of -5. If the lower bound is greater than -5, the 
null hypothesis will be rejected, and the Test lens will be considered non-inferior to the Control 
lens. If non-inferiority of the Test lens over Control lens is met, then superiority test will be 
also conducted on the ITT population. If the lower bound is greater than 0, then the superiority 
of the Test lens over the Control lens will be established
14.6. Secondary Analysis 
The secondary endpoints are the change in (1) CLDEQ-8 total score from baseline to 2-week,
(2) CLDEQ-8 total scores and (3) CLUE comfort scores at 2-week follow-up. For the first 
secondary endpoint, the data from the ARM 1 (Test) will be compared to the first period of the 
ARM 2 (Control, habitual lens). The analysis will be conducted on the Per-Protocol (PP) 
population. A sensitivity analysis will be conducted on the Intent-to-Treat (ITT) population.
Non-inferiority will be assessed on PP population, while superiority will be assessed on ITT 
population. The remaining other secondary analyses will be conducted on the PP population
within the ARM 2 only.
Change in CLDEQ-8 Total Scores:
The CLDEQ-8 total scores will be analyzed using a linear mixed model to assess the difference 
between the Test and Control (subjects’ habitual lens) lenses. The regression model will 
include ARM (ARM1 – Test, and ARM 2 – Habitual Lens), time (Baseline and Follow-up
evaluation) and ARM by time interaction as fixed effect factors. Baseline characteristics such 
as age and gender may be included as fixed effect covariates in the model when appropriate.
Investigational site will be included as a random effect (G-side). An Unstructured (UN) or 
compound symmetric (CS) covariance or heterogenous compound symmetry (CSH) structures 
will be used to model the residual errors between measurements within the same subject across 
time (R-side). The log-likelihood ratio test will be used to assess homogeneity between the 
residual covariance structure across ARM. The Kenward and Roger method9 will be used to 
calculate the denominator degree of freedom. 
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Hypothesis Testing:
The null and alternative hypotheses for non-inferiority of the Test relative to Control are as
follows:
ܪϸ≥
ܪܣϸ,
where ϸis the difference between lens types (Test minus habitual lens) in mean change from 
baseline at 2-week follow-up. Non-inferiority of the Test lens relative to the Control lens will 
be based on the least square mean (LS Mean) difference in the score change from baseline at 
2-week follow-up and its corresponding 95% confidence interval (CI) from the final model. 
The upper bound of the 95% CI will be compared to the non-inferiority margin of 3. If the 
upper bound is less than 3, the null hypothesis will be rejected, and the Test lens will be 
considered non-inferior to the Control lens. If non-inferiority of the Test lens over Control lens 
is met, then superiority test will be also conducted on the ITT population. If the upper bound 
is less than 0, then the superiority of the Test lens over the Control lens will be established. 
CLDEQ-8 Total Scores:
The CLDEQ-8 total scores will be analyzed using a linear mixed model to assess the difference 
between the Test and Control (subjects’ habitual lens) lenses within ARM 2. The regression 
model will include lens type (Habitual lens and AO1D), and baseline score as fixed effect 
factors.  Baseline characteristics such as age and gender may be included as fixed effect 
covariates in the model when appropriate Investigational site will be included as a random 
effect.. The correlation measurements from the same subjects across lens type (Habitual and 
AO1D) will be model using Unstructured (UN) variance-covariance matrix. If the estimation 
algorithm does not converge, then a Compound Symmetry (CS) or heterogenous compound 
symmetric (CSH) matrix will be used. The Kenward and Roger method9 will be used to 
calculate the denominator degree of freedom. 
Hypothesis Testing:
The null and alternative hypotheses for non-inferiority of the Test relative to Control are as
follows:
ܪϸ≥
ܪܣϸ,
where ϸ is the difference between lens types at 2-week follow-up (Test (AO1D) minus 
Control (Habitual Lenses)). Non-inferiority of the Test lens relative to the Control lens will be 
teste using a 2-sided 95% CI constructed for the LSM difference at 2-week follow-up Non-
inferiority will be established if the upper bound of the 95% CI is below 3 CLDEQ-8 points.
If non-inferiority of the Test lens over Control lens is met, then superiority test will be also 
conducted on the ITT population. If the upper bound is less than 0, then the superiority of the 
Test lens over the Control lens will be established. 
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CLUE Scores:
The CLUE comfort scores will be analyzed using a linear mixed model to assess the difference 
between the Test (AO1D) and Control (subjects’ habitual lens). The regression model will 
include lens type and baseline score as fixed effect factors. Baseline characteristics such as age 
and gender may also be included as fixed effect covariates in the model when appropriate. 
Investigational site will be included as a random effect. The correlation measurements from 
the same subjects across lens type will be modeled using UN variance-covariance matrix. If 
the estimation algorithm does not converge, then a CS or CSH covariance matrix will be used. 
The Kenward and Roger method9 will be used to calculate the denominator degree of freedom. 
Hypothesis Testing:
The null and alternative hypotheses for non-inferiority of the Test relative to Control are as
follows:
ܪϸ≤
ܪܣϸ!,
where ϸis the difference between lens types at 2-week follow-up (Test minus Control). Non-
inferiority of the Test lens relative to the Control lens will be test using 2-sided 95% CIs 
constructed for the LSM difference at 2-week follow-up from the final model. Non-inferiority 
of the Test relative to the Control (Subjects’ habitual lens) will be established is the lower 
bound of the 95% CI is greater than -5. If non-inferiority of the Test lens over Control lens is 
met, then superiority test will be also conducted on the ITT population. If the lower bound is 
greater than 0, then the superiority of the Test lens over the Control lens will be established.
14.7. Other Exploratory Analysis 
The following other study endpoints will be assessed in support of primary and secondary 
endpoints. Exploratory Endpoints will only be tested and analyzed if all primary and secondary 
hypotheses are met. 
1. CLDEQ Questions:
x
During a typical day in the past 2 weeks, how often did your eyes feel discomfort while
wearing your contact lenses?
x
When your eyes felt discomfort with your contact lenses, how intense was this feeling 
of discomfort (on a scale of 1-5) at the end of your wearing time?
x
During a typical day in the past 2 weeks, how often did your eyes feel dry?
x
When your eyes felt dry, how intense was this feeling of dryness (on a scale of 1-5) at 
the end of your wearing time?
2. CLUE Comfort Questions:
x
These contact lenses were very comfortable (C001_2)
x
I could wear these contact lenses comfortably for as long as I wanted to (C008_1)
x
These lenses were very comfortable at the end of the day (C020_2)
x
My eyes felt very dry at the end of the day (C021_2)
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x
My eyes felt dry all day (C022_1)
x
My eyes felt dry at the end of the day (C023_1)
x
I have experienced dry eyes (C041_1)
x
The comfort of these lenses decreased throughout the day (C061_1)
3. CLUE Vision Questions:
x
I had very good vision at the end of the day (V004_2)
x
I experienced fluctuations in the quality of my vision (V009_1)
x
I was very satisfied with the quality of my vision in dim lighting (V013_2)
x
I was satisfied with the quality of my vision at night (V014_1)
x
I was very satisfied with the clarity of distant objects (V034_2)
x
I was satisfied with the clarity of near objects (V035_1) 
x
I was very satisfied by the clarity of my vision at the end of the day (V037_2)
x
My vision with these lenses was exceptional (V124_3)
4. MRD Questions:
x
These lenses help to reduce the feeling of dryness at the end of the day (MIS01977)
x
Have you been able to use these lenses for 8 hours or more with digital devices? 
(MIS01978)
x
I would recommend them to people who experience dryness with their own contact 
lenses (P3_0021_p10)
x
Not making your eyes feel dry throughout the day (P3_0006_p38)
x
Keeping your eyes from feeling dry at the end of the day (P3_0006_p39)
x
Burning (P3_0023_p01)
x
Dryness (P3_0023_p02)
x
Grittiness (P3_0023_p03)
5. Preference Questions:
x
Based on your overall opinion of both study lenses, do you prefer one lens more than 
the other?  (PVC015_1)
x
Overall Comfort (PREF10_3)
x
Comfort at the end of the day (PREF10_5)
x
Overall vision (PREF10_7)
x
Keeping your eyes from feeling dry (PREF10_14)
Tertiary hypotheses will be evaluated in the following manner. 
1. If  the primary hypothesis is not met, then the tertiary hypotheses will not be evaluated.
2. If  the primary and secondary hypotheses are met: All tertiary hypotheses will be 
evaluated for both between the study arms and within the second arm. 
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a.
If the primary and secondary hypotheses regarding CLUE comfort are met then 
the tertiary hypotheses relevant to this endpoint will be evaluated for both 
between the study arms and within the second arm. 
b. If only the primary hypothesis for CLUE comfort is met then, then associated 
tertiary hypotheses relevant to this endpoint will only be evaluated between
study arms. 
c.
If both secondary hypotheses regarding CLDEQ8-Scores are met, then the 
tertiary hypotheses relevant to this endpoint will be evaluated for between the 
study arms only and within the second arm.
d. If only 1 of the secondary hypotheses regarding CLDEQ8-scores is met, then 
the associated tertiary hypotheses relevant to this endpoint will be evaluated 
between study arms. 
CLUE, MRD and CLDEQ-8 Individual Questions
Each of individual questions (not including preference questions) will be analyzed using a 
generalized linear mixed model for ordinal data with a multinomial distribution and cumulative 
logit function as a link function. The model will include lens type as a fixed effect factor and 
site as a random effect factor. The assumption of proportionality of odds ratio across response 
categories will be assessed graphically. If this assumption is violated, then the distribution of 
response will be investigated. If sparse data is observed, then the spare responses may be 
collapsed to ensure that each response category has sufficient data for the analysis. If the 
assumption of proportionality of odds is still violated in the collapsed categories, then a partial 
proportional odds model may be considered. A generalized estimation equation (GEE) may 
also be considered if necessary. Comparison between the Test and Control lenses at 2-week 
follow-up will be carried out using 2-sided 95% CI of odds ratio (OR, Test over Control) where 
the odds ratio represents the odds of having a higher positive rating/experience for the Test 
lens compared to the Control lens. Non-inferiority will be conducted on the Per-Protocol 
population. Non-inferiority will be tested by comparing the lower limit of the 95% confidence 
interval for the odds ratio (Test over Control) to 0.67. If the lower limit is above 0.67 non-
inferiority of the Test lens relative to the Control lens will be established. If non-inferiority is 
met then Superiority will be tested on the ITT population by comparing the lower limit of the 
95% CI to 1. The Test lens will be concluded to be superior to the Control lens if the lower 
limit of the CI is above 1.
Preference Questions
The 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 may 
include lens type and other subject characteristics such as gender as fixed covariates when 
appropriate. Site will be included as a random effect (G-side). 
Comparisons between the Test and Control will be constructed using two-sided 95% 
confidence intervals for the preference ratio (the proportion of subjects preferring the Test lens 
compared to the Control lens – Test over Control). Superiority will be conducted on the ITT 
population by comparing the lower limit of the 95% CI to 1. The Test lens will be concluded 
to be superior to the Control lens if the lower limit of the CI is above 1.
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14.8. Interim Analysis  
No Interim analysis will be performed on this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 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 
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. 
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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.
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov.
x
The study type is interventional.
x
The primary purpose of the clinical trial is other than a feasibility study. 
x
The clinical trial studies U.S. FDA-regulated Device Product. 
At least one facility location is within the United States or one of its territories.
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 
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the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
An independent Data Monitoring Committee (DMC) will be established to oversee the study. 
Members of DMC must be free of significant conflicts of interest (i.e., financial, intellectual, 
professional, or regulatory), and are experts in all scientific disciplines needed to interpret the 
data and ensure study participant safety.
During the conduct of the trial, responsibilities of the DMC will be to periodically review and 
monitor the incidence of adverse events, determine whether the basic study assumptions 
remain valid, evaluate whether the overall integrity, scientific merit and conduct of the study 
remain acceptable, and make recommendations to the Sponsor. DMC meetings will be held 
quarterly until all subjects have completed the study. The DMC may also meet for an ad hoc 
review of data in the event that a UADE or other event is reported that may affect the outcome 
and/or continuation of the study.
The DMC will receive a data review package prior to the scheduled meeting. Data packages 
will include the following information/listings:
x
Subjects enrollment and disposition information, such as
o
Number and Reason for Subject Early Withdrawal
o
Number of subjects screened, randomized, early withdrawal, and complete
o
Number and Reason for Screen Failure
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x
Medical History
x
Concomitant Medications
x
Adverse Events
x
Protocol Deviations
x
Product Quality Complaints
Additional descriptive summary statistics of study endpoints may be provided per the DMC’s 
requests. Unless otherwise specified, the masking of the treatment information will be 
maintained in the data prepared for the DMC.
Detailed information regarding the roles and responsibilities of the DMC for this study is 
provided in the Data Monitoring Committee Charter.
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 
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an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
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
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x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 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 States13 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 study will be registered on ClinicalTrials.gov by the Sponsor.
22. REFERENCES 
1.
ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. In. https://www.iso.org/standard/45557.html.
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2.
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). In: 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
3.
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. In. 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). 
In: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5.
Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye 
Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 
2012;89(10):1435-1442.
6.
Chalmers RL, Keay L, Hickson-Curran SB, Gleason WJ. Cutoff score and 
responsiveness of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) in a 
Large daily disposable contact lens registry. Contact Lens and Anterior Eye. 
2016;39(5):342-352.
7.
Chalmers RL, Hickson-Curran S, Keay L, Gleason B, Albright R. Struggle with Soft 
Contact Lens Wear is Addressed by Refitting with Daily Disposable Lenses: 4 Month 
Follow-up from the TEMPO Registry. 
8.
Wirth RJ, Edwards MC, Henderson M, et al. Development of the Contact Lens User 
Experience: CLUE Scales. Optom Vis Sci. 2016;93(8):801-808.
9.
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53(3):983.
10.
SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary NC: SAS Institute Inc.
11.
SAS Institute Inc: SAS® 9.4 Statements: Reference TEC, NC: SAS Institute Inc; 2014.
12.
Bonferroni C. Calculation of the insurance groups of heads. Studies in Honour of 
Professor Salvatore Ortu Carboni. 1935;Rome: Italy:13-60.
13.
Health Information Portability and Accountability Act (HIPAA). In:
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
14.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at: http://data.europa.eu/eli/reg/2017/745/2017-
05-05
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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11
Page 95 of 186

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
This will be provided separately. 
Page 96 of 186

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Alcon DAILIES® Aqua Comfort Plus® (nelfilcon A)
 
 
Page 97 of 186

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Alcon DAILIES TOTAL1® (delfilcon A)
Page 100 of 186

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
CooperVision® clariti® 1 day (somofilcon A)
Page 103 of 186

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 1 of 12
Revision: A
Revision Date: February 2019
PACKAGE INSERT
Clariti 1 Day (somofilcon A)
Clariti 1 Day Toric (somofilcon A)
Clariti 1 Day Multifocal (somofilcon A)
Clariti 1 Day Multifocal Toric (somofilcon A)
Soft (hydrophilic) Contact Lenses for Daily Wear Single Use Only
with UV Blocker
SYMBOLS KEY  
The following symbols may appear on the label or carton.
SYMBOL
DEFINITION
Reference
Caution: Federal (USA) law restricts this device to sale 
by or on the order of a licensed practitioner
81 FR 38911
Caution / See Instructions for Wearers
BS EN ISO 15223-1
Table 1, Symbol 5.4.4
Use by Date (expiration date)
BS EN ISO 15223-1
Table 1, Symbol 5.1.4
Batch Code
BS EN ISO 15223-1
Table 1, Symbol 5.1.5
Sterile using Steam Heat
BS EN ISO 15223-1
Table 1, Symbol 5.2.5
Manufacturer
BS EN ISO 15223-1
Table 1  Symbol 5.1.1
Authorized representative in the European Community
BS EN ISO 15223-1
Table 1, Symbol 5.1.2 
 
Do not use if package is damaged
BS EN ISO 15223-1
Table 1, Symbol 5.2.8
 
Consult instructions for use / consult electronic 
instructions for use
BS EN ISO 15223-1
Table 1  Symbol 5.4.3
 
Do not re-use
BS EN ISO 15223-1
Table 1, Symbol 5.4.2
 
Date of manufacture
BS EN ISO 15223-1
Table 1  Symbol 5.1.3
DESCRIPTION
Clariti 1 Day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a
hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is 
cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-
terminated poly(dimethylsiloxane).
When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline 
immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to 
help protect against transmission of harmful UV radiation and Clariti 1 Day (somofilcon A) Soft 
contact lenses help protect against transmission of harmful UV radiation to the cornea and into the 
eye. 
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and 
less than 50% in the UVA range of 316-380nm.
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CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 2 of 12
Revision: A
Revision Date: February 2019
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent 
sclera, with the following dimensions:
x
Chord Diameter:
13.0mm to 15.5mm
x
Centre Thickness:
0.03mm to 0.50mm
x
Base Curve:
7.5mm to 9.30mm
x
Powers:
-20.00 DS to +20.00 DS
x
Toric Cylinder options:
-0.75, -1.25, -1.75 and -2.25
x
Toric Axis options:
10o to 180o (10o steps)
x
Multifocal Add:
Lens “LOW” = “low” for spectacle near ADD lens (Max +2.25 ADD)
Lens “HIGH” = “high” for spectacle near ADD lens (+2.50 ADD or greater)
The physical/optical properties of the lenses are:
x
Refractive Index:
1.4003
x
%Transmittance @ 590nm:
98.13
x
%Transmittance @ 280-315nm:
0.71
x
%Transmittance @ 316-380nm:
20.62
x
Surface Character:
Hydrophilic
x
Water Content:
56%
x
Oxygen Permeability (DK):
60 x 10-11 (cm2/sec) (ml O2/ml x mmHg) 
at 35oC (Fatt Method for determination 
of oxygen permeability)
x
Specific Gravity:
1.17
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CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 3 of 12
Revision: A
Revision Date: February 2019
LENS PARAMETERS 
The lenses are available as follows:
Clariti 1 Day (somofilcon A) 
Sphere Powers:
+20.00 to –20.00 DS
Centre Thickness:
varies with power, e.g., 0.07mm (at -3.00 DS)
Diameter:
13.0 through to 15.5mm
Base Curve:
7.50 through to 9.30mm 
Clariti 1 Day Toric (somofilcon A)
Sphere Powers:
+20.00 to –20.00 DS
Centre Thickness:
varies with power, e.g., 0.105mm (at -3.00 DS)
Diameter:
13.0 through to 15.5mm
Base Curve:
7.50 through to 9.30mm 
Cylinder Options:
-0.75, -1.25, -1.75, -2.25
Axis:
10o to 180o (10o steps)
Clariti 1 Day Multifocal (somofilcon A)
Sphere Powers:
+20.00 to –20.00 DS
Centre Thickness:
varies with power, e.g., 0.07mm (at -3.00 DS)
Diameter:
13.0 through to 15.5mm
Base Curve:
7.50 through to 9.30mm 
Add powers are to be prescribed dependent on specific patient requirements as determined by the 
Eye Care Professional; however, as a guide, the lenses come in the following ADD powers:
Lens “LOW” = “low” for spectacle near ADD lens (Max +2.25 ADD)
Lens “HIGH” = “high” for spectacle near ADD lens (+2.50 ADD or greater)
Clariti 1 Day Multifocal Toric (somofilcon A)
Parameters are the same as above for Clariti 1 Day Multifocal and Toric lenses.
Call our Customer Service Department at (800) 341-2020 for current availability.
ACTIONS
In its hydrated state, Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens 
with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the 
retina.
Page 106 of 186

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 4 of 12
Revision: A
Revision Date: February 2019
TRANSMITTANCE CURVES
The transmittance curve below compares Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily 
Disposable Contact Lens with UV Blocker, a 24-yr. old human cornea and 25-yr. old human 
crystalline lens.
1.  Lerman, S., Radiant Energy and the Eye, MacMillan, New York, 1980, p.58, fig. 2-21
2.  Waxler, M., Hitchins, V.M., Optical Radiation and Visual Health, CRC Press, Boca Raton, 
Florida, 1986, p.19, fig. 5
 
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CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 5 of 12
Revision: A
Revision Date: February 2019
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 the surrounding area. You should continue to use UV-absorbing eyewear as directed.
Note: 
Long-term exposure to UV radiation is one of the risk factors associated with 
cataracts.  Exposure is based on a number of factors such as environmental conditions 
(altitude, geography, cloud cover) and personal factors (extent and nature of outdoor 
activities).  UV blocking contact lenses help provide protection against harmful UV 
radiation.  However, clinical studies have not been done to demonstrate that wearing 
UV blocking contact lenses reduces the risk of developing cataracts or other eye 
disorders.  Consult your eyecare practitioner for more information.
INDICATIONS (USES)
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV 
blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia 
and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism 
up to 2.00 Diopters that does not interfere with visual acuity.
The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens
with UV blocker is indicated for daily wear single use only for the optical correction of refractive 
ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may 
exhibit astigmatism up to 10.00 Diopters.   
The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable 
Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction 
of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons 
with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may 
exhibit astigmatism up to 1.50 Diopters or less.   
The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily 
Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical 
correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic 
persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a 
reading addition of +3.00 Diopters or less.
The Clariti 1 Day (somofilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear
single use only. The lenses are to be discarded upon removal; therefore, no cleaning or
disinfection is required.
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CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 6 of 12
Revision: A
Revision Date: February 2019
CONTRAINDICATIONS (REASONS NOT TO USE)
DO NOT USE your contact lenses when any of the following conditions exist:
x
Acute and subacute inflammation or infection of the anterior chamber of the eye
x
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids
x
Insufficiency of lacrimal secretion (dry eyes)
x
Corneal hypoesthesia (reduced corneal sensitivity)
x
Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses
x
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing 
contact lenses 
x
Any active corneal infection (bacterial, fungal, protozoal, or viral)
x
If the eyes become red or irritated
WARNINGS
You should be advised of the following warnings pertaining to contact lens wear:
x
Problems with contact lenses or lens care products could result in serious injury to the eye.  
Proper use and care of your contact lenses and lens care products, including lens cases are 
essential for the safe use of these products.
x
Eye problems, including a sore or lesion on the cornea (corneal ulcers) can develop rapidly and 
lead to loss of vision.
x
The risk of an infected sore or lesion on the cornea (ulcerative keratitis) is greater for people 
who wear extended wear contact lenses than for those who wear daily wear lenses.  Do not 
wear your lenses while sleeping as the risk of sore or lesion on the cornea (ulcerative keratitis) 
is greater than among those who do not wear them while sleeping.
x
The risk of ulcerative keratitis among contact lens users who smoke is greater than among non-
smokers.
x
If you experience eye discomfort, excessive tearing, vision changes, or redness of the eye, you 
should immediately remove the lenses and promptly contact your eyecare practitioner.  It is 
recommended that you see your eyecare practitioner routinely as directed.
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JJVC CONFIDENTIAL

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 7 of 12
Revision: A
Revision Date: February 2019
x
Water Activity – Do not expose your contact lenses to water while you are wearing them.
Water can harbor microorganisms that can lead to severe infection, vision loss or blindness. If 
your lenses have been submersed in water when swimming in pools, lakes or oceans, you should 
discard them and replace them with a new pair. Ask your eye care practitioner (professional) 
for recommendations about wearing your lenses during any activity involving water.
PRECAUTIONS
At your initial visit to your eyecare practitioner:
x
Be sure you read and understand the full contents of this booklet and discuss it with your 
eyecare practitioner.
x
Give your eyecare practitioner a complete history of your eye health, including any eye injuries, 
diseases, conditions or other problems you have had with your eyes, even if they seem 
unimportant to you.
x
Tell your eyecare practitioner about your general health, any medicines you are taking, current 
treatment by a physician, any disease you had or now have and any prior surgery.
x
Before leaving the eyecare practitioner’s office, you should be able to promptly remove lenses 
or should have someone else available who can remove the lenses.
Lens Handling Precautions:
x
Always wash and rinse your hands before handling lenses.  Do not get cosmetics, lotions, 
soaps, creams, deodorants or sprays in your eyes or on the lenses.  It is best to put on lenses 
before putting on makeup.  Water-based cosmetics are less likely to cause damage to lenses 
than oil-based products.
x
Do not touch contact lenses with your fingers or hands if your hands are not free of foreign 
materials, as microscopic scratches of the lenses may occur, causing distorted vision and/or 
injury to the eye. 
x
Do not touch the lens with your fingernails.
x
Carefully follow the handling, insertion, removal and wearing instructions in the Patient 
Instructions for Clariti 1 Day and those prescribed by your eyecare practitioner.
x
Always handle lenses gently and avoid dropping them. 
x
Never use tweezers or other tools to remove lenses from the lens container unless specifically 
indicated for that use.  Pour the lens into your hand when removing from lens blister.
CR-6388, v3.0
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CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 8 of 12
Revision: A
Revision Date: February 2019
Lens Wearing Precautions:
x
You should remove your lenses immediately if your eyes become red or irritated.
x
Never wear lenses beyond the period recommended by your eyecare practitioner.
x
Always discard lenses worn as prescribed by your eyecare practitioner.
x
If aerosol products such as hair spray are used while wearing lenses, exercise caution and keep 
your eyes closed until the spray has settled.
x
Avoid all harmful or irritating vapours and fumes while wearing lenses.
x
Avoid rubbing your eyes with the lenses on; this can irritate your eye or dislodge the lens.
x
Keep your eyes closed tightly when washing or showering to keep water and soaps out of your 
eyes; these may cause loss of the senses, contamination or injury to your eyes.
x
Always contact your eyecare practitioner before using any medicine in the eyes.
x
Ask your eyecare practitioner whether there are any other wearing restrictions that apply to 
you.  
Follow-up visits to your eyecare practitioner:
x
As with any contact lens, follow-up visits are necessary to assure the continuing health of your 
eyes.  Be sure to keep your follow-up appointments.
x
When you return for follow-up visits, be sure to tell your eye care practitioner if your eyes have 
felt dry, irritated or anything other than completely comfortable while wearing your contact 
lenses.
x
If there is any question in your mind about your wearing schedule and restrictions, cleaning 
lens handling procedures, lens replacement program, the condition of your lenses, your follow-
up visit schedule, or anything else about contact lens wear, be sure to discuss the subject with 
your eyecare practitioner, who is there to help you and see you use your contact lenses safely 
and properly.
x
If your eye care practitioner puts a dye or drops in your eyes during the examination, ask when 
you may reinsert the lenses.  The use of most dyes or drops will require a waiting period before 
the lenses may be reinserted.
CR-6388, v3.0
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JJVC CONFIDENTIAL

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 9 of 12
Revision: A
Revision Date: February 2019
Who should know that you are wearing Contact Lenses?
x
Inform your doctor (health care professional) about being a contact lens wearer.
x
Always inform your employer of being a contact lens wearer.  Some jobs may require use of 
eye protection equipment or may require that the patient not wear contact lenses.
ADVERSE REACTIONS
Be aware that the following problems may occur when wearing contact lenses:
x
Your eyes may sting, burn and/or itch (irritation).
x
There may be less comfort than when the lens was first placed on your eye.
x
There may be an abnormal feeling of something in the eye (foreign body, scratched area).
x
There may be potential for some temporary impairment due to peripheral infiltrates, peripheral 
corneal ulcers and corneal erosion.  There may be potential for other physiological observations, 
such as local or generalized edema, corneal neovascularisation, corneal staining, injection, 
tarsal abnormalities, iritis and conjunctivitis, some of which are clinically acceptable in low 
amounts.
x
There may be excessive watering (tearing), unusual secretions or redness of your eyes.
x
There may be poor visual acuity, blurred vision, rainbows, or halos around objects, sensitivity 
to light (photophobia) or dry eyes may also occur if your lenses are worn continuously or for 
too long a time.
If you notice any of the above symptoms:
x
Immediately remove the lenses.
x
If the discomfort or problem stops, look closely at the lens.  
x
If the lens is in any way damaged, do not put the lens back on your eye.  You should discard 
the lens and insert a new fresh lens on your eye.
x
If your lens has dirt, an eyelash, or foreign body on it, or the problem stops and the lens appears 
undamaged, you should dispose of the lens and insert a new fresh lens.
x
If the problem continues, you should not put the lens back on your eye but immediately consult 
your eye care professional.
x
When any of the above symptoms occur, a serious condition such as infection, corneal ulcer, 
neovascularisation or iritis may be present.  Seek immediate professional identification of the 
problem and prompt treatment to avoid serious eye damage.
CR-6388, v3.0
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JJVC CONFIDENTIAL

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 10 of 12
Revision: A
Revision Date: February 2019
FITTING
Conventional methods of fitting contact lenses apply.  For a detailed description of the fitting 
techniques, refer to the Patient Instructions Guide, copies of which are available from:
CooperVision
Attn: Product Services
711 North Road
Scottsville, New York 14546
(800) 341-2020
www.coopervision.com
WEARING AND APPOINTMENT SCHEDULE
Your eyecare practitioner should prescribe the lenses for daily wear single use only.  Your eyecare 
practitioner will determine your wearing schedule.  
The maximum suggested daily wearing time for the lenses is:
Day 
Hours
1
(4)
2
(5)
3
(6)
4
(7)
5
(8)
6
(9)
7
(10)
8
(11)
9
(12)
10 and after – all waking hours
Follow-up examinations are necessary to ensure continued successful contact lens wear and to 
ascertain the effects of the lenses on the eyes.  The following appointment schedule is a suggested 
guideline:
x
24 hours post-dispensing
x
7 days 
x
1 month                                                                                                       
x
3 months
Every 6 months thereafter
CR-6388, v3.0
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JJVC CONFIDENTIAL

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 11 of 12
Revision: A
Revision Date: February 2019
LENS CARE DIRECTIONS
1. Basic Lens Care Instructions
Eyecare practitioners should review lens care directions with you, including basic lens care 
information.
It is essential that you learn and use good hygienic methods in the care and handling of your new
lenses.  Cleanliness is the first and most important aspect of proper contact lens care.  In particular, 
your hands should be clean and free of any foreign substances when you handle your lenses.  The 
procedures are:
x
Always, wash, rinse and dry your hands before handling contact lenses.
x
Do not use saliva or anything other than the recommended solutions for lubricating or rewetting 
lenses.  Do not put lenses in your mouth.
x
Never rinse your lenses in water from the tap.  There are two reasons for this:
a.
Tap water may contain impurities that can contaminate or damage your lenses 
and may lead to eye infection or injury.
b.
You might lose your lens down the drain.
For Single Use Daily Wear
Remember there is no cleaning or disinfection needed with Clariti 1 Day contact lenses prescribed 
for daily wear single use wear only.
The lenses are to be discarded upon removal and have 
replacement lenses or spectacles available.
2. Care for a Sticking (Non-Moving) Lens
If the lens stops moving or cannot be removed, you should be instructed to apply a few drops of the 
recommended lubricating solution directly to your eye and wait until the lens begins to move freely 
on your eye before removing it.  If non-movement of the lens continues, you should immediately 
consult your eyecare practitioner.
3. Care for a Dehydrated Lens
If a soft, hydrophilic lens is exposed to air while off the eye, it may become dry and brittle.  If this 
happens, dispose of the lens and use a fresh one.
4. Emergencies
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) are 
splashed into your eyes, you should: FLUSH EYES IMMEDIATELY WITH TAP WATER 
AND THEN REMOVE LENSES PROMPTLY. CONTACT YOUR EYECARE 
PRACTITIONER OR VISIT A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
CR-6388, v3.0
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JJVC CONFIDENTIAL

CLARITI 1 DAY CONTACT LENS
Part Number: PI01092
Page 12 of 12
Revision: A
Revision Date: February 2019
HOW SUPPLIED:
Each lens is supplied sterile in a blister pack containing isotonic saline solution with 0.005% or 
0.020% w/v poloxamer 407 added. The blister pack is labelled with the base curve, diopter for 
spherical lenses or toric power, cylinder and axis for toric lenses, multifocal add for multifocal 
lenses, diameter, lot number, UV blocker and expiration date of the product.
Do not use if blister pack has been broken or damaged.
REPORTING OF ADVERSE REACTIONS:
All serious adverse experiences and adverse reactions observed in patients should be reported to:
CooperVision
Attn: Product Services
711 North Road
Scottsville, New York 14546
(800) 341-2020
www.coopervision.com
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed eyecare 
professional.
CR-6388, v3.0
Page 115 of 186
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
CooperVision® MyDay® (stenfilcon A)
CR-6388, v3.0
Page 116 of 186
JJVC CONFIDENTIAL

Part Number: PI01100
Page 1 of 3
Revision: A
Revision Date: January 2019
CooperVision MyDay
Soft (Hydrophilic) Daily Disposable
Contact Lenses
IMPORTANT: Please read carefully and keep this information for 
future use. This package insert is intended for the eye care 
practitioner, but should be made available to patients upon request. 
The eye care practitioner should provide the patient with the patient 
instructions that pertain to the patient's prescribed lens.
SYMBOLS KEY:
The following symbols may appear on the label or carton.
SYMBOL
DEFINITION
REFERENCE
Caution: Federal (USA) law restricts 
this device to sale by or on the order 
of a licensed practitioner
81 FR 38911
Caution / See Instructions for 
Wearers
BS EN ISO 15223-1
Table 1, Symbol 5.4.4
Use by Date (expiration date)
BS EN ISO 15223-1
Table 1, Symbol 5.1.4
Batch Code
BS EN ISO 15223-1
Table 1, Symbol 5.1.5
Sterile using Steam Heat
BS EN ISO 15223-1
Table 1, Symbol 5.2.5
Manufacturer
BS EN ISO 15223-1
Table 1, Symbol 5.1.1
Authorized representative in the 
European Community
BS EN ISO 15223-1
Table 1, Symbol 5.1.2
Do not use if package is damaged
BS EN ISO 15223-1
Table 1, Symbol 5.2.8
Consult instructions for use / consult 
electronic instructions for use
BS EN ISO 15223-1
Table 1, Symbol 5.4.3
Do not re-use
BS EN ISO 15223-1
Table 1, Symbol 5.4.2
Date of manufacture
BS EN ISO 15223-1
Table 1, Symbol 5.1.3
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY 
OR ON THE ORDER OF A LICENSED PRACTITIONER.
DESCRIPTION
MyDay Contact Lenses are available as an Asphere, Toric, Multifocal, 
and Multifocal Toric lens designs.
The MyDay material stenfilcon A is primarily a random copolymer of 
polydimethylsiloxane methacrylate and vinylmethyl acetamide. The UV 
blocker used is a benzotriazolyl methacrylate. The lenses have a blue 
tint which is added to make the lens more visible for handling. The 
lenses also contain a UV absorbing monomer which is used to block 
UV radiation.
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 
the surrounding area. You should continue to use UV-absorbing 
eyewear as directed.
Long term exposure to the 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 the 
outdoor activities). UV-absorbing contact lenses help provide 
protection against harmful UV radiation. However, clinical studies 
have not been done to demonstrate that wearing UV-absorbing 
contact lenses reduces the risk of developing cataracts or other 
eye disorders. Consult your eye care practitioner for more 
information.
The MyDay (stenfilcon A) Soft (Hydrophilic) Contact Lens (-6.00 D) 
blocks 86% of UVA radiation and 97% UVB radiation average 
across the spectrum. The radiation blockage of the MyDay 
(stenfilcon A) lens will increase for thicker lenses (Please refer to 
accompanying transmittance curve graph).
1.
Leman, S., Radiant Energy and the Eye, MacMillan, New York, 1980,
p. 58, figure 2-21. Transmittance profile of the human cornea of a 24-
year-old person.
2.
Waxler M., and V. M. Hitchins, Optical Radiation and Visual Health,
CRC Press, Boca Raton, Florida, 1986, p. 19, figure 5. Transmittance 
profile for the human crystalline lens of a 25-year-old person.
MyDay (stenfilcon A) contact lenses parameters:
o Chord Diameter: 
13.0 mm to 15.5mm
o Base Curve: 
8.4 ± 0.5 mm and 8.7 ± 0.5 mm
o Center Thickness: 
0.08 mm to 0.218 mm (varies with power)
o Powers:
–20.00D to +20.00D
o Cylinder Powers:
-0.25D to -10.00D
o Axis:
0o to 180o in 10o increments
o Add Power Range:
+0.50 to +4.00
The physical/optical properties of the lens are:
o Specific Gravity
1.033
o Refractive Index:
1.401
o Light Transmittance:
96%
o Surface Character
Hydrophilic
o Water Content
54%
o Oxygen Permeability
80x10-11
[(cm2/sec)x(ml O2)/(ml x mm Hg)]
Call our Customer Service Department at (800) 341-2020
for current availability.
ACTIONS
When placed on the cornea in its hydrated state, the MyDay Soft 
(Hydrophilic) Contact Lens acts as a refracting medium to focus light 
rays on the retina. 
INDICATIONS FOR USE
Aspherical
MyDay ASPHERE Soft Contact lenses are indicated for the correction 
of ametropia (myopia and hyperopia) in aphakic and non-aphakic
persons with non-diseased eyes in powers from -20.00D to +20.00D
diopters. The lenses may be worn by persons who exhibit astigmatism 
of -2.00 diopters or less that does not interfere with visual acuity.
CR-6388, v3.0
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Part Number: PI01100
Page 2 of 3
Revision: A
Revision Date: January 2019
Toric: MyDay (stenfilcon A) Toric Soft Contact lenses are indicated for 
the correction of ametropia (myopia or hyperopia with astigmatism) in 
aphakic and non-aphakic persons with non-diseased eyes in powers 
from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to 
-10.00 diopters.
Multifocal: MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are 
indicated for the correction of refractive ametropia (myopia and 
hyperopia) and emmetropia with presbyopia in aphakic and non-
aphakic persons with non-diseased eyes. The lenses may be worn by 
persons who exhibit astigmatism of -2.00 diopters or less that does not 
interfere with visual acuity.
Multifocal Toric: MyDay (stenfilcon A) MULTIFOCAL TORIC Soft 
Contact lenses are indicated for the optical correction of distance and 
near vision in presbyopic phakic or aphakic persons with non-
dieseased eyes who may have -10.00 diopters of astigmatism or less.
CONTRAINDICATIONS (REASONS NOT TO USE):
Do not use the MyDay lens when any of the following conditions exist:
o Acute and subacute inflammation or infection of the anterior 
chamber of the eye.
o Any eye disease, injury, or abnormality that affects the cornea, 
conjunctiva, or eyelids.
o Severe insufficiency of lacrimal secretion (dry eyes).
o Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
o Any systemic disease that may affect the eye or be exaggerated 
by wearing contact lenses.
o Allergic reactions of ocular surfaces or adnexa that may be 
induced or exaggerated by wearing contact lenses.
o Any active corneal infection (bacterial, fungal, or viral).
o If eyes become red or irritated.
o The patient is unable to follow lens care regimen or unable to 
obtain assistance to do so.
WARNINGS
Patients should be advised of the following warnings pertaining 
to contact lens wear:
o PROBLEMS WITH CONTACT LENSES AND LENS CARE 
PRODUCTS COULD RESULT IN SERIOUS INJURY TO THE 
EYE. It is essential that patients follow their eye care practitioner’s 
directions and all labeling instructions for proper use of lenses.
Eye problems, including corneal ulcers, can develop rapidly and 
lead to loss of vision. Daily wear lenses are not indicated for 
overnight wear, and patients should be instructed not to wear 
lenses while sleeping. Clinical studies have shown that the risk of 
serious adverse reactions is increased when these lenses are 
worn overnight. Studies have shown that contact lens wearers 
who are smokers have a higher incidence of adverse reactions 
than nonsmokers. If a patient experiences eye discomfort, 
excessive tearing, vision changes, or redness of the eye, the
patient should be instructed to immediately remove lenses and 
promptly contact his or her eyecare practitioner.
PRECAUTIONS
Special Precautions for Eye Care Practitioners
o
Due to the small numbers of patients enrolled in clinical 
investigation of lenses, all refractive powers, design 
configurations, or lens parameters available in the lens material 
are not evaluated in significant numbers. Consequently, when 
selecting an appropriate lens design and parameters, the eye 
care practitioner 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.
o
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 practitioner.
o
Patients who wear aspheric contact lenses to correct presbyopia 
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.
o
Aphakic patients should not be fitted with any MyDay contact 
lenses until the determination is made that the eye has healed 
completely.
o
Fluorescein, a yellow dye, should not be used while the lenses 
are on the eyes. The lenses absorb the dye and become 
discolored. Whenever fluorescein is used in the eyes, the eyes 
should be flushed with a sterile saline solution that is 
recommended for in-eye use.
o
Before leaving the eye care practitioner’s office, 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. Eye care 
practitioners should instruct the patient to remove the lenses 
immediately if the eye becomes red or irritated.
Eye care practitioners should carefully instruct patients about the 
following safety precautions:
o
Always discard disposable lenses after the recommended 
wearing schedule prescribed by the Eye Care Practitioner.
o
The compatibility of the lens with lens care regimens has not been
evaluated. 
o
Do not use saliva or any solutions for lubricating or wetting 
lenses.
o
If the lens sticks (stops moving) on the eye, follow the 
recommended directions on Care for a Sticking 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 practitioner.
o
Always wash and rinse hands before handling lenses. Do not get 
cosmetics, lotions, soaps, creams, deodorant, 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.
o
Do not touch the contact lenses with the finger or hands if the 
hands are not free of foreign materials, as lens damage may 
occur.
o
Carefully follow the handling, insertion, removal, and wearing 
instructions in the Patient Instructions for MyDay contact lenses 
and those prescr bed by the eye care practitioner.
o
Never wear lenses beyond the period recommended by the eye 
care practitioner.
o
If aerosol products such as hairspray are used while wearing 
lenses, exercise caution and keep eyes closed until the spray has 
settled.
o
Always handle lenses gently and avoid dropping them.
o
Avoid all harmful or irritating vapors and fumes while wearing 
lenses.
o
Ask the eye care practitioner about wearing the lenses during 
sporting activities.
o
Inform the doctor (health care practitioner) about being a contact 
lens wearer.
o
Never use tweezers or other tools to remove lenses from the lens 
container unless specifically indicated for that use. Pour the lens 
into your hand.
o
Do not touch the lens with fingernails.
o
Always contact the eye care practitioner before using any 
medicine in the eyes.
o
Always inform the employer of being a contact lens wearer. Some 
jobs may require use of eye protection equipment or may require 
that the patient not wear contact lenses.
o
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.
CR-6388, v3.0
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JJVC CONFIDENTIAL

Part Number: PI01100
Page 3 of 3
Revision: A
Revision Date: January 2019
ADVERSE REACTIONS
The patient should be informed that the following problems may occur:
o
Eyes stinging, burning, or itching (irritation), or other eye pain.
o
Comfort is less than when the lens was first placed on the eye.
o
Feeling that something is in the eye such as a foreign body or a 
scratched area.
o
Excessive watering (tearing) of the eyes.
o
Unusual eye secretions.
o
Redness of the eyes.
o
Reduced sharpness of vision (poor visual acuity).
o
Blurred vision, rainbows, or halos around objects.
o
Sensitivity to light (photophobia).
o
Dry eyes.
If the patient notices any of the above, he or she should be instructed 
to:
o
Immediately remove the lenses.
o
If the discomfort or the problem stops, then look closely at the 
lens. If the lens is in some way damaged, do not put the lens back 
on the eye. Place the lens in a storage case and contact the eye 
care practitioner. Daily disposible lenses should not be reinserted.
If the problem continues, the patient should immediately remove 
the lenses and consult the eye care practitioner.
When any of the above problems occur, a serious condition such as 
infection, corneal ulcer, neovascularization, or iritis may be present. 
The patient should be instructed to keep the lens off the eye and 
seek immediate professional identification of the problem and prompt 
treatment to avoid serious eye damage.
FITTING
Conventional methods of fitting contact lenses apply to all MyDay 
contact lenses. For a detailed description of the fitting techniques, refer 
to the MyDay Professional Fitting and Information Guide, copies of 
which are available from:
CooperVision, Inc.
www.coopervision.com
WEARING SCHEDULE
The wearing schedule should be determined by the eye care 
practitioner. Patients tend to over-wear the lenses initially. The eye 
care practitioner should emphasize the importance of adhering to the 
initial maximum wearing schedule. Regular checkups, as determined 
by the eye care practitioner are also extremely important.
CooperVision recommends that all MyDay lenses be discarded and 
replaced with a new lens on a daily basis. 
DAILY DISPOSABLE WEAR: (less than 24 hours, while awake). 
The maximum suggested wearing time is 12 hours:
LENS CARE DIRECTIONS
The MyDay (stenfilcon A) Soft (Hydrophilic) Contact Lenses are 
indicated for daily wear single use only.. The lenses are to be 
discarded upon removal; therefore, no cleaning or disinfection is 
required.
For MyDay contact lenses prescribed for daily wear single use only:
The Eye Care Professional should review with patients that no 
cleaning or disinfection is needed. Patients should always dispose of 
lenses when they are removed and have replacement lenses or 
spectacles available.
Eye care practitioners should review with the patient lens care 
directions, including basic lens care information in accordance with 
patients lens type and wearing schedule.
o
Always wash, rinse, and dry hands before handling contact 
lenses.
o
Do not use saliva or any solutions for lubricating or rewetting. Do 
not put lenses in the mouth.
o
The patient should always have a spare pair of lenses at all times.
o
Eye care practitioners may recommend a lubrication/rewetting 
solution, which can be used to wet (lubricate) the lenses while 
they are being worn to make them more comfortable.
CARE FOR A DRIED OUT (DEHYDRATED) LENS
If any MyDay lens is exposed to air while off the eye, it may become 
dry and brittle. In this event, simply dispose of the lens and replace 
with a fresh one.
CARE FOR A STICKING (NONMOVING) LENS
If the lens sticks (stops moving or cannot be removed), the patient 
should be instructed to apply 2 to 3 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 more than 5 minutes, the patient 
should immediately consult the eye care practitioner.
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 THE EYES 
IMMEDIATELY WITH TAP WATER AND IMMEDIATELY CONTACT 
THE EYE CARE PRACTITIONER OR VISIT A HOSPITAL 
EMERGENCY ROOM WITHOUT DELAY.
HOW SUPPLIED
Each lens is supplied sterile in a blister containing buffered saline 
solution. The blister is labeled with the base curve, diameter, dioptic 
power, manufacturing lot number, and expiration date of the lens.
DO NOT USE IF THE BLISTER IS BROKEN OR 
THE SEAL HAS BEEN DAMAGED
REPORTING OF ADVERSE REACTIONS
All serious adverse experiences and adverse reactions observed in 
patients wearing any MyDay contact lens or experienced with the 
lenses should be reported to:
Product Services
(800) 341-2020
www.coopervision.com
CooperVision, Inc.
6150 Stoneridge Mall Road
Suite 370
Pleasanton, CA 94588
CR-6388, v3.0
Page 119 of 186
JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Johnson & Johnson 1-Day ACUVUE® Moist (etafilcon A)
CR-6388, v3.0
Page 120 of 186
JJVC CONFIDENTIAL

1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s ( et aﬁ l c o n A) Vi si bilit y Ti nt e d wit h 
U V Bl o c k er v s. 2 4 yr. ol d h u m a n c or n e a a n d 2 5 yr. ol d h u m a n cr y st alli n e l e n s. 
*The data are representative measure ments taken through the central 3- 5 m m portion for the 
thinnest marketed lens (- 3. 0 0 D lens, 0. 0 8 4 m m center thickness).
1 L er m a n, S., R a di a nt E n er g y a n d t h e E y e, M a c Mill a n, N e w Y or k, 1 9 8 0, p. 5 8, ﬁ g ur e 2- 2 1
2 W a xl er, M., Hit c hi n s, V. M., O pti c al R a di ati o n a n d Vi s u al H e alt h, C R C Pr e s s, B o c a R at o n, Fl ori d a, 
1 9 8 6, p. 1 9, ﬁ g ur e 5
W A R NI N G: U V a b s or bi n g c o nt a ct l e n s e s ar e N O T s u b stit ut e s f or 
pr ot e cti v e U V a b s or bi n g e y e w e ar, s u c h a s U V a b s or bi n g g o g gl e s 
or s u n gl a s s e s b e c a u s e t h e y d o n ot c o m pl et el y c o v er t h e e y e a n d 
s urr o u n di n g ar e a. T h e p ati e nt s h o ul d c o nti n u e t o u s e U V a b s or bi n g 
e y e w e ar a s dir e ct e d.
A C TI O N S
I n it s h y dr at e d st at e, t h e c o nt a ct l e n s, w h e n pl a c e d o n t h e c or n e a, a ct s a s a 
r efr a cti n g m e di u m t o f o c u s li g ht r a y s o n t h e r eti n a.
T h e U V Bl o c ki n g f or t h e s e l e n s e s a v er a g e s 9 7 % i n t h e U V B r a n g e of 2 8 0 n m t o 
3 1 5 n m a n d 8 2 % i n t h e U V A r a n g e of 3 1 6 n m t o 3 8 0 n m f or t h e e ntir e p o w er 
r a n g e.
T R A N S MI T T A N C E C U R V E S
1- D AY A C U V UE ®  M OI ST
Brand Contact Lenses*
24 Y R. OL D H U M A N 
C O R NE A 1
25 Y R. OL D H U M A N
C R Y STALLI NE LE N S 2
5
N O T E: L o n g-t er m e x p o s ur e t o U V r a di ati o n i s o n e of t h e ri s k f a ct or s 
a s s o ci at e d wit h c at ar a ct s. E x p o s ur e i s b a s e d o n a n u m b er of f a ct or s 
s u c h a s e n vir o n m e nt al c o n diti o n s ( altit u d e, g e o gr a p h y, cl o u d c o v er) a n d 
p er s o n al f a ct or s ( e xt e nt a n d n at ur e of o ut d o or a cti viti e s). U V- Bl o c ki n g 
c o nt a ct l e n s e s h el p pr o vi d e pr ot e cti o n a g ai n st h ar mf ul U V r a di ati o n. 
H o w e v er, cli ni c al st u di e s h a v e n ot b e e n d o n e t o d e m o n str at e t h at 
w e ari n g U V- Bl o c ki n g c o nt a ct l e n s e s r e d u c e s t h e ri s k of d e v el o pi n g 
c at ar a ct s or ot h er e y e di s or d er s. T h e E y e C ar e Pr of e s si o n al s h o ul d b e 
c o n s ult e d f or m or e i nf or m ati o n.
I N DI C A TI O N S ( U S E S)
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s ar e i n di c at e d f or d ail y 
di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of r efr a cti v e a m etr o pi a ( m y o pi a a n d 
h y p er o pi a) i n p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y h a v e 
1. 0 0 D or l e s s of a sti g m ati s m.
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s f or A S TI G M A TI S M ar e i n di c at e d 
f or d ail y di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of r efr a cti v e a m etr o pi a ( m y o pi a 
a n d h y p er o pi a) i n p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y 
h a v e 0. 5 0 D t o 3. 0 0 D of a sti g m ati s m.
1- D A Y A C U V U E ®  M OI S T Br a n d M U L TI F O C A L C o nt a ct L e n s e s ar e i n di c at e d 
f or d ail y di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of di st a n c e a n d n e ar vi si o n i n 
pr e s b y o pi c p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y h a v e 
4. 0 0 D of A D D p o w er or l e s s a n d 0. 7 5 D or l e s s of a sti g m ati s m.
T h e l e n s e s c o nt ai n a U V Bl o c k er t o h el p pr ot e ct a g ai n st tr a n s mi s si o n of h ar mf ul 
U V r a di ati o n t o t h e c or n e a a n d i nt o t h e e y e.
W h e n pr e s cri b e d f or d ail y di s p o s a bl e u s e, n o cl e a ni n g or di si nf e cti o n i s r e q uir e d. 
L e n s e s s h o ul d b e di s c ar d e d u p o n r e m o v al.
C O N T R AI N DI C A TI O N S ( R E A S O N S N O T T O U S E) 
D O N O T U S E t h e s e l e n s e s w h e n a n y of t h e f oll o wi n g c o n diti o n s e xi st:
•  A c ut e or s u b a c ut e i nﬂ a m m ati o n or i nf e cti o n of t h e a nt eri or c h a m b er of 
t h e e y e.
•  A n y e y e di s e a s e, i nj ur y, or a b n or m alit y t h at aff e ct s t h e c or n e a, 
c o nj u n cti v a, or e y eli d s.
•  S e v er e i n s ufﬁ ci e n c y of l a cri m al s e cr eti o n ( dr y e y e).
•  C or n e al h y p o e st h e si a (r e d u c e d c or n e al s e n siti vit y).
6
•  A n y s y st e mi c di s e a s e t h at m a y aff e ct t h e e y e or b e e x a g g er at e d b y 
w e ari n g c o nt a ct l e n s e s.
•  All er gi c r e a cti o n s of o c ul ar s urf a c e s or a d n e x a t h at m a y b e i n d u c e d or 
e x a g g er at e d b y w e ari n g c o nt a ct l e n s e s or u s e of c o nt a ct l e n s s ol uti o n s.
•  O c ul ar irrit ati o n d u e t o all er gi c r e a cti o n s w hi c h m a y b e c a u s e d b y u s e 
of c o nt a ct l e n s s ol uti o n s (i. e., r e w etti n g dr o p s) t h at c o nt ai n c h e mi c al s or 
pr e s er v ati v e s ( s u c h a s m er c ur y, T hi m er o s al, et c.) t o w hi c h s o m e p e o pl e 
m a y d e v el o p a n all er gi c r e s p o n s e.
•  A n y a cti v e c or n e al i nf e cti o n ( b a ct eri al, f u n g al, pr ot o z o al, or vir al).
•  If e y e s b e c o m e r e d or irrit at e d.
W A R NI N G S
P ati e nt s s h o ul d b e a d vi s e d of t h e f oll o wi n g w ar ni n g s p ert ai ni n g t o 
c o nt a ct l e n s w e ar:
E Y E P R O B L E M S, I N C L U DI N G C O R N E A L U L C E R S, C A N D E V E L O P 
R A PI D L Y A N D L E A D T O L O S S O F VI SI O N. I F T H E P A TI E N T 
E X P E RI E N C E S:
•  E y e  Di s c o mf ort,
•  E x c e s si v e  T e ari n g,
•  Vi si o n  C h a n g e s,
•  L o s s of Vi si o n,
•  E y e R e d n e s s, or
•  Ot h er E y e Pr o bl e m s,
T H E P A TI E N T S H O U L D B E I N S T R U C T E D T O I M M E DI A T E L Y 
R E M O V E T H E L E N S E S A N D P R O M P T L Y C O N T A C T T H E E Y E C A R E 
P R O F E S SI O N A L.
•  W h e n pr e s cri b e d f or d ail y w e ar, p ati e nt s s h o ul d b e i n str u ct e d n ot t o w e ar 
t h eir l e n s e s w hil e sl e e pi n g. Cli ni c al st u di e s h a v e s h o w n t h at w h e n l e n s e s 
ar e w or n o v er ni g ht, t h e ri s k of ul c er ati v e k er atiti s i s gr e at er t h a n a m o n g 
t h o s e w h o d o n ot w e ar t h e m o v er ni g ht.3
•  St u di e s h a v e s h o w n t h at c o nt a ct l e n s w e ar er s w h o ar e s m o k er s h a v e a 
hi g h er i n ci d e n c e of a d v er s e r e a cti o n s t h a n n o n s m o k er s.
•  Pr o bl e m s wit h c o nt a ct l e n s e s or l e n s c ar e pr o d u ct s c o ul d r e s ult i n 
s eri o u s i nj ur y t o t h e e y e. P ati e nt s s h o ul d b e c a uti o n e d t h at pr o p er u s e 
a n d c ar e of c o nt a ct l e n s e s a n d l e n s c ar e pr o d u ct s ar e e s s e nti al f or t h e 
s af e u s e of t h e s e pr o d u ct s.
7
•  T h e o v er all ri s k of ul c er ati v e k er atiti s m a y b e r e d u c e d b y c ar ef ull y 
f oll o wi n g dir e cti o n s f or l e n s c ar e.
3 N e w E n gl a n d J o ur n al of M e di ci n e, S e pt e m b er 2 1, 1 9 8 9; 3 2 1 ( 1 2), p p. 7 7 3- 7 8 3
S p e ci ﬁ c I n str u cti o n s f or U s e a n d W ar ni n g s:
•  W at er  A cti vit y
I n str u cti o n f or U s e
D o n ot e x p o s e c o nt a ct l e n s e s t o w at er w hil e w e ari n g t h e m.
W A R NI N G:
W at er c a n h ar b or mi cr o or g a ni s m s t h at c a n l e a d t o s e v er e i nf e cti o n, 
vi si o n l o s s, or bli n d n e s s. If l e n s e s h a v e b e e n s u b m er s e d i n w at er w h e n 
p arti ci p ati n g i n w at er s p ort s or s wi m mi n g i n p o ol s, h ot t u b s, l a k e s, or 
o c e a n s, t h e p ati e nt s h o ul d b e i n str u ct e d t o di s c ar d t h e m a n d r e pl a c e 
t h e m wit h a n e w p air. T h e E y e C ar e Pr of e s si o n al s h o ul d b e c o n s ult e d f or 
r e c o m m e n d ati o n s r e g ar di n g w e ari n g l e n s e s d uri n g a n y a cti vit y i n v ol vi n g 
w at er.
P R E C A U TI O N S
S p e ci al Pr e c a uti o n s f or E y e C ar e Pr of e s si o n al s:
•  D u e t o t h e s m all n u m b er of p ati e nt s e nr oll e d i n cli ni c al i n v e sti g ati o n of 
l e n s e s, all r efr a cti v e p o w er s, d e si g n c o nﬁ g ur ati o n s, or l e n s p ar a m et er s 
a v ail a bl e i n t h e l e n s m at eri al ar e n ot e v al u at e d i n si g niﬁ c a nt n u m b er s. 
C o n s e q u e ntl y, w h e n s el e cti n g a n a p pr o pri at e l e n s d e si g n a n d 
p ar a m et er s, t h e E y e C ar e Pr of e s si o n al s h o ul d c o n si d er all c h ar a ct eri sti c s 
of t h e l e n s t h at c a n aff e ct l e n s p erf or m a n c e a n d o c ul ar h e alt h, i n cl u di n g 
o x y g e n p er m e a bilit y, w ett a bilit y, c e ntr al a n d p eri p h er al t hi c k n e s s, a n d 
o pti c z o n e di a m et er.
T h e p ot e nti al i m p a ct of t h e s e f a ct or s o n t h e p ati e nt’s o c ul ar h e alt h 
s h o ul d b e c ar ef ull y w ei g h e d a g ai n st t h e p ati e nt’s n e e d f or r efr a cti v e 
c orr e cti o n; t h er ef or e, t h e c o nti n ui n g o c ul ar h e alt h of t h e p ati e nt a n d l e n s 
p erf or m a n c e o n t h e e y e s h o ul d b e c ar ef ull y m o nit or e d b y t h e pr e s cri bi n g 
E y e C ar e Pr of e s si o n al.
•  P ati e nt s w h o w e ar t h e s e l e n s e s t o c orr e ct pr e s b y o pi a u si n g m o n o vi si o n 
( or m o diﬁ e d m o n o vi si o n u si n g 1- D A Y A C U V U E®  M OI S T Br a n d 
M U L TI F O C A L) m a y n ot a c hi e v e t h e b e st c orr e ct e d vi s u al a c uit y f or eit h er 
f ar or n e ar vi si o n. Vi s u al r e q uir e m e nt s v ar y wit h t h e i n di vi d u al a n d s h o ul d 
b e c o n si d er e d w h e n s el e cti n g t h e m o st a p pr o pri at e t y p e of l e n s f or e a c h 
p ati e nt.
8
C R- 6 3 8 8, v 3. 0
P a ge 1 2 2 of 1 8 6
J J V C C O N FI D E N TI A L

•  Fl u or e s c ei n, a y ell o w d y e, s h o ul d n ot b e u s e d w hil e t h e l e n s e s ar e o n 
t h e e y e s. T h e l e n s e s a b s or b t hi s d y e a n d b e c o m e di s c ol or e d. W h e n e v er 
ﬂ u or e s c ei n i s u s e d i n e y e s, t h e e y e s s h o ul d b e ﬂ u s h e d wit h a st eril e 
s ali n e s ol uti o n t h at i s r e c o m m e n d e d f or i n- e y e u s e.
•  E y e C ar e Pr of e s si o n al s s h o ul d i n str u ct t h e p ati e nt t o r e m o v e l e n s e s 
i m m e di at el y if t h e e y e s b e c o m e r e d or irrit at e d. 
E y e C ar e Pr of e s si o n al s s h o ul d c ar ef ull y i n str u ct p ati e nt s a b o ut t h e 
f oll o wi n g c ar e r e gi m e n a n d s af et y pr e c a uti o n s.
H a n dli n g Pr e c a uti o n s:
•  B ef or e l e a vi n g t h e E y e C ar e Pr of e s si o n al’s ofﬁ c e, t h e p ati e nt s h o ul d 
b e a bl e t o pr o m ptl y r e m o v e t h e l e n s e s or s h o ul d h a v e s o m e o n e el s e 
a v ail a bl e w h o c a n r e m o v e t h e l e n s e s f or hi m or h er.
•  D O N O T u s e if t h e st eril e bli st er p a c k a g e i s o p e n e d or d a m a g e d.
•  Al w a y s w a s h a n d ri n s e h a n d s b ef or e h a n dli n g l e n s e s. D o n ot g et 
c o s m eti c s, l oti o n s, s o a p s, cr e a m s, d e o d or a nt s, or s pr a y s i n t h e e y e s or 
o n t h e l e n s e s. It i s b e st t o p ut o n l e n s e s b ef or e p utti n g o n m a k e u p.
•  D O N O T t o u c h c o nt a ct l e n s e s wit h t h e ﬁ n g er s or h a n d s if t h e h a n d s ar e 
n ot fr e e of f or ei g n m at eri al s, a s mi cr o s c o pi c s cr at c h e s of t h e l e n s e s m a y 
o c c ur, c a u si n g di st ort e d vi si o n a n d/ or i nj ur y t o t h e e y e.
•  C ar ef ull y f oll o w t h e h a n dli n g, i n s erti o n, r e m o v al, a n d w e ari n g i n str u cti o n s 
i n t h e P ati e nt I n str u cti o n G ui d e f or t h e s e l e n s e s a n d t h o s e pr e s cri b e d b y 
t h e E y e C ar e Pr of e s si o n al.
•  Al w a y s h a n dl e l e n s e s c ar ef ull y a n d a v oi d dr o p pi n g t h e m.
•  N e v er u s e t w e e z er s or ot h er t o ol s t o r e m o v e l e n s e s fr o m t h e l e n s 
c o nt ai n er. Sli d e t h e l e n s u p t h e si d e of t h e b o wl u ntil it i s fr e e of t h e 
c o nt ai n er.
•  D o n ot t o u c h t h e l e n s wit h ﬁ n g er n ail s.
L e n s W e ari n g Pr e c a uti o n s:
•  If t h e l e n s sti c k s ( st o p s m o vi n g) o n t h e e y e, f oll o w t h e r e c o m m e n d e d 
dir e cti o n s i n “ C ar e f or Sti c ki n g ( N o n- M o vi n g) L e n s e s.” T h e l e n s s h o ul d 
m o v e fr e el y o n t h e e y e f or t h e c o nti n u e d h e alt h of t h e e y e. If n o n-
m o v e m e nt of t h e l e n s c o nti n u e s, t h e p ati e nt s h o ul d b e i n str u ct e d t o 
i m m e di at el y c o n s ult hi s or h er E y e C ar e Pr of e s si o n al.
•  N e v er w e ar l e n s e s b e y o n d t h e p eri o d r e c o m m e n d e d b y t h e E y e C ar e 
Pr of e s si o n al.
9
•  T h e p ati e nt s h o ul d b e a d vi s e d t o n e v er all o w a n y o n e el s e t o w e ar t h eir 
l e n s e s. T h e y h a v e b e e n pr e s cri b e d t o ﬁ t t h eir e y e s a n d t o c orr e ct t h eir 
vi si o n t o t h e d e gr e e n e c e s s ar y. S h ari n g l e n s e s gr e atl y i n cr e a s e s t h e 
c h a n c e of e y e i nf e cti o n s.
•  If a er o s ol pr o d u ct s, s u c h a s h air s pr a y, ar e u s e d w hil e w e ari n g l e n s e s, 
e x er ci s e c a uti o n a n d k e e p e y e s cl o s e d u ntil t h e s pr a y h a s s ettl e d.
•  Av oi d all h ar mf ul or irrit ati n g v a p or s a n d f u m e s w hil e w e ari n g l e n s e s.
L e n s C ar e Pr e c a uti o n s:
•  T h e p ati e nt s h o ul d b e i nf or m e d t h at n o cl e a ni n g or di si nf e cti o n i s n e e d e d 
w h e n l e n s e s ar e w or n f or d ail y di s p o s a bl e w e ar. P ati e nt s s h o ul d al w a y s 
di s p o s e of l e n s e s w h e n r e m o v e d a n d h a v e s p ar e l e n s e s or s p e ct a cl e s 
a v ail a bl e.
Ot h er T o pi c s t o Di s c u s s wit h P ati e nt s:
•  Al w a y s c o nt a ct t h e E y e C ar e Pr of e s si o n al b ef or e u si n g a n y m e di ci n e i n 
t h e e y e s.
•  C ert ai n m e di c ati o n s, s u c h a s a nti hi st a mi n e s, d e c o n g e st a nt s, di ur eti c s, 
m u s cl e r el a x a nt s, tr a n q uili z er s, a n d t h o s e f or m oti o n si c k n e s s m a y c a u s e 
dr y n e s s of t h e e y e, i n cr e a s e d l e n s a w ar e n e s s, or bl urr e d vi si o n. S h o ul d 
s u c h c o n diti o n s e xi st, pr o p er r e m e di al m e a s ur e s s h o ul d b e pr e s cri b e d. 
•  Or al c o ntr a c e pti v e u s er s c o ul d d e v el o p vi s u al c h a n g e s or c h a n g e s i n 
l e n s t ol er a n c e w h e n u si n g c o nt a ct l e n s e s. P ati e nt s s h o ul d b e c a uti o n e d 
a c c or di n gl y.
•  A s wit h a n y c o nt a ct l e n s, f oll o w- u p vi sit s ar e n e c e s s ar y t o a s s ur e t h e 
c o nti n ui n g h e alt h of t h e p ati e nt’s e y e s. T h e p ati e nt s h o ul d b e i n str u ct e d 
a s t o a r e c o m m e n d e d f oll o w- u p s c h e d ul e.
W h o S h o ul d K n o w T h at t h e P ati e nt i s W e ari n g C o nt a ct L e n s e s ?
•  P ati e nt s s h o ul d i nf or m all d o ct or s ( H e alt h C ar e Pr of e s si o n al s) a b o ut 
b ei n g a c o nt a ct l e n s w e ar er.
•  P ati e nt s s h o ul d al w a y s i nf or m t h eir e m pl o y er of b ei n g a c o nt a ct l e n s 
w e ar er. S o m e j o b s m a y r e q uir e u s e of e y e pr ot e cti o n e q ui p m e nt or m a y 
r e q uir e t h at t h e p ati e nt n ot w e ar c o nt a ct l e n s e s.
1 0
A D V E R S E R E A C TI O N S
T h e p ati e nt s h o ul d b e i nf or m e d t h at t h e f oll o wi n g pr o bl e m s m a y o c c ur 
w h e n w e ari n g c o nt a ct l e n s e s:
•  T h e e y e m a y b ur n, sti n g, a n d/ or it c h.
•  T h er e m a y b e l e s s c o mf ort t h a n w h e n t h e l e n s w a s ﬁ r st pl a c e d o n t h e 
e y e.
•  T h er e m a y b e a f e eli n g of s o m et hi n g i n t h e e y e (f or ei g n b o d y, s cr at c h e d 
ar e a).
•  T h er e m a y b e t h e p ot e nti al f or s o m e t e m p or ar y i m p air m e nt d u e t o 
p eri p h er al i nﬁ ltr at e s, p eri p h er al c or n e al ul c er s, or c or n e al er o si o n. T h er e 
m a y b e t h e p ot e nti al f or ot h er p h y si ol o gi c al o b s er v ati o n s, s u c h a s l o c al 
or g e n er ali z e d e d e m a, c or n e al n e o v a s c ul ari z ati o n, c or n e al st ai ni n g, 
i nj e cti o n, t ar s al a b n or m aliti e s, iriti s, a n d c o nj u n cti viti s, s o m e of w hi c h ar e 
cli ni c all y a c c e pt a bl e i n l o w a m o u nt s.
•  T h er e m a y b e e x c e s si v e w at eri n g, u n u s u al e y e s e cr eti o n s, or r e d n e s s 
of t h e e y e.
•  P o or vi s u al a c uit y, bl urr e d vi si o n, r ai n b o w s or h al o s ar o u n d o bj e ct s, 
p h ot o p h o bi a, or dr y e y e s m a y al s o o c c ur if t h e l e n s e s ar e w or n 
c o nti n u o u sl y or f or t o o l o n g a ti m e.
T h e p ati e nt s h o ul d b e i n str u ct e d t o c o n d u ct a si m pl e 3- p art s elf- e x a mi n ati o n at 
l e a st o n c e a d a y. T h e y s h o ul d a s k t h e m s el v e s:
•  H o w d o t h e l e n s e s f e el o n m y e y e s ?
•  H o w d o m y e y e s l o o k ?
•  H a v e I n oti c e d a c h a n g e i n m y vi si o n ? 
If t h e p ati e nt r e p ort s a n y pr o bl e m s, h e or s h e s h o ul d b e i n str u ct e d t o 
I M M E DI A T E L Y R E M O V E T H E L E N S. If t h e pr o bl e m or di s c o mf ort st o p s, t h e 
p ati e nt s h o ul d di s c ar d t h e l e n s a n d pl a c e a n e w fr e s h l e n s o n t h e e y e.
If aft er i n s erti n g t h e n e w l e n s, t h e pr o bl e m c o nti n u e s, t h e p ati e nt s h o ul d b e 
dir e ct e d t o I M M E DI A T E L Y R E M O V E T H E L E N S A N D C O N T A C T HI S O R H E R 
E Y E C A R E P R O F E S SI O N A L.
T h e p ati e nt s h o ul d b e a d vi s e d t h at w h e n a n y of t h e a b o v e s y m pt o m s o c c ur, 
a s eri o u s c o n diti o n s u c h a s i nf e cti o n, c or n e al ul c er, n e o v a s c ul ari z ati o n, or iriti s 
m a y b e pr e s e nt. H e or s h e s h o ul d b e i n str u ct e d t o s e e k i m m e di at e pr of e s si o n al 
i d e ntiﬁ c ati o n of t h e pr o bl e m a n d pr o m pt tr e at m e nt t o a v oi d s eri o u s e y e d a m a g e.
1 1
G E N E R A L FI T TI N G G UI D E LI N E S
A.  P ati e nt  S el e cti o n
P ati e nt s s el e ct e d t o w e ar t h e s e l e n s e s s h o ul d b e c h o s e n b a s e d o n: 
• 
M oti v ati o n t o w e ar l e n s e s 
• 
A bilit y t o f oll o w i n str u cti o n s r e g ar di n g l e n s w e ar
• 
G e n er al h e alt h 
• 
A bilit y t o a d e q u at el y h a n dl e a n d c ar e f or t h e l e n s e s 
• 
A bilit y t o u n d er st a n d t h e ri s k s a n d b e n eﬁ t s of l e n s w e ar
P ati e nt s w h o d o n ot m e et t h e a b o v e crit eri a s h o ul d n ot b e pr o vi d e d wit h c o nt a ct 
l e n s e s. 
B.  Pr e- ﬁ tti n g E x a mi n ati o n
I niti al e v al u ati o n of t h e p ati e nt s h o ul d b e gi n wit h a t h or o u g h c a s e hi st or y 
t o d et er mi n e if t h er e ar e a n y c o ntr ai n di c ati o n s t o c o nt a ct l e n s w e ar. D uri n g 
t h e c a s e hi st or y, t h e p ati e nt’s vi s u al n e e d s a n d e x p e ct ati o n s s h o ul d b e 
d et er mi n e d a s w ell a s a n a s s e s s m e nt of t h eir o v er all o c ul ar, p h y si c al, a n d 
m e nt al h e alt h. 
Pr e c e di n g t h e i niti al s el e cti o n of tri al c o nt a ct l e n s e s, a c o m pr e h e n si v e o c ul ar 
e v al u ati o n s h o ul d b e p erf or m e d t h at i n cl u d e s, b ut i s n ot li mit e d t o, t h e 
m e a s ur e m e nt of di st a n c e a n d n e ar vi s u al a c uit y, di st a n c e a n d n e ar r efr a cti v e 
pr e s cri pti o n (i n cl u di n g d et er mi ni n g t h e pr ef err e d r e a di n g di st a n c e f or 
pr e s b y o p e s), k er at o m etr y, a n d bi o mi cr o s c o pi c e v al u ati o n. 
B a s e d o n t hi s e v al u ati o n, if it i s d et er mi n e d t h at t h e p ati e nt i s eli gi bl e t o w e ar 
t h e s e l e n s e s, t h e E y e C ar e Pr of e s si o n al s h o ul d pr o c e e d t o t h e l e n s ﬁ tti n g 
i n str u cti o n s a s o utli n e d b el o w. 
C.  I niti al P o w er D et er mi n ati o n
A s p e ct a cl e r efr a cti o n s h o ul d b e p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e 
r efr a cti v e st at u s a n d t o g ui d e i n t h e s el e cti o n of t h e a p pr o pri at e l e n s p o w er. 
R e m e m b er t o c o m p e n s at e f or v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er t h a n 
± 4. 0 0 D.
D.  B a s e C ur v e S el e cti o n ( Tri al L e n s Fitti n g)
T h e f oll o wi n g tri al l e n s e s s h o ul d b e s el e ct e d f or p ati e nt s r e g ar dl e s s of 
k er at o m etr y r e a di n g s. H o w e v er, c or n e al c ur v at ur e m e a s ur e m e nt s s h o ul d b e 
p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e o c ul ar st at u s  
1 2
C R- 6 3 8 8, v 3. 0
P a ge 1 2 3 of 1 8 6
J J V C C O N FI D E N TI A L

• 
1- D A Y A C U V U E ®  M OI S T: 8. 5 m m/ 1 4. 2 m m
• 
1- D A Y A C U V U E ®  M OI S T f or A S TI G M A TI S M: 8. 5 m m/ 1 4. 5 m m
• 
1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L: 8. 4 m m/ 1 4. 3 m m
T h e tri al l e n s s h o ul d b e pl a c e d o n e a c h of t h e p ati e nt’s e y e s a n d e v al u at e d 
aft er t h e p ati e nt h a s a dj u st e d t o t h e l e n s e s.
1.  Crit eri a of a Pr o p erl y Fit L e n s
A pr o p erl y ﬁ t l e n s will c e nt er a n d c o m pl et el y c o v er t h e c or n e a (i. e., n o 
li m b al e x p o s ur e), h a v e s ufﬁ ci e nt m o v e m e nt t o pr o vi d e t e ar e x c h a n g e 
u n d er t h e c o nt a ct l e n s wit h t h e bli n k, a n d b e c o mf ort a bl e. T h e l e n s 
s h o ul d m o v e fr e el y w h e n m a ni p ul at e d di git all y wit h t h e l o w er li d, a n d t h e n 
r et ur n t o it s pr o p erl y c e nt er e d p o siti o n w h e n r el e a s e d.
2.  Crit eri a of a Fl at Fitti n g L e n s
A ﬂ at ﬁ tti n g l e n s m a y e x hi bit o n e or m or e of t h e f oll o wi n g c h ar a ct eri sti c s: 
d e c e ntr ati o n, i n c o m pl et e c or n e al c o v er a g e (i. e., li m b al e x p o s ur e), 
e x c e s si v e m o v e m e nt wit h t h e bli n k a n d/ or e d g e st a n d off. If t h e l e n s i s 
j u d g e d t o b e ﬂ at ﬁ tti n g, it s h o ul d n ot b e di s p e n s e d t o t h e p ati e nt.
3.  Crit eri a of a St e e p Fitti n g L e n s
A st e e p ﬁ tti n g l e n s m a y e x hi bit o n e or m or e of t h e f oll o wi n g 
c h ar a ct eri sti c s: i n s ufﬁ ci e nt m o v e m e nt wit h t h e bli n k, c o nj u n cti v al 
i n d e nt ati o n, a n d r e si st a n c e w h e n p u s hi n g t h e l e n s u p di git all y wit h 
t h e l o w er li d. If t h e l e n s i s j u d g e d t o b e st e e p ﬁ tti n g, it s h o ul d n ot b e 
di s p e n s e d t o t h e p ati e nt.
If t h e i niti al tri al b a s e c ur v e i s j u d g e d t o b e ﬂ at or st e e p ﬁ tti n g, t h e alt er n at e 
b a s e c ur v e, if a v ail a bl e, s h o ul d b e tri al ﬁ t a n d e v al u at e d aft er t h e p ati e nt h a s 
a dj u st e d t o t h e l e n s. T h e l e n s s h o ul d m o v e fr e el y w h e n m a ni p ul at e d di git all y 
wit h t h e l o w er li d, a n d t h e n r et ur n t o a pr o p erl y c e nt er e d p o siti o n w h e n 
r el e a s e d. If r e si st a n c e i s e n c o u nt er e d w h e n p u s hi n g t h e l e n s u p, t h e l e n s i s 
ﬁ tti n g ti g htl y a n d s h o ul d n ot b e di s p e n s e d t o t h e p ati e nt.
E.  Fi n al L e n s P o w er ( S p h eri c al)
A s p h eri c al o v er-r efr a cti o n s h o ul d b e p erf or m e d t o d et er mi n e t h e ﬁ n al l e n s 
p o w er aft er t h e l e n s ﬁ t i s j u d g e d a c c e pt a bl e. T h e s p h eri c al o v er-r efr a cti o n 
s h o ul d b e c o m bi n e d wit h t h e tri al l e n s p o w er t o d et er mi n e t h e ﬁ n al l e n s 
pr e s cri pti o n. T h e p ati e nt s h o ul d e x p eri e n c e g o o d vi s u al a c uit y wit h t h e 
c orr e ct l e n s p o w er u nl e s s t h er e i s e x c e s si v e r e si d u al a sti g m ati s m.
1 3
E x a m pl e 1
Dia g n ostic le ns: 
- 2. 0 0 D
S p herical over-refracti o n:  
- 0. 2 5 D
Fi nal le ns p o wer:  
- 2. 2 5 D
E x a m pl e 2
Dia g n ostic le ns: 
- 2. 0 0 D
S p herical over-refracti o n:  
+ 0. 2 5 D
Fi nal le ns p o wer:  
- 1. 7 5 D
If vi si o n i s a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e ﬁ t 
( c e ntr ati o n a n d m o v e m e nt). If t h e ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s a n d 
i n str u ct t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e P A TI E N T 
M A N A G E M E N T  s e cti o n).
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
Alt h o u g h m o st a s p e ct s of t h e ﬁ tti n g pr o c e d ur e ar e i d e nti c al f or all t y p e s of s oft 
c o nt a ct l e n s e s, i n cl u di n g t ori c l e n s e s, t h er e ar e s o m e a d diti o n al st e p s a n d/ or 
r ul e s t o f oll o w t o a s s ur e t h e pr o p er ﬁ t of t ori c l e n s e s. 
T h e o nl y n e w st e p s y o u m u st f oll o w i n pr e s cri bi n g 1- D A Y A C U V U E ®  M OI S T 
f or A S TI G M A TI S M ar e t h at y o u m u st d et er mi n e t h e st a bilit y, r e p e at a bilit y, a n d 
drift a n gl e of t h e l e n s a xi s s o t h at y o u c a n pr e s cri b e t h e c orr e ct l e n s a xi s f or t h e 
p ati e nt. 
A. H o w t o D et er mi n e L e n s C yli n d er a n d A xi s Ori e nt ati o n
1.  L o c at e t h e Ori e nt ati o n M ar k s 
To h el p d et er mi n e t h e pr o p er ori e nt ati o n of t h e t ori c l e n s, y o u’ll ﬁ n d t w o 
pri m ar y m ar k s a p pr o xi m at el y 1 m m fr o m t h e l e n s e d g e r e pr e s e nti n g t h e 
v erti c al p o siti o n o n o p p o sit e e n d s of t h e l e n s at 6 a n d 1 2 o’ cl o c k ( Fi g. 1). 
B e c a u s e of t h e l e n s’ b all a sti n g s y st e m, eit h er m ar k c a n r e pr e s e nt t h e v er-
ti c al p o siti o n – t h er e i s n o “t o p” a n d “ b ott o m” a s i n a pri s m- b all a st e d l e n s. 
Y o u d o n’t n e e d t o vi e w b ot h m ar k s t o a s s e s s ori e nt ati o n; si m pl y l o o k f or t h e 
6 o’ cl o c k m ar k a s y o u w o ul d wit h a pri s m- b all a st e d l e n s.
T O RI C FI T TI N G G UI D E LI N E S
1 4
     Fi g ur e 1
Y o u’ll n e e d a slit l a m p bi o mi cr o s c o p e wit h a 1 t o 2 m m p ar all el e pi p e d 
b e a m t o hi g hli g ht t h e m ar k s w h e n t h e l e n s i s ﬁ tt e d t o t h e e y e. T h er e ar e a 
n u m b er of t e c h ni q u e s y o u c a n u s e t o i m pr o v e t h e vi si bilit y of t h e 6 o’ cl o c k 
m ar k. U si n g a p ar all el e pi p e d b e a m a n d m e di u m m a g niﬁ c ati o n ( 1 0 x or 1 5 x), 
sl o wl y p a n d o w n t h e l e n s, l o o ki n g j u st b el o w t h e dir e ct ill u mi n ati o n at t h e 
r etr oill u mi n at e d ar e a. B a c kli g hti n g t h e m ar k t hi s w a y s h o ul d m a k e it m or e 
vi si bl e. S o m eti m e s m a ni p ul ati n g t h e l o w er li d m a y b e n e c e s s ar y t o u n c o v er 
t h e m ar k.
2.  O b s er v e L e n s R ot ati o n a n d St a bilit y 
O b s er v e t h e p o siti o n a n d st a bilit y of t h e “ b ott o m” m ar k. It u s u all y st a bili z e s 
at t h e 6 o’ cl o c k p o siti o n. If it d o e s, c al c ul ati o n of t h e l e n s p o w er will b e 
str ai g htf or w ar d. T h e 6 o’ cl o c k p o siti o n i s n ot a “ m u st”; h o w e v er, t h e 
a b s ol ut e r e q uir e m e nt i s t h at t h e a xi s p o siti o n b e st a bl e a n d r e p e at a bl e. 
T h e m ar k m a y st a bili z e s o m e w h at l eft or ri g ht ( drift) of t h e v erti c al m eri di a n 
a n d still e n a bl e y o u t o ﬁ t a t ori c l e n s f or t h at e y e, a s l o n g a s t h e l e n s al w a y s 
r et ur n s t o t h e s a m e “ drift a xi s” p o siti o n aft er s ettli n g. T h e d e vi ati o n c a n 
b e c o m p e n s at e d f or i n t h e ﬁ n al pr e s cri pti o n. Y o ur o bj e cti v e i s t o e n s ur e 
t h at w h at e v er p o siti o n t h e i niti al l e n s a s s u m e s n e ar 6 o’ cl o c k, t hi s p o siti o n 
m u st b e st a bl e a n d r e p e at a bl e. Wit h f ull e y e m o v e m e nt or h e a v y bli n k, y o u 
m a y s e e t h e m ar k s s wi n g a w a y, b ut t h e y m u st r et ur n q ui c kl y t o t h e ori gi n al 
st a bl e p o siti o n. If t h e l e n s d o e s n ot r et ur n q ui c kl y, y o u m a y n e e d t o s el e ct 
a diff er e nt l e n s. 
3.  A s s e s si n g R ot ati o n 
I m a gi n e t h e e y e a s a cl o c k di al a n d e v er y h o ur r e pr e s e nt s a 3 0° i nt er v al. If 
t h e ori e nt ati o n m ar k of t h e i niti al l e n s st a bili z e s s o m e w h at l eft or ri g ht of t h e 
v erti c al p o siti o n, t h e ﬁ n al l e n s will ori e nt o n t h e e y e wit h t h e s a m e d e vi ati o n. 
Y o u c a n u s e a n a xi s r eti c ul e i n t h e slit l a m p or u s e a li n e- s cri b e d l e n s i n a 
s p e ct a cl e tri al fr a m e t o m e a s ur e or e sti m at e t h e “ drift a n gl e” of t h e c yli n d er 
a xi s. 
To c o m p e n s at e f or t hi s “ drift,” m e a s ur e or e sti m at e t h e “ drift,” t h e n a d d 
or s u btr a ct it fr o m t h e r efr a cti v e a xi s t o d et er mi n e t h e c orr e ct c yli n d er 
a xi s. U s e t h e L A R S ( L eft A d d, Ri g ht S u btr a ct) m et h o d t o d et er mi n e w hi c h 
dir e cti o n t o c o m p e n s at e.
 
1 5
B. Fi n al L e n s P o w er
W h e n t h e di a g n o sti c l e n s h a s it s a xi s ali g n e d i n t h e s a m e m eri di a n a s t h e 
p ati e nt’s r efr a cti v e a xi s, a s p h er o c yli n dri c al o v er-r efr a cti o n m a y b e p erf or m e d 
a n d vi s u al a c uit y d et er mi n e d. H o w e v er, i n t h e c a s e of cr o s s e d a x e s, s u c h a s 
w h e n t h e di a g n o sti c l e n s a xi s i s diff er e nt fr o m t h e s p e ct a cl e c yli n d er a xi s, it i s 
n ot a d vi s a bl e t o p erf or m a f ull s p h er o c yli n dri c al o v er-r efr a cti o n b e c a u s e of t h e 
difﬁ c ult y i n c o m p uti n g t h e r e s ult a nt p o w er. A s p h eri c al o v er-r efr a cti o n wit h o ut 
c yli n d er r efr a cti o n m a y b e p erf or m e d.
If t h e r e q uir e d c yli n d er c orr e cti o n f all s b et w e e n t w o a v ail a bl e c yli n d er p o w er s, 
it i s r e c o m m e n d e d t o pr e s cri b e t h e l o w er c yli n d er p o w er l e n s. S e e b el o w f or 
i n str u cti o n s o n h o w t o d et er mi n e t h e ﬁ n al l e n s p o w er.
1.  F or t h e S p h er e 
If s p h er e al o n e or c o m bi n e d s p h er e a n d c yli n d er R x > 4. 0 0 D, c o m p e n s at e 
f or v ert e x di st a n c e. If s p h er e al o n e or c o m bi n e d s p h er e a n d c yli n d er 
R x < ± 4. 0 0 D, v ert e x c o m p e n s ati o n i s n ot n e c e s s ar y.
2.  F or t h e C yli n d er
A dj u st t h e a xi s b y t h e drift a n gl e u si n g t h e L A R S m et h o d. C h o o s e a c yli n d er 
t h at i s ≤ 0. 5 0 D fr o m t h e r efr a cti v e c yli n d er.
3.  C a s e E x a m pl e s
E x a m pl e 1
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 2. 5 0 D / - 1. 2 5 D x 1 8 0° 2 0/ 2 0
O. S. - 2. 0 0 D / - 1. 0 0 D x 1 8 0° 2 0/ 2 0
C h o o s e a di a g n o sti c l e n s f or e a c h e y e wit h a xi s 1 8 0°. Pl a c e t h e l e n s o n 
e a c h e y e a n d all o w a mi ni m u m of 3 mi n ut e s f or it t o e q uili br at e, b a s e d o n 
t h e p ati e nt’s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s h a s n ot y et st a bili z e d, 
r e c h e c k u ntil st a bl e.
C h e c k t h e ori e nt ati o n of t h e a xi s m ar k. If t h e b ott o m a xi s m ar k i s i n t h e 6 
o’ cl o c k p o siti o n o n b ot h e y e s, c h o o s e t h e a p pr o pri at e c yli n d er a s li st e d 
pr e vi o u sl y. If t h e l e n s h a s n ot y et st a bili z e d, r e c h e c k u ntil st a bl e.
H er e i s t h e R x pr e s cri b e d:
O. D. - 2. 5 0 D / - 1. 2 5 D x 1 8 0°
O. S. - 2. 0 0 D / - 0. 7 5 D x 1 8 0°
1 6
C R- 6 3 8 8, v 3. 0
P a ge 1 2 4 of 1 8 6
J J V C C O N FI D E N TI A L

E x a m pl e 2
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 3. 0 0 D / - 1. 0 0 D x 9 0° 2 0/ 2 0
O. S. - 4. 7 5 D / - 2. 0 0 D x 9 0° 2 0/ 2 0
C h o o s e di a g n o sti c l e n s e s of - 3. 0 0 D / - 0. 7 5 D x 9 0° f or t h e ri g ht e y e a n d 
- 4. 5 0 D / - 1. 7 5 D x 9 0° f or t h e l eft e y e, t h e n e ar e st l e n s e s a v ail a bl e t o t h e 
s p h eri c al p o w er a n d a xi s n e e d e d. F or t h e l eft e y e, si n c e t h e m a nif e st 
r efr a cti o n c all e d f or - 4. 7 5 D, c o m p e n s ati n g f or v ert e x di st a n c e t h e s p h er e 
i s r e d u c e d b y 0. 2 5 D t o - 4. 5 0 D. T h e c yli n d er p o w er will b e - 1. 7 5 D. Pl a c e 
t h e l e n s o n e a c h e y e a n d all o w a mi ni m u m of 3 mi n ut e s f or it t o e q uili br at e, 
b a s e d o n t h e p ati e nt' s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s h a s n ot y et 
st a bili z e d, r e c h e c k u ntil st a bl e.
Ri g ht E y e
T h e ori e nt ati o n m ar k o n t h e ri g ht l e n s r ot at e s l eft fr o m t h e 6 o’ cl o c k p o siti o n 
b y 1 0° a n d r e m ai n s st a bl e i n t hi s p o siti o n. C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d b e d o n e a s f oll o w s:
C o m p e n s at e t h e 1 0° a xi s drift b y a d di n g it t o t h e m a nif e st r efr a cti o n a xi s.
H er e i s t h e R x pr e s cri b e d:
O. D. - 3. 0 0 D / - 0. 7 5 D x 1 0 0°
L eft E y e
T h e ori e nt ati o n m ar k o n t h e l eft l e n s r ot at e s ri g ht fr o m t h e 6 o’ cl o c k p o siti o n 
b y 1 0° a n d r e m ai n s st a bl e i n t hi s p o siti o n. C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d b e d o n e a s f oll o w s:
C o m p e n s at e f or t h e 1 0° a xi s drift b y s u btr a cti n g it fr o m t h e m a nif e st 
r efr a cti o n a xi s. 
H er e i s t h e R x pr e s cri b e d:
O. S. - 4. 5 0 D / - 1. 7 5 D x 8 0° 
If vi si o n i s a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e 
ﬁ t ( c e ntr ati o n a n d m o v e m e nt). If ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s 
i n str u cti n g t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T M A N A G E M E N T  s e cti o n).
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
1 7
A.  Pr e s b y o pi c N e e d s A s s e s s m e nt & P ati e nt E d u c ati o n
M ultif o c al c o nt a ct l e n s e s m a y pr o d u c e c o m pr o mi s e t o vi si o n u n d er c ert ai n 
cir c u m st a n c e s a n d t h e p ati e nt s h o ul d u n d er st a n d t h at t h e y mi g ht n ot ﬁ n d 
t h eir vi si o n a c c e pt a bl e i n s p e ciﬁ c sit u ati o n s (i. e., r e a di n g a m e n u i n a di m 
r e st a ur a nt, dri vi n g at ni g ht i n r ai n y/f o g g y c o n diti o n s, et c.). T h er ef or e, c a uti o n 
s h o ul d b e e x er ci s e d w h e n t h e p ati e nt i s w e ari n g t h e c orr e cti o n f or t h e ﬁ r st 
ti m e u ntil t h e y ar e f a mili ar wit h t h e vi si o n pr o vi d e d i n vi s u all y c h all e n gi n g 
e n vir o n m e nt s. O c c u p ati o n al a n d e n vir o n m e nt al vi s u al d e m a n d s s h o ul d 
b e c o n si d er e d. If t h e p ati e nt r e q uir e s criti c al vi s u al a c uit y a n d st er e o p si s, it 
s h o ul d b e d et er mi n e d b y tri al w h et h er t hi s p ati e nt c a n f u n cti o n a d e q u at el y 
wit h 1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L. W e ari n g t h e s e l e n s e s m a y n ot 
b e o pti m al f or a cti viti e s s u c h a s:
• 
Vi s u all y d e m a n di n g sit u ati o n s s u c h a s o p er ati n g p ot e nti all y d a n g er o u s 
m a c hi n er y or p erf or mi n g ot h er p ot e nti all y h a z ar d o u s a cti viti e s; a n d
• 
Dri vi n g a ut o m o bil e s ( e. g., dri vi n g at ni g ht). P ati e nt s w h o c a n n ot m e et 
t h eir st at e dri v er’s li c e n s e r e q uir e m e nt s wit h t h e 1- D A Y A C U V U E®  M OI S T 
M U L TI F O C A L s h o ul d b e a d vi s e d t o n ot dri v e wit h t hi s c orr e cti o n, O R m a y 
r e q uir e t h at a d diti o n al o v er- c orr e cti o n b e pr e s cri b e d.
1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L i s n ot r e c o m m e n d e d f or p ati e nt s 
w h o h a v e - 1. 0 0 D or gr e at er of r efr a cti v e c yli n d er a s t hi s l e v el of u n c orr e ct e d 
c yli n d er m a y l e a d t o a d diti o n al vi s u al c o m pr o mi s e. T h e s e l e n s e s ar e a v ail a bl e 
i n t h e f oll o wi n g A D D p o w er s: 
• 
L e n s “ L O W” = l o w n e ar A D D l e n s ( M a x A D D + 1. 2 5) 
• 
L e n s “ MI D” = m e di u m n e ar A D D l e n s ( M a x A D D + 1. 7 5) 
• 
L e n s “ H G H” = hi g h n e ar A D D l e n s ( M a x A D D + 2. 5 0)
B.  I niti al P o w er D et er mi n ati o n
A s p e ct a cl e r efr a cti o n s h o ul d b e p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e 
r efr a cti v e st at u s a n d t o g ui d e i n t h e s el e cti o n of t h e a p pr o pri at e l e n s p o w er. 
R e m e m b er t o c o m p e n s at e f or v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er 
t h a n ± 4. 0 0 D. D et er mi n e t h e s p h eri c al e q ui v al e nt di st a n c e pr e s cri pti o n f or a 
m ultif o c al p ati e nt. D et er mi n e t h e e y e d o mi n a n c e u si n g o n e of t h e m et h o d s 
b el o w:
M U L TI F O C A L FI T TI N G G UI D E LI N E S
1 8
M et h o d 1    D et er mi n e w hi c h e y e i s t h e “ si g hti n g e y e.” H a v e t h e p ati e nt p oi nt 
t o a n o bj e ct at t h e f ar e n d of t h e r o o m. C o v er o n e e y e. If t h e 
p ati e nt i s still p oi nti n g dir e ctl y at t h e o bj e ct, t h e e y e b ei n g u s e d i s 
t h e d o mi n a nt ( si g hti n g) e y e.
M et h o d 2    D et er mi n e w hi c h e y e d o e s n ot a c c e pt a d d e d pl u s p o w er. Pl a c e a 
+ 1. 0 0 D h a n d- h el d tri al l e n s i n fr o nt of o n e e y e a n d t h e n t h e ot h er 
w hil e t h e di st a n c e r efr a cti v e err or c orr e cti o n i s i n pl a c e f or b ot h 
e y e s w hil e t h e p ati e nt i s vi e wi n g t h e di st a n c e vi s u al a c uit y c h art. 
T h e e y e wit h t h e pl u s o v er it t h at t h e p ati e nt n oti c e s t h e gr e at e st 
r e d u cti o n i n vi si o n i s d et er mi n e d t o b e t h e d o mi n a nt e y e.
C. S el e ct t h e I niti al Tri al L e n s 
1.  F or e a c h e y e, s el e ct t h e tri al l e n s di st a n c e p o w er t h at i s cl o s e st t o t h e 
p ati e nt’s di st a n c e s p h eri c al e q ui v al e nt. R e m e m b er t o c o m p e n s at e f or 
v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er t h a n ± 4. 0 0 D.
2.  S el e ct t h e n e ar p o w er of t h e l e n s b a s e d o n t h e p ati e nt s A D D r a n g e a s 
f oll o w s: 
• 
A D D: + 0. 7 5 D t o + 1. 2 5 D u s e a l o w n e ar A D D ( L O W) l e n s o n e a c h e y e 
• 
A D D: + 1. 5 0 D t o + 1. 7 5 D u s e a m e di u m n e ar A D D ( MI D) l e n s o n e a c h 
e y e 
• 
A D D: + 2. 0 0 D t o + 2. 5 0 D u s e a m e di u m n e ar A D D ( MI D) o n t h e 
d o mi n a nt e y e a n d a hi g h n e ar A D D ( H G H) l e n s o n t h e n o n- d o mi n a nt 
e y e
3.  All o w t h e l e n s e s t o s ettl e f or a mi ni m u m of 1 0 mi n ut e s. 
4.  A s s e s s di st a n c e a n d n e ar vi si o n bi n o c ul arl y a n d m o n o c ul arl y. 
5.  D e m o n str at e t h e vi si o n u n d er v ari o u s li g hti n g c o n diti o n s ( n or m al a n d 
d e cr e a s e d ill u mi n ati o n) a n d at di st a n c e, i nt er m e di at e, a n d n e ar. 
6.  M a k e a dj u st m e nt s i n p o w er a s n e c e s s ar y b a s e d o n t h e di st a n c e o v er-
r efr a cti o n. T h e u s e of h a n d- h el d tri al l e n s e s i s r e c o m m e n d e d. C h e c k t h e 
i m p a ct o n di st a n c e a n d n e ar vi si o n.
7. If vi si o n i s still u n a c c e pt a bl e, m a k e a dj u st m e nt s i n p o w er a s n e c e s s ar y 
( s e e " M ultif o c al Tr o u bl e s h o oti n g" b el o w). If di st a n c e a n d n e ar vi si o n 
ar e a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e 
ﬁ t ( c e ntr ati o n a n d m o v e m e nt). If ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s 
i n str u cti n g t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T M A N A G E M E N T  s e cti o n).
1 9
D. M ultif o c al Tr o u bl e s h o oti n g
U n a c c e pt a bl e N e ar Vi si o n
If it h a s b e e n d et er mi n e d t h at n o c h a n g e i s r e q uir e d b a s e d o n t h e o v er-
r efr a cti o n, t h e n a d d + 0. 2 5 D t o t h e s p h eri c al p o w er of t h e n o n- d o mi n a nt e y e.
U n a c c e pt a bl e Di st a n c e Vi si o n
If it h a s b e e n d et er mi n e d t h at n o c h a n g e i s r e q uir e d b a s e d o n t h e o v er-
r efr a cti o n, t h e n m a k e t h e c h a n g e s a s li st e d b el o w:
• 
If t h e p ati e nt i s w e ari n g t w o " L O W" A D D l e n s e s, c h a n g e t h e d o mi n a nt 
e y e t o a 1- D A Y A C U V U E ®  M OI S T s p h er e l e n s wit h a p o w er e q u al t o t h e 
s p h eri c al e q ui v al e nt di st a n c e pr e s cri pti o n.
• 
If t h e p ati e nt i s w e ari n g t w o " MI D" A D D l e n s e s, c h a n g e t h e A D D p o w er i n 
t h e d o mi n a nt e y e t o t h e " L O W" A D D p o w er.
• 
If t h e p ati e nt i s w e ari n g a " MI D" A D D l e n s i n t h e d o mi n a nt e y e a n d a 
" H G H" A D D l e n s i n t h e n o n- d o mi n a nt e y e, c h a n g e t h e n o n- d o mi n a nt e y e 
t o a " MI D" A D D l e n s a n d a d d + 0. 2 5 D t o t h e di st a n c e p o w er.
E. A d a pt ati o n
Vi s u all y d e m a n di n g sit u ati o n s s h o ul d b e a v oi d e d d uri n g t h e i niti al w e ari n g 
p eri o d. A p ati e nt m a y at ﬁ r st e x p eri e n c e s o m e mil d bl urr e d vi si o n, di z zi n e s s, 
h e a d a c h e s a n d a f e eli n g of sli g ht i m b al a n c e. Y o u s h o ul d e x pl ai n t h e 
a d a pt ati o n al s y m pt o m s t o t h e p ati e nt. T h e s e s y m pt o m s m a y l a st f or a bri ef 
mi n ut e or f or s e v er al w e e k s. T h e l o n g er t h e s e s y m pt o m s p er si st, t h e p o or er 
t h e pr o g n o si s f or s u c c e s sf ul a d a pt ati o n.
To h el p i n t h e a d a pt ati o n pr o c e s s, t h e p ati e nt c a n b e a d vi s e d t o ﬁ r st u s e t h e 
l e n s e s i n a c o mf ort a bl e, f a mili ar e n vir o n m e nt s u c h a s i n t h e h o m e.
S o m e p ati e nt s f e el t h at a ut o m o bil e dri vi n g p erf or m a n c e m a y n ot b e o pti m al 
d uri n g t h e a d a pt ati o n pr o c e s s. T hi s i s p arti c ul arl y tr u e w h e n dri vi n g at ni g ht. 
B ef or e dri vi n g a m ot or v e hi cl e, it m a y b e r e c o m m e n d e d t h at t h e p ati e nt b e 
a p a s s e n g er ﬁ r st t o m a k e s ur e t h at t h eir vi si o n i s s ati sf a ct or y f or o p er ati n g 
a n a ut o m o bil e. D uri n g t h e ﬁ r st s e v er al w e e k s of w e ar ( w h e n a d a pt ati o n i s 
o c c urri n g), it m a y b e a d vi s a bl e f or t h e p ati e nt t o o nl y dri v e d uri n g o pti m al 
dri vi n g c o n diti o n s. Aft er a d a pt ati o n a n d s u c c e s s wit h t h e s e a cti viti e s, t h e 
p ati e nt s h o ul d b e a bl e t o dri v e u n d er ot h er c o n diti o n s wit h c a uti o n.
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
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J J V C C O N FI D E N TI A L

A. P ati e nt S el e cti o n
1. M o n o vi si o n N e e d s A s s e s s m e nt
F or a g o o d pr o g n o si s, t h e p ati e nt s h o ul d h a v e a d e q u at el y c orr e ct e d 
di st a n c e a n d n e ar vi s u al a c uit y i n e a c h e y e. T h e a m bl y o pi c p ati e nt or t h e 
p ati e nt wit h si g niﬁ c a nt a sti g m ati s m ( gr e at er t h a n 1. 0 0 D) i n o n e e y e m a y n ot 
b e a g o o d c a n di d at e f or m o n o vi si o n c orr e cti o n wit h t h e s e l e n s e s.
O c c u p ati o n al a n d e n vir o n m e nt al vi s u al d e m a n d s s h o ul d b e c o n si d er e d. 
If t h e p ati e nt r e q uir e s criti c al vi si o n ( vi s u al a c uit y a n d st er e o p si s), it s h o ul d 
b e d et er mi n e d b y tri al w h et h er t hi s p ati e nt c a n f u n cti o n a d e q u at el y wit h 
m o n o vi si o n c orr e cti o n. M o n o vi si o n c o nt a ct l e n s w e ar m a y n ot b e o pti m al 
f or a cti viti e s s u c h a s:
• 
Vi s u all y d e m a n di n g sit u ati o n s s u c h a s o p er ati n g p ot e nti all y d a n g er o u s 
m a c hi n er y or p erf or mi n g ot h er p ot e nti all y h a z ar d o u s a cti viti e s; a n d
• 
Dri vi n g a ut o m o bil e s ( e. g., dri vi n g at ni g ht). P ati e nt s w h o c a n n ot m e et 
t h eir st at e dri v er’s li c e n s e r e q uir e m e nt s wit h m o n o vi si o n c orr e cti o n 
s h o ul d b e a d vi s e d t o n ot dri v e wit h t hi s c orr e cti o n, O R m a y r e q uir e t h at 
a d diti o n al o v er- c orr e cti o n b e pr e s cri b e d.
2. P ati e nt E d u c ati o n
All p ati e nt s d o n ot f u n cti o n e q u all y w ell wit h m o n o vi si o n c orr e cti o n. P ati e nt s 
m a y n ot p erf or m a s w ell f or c ert ai n t a s k s wit h t hi s c orr e cti o n a s t h e y h a v e 
wit h s p e ct a cl e s ( m ultif o c al, bif o c al, trif o c al, r e a d er s, pr o gr e s si v e s). E a c h 
p ati e nt s h o ul d u n d er st a n d t h at m o n o vi si o n, a s w ell a s ot h er pr e s b y o pi c 
alt er n ati v e s, c a n cr e at e a vi si o n c o m pr o mi s e t h at m a y r e d u c e vi s u al a c uit y 
a n d d e pt h p er c e pti o n f or di st a n c e a n d n e ar t a s k s. T h er ef or e, c a uti o n 
s h o ul d b e e x er ci s e d w h e n t h e p ati e nt i s w e ari n g t h e c orr e cti o n f or t h e ﬁ r st 
ti m e u ntil t h e y ar e f a mili ar wit h t h e vi si o n pr o vi d e d i n vi s u all y c h all e n gi n g 
e n vir o n m e nt s ( e. g., r e a di n g a m e n u i n a di ml y lit r e st a ur a nt, dri vi n g at ni g ht 
i n r ai n y/f o g g y c o n diti o n s, et c.). D uri n g t h e ﬁ tti n g pr o c e s s, it i s n e c e s s ar y f or 
t h e p ati e nt t o r e ali z e t h e di s a d v a nt a g e s a s w ell a s t h e a d v a nt a g e s of cl e ar 
n e ar vi si o n, a n d str ai g ht a h e a d a n d u p w ar d g a z e t h at m o n o vi si o n c o nt a ct 
l e n s e s pr o vi d e.
M O N O VI SI O N FI T TI N G G UI D E LI N E S
2 1
B. E y e S el e cti o n
1.  O c ul ar Pr ef er e n c e D et er mi n ati o n M et h o d s
G e n er all y, t h e n o n- d o mi n a nt e y e i s c orr e ct e d f or n e ar vi si o n. T h e f oll o wi n g 
t w o m et h o d s f or e y e d o mi n a n c e c a n b e u s e d.
M et h o d 1    D et er mi n e w hi c h e y e i s t h e “ si g hti n g e y e.” H a v e t h e p ati e nt 
p oi nt t o a n o bj e ct at t h e f ar e n d of t h e r o o m. C o v er o n e e y e. 
If t h e p ati e nt i s still p oi nti n g dir e ctl y at t h e o bj e ct, t h e e y e 
b ei n g u s e d i s t h e d o mi n a nt ( si g hti n g) e y e.
M et h o d 2    D et er mi n e w hi c h e y e will a c c e pt t h e a d d e d p o w er wit h t h e 
l e a st r e d u cti o n i n vi si o n. Pl a c e a h a n d- h el d tri al l e n s e q u al t o 
t h e s p e ct a cl e n e ar A D D i n fr o nt of o n e e y e a n d t h e n t h e ot h er 
w hil e t h e di st a n c e r efr a cti v e err or c orr e cti o n i s i n pl a c e f or 
b ot h e y e s. D et er mi n e w h et h er t h e p ati e nt f u n cti o n s b e st wit h 
t h e n e ar A D D l e n s o v er t h e ri g ht or l eft e y e.
2.  Ot h er E y e S el e cti o n M et h o d s
Ot h er m et h o d s i n cl u d e t h e “ R efr a cti v e Err or M et h o d” a n d t h e “ Vi s u al 
D e m a n d s M et h o d.”
R efr a cti v e Err or M et h o d
F or a ni s o m etr o pi c c orr e cti o n, it i s g e n er all y b e st t o ﬁ t t h e m or e h y p er o pi c 
(l e s s m y o pi c) e y e f or di st a n c e a n d t h e m or e m y o pi c (l e s s h y p er o pi c) e y e 
f or n e ar.
Vi s u al D e m a n d s M et h o d
C o n si d er t h e p ati e nt’s o c c u p ati o n d uri n g t h e e y e s el e cti o n pr o c e s s t o 
d et er mi n e t h e criti c al vi si o n r e q uir e m e nt s. If a p ati e nt’s g a z e f or n e ar t a s k s 
i s u s u all y i n o n e dir e cti o n, c orr e ct t h e e y e o n t h at si d e f or n e ar.
E x a m pl e: A s e cr et ar y w h o pl a c e s c o p y t o t h e l eft si d e of t h e d e s k will 
f u n cti o n b e st wit h t h e n e ar l e n s o n t h e l eft e y e.
C.  S p e ci al Fitti n g C h ar a ct eri sti c s
1.  U nil at er al Vi si o n C orr e cti o n
T h er e ar e cir c u m st a n c e s w h er e o nl y o n e c o nt a ct l e n s i s r e q uir e d. A s a n 
e x a m pl e, a n e m m etr o pi c p ati e nt w o ul d o nl y r e q uir e a n e ar l e n s, w h er e a s 
a bil at er al m y o p e w o ul d r e q uir e c orr e cti v e l e n s e s o n b ot h e y e s. 
2 2
E x a m pl e s:
A pr e s b y o pi c e m m etr o pi c p ati e nt w h o r e q uir e s a + 1. 7 5 D A D D w o ul d 
h a v e a + 1. 7 5 D l e n s o n t h e n e ar e y e a n d t h e ot h er e y e l eft wit h o ut 
c orr e cti o n.
A pr e s b y o pi c p ati e nt r e q uiri n g a + 1. 5 0 D A D D w h o i s - 2. 5 0 D m y o pi c i n 
t h e ri g ht e y e a n d - 1. 5 0 D m y o pi c i n t h e l eft e y e m a y h a v e t h e ri g ht e y e 
c orr e ct e d f or di st a n c e a n d t h e l eft e y e u n c orr e ct e d f or n e ar.
2.  N e ar A D D D et er mi n ati o n
Al w a y s pr e s cri b e t h e l e n s p o w er f or t h e n e ar e y e t h at pr o vi d e s o pti m al 
n e ar a c uit y at t h e mi d p oi nt of t h e p ati e nt’s h a bit u al r e a di n g di st a n c e. 
H o w e v er, w h e n m or e t h a n o n e p o w er pr o vi d e s o pti m al r e a di n g 
p erf or m a n c e, pr e s cri b e t h e l e a st pl u s ( m o st mi n u s) of t h e p o w er s.
3.  Tri al L e n s Fitti n g
A tri al ﬁ tti n g i s p erf or m e d i n t h e ofﬁ c e t o all o w t h e p ati e nt t o e x p eri e n c e 
m o n o vi si o n c orr e cti o n. L e n s e s ar e ﬁ t a c c or di n g t o t h e G E N E R A L 
FI T TI N G G UI D E LI N E S f or b a s e c ur v e s el e cti o n d e s cri b e d i n t hi s 
P a c k a g e I n s ert.
C a s e hi st or y a n d a st a n d ar d cli ni c al e v al u ati o n pr o c e d ur e s h o ul d b e u s e d 
t o d et er mi n e t h e pr o g n o si s. D et er mi n e t h e di st a n c e c orr e cti o n a n d t h e 
n e ar c orr e cti o n. N e xt, d et er mi n e t h e n e ar A D D. Wit h tri al l e n s e s of t h e 
pr o p er p o w er i n pl a c e, o b s er v e t h e r e a cti o n t o t hi s m o d e of c orr e cti o n.
All o w t h e l e n s e s t o s ettl e f or a b o ut 2 0 mi n ut e s wit h t h e c orr e ct p o w er 
l e n s e s i n pl a c e. W al k a cr o s s t h e r o o m a n d h a v e t h e p ati e nt l o o k at 
y o u. A s s e s s t h e p ati e nt’s r e a cti o n t o di st a n c e vi si o n u n d er t h e s e 
cir c u m st a n c e s. T h e n h a v e t h e p ati e nt l o o k at f a mili ar n e ar o bj e ct s s u c h 
a s a w at c h f a c e or ﬁ n g er n ail s. A g ai n a s s e s s t h e r e a cti o n. A s t h e p ati e nt 
c o nti n u e s t o l o o k ar o u n d t h e r o o m at b ot h n e ar a n d di st a n c e o bj e ct s, 
o b s er v e t h e r e a cti o n s. O nl y aft er t h e s e vi si o n t e st s ar e c o m pl et e d, s h o ul d 
t h e p ati e nt b e a s k e d t o r e a d pri nt. E v al u at e t h e p ati e nt’s r e a cti o n t o l ar g e 
pri nt ( e. g., t y p e writt e n c o p y) at ﬁ r st a n d t h e n gr a d u at e t o n e w s pri nt a n d 
ﬁ n all y s m all er t y p e si z e s.
Aft er t h e p ati e nt’s p erf or m a n c e u n d er t h e a b o v e c o n diti o n s i s c o m pl et e d, 
t e st s of vi s u al a c uit y a n d r e a di n g a bilit y u n d er c o n diti o n s of m o d er at el y 
di m ill u mi n ati o n s h o ul d b e att e m pt e d.
2 3
A n i niti al u nf a v or a bl e r e s p o n s e i n t h e ofﬁ c e, w hil e i n di c ati v e of a g u ar d e d 
pr o g n o si s, s h o ul d n ot i m m e di at el y r ul e o ut a m or e e xt e n si v e tri al u n d er 
t h e u s u al c o n diti o n s i n w hi c h a p ati e nt f u n cti o n s.
4.  A d a pt ati o n
Vi s u all y d e m a n di n g sit u ati o n s s h o ul d b e a v oi d e d d uri n g t h e i niti al w e ari n g 
p eri o d. A p ati e nt m a y at ﬁ r st e x p eri e n c e s o m e mil d bl urr e d vi si o n, 
di z zi n e s s, h e a d a c h e s, a n d a f e eli n g of sli g ht i m b al a n c e. Y o u s h o ul d 
e x pl ai n t h e a d a pt ati o n al s y m pt o m s t o t h e p ati e nt. T h e s e s y m pt o m s m a y 
l a st f or a bri ef mi n ut e or f or s e v er al w e e k s. T h e l o n g er t h e s e s y m pt o m s 
p er si st, t h e p o or er t h e pr o g n o si s f or s u c c e s sf ul a d a pt ati o n. 
To h el p i n t h e a d a pt ati o n pr o c e s s, t h e p ati e nt c a n b e a d vi s e d t o ﬁ r st u s e 
t h e l e n s e s i n a c o mf ort a bl e, f a mili ar e n vir o n m e nt s u c h a s i n t h e h o m e.
S o m e p ati e nt s f e el t h at a ut o m o bil e dri vi n g p erf or m a n c e m a y n ot b e 
o pti m al d uri n g t h e a d a pt ati o n pr o c e s s. T hi s i s p arti c ul arl y tr u e w h e n 
dri vi n g at ni g ht. B ef or e dri vi n g a m ot or v e hi cl e, it m a y b e r e c o m m e n d e d 
t h at t h e p ati e nt b e a p a s s e n g er ﬁ r st t o m a k e s ur e t h at t h eir vi si o n i s 
s ati sf a ct or y f or o p er ati n g a n a ut o m o bil e. D uri n g t h e ﬁ r st s e v er al w e e k s of 
w e ar ( w h e n a d a pt ati o n i s o c c urri n g), it m a y b e a d vi s a bl e f or t h e p ati e nt t o 
o nl y dri v e d uri n g o pti m al dri vi n g c o n diti o n s. Aft er a d a pt ati o n a n d s u c c e s s 
wit h t h e s e a cti viti e s, t h e p ati e nt s h o ul d b e a bl e t o dri v e u n d er ot h er 
c o n diti o n s wit h c a uti o n.
D. Ot h er S u g g e sti o n s
T h e s u c c e s s of t h e m o n o vi si o n t e c h ni q u e m a y b e f urt h er i m pr o v e d b y h a vi n g 
y o ur p ati e nt f oll o w t h e s u g g e sti o n s b el o w:
• 
H a v e a t hir d c o nt a ct l e n s ( di st a n c e p o w er) t o u s e w h e n criti c al 
di st a n c e vi e wi n g i s n e e d e d.
• 
H a v e a t hir d c o nt a ct l e n s ( n e ar p o w er) t o u s e w h e n criti c al n e ar 
vi e wi n g i s n e e d e d.
• 
H a v e s u p pl e m e nt al s p e ct a cl e s t o w e ar o v er t h e m o n o vi si o n 
c o nt a ct l e n s e s f or s p e ciﬁ c vi s u al t a s k s m a y i m pr o v e t h e s u c c e s s of 
m o n o vi si o n c orr e cti o n. T hi s i s p arti c ul arl y a p pli c a bl e f or t h o s e p ati e nt s 
w h o c a n n ot m e et st at e dri v er’s li c e n si n g r e q uir e m e nt s wit h m o n o vi si o n 
c orr e cti o n.
• 
M a k e u s e of pr o p er ill u mi n ati o n w h e n c arr yi n g o ut vi s u al t a s k s.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Johnson and Johnson ACUVUE OASYS®1-Day with HydraLuxe™ Technology 
(senofilcon A)
CR-6388, v3.0
Page 128 of 186
JJVC CONFIDENTIAL

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.
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).
• 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 
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 
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.
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 
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. 
• 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 is excessive residual astigmatism.
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.
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°
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.
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.
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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JJVC CONFIDENTIAL

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 
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.
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. 
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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APPENDIX D: 
 
 
 LENS FITTING CHARACTERISTICS
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
 BIOMICROSCOPY SCALE
 KERATOMETRY PROCEDURE
DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION
 PATIENT REPORTED OUTCOMES
 LENS INSERTION AND REMOVAL 
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 LENS FITTING CHARACTERISTICS 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
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Document Type:  
Work Instructions
Document Number:  
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Page 2 of 5
           
       
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Document Type:  
Work Instructions
Document Number:  
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Document Type:  
Work Instructions
Document Number:  
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
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Title:                         Subject Reported Ocular Symptoms/Problems
Document Type:  
Work Instructions
Document Number:  
Revision Number:  3
Page 1 of 1
  
  
            
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 1 of 5
  
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 2 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 3 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 4 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 5 of 5
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BIOMICROSCOPY SCALE 
 
 
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
  
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Johnson & Johnson Vision Care, Inc.
 KERATOMETRY PROCEDURE 
 
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 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
 
 
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 1 of 4
  
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 2 of 4
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 3 of 4
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 4 of 4
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PATIENT REPORTED OUTCOMES 
 
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Title:
Patient Reported Outcomes
Document Type:
Procedure
Document Number:
Revision Number: 
2
Page 1 of 1
                      
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 LENS INSERTION AND REMOVAL 
 
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Title:   
Lens Insertion and Removal
Document Type:
Work Instructions
Document Number:
Revision Number:  2
Page 1 of 2
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APPENDIX E: 
GUIDELINES FOR COVID-19 RISK MITIGATION 
 
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
Revision Number: 5
 
1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Document Type:
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures.
x
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
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Document Type:
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Revision Number: 5
 
STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
4.1.3
Protocol Compliance Investigator(s) Signature Page:
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.
 
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable.  
Study site training will be documented utilizing Site Initiation Report
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.).
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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Document Type:
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6.1.3
Study Site Closure:  
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).  
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Title:
Guidelines for COVID-19 Risk Mitigation
Document Type:
Work Instruction
Document Number:
Revision Number: 5
 
Attachment A: Study Site Correspondence
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principal Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.   
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
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Title:
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Document Type:
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Document Number:
Revision Number: 5
 
RESOURCE LINKS
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist   
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf
OUS Resource Links 
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings html
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x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health:
https://www health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
 
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
 
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Johnson & Johnson Vision Care, Inc.
APPENDIX F: PRE-SCREENING TELEPHONE SCRIPT WITH QUESTIONS 
 
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Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6388 Evaluation of Dryness in a Silicone Hydrogel Daily Disposable 
Contact Lens
Version and Date: 3.0 07 April 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 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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