Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced with 
Different Manufacturing Processes
Protocol CR-6418
Version: 2.0
Date: 10 February 2021
Investigational Products: JJVC Investigational Multifocal-PG Contact Lenses manufactured 
in senofilcon A C3 
Control: Dailies Total 1® Multifocal Contact Lenses manufactured in delefilcon A material
Keywords: Multifocal, Senofilcon A C3, Delefilcon A, Manufacturing, Presbyopia, Daily 
Wear, Daily Disposable, Dispensing, Randomized
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................................................................................................................ 9 
SYNOPSIS.............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 16 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 18 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 18 
2.1. 
Objectives................................................................................................................. 18 
2.2. 
Endpoints.................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 19 
3. 
TARGETED STUDY POPULATION........................................................................... 20 
3.1. 
General Characteristics ............................................................................................ 20 
3.2. 
Inclusion Criteria...................................................................................................... 20 
3.3. 
Exclusion Criteria..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 21 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 22 
4.1. 
Description of Study Design .................................................................................... 22 
4.2. 
Study Design Rationale............................................................................................ 22 
4.3. 
Enrollment Target and Study Duration.................................................................... 22 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 22 
5.1. 
Test Article Allocation............................................................................................. 22 
5.2. 
Masking.................................................................................................................... 23 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 23 
6. 
STUDY INTERVENTION............................................................................................. 24 
6.1. 
Identity of Test Articles............................................................................................ 24 
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6.2. 
Ancillary Supplies/Products..................................................................................... 24 
6.3. 
Administration of Test Articles................................................................................ 25 
6.4. 
Packaging and Labeling ........................................................................................... 25 
6.5. 
Storage Conditions................................................................................................... 25 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 26 
7. 
STUDY EVALUATIONS.............................................................................................. 27 
7.1. 
Time and Event Schedule......................................................................................... 27 
7.2. 
Detailed Study Procedures ....................................................................................... 30 
VISIT 1 ........................................................................................................................... 30 
VISIT 2........................................................................................................................... 35 
VISIT 3........................................................................................................................... 39 
VISIT 4........................................................................................................................... 45 
VISIT 5........................................................................................................................... 49 
VISIT 6........................................................................................................................... 55 
FINAL EVALUATION.................................................................................................. 57 
7.3. 
Unscheduled Visits................................................................................................... 58 
7.4. 
Laboratory Procedures ............................................................................................. 59 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 59 
8.1. 
Completion Criteria.................................................................................................. 59 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 60 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 60 
9.1. 
Systemic Medications .............................................................................................. 61 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 61 
11. 
STUDY TERMINATION ........................................................................................... 62 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 63 
13. 
ADVERSE EVENTS................................................................................................... 64 
13.1. 
Definitions and Classifications............................................................................. 64 
13.2. 
Assessing Adverse Events.................................................................................... 66 
13.2.1. 
Causality Assessment.................................................................................... 67 
13.2.2. 
Severity Assessment...................................................................................... 67 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 67 
13.4. 
Reporting Adverse Events.................................................................................... 69 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 69 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
70 
13.5. 
Event of Special Interest....................................................................................... 70 
13.6. 
Reporting of Pregnancy........................................................................................ 70 
14. 
STATISTICAL METHODS........................................................................................ 70 
14.1. 
General Considerations......................................................................................... 70 
14.2. 
Sample Size Justification...................................................................................... 71 
14.3. 
Analysis Populations ............................................................................................ 71 
14.4. 
Level of Statistical Significance........................................................................... 72 
14.5. 
Primary Analysis .................................................................................................. 72 
14.6. 
Secondary Analysis .............................................................................................. 73 
14.7. 
Other Exploratory Analysis.................................................................................. 74 
14.8. 
Interim Analysis ................................................................................................... 74 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 74 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 74 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING................................ 74 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 74 
15.2. 
Subject Record...................................................................................................... 75 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 75 
16. 
DATA MANAGEMENT............................................................................................. 76 
16.1. 
Access to Source Data/Document ........................................................................ 76 
16.2. 
Confidentiality of Information.............................................................................. 76 
16.3. 
Data Quality Assurance........................................................................................ 76 
16.4. 
Data Monitoring Committee (DMC).................................................................... 76 
17. 
CLINICAL MONITORING........................................................................................ 77 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 77 
18.1. 
Study-Specific Design Considerations ................................................................. 77 
18.2. 
Investigator Responsibility................................................................................... 78 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 78 
18.4. 
Informed Consent ................................................................................................. 79 
18.5. 
Privacy of Personal Data ...................................................................................... 80 
19. 
STUDY RECORD RETENTION................................................................................ 81 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 81 
21. 
PUBLICATION........................................................................................................... 82 
22. 
REFERENCES ............................................................................................................ 82 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
................................................................................................................................................. 83 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ................................. 111 
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE............................... 115 
APPENDIX F: OCULAR DOMINANCE ........................................................................ 116 
APPENDIX G: LENS FITTING GUIDE......................................................................... 117 
APPENDIX H: CONTROL LENS FITTING GUIDE.................................................... 119 
APPENDIX I:  C-QUANT STRAYLIGHT MEASUREMENT..................................... 152 
APPENDIX J:  VISIONIX CORNEAL TOPOGRAPHY AND WAVEFRONT ......... 159 
APPENDIX K: 
.............................. 168 
, LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS.............................. 169 
, EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING............ 176 
, DETERMINATION OF NEAR ADDITION................................................ 183 
, NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 189 
, LENS FITTING CHARACTERISTICS....................................................... 192 
, SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS................ 198 
, 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR..................................................................................................... 200 
, BIOMICROSCOPY SCALE.......................................................................... 206 
, DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 212 
, 
DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE ..................................................................................................................... 217 
, PATIENT REPORTED OUTCOMES.......................................................... 221 
, VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING............................................................................................................................. 223 
APPENDIX L: VWI-0081, GUIDELINES FOR COVID-19 RISK MITIGATION .... 232 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 243 
 
LIST OF TABLES
Table 1: Test Articles.............................................................................................................. 24 
Table 2: Ancillary Supplies .................................................................................................... 25 
Table 3: Time and Events ....................................................................................................... 27 
Table 4: Disallowed systemic medications............................................................................. 61 
Table 5: Examples of major and minor protocol deviations................................................... 62 
Table 6: 
 Binocular High Luminance High Contrast Visual Performance – 1-Week 
Follow-up................................................................................................................................ 71 
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LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 15 
PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced with 
Different Manufacturing Processes
Protocol Number: CR-6418
Version: 2.0
Date: 10 February 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
See Electronic Signature Report
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
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Medical Safety 
Officer
See Electronic Signature Report
Reviewer
See Electronic Signature Report
DATE
See Electronic Signature Report
DATE
Reviewer
DATE
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CHANGE HISTORY 
Version
Originator
Description of Change(s) and Section 
Number(s) Affected
Date
1.0
Original Protocol
21 Jan 2021
2.0
Section 7.1-removed corneal 
topography and wavefront procedure 
in time and events.
Section 3.1-corrected typo referring 
to myopes in population description.
Appendix A-added preference 
questionnaires at visit 5. 
10 Feb 2021
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SYNOPSIS  
Protocol Title
Evaluation of Investigational Daily Disposable Multifocal 
Contact Lenses Produced with Different Manufacturing 
Processes
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Phase 2
Trial Registration
This study will be registered on ClinicalTrials.gov.
Test Article(s)
Investigational Product:  JJVC Investigational Multifocal-PG
Contact Lenses manufactured in senofilcon A C3
Control: Dailies Total 1® Multifocal Contact Lenses 
manufactured in delefilcon A material
Wear and Replacement 
Schedules
Wear Schedule: The test lenses will be used on a daily 
disposable basis.  
Replacement Schedule: The lenses will be replaced after a day 
of wear.
Objectives 
The objective of this study is to evaluate the visual 
performance (logMAR) and subjective vision responses of the 
JJVC 
Investigational 
Multifocal-PG
Contact 
Lenses 
manufactured in senofilcon A C3 and compare the results to 
Dailies Total 1® Multifocal Contact Lenses manufactured in 
delefilcon A material.
Study Endpoints
Primary endpoint: logMAR visual acuity scores
Secondary endpoint: CLUE vision scores
Study Design
This is a single-masked, 2×3 crossover, randomized-
controlled, dispensing clinical trial.  A total of approximately 
70 hyperopic eligible subjects will be targeted to complete the 
study.  The subjects will be randomized and fit (Visit 1) in a 
study lens and wear the lens for 3±1 day then undergo 
optimization (Visit 2) and wear the optimized pair for 
approximately 1 week (7±1 day). At the follow-up visit (Visit 
3) the endpoints will be measured and subjects will be fit in 
the 2nd study lens. The visits will be repeated wearing the 2nd
study lens (Visit 3 Fit/Visit 4 Optimization/Visit 5 Follow up). 
At Visit 5 the subjects will be fit in a new pair of lenses that 
match the same type and power they were dispensed at Visit 4, 
and wear the lenses for 1 week (7±1 day). At the follow-up 
visit (Visit 6) the endpoints will be measured and the subject 
will be exited from the study
The primary endpoint will be logMAR visual acuity scores 
and the secondary endpoint will be CLUE vision scores.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
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Sample Size
A total of approximately 80 eligible subjects will be enrolled 
with 70 subjects targeted to complete.
Study Duration
The study will last approximately 2 to 4 months.
Anticipated Study 
Population
Healthy male and female volunteers with presbyopia will be 
screened as per criteria outlined below.  All volunteers will 
have baseline measurements taken to ensure eligibility.  The 
baseline procedures will occur after informed consent has 
been obtained.  Subjects will have medical and contact lens 
history recorded, baseline questionnaires completed, and 
refractive and anterior segment status determined.  For a detail 
flowchart of procedures below.
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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. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol.
3. The subject must be at least 40 years of age and not 
greater than 70 years of age at the time of consent.
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision.
5. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 6 hours per wear day, for 1 
month or more duration).
6. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over 
contact lenses, multifocal or 
monovision contact lenses, etc.) or if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”.
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction 
must be in the range of +1.25 D to +3.75 D in each 
eye.
8. The subject’s refractive cylinder must be ≤0.75 D in 
each eye.
9. The subject’s ADD power must be in the range of 
+0.75 D to +2.50 D.
10. The subject must have distance best corrected visual 
acuity of 20/20-3 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. Currently pregnant or lactating.
2. Any active or ongoing ocular or systemic allergies that 
may interfere with contact lens wear.  
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere 
with contact lens wear. This may include, but not be 
limited to, diabetes, hyperthyroidism, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases 
or any infectious diseases (e.g. hepatitis, tuberculosis).
4. Any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular vision 
abnormality.
6. Use of any of the following medications within 1 week 
prior to enrollment: oral retinoid, oral tetracyclines, 
anticholinergics, oral phenothiazines, oral/inhaled 
corticosteroids.  See Table 9.1 for further examples.
7. Use of any ocular medication, with the exception of 
rewetting drops.
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye.
11. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment.
12. Employee or immediate family member of an 
employee 
of 
clinical 
site 
(e.g., 
Investigator, 
Coordinator, Technician).
13. Any known hypersensitivity or allergic reaction to 
non-preserved rewetting drop solutions or sodium 
fluorescein.
Exclusion Criteria after Baseline:
14. Clinically significant (Grade 3 or greater) corneal 
edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal 
or ocular abnormalities which would contraindicate 
contact lens wear.
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15. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, glaucoma, history of recurrent corneal erosions.
16. Any current ocular infection or inflammation.
17. Any current ocular abnormality that may interfere with 
contact lens wear.
Disallowed 
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear. 
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
logMAR Visual acuity and Subjective responses for vision 
using the CLUE questionnaire. 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any serious adverse event (SAE) where 
relationship to study agent cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Non-Preserved Rewetting drops, lens cases, glass vials, saline, 
ETDRS light cabinet, 4 M logMAR charts, and Near logMAR 
charts.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
70 Subjects to Complete
Potential Subjects Identified Based On:
x
Age: 40-70 yrs. (inclusive)  
x
Habitual contact lens wearers with Presbyopic correction or symptoms
x
Refraction: Spherical Equivalent +1.25D to +3.75D
x
Cylinder: ≤ 0.75D
x
Add: +0.75D to +2.50D
x
Visual Acuity: Best corrected 20/20-3 or better in each eye 
Informed Consent 
Eligibility Criteria
Baseline Information
x
Habitual lens type, modality, and contact lens history. Wear Time
x
Baseline and CLDEQ-8 Questionnaire
x
Subjective refraction, Add Determination, Ocular Dominance, Add Refinement
x
Biomicroscopy
Modifications
(if necessary)
Yes
No
After 10 Minute Settling
x
Exit Visual Acuity
x
Dispensing Criteria, Subject Instructions
x
Schedule Follow-up 3 ± 1 Day
Yes
Visit 1 Treatment 1 / Visit 3 Treatment 2 / Visit 5 Treatment 3 (Optimized 
lens pair and NO Modification)
x
Lens Selection
x
Lens Insertion and Lens Damage
x
Lens Settling, Visual Satisfaction, Visual Acuity, Over-Refraction
x
Lens fit assessment
Visit 2 Treatment 1 Follow-up 1 /Visit 4 Treatment 2 Follow-up 1
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
PRO Questionnaire
x
Visual Satisfaction, Entrance,  Visual Acuity, Over-Refraction
Modifications
(if necessary)
Yes
Yes
After 10 Minute Settling
x
Exit Visual Acuity
x
Dispensing Criteria. Subject Instructions
x
Biomicroscopy
x
Schedule Follow-up 7±1 Day
No
Visit 3 Treatment 1 Follow-up 2 / Visit 5 Treatment 2 Follow-up 2 / 
Visit 6 Treatment 3 Follow-up 1
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
PRO and CLDEQ-8 Questionnaire
x
Visual Satisfaction, Entrance,  Visual Acuity, Binocular Over-Refraction
x
logMAR Visual Performance
x
Biomicroscopy
Final Evaluation
Crossover
The Subject will 
be fit with the 
2nd Test lens at 
Visit 3 and 
repeat the 
Process for Trial 
Fitting 2,           
Visits 3-5
At Visit 5 the 
Subject will be 
fit with the 3rd
optimized study 
lens and wear 
for 7±1 Day.
At Visit 6 the 
endpoints will 
be measured and 
the subject will 
be exited from 
the study
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
Add
Near addition; the additional power required for near vision correction
ADE
Adverse Device Effect
ADHD
Attention Deficit Hyperactivity Disorder
AE
Adverse Event/Adverse Experience
AO1DfA
ACUVUE OASYS® 1-DAY with HydraLuxe™ TECHNOLOGY for 
ASTIGMATISM
AOfA
ACUVUE OASYS® 2-WEEK for ASTIGMATISM
BSCVA
Best Spectacle Corrected Visual Acuity
CFR
Code of Federal Regulations
CLUE
Contact Lens User Experience
COM
Clinical Operations Manager
CRA
Clinical Research Associate
CRF
Case Report Form
CRO
Contract Research Organization
D
Diopter
DMC
Data Monitoring Committee
eCRF
Electronic Case Report Form
EDC
Electronic Data Capture
ESD
Eyelid Stabilized Design
ETDRS
Early Treatment Diabetic Retinopathy Study
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
HIV
Human Immunodeficiency Virus
IB
Investigator’s Brochure
ICH
The International Council for Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LASIK
Laser-Assisted in Situ Keratomileusis
LogMAR
Logarithm of Minimal Angle of Resolution
OD
Right Eye
OS
Left Eye
OU
Both Eyes
PIG
Patient Instruction Guide
PQC
Product Quality Complaint
PRK
Photorefractive Keratectomy
PRO
Patient Reported Outcome
QA
Quality Assurance
SAE
Serious Adverse Event/Serious Adverse Experience
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SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
1.
INTRODUCTION AND BACKGROUND 
The purpose of this study is to evaluate the visual performance and subjective responses of the 
JJVC Investigational Multifocal Contact Lens using a different manufacturing lens hydration 
process. The lenses differ from previous prototypes by using a different lens hydration process 
form previous similar lens prototypes that have been evaluated.  The lens hydration process 
used in this study for the test lenses is used in some marketed lenses that are manufactured by 
Johnson & Johnson Vision Care, Inc
1.1.
Name and Descriptions of Investigational Products  
Investigational Product: JJVC Investigational Multifocal-PG Contact Lenses manufactured 
in senofilcon A C3 
Control: Dailies Total 1® Multifocal Contact Lenses manufactured in delefilcon A material.
1.2.
Intended Use of Investigational Products 
All lenses are intended to correct spherical refractive error and presbyopia.  For this study both 
of the lenses will be worn as a daily disposable lens, with the lenses being discarded after a 
day of wear.  The Lenses will be fit in a randomized fashion.  After fitting, each subject will 
return for an optimization visit and then a follow-up.  The sequence will then be repeated with 
the other study lens type and then the lens type worn at visit 5 will be re-worn for an additional 
6-8 days.  Each subject will wear each study lens type for approximately 16-24 days. In 
addition, approximately half of the subjects will wear the test lens, with the other half wearing 
control lens, for another 6-8 days for a total 22-32 days of lens wear.  
1.3.
Summary of Findings from Nonclinical Studies 
Not Applicable
1.4.
Summary of Known Risks and Benefits to Human Subjects 
Anticipated risks and adverse reactions with this lens are similar to those with other soft daily 
wear contact lenses used to correct presbyopia.  A listing of examples of adverse reactions is 
found in the Section 13 of this protocol. The investigator should follow normal clinical 
guidelines regarding examination and care of subjects who participate in this trial.  Refer to 
study lens package insert for additional details for the control lens and the Investigational 
Brochure (IB) for the Investigational lens.  Both the study multifocal contact lenses are
designed for the correction of refractive spherical refractive error and presbyopia. The 
investigational study contact lens is manufactured in senofilcon A C3 and the control lens is 
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manufactured in delefilcon A.  Both of the lenses will be worn in a daily disposable wear 
modality. These lenses are not intended for extended wear in this study.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
The Test lenses have been previously tested in clinical studies 
  
 was discontinued early by the Sponsor due to the COVID-
19 pandemic.  There were no Adverse Events reported in 
  At the time of writing of 
this protocol studies 
 and 
do not have a final clinical study report.
A
summary of the lens performance in studies 
 and 
 is provided below. 
In 
 30 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.057 and 0.091 at distance and near respectively. 
There was one adverse event reported during the study.  The subject experienced mild upper
respiratory virus and did not receive any treatment for this event.  The event resolved and the 
subject completed the study.  The investigator considered the event to be not related to study
article/procedure.  
In 
41 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.104 and 0.058 at distance and near respectively.
There were no adverse events reported during the study.    
For information about the control product refer to study lens package insert for additional 
details
(APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
and the 
Investigational Brochure (IB) for the Investigational product.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
The objective of this study is to evaluate the visual performance (logMAR) and subjective 
vision responses of the JJVC Investigational Multifocal-PG Contact Lenses manufactured in 
senofilcon A C3 and compare the results to Dailies Total 1® Multifocal Contact Lenses 
manufactured in delefilcon A material.
2.2.
Endpoints  
Primary Endpoint:
Visual Performance (logMAR)
Visual Performance will be assessed binocularly at each 1-week follow-up evaluation under 
high luminance high contrast conditions. At distance (4 meters), VA is assessed using ETDRS 
Charts; while near (40 cm) and intermediate (64 cm) assessments will be made using reduced 
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Guillon-Poling charts. See 
 in Appendix I for details 
regarding the collection of visual acuity (logMAR).
Secondary Endpoint:
Subjective Vision 
Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) 
questionnaire at each 1-Week follow-up evaluation.  CLUE™ is a validated patient-reported 
outcomes questionnaire to assess patient-experience attributes of soft, disposable contact 
lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the 
US, ages 18-65.  Derived CLUE™ scores using Item Response Theory (IRT) follow a normal 
distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response with a range of 0-120.  A 5-point increase in an average CLUE™ 
score translates into 10% shift in the distribution of scores for population of soft contact lens 
wearers.6
Other Endpoints:
x
CLUETM Comfort 
x
CLUETM Handling 
x
Lens Optimization Summary 
x
Mechanical Lens Fit
x
Slit Lamp Findings
2.3.
Hypotheses 
All primary and secondary hypotheses must be met in order to satisfy the objective of this 
study.
Primary Hypotheses
1. After approximately 1 week of wear in the optimized lenses, the distance, binocular, 
high luminance, high contrast visual performance of the Test lens will be non-inferior 
compared to that of the Control lens.  A non-inferiority margin of 0.05 logMAR will 
be used.
2. After approximately 1 week of wear in the optimized lenses, the intermediate, 
binocular, high luminance, high contrast visual performance of the Test lens will be 
non-inferior compared to that of the Control lens.  A non-inferiority margin of 0.05 
logMAR will be used.
3. After approximately 1 week of wear in the optimized lenses, the near, binocular, high 
luminance, high contrast visual performance of the Test lens will be non-inferior 
compared to that of the Control lens. A non-inferiority margin of 0.05 logMAR will 
be used.
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Secondary Hypotheses
1. After approximately 1 week of wear in the optimized lenses, the overall quality of 
vision of the Test lens will be non-inferior compared to that of the Control lens.  A 
non-inferiority margin of -5 CLUE points will be used.
3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
Healthy male and female subjects who are habitual soft contact lens wearers will be recruited.  
Subjects will be at least 40 years of age and not older than 70 years of age.  They will be 
hyperopic and have presbyopia.
3.2.
Inclusion Criteria 
Potential subjects must satisfy all 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. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. The subject must be at least 40 years of age and not greater than 70 years of age at the 
time of consent.
4. Subjects must own a wearable pair of spectacles if required for their distance vision.
5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses 
a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more 
duration).
6. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or, if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire” (Appendix E).
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction must be in the range of +1.25 D 
to +3.75 D in each eye.
8. The subject’s refractive cylinder must be ≤0.75 D in each eye.
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D.
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each 
eye.
3.3.
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
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Exclusion Criteria after Screening:
1. Currently pregnant or lactating.
2. Any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.  
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, 
Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious 
diseases (e.g. hepatitis, tuberculosis).
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular vision abnormality.
6. Use of any of the following medications within 1 week prior to enrollment: oral 
retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled 
corticosteroids.  See Table 9.1 for further examples.
7. Use of any ocular medication, with the exception of rewetting drops.
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye.
11. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment.
12. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician).
13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop 
solutions or sodium fluorescein.
Exclusion Criteria after Baseline:
14. Clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions.
16. Any current ocular infection or inflammation.
17. Any current ocular abnormality that may interfere with contact lens wear.
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.
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4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
This is a 6-visit, subject-masked, multi-site, 2×3 crossover dispensing trial. Approximately 80 
subjects will be enrolled with an aim of approximately 70 subjects to complete the study. 
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
they will be randomized to one of two lens wear sequences (Test/Control/Control or 
Control/Test/Test) in a bilateral fashion. 
If the subject is dispensed study lenses at the initial visit, five additional visits will be 
conducted. The first follow-up visit (Visit 2) will occur 3±1 days after the initial visit. At 
Visit 2, subjects will undergo lens optimization if necessary. Subjects will wear the study 
lenses for 7±1 days and then will return for their second follow-up at Visit 3.  At Visit 3, 
subjects will be dispensed their second study lens per the randomization schedule. Subjects 
will return for their first follow-up visit (Visit 4) 3±1 days after Visit 3, for lens optimization. 
Subjects will return for their second follow-up visit 7±1 days after Visit 4. At Visit 5, subjects 
will be dispensed their 3rd study lens per the randomization schedule and wear the lens for 7±1 
days. The final visit will be the follow-up (Visit 6).
4.2.
Study Design Rationale 
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×3 bilateral crossover design was considered to 
be the optimal design since the study period is relatively short the design can be cost effective 
and more efficient comparisons between treatments can be made than compared to a parallel 
study since fewer subjects are required to achieve the same pre-specified statistical power. 
Each subject will act as their own control to reduce the influence of potential confounding factors 
such as age, gender and vision correction.
4.3.
Enrollment Target and Study Duration 
Approximately 80 eligible subjects will be enrolled with the aim of approximately 70 to 
complete the study. The study will last approximately 2-4 months.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using a 2×3 crossover design. 
A computer-generated randomization scheme will be used to randomly assign subjects, in 
blocks of 4, to one of the two possible lens wear sequences: Test/Control/Control or 
Control/Test/Test. The random scheme will be generated using the PROC PLAN procedure 
from Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, 
NC).9
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 
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subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization:
o
Informed consent has been obtained
o
Subject meets all the inclusion / exclusion criteria
o
Subject history and baseline information has been collected.
5.2.
Masking 
This is a single-masked study with the subjects being masked.  The term partial masking is 
being used as subjects will not be told any information regarding the optical designs of the 
lenses beyond that they are intended to correct for their refractive error and presbyopia, 
however there are slight differences in the tint of the lenses which is impossible to mask from 
the subject.   
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel. 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before 
the mask is broken.
When dispensing test articles, the following steps should be followed to maintain 
randomization codes:
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing.
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme if applicable
Investigator or designee will pull the appropriate test articles from the study supply. All test 
articles that are opened, whether dispensed (placed/fit on eye or dispensed outside the clinical 
site) or not, must be recorded on the Test Article Accountability Log in the “Dispensed” section
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6.
STUDY INTERVENTION 
6.1.
Identity of Test Articles  
The following contact lenses will be used in this study:
Table 1: Test Articles
6.2.
Ancillary Supplies/Products 
The following solutions will be used in this study:
Test
Control
Name
JJVC Investigational
Multifocal Contact Lens 
Process A
Dailies Total 1® Multifocal 
Contact  Lens
Manufacturer
Johnson & Johnson® Vision 
Care, Inc.
Alcon
N/A
Lens Material
senofilcon A (C3)
delefilcon A 
Nominal Base Curve 
8.35 mm
8.5 mm
Nominal Diameter 
14.3 mm
14.1 mm
Nominal Distance 
Powers (D)
+1.00 D to +4.00 D in 0.25 D 
steps
+1.00 D to +4.25 D in 0.25 D 
steps
Nominal ADD Powers 
(D)
LOW, MID, HI
LO, MED, HI
Water Content 
38%
33%
Center Thickness 
@ -3.00 D
0.07 mm
@ -3.00 D
0.09 mm@ -1.00 D
Oxygen Permeability 
(Dk)
103
156
@ -3.00 D
Wear Schedule in 
Current Study 
Daily Wear
Daily Wear 
Replacement 
Frequency
Daily
Daily
Packaging Form (vial, 
blister, etc.)
Blister
Blister
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Table 2: Ancillary Supplies
Single-Use Preservative-Free Rewetting Solutions (any one 
of these three rewetting solutions options may be supplied)
Solution Name/Description
Eye-Cept®
Rewetting Drops
ScleralFil®
Preservative Free 
Saline Solution
LacriPure Saline 
Solution
Manufacturer
Optics Laboratory
B&L
Menicon
Preservative
Non-Preserved
Non-preserved
Non-preserved
6.3.
Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.
6.4.
Packaging and Labeling 
The test articles will be packaged in blisters, as the primary packaging. The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic bags 
as the secondary packaging form. The sample study label is shown below:
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 
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.
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6.7.
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.
2. What was returned to the Investigator unused, including expired or malfunctioning 
product.
3. The number and reason for unplanned replacements.
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study
monitor immediately.
 
 
 
 
 
 
 
 
 
 
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7.
STUDY EVALUATIONS  
7.1.
Time and Event Schedule 
Table 3: Time and Events
Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 
1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2 
Treatment 2
Visit 4
Treatment 
2
Follow-up
1
Optimizati
on
Visit 5
Treatment 
2
Follow-up
2
Treatment 
3
Visit 6
Treatment 
3
Follow-up
1
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 3±1
from V3
Day 7±1
from V4
Day 7±1 
from V5
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.0 hour
2.0 hour
1.5 hour
Statement of 
Informed 
Consent
x
Demographics
x
Medical 
History/Concomit
ant Medications
x
Adverse Events 
and Concomitant 
Medications 
Review
x
X
X
x
x
Compliance
x
X
X
x
x
Habitual Contact 
Lens Information
x
Contact Lens 
History
x
Wear Time and 
Comfortable 
Wear Time with 
Habitual lenses
x
Wear Time and 
Comfortable 
Wear Time with 
Study lenses
x
X
X
x
x
Screening
Inclusion/Exclusi
on Criteria
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 
1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2 
Treatment 2
Visit 4
Treatment 
2
Follow-up
1
Optimizati
on
Visit 5
Treatment 
2
Follow-up
2
Treatment 
3
Visit 6
Treatment 
3
Follow-up
1
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 3±1
from V3
Day 7±1
from V4
Day 7±1 
from V5
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.0 hour
2.0 hour
1.5 hour
Subject Reported 
Ocular 
Symptoms
x
x
X
X
x
x
Baseline PRO 
(CLUE and 
MRD) 
Questionnaire
x
CLDEQ-8
Questionnaire
x
X
x
x
Distance and 
Near Entrance 
Visual Acuity
x
x
X
X
x
x
Lens Removal
x
x
X
X
x
x
Subjective 
Refraction and 
Distance Visual 
Acuity
x
Near ADD
Determination
x
Ocular 
Dominance
x
ADD Refinement
x
Near Visual 
Acuity
x
Biomicroscopy
x
x
X
X
x
x
Baseline 
Inclusion/
Exclusion 
Criteria
x
Continuance
X
x
Lens Selection
x
x (if 
modified)
X
x (if 
modified)
x
Lens Insertion
x
x
X
X
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 
1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2 
Treatment 2
Visit 4
Treatment 
2
Follow-up
1
Optimizati
on
Visit 5
Treatment 
2
Follow-up
2
Treatment 
3
Visit 6
Treatment 
3
Follow-up
1
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 3±1
from V3
Day 7±1
from V4
Day 7±1 
from V5
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.0 hour
2.0 hour
1.5 hour
10-Minute 
Settling
x
x (if 
modified)
x (if 
modified)
x
Visual 
Satisfaction /
Subjective 
Acceptance
x
x
X
X
x
x
Study Lens 
Distance and 
Near Visual 
Acuity 
x
x
X
X
x
x
Distance Over 
Refraction and 
Visual Acuity
x
x
X
X
x
x
Subjective Lens 
Fit Assessment
x
x
X
X
x
x
Lens Deposits
X
x
x
Lens Wettability
X
x
x
Binocular Over 
Refraction
X
x
x
Compliance
x
X
X
x
x
Follow-up PRO 
(CLUE / MRD) 
Questionnaire
x
X
X
x
x
Visual 
Performance
X
x
x
Modifications
x
x
X
Distance and 
Near Exit Visual 
Acuity
x
x
X
X
x
Dispensing 
Criteria
x
x
X
X
x
Instructions
x
x
X
X
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 
1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2 
Treatment 2
Visit 4
Treatment 
2
Follow-up
1
Optimizati
on
Visit 5
Treatment 
2
Follow-up
2
Treatment 
3
Visit 6
Treatment 
3
Follow-up
1
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 3±1
from V3
Day 7±1
from V4
Day 7±1 
from V5
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.0 hour
2.0 hour
1.5 hour
Schedule Follow-
up
x
x
X
X
x
Final Evaluation
x
7.2.
Detailed Study Procedures 
VISIT 1
Subjects must report to the visit wearing their habitual contact lenses to accurately assess 
baseline PRO (CLUE and MRD) performance.  If the subject is not wearing their lenses they 
must be rescheduled.
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of 
Informed Consent
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study.  The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form.
NOTE: The subject must be provided a 
signed copy of this document.
1.2
Demographics
Record the subject’s age, gender, race and 
ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Questions regarding the subject’s medical 
history and concomitant medications.
1.4
Habitual Lenses
Questions regarding the subject’s habitual 
lens type and parameters.
1.5
Habitual Lens 
Duration of 
Wear/Days per week
Questions regarding the subject’s duration of 
contact lens wear and the minimum number 
of days they wear their lenses per week.  
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1.6
Contact Lens History
Record the subject’s correction type (i.e. 
monovision, multifocal, sphere with readers, 
etc.).
1.7
Wear time and 
Comfortable Wear 
time with Habitual 
lenses
Record the subject’s wear time and 
comfortable wear time with their habitual 
contact lenses.  
1.8
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible.
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms are not required.
Visit 1: Baseline
Step
Procedure
Details
1.9
Baseline PRO 
(CLUE and MRD) 
and CLDEQ-8
Questionnaires
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of their habitual lenses using the PRO (CLUE 
and MRD) questions.  
1.10
Ocular Symptoms
The subject will respond to a verbal open-
ended symptoms questionnaire.
1.11
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the subject’s 
habitual contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2.  The acuity will be 
recorded to the nearest letter OD, OS and 
OU.  
1.12
Lens Removal 
Have the subject remove their habitual lenses 
and store in an approved storage solution.
1.13
Subjective 
Refraction and 
Distance Visual 
Acuity
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and 
distance visual acuity to the nearest letter.
NOTE: Best distance visual acuity with 
sphero-cylindrical refraction must be at 
least 20/20-3 in each eye for the subject to be 
eligible in the study.
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1.14
Near ADD 
Determination
The near reading addition will be determined 
using the binocular crossed cylinder
technique (BCC) at 40 cm. 
1.15
Ocular Dominance
Determine the distance ocular dominance 
with the best distance correction in place 
using a +1.00-blur test. If the results are 
equivocal use the sighting dominance test to 
determine the dominant eye used for the 
study.
1.16
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses 
(or flippers) under binocular conditions. 
1.17
Near Visual Acuity
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm.  Record the near 
visual acuity OD, OS and OU at 40 cm.
1.18
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
1.19
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible.
If so, proceed to lens fitting.  
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete all forms.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.20
Randomization 
Record the randomization ID.
1.21
Lens Selection
Select the lens pair and power based on the 
randomization scheme, spherical equivalent 
refraction and fitting guide for each eye.  
Record the Test lens parameters (power and 
lot number).  
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1.22
Lens Insertion
Subjects will insert the lenses themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be 
shipped back to the Sponsor. Complete the 
Product Quality Complaint form.
1.23
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
1.24
Determine Visual 
Satisfaction
Determine if the subject’s vision is 
acceptable with the lenses.  Allow the subject 
to look down a hallway or out of a window 
for distance vision assessments, and for them 
to read a book, magazine or similar for near 
vision.  
1.25
Study Lens Distance 
and Near Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
Note: Use the ETDRS 2000 Series Chart 1 or
2 near card placed at 40 cm to measure the 
Near visual acuity
1.26
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results.  The results of the distance over-
refraction may also be checked for the impact 
on near vision under monocular and/or 
binocular conditions.   
1.27
Modifications
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted. If the
subject reports satisfactory vision with the
lenses a modification is not required, however
at the Investigator’s discretion and based
upon their findings on the measured visual
acuity and/or over- refraction the investigator 
may make a modification.
Up to two attempts at modification are 
permitted, if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  
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Follow the fitting guide allowing for at least 
10 minutes of settling time between each lens 
modification attempted.   
If modifications are required steps 1.22-1.27
will be repeated for each modification. 
1.28
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
1.29
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
1.30
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued.
x
Distance Snellen acuity equal to or
better than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
1.31
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses.
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x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type. 
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study.
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
1.32
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days.
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 2
The subjects must present to Visit 2 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit.
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
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2.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
2.2
Wear time and 
Comfortable Wear 
time with Study 
lenses
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up.
2.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
NOTE: Subjects must have worn lenses for 
at least 6 hours per day. 
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
2.4
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.5
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
2.6
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
Use the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm to measure the 
Near visual acuity
2.7
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results and distance visual acuity OD and 
OS.
The results of the distance over-refraction 
may also be checked for the impact on near 
vision under monocular and/or binocular 
conditions.   
2.8
Determination of 
Lens Optimization
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted.
If the subject reports satisfactory vision with
the lenses a modification is not required,
however at the Investigator’s discretion and 
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based upon their findings on the measured
visual acuity and/or over- refraction the 
investigator may make a modification.
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  
Follow the fitting guide and steps 1.22-1.27
in Visit 1 Fitting allowing for at least 10 
minutes of settling time between each lens 
modification.
2.9
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
2.10
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the subject
when lens power has been optimized.
If lens power was not changed allow the
subject to use the unworn lenses dispensed at
Visit 1 and dispense enough lenses of the
same power to last the subject until their next
visit.
2.11
Lens Removal
The study lenses will be removed and 
discarded.
2.12
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings. 
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If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
2.13
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.11 above.  
2.14
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
2.15
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued.
x
Distance Snellen acuity equal to or 
better than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
2.16
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses.
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type. 
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x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study.
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
2.17
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 3
The subjects must present to Visit 3 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit.
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Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
3.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
3.2
Wear time and 
Comfortable Wear 
time with Study 
lenses
Record the hours the subject has worn the 
study lenses and the comfortable wear time on 
the day of follow-up.
3.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
NOTE: Subjects must have worn lenses for 
at least 6 hours per day. 
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
3.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(CLUE and MRD) and lens preference 
questionnaires.  
3.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
3.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
3.7
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
3.8
Visual Performance
Distance (4M) 
Intermediate (64 cm)
Near (40 cm)
Binocular Visual performance will be
recorded for the following:
Distance, Bright Illuminance
High and Low Contrast ETDRS Charts        
4M-HC#3 and LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
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Near (40 cm) High Contrast and Low
Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
3.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.  
3.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
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NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
3.11
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
3.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
3.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
3.14
Continuance
Determine whether the subject is eligible to 
continue in the study based on the 
examination findings.  
Visit 3: Treatment 2 Lens Fitting
Step
Procedure
Details
3.19
Lens Selection
Select the lens pair and power based on the 
randomization scheme, spherical equivalent 
refraction (measured at Visit 1 baseline) and 
fitting guide for each eye.  Record the Test 
lens parameters (power and lot number).  
3.20
Lens Insertion
Subjects will insert the lenses themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be 
shipped back to the Sponsor. Complete the 
Product Quality Complaint form.
3.21
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
3.22
Determine Visual 
Satisfaction
Determine if the subject’s vision is acceptable 
with the lenses.  Allow the subject to look 
down a hallway or out of a window for 
distance vision assessments, and for them to 
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Johnson & Johnson Vision Care, Inc.
read a book, magazine or similar for near 
vision.  
3.23
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
3.24
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results.  The results of the distance over-
refraction may also be checked for the impact 
on near vision under monocular and/or 
binocular conditions.   
3.25
Modifications
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted. If the subject
reports satisfactory vision with the lenses a
modification is not required, however at the
Investigator’s discretion and based upon their
findings on the measured visual acuity and/or
over- refraction the investigator may make a 
modification.
Up to two attempts at modification are 
permitted, if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  Follow 
the fitting guide allowing for at least 10
minutes of settling time between each lens 
modification attempted.   
If modifications are required steps 3.19-3.25
will be repeated for each modification. 
3.26
Lens Fit Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
3.27
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
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Johnson & Johnson Vision Care, Inc.
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
3.28
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued.
x
Distance Snellen acuity equal to or 
better than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
3.29
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses.
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type. 
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study.
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x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
3.30
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days.
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 4
The subjects must present to Visit 4 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit.
Visit 4: Treatment 2 Follow-up 1
Step
Procedure
Details
4.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
4.2
Wear time and 
Comfortable Wear 
time with Study 
lenses Wear Time
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up.
4.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
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NOTE: Subjects must have worn lenses for 
at least 6 hours per day 
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
4.4
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
4.5
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
4.6
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
Use the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm to measure the 
Near visual acuity
4.7
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results and distance visual acuity OD and 
OS.
The results of the distance over-refraction 
may also be checked for the impact on near 
vision under monocular and/or binocular 
conditions.   
4.8
Determination of 
Lens Optimization
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted.
If the subject reports satisfactory vision with
the lenses a modification is not required,
however at the Investigator’s discretion and 
based upon their findings on the measured
visual acuity and/or over- refraction the 
investigator may make a modification.
Up to two attempts at modification are 
permitted, if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  
Follow the fitting guide and steps 3.20-3.25
in Visit 3 Fitting allowing for at least 10 
minutes of settling time between each lens 
modification.
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4.9
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
4.10
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the subject 
when lens power has been optimized.
If lens power was not changed allow the
subject to use the unworn lenses dispensed at
Visit 3 and dispense enough lenses of the
same power to last the subject until their next
visit.
4.11
Lens Removal
The study lenses will be removed and 
discarded.
4.12
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
4.13
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 4.12 above.  
4.14
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
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NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
4.15
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued.
x
Distance Snellen acuity equal to or 
better than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
4.16
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses.
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type. 
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study.
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
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x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn
lenses that will be shipped back to the 
Sponsor.
4.17
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 5
The subjects must present to Visit 5 wearing the study lenses.  To be counted as a day of 
wear the lenses need to have been worn for at least six (6) hours prior to the visit.
Visit 5: Treatment 2 Follow-up 2
Step
Procedure
Details
5.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
5.2
Wear time and
Comfortable Wear 
time with Study 
lenses 
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up.
5.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
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NOTE: Subjects must have worn lenses for 
at least 6 hours per day 
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
5.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires  
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(CLUE and MRD) lens preference 
questionnaires.  
5.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
5.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
5.7
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
5.8
Visual Performance
Distance (4M) 
Intermediate (64 cm)
Near (40 cm)
Binocular Visual performance will be
recorded for the following:
Distance, Bright Illuminance
High and Low Contrast ETDRS Charts        
4M- HC#3 and LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low
Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
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lux).
x
Distance, HC-1 Chart luminance
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
5.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.   
5.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
The subject should not proceed to wear the 
lenses if any of the following is observed:
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
5.11
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
5.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
5.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.
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If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
5.14
Continuance
Determine whether the subject is eligible to 
continue in the study based on the 
examination findings.  
Visit 5: Treatment 3 Lens Fitting
Step
Procedure
Details
5.19
Lens Selection
Select the same lens pair and power that was 
dispensed at Visit 4.
Record the Test lens parameters (power and 
lot number).  
5.20
Lens Insertion
Subjects will insert the lenses themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be 
shipped back to the Sponsor. Complete the 
Product Quality Complaint form.
5.21
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
5.22
Determine Visual 
Satisfaction
Determine if the subject’s vision is acceptable 
with the lenses.  Allow the subject to look
down a hallway or out of a window for 
distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision.  
5.23
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results.
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
5.24
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results.  The results of the distance over-
refraction may also be checked for the impact 
on near vision under monocular and/or 
binocular conditions.   
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5.25
Lens Fit Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
5.26
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
5.27
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued.
x
Distance Snellen acuity equal to or 
better than 20/30 OU
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
5.28
Patient Instructions 
Instruct the Subject the following:
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x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day.
x
Instruct the subject to bring back all 
unworn study lenses.
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type. 
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study.
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided.
x
Subjects will be instructed to bring their 
habitual contacts or glasses to the next 
visit.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
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5.29
Schedule
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days.
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 6
The subjects must present to Visit 6 wearing the study lenses.  To be counted as a day of 
wear the lenses need to have been worn for at least six (6) hours prior to the visit.
Visit 6: Treatment 2 Follow-up 1
Step
Procedure
Details
6.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
6.2
Wear time and 
Comfortable Wear 
time with Study 
lenses
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up.
6.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
NOTE: Subjects must have worn lenses for 
at least 6 hours per day 
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
6.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires  
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(CLUE and MRD) questionnaires.  
6.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
6.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
6.7
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000
Series Chart 1 or 2. The acuity will be 
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recorded to the nearest letter OD, OS and 
OU. 
6.8
Visual Performance
Distance (4M) 
Intermediate (64 cm)
Near (40 cm)
Binocular Visual performance will be
recorded for the following:
Distance, Bright Illuminance
High and Low Contrast ETDRS Charts        
4M- HC#3 and LC#3
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low
Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M- HC#6
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
6.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.
6.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
The subject should not proceed to wear the 
lenses if any of the following is observed:
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x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
6.11
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
6.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
6.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study.
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason.
F.2
Exit Refraction 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter and record the 
best-corrected distance visual acuity (OD and
OS) to the nearest letter. 
Note: This step is not necessary if the subject 
was exited due to screen failure.
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Final Evaluation
Step
Procedure
Details
F.3
Exit Slit Lamp 
Biomicroscopy (for 
subjects that are 
discontinued early)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. This step is not 
necessary if the subject was exited due to 
screen failure.
Note: This step is not necessary if the subject 
was exited due to screen failure, or if
biomicroscopy was performed as part of the 
final follow-up visit procedures (i.e., 
immediately prior to the final evaluation).
7.3.
Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected, as appropriate:
x
Chief complaint prompting the visit. If the reason is an adverse event, the applicable 
eCRF for the adverse event must be completed and subject record completed as 
appropriate.
x
Date and time of the visit and all procedures completed at the unscheduled visit.
x
Review of adverse event and concomitant medications.
x
Documentation of any test article dispensed or collected from the subject, if applicable.
x
Slit lamp findings (using the Slit Lamp Classification Scale).
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified.
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider. 
The following information will be collected during an unscheduled visit.
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Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for 
reasons for the unscheduled visit.
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
U.4
Entrance VA (if 
applicable)
Record the entrance distance visual acuity 
(OD, OS) to the nearest letter. 
U.5
Subjective Sphero-
cylindrical 
Refraction (if 
applicable)
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.  If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled.
U.7
Dispensing (if 
applicable)
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the
dispensing instructions given in the detailed 
study procedures.
U.8
Exit Visual Acuity 
(if applicable)
Record the subject’s exit distance visual 
acuity (OD, OS) to the nearest letter. 
Note: If the only reason for the unscheduled visit is that the subject requires additional test 
articles, only the dispensing information needs to be recorded.
7.4.
Laboratory Procedures  
Not Applicable
8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
Subjects are considered to have completed the study if they: 
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x
provided informed consent.
x
they are eligible.
x
completed all study visits
8.2.
Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject withdrawal of consent.
x
Subject not compliant to protocol.
x
Subject lost to follow-up.
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear
x
Subjects who have experienced a Corneal Infiltrative Event (CIE).
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment).
x
Subject missed any study visits
x
Subject not compliant with study lens wear schedule 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor
vision, poor comfort or unacceptable fit.
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled).
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity.
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2.
x
Collect all unused test article(s) from the subject.
x
Make arrangements for subject care, if needed, due to their study participation
Additional subjects may be enrolled 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 and therapies are medications or therapies that contraindicate contact 
lens wear.
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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 medications is shown 
in Table 4.
NOTE: Subjects who previously used these medications on a temporary basis must have 
ceased that medication at least 1 week prior to signing the informed consent.
Table 4: Disallowed systemic medications
Class of Drug
Common Indication(s)
Common Examples
Anticholinergics
Irritable bowel syndrome, 
Parkinson’s disease, peptic 
ulcer, cystitis, nasal 
congestion, cold symptoms, 
overactive bladder, COPD
Bentyl, Spiriva, Atrovent, 
Hyosyne, Levsin, Symax 
Fastab, Symax SL, Homax 
SL, Cogentin, Transderm 
Scop, etc.
Oral Phenothiazines
Antipsychotic disorders 
(schizophrenia, mania)
Compazine, Mellarill, 
Thorazine, Phenagran, etc. 
Oral/Inhaled 
Corticosteroids
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions 
Cortisone, Prednisone, 
Hydrocortisone, Medrol, 
Kenalog, Flonase etc. 
Oral Retinoids 
Seborrhea, acne 
Isotretinoin, Acitretin, 
Alitretinoin, etc. 
Oral Tetracycline 
Urinary Tract Infection, acne, 
chlamydia, gonorrhea 
Sumcyin, Acitsite, 
Achromycin V, etc. 
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations
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that contradict the information contained in the Informed Consent/Assent forms will be
considered Major Deviations.
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. 
Protocol waivers are prohibited.
Table 5 lists examples of deviations that will constitute major and minor protocol deviations
for this study. 
Table 5: Examples of major and minor protocol deviations
Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended more than 2
days out of visit window 
defined in study procedures
Visit attended 2 or fewer
days out of visit window 
defined in study procedures
Unanswered PRO questions
For questionnaires where 
data is related to a primary or
secondary endpoint,
more 
than 2 PRO questions are 
unanswered (i.e., left blank)
in a single domain (i.e. 
vision).
For questionnaires where 
data is related to a primary or
secondary endpoint,
2
or
fewer PRO questions are
unanswered (i.e., left blank).
For questionnaires where 
data where data is not related 
to a primary or secondary 
endpoint, any PRO questions 
are unanswered (i.e., left 
blank).
In the case of a major protocol deviation, the decision of whether or not the subject will be 
excluded from the Per-Protocol analysis population will be made at the time of cohort 
review.
11. STUDY TERMINATION 
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.
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The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
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x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
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
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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
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
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Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
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.
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13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time
suggests that a causal relationship is not likely.
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded.
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge.
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
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. 
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All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
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 
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health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
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.
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Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).9 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
 
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Summaries will be presented by study lens type (Test and Control) and will be performed 
separately by completion status (Safety Population, Per-Protocol Population or Intent-to-Treat 
Population). 
14.2. Sample Size Justification 
This study was designed and powered to demonstrate that the binocular high luminance high
contrast, visual performance (logMAR) of the Test lens at distance (4 meters), intermediate 
(64 cm) and near (40 cm) after1-week of lens wear is non-inferior to the Control lens. Historical 
data for the Test lens with respect to visual acuity is presented in the Table below.
Table 6:
Binocular High Luminance High Contrast Visual Performance – 1-Week 
Follow-up
Position
Lens
Mean
SD*
Minimum
Maximum
Distance (4 M)
Test
-0.07354
0.08265
-0.2400
0.2400
Control
-0.05216
0.08397
-0.2200
0.1600
Intermediate (64 cm)
Test
-0.05455
0.08698
-0.2600
0.2600
Control
-0.04216
0.08039
-0.2400
0.2200
Near (40 cm)
Test
0.0667
0.10249
-0.1000
0.4400
Control
0.0790
0.00947
-0.1600
0.3000
*SD: Standard Deviation 
Visual Performance (logMAR)
Sample size calculation for Visual performance (logMAR) was carried out using Monte Carlo 
simulation methods using PROC IML. One-thousand boot strap samples were simulated based 
on the historical data in Table 6 above for each Position separately. An interclass correlation 
of 0.8 between study periods was used. For this sample size calculation, we assumed that there 
was no period or sequence effect since the Test and Control have not be evaluated together in 
the same clinical study. For each replicated sample a linear mixed model was used; lens was 
included as the only fixed effect.  A variance component (VC) covariance structure was used 
to model measurements from the same subject across study periods. Seventy subjects to
complete provides >99% power to meet all primary hypotheses (Distance, Intermediate and 
Near) associated with visual performance.
The plan is to enroll 80 eligible subjects with a target completion of 70 subjects. During the 
enrollment period, the subject drop-out rate with be closely monitored, if an unexpectedly high 
dropout rate is observed, then the targeted total enrollment number maybe be increased 
accordingly to ensure that a minimum of 70 subjects complete the study.
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
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Per-Protocol Population:
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All subjects regardless of actual treatment and subsequent withdrawal from study or deviation 
from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analysis  
All primary analysis will be conducted on the Intent-to-Treat Population. A sensitivity analysis 
will be conducted on the Per-Protocol population. 
Visual Performance (logMAR)
Binocular, high luminance, high contrast visual performance (logMAR) will be analyzed using 
a linear mixed model. Sequence of lens wear, study period, lens type, distance (4 M, 64 cm 
and 40 cm), first order carryover effect and the lens by distance interaction will be included as 
fixed effects. Other characteristics including, age, gender and race and ADD power may be 
included when appropriate. Site will be included as a random effect (G-side). The covariance
between residual errors from the same subject and distance across study periods will be 
modeled using either homogenous compound symmetry (CS) or unstructured (UN) covariance 
structure. The structure that returns the lowest finite-sample corrected Akaike’s Information 
criterion7 will be selected as the structure that best fits the model. The Kenward and Roger 
method8 will be used for the denominator degrees of freedom.
Comparisons between the Test and Control lenses will be carried out at each distance (4 M, 64 
cm and 40 cm) using 2-sided 95% confidence intervals constructed of least square means 
(LSM) differences (Test minus Control) at the 1-week follow-up evaluation.
Primary hypothesis 1: 
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for non-inferiority of the Test lens relative to the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟≥0.05 logMAR
ܪ஺: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟< 0.05 logMAR
Non-inferiority will be declared if the upper limit of the 95% confidence interval of the LSM 
difference between the Test and Control is below 0.05 logMAR. i.e. P(ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟<0 .05)
≥ 0.975. 
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Primary hypothesis 2: 
The null and alternative hypothesis for binocular Intermediate HLHC visual performance to 
test for non-inferiority of the Test lens relative to the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟≥0.05 logMAR
ܪ஺: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟< 0.05 logMAR
Non-inferiority will be declared if the upper limit of the 95% confidence interval of the LSM 
difference between the Test and Control is below 0.05 logMAR. i.e. P(ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟<0 .05) 
≥ 0.975. 
Primary hypothesis 3: 
The null and alternative hypothesis for binocular near HLHC visual performance to test for 
non-inferiority of the Test lens relative to the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟≥0.05 logMAR
ܪ஺: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟< 0.05 logMAR
Non-inferiority will be declared if the upper limit of the 95% confidence interval of the LSM 
difference between the Test and Control is below 0.05 logMAR. i.e. P(ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟<0 .05) 
≥ 0.975. 
14.6. Secondary Analysis  
CLUE Vision
CLUE vision scores at the 1-week follow-up will be analyzed using a linear mixed model 
adjusting for baseline values as a covariate. Sequence of lens wear, study period, lens type will 
be included as fixed effects. Other factors such as, race, gender or ADD power may be included 
in the model as covariates when appropriate. Site will be included as a random effect (G-side). 
The covariance between residual errors from the same subject across study periods will be 
modeled using either homogenous compound symmetry (CS) or unstructured (UN). The 
structure that returns the lowest finite-sample corrected Akaike’s Information criterion7 will 
be selected as the structure that best fits the model. The Kenward and Roger method, (Kenward 
and Roger, 1997)8 will be used for the denominator degrees of freedom. 
Comparisons between the Test and Control lenses at the 1-week follow-up evaluation will be 
carried out using two-sided 95% confidence intervals constructed for the least-square mean 
difference (Test minus Control).     
Secondary Hypothesis 1:
The null and alternative hypothesis for CLUE vision to test for non-inferiority of the Test lens 
relative the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧− ߤ஼௢௡௧௥௢௟≤-5
ܪ஺: ߤ்௘௦௧−ߤ஼௢௡௧௥௢௟> -5
Non-inferiority will be declared if the lower limit of the 95% confidence interval for the least-
square mean difference is greater than -5. i.e. P(ߤ்௘௦௧− ߤ஼௢௡௧௥௢௟>-5) ≥ 0.975
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14.7. Other Exploratory Analysis 
CLUETMcomfort and handling scores will be descriptively summarized for each timepoint and 
lens type.
Further exploratory analysis may be undertaken at the discretion of the study responsible 
clinician.
14.8. Interim Analysis 
An interim analysis will be conducted after at least 20 subjects have completed the study. The 
interim read will include descriptive summaries on all primary and secondary endpoints. 
Additionally, descriptive summaries on other objectives will also be provided including: 
CLUE™ Comfort, Handling, Lens Optimization Summary, Mechanical Lens Fit and Slit 
Lamp Findings. Listings on any adverse events, corneal infiltrates of other slit lamp findings 
may also be provided if necessary. 
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 15 imputations.9
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
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The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3. Trial Registration on ClinicalTrials.gov 
This study will be registered on ClincalTrials.gov.
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16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
16.4. Data Monitoring Committee (DMC) 
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 
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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
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 
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participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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
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x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
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.
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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 States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
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19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study.
x
Scheduling a study visit outside the subject’s acceptable visit range.
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution.
x
Case Report Form signature.
x
Completion of any follow-up action items.
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21. PUBLICATION 
This 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. Available at: https://www.iso.org/standard/45557.html
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
6. Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci. 2016;93(8):801-808.
7. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation.
1998;27:591-604.
8. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983–997.
9. SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC: SAS 
Institute Inc; 2014.
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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Clinical Study Protocol
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APPENDIX B: PATIENT INSTRUCTION GUIDE (TO BE PROVIDED 
SEPERATLEY) 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Dailies Total 1® Multifocal Contact Lenses 
 
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W900236420
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal (delefilcon A) soft 
contact lenses for Daily Disposable Wear
Important: This package insert is effective as of December 2019 and applicable to the delefilcon A contact lenses described below. Please read carefully and keep this information for future use. This package insert is intended for the eye care 
professional, but should be made available to patients upon request. The eye care professional should provide the patient with appropriate instructions that pertain to the patient’s prescribed lenses. Copies of this package insert are available without 
charge from Alcon by calling Customer Service at 1-800-241-5999 or download from our website at www.alcon.com. In addition, a Patient Instruction Booklet is available which is recommended to be given to patients.
CAUTION: Federal law (United States) restricts this device to 
sale by or on the order of a licensed eye care professional.
PRODUCT DESCRIPTION
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal (delefilcon 
A) soft contact lenses are made from a lens material that is 33% 
water and 67% (delefilcon A) polymer, a silicone containing 
hydrogel with added phosphatidylcholine. The core lens material 
containing 33% water transitions through a water gradient to a 
hydrogel surface layer that exceeds 80% water. Lenses contain 
the color additive copper phthalocyanine, a light blue tint, which 
makes them easier to see when handling.
Lens Properties
• Refractive Index hydrated: 
1.42
• Light Transmittance: 
93% (@ 610 nm, -1.00 D)
• Oxygen Permeability (Dk): 
140  x 10-11 (cm2/sec)(ml O2 /ml 
x mm Hg), measured at 35° C 
(intrinsic Dk-Coulometric 
method)
• Water Content: 
33% by weight in normal saline
• Surface Water Content: 
≥ 80%
Lens Parameters
• Diameter Range 
13.0 to 15.0 mm
• Spherical Power Range -20.00 to +20.00 D
• Base Curve Range 
8.0 to 9.2 mm
Lens Parameters Available1
DAILIES TOTAL1® (delefilcon A) spherical contact lenses
• Chord Diameter: 
14.1 mm
• Center Thickness: 
0.09 mm @ -3.00 D (varies with  
  
power)
• Base Curve: 
8.5 mm
• Powers: 
-0.50 to -6.00 D (0.25 D steps)
-6.50 to -12.00 D (0.50 D steps)
+0.50 to +6.00 D (0.25 D steps)
DAILIES TOTAL1® Multifocal (delefilcon A) contact lenses
• Chord Diameter: 
14.1 mm
• Center Thickness: 
0.09 mm @ -3.00 D (varies with  
  
 
power)
• Base Curve: 
8.5 mm
• Powers: 
+6.00 D to -10.00 D (0.25 D steps) 
ADD: LO, MED, HI
NOTE: Hereafter, DAILIES TOTAL1® spherical contact lenses 
and DAILIES TOTAL1® Multifocal contact lenses will simply be 
referred to as delefilcon A contact lenses unless product 
distinction is necessary.
ACTIONS
When hydrated and placed on the cornea, delefilcon A contact 
lenses act as a refracting medium to focus light rays on the 
retina. 
INDICATIONS (Uses)
DAILIES TOTAL1® (delefilcon A) spherical soft contact lenses 
are indicated for the optical correction of refractive ametropia 
(myopia and hyperopia) in phakic or aphakic persons with 
non-diseased eyes with up to approximately 1.50 diopters (D) of 
astigmatism that does not interfere with visual acuity.
DAILIES TOTAL1® Multifocal (delefilcon A) soft contact lenses 
are indicated for the optical correction of refractive ametropia 
(myopia and hyperopia) and/or presbyopia in phakic or aphakic 
persons with non-diseased eyes who may require a reading 
addition of +3.00 (D) or less and who may have up to 
approximately 1.50 diopters (D) of astigmatism that does not 
interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable 
wear. The lenses are not intended to be cleaned or disinfected 
and should be discarded after a single use. 
CONTRAINDICATIONS (Reasons Not To Use)
DO NOT use delefilcon A contact lenses when any of the 
following exists:
• Inflammation or infection of the anterior chamber of the eye
• Active disease, injury or abnormality affecting the cornea, 
conjunctiva, or eyelids 
• Microbial infection of the eye
• Insufficiency of lacrimal secretion (dry eye) that interferes with 
contact lens wear
• Corneal hypoesthesia (reduced corneal sensitivity)
• Use of any medication that is contraindicated or interferes 
with contact lens wear, including eye medications
• Any systemic disease which may be exacerbated by or 
interferes with contact lens wear
• Allergic reactions or ocular irritation of the ocular surfaces or 
adnexa that may be caused by or exaggerated by the wearing 
of contact lenses
• Patient history of recurring eye or eyelid infections, adverse 
effects associated with contact lens wear, intolerance or 
abnormal ocular response to contact lens wear
• If eyes become red or irritated
WARNINGS
Advise patients of the following warnings pertaining to 
contact lens wear:
• 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 professional’s directions and all labeling 
instructions for proper use of lenses and lens care products. 
Serious 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 study results have shown that the risk of 
serious adverse reactions is increased when contact lenses 
are worn overnight2.
• Studies2 have shown that contact lens wearers who are 
smokers have a higher incidence of adverse reactions than 
nonsmokers.
• If a patient experiences eye discomfort, foreign body 
sensation, excessive tearing, vision changes, or redness of the 
eye, the patient should be instructed to immediately remove 
lenses and promptly contact his or her eye care professional. 
It is recommended that contact lens wearers see their eye 
care professional regularly as directed.
PRECAUTIONS
To prevent damage to the eyes or to the contact lenses, the 
following precautions should be taken:
Special Precautions for the Eye Care Professional
Due to the small number of patients enrolled in the clinical 
investigation of lenses, all refractive powers, design 
configurations, or lens parameters available in the lens material 
are not evaluated in significant numbers. Consequently when 
selecting an appropriate lens design and parameters, the eye 
care professional should consider all characteristics of the lens 
that can affect lens performance and ocular health, including 
oxygen permeability, central and peripheral thickness and optic 
zone diameter.
The potential impact of these factors on the patient’s ocular 
health should be carefully weighed against the patient’s need for 
refractive correction; therefore the continuing ocular health of the 
patient and lens performance on the eye should be carefully 
evaluated on initial dispensing and monitored on an ongoing 
basis by the prescribing eye care professional.
• Fluorescein, a yellow dye, should not be used while the lenses 
are on the patient’s eyes. The lenses absorb this dye and 
become discolored. Whenever fluorescein is used, the eyes 
should be flushed thoroughly with sterile saline solution that is 
recommended for in eye use prior to inserting lenses. Avoid 
dispensing saline from an aerosol can directly into the eye.
• Patients who wear contact lenses to correct presbyopia may 
not achieve the best possible 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.
• Before leaving the eye care professional’s office, the patient 
should be able to promptly remove their lenses or should have 
someone else available who can remove their lenses for them.
• Eye care professionals should instruct the patient to remove 
the lenses immediately if the eye becomes red or irritated.
• Routine eye examinations are necessary to help assure the 
continued health of the patient’s eyes. Eye care professionals 
should make arrangements with the patient for appropriate 
follow-up visits. Alcon recommends that patients see their eye 
care professional once each year, or more often, as 
recommended by the eye care professional.
• Diabetics may have reduced corneal sensitivity and thus are 
more prone to corneal injury and do not heal as quickly or 
completely as non-diabetics.
• Visual changes or changes in lens tolerance may occur during 
pregnancy or use of oral contraceptives. Caution patients 
accordingly.
Eye Care Professionals should carefully instruct patients 
about the following safety precautions:
Handling Precautions
• Be sure that before leaving the eye care professional’s office 
the patient is able to promptly remove lenses or have 
someone else available to remove them.
• Good hygiene habits help promote safe and comfortable lens 
wear. Always wash, rinse and thoroughly dry hands with a 
lint-free towel before handling lenses.
• REMOVE A LENS IMMEDIATELY if an eye becomes red or 
irritated.
• Always handle lenses carefully. Never use tweezers or other 
sharp objects such as fingernails to remove lenses from the 
lens container unless specifically indicated for that use.
• Do not use if blister package is damaged or not sealed 
completely. This may result in product contamination which 
can lead to a serious eye infection.
• Ensure that the correct lens for each eye is available. Shake 
the blister pack gently prior to opening. Remove the lens from 
the blister pack by carefully pouring the lens onto the palm of 
your clean hand. Ensure the lens is right side out. Inspect 
lenses prior to insertion. Do not insert damaged lenses.
• To insert lenses:
- Wash and rinse hands thoroughly and dry completely with a 
clean, lint free towel before handling lenses.
- Place a lens on the tip of your clean and dry right or left 
index finger, place the middle finger of the same hand close 
to lower eyelashes and pull down the lower eyelid.
- Use the fingers of the other hand to lift the upper eyelid.
- Place the lens directly on the eye (cornea) and gently roll 
finger away from the lens.
- Look down and slowly remove the hand, releasing the 
lower lid.
- Look straight ahead and slowly remove the other hand, 
releasing the upper lid.
- Blink gently.
• To remove lenses:
- Wash and rinse hands thoroughly and dry completely with a 
clean, lint free towel before handling lenses. Make sure 
hands are clean and completely dry.
- Blink fully several times.
- While looking up, slide the lens down onto the white part of 
the eye.
- Remove the lens by pinching gently between the thumb and 
forefinger. Do not pinch the eye tissue.
- If the lens is difficult to grasp, dry fingers once more and try 
again. Do not use rewetting drops in this instance.
• If a lens decenters on the eye, it may be possible to recenter it by:
- Closing the eye and massaging the lens into place, or
- Looking in the direction of the lens and blinking gently, or
- Gently pushing the off-centered lens onto the cornea with 
light finger pressure on the edge of the upper or lower 
eyelid.
• If a lens tears in the eye it will feel uncomfortable. Advise 
wearers it is impossible to lose a contact lens or part of a 
contact lens behind the eye and to remain calm. Lens pieces 
may be removed by pinching them as for normal lens removal, 
carefully avoiding pinching the eye tissue. If the lens pieces do 
not seem to remove easily, rinsing with saline is 
recommended. If this does not help, the wearer should contact 
an eye care professional for assistance.
Lens Wearing Precautions:
• Patients should never exceed the prescribed wearing schedule 
regardless of how comfortable the lenses feel. Doing so may 
increase the risk of adverse effects.
• The lens should move freely on the eye at all times. If the lens 
sticks (stops moving) on the eye, follow the recommended 
directions in the Care for a Sticking Lens section. If 
non-movement of the lens continues, the patient should be 
instructed to consult their eye care professional immediately.
• The eye care professional should be consulted about wearing 
lenses during water sports and water related activities. 
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contact lenses in activities such as swimming, water skiing, and 
hot tubs may increase the risk of ocular infection, including 
but not limited to Acanthamoeba keratitis. 
• Never allow contact lenses to come into contact with 
non-sterile liquids (including tap water and saliva) as microbial 
contamination can occur, which may lead to permanent eye 
damage.
• Eye irritation, infection, or lens damage may result if 
cosmetics, lotion, soap, cream, hair spray, deodorant, aerosol 
products or foreign particles come in contact with lenses. 
• Environmental fumes, smoke, and vapors should be avoided in 
order to reduce the chance of lens contamination or physical 
trauma to the cornea.
• Lenses should be disposed of each day upon removal from the 
eye.
• Discard any lens which has become dehydrated or damaged. 
Replace with a sterile, fresh, new lens.
• Note the correct lens power for each eye to prevent getting 
them mixed up.
• Always carry spare lenses with you or have back-up 
spectacles available.
• Do not share lenses with anyone as this may spread 
micro-organisms which could result in serious eye health 
problems.
• Do not use lenses beyond their expiration date.
Other Topics to Discuss with Patients:
• Periodic eye examinations are extremely important for contact 
lens wearers. Schedule and conduct appropriate follow-up 
examinations to determine ocular response. Alcon 
recommends that patients see their eye care professional 
once each year or as recommended by the eye care 
professional.
• Certain medications may cause dryness of the eye, increased 
lens awareness, lens intolerance, and blurred vision or visual 
changes. These include, but are not limited to, antihistamines, 
decongestants, diuretics, muscle relaxants, tranquilizers, and 
those for motion sickness. Caution patients using such 
medications accordingly and prescribe proper remedial 
measures.
• Visual changes or changes in lens tolerance may occur during 
pregnancy or use of oral contraceptives. Caution patients 
accordingly.
Who Should Know that the Patient is Wearing Contact 
Lenses:
• Patients should inform their health care practitioners that they 
are wearing contact lenses.
• Patients should inform their employers that they are wearing 
contact lenses. Some jobs may require the use of eye 
protection equipment or may require that contact lenses not 
be worn.
It is strongly recommended that patients be provided with a copy 
of the DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal 
(delefilcon A) Contact Lenses Patient Instruction Booklet available 
from Alcon and understand its contents prior to dispensing the 
lenses.
WATER ACTIVITIES
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 showering or swimming, discard them and 
replace with a new pair. Ask the Eye Care Professional for 
recommendations about wearing lenses during any activity 
involving water.
ADVERSE EFFECTS
Patients should be instructed to check eyes regularly to 
make sure they look well, feel comfortable and vision is 
clear. Potentially serious complications are usually 
accompanied by one or more of the following signs or 
symptoms:
• Moderate to severe eye pain not relieved by removing the lens
• Foreign body sensation
• Excessive watering or other eye secretions including 
mucopurulent discharge
• Redness of the eyes
• Photophobia (light sensitivity)
• Burning, stinging or itching or other pain associated with the 
eyes
• Comfort is less compared to when the lens was first placed on 
eye
• Poor visual acuity (reduced sharpness of vision)
• Blurred vision, rainbows or halos around objects
• Feeling of dryness
WHAT TO DO IF A PROBLEM OCCURS
Patients should be instructed that if any of the above signs 
or symptoms are noticed, he or she should: 
• IMMEDIATELY REMOVE THE LENSES.
• If the discomfort or problem stops, discard the lens and 
replace it with a new one.
• If the discomfort or problem continues after removing 
lens(es) or upon insertion of a new lens, IMMEDIATELY 
remove the lens(es) and contact the eye care professional 
for identification of the problem and prompt treatment to 
avoid serious eye damage.
• The patient should be informed that a serious condition 
such as corneal ulcer, infection, corneal vascularization, 
or iritis may be present, and may progress rapidly. Less 
serious reactions such as abrasions, infiltrates, and 
bacterial conjunctivitis must be managed and treated 
carefully to avoid more serious complications.
• Additionally, contact lens wear may be associated with ocular 
changes that require consideration of discontinuation or 
restriction of wear. These include but are not limited to local or 
generalized corneal edema, epithelial microcysts, epithelial 
staining, infiltrates, neovascularization, endothelial 
polymegathism, tarsal papillary changes, conjunctival injection 
or iritis.
ADVERSE EFFECT REPORTING
If a patient experiences any serious adverse effects associated 
with the use of DAILIES TOTAL1® brand (delefilcon A) contact 
lenses, please notify: Alcon Medical Safety in the USA at 
1-800-757-9780.
FITTING GUIDE AND PATIENT BOOKLET
Conventional methods of fitting contact lenses apply to delefilcon 
A contact lenses. For a detailed description of the fitting 
techniques, refer to the DAILIES TOTAL1® and DAILIES TOTAL1® 
Multifocal (delefilcon A) Contact Lenses Professional Fitting and 
Information Guide. Both the professional fitting guide and a 
patient instruction booklet are available free of charge from:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX, USA 76134-2099
1-800-241-5999
LENS WEAR & REPLACEMENT SCHEDULES
DAILY WEAR (less than 24 hours, while awake):
• To avoid tendency of the daily wear patient to over-wear the 
lenses initially, stress the importance of adhering to a proper, 
initial wearing schedule. Normal daily wear of lenses assumes 
a minimum of 6 hours of non lens wear per 24 hour period. 
• It may be advisable for patients who have never worn contact 
lenses previously to be given a wearing schedule that 
gradually increases wearing time over a few days. This allows 
more gradual adaptation of the ocular tissues to contact lens 
wear.
• The maximum daily wearing time should be determined by the 
eye care professional based upon the patient’s physiological 
eye condition because individual responses to contact lenses 
vary. There may be a tendency for patients to over-wear the 
lenses initially. The eye care professional should stress the 
importance of adhering to the initial maximum wearing 
schedule. Studies have not been conducted to show that 
delefilcon A contact lenses are safe to wear during sleep, 
therefore patients should be advised to remove their lenses 
while sleeping. Normal daily wear of lenses assumes a 
minimum of 6 hours of non-lens wear per 24 hour period. 
Optimum individual wearing schedule will vary.
• Delefilcon A contact lenses are intended to be worn once (daily 
disposable wear) and then discarded at the end of each 
wearing period. The patient should be instructed to start the 
next wearing period with a fresh new lens.
EMERGENCY LENS CARE
Cleaning and disinfection of daily disposable lenses is not 
recommended. The patient should be reminded to have 
replacement lenses or back-up spectacles available at all times.
CARE FOR A STICKING LENS
If the lens sticks (stops moving) or begins to dry on the eye, 
instruct the patient to apply several drops of a recommended 
lubricating solution (used in accordance with package labeling). 
The patient should wait until the lens begins to move freely on 
the eye before attempting to remove it. It is important that the 
patient wash and dry their hands thoroughly before removing the 
lens. If the lens continues to stick, the patient should 
IMMEDIATELY consult the eye care professional.
IN OFFICE USE OF TRIAL LENSES
Eye care professionals should educate contact lens technicians 
concerning proper use of trial lenses.
Each contact lens is shipped sterile in a blister pack containing 
phosphate buffered saline solution.  Hands should be thoroughly 
washed and rinsed and dried with a lint-free towel prior to 
handling a lens. In order to ensure sterility, the blister pack 
should not be opened until immediately prior to use. For fitting 
and diagnostic purposes lenses should be disposed of after a 
single use and not be re-used from patient to patient.
EMERGENCIES
The patient should be informed that if chemicals of any kind 
(household products, gardening solutions, laboratory chemicals, 
etc.) are splashed into the eyes, the patient should: 
flush eyes immediately with tap water or fresh saline 
solution and immediately contact the eye care 
professional or visit a hospital emergency room without 
delay.
DISPOSAL AND RECYCLING
Dispose of contact lenses and the blister pack lidding in the 
waste bin, not down the sink or toilet. The carton packaging and 
the polypropylene (PP) plastic shell of the blister pack should be 
placed in the waste bin or recycled according to local waste 
management guidance.
HOW SUPPLIED
Each lens is packaged in a foil-sealed plastic container 
containing phosphate buffered saline solution with approximately 
0.3% of polymeric wetting agents consisting of copolymers of 
polyamidoamine and poly(acrylamide-acrylic) acid and is steam 
sterilized. The package is marked with the base curve, diameter, 
dioptric power (and ADD power for multifocal lenses), 
manufacturing lot number, date of manufacture, and expiration 
date.
The following may appear on the labels or cartons:
Manufacturer:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX, USA 76134-2099
1-800-241-5999
www.alcon.com
U.S. Pat.: www.alconpatents.com
© 2019 Alcon Inc.
1 Check for actual product availability as additional parameters 
may be introduced over time.
2 Schein, OD, Glynn RJ, Poggio EC, Seddon JM, Kenyon KR. The 
Relative Risk of Ulcerative Keratitis Among Users of Daily Wear 
and Extended Wear Soft Contact lenses. N Eng J Med. 1989; 
321 (12):773-783.
DIA
BC
PWR
L
R
D
ADD
MAX ADD
LO
MED
HI
en
EXP
CAUTION: Federal law (United States) restricts this device to sale by or on 
the order of a licensed eye care professional.
Single sterile barrier system
Sterilized using steam
Use-by date (Expiry date)
Batch code
Two letter code for the language (Example shown: English)
Do not re-use 
Do not use if blister package is damaged
Diameter
Base curve
Power
Left
Right
Diopter (lens power)
Addition power
Maximum effective addition power
Low
Medium
High
European conformity mark
Caution
Consult instructions for use
Authorized representative in the European Community
Manufacturer
Date of manufacture
Medical device
Packaging waste license sign
Symbol/Abbreviation Description
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APPENDIX F: OCULAR DOMINANCE 
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APPENDIX G: LENS FITTING GUIDE 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
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DETERMINATION OF NEAR ADDITION
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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Clinical Study Protocol
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Clinical Study Protocol
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Clinical Study Protocol
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Clinical Study Protocol
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
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Clinical Study Protocol
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JJVC CONFIDENTIAL 

Clinical Study Protocol
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Clinical Study Protocol
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JJVC CONFIDENTIAL 

Clinical Study Protocol
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Clinical Study Protocol
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Page 231 of 243
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Clinical Study Protocol
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CR-6418, v 2.0
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6418 Evaluation of Investigational Daily Disposable Multifocal 
Contact Lenses Produced with Different Manufacturing Processes
Version and Date: 2.0 10 February 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
CR-6418, v 2.0
 
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JJVC CONFIDENTIAL