Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes in Myopes
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 in Myopes
Protocol CR-6444
Version: 1.0
Date: 23 April 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
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ……………………………………………………………………………………...17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives................................................................................................................. 17 
2.2. 
Endpoints.................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION........................................................................... 19 
3.1. 
General Characteristics ............................................................................................ 19 
3.2. 
Inclusion Criteria...................................................................................................... 19 
3.3. 
Exclusion Criteria..................................................................................................... 20 
3.4. 
Enrollment Strategy.................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE.......................................................................... 21 
4.1. 
Description of Study Design .................................................................................... 21 
4.2. 
Study Design Rationale............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration.................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING..................................................... 21 
5.1. 
Test Article Allocation............................................................................................. 21 
5.2. 
Masking.................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION............................................................................................. 23 
6.1. 
Identity of Test Articles............................................................................................ 23 
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6.2. 
Ancillary Supplies/Products..................................................................................... 24 
6.3. 
Administration of Test Articles................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS.............................................................................................. 26 
7.1. 
Time and Event Schedule......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 29 
VISIT 1 ........................................................................................................................... 29 
VISIT 2........................................................................................................................... 35 
VISIT 3........................................................................................................................... 39 
VISIT 4........................................................................................................................... 45 
VISIT 5........................................................................................................................... 50 
VISIT 6........................................................................................................................... 55 
FINAL EVALUATION.................................................................................................. 58 
7.3. 
Unscheduled Visits................................................................................................... 59 
7.4. 
Laboratory Procedures ............................................................................................. 60 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 60 
8.1. 
Completion Criteria.................................................................................................. 60 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 60 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 61 
9.1. 
Systemic Medications .............................................................................................. 61 
10. 
DEVIATIONS FROM THE PROTOCOL.................................................................. 62 
11. 
STUDY TERMINATION ........................................................................................... 63 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............. 63 
13. 
ADVERSE EVENTS................................................................................................... 65 
13.1. 
Definitions and Classifications............................................................................. 65 
13.2. 
Assessing Adverse Events.................................................................................... 67 
13.2.1. 
Causality Assessment.................................................................................... 67 
13.2.2. 
Severity Assessment...................................................................................... 67 
13.3. 
Documentation and Follow-Up of Adverse Events.............................................. 68 
13.4. 
Reporting Adverse Events.................................................................................... 69 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 69 
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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........................................................................................ 71 
14.1. 
General Considerations......................................................................................... 71 
14.2. 
Sample Size Justification...................................................................................... 71 
14.3. 
Analysis Populations ............................................................................................ 72 
14.4. 
Level of Statistical Significance........................................................................... 72 
14.5. 
Primary 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................................ 75 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 75 
15.2. 
Subject Record...................................................................................................... 75 
15.3. 
Trial Registration on ClinicalTrials.gov............................................................... 76 
16. 
DATA MANAGEMENT............................................................................................. 76 
16.1. 
Access to Source Data/Document ........................................................................ 76 
16.2. 
Confidentiality of Information.............................................................................. 76 
16.3. 
Data Quality Assurance........................................................................................ 76 
16.4. 
Data Monitoring Committee (DMC).................................................................... 77 
17. 
CLINICAL MONITORING........................................................................................ 77 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 78 
18.1. 
Study-Specific Design Considerations ................................................................. 78 
18.2. 
Investigator Responsibility................................................................................... 78 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 78 
18.4. 
Informed Consent ................................................................................................. 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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Table 6: 
 Binocular High Luminance High Contrast Visual Performance – 1-Week 
Follow-up................................................................................................................................ 71 
 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 14 
PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Title: Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced with 
Different Manufacturing Processes in Myopes
Protocol Number: CR-6444
Version: 1.0
Date: 23 April 2021
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway 
Jacksonville, FL 32256
MEDICAL MONITOR 
The Medical Monitor must be notified by the clinical institution/site by e-mail or telephone 
within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may be contacted 
during business hours for adverse event questions. General study related questions should be 
directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ISO 14155,1 ICH guidelines,2
and the Declaration of Helsinki.3
Author
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
Medical Safety 
Officer
See Electronic Signature Report
Reviewer
See Electronic Signature Report
DATE
DATE
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See Electronic Signature Report
Approver
DATE
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SYNOPSIS  
Protocol Title
Evaluation of Investigational Daily Disposable Multifocal 
Contact Lenses Produced with Different Manufacturing 
Processes in Myopes
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 myopic 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.
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 section 9.1for 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. Any current ocular infection or inflammation.
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16. 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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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 study
did not have a final clinical study report. A summary of the lens 
performance in studies 
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.    
In 
, 67 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, high luminance, high contrast logMAR visual 
acuity of -0.078 and 0.062 at distance and near respectively.  
There were six adverse of events during the study.  Two of the six were ocular adverse events 
that were related to the control lens.  Both were corneal infiltrative events, one was non-
significant and the other was significant and both were classified as possibly related to the 
contact lenses.  
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 
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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 
Guillon-Poling charts. See 
 in Appendix K 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 
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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.
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 
myopic 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.
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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: 
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 section 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. Any current ocular infection or inflammation.
16. 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 (partial) 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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6.7.
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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in a single domain (i.e. 
vision).
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.
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:
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x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether the lens was inserted.
x
Any related AE number if applicable.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.).
x
Eye Care Provider objective (slit lamp) findings if applicable.
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 apply and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
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13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.”
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study.
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states.
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event.
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
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
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Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.”
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device.
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
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other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1).
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly
related, or related - see definition in section 13.2.1).
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 13.2.2).
x
Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or
unknown.
x
Actions Taken – none, temporarily discontinued, permanently discontinued, or other.
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely.
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.
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x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom).
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.).
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable.
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements.
x
Any referral to another health care provider if needed.
x
Outcome, ocular damage (if any).
x
Likely etiology.
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
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 
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infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
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.
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x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.5. Event of Special Interest 
None
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.
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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.
 
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 
CR-6444, v1.0
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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.
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.
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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௘௦௧െߤ஼௢௡௧௥௢௟൒0.05 logMAR
ܪ஺: ߤ்௘௦௧െߤ஼௢௡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௘௦௧െߤ஼௢௡௧௥௢௟<0 .05)
≥ 0.975. 
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௘௦௧െߤ஼௢௡௧௥௢௟൒0.05 logMAR
ܪ஺: ߤ்௘௦௧െߤ஼௢௡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௘௦௧െߤ஼௢௡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௘௦௧െߤ஼௢௡௧௥௢௟൒0.05 logMAR
ܪ஺: ߤ்௘௦௧െߤ஼௢௡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௘௦௧െߤ஼௢௡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 
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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௘௦௧െߤ஼௢௡௧௥௢௟൑-5
ܪ஺: ߤ்௘௦௧െߤ஼௢௡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௘௦௧െߤ஼௢௡௧௥௢௟>-5) ≥0.975
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 
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a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
using the EDC system. Data collected on equipment that is not captured in EDC will be 
formatted to the specification of the JJVC database manager and sent to JJVC for analysis. 
External data sources for this study include: Not Applicable
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
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
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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.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
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16.4. Data Monitoring Committee (DMC) 
An independent Data Monitoring Committee (DMC) will be established to oversee the study. 
Members of DMC must be free of significant conflicts of interest (i.e., financial, intellectual, 
professional, or regulatory), and are experts in all scientific disciplines needed to interpret the 
data and ensure study participant safety.
During the conduct of the trial, responsibilities of the DMC will be to periodically review and 
monitor the incidence of adverse events, determine whether the basic study assumptions 
remain valid, evaluate whether the overall integrity, scientific merit and conduct of the study 
remain acceptable, and make recommendations to the Sponsor. DMC meetings will be held 
quarterly until all subjects have completed the study. The DMC may also meet for an ad hoc 
review of data in the event that a UADE or other event is reported that may affect the outcome 
and/or continuation of the study.
The DMC will receive a data review package prior to the scheduled meeting. Data packages 
will include the following information/listings:
x
Subjects enrollment and disposition information, such as
o
Number and Reason for Subject Early Withdrawal
o
Number of subjects screened, randomized, early withdrawal, and complete
o
Number and Reason for Screen Failure
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.
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18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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.
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During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
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. 
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The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United 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.
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Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor.
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.
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x
Case Report Form signature.
x
Completion of any follow-up action items.
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor.
22. REFERENCES 
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects —
Good Clinical Practice. 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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21
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24
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX 
B: 
PATIENT 
INSTRUCTION 
GUIDE 
(TO 
BE 
PROVIDED 
SEPERATLEY)
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Dailies Total 1® Multifocal Contact Lenses 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
APPENDIX D: BINOCULAR OVER REFRACTION 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: OCULAR DOMINANCE 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
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.
APPENDIX H: CONTROL LENS FITTING GUIDE  
 
 
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Table of Contents
Introduction........................……………………………………………….....5
Product Description…..........……………..………………………...……....5
Lens Properties..…………………………………….……………6
Available Lens Parameters...………………………….…………6
Actions...………………...............................................………….…………6
Indications (Uses)........……......……………………………………………..6
Contraindications, Warnings, Precautions, Adverse Effects...............................7
Adverse Effect Reporting………...............……………………………......7
Fitting Guidelines (Spherical Lenses)....................................................8
Patient Selection...................................................................8
Pre fitting Examination.........................................................8 
Trial Lens Evaluation.............................................................8
Lens Base Curve Selection..............................................8
Initial Lens Power Selection.............................................8
Lens Fit Assessment........................................................9
Final Lens Power Determination....................................10
Fitting Guidelines (Multifocal  Lenses).................................................11
Pre Fitting Examination.......................................................11
Patient Selection..................................................................11 
Initial Lens Selection............................................................13
Initial Lens Fitting Evaluation...............................................14
Initial Lens Visual Evaluation...............................................15
Fitting Procedures...............................................................16
Fitting Guidelines (Monovision)............................................................18
Patient Selection..................................................................18 
Eye Selection.......................................................................18
Special Fitting Considerations............................................19
Near Add Determination.....................................................20
Trial Lens Fitting..................................................................20
Adaptation...........................................................................20
Other Suggestions..............................................................21
Dispensing Visit....................................................................................22
Follow Up Examinations..………...................………...........23
Follow up Examination Procedures..……....….....…...........23
Lens Handling Hints.............................................................................24
Lens Insertion.......................................................................24
Lens Removal.......................................................................25
Care for a Sticking Lens.......................................................25
In Office Care of Trial Lenses...............................................................25
Disposal and Recycling........................................................................25
Additional Information..........................................................................25
Product Package Insert........................................................................26
Vertex Distance Conversion Chart......................................................28
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INTRODUCTION
Thank you for prescribing DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal 
GHOH¿OFRQ$GDLO\GLVSRVDEOHVRIWFRQWDFWOHQVHV7KHEHQH¿WVRIDKLJKR[\JHQ
transmissible and wettable lens material with a state of the art manufacturing 
process are combined to make DAILIES TOTAL1® and DAILIES TOTAL1® 
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¿WWLQJSURFHGXUHVDQGDIWHUFDUHRIWKH'$,/,(6727$/® and DAILIES TOTAL1® 
0XOWLIRFDOGHOH¿OFRQ$FRQWDFWOHQVSDWLHQW
Daily Disposability 
By eliminating the need for lens care, daily disposable lenses offer your patients a 
PDMRUDGYDQFHPHQWLQZHDULQJFRQYHQLHQFH7KHQH[WWLPH\RXSUHVFULEHOHQVHV
FRQVLGHUWKHKHDOWKDQGFRPIRUWEHQH¿WVRIEHJLQQLQJHDFKZHDULQJSHULRGZLWKD
QHZSDLURIIUHVKVWHULOHOHQVHVWKDWDUHZRUQRQFHDQGWKHQGLVFDUGHG
LightStream® Lens Technology
DAILIES TOTAL1® and DAILIES TOTAL1®0XOWLIRFDOGHOH¿OFRQ$FRQWDFWOHQVHV
are made from a proprietary silicone hydrogel material with a water content of 
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quartz molds and photolithographic edge forming help ensure every lens has the 
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OHQV'HOH¿OFRQ$FRQWDFWOHQVHVDUHSURGXFHGXQGHUVWULFWO\FRQWUROOHGSURFHVV
FRQGLWLRQVDQGLQVSHFWHGWRH[DFWLQJTXDOLW\WROHUDQFHV$VDUHVXOW\RXFDQEH
FRQ¿GHQW \RXU SDWLHQWV ZLOO H[SHULHQFH FRQVLVWHQW YLVLRQ FRPIRUW DQG HDVH RI
KDQGOLQJHYHU\GD\
PRODUCT DESCRIPTION
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal soft contact lenses are 
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GHOH¿OFRQ $ SRO\PHU ZLWK DGGHG SKRVSKDWLG\OFKROLQH 7KH FRUH OHQV PDWHULDO
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a water gradient that has:
• 
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• 
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7KH OHQVHV FRQWDLQ DQG UHOHDVH SKRVSKDWLG\OFKROLQH '03& D SKRVSKROLSLG
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SKWKDORF\DQLQHDOLJKWEOXHWLQWZKLFKPDNHVWKHPHDVLHUWRVHHZKHQKDQGOLQJ
The lenses are packaged in strips of 5 individual blisters containing buffered saline 
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SRO\DPLGRDPLQHDQGSRO\DFU\ODPLGHDFU\OLFDFLG
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Lens Properties
• 
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[-11 (cm2VHF
 (ml O2 PO[PP+JPHDVXUHGDWÛ&
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• 
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
Available Lens Parameters1
DAILIES TOTAL1®GHOH¿OFRQ$VSKHULFDOFRQWDFWOHQVHV
• 
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PP
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• 
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WR''VWHSV
DAILIES TOTAL1®0XOWLIRFDOGHOH¿OFRQ$FRQWDFWOHQVHV
• 
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ADD: LO, MED, HI
1Check for actual product availability as additional parameters may be introduced 
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ACTIONS
When hydrated and placed on the cornea GHOH¿OFRQ$VRIWFRQWDFWOHQVHVDFWDVD
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INDICATIONS (USES)
DAILIES TOTAL1® GHOH¿OFRQ$VSKHULFDO soft contact lenses are indicated for 
WKHRSWLFDOFRUUHFWLRQRIUHIUDFWLYHDPHWURSLDP\RSLDDQGK\SHURSLDLQSKDNLFRU
DSKDNLFSHUVRQVZLWKQRQGLVHDVHGH\HVZLWKXSWRDSSUR[LPDWHO\GLRSWHUV
'RIDVWLJPDWLVPWKDWGRHVQRWLQWHUIHUHZLWKYLVXDODFXLW\
DAILIES TOTAL1® Multifocal GHOH¿OFRQ $ VRIW FRQWDFW OHQVHV DUH LQGLFDWHG
IRUWKHRSWLFDOFRUUHFWLRQRIUHIUDFWLYHDPHWURSLDP\RSLDDQGK\SHURSLDDQGRU
presbyopia in phakic or aphakic persons with non-diseased eyes who may require 
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7KHOHQVHVDUHWREHSUHVFULEHGIRUVLQJOHXVHGDLO\GLVSRVDEOHZHDU7KHOHQVHV
are not intended to be cleaned or disinfected and should be discarded after a 
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
See WARNINGS for information about the relationship between wearing 
schedule and corneal complications.
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE 
EFFECTS
For additional important prescribing and safety information, refer to the Package 
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ADVERSE EFFECT REPORTING 
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DAILIES TOTAL1® or DAILIES TOTAL1®0XOWLIRFDOGHOH¿OFRQ$FRQWDFWOHQVHVLQ
the USA please contact Alcon Medical Safety at .
FITTING GUIDELINES 
Please see the appropriate sections of this booklet that contain guidelines for 
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FITTING GUIDELINES (Spherical Lenses)
1. Patient Selection
The patient characteristics necessary to achieve success with DAILIES 
TOTAL1® GHOH¿OFRQ$ VSKHULFDO lenses are similar to those for other 
VSKHULFDOVRIWFRQWDFWOHQVHV$WKRURXJKSUH¿WWLQJH[DPLQDWLRQVKRXOG
be conducted to ensure the patient is a suitable candidate for soft contact 
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TOTAL1®GHOH¿OFRQ$VSKHULFDO OHQVHV)RUDGGLWLRQDOWLSVRQ¿WWLQJWKH
monovision patient refer to the section Monovision Fitting Guidelines.
2. 3UH¿WWLQJ([DPLQDWLRQ
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$SUH¿WWLQJH[DPLQDWLRQLVQHFHVVDU\WR
• 
 assess the patient’s motivation, physical state and willingness to 
comply with instructions regarding hygiene and wear schedule
• 
 make ocular measurements for initial contact lens parameter 
selection
• 
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results can be compared
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• 
a thorough case history
• 
a spherocylindrical refraction
• 
keratometry
• 
WHDU¿OPDVVHVVPHQW
• 
biomicroscopy
3. Trial Lens Evaluation
A. Lens Base Curve Selection
$ZHOO¿WWHGOHQVSURYLGHVJRRGPRYHPHQWFHQWUDWLRQDQGFRPIRUW$Q
RSWLPDO¿WFDQEHDFKLHYHGIRUWKHYDVWPDMRULW\RISDWLHQWVZLWKWKHVLQJOH
PPEDVHFXUYH
 B.  Initial Lens Power Selection
 The initial power selection should be as close as possible to the patient’s 
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FDOFXODWLRQVLIQHFHVVDU\
 Spherical Equivalent Calculation
 To determine initial lens power, convert the spherocylindrical spectacle 
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Spherical Equivalent = Sphere power + 1/2 (Cylinder Power)
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Vertex Distance Conversion
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correction is necessary (see Vertex Distance Conversion Chart WR
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
$QLQYHUWHGOHQVPD\PLPLFWKHFKDUDFWHULVWLFVRIDORRVHOHQV,IDQ\RI
the above signs occur remove the lens and check to make sure it is not 
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General Fitting Tips
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D. Final Lens Power Determination
$IWHUWKHFKDUDFWHULVWLFVRIDZHOO¿WWHGOHQVKDYHEHHQVDWLV¿HGFRQGXFW
a spherical over-refraction to determine the proper lens power to be 
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11
FITTING GUIDELINES (Multifocal)
The DAILIES TOTAL1® MultifocalGHOH¿OFRQ$VRIWFRQWDFWOHQVLVDSURJUHVVLYH
aspheric simultaneous vision soft contact lens, intended to correct presbyopia 
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concentrated primarily in the central portion of the optical zone while the distance 
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across the surface of the lens allow patients requiring a reading addition of up to 
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Achieving high success with DAILIES TOTAL1®0XOWLIRFDOGHOH¿OFRQ$FRQWDFW
lenses is dependent on several factors, including the patient’s motivation, 
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information in this guide is designed to provide you with the tools to manage your 
presbyopic patients through each stage of the process from the initial case history 
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• 
 determine whether a patient is a suitable candidate for 
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• 
 make ocular measurements and assessments for initial contact 
lens parameter selection
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• 
 a thorough case history
• 
 detailed assessment of patient’s individual visual demands
• 
 understanding of patient’s objectives for lens wear and 
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• 
 a distance spherocylindrical refraction, near add determination 
and measurement of pupil diameter
• 
 keratometry
• 
 tear assessment
• 
 biomicroscopy
 
 
 Note: The importance of a thorough case history should not be 
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 Patient Selection
 The eye care professional should weigh several factors when considering 
patient selection for a DAILIES TOTAL1® 0XOWLIRFDO GHOH¿OFRQ$ VRIW
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is especially important to evaluate the particular visual needs, objectives, 
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may include current contact lens wearers, former wearers, and persons 
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 There are two general categories of candidates based on anticipated 
usage: those who seek
 lenses as their principal means 
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14
 
([DPSOH
OD
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Spherical equivalent 
(least minus):
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power:
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Spectacle Add:
'
Eye Dominance:
OS
Initial Trial Lens:
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LVQRWDYDLODEOHFKRRVHWKHQH[WFORVHVWOHDVWPLQXVPRVWSOXVOHQV
SRZHULQ\RXUWULDOVHW
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This allows time for the patient to adapt to the lenses and time for the 
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F
(YDOXDWH WKH ¿W RI WKH OHQVHV RQ WKH H\H The Push-up Test as 
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lens:
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
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A lens that is decentered > 1 mm, particularly temporal, is less 
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
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Push-up Test:
• 
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¿QJHURQWKHSDWLHQW¶VORZHUOLGDQGQXGJHWKHHGJH
of the lens upward while observing lens movement. 
Then pull the lid back down and observe the return 
of the lens. 
• 
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shortly after passing the limbus and then return 
freely to its original position.
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Characteristics of a Tight (Steep) Lens Fit
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EHWRRVWHHSDÀDWWHUOHQVODUJHUEDVHFXUYHLIDYDLODEOHVKRXOGEH
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following characteristics:
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,QVXI¿FLHQWRUQROHQV movement during a blink in primary gaze 
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conjunctival vessels when the lens moves during a blink or 
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conjunctiva, some conjunctival movement is occasionally seen 
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Push-up Test:
• 
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successfully nudged upward, the lens may 
remain decentered or return slowly to its original 
position.
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Characteristics of a Loose (Flat) Lens Fit
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LIDYDLODEOHVKRXOGEHHYDOXDWHG$ORRVHOHQV¿WZRXOGGLVSOD\VRPH
or all of the following characteristics:
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Push-up Test:
• 
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beyond the limbus and possibly encroaching upon 
or going beyond the pupil. It will then return very 
quickly to its original position and often times 
return lower than its original position.
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URRPWRD³UHDOZRUOG´VHWWLQJVXFKDVDURRPZLWKDQRXWVLGHYLHZ2QFHDQ
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over-refraction should be performed using a trial frame or hand held lenses 
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lenses because it allows the patient to maintain the head posture and 
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QDWXUDOO\XVHGXULQJHYHU\GD\WDVNV7KLVHQVXUHVWKDWWKHYLVXDOSHUIRUPDQFH
of the lens is being assessed under conditions where the on-eye positioning 
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FITTING GUIDELINES (Monovision)
Patient Selection
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 For a good prognosis, the patient should have adequately corrected 
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acuity, such as the amblyopic patient, may not be a good candidate for 
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,IWKHSDWLHQWUHTXLUHVFULWLFDOYLVLRQYLVXDODFXLW\DQGVWHUHRSVLVLWPXVW
be determined by trial whether this patient can function adequately with 
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activities as:
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dangerous machinery or performing other potentially hazardous 
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GULYLQJDXWRPRELOHVHJGULYLQJDWQLJKW3DWLHQWVZKRFDQQRW
pass requirements for a driver’s license with monovision 
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RYHUFRUUHFWLRQFDQEHSUHVFULEHGWRLPSURYHYLVLRQ
% 3DWLHQW(GXFDWLRQ
$OO SDWLHQWV GR QRW IXQFWLRQ HTXDOO\ ZHOO ZLWK PRQRYLVLRQ FRUUHFWLRQ
Patients may not perform as well for certain tasks with this correction as 
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that monovision, as well as other presbyopic contact lenses, or other 
alternatives, can create a vision compromise that may reduce visual 
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process, it is necessary for the patient to realize the disadvantages as well 
as the advantages of clear near vision in straight-ahead and upward gaze 
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Eye Selection
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test for eye dominance can be used:
A). 
Ocular Preference Determination Methods
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• 
 Method 2 - Determine which eye will accept the added 
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Place a trial spectacle near ADD lens in front of one eye and 
then the other while the distance refractive error correction 
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functions best with the near ADD lens over the right or left 
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B). 
Refractive Error Method
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PRUHP\RSLFOHVVK\SHURSLFH\HIRUQHDU
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
C). 
Visual Demands Method
• 
 Consider the patient’s occupation during the eye selection 
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patient’s gaze for near tasks is usually in one direction, 
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([DPSOH
 A person who places copy to the left side of the desk will 
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Special Fitting Considerations
Unilateral Lens Correction
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• 
 ([DPSOHV
• 
 Emmetrope: A presbyopic emmetropic patient who requires a
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WKHRWKHUH\HOHIWZLWKRXWDOHQV
• 
 Bilateral myope  $ SUHVE\RSLF SDWLHQW UHTXLULQJ D  GLRSWHU
$''ZKRLVGLRSWHUVP\RSLFLQWKHULJKWH\HDQGGLRSWHUV
myopic in the left eye may have the right eye corrected for distance 
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• 
Unilateral astigmat:
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Astigmatism
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in DAILIES TOTAL1®GHOH¿OFRQ$VSKHULFDOOHQVHV
• 
 Determine which eye to use for the near prescription (see Eye Selection, 
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• 
 Add the appropriate near add power to the spherical component of the 
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21
ZHHNVRIZHDUZKHQDGDSWDWLRQLVRFFXUULQJLWPD\EHDGYLVDEOHIRUWKHSDWLHQW
WRRQO\GULYHXQGHURSWLPDOGULYLQJFRQGLWLRQV$IWHUDGDSWDWLRQDQGVXFFHVVZLWK
these activities, the patient should be able to drive under other conditions with 
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Other Suggestions
The success of the monovision technique may be further improved by having your 
patient follow the suggestions below:
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LVQHHGHG
• 
 Have supplemental spectacles to wear over the monovision contact 
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those patients who cannot meet driver’s licensing requirements with a 
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the eye care professional in conjunction with the patient after carefully considering 
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Instruction Booklet, which contains important instructions for the monovision 
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LQWKH86$DW
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22
DISPENSING VISIT
To help ensure patient success the following steps should be conducted with 
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ZHDUHUVDUHSURQHWRGHYHORSEDGKDELWVRYHUWLPH
DAILIES TOTAL1®EUDQGGHOH¿OFRQ$OHQVHVDUHVXSSOLHGVWHULOHLQIRLOVHDOHG
EOLVWHUSDFNFRQWDLQHUV2SHQWKHIRLOSDFNE\SHHOLQJEDFNWKHIRLOOLGGLQJPDWHULDO
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WKHSDOPRI\RXUFOHDQKDQG
Conduct the following steps with each patient, even if they have previously worn 
contact lenses:
A. 9HUL¿FDWLRQRI/HQV)LW
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RIDZHOO¿WWHGOHQVVKRXOGEHPHWDQGWKHSDWLHQW¶VYLVXDODFXLW\VKRXOGEH
DFFHSWDEOH,IQRWWKHSDWLHQWVKRXOGEHUH¿WWHGZLWKDPRUHDSSURSULDWH
OHQV
B. +\JLHQHDQG/HQV+DQGOLQJ,QVWUXFWLRQV
*RRGK\JLHQHDQGSURSHUOHQVKDQGOLQJDUHLPSRUWDQWIDFWRUVLQDFKLHYLQJ
VDIHFRPIRUWDEOHOHQVZHDU,QVWUXFWWKHSDWLHQWRQK\JLHQHDQGKDQGOLQJ
RIOHQVHV3DWLHQWVZKRDUHXQDEOHWRSODFHDQGUHPRYHOHQVHVVKRXOGQRW
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contact lenses consider a wearing schedule that allows for a gradual 
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The lenses are not intended to be cleaned or disinfected and should be 
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information and instructions have proven useful in advising patients who 
wear DAILIES TOTAL1®0XOWLIRFDOGHOH¿OFRQ$VRIWFRQWDFWOHQVHV
- 
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GRHVDELIRFDORUPXOWLIRFDOVSHFWDFOHOHQV7KLVLVEHFDXVHWKH
contact lens moves with the eye, rather than having the eye 
move up and down while the lens remains suspended in a 
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advantages may mean that the sharpness of vision may not 
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wear spectacles, or where the disadvantages associated with 
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normal and natural response to the challenges presented by 
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URRPUHGXFHGYLVLELOLW\HJRXWGRRUFRQGLWLRQVRIIRJRUKHDY\
UDLQ RU LVRODWHG VRXUFHV RI YHU\ EULJKW OLJKW HJ KHDGOLJKWV
RI DQ RQFRPLQJ YHKLFOH RQ D QDUURZ FRXQWU\ URDG Patients 
should be instructed to make use of good light when 
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operating heavy machinery while wearing their lenses until 
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individual needs and environmental conditions that the patient 
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achieved are important for patient motivation during the initial 
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• 
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
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OHQVHV 5HYLHZ WKH FRQWHQWV VR WKH SDWLHQW FOHDUO\ XQGHUVWDQGV WKH
SUHVFULEHGOHQVZHDUFDUHDQGUHSODFHPHQWVFKHGXOH,QWKH86$\RX
can obtain copies of the instruction book by calling Alcon customer 
serviceDW
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Lens Removal
• 
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¿QJHUWLSVDUHZHWWKH\DUHOLNHO\WRVOLSDFURVVWKHVXUIDFHRIWKHOHQVPDNLQJ
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on the eye, instruct the patient to apply several drops of a recommended 
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patient should wait until the lens begins to move freely on the eye before 
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immediately FRQVXOWWKHH\HFDUHSURIHVVLRQDO
IN OFFICE CARE OF TRIAL LENSES
Eye care professionals should understand and educate contact lens technicians 
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- 
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washed and rinsed and dried with a lint-free towel prior to handling a 
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GLVFDUGHGDIWHUDVLQJOHXVH7KHlenses should be disposed of after 
a single use and not be re-used from patient to patient.
DISPOSAL AND RECYCLING
Dispose of contact lenses and the blister pack lidding in the waste bin, not down 
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the blister pack should be placed in the waste bin or recycled according to local 
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ADDITIONAL INFORMATION
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and DAILIES TOTAL1® Multifocal contact lenses eye care professionals having 
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DW7RRUGHU'$,/,(6727$/® and DAILIES TOTAL1® Multifocal 
contact lenses contact your Alcon sales representative or call Customer Service, 
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
VERTEX DISTANCE CONVERSION CHART
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
$OFRQ,QF 
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Manufacturer: 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX I:  C-QUANT STRAYLIGHT MEASUREMENT 
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Johnson & Johnson Vision Care, Inc.
APPENDIX I:  C-QUANT STRAYLIGHT MEASUREMENT
VCT-0007 (10)
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Work Aid: Optical Scatter Measurement (C-Quant)    
VCT-0007 (10) 
 
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Work Aid: Optical Scatter Measurement (C-Quant)    
VCT-0007 (10) 
 
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Work Aid: Optical Scatter Measurement (C-Quant)    
VCT-0007 (10) 
 
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Page 4 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
VCT-0007 (10) 
 
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Page 5 of 6
Work Aid: Optical Scatter Measurement (C-Quant)    
VCT-0007 (10) 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX J:  VISIONIX CORNEAL TOPOGRAPHY AND WAVEFRONT 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX K: 
 
 
x
DETERMINATION OF NEAR ADDITION
x
 NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE
x
 LENS FITTING CHARACTERISTICS
x
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIVE ERROR
x
 BIOMICROSCOPY SCALE
x
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION
x
DISTANCE LOGMAR VISUAL ACUITY MEASURMENT PROCEDURE
x
 PATIENT REPORTED OUTCOMES
x
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DETERMINATION OF NEAR ADDITION 
 
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Title:                          Determination of Near Addition
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 1 of 5
  
    
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Title:                          Determination of Near Addition
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 2 of 5
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Title:                          Determination of Near Addition
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 3 of 5
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Title:                          Determination of Near Addition
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 4 of 5
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Title:                          Determination of Near Addition
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 5 of 5
  
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
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Title:                         Near LogMAR Visual Acuity Measurement Procedure
Document Type:  
Work Instructions
Document Number:  
Revision Number:  8
Page 1 of 2
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Title:                         Near LogMAR Visual Acuity Measurement Procedure
Document Type:  
Work Instructions
Document Number:  
Revision Number:  8
Page 2 of 2
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
LENS FITTING CHARACTERISTICS 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 1 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 2 of 5
      
       
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:
Revision Number:  5
Page 3 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 4 of 5
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Title:                          Lens Fitting Characteristics
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 5 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
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Title:                         Subject Reported Ocular Symptoms/Problems
Document Type:  
Work Instructions
Document Number:
Revision Number:  3
Page 1 of 1
  
  
            
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIVE ERROR 
 
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:
Revision Number:  5
Page 1 of 5
  
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:
Revision Number:  5
Page 2 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 3 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 4 of 5
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Title:                        Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Work Instructions
Document Number:  
Revision Number:  5
Page 5 of 5
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
BIOMICROSCOPY SCALE  
 
 
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
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Title:
Biomicroscopy Scale
Document Type:
Work Instruction
Document Number:
Revision Number:  9
  
CR-6444, v1.0
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 1 of 4
  
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Title:                        Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Work Instructions
Document Number:  
Revision Number:  4
Page 2 of 4
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DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
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 PATIENT REPORTED OUTCOMES 
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Patient Reported Outcomes
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Procedure
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2
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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APPENDIX L: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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Title:
Guidelines for COVID-19 Risk Mitigation
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Work Instruction
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Revision Number: 5
 
1.0
PURPOSE
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19
pandemic.
2.0
SCOPE
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as
appropriate.
NOTE:  Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance.
3.0
DEFINITIONS
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements.
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care.
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia.
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-
19).
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols.
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator.
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial.
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements.
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety.
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle.
4.0
GUIDANCE FOR STUDY DOCUMENTS
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol.  
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel:
Additional Risks Related to the COVID-19 Pandemic:
x
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures.
x
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms.
x
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits.
x
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including
an unscheduled visit, up to discontinuation from the study, as appropriate.
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution.
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks:
4.1.1
Informed Consent:
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document:
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STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff.
4.1.2
COVID-19 Risk Control Checklist (Attachment-B):
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting.
4.1.3
Protocol Compliance Investigator(s) Signature Page:
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
4.1.4
Study Site Initiation Training Slides:
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients,
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment.
5.0
GUIDANCE FOR REMOTE SUBJECT VISITS
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions.  Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits.
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible.  Discussions with the subject during remote assessments 
may include:
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The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.
 
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable.  
Study site training will be documented utilizing Site Initiation Report
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.).
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan (
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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6.1.3
Study Site Closure:  
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.).  
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Attachment A: Study Site Correspondence
XXXX XX, 2020
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>>
Dear <<Principal Investigator>> and Study Team,
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
Protocol:
x
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section.
Protocol Signature Page:
x
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Informed Consent:
x
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document.
COVID-19 Risk Control Checklist for Clinical Studies:
x
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic.   
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers).  
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
Please file this letter in your site file study correspondence. 
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RESOURCE LINKS
US Resource Links 
x
OSHA Training
https://www.osha.gov/SLTC/covid-19/controlprevention.html
Personal Protective Equipment (PPE) Training
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html
x
I&R Training
ACUVUE® LensAssist: https://www.acuvue.com/lensassist   
x
Clinic Preparedness Guides
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness html
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covid·19/1?m4=
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness-
guide
x
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic-
lenses.pdf
OUS Resource Links 
x
Updates on local regulations in Hong Kong
https://www.coronavirus.gov hk/eng/index.html
x
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical-
services-letter-17-june-2020.pdf
x
NHS Optical Letter
https://www.england nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april-
2020.pdf
x
The College of Optometrists primary eye care COVID-19 guidance: Red phase
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance-
for-optometrists.html
x
The College of Optometrists COVID-19: College updates
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for-
optometrists.html#CollegeGuidelines
x
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf
x
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public-
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance-
outpatient-ambulatory-care-settings html
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x
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf
x
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health:
https://www health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals-
including-aged-care-providers-pathology-providers-and-health-care-managers
 
x
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection-
principles-for-covid-19.pdf
x
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need-
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6444 Evaluation of Investigational Daily Disposable Multifocal 
Contact Lenses Produced with Different Manufacturing Processes in Myopes
Version and Date: 1.0 23 April 2021
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion.
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix L of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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