Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed Product
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Protocol Title: Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed 
Product 
Protocol CR-6468
Version: 2.0
Date: 29 September 2021 
Investigational Products: JJVC Investigational Multifocal-PG Contact Lenses manufactured in 
senofilcon A C3 
Keywords:   
Senofilcon A C3, Delefilcon A, 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 14155:2020,1 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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Johnson & Johnson Vision Care, Inc.
TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
AUTHORIZED SIGNATURES............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study ...................................................................................................................................17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 19 
2.1. 
Objectives ................................................................................................................. 19 
2.2. 
Endpoints .................................................................................................................. 19 
2.3. 
Hypotheses ............................................................................................................... 20 
3. 
TARGETED STUDY POPULATION ........................................................................... 21 
3.1. 
General Characteristics ............................................................................................ 21 
3.2. 
Inclusion Criteria ...................................................................................................... 21 
3.3. 
Exclusion Criteria ..................................................................................................... 22 
3.4. 
Enrollment Strategy.................................................................................................. 23 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 23 
4.1. 
Description of Study Design .................................................................................... 23 
4.2. 
Study Design Rationale ............................................................................................ 23 
4.3. 
Enrollment Target and Study Duration .................................................................... 23 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 24 
5.1. 
Test Article Allocation ............................................................................................. 24 
5.2. 
Masking .................................................................................................................... 24 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 25 
6. 
STUDY INTERVENTION ............................................................................................. 26 
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6.1. 
Identity of Test Articles............................................................................................ 26 
6.2. 
Ancillary Supplies/Products ..................................................................................... 27 
6.3. 
Administration of Test Articles ................................................................................ 27 
6.4. 
Packaging and Labeling ........................................................................................... 27 
6.5. 
Storage Conditions ................................................................................................... 27 
6.6. 
Collection and Storage of Samples .......................................................................... 27 
6.7. 
Accountability of Test Articles ................................................................................ 28 
7. 
STUDY EVALUATIONS .............................................................................................. 28 
7.1. 
Time and Event Schedule ......................................................................................... 28 
7.2. 
Detailed Study Procedures ....................................................................................... 31 
VISIT 1 ........................................................................................................................... 31 
VISIT 2 ........................................................................................................................... 37 
VISIT 3 ........................................................................................................................... 41 
VISIT 4 ........................................................................................................................... 45 
FINAL EVALUATION .................................................................................................. 48 
7.3. 
Unscheduled Visits ................................................................................................... 49 
7.4. 
Laboratory Procedures ............................................................................................. 50 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 51 
8.1. 
Completion Criteria .................................................................................................. 51 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 51 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 52 
9.1. 
Systemic Medications .............................................................................................. 52 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 52 
11. 
STUDY TERMINATION ........................................................................................... 53 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 54 
13. 
ADVERSE EVENTS ................................................................................................... 55 
13.1. 
Definitions and Classifications ............................................................................. 55 
13.2. 
Assessing Adverse Events .................................................................................... 57 
13.2.1. 
Causality Assessment .................................................................................... 57 
13.2.2. 
Severity Assessment ...................................................................................... 58 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 58 
13.4. 
Reporting Adverse Events .................................................................................... 60 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 60 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
........................................................................................................................61 
13.5. 
Event of Special Interest ....................................................................................... 61 
13.6. 
Reporting of Pregnancy ........................................................................................ 61 
14. 
STATISTICAL METHODS ........................................................................................ 61 
14.1. 
General Considerations ......................................................................................... 61 
14.2. 
Sample Size Justification ...................................................................................... 62 
14.3. 
Analysis Populations ............................................................................................ 63 
14.4. 
Level of Statistical Significance ........................................................................... 63 
14.5. 
Primary Analysis .................................................................................................. 63 
14.6. 
Secondary Analysis .............................................................................................. 65 
14.7. 
Other Exploratory Analysis .................................................................................. 65 
14.8. 
Interim Analysis ................................................................................................... 67 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 67 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 67 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 68 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 68 
15.2. 
Subject Record ...................................................................................................... 68 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 69 
16. 
DATA MANAGEMENT............................................................................................. 69 
16.1. 
Access to Source Data/Document ........................................................................ 69 
16.2. 
Confidentiality of Information.............................................................................. 69 
16.3. 
Data Quality Assurance ........................................................................................ 69 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 70 
17. 
CLINICAL MONITORING ........................................................................................ 70 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 70 
18.1. 
Study-Specific Design Considerations ................................................................. 70 
18.2. 
Investigator Responsibility ................................................................................... 70 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 71 
18.4. 
Informed Consent ................................................................................................. 72 
18.5. 
Privacy of Personal Data ...................................................................................... 72 
19. 
STUDY RECORD RETENTION................................................................................ 73 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 74 
21. 
PUBLICATION ........................................................................................................... 74 
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Johnson & Johnson Vision Care, Inc.
22. 
REFERENCES ............................................................................................................ 74 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 76 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 99 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 100 
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE .................................... 103 
APPENDIX E: OCULAR DOMINANCE ........................................................................... 104 
APPENDIX F: LENS FITTING GUIDE ............................................................................. 105 
APPENDIX G: CONTROL LENS FITTING GUIDE ......................................................... 107 
APPENDIX H: BINOCULAR OVER REFRACTION ....................................................... 138 
APPENDIX I: 
 ...................................... 139 
, Determination of Near Addition ........................................................................ 140 
, Near LogMAR Visual Acuity Measurement Procedure .................................... 146 
, Lens Fitting Characteristics ................................................................................ 149 
, Subject Reported Ocular Symptoms/Problems .................................................. 155 
, Determination of Distance Spherocylindrical Refractive Error ......................... 157 
, Biomicroscopy Scale .......................................................................................... 163 
, Distance and Near Snellen Visual Acuity Evaluation ........................................ 169 
, Distance LogMAR Visual Acuity Measurement Procedure .............................. 174 
, Patient Reported Outcomes ................................................................................ 178 
, Visual Acuity Chart Luminance and Room Illumination Testing ..................... 180 
APPENDIX J: 
 Guidelines for COVID-19 Risk Mitigation................................ 189 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 201 
LIST OF TABLES
Table 1: Test Articles .............................................................................................................. 26 
Table 2: Ancillary Supplies .................................................................................................... 27 
Table 3: Time and Events ....................................................................................................... 28 
Table 4: Disallowed systemic medications ............................................................................. 52 
Table 5: Examples of major and minor protocol deviations ................................................... 53 
Table 6: Historical Data by Endpoint and Lens – 1-Week Follow-up: Period 1 Only ........... 62 
Table 7: Sample Size Estimates by Endpoint ......................................................................... 62 
LIST OF FIGURES
Figure 1: Study Flowchart ...................................................................................................... 14 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE
Title: Protocol Title: Comparison of a Daily Disposable Multifocal Contact Lens to a Marketed 
Product 
Protocol Number:  CR-6468 
Version: 2.0 
Date: 29 September 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 14155:2020,1 ICH guidelines,2 and the 
Declaration of Helsinki.3
Study Responsible 
Clinician
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
Reviewer
See Electronic Signature Report
DATE
Reviewer
See Electronic Signature Report
DATE
Medical Safety Officer
See Electronic Signature Report
DATE
Approver
See Electronic Signature Report
  
DATE
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Johnson & Johnson Vision Care, Inc.
CHANGE HISTORY
Version
Originator
Description of Change(s) and 
Section Number(s) Affected
Justification 
for Change
Date
1.0
Original Protocol
N/A
03 Sep 2021
2.0
Throughout document-
updated version, date and 
removed myope population 
information.
Synopsis and Section 3.3-
corrected typo in exclusion 
#6.
Project Team 
decision to 
evaluate 
hyperopes 
Corrected 
typo 
29 Sep 2021
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Johnson & Johnson Vision Care, Inc.
SYNOPSIS 
Protocol Title
Comparison of a Daily Disposable Multifocal Contact Lens to 
a Marketed Product
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Clinical trial phase: Confirmation Clinical
Design control phase:  Phase 3
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 (Aurora)
Control: Dailies Total 1® Multifocal Contact Lenses 
manufactured in delefilcon A material (DT1MF)
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 
Primary Objectives:
The primary objective of this study is to evaluate the binocular 
visual performance (logMAR acuity) and subjective vision 
responses (CLUE Vision) with respect to the Aurora lens after 
1-week of optimized lens wear.
Secondary Objectives: 
The secondary objective of this study is to compare the 
clinical performance of Aurora relative to DT1MF after 1-
week of optimized lens wear with respect to binocular visual 
performance and subjective vision responses.  
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Johnson & Johnson Vision Care, Inc.
Study Endpoints
Primary endpoints:
1. binocular  HLHC visual performance (logMAR) – 
distance, intermediate and near
2. CLUE vision scores 
Secondary endpoints:
1. binocular  HLHC visual performance (logMAR) – 
distance, intermediate and near
2. CLUE vision scores 
Other Endpoints: 
1. CLUETM Comfort 
2. CLUETM Handling  
3. Lens Optimization Summary 
4. Mechanical Lens Fit
5. Slit Lamp Findings
6. Individual Item “I experienced crisp clear vision at all 
distances” [
] 
7. Individual Item “I experienced crisp clear vision at all 
lighting conditions” [
]
Study Design
This 
is 
a 
single-masked, 
two-arm, 
parallel-group, 
randomized-controlled, dispensing clinical trial. Up to 70 
subjects will be enrolled into the study with the aim of 
completing approximately 60 subjects .  The subjects will be 
randomized and fit (Visit 1) in a study lens (Aurora  or 
DT1MF) 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), study endpoints will be collected and subjects will be 
dispensed a fresh lens with the same power as dispensed at 
Visit 2. Lenses will be worn for an additional week (7±1 day).  
At the follow-up visit (Visit 4) the study endpoints will be 
collected and the subject will be exited from the study. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
A total of approximately 70 eligible subjects will be enrolled  
with 60 subjects targeted to complete.
Study Duration
The study will last approximately 2 to 3 months.
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Johnson & Johnson Vision Care, Inc.
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:
The subject must: 
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Be at least 40 years of age and not greater than 70 years 
of age at the time of consent.
4. Own a wearable pair of spectacles if required for their 
distance vision. 
5. 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. 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 at 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. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQ
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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Johnson & Johnson Vision Care, Inc.
Eligibility Criteria –
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic 
allergies that may interfere with contact lens wear.  
3. Have 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. Have any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.).
5. Have 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. Have a history of herpetic keratitis.
9. Have a history of irregular cornea.
10. Have a history of pathological dry eye. 
11. Have Participated in any contact lens or lens care 
product clinical trial within 30 days prior to study 
enrollment.
12. Be and employee or immediate family member of an 
employee 
of 
clinical 
site 
(e.g., 
Investigator, 
Coordinator, Technician). 
13. Have any known hypersensitivity or allergic reaction 
to non-preserved rewetting drop solutions or sodium 
fluorescein.
Exclusion Criteria at Baseline:
The subject must not:
14. Have clinically significant (Grade 3 or greater) corneal 
edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal 
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Johnson & Johnson Vision Care, Inc.
or ocular abnormalities which would contraindicate 
contact lens wear.
15. Have any current ocular infection or inflammation. 
16. Have 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 in the protocol for details regarding disallowed 
systemic medications.
Measurements and 
Procedures
logMAR 
acuity, 
subjective 
responses 
for 
vision, 
biomicroscopy and fit evaluations. 
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, may result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Non-Preserved Rewetting drops, lens cases, glass vials, saline, 
ETDRS light cabinet, 4 M logMAR charts, and Near logMAR 
charts.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart
 60 to complete
Potential Subjects Identified Based On:
x
Age: 40-70 yrs. (inclusive)  
x
Habitual contact lens wearers with Presbyopic correction or symptoms
x
Refraction: Spherical Equivalent +1.25D to +3.75DCylinder: ч0.75D
x
Add: +0.75D to +2.50D
x
Visual Acuity: Best corrected 20/20-3 or better in each eye 
Informed Consent 
Eligibility
Baseline Information
x
Medical History, Habitual lens type, modality, and contact lens history. Wear Time
x
Baseline PRO, MRD and  CLDEQ-8 Questionnaire
x
Ocular Symptoms, Entrance Visual Acuity, Subjective refraction, Add Determination, Ocular Dominance, Add Refinement, Near Visual Acuity
x
Biomicroscopy
x
Randomization
Visit 1 Treatment 1 Lens Fitting
x
Lens Selection, Lens Insertion, Lens Settling, Visual Satisfaction, Near Visual Acuity, Distance Over Refraction, Distance Visual Acuity, Lens Fit 
Assessment
Lens Moification 
x
Exit Visual Acuity, Dispensing Criteria, Patient Instructions
x
Follow-up 3±1 days.
Visit 2 Treatment 1 Follow-up 1
x
Adverse Events, Concomitant Medications, Wear Time, Compliance, Ocular Symptoms, Subjective Acceptance
x
Entrance Visual Acuity, Distance Over Refraction, Distance Visual Acuity
x
Determination of Lens Optimization
Lens modification
After 10 minutes settling
x
Lens Fit Assessment, Collection of Unworn Lenses, Lens Removal
x
Biomicroscopy, 
x
Lens Insertion, Exit Visual Acuity
x
Dispensing Criteria, Patient Instructions
x
Follow-up 7±1 days
Visit 3 Treatment 1 Follow-2
x
Adverse Events, Concomitant Medications, Wear Time, Compliance PRO, CLUE, MRD, CLEDQ-8 Questionnaires, Ocular Symptoms, Subjective 
Acceptance
x
Entrance Visual Acuity, Visual Performance, Binocular Distance Over Refraction and Distance Visual Acuity, Lens Fit Assessment, Lens Removal
x
Bimicroscopy, Lens Insertion, Exit Visual Acuity
x
Dispensing Criteria, Patient Instructions
x
Follow-up 7±1 days
Visit 4 Treatment 1 Follow-up 3
x
Adverse Events, Concomitant Medications, Wear Time, Compliance PRO, CLUE, MRD, CLEDQ-8 Questionnaires, Ocular Symptoms, Subjective 
Acceptance
x
Entrance Visual Acuity, ,Visual Performance, Binocular Distance Over Refraction and Distance Visual Acuity, Lens Fit Assessment
x
Collection of Unworn lenses, Lens Removal
x
Bimicrroscopy
Final Evaluation
No
Yes
Yes
No
Yes
Yes
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
COVID-19 
 
Coronavirus Disease 2019 
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NAVQ  
 
Near Activity Visual Questionnaire
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
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PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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Johnson & Johnson Vision Care, Inc.
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 manufactured on a different manufacturing line.  
The last set of prototypes evaluated were manufactured on a different manufacturing line, 
however used a similar process that is being used on the new line.  The performance of these 
new lenses will be compared to a marketed product, Dailies Total 1® Multifocal Contact 
Lenses.  
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.   
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical
trials on humans. For the most comprehensive nonclinical information regarding the Test 
lenses refer to the latest version of the CR-6468 Investigational Brochure.5
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.   
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
The Test lenses have been previously tested in clinical studies
was discontinued 
early by the Sponsor due to the COVID-19 pandemic.  There were no Adverse Events 
reported in 
.  At the time of writing of this protocol studies 
 and 
 did not have final study reports.  A summary of the lens performance in studies 
 is provided below.6-13    
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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 unrelated related to 
study article/procedure.6
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.7    
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 
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.9
 was a single masked, randomized controlled, dispensing clinical trial and had a 
primary endpoint of logMAR visual acuity.  There were 60 subjects that completed the study 
per the protocol.  The lenses displayed good clinical vision performance with binocular, high 
luminance, high contrast logMAR visual acuity of -0.132, -0.066 and 0.072 at distance, 
intermediate and near respectively.  There were four adverse of events during the study.  
Three of the four were non-ocular adverse events.  Two of those not related to the study 
lenses and one (headache) was related to the Control Contact lens.  There was one ocular 
adverse event (non-significant infiltrative event) that was possibly related to the test lens.10   
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. 
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2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective:
The primary objective of this study is to evaluate the binocular visual performance (logMAR
acuity) and subjective vision responses (CLUE Vision) with respect to the Aurora lens after 1-
week of optimized lens wear.
Secondary Objective:
The secondary objective of this study is to compare the clinical performance of Aurora relative 
to DT1MF after 1-week of optimized lens wear with respect to binocular visual performance 
and subjective vision responses.  
2.2.
Endpoints 
Primary  and Secondary Endpoints: 
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 I for details 
regarding the collection of visual acuity (logMAR) visual ability.
Subjective Vision  
Subjective vision will be assessed using the Contact Lens User Experience (CLUE™) 
questionnaire at both the 1- and 2-week follow-up evaluations. However, data collected at the 
1-week follow-up will be used to test primary hypotheses with respect to CLUE vision.  
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. 
Other Endpoints: 
8. CLUETM Comfort 
9. CLUETM Handling  
10. Lens Optimization Summary 
11. Mechanical Lens Fit
12. Slit Lamp Findings
13. Individual Item “I experienced crisp clear vision at all distances” [
] 
14. Individual Item “I experienced crisp clear vision at all lighting conditions” [
 
] 
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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 superior to 
0.0 logMAR. 
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 
superior to 0.17 logMAR. 
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 superior to 0.17 
logMAR. 
4. After approximately 1-week of wear in the optimized lenses, the CLUE vision score of 
the Test lens for the hyperope population will be superior to 32 CLUE points. 
All primary hypotheses must be met prior to testing the secondary hypothesis. 
Secondary 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. 
All primary and secondary hypotheses must be met in order to test any exploratory hypotheses. 
Exploratory 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 within 
the hyperopes.  A non-inferiority margin of -5 CLUE points will be used. 
2. After approximately 2-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 within 
the hyperopes.  A non-inferiority margin of -5 CLUE points will be used.
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3. After approximately 1-week of wear in the optimized lenses, the intermediate, 
binocular, high luminance, high contrast visual performance of the Test lens will be 
non-inferior compared to that of the Control lens.  A non-inferiority margin of 0.05 
logMAR will be used. 
4. 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. 
5. After approximately 2-weeks of wear in the optimized lenses, the distance, binocular, 
high luminance, high contrast visual performance of the Test lens will be superior to 
0.0 logMAR. 
6. After approximately 2-weeks of wear in the optimized lenses, the intermediate, 
binocular, high luminance, high contrast visual performance of the Test lens will be 
superior to 0.17 logMAR. 
7. After approximately 2-weeks of wear in the optimized lenses, the near, binocular, high 
luminance, high contrast visual performance of the Test lens will be superior to 0.17 
logMAR. 
8. After approximately 2-weeks of wear in the optimized lenses, the CLUE vision score
of the Test lens for the hyperope population will be superior to 32 CLUE points. 
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. Subjects enrolled 
in this study will be hyperopic have presbyopia.    
3.2.
Inclusion Criteria
Potential subjects must satisfy all the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening:
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be at least 40 years of age and not greater than 70 years of age at the time of consent. 
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4. Own a wearable pair of spectacles if required for their distance vision.
5. 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. 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 at 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. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQHDFKeye.
9. The subject’s ADD power must be in the range of +0.75 D to +2.50 D. 
10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each 
eye.
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
Exclusion Criteria after Screening:
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear.  
3. Have 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. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, 
PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.). 
5. Have 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. Have a history of herpetic keratitis.
9. Have a history of irregular cornea.
10. Have a history of pathological dry eye. 
11. Have Participated in any contact lens or lens care product clinical trial within 30 days 
prior to study enrollment. 
12. Be and employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
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13. Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop 
solutions or sodium fluorescein. 
Exclusion Criteria at Baseline:
The subject must not: 
14. Have 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. Have any current ocular infection or inflammation. 
16. Have 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. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a single-masked, multi-site, two-arm, parallel-group, randomized-controlled, 
dispensing clinical trial. Up to 70 subjects will be enrolled in this study with the aim of 
completing approximately 60. 
At Visit 1 (Day 0), eligible subjects will be randomized and fit into one of the study lenses
(test or control) in a bilateral fashion. Subjects will be dispensed to wear the lenses for 3±1 day 
and return for Visit 2 to undergo optimization. Subjects will be dispensed the study lenses and 
wear the optimized pair for approximately 1 week (7±1 days). At the follow-up visit (Visit 3) 
study endpoints will be measured, and a new study lens will be dispensed for the same lens 
type and power and will be worn for an approximately 1 week (7±1 days).  At the final follow-
up visit (Visit 4) the study endpoints will be measured, and the subject will be exited from the 
study. 
4.2.
Study Design Rationale 
The study objectives are to assess and compare the clinical performance of Aurora compared 
to DT1MF, therefore, a two-arm parallel study was chosen as the design most optimal to 
evaluate the primary and secondary hypotheses.  
4.3.
Enrollment Target and Study Duration
A total of 70 subjects will be enrolled with a target of approximately 60 eligible subjects to 
complete the study.  The study is anticipated to last 2-3 months. 
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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- arm parallel design. 
A computer-generated randomization scheme will be used to randomly assign subjects, in 
blocks of 2, to one of the two possible study lenses: Aurora or DT1MF . The randomization 
scheme will be stratified by site. 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).14
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  Randomization will be performed 
at visit first visit prior to the first fitting. The following must have occurred prior to
randomization: 
ͻ
Informed consent must have been obtained.  
ͻ
The subject must have met all eligibility criteria.
ͻ
The subject’s screening and baseline information must have been collected.
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 to obtain the test article assignment for that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
lens fitting schedule.
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2.
Masking
This is a single-masked study. 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. 
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5.3.
Procedures for Maintaining and Breaking the Masking
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before
the mask is broken. 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme if applicable
Investigator or designee will pull the appropriate test articles from the study supply. All test 
articles that are opened, whether dispensed (placed/fit on eye or dispensed outside the clinical 
site) or not, must be recorded on the Test Article Accountability Log in the “Dispensed”
section.
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6.
STUDY INTERVENTION
6.1.
Identity of Test Articles 
The following contact lenses will be used in this study: 
Table 1: Test Articles
Test
Control
Name
JJVC Investigational 
Multifocal Contact Lens 
Process A
Dailies Total 1® Multifocal 
Contact Lens
Manufacturer
Johnson & Johnson® Vision 
Care, Inc.
Alcon
 
 
 
 
 
 
 
N/A
Lens Material
senofilcon A (C3)
delefilcon A 
Nominal Base Curve 
8.35 mm
8.5 mm
Nominal Diameter 
14.3 mm
14.1 mm
Nominal Distance 
Powers (D)
+1.00 D to +4.00 D in 0.25 
D steps
+1.00 D to +4.25 D in 0.25 D 
steps
Nominal ADD Powers 
(D)
LOW, MID, HI
LO, MED, HI
Water Content 
38%
33%
Center Thickness 
@ -3.00 D
0.07 mm
@ -3.00 D
0.09 mm@ -1.00 D
Oxygen Permeability 
(Dk)
103
156
@ -3.00 D
Wear Schedule in 
Current Study 
Daily Wear
Daily Wear 
Replacement Frequency
Daily
Daily
Packaging Form (vial, 
blister, etc.)
Blister
Blister
Packaging Form (vial, 
blister, etc.)
Blister
Blister
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6.2.
Ancillary Supplies/Products
The following solutions will be used in this study: 
Table 2: Ancillary Supplies
Single-Use Preservative-Free Rewetting Solutions (any one 
of these three rewetting solutions options may be supplied)
Solution Name/Description
Eye-Cept®
Rewetting Drops 
ScleralFil®
Preservative Free 
Saline Solution
LacriPure Saline 
Solution 
Manufacturer
Optics Laboratory
B&L
Menicon
Preservative
Non-Preserved
Non-preserved
Non-preserved
6.3.
Administration of Test Articles
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the investigator and/or the sponsor.  
6.4.
Packaging and Labeling
The test articles will be packaged in blisters, as the primary packaging.  The test article will be 
over-labeled to mask the subject to the identity of the lens.  The test articles will be in 
investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic bags 
as the secondary packaging form. The sample study label is shown below: 
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
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6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately.
7.
STUDY EVALUATIONS 
7.1.
Time and Event Schedule
Table 3: Time and Events 
Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Treatment 1
Follow-up 3 
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 7±1 
from V3 
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.5 hour
Statement of Informed 
Consent
x
Demographics
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Treatment 1
Follow-up 3 
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 7±1 
from V3 
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.5 hour
Medical 
History/Concomitant 
Medications
x
Adverse Events and 
Concomitant 
Medications Review
x
X 
X 
Compliance
x
X 
X 
Habitual Contact Lens 
Information
x
Contact Lens History
x
Wear Time and 
Comfortable Wear 
Time with Habitual 
lenses
x
Wear Time and 
Comfortable Wear 
Time with Study lenses
x
X 
X 
Screening 
Inclusion/Exclusion 
Criteria
x
Subject Reported 
Ocular Symptoms
x
x
X 
X 
Baseline PRO (CLUE 
and MRD) 
Questionnaire
x
CLDEQ-8
Questionnaire
x
X 
X 
Distance and Near 
Entrance Visual Acuity
x
x
X 
X 
Lens Removal
x
x
X 
X 
Subjective Refraction 
and Distance Visual 
Acuity
x
Near ADD 
Determination
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Treatment 1
Follow-up 3 
Time Point
Day 0
Day 3±1
from V1
Day 7±1 
from V2
Day 0
Day 7±1 
from V3 
Estimated Visit 
Duration
2.5 hours
1.0 hour
2.0 hour
1.5 hour
Ocular Dominance
x
ADD Refinement
x
Near Visual Acuity
x
Biomicroscopy
x
x
X 
X 
Baseline Inclusion/ 
Exclusion Criteria
x
Continuance
x
X 
Lens Selection
x
x (if modified)
X 
Lens Insertion
x
x
X 
10-Minute Settling
x
x (if modified) 
Visual Satisfaction / 
Subjective Acceptance
x
x
X 
X 
Study Lens Distance 
and Near Visual Acuity 
x
x
X 
X 
Distance Over 
Refraction and Visual 
Acuity
x
x
X 
X 
Subjective Lens Fit 
Assessment
x
x
X 
X 
Binocular Over 
Refraction
X 
X 
Compliance
x
X 
X 
Follow-up PRO (CLUE 
/ MRD) Questionnaire
X 
X 
Visual Performance
X 
X 
Modifications
x
x
Distance and Near Exit 
Visual Acuity
x
x
X 
Dispensing Criteria
x
x
X 
Instructions
x
x
X 
Schedule Follow-up
x
x
X 
Final Evaluation
X 
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7.2.
Detailed Study Procedures
VISIT 1
Subjects must report to the visit wearing their habitual contact lenses to accurately assess 
baseline PRO (CLUE and MRD) performance.  If the subject is not wearing their lenses they 
must be rescheduled. 
Visit 1: Screening
Step
Procedure
Details
1.1
Statement of 
Informed Consent 
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study.  The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form. 
NOTE: The subject must be provided a 
signed copy of this document.
1.2
Demographics
Record the subject’s age, gender, race and 
ethnicity.
1.3
Medical History and 
Concomitant 
Medications
Questions regarding the subject’s medical 
history and concomitant medications. 
1.4
Habitual Lenses
Questions regarding the subject’s habitual 
lens type and parameters.
1.5
Habitual Lens 
Duration of 
Wear/Days per week
Questions regarding the subject’s duration of 
contact lens wear and the minimum number 
of days they wear their lenses per week.  
1.6
Contact Lens History
Record the subject’s correction type (i.e. 
monovision, multifocal, sphere with readers, 
etc.).
1.7
Wear time and 
Comfortable Wear 
time with Habitual 
lenses
Record the subject’s wear time and 
comfortable wear time with their habitual 
contact lenses.  
1.8
Eligibility after 
Screening
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible.
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms are not required.
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Visit 1: Baseline
Step
Procedure
Details
1.9
Baseline PRO 
(CLUE and MRD) 
and CLDEQ-8 
Questionnaires 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of their habitual lenses using the PRO (CLUE 
and MRD) questions.  
Appendix 
A 
1.10
Ocular Symptoms
The subject will respond to a verbal open-
ended symptoms questionnaire.
1.11
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the subject’s 
habitual contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2.  The acuity will be 
recorded to the nearest letter OD, OS and 
OU.  
1.12
Lens Removal 
Have the subject remove their habitual lenses 
and store in an approved storage solution.
1.13
Subjective 
Refraction and 
Distance Visual 
Acuity
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.  Record the refraction and 
distance visual acuity to the nearest letter.
NOTE: Best distance visual acuity with 
sphero-cylindrical refraction must be at 
least 20/20-3 in each eye for the subject to be 
eligible in the study.
1.14
Near ADD 
Determination
The near reading addition will be determined 
using the binocular crossed cylinder 
technique (BCC) at 40 cm. 
1.15
Ocular Dominance
Determine the distance ocular dominance 
with the best distance correction in place 
using a +1.00-blur test. If the results are 
equivocal use the sighting dominance test to 
determine the dominant eye used for the 
study.
Appendix 
E 
1.16
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses 
(or flippers) under binocular conditions. 
1.17
Near Visual Acuity
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm.  Record the near 
visual acuity OD, OS and OU at 40 cm.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Baseline
Step
Procedure
Details
1.18
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
1.19
Eligibility after 
Baseline
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible.
If so, proceed to lens fitting.   
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete all forms.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.20
Randomization 
Record the randomization ID.
1.21
Lens Selection
Select the lens pair and power based on the 
randomization scheme, spherical equivalent 
refraction and fitting guide for each eye.  
Record the Test lens parameters (power and 
lot number).  
Appendix 
F
or G (Fitting 
Guide) 
1.22
Lens Insertion
Subjects will insert the lenses themselves. If 
the lens is uncomfortable, inspect for 
damage and remove, reinsert or replace as 
necessary.
Damaged lenses will be stored in labeled vial 
with sterile saline, and clearly differentiated 
from the other worn lenses that will be 
shipped back to the Sponsor. Complete the 
Product Quality Complaint form.
1.23
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
1.24
Determine Visual 
Satisfaction
Determine if the subject’s vision is 
acceptable with the lenses.  Allow the 
subject to look down a hallway or out of a 
window for distance vision assessments, and 
for them to read a book, magazine or similar 
for near vision.  
1.25
Study Lens 
Distance and Near 
Visual Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
Note: Use the ETDRS 2000 Series Chart 1 
or 2 near card placed at 40 cm to measure 
the Near visual acuity
1.26
Distance Over-
Refraction and
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results.  The results of the distance over-
refraction may also be checked for the 
impact on near vision under monocular 
and/or binocular conditions.   
1.27
Modifications
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted. If the
subject reports satisfactory vision with the
lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted, if necessary, in order to achieve 
an acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  
Follow the fitting guide allowing for at least 
10 minutes of settling time between each 
lens modification attempted.   
If modifications are required steps 1.22-1.27 
will be repeated for each modification. 
Appendix F
or G (Fitting 
Guide) 
1.28
Lens Fit 
Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
• 
The subject should not proceed to 
wear the lenses if any of the following is 
observed: 
• 
presence of limbal exposure 
(appearance of clear cornea) in any gaze
•
presence of edge lift
• 
presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, upgaze, 
and push-up). 
NOTE: If lens fit is unacceptable subject will 
be discontinued from the study. Remove the 
lenses, and complete the Final Evaluation 
forms.
1.29
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
1.30
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
1.31
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up 
visit. No additional lenses will be 
dispensed. 
x
A new lens will be opened and worn 
each day.
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for 
this lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
NOTE: In the event a lens is lost or 
damaged, the subject will return to the 
clinical site for replacement.  As much as 
reasonably possible, a damaged lens and 
packaging should be returned to the clinical 
site (wet, if possible) and then returned to the 
Sponsor.  If lens damage is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 
with saline, and clearly differentiated from 
the other worn lenses that will be shipped 
back to the Sponsor.
1.32
Schedule 
Follow-up
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days.
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 1: Treatment 1 Lens Fitting
Step
Procedure
Details
NOTE: To count the follow-up visit as a 
day of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 2
The subjects must present to Visit 2 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit. 
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
2.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit. 
Record any adverse events or medical history 
changes from the previous study visit.
2.2
Wear time and 
Comfortable Wear 
time with Study 
lenses
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
2.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.   
NOTE: Subjects must have worn lenses for 
at least 6 hours per day.  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
2.4
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
2.5
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
2.6
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
Use the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm to measure the 
Near visual acuity
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
2.7
Distance Over-
Refraction and 
Distance Visual 
Acuity
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination.  
The distance over-refraction may also be 
refined under binocular conditions.  Record 
the results and distance visual acuity OD and 
OS.
The results of the distance over-refraction 
may also be checked for the impact on near 
vision under monocular and/or binocular 
conditions.   
2.8
Determination of 
Lens Optimization
If the subject reports unsatisfactory vision or
is unable to obtain 20/30 distance visual 
acuity OU with the lenses, then a 
modification must be attempted.  
If the subject reports satisfactory vision with
the lenses a modification is not required, 
however at the Investigator’s discretion and 
based upon their findings on the measured 
visual acuity and/or over- refraction the 
investigator may make a modification. 
Up to two attempts at modification are 
permitted if necessary, in order to achieve an 
acceptable distance and near binocular 
performance for the subject, and to enable 
them to wear that particular lens type.  
Follow the fitting guide and steps 1.22-1.27 
in Visit 1 Fitting allowing for at least 10 
minutes of settling time between each lens 
modification.
Appendix F
or G 
(Fitting 
Guide)  
2.9
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
2.10
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the subject
when lens power has been optimized. 
If lens power was not changed allow the
subject to use the unworn lenses dispensed at
Visit 1 and dispense enough lenses of the
same power to last the subject until their next
visit.
2.11
Lens Removal
The study lenses will be removed and 
discarded.
2.12
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
2.13
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 2.11 above.  
2.14
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
2.15
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
2.16
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 2: Treatment 1 Follow-up 1
Step
Procedure
Details
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
2.17
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days. 
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 3 
The subjects must present to Visit 3 wearing the study lenses.  To be counted as a day of 
wear the lenses need to have been worn for at least six (6) hours prior to the visit. 
Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
3.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit. 
Record any adverse events or medical history 
changes from the previous study visit.
3.2
Wear time and 
Comfortable Wear 
time with Study 
lenses 
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
3.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.   
NOTE: Subjects must have worn lenses for 
at least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
3.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires   
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO (CLUE and 
MRD) lens preference questionnaires.  
Appendix 
A 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
3.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
3.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
3.7
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
3.8
Visual Performance
Distance (4M) 
Intermediate (64 cm) 
Near (40 cm) 
Binocular Visual performance will be
recorded for the following: 
Distance, Bright Illuminance 
High and Low Contrast ETDRS Charts        
4M- HC#3 and LC#3 
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low 
Contrast
Distance, Dim Illuminance (with Distance
goggles)
High Contrast ETDRS Charts 4M-HC#6 
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
Dim luminance (Dim luminance will 
be simulated by using the goggles)
3.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.   
Note: No lens changes are allowed based on 
the over-refraction.   
Appendix 
H 
3.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
3.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
3.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
3.14
Insertion of Study 
Lenses
Dispense the subject a new pair of lenses that 
match the distance and ADD power of the 
lenses that were removed in Step 3.12 above.  
3.15
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
NOTE: The distance visual acuity must be at 
least 20/30 OU for the lenses to be 
dispensed. 
3.16
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if all are not met the 
subject will be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
3.17
Patient Instructions 
Instruct the Subject the following:
x
The lenses will be worn on a daily wear 
basis.  
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed. 
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
CR-6468, v 2.0
 
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 3: Treatment 1 Follow-up 2
Step
Procedure
Details
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
x
Subjects will be instructed to bring their 
habitual contacts or glasses to the next 
visit.
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
3.18
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days. 
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 4 
The subjects must present to Visit 4 wearing the study lenses.  To be counted as a day of 
wear the lenses need to have been worn for at least six (6) hours prior to the visit. 
Visit 4: Treatment 1 Follow-up 3
Step
Procedure
Details
4.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 4: Treatment 1 Follow-up 3
Step
Procedure
Details
Record any adverse events or medical history 
changes from the previous study visit.
4.2
Wear time and 
Comfortable Wear 
time with Study 
lenses 
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
4.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.   
NOTE: Subjects must have worn lenses for 
at least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
4.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires   
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(CLUE and MRD) questionnaires.  
Appendix A
4.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
4.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
4.7
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
4.8
Visual Performance
Distance (4M) 
Intermediate (64 cm) 
Near (40 cm) 
Binocular Visual performance will be
recorded for the following: 
Distance, Bright Illuminance 
High and Low Contrast ETDRS Charts        
4M- HC#3 and LC#3 
Near, Bright Illuminance
Reduced Guillon-Poling Charts Intermediate
(64 cm) High Contrast and Low Contrast
Near (40 cm) High Contrast and Low 
Contrast
Distance, Dim Illuminance (with Distance
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 4: Treatment 1 Follow-up 3
Step
Procedure
Details
goggles)
High Contrast ETDRS Charts 4M- HC#6 
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
Note:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597 
lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
4.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.   
Note: No lens changes are allowed based on 
the over-refraction.   
Appendix H
4.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
The subject should not proceed to wear the 
lenses if any of the following is observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
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JJVC CONFIDENTIAL

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Visit 4: Treatment 1 Follow-up 3
Step
Procedure
Details
the lenses, and complete the Final 
Evaluation forms.
4.11
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject.
4.12
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
4.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
FINAL EVALUATION
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study. 
Final Evaluation
Step
Procedure
Details
F.1
Final Exam Form
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason.
F.2
Exit Refraction 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter and record the 
best-corrected distance visual acuity (OD,
OS, OU) to the nearest letter. 
Note: This step is not necessary if the subject 
was exited due to screen failure.
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Final Evaluation
Step
Procedure
Details
F.3
Exit Slit Lamp 
Biomicroscopy (for 
subjects that are 
discontinued early) 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. This step is not 
necessary if the subject was exited due to 
screen failure.
Note: This step is not necessary if the subject 
was exited due to screen failure, or if 
biomicroscopy was performed as part of the 
final follow-up visit procedures (i.e., 
immediately prior to the final evaluation).
7.3.
Unscheduled Visits
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected, as appropriate: 
x
Chief complaint prompting the visit. If the reason is an adverse event, the applicable 
eCRF for the adverse event must be completed and subject record completed as 
appropriate. 
x
Date and time of the visit and all procedures completed at the unscheduled visit. 
x
Review of adverse event and concomitant medications.
x
Documentation of any test article dispensed or collected from the subject, if applicable.
x
Slit lamp findings (using the Slit Lamp Classification Scale). 
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified. 
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre-
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider.  
The following information will be collected during an unscheduled visit.  
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Unscheduled Visit
Step
Procedure
Details
U.1
Reason for 
unscheduled visit 
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit.
U.2
Chief Complaints (if 
applicable)
Record the subject’s chief complaints for 
reasons for the unscheduled visit.
U.3
Adverse Events and 
Concomitant 
Medications Review
(if applicable)
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events.
U.4
Entrance VA (if 
applicable)
Record the entrance distance visual acuity 
(OD, OS) to the nearest letter. 
U.5
Subjective Sphero-
cylindrical 
Refraction (if 
applicable)
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS). 
U.6
Slit Lamp 
Biomicroscopy (if 
applicable)
FDA Slit Lamp Classification Scale will be 
used to grade the findings.  If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled.
U.7
Dispensing (if 
applicable)
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the 
dispensing instructions given in the detailed 
study procedures.
U.8
Exit Visual Acuity 
(if applicable)
Record the subject’s exit distance visual 
acuity (OD, OS) to the nearest letter. 
NOTE: If the only reason for the unscheduled visit is that the subject requires additional 
test articles, only the dispensing information needs to be recorded.
7.4.
Laboratory Procedures 
Not Applicable 
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8.
SUBJECTS COMPLETION/WITHDRAWAL 
8.1.
Completion Criteria
Subjects are considered to have completed the study if they:  
x
provided informed consent. 
x
they are eligible.
x
completed all study visits
8.2.
Withdrawal/Discontinuation from the Study
A subject will be withdrawn from the study for any of the following reasons: 
x
Subject withdrawal of consent. 
x
Subject not compliant to protocol  
x
Subject lost to follow-up. 
x
Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant).
x
Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear  
x
Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment).
x
Subject not compliant with study lens wear schedule 
x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
For discontinued subjects, the Investigator will: 
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x
Record the spherocylindrical refraction with best corrected distance visual acuity.
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation 
Additional subjects will be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
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9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear.  See the Exclusion criteria for specific details.
9.1.
Systemic Medications
The following table lists the medications disallowed in this study.  
Table 4: Disallowed systemic medications  
Class of Drug
Common Indication(s)
Common Examples
Anticholinergics
Irritable bowel syndrome, 
Parkinson’s disease, peptic ulcer, 
cystitis, nasal congestion, cold 
symptoms, overactive bladder, 
COPD
Bentyl, Spiriva, Atrovent, 
Hyosyne, Levsin, Symax Fastab, 
Symax SL, Homax SL, Cogentin, 
Transderm Scop, etc., … 
Oral 
Phenothiazines 
Antipsychotic disorders 
(schizophrenia, mania)  
Compazine, Mellarill, Thorazine, 
Phenagran, etc.… 
Oral Retinoids
Cystic acne
Isotretinoin
Corticosteroids
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions 
Cortisone, Prednisone, 
Hydrocortisone, Medrol, Kenalog 
etc., …
Oral Tetracycline
Urinary Tract Infection, acne, 
chlamydia, gonorrhea 
Sumcyin, Acitsite, Achromycin 
V, etc.
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB.   This is a "Major Deviation". Deviations 
that contradict the information contained in the Informed Consent/Assent forms will be 
considered Major Deviations. 
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Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. 
Protocol waivers are prohibited. 
Table 5 lists examples of deviations that will constitute major and minor protocol deviations 
for this study.  
Table 5: Examples of major and minor protocol deviations 
Deviation category
Major deviation
Minor deviation
Out-of-window visit
Visit attended more than 2
days out of visit t window 
defined in study procedures 
Visit attended 2 or fewer
days out of visit window 
defined in study procedures 
Unanswered PRO questions
For questionnaires where 
data is related to a primary or 
secondary endpoint, more 
than 2 PRO questions are 
unanswered (i.e., left blank). 
For questionnaires where 
data is related to a primary or 
secondary endpoint, 2 or 
fewer PRO questions are 
unanswered (i.e., left blank). 
For questionnaires where 
data where data is not related 
to a primary or secondary 
endpoint, any PRO questions 
are unanswered (i.e., left 
blank). 
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.
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JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
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. 
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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. 
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.
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. 
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x
Chronic disease 
x
Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
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)
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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.
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include:
x
Seriousness/Classifications (see definition in section 13.1). 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
section 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. 
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x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
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). 
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x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x
Date the clinical site was notified.
x
Date and time of onset.
x
Date and time of resolution.
x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x
Any referral to another health care provider if needed. 
x
Outcome, ocular damage (if any). 
x
Likely etiology. 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system.
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
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. 
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13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately.
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
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. 
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13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.5. Event of Special Interest
None 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC).14  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 separately for each lens type (Aurora and DT1MF) and time 
point (Baseline, fitting, 3-Day follow-up, 1-week follow-up and 2-week follow-up) and will 
be performed separately by completion status (Safety Population and Per-Protocol Population, 
when appropriate).   
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14.2. Sample Size Justification
This study was designed and powered to test for superiority of the Aurora lens after 1-week of 
optimized lens wear with respect to binocular HLHC visual performance at distance, 
intermediate and near. Additionally, this study was powered to test non-inferiority of Aurora 
relative to DT1MF with respect to visual performance at distance (4m) after 1-week of lens 
wear. 
Historical data from one study was utilized in the sample size calculation. Clinical study, 
was a 2x3 crossover designs with 1-week follow-up evaluation for the optimized lens 
wear.11,13 However, for the sample size estimate for this study, only data from period 1 was 
utilized. Table 6 below summaries the historical data by endpoint.  
Table 6: Historical Data by Endpoint and Lens – 1-Week Follow-up: Period 1 Only 
Endpoint
Aurora Mean (SD)
DT1MF Mean (SD)
VP - Distance
-0.087 (0.0820)
-0.063 (0.0812)
VP - Intermediate
0.007(0.1061)
0.014 (0.0983)
VP - Near
0.117 (0.1081)
0.096 (0.0852)
CLUE Vision- Hyperopes 
57.1 (17.27)
58.2 (24.85)
VP: Visual Performance, SD=Standard Deviation 
Sample size calculations for each primary endpoint were carried out using a 2-sided one sample 
mean t-test, with a family wise error rate of 5%. The calculation was performed using the 
POWER procedure in SAS Version 9.4. The Bonferroni9 method was used to adjust the type I 
HUURUIRUPXOWLSOHSULPDU\K\SRWKHVHVĮ 4= 0.0125.
Sample size calculations for each secondary hypothesis to test for non-inferiority of the 1-week 
follow-up with respect to visual performance and CLUE vision scores. Sample size 
calculations for the secondary hypothesis was performed using the POWER procedure for two-
sample means  with a 2-sided type I error rate of 5%. The sample size required to test all 
primary and secondary hypotheses was calculated  to achieve at least 90% power is displayed 
in Table 7, below. 
Table 7: Sample Size Estimates by Endpoint 
Endpoint 
Type 
Endpoint
Test Type 
Sample Size 
Power (%)
Primary 
VP - Distance
Superiority (0.00)
22
>99
VP - Intermediate
Superiority  (0.17)
12
>99
VP - Near
Superiority  (0.17)
60
93.4
CLUE Vision-
Hyperopes 
Superiority  (32)
13
>99
Secondary VP – Distance
Non-inferiority 
(Test vs Control)
60
96.4
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Based on the table above a total of at least 60 subjects are required to complete the study. To 
account for screen failures and subject dropout up to 70  hyperopic subject will be targeted to 
be enrolled in this study to the aim of 60 to complete.   
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the
per-protocol population set will be documented in a memo to file. 
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance
Primary and secondary hypotheses will be tested using a gate keeping strategy. Primary 
endpoints will be tested using a familywise error rate of 5%. All primary hypotheses must be 
met in order to test the secondary hypothesis. A Bonferroni correction will be utilized for the 
adjustment of multiple endpoints within each the primary hypotheses. All primary and 
secondary hypotheses must be met in order to test any exploratory hypotheses.  
14.5. Primary Analysis  
While a simple t-test was utilized for the sample size calculations to test all primary and 
secondary hypotheses, the primary and secondary analyses will perform the hypotheses tests 
by a t-test using a model-based approach with the Kenward and Roger degrees of freedom. 
Given the size of our historical data (N=67 Hyperopes) the historical sample was large enough 
for a simple t-test to provide an accurate approximation of the sample size estimates. Therefore, 
since the sample size estimates are valid, and this study aims to complete 60 subjects, a model-
based approach will yield similar results to a simple t-test approach.   
All primary analysis will be conducted on the intent-to-treat population.  
Visual Performance (logMAR)
Binocular HLHC visual performance will be analyzed using a linear mixed model for repeated 
measures. Lens type, distance (distance, intermediate and near), timepoint and all possible 
interactions between lens type, distance and timepoint will be included in the model as fixed 
effects. Other subject characteristics such as age or ADD power may be included as covariates 
when appropriate. Site and subject nested within site will be included as random effects (G-
side). The covariance between repeated measurements within a subject across distance will be 
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modeled using an unstructured covariance structure (UN). The Kenward and Roger Method 
will be used for the denominator degrees of freedom. A likelihood ratio test will be performed 
to test for homogenous variance between study lenses and site.     
Primary Hypothesis 1:  
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of Aurora relative to the threshold 0.0 logMAR are as follows: 
ܪ௢: ߤ்௘௦௧൒0 logMAR 
ܪ஺: ߤ்௘௦௧< 0 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to distance HLHC visual performance. Superiority will be declared if the upper limit of the 
95% CI  is below 0.0.   
Primary Hypotheses 2 and 3:  
The null and alternative hypothesis for binocular intermediate and near HLHC visual 
performance to test for superiority of Aurora relative to the threshold 0.17 logMAR are as 
follows: 
ܪ௢: ߤ்௘௦௧൒0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to HLHC visual performance. Superiority will be declared if the upper limit of the 95% CI  
for either intermediate or near is below 0.17.   
CLUE Vision Scores  
CLUE vision scores will be analyzed using a linear mixed model for repeated measures. Lens 
type, timepoint (1-week and 2-week follow-up evaluations) and the interaction between lens 
and time will be included in the model as fixed effects. Other subject characteristics such as 
age or ADD power may be included as covariates when appropriate. Site will be included as a 
random effect (G-side). The covariance between repeated measurements within a subject will 
be modeled using an unstructured covariance structure (UN). The Kenward and Roger Method 
will be used for the denominator degrees of freedom. A likelihood ratio test will be performed 
to test for homogenous variance between study lenses and site and strata.        
Primary Hypothesis 4:  
The null and alternative hypothesis to test for superiority of Aurora Hyperopes relative to the 
threshold 32 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑32
ܪ஺: ߤ்௘௦௧> 32
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Where ߤ்௘௦௧, represents the population mean for Aurora Hyperopes at the 1-week follow-up 
with respect to CLUE vision scores. Superiority will be declared if the lower limit of the 95% 
CI  is above 32.   
14.6. Secondary Analysis  
The secondary analysis will be conducted on the Per-protocol population.  
Visual Performance
Comparisons between the Test and Control lenses will be carried out at distance (4 m) using 
2-sided 95% confidence intervals constructed LSM differences (Test minus Control) at the 1-
week follow-up evaluation using the model describe for visual performance above. 
Secondary hypotheses 1 
The null and alternative hypothesis for binocular HLHC visual performance to test for non-
inferiority of the Test lens relative to the Control is as follows:
ܪ௢: ߤ்௘௦௧൒ 0.05 logMAR 
ܪ஺: ߤ்௘௦௧< 0.05 logMAR 
Where ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟is the LSM difference between the Test and Control. Non-inferiority 
will be declared if the upper limit of the 95% confidence interval for the LSM difference is 
below 0.05 logMAR. 
14.7. Other Exploratory Analysis  
CLUE Vision Scores 
Comparisons between the Test and Control lenses at the 1- and 2-week follow-up evaluation 
will be performed separately using two-sided 95% confidence intervals constructed for the 
least-square mean (LSM) difference (Test minus Control) from the model of CLUE vision 
above. 
Exploratory Hypotheses 1 and 2: 
The null and alternative hypothesis for CLUE vision to test for non-inferiority of the Test lens 
relative the Control lens for the hyperopes is as follows: 
ܪ௢: ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟൑ -5 
ܪ஺: ߤ்௘௦௧െߤ஼௢௡௧௥௢௟> -5 
Where ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟is the LSM difference between the Test and Control. Non-inferiority 
will be concluded if the lower limit of the 95% confidence interval for the least square mean 
difference is greater than -5.  
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Exploratory analyses will only be conducted if all primary and secondary hypotheses are met.  
If conducted, exploratory analysis will be analyzed for the per-protocol population.  
Visual Performance
Comparisons between the Test and Control lenses will be carried out at each distance (64 cm 
and 40 cm) using 2-sided 95% confidence intervals constructed LSM differences (Test minus 
Control) at the 1-week follow-up evaluation using the model describe for visual performance 
above. 
Exploratory hypotheses 3 and 4: 
The null and alternative hypothesis for binocular HLHC visual performance to test for non-
inferiority of the Test lens relative to the Control is as follows:
ܪ௢: ߤ்௘௦௧൒ 0.05 logMAR 
ܪ஺: ߤ்௘௦௧< 0.05 logMAR 
Where ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟is the LSM difference between the Test and Control. Non-inferiority 
will be declared if the upper limit of the 95% confidence interval for the LSM difference is 
below 0.05 logMAR. Hypothesis testing will be performed separately for each distance. 
Visual Performance 
Exploratory hypotheses 5, 6 and 7 will be tested using the same model as described for visual 
performance in section 14.5. Hypotheses tests will be performed using 2-sided 95% confidence 
intervals constructed LSM (Test)at the 2-week follow-up evaluation at each distance (4 m, 64 
cm and 40 cm). 
Exploratory Hypothesis 5: 
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of Aurora relative to the threshold 0.0 logMAR are as follows: 
ܪ௢: ߤ்௘௦௧൒0 logMAR 
ܪ஺: ߤ்௘௦௧< 0 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to distance HLHC visual performance. Superiority will be declared if the upper limit of the 
95% CI  is below 0.0.   
Exploratory Hypotheses 6 and 7:  
The null and alternative hypothesis for binocular intermediate and near HLHC visual 
performance to test for superiority of Aurora relative to the threshold 0.17 logMAR are as 
follows: 
ܪ௢: ߤ்௘௦௧൒0.17 logMAR 
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ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Where ߤ்௘௦௧, represents the population mean for Aurora at the 1-week follow-up with respect 
to HLHC visual performance. Superiority will be declared if the upper limit of the 95% CI  
for either intermediate or near is below 0.17.   
CLUE Vision
Exploratory hypothesis 8 will be tested using the same model as described for CLUE Vision 
in section 14.5. The hypothesis tests will be performed using 2-sided 95% confidence intervals 
constructed LSM (Test)at the 2-week follow-up evaluation. 
Exploratory Hypothesis 8:  
The null and alternative hypothesis to test for superiority of Aurora Hyperopes relative to the 
threshold 32 CLUE points are as follows: 
ܪ௢: ߤ்௘௦௧൑32
ܪ஺: ߤ்௘௦௧> 32
Where ߤ்௘௦௧, represents the population mean for Aurora Hyperopes at the 1-week follow-up 
with respect to CLUE vision scores. Superiority will be declared if the lower limit of the 95% 
CI  is above 32.   
14.8. Interim Analysis  
There will not be an interim analysis performed on this study.  
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 10%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 50 imputations.
14.10.Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
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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 ISO14155:2020.1
15.2. Subject Record
At a minimum, subject record should be available for the following:  
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
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Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: This study is not an 
early feasibility study.  
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 
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data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC)
Not Applicable.  
17. CLINICAL MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x
Ensuring the rights and wellbeing of subjects are protected. 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel.
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x
Ensuring that the clinical site has sufficient test article and supplies. 
x
Clarifying questions regarding the study. 
x
Resolving study issues or problems that may arise. 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide
their consent voluntarily. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2)
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
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clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol. 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information). 
x
Sponsor-approved subject recruitment materials. 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x
Any other documents that the IEC/IRB requests to fulfill its obligation. 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol revisions 
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x
Investigator’s Brochure revisions  
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
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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 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
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) and other 
applicable personal data protection and security laws and regulations.15,16 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. 
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH GCP guidelines,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 GCP and all study documents as specified by the applicable 
regulatory requirement(s).2 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 
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accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
There is no plan to publish the outcome of this investigation. 
22. REFERENCES
1.
ISO 14155:2020: 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.
Karkkainen TR.  Investigator Brochure CR-6468 (
) Comparison of a 
Daily Disposable Multifocal Contact Lens to a Marketed Product. August 2021 
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6.
Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Multifocal Contact Lens with an UV Blocker Additive. June 25, 2019 
7.
Thomas R. Karkkainen.  Clinical Study Report 
Dispensing evaluation of daily disposable multifocal contact lenses in a population of 
hyperopic presbyopes. March 18, 2020 
8.
Thomas R. Karkkainen.  Clinical Study Report 
 Evaluation 
of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population. January 
06, 2021 
9.
Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Novel Multifocal Contact Lens in a Hyperopic Population. April 05, 
2021
10. Karkkainen TR.  Clinical Study Report 
 Evaluation of a 
Daily Disposable Novel Multifocal Contact Lens in a Myopic Population. May 21, 2021 
11. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Investigational Daily Disposable Multifocal Contact Lenses Produced with Different 
Manufacturing Processes. February 10, 2021 
12. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Daily Disposable Multifocal Contact Lenses Made With Two Different Manufacturing 
Processes. April 19, 2021 
13. Karkkainen TR.  Clinical Study Protocol 
 Evaluation of 
Investigational Daily Disposable Multifocal Contact Lenses Produced with Different 
Manufacturing Processes in Myopes. April 23, 2021 
14. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute Inc.  
15. Health Information Portability and Accountability Act (HIPAA). Available at 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
16. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 
2017 on medical devices. Available at http://data.europa.eu/eli/reg/2017/745/2017-05-05
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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APPENDIX B: PATIENT INSTRUCTION GUIDE 
The patient instruction guide (PIG) will be provided separately. 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
CR-6468, v 2.0
 
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W900236420
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal (delefilcon A) soft 
contact lenses for Daily Disposable Wear
Important: This package insert is effective as of December 2019 and applicable to the delefilcon A contact lenses described below. Please read carefully and keep this information for future use. This package insert is intended for the eye care 
professional, but should be made available to patients upon request. The eye care professional should provide the patient with appropriate instructions that pertain to the patient’s prescribed lenses. Copies of this package insert are available without 
charge from Alcon by calling Customer Service at 1-800-241-5999 or download from our website at www.alcon.com. In addition, a Patient Instruction Booklet is available which is recommended to be given to patients.
CAUTION: Federal law (United States) restricts this device to 
sale by or on the order of a licensed eye care professional.
PRODUCT DESCRIPTION
DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal (delefilcon 
A) soft contact lenses are made from a lens material that is 33% 
water and 67% (delefilcon A) polymer, a silicone containing 
hydrogel with added phosphatidylcholine. The core lens material 
containing 33% water transitions through a water gradient to a 
hydrogel surface layer that exceeds 80% water. Lenses contain 
the color additive copper phthalocyanine, a light blue tint, which 
makes them easier to see when handling.
Lens Properties
• Refractive Index hydrated: 
1.42
• Light Transmittance: 
93% (@ 610 nm, -1.00 D)
• Oxygen Permeability (Dk): 
140  x 10-11 (cm2/sec)(ml O2 /ml 
x mm Hg), measured at 35° C 
(intrinsic Dk-Coulometric 
method)
• Water Content: 
33% by weight in normal saline
• Surface Water Content: 
≥ 80%
Lens Parameters
• Diameter Range 
13.0 to 15.0 mm
• Spherical Power Range -20.00 to +20.00 D
• Base Curve Range 
8.0 to 9.2 mm
Lens Parameters Available1
DAILIES TOTAL1® (delefilcon A) spherical contact lenses
• Chord Diameter: 
14.1 mm
• Center Thickness: 
0.09 mm @ -3.00 D (varies with  
  
power)
• Base Curve: 
8.5 mm
• Powers: 
-0.50 to -6.00 D (0.25 D steps)
-6.50 to -12.00 D (0.50 D steps)
+0.50 to +6.00 D (0.25 D steps)
DAILIES TOTAL1® Multifocal (delefilcon A) contact lenses
• Chord Diameter: 
14.1 mm
• Center Thickness: 
0.09 mm @ -3.00 D (varies with  
  
 
power)
• Base Curve: 
8.5 mm
• Powers: 
+6.00 D to -10.00 D (0.25 D steps) 
ADD: LO, MED, HI
NOTE: Hereafter, DAILIES TOTAL1® spherical contact lenses 
and DAILIES TOTAL1® Multifocal contact lenses will simply be 
referred to as delefilcon A contact lenses unless product 
distinction is necessary.
ACTIONS
When hydrated and placed on the cornea, delefilcon A contact 
lenses act as a refracting medium to focus light rays on the 
retina. 
INDICATIONS (Uses)
DAILIES TOTAL1® (delefilcon A) spherical soft contact lenses 
are indicated for the optical correction of refractive ametropia 
(myopia and hyperopia) in phakic or aphakic persons with 
non-diseased eyes with up to approximately 1.50 diopters (D) of 
astigmatism that does not interfere with visual acuity.
DAILIES TOTAL1® Multifocal (delefilcon A) soft contact lenses 
are indicated for the optical correction of refractive ametropia 
(myopia and hyperopia) and/or presbyopia in phakic or aphakic 
persons with non-diseased eyes who may require a reading 
addition of +3.00 (D) or less and who may have up to 
approximately 1.50 diopters (D) of astigmatism that does not 
interfere with visual acuity.
The lenses are to be prescribed for single use, daily disposable 
wear. The lenses are not intended to be cleaned or disinfected 
and should be discarded after a single use. 
CONTRAINDICATIONS (Reasons Not To Use)
DO NOT use delefilcon A contact lenses when any of the 
following exists:
• Inflammation or infection of the anterior chamber of the eye
• Active disease, injury or abnormality affecting the cornea, 
conjunctiva, or eyelids 
• Microbial infection of the eye
• Insufficiency of lacrimal secretion (dry eye) that interferes with 
contact lens wear
• Corneal hypoesthesia (reduced corneal sensitivity)
• Use of any medication that is contraindicated or interferes 
with contact lens wear, including eye medications
• Any systemic disease which may be exacerbated by or 
interferes with contact lens wear
• Allergic reactions or ocular irritation of the ocular surfaces or 
adnexa that may be caused by or exaggerated by the wearing 
of contact lenses
• Patient history of recurring eye or eyelid infections, adverse 
effects associated with contact lens wear, intolerance or 
abnormal ocular response to contact lens wear
• If eyes become red or irritated
WARNINGS
Advise patients of the following warnings pertaining to 
contact lens wear:
• Problems with contact lenses and lens care products could 
result in serious injury to the eye. It is essential that patients 
follow their eye care professional’s directions and all labeling 
instructions for proper use of lenses and lens care products. 
Serious eye problems, including corneal ulcers, can 
develop rapidly and lead to loss of vision.
• Daily wear lenses are not indicated for overnight wear, and 
patients should be instructed not to wear lenses while 
sleeping. Clinical study results have shown that the risk of 
serious adverse reactions is increased when contact lenses 
are worn overnight2.
• Studies2 have shown that contact lens wearers who are 
smokers have a higher incidence of adverse reactions than 
nonsmokers.
• If a patient experiences eye discomfort, foreign body 
sensation, excessive tearing, vision changes, or redness of the 
eye, the patient should be instructed to immediately remove 
lenses and promptly contact his or her eye care professional. 
It is recommended that contact lens wearers see their eye 
care professional regularly as directed.
PRECAUTIONS
To prevent damage to the eyes or to the contact lenses, the 
following precautions should be taken:
Special Precautions for the Eye Care Professional
Due to the small number of patients enrolled in the clinical 
investigation of lenses, all refractive powers, design 
configurations, or lens parameters available in the lens material 
are not evaluated in significant numbers. Consequently when 
selecting an appropriate lens design and parameters, the eye 
care professional should consider all characteristics of the lens 
that can affect lens performance and ocular health, including 
oxygen permeability, central and peripheral thickness and optic 
zone diameter.
The potential impact of these factors on the patient’s ocular 
health should be carefully weighed against the patient’s need for 
refractive correction; therefore the continuing ocular health of the 
patient and lens performance on the eye should be carefully 
evaluated on initial dispensing and monitored on an ongoing 
basis by the prescribing eye care professional.
• Fluorescein, a yellow dye, should not be used while the lenses 
are on the patient’s eyes. The lenses absorb this dye and 
become discolored. Whenever fluorescein is used, the eyes 
should be flushed thoroughly with sterile saline solution that is 
recommended for in eye use prior to inserting lenses. Avoid 
dispensing saline from an aerosol can directly into the eye.
• Patients who wear contact lenses to correct presbyopia may 
not achieve the best possible corrected visual acuity for either 
far or near vision. Visual requirements vary with the individual 
and should be considered when selecting the most 
appropriate type of lens for each patient.
• Before leaving the eye care professional’s office, the patient 
should be able to promptly remove their lenses or should have 
someone else available who can remove their lenses for them.
• Eye care professionals should instruct the patient to remove 
the lenses immediately if the eye becomes red or irritated.
• Routine eye examinations are necessary to help assure the 
continued health of the patient’s eyes. Eye care professionals 
should make arrangements with the patient for appropriate 
follow-up visits. Alcon recommends that patients see their eye 
care professional once each year, or more often, as 
recommended by the eye care professional.
• Diabetics may have reduced corneal sensitivity and thus are 
more prone to corneal injury and do not heal as quickly or 
completely as non-diabetics.
• Visual changes or changes in lens tolerance may occur during 
pregnancy or use of oral contraceptives. Caution patients 
accordingly.
Eye Care Professionals should carefully instruct patients 
about the following safety precautions:
Handling Precautions
• Be sure that before leaving the eye care professional’s office 
the patient is able to promptly remove lenses or have 
someone else available to remove them.
• Good hygiene habits help promote safe and comfortable lens 
wear. Always wash, rinse and thoroughly dry hands with a 
lint-free towel before handling lenses.
• REMOVE A LENS IMMEDIATELY if an eye becomes red or 
irritated.
• Always handle lenses carefully. Never use tweezers or other 
sharp objects such as fingernails to remove lenses from the 
lens container unless specifically indicated for that use.
• Do not use if blister package is damaged or not sealed 
completely. This may result in product contamination which 
can lead to a serious eye infection.
• Ensure that the correct lens for each eye is available. Shake 
the blister pack gently prior to opening. Remove the lens from 
the blister pack by carefully pouring the lens onto the palm of 
your clean hand. Ensure the lens is right side out. Inspect 
lenses prior to insertion. Do not insert damaged lenses.
• To insert lenses:
- Wash and rinse hands thoroughly and dry completely with a 
clean, lint free towel before handling lenses.
- Place a lens on the tip of your clean and dry right or left 
index finger, place the middle finger of the same hand close 
to lower eyelashes and pull down the lower eyelid.
- Use the fingers of the other hand to lift the upper eyelid.
- Place the lens directly on the eye (cornea) and gently roll 
finger away from the lens.
- Look down and slowly remove the hand, releasing the 
lower lid.
- Look straight ahead and slowly remove the other hand, 
releasing the upper lid.
- Blink gently.
• To remove lenses:
- Wash and rinse hands thoroughly and dry completely with a 
clean, lint free towel before handling lenses. Make sure 
hands are clean and completely dry.
- Blink fully several times.
- While looking up, slide the lens down onto the white part of 
the eye.
- Remove the lens by pinching gently between the thumb and 
forefinger. Do not pinch the eye tissue.
- If the lens is difficult to grasp, dry fingers once more and try 
again. Do not use rewetting drops in this instance.
• If a lens decenters on the eye, it may be possible to recenter it by:
- Closing the eye and massaging the lens into place, or
- Looking in the direction of the lens and blinking gently, or
- Gently pushing the off-centered lens onto the cornea with 
light finger pressure on the edge of the upper or lower 
eyelid.
• If a lens tears in the eye it will feel uncomfortable. Advise 
wearers it is impossible to lose a contact lens or part of a 
contact lens behind the eye and to remain calm. Lens pieces 
may be removed by pinching them as for normal lens removal, 
carefully avoiding pinching the eye tissue. If the lens pieces do 
not seem to remove easily, rinsing with saline is 
recommended. If this does not help, the wearer should contact 
an eye care professional for assistance.
Lens Wearing Precautions:
• Patients should never exceed the prescribed wearing schedule 
regardless of how comfortable the lenses feel. Doing so may 
increase the risk of adverse effects.
• The lens should move freely on the eye at all times. If the lens 
sticks (stops moving) on the eye, follow the recommended 
directions in the Care for a Sticking Lens section. If 
non-movement of the lens continues, the patient should be 
instructed to consult their eye care professional immediately.
• The eye care professional should be consulted about wearing 
lenses during water sports and water related activities. 
Exposure to water or other non-sterile liquids while wearing 
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contact lenses in activities such as swimming, water skiing, and 
hot tubs may increase the risk of ocular infection, including 
but not limited to Acanthamoeba keratitis. 
• Never allow contact lenses to come into contact with 
non-sterile liquids (including tap water and saliva) as microbial 
contamination can occur, which may lead to permanent eye 
damage.
• Eye irritation, infection, or lens damage may result if 
cosmetics, lotion, soap, cream, hair spray, deodorant, aerosol 
products or foreign particles come in contact with lenses. 
• Environmental fumes, smoke, and vapors should be avoided in 
order to reduce the chance of lens contamination or physical 
trauma to the cornea.
• Lenses should be disposed of each day upon removal from the 
eye.
• Discard any lens which has become dehydrated or damaged. 
Replace with a sterile, fresh, new lens.
• Note the correct lens power for each eye to prevent getting 
them mixed up.
• Always carry spare lenses with you or have back-up 
spectacles available.
• Do not share lenses with anyone as this may spread 
micro-organisms which could result in serious eye health 
problems.
• Do not use lenses beyond their expiration date.
Other Topics to Discuss with Patients:
• Periodic eye examinations are extremely important for contact 
lens wearers. Schedule and conduct appropriate follow-up 
examinations to determine ocular response. Alcon 
recommends that patients see their eye care professional 
once each year or as recommended by the eye care 
professional.
• Certain medications may cause dryness of the eye, increased 
lens awareness, lens intolerance, and blurred vision or visual 
changes. These include, but are not limited to, antihistamines, 
decongestants, diuretics, muscle relaxants, tranquilizers, and 
those for motion sickness. Caution patients using such 
medications accordingly and prescribe proper remedial 
measures.
• Visual changes or changes in lens tolerance may occur during 
pregnancy or use of oral contraceptives. Caution patients 
accordingly.
Who Should Know that the Patient is Wearing Contact 
Lenses:
• Patients should inform their health care practitioners that they 
are wearing contact lenses.
• Patients should inform their employers that they are wearing 
contact lenses. Some jobs may require the use of eye 
protection equipment or may require that contact lenses not 
be worn.
It is strongly recommended that patients be provided with a copy 
of the DAILIES TOTAL1® and DAILIES TOTAL1® Multifocal 
(delefilcon A) Contact Lenses Patient Instruction Booklet available 
from Alcon and understand its contents prior to dispensing the 
lenses.
WATER ACTIVITIES
Do not expose contact lenses to water while wearing them.
Warning:
Water can harbor microorganisms that can lead to severe 
infection, vision loss or blindness. If lenses have been submersed 
in water when showering or swimming, discard them and 
replace with a new pair. Ask the Eye Care Professional for 
recommendations about wearing lenses during any activity 
involving water.
ADVERSE EFFECTS
Patients should be instructed to check eyes regularly to 
make sure they look well, feel comfortable and vision is 
clear. Potentially serious complications are usually 
accompanied by one or more of the following signs or 
symptoms:
• Moderate to severe eye pain not relieved by removing the lens
• Foreign body sensation
• Excessive watering or other eye secretions including 
mucopurulent discharge
• Redness of the eyes
• Photophobia (light sensitivity)
• Burning, stinging or itching or other pain associated with the 
eyes
• Comfort is less compared to when the lens was first placed on 
eye
• Poor visual acuity (reduced sharpness of vision)
• Blurred vision, rainbows or halos around objects
• Feeling of dryness
WHAT TO DO IF A PROBLEM OCCURS
Patients should be instructed that if any of the above signs 
or symptoms are noticed, he or she should: 
• IMMEDIATELY REMOVE THE LENSES.
• If the discomfort or problem stops, discard the lens and 
replace it with a new one.
• If the discomfort or problem continues after removing 
lens(es) or upon insertion of a new lens, IMMEDIATELY 
remove the lens(es) and contact the eye care professional 
for identification of the problem and prompt treatment to 
avoid serious eye damage.
• The patient should be informed that a serious condition 
such as corneal ulcer, infection, corneal vascularization, 
or iritis may be present, and may progress rapidly. Less 
serious reactions such as abrasions, infiltrates, and 
bacterial conjunctivitis must be managed and treated 
carefully to avoid more serious complications.
• Additionally, contact lens wear may be associated with ocular 
changes that require consideration of discontinuation or 
restriction of wear. These include but are not limited to local or 
generalized corneal edema, epithelial microcysts, epithelial 
staining, infiltrates, neovascularization, endothelial 
polymegathism, tarsal papillary changes, conjunctival injection 
or iritis.
ADVERSE EFFECT REPORTING
If a patient experiences any serious adverse effects associated 
with the use of DAILIES TOTAL1® brand (delefilcon A) contact 
lenses, please notify: Alcon Medical Safety in the USA at 
1-800-757-9780.
FITTING GUIDE AND PATIENT BOOKLET
Conventional methods of fitting contact lenses apply to delefilcon 
A contact lenses. For a detailed description of the fitting 
techniques, refer to the DAILIES TOTAL1® and DAILIES TOTAL1® 
Multifocal (delefilcon A) Contact Lenses Professional Fitting and 
Information Guide. Both the professional fitting guide and a 
patient instruction booklet are available free of charge from:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX, USA 76134-2099
1-800-241-5999
LENS WEAR & REPLACEMENT SCHEDULES
DAILY WEAR (less than 24 hours, while awake):
• To avoid tendency of the daily wear patient to over-wear the 
lenses initially, stress the importance of adhering to a proper, 
initial wearing schedule. Normal daily wear of lenses assumes 
a minimum of 6 hours of non lens wear per 24 hour period. 
• It may be advisable for patients who have never worn contact 
lenses previously to be given a wearing schedule that 
gradually increases wearing time over a few days. This allows 
more gradual adaptation of the ocular tissues to contact lens 
wear.
• The maximum daily wearing time should be determined by the 
eye care professional based upon the patient’s physiological 
eye condition because individual responses to contact lenses 
vary. There may be a tendency for patients to over-wear the 
lenses initially. The eye care professional should stress the 
importance of adhering to the initial maximum wearing 
schedule. Studies have not been conducted to show that 
delefilcon A contact lenses are safe to wear during sleep, 
therefore patients should be advised to remove their lenses 
while sleeping. Normal daily wear of lenses assumes a 
minimum of 6 hours of non-lens wear per 24 hour period. 
Optimum individual wearing schedule will vary.
• Delefilcon A contact lenses are intended to be worn once (daily 
disposable wear) and then discarded at the end of each 
wearing period. The patient should be instructed to start the 
next wearing period with a fresh new lens.
EMERGENCY LENS CARE
Cleaning and disinfection of daily disposable lenses is not 
recommended. The patient should be reminded to have 
replacement lenses or back-up spectacles available at all times.
CARE FOR A STICKING LENS
If the lens sticks (stops moving) or begins to dry on the eye, 
instruct the patient to apply several drops of a recommended 
lubricating solution (used in accordance with package labeling). 
The patient should wait until the lens begins to move freely on 
the eye before attempting to remove it. It is important that the 
patient wash and dry their hands thoroughly before removing the 
lens. If the lens continues to stick, the patient should 
IMMEDIATELY consult the eye care professional.
IN OFFICE USE OF TRIAL LENSES
Eye care professionals should educate contact lens technicians 
concerning proper use of trial lenses.
Each contact lens is shipped sterile in a blister pack containing 
phosphate buffered saline solution.  Hands should be thoroughly 
washed and rinsed and dried with a lint-free towel prior to 
handling a lens. In order to ensure sterility, the blister pack 
should not be opened until immediately prior to use. For fitting 
and diagnostic purposes lenses should be disposed of after a 
single use and not be re-used from patient to patient.
EMERGENCIES
The patient should be informed that if chemicals of any kind 
(household products, gardening solutions, laboratory chemicals, 
etc.) are splashed into the eyes, the patient should: 
flush eyes immediately with tap water or fresh saline 
solution and immediately contact the eye care 
professional or visit a hospital emergency room without 
delay.
DISPOSAL AND RECYCLING
Dispose of contact lenses and the blister pack lidding in the 
waste bin, not down the sink or toilet. The carton packaging and 
the polypropylene (PP) plastic shell of the blister pack should be 
placed in the waste bin or recycled according to local waste 
management guidance.
HOW SUPPLIED
Each lens is packaged in a foil-sealed plastic container 
containing phosphate buffered saline solution with approximately 
0.3% of polymeric wetting agents consisting of copolymers of 
polyamidoamine and poly(acrylamide-acrylic) acid and is steam 
sterilized. The package is marked with the base curve, diameter, 
dioptric power (and ADD power for multifocal lenses), 
manufacturing lot number, date of manufacture, and expiration 
date.
The following may appear on the labels or cartons:
Manufacturer:
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX, USA 76134-2099
1-800-241-5999
www.alcon.com
U.S. Pat.: www.alconpatents.com
© 2019 Alcon Inc.
1 Check for actual product availability as additional parameters 
may be introduced over time.
2 Schein, OD, Glynn RJ, Poggio EC, Seddon JM, Kenyon KR. The 
Relative Risk of Ulcerative Keratitis Among Users of Daily Wear 
and Extended Wear Soft Contact lenses. N Eng J Med. 1989; 
321 (12):773-783.
DIA
BC
PWR
L
R
D
ADD
MAX ADD
LO
MED
HI
en
EXP
CAUTION: Federal law (United States) restricts this device to sale by or on 
the order of a licensed eye care professional.
Single sterile barrier system
Sterilized using steam
Use-by date (Expiry date)
Batch code
Two letter code for the language (Example shown: English)
Do not re-use 
Do not use if blister package is damaged
Diameter
Base curve
Power
Left
Right
Diopter (lens power)
Addition power
Maximum effective addition power
Low
Medium
High
European conformity mark
Caution
Consult instructions for use
Authorized representative in the European Community
Manufacturer
Date of manufacture
Medical device
Packaging waste license sign
Symbol/Abbreviation Description
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APPENDIX H: BINOCULAR OVER REFRACTION
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APPENDIX I: 
 
 
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
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NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
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DETERMINATION 
OF 
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SPHEROCYLINDRICAL 
REFRACTIVE ERROR
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BIOMICROSCOPY SCALE
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VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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APPENDIX J:
GUIDELINES FOR COVID-19 RISK MITIGATION
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Title:
Guidelines for COVID-19 Risk Mitigation
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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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Procedure
Details
Subject Reported Ocular 
Symptoms
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test article when applicable and feasible. 
Change of Medical History 
(Adverse Events) and 
Concomitant Medications / 
Therapies Review
Record any adverse events or medical history changes from the 
previous study visit with the subject/parents.
Review the subject’s concomitant medications/therapies and record 
any changes from the previous study visit.
Wearing Time and 
Compliance
Record the average wearing time (including number of hours per day 
during weekdays and weekends, and number of days per week).
Confirm compliance with the prescribed wear schedule.
x
Record and discuss the lens wear compliance based on the 
subject’s self-report. For example, the subjects will be asked the 
time of the day the subject typically puts on the study lenses in the 
morning and takes off in the evening, the number of days per week 
lenses were worn, and the number of consecutive days the subject 
didn’t wear the study lenses, etc.
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If during the telephone consultation, a subject states he/she wishes to discontinue participating 
in the study, instruct the subject to stop wearing the study lenses and schedule the subject to return to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should return all unused lenses to the 
clinic at the last visit.
Changes in study visit schedules, missed visits, or participant discontinuations may lead to missing data, 
including data related to protocol-specified procedures. Case report forms should capture specific 
information regarding the basis of missing data, including the relationship to the COVID-19 pandemic.
6.0
STUDY CONDUCT DURING PANDEMIC
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometry Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge.
Every effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be performed to the extent possible remotely/virtually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, participants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be performed if required and as feasible.
Modifications to protocol-required assessments may be permitted via COVID-19 Appendix after consultation 
with the participant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol deviations. Interruptions of test article wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix “COVID-19-
related” in the case report form (CRF).
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The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance.  
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report.  
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits.
Monitoring Visits
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with
increased frequency to address the source data verification backlog.
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed.
6.1.1
Study Site Initiation:  
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable.  
Study site training will be documented utilizing Site Initiation Report
per Study Site Initiation
  
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site.
6.1.2
Interim Monitoring Visits (if applicable):  
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.). 
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site.
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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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Attachment B: COVID-19 Risk Control Checklist
Study Number
Site Number
Principal Investigator (PI) Name
The following COVID-19 risk control methods are required to conduct Johnson & Johnson Vison Care clinical 
studies. Please review the following requirements and Initial each requirement.
PI Initials
General Site Safety Planning Measures
Signage within site describing Risk Control methods
Social Distancing practices throughout site (waiting rooms, lobby, exam rooms, etc.)
Non-contact thermometer available to assess temperatures of staff and patients
Training on patient flow and physical distancing in waiting room
Establish longer time frame between patient appointments to reduce persons in the site
Staff should receive job-specific training on PPE and demonstrate competency with selection and 
proper use of PPE and wear at all times during interactions with subjects (e.g., putting on and 
removing without self-contamination)
PI Initials
Site Staff Daily Safety Measures
As part of routine practice, site staff should regularly monitor themselves for fever and symptoms 
of COVID-19, including temperature checks 
Any staff member (including non-study clinic staff and Investigators) showing signs of being sick 
or testing positive for COVID-19 must not be permitted to work on activity that may  expose study 
related staff  and subject and the Sponsor shall be informed
NOTE: Inform JJVC in 24 hours of any COVID-19 cases and all potential exposure during
the clinical study.
Ensure that all staff wear a mask
Gloves should be required when working directly with patients and changed between each patient
Have staff thoroughly wash hands for at least 20 seconds or use an alcohol-based hand sanitizer 
when they arrive, before and after each patient, before eating and after using the bathroom.
Cleaning and disinfection procedures for exam rooms and instruments or equipment between 
patients with gloves.
Cleaning and disinfection procedures for commonly touched surfaces (doors, chairs, computers, 
phones, etc.) with gloves.
PI Initials
Before a Patient or Study Visit:
Patients should be asked prior to entering the site about fever and respiratory illness and whether 
they or a family member have had contact with another person with confirmed COVID-19 in the 
past 14 days. Patients exhibiting signs of being sick should be rescheduled when their symptoms 
resolve.
Instruct patients that companions should remain outside of the facility and not accompany the 
patient into the facility unless they are a parent/guardian of the patient or if they are a true 
caregiver and need to assist the patient
Request the patient to call or text the office upon arrival so entrance to and movement through 
facility can be coordinated by site staff
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PI Initials
Patients Entering the site:
Temperature checks utilizing a non-contact thermometer for all patients and companions entering 
the site.
All patients and companions must wear cloth or disposable mask at all times in the site
Maintain social distancing. Waiting rooms or lobbies should be as empty as possible. Advise 
seated patients to remain at least 6 feet from one another. 
Communal objects in (e.g. toys, reading materials, etc.) should be removed or cleaned regularly.
I certify that I have read and agree to implement all the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Vision Care studies. 
Principal Investigator Signature and Date
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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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Clinical Study Protocol
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6468 Protocol Title: Comparison of a Daily Disposable Multifocal 
Contact Lens to a Marketed Product
Version and Date: 2.0 29 September 2021 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155:2020,1 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 J 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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