Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Protocol Title
Evaluation of a daily disposable novel multifocal contact lens in a myopic population  
Protocol CR-6385
Version: 4.0, Amendment 3
Date: 05 March 2020
Investigational Products: JJVC Investigational Multifocal Contact Lenses manufactured in 
senofilcon A C3 material 
Control: Dailies Total 1® Multifocal Contact Lenses manufactured in delefilcon A material
Key Words: Multifocal, 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 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (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. 
Clinical Study Protocol 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION........................................................................... 6 
SPONSOR NAME AND ADDRESS....................................................................................... 6 
MEDICAL MONITOR............................................................................................................. 6 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 15 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products ................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria ...................................................................................................... 18 
3.3. 
Exclusion Criteria ..................................................................................................... 19 
3.4. 
Enrollment Strategy .................................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE .......................................................................... 20 
4.1. 
Description of Study Design .................................................................................... 20 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking ........................................... 22 
6. 
STUDY INTERVENTION ............................................................................................. 22 
6.1. 
Identity of Test Articles ............................................................................................ 22 
6.2. 
Ancillary Supplies/Products ..................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 24 
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6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7. 
STUDY EVALUATIONS .............................................................................................. 26 
7.1. 
Time and Event Schedule ......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 31 
VISIT 1 ........................................................................................................................... 31 
VISIT 2 ........................................................................................................................... 37 
VISIT 3 ........................................................................................................................... 41 
VISIT 4 ........................................................................................................................... 44 
VISIT 5 ........................................................................................................................... 48 
VISIT 6 ........................................................................................................................... 53 
FINAL EVALUATION .................................................................................................. 55 
7.3. 
Unscheduled Visits ................................................................................................... 56 
7.4. 
Laboratory Procedures ............................................................................................. 58 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 58 
8.1. 
Completion Criteria .................................................................................................. 58 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 58 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 59 
9.1. 
Systemic Medications .............................................................................................. 59 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 60 
11. 
STUDY TERMINATION ........................................................................................... 60 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 61 
13. 
ADVERSE EVENTS ................................................................................................... 62 
13.1. 
Definitions and Classifications ............................................................................. 62 
13.2. 
Assessing Adverse Events .................................................................................... 64 
13.2.1. 
Causality Assessment .................................................................................... 64 
13.2.2. 
Severity Assessment ...................................................................................... 65 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 65 
13.4. 
Reporting Adverse Events .................................................................................... 66 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 66 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
67 
13.4.3. 
Event of Special Interest ............................................................................... 67 
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13.5. 
Reporting of Pregnancy ........................................................................................ 68 
14. 
STATISTICAL METHODS ........................................................................................ 68 
14.1. 
General Considerations ......................................................................................... 68 
14.2. 
Sample Size Justification ...................................................................................... 68 
14.3. 
Analysis Populations ............................................................................................ 69 
14.4. 
Level of Statistical Significance ........................................................................... 69 
14.5. 
Primary Analysis .................................................................................................. 69 
14.6. 
Secondary Analysis .............................................................................................. 70 
14.7. 
Other Exploratory Analyses ................................................................................. 72 
14.8. 
Interim Analysis ................................................................................................... 72 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 72 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 72 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 72 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 72 
15.2. 
Subject Record ...................................................................................................... 73 
15.3. 
ClinicalTrials.gov ................................................................................................. 73 
16. 
DATA MANAGEMENT............................................................................................. 73 
16.1. 
Access to Source Data/Document ........................................................................ 73 
16.2. 
Confidentiality of Information.............................................................................. 74 
16.3. 
Data Quality Assurance ........................................................................................ 74 
17. 
CLINICAL MONITORING ........................................................................................ 74 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................. 75 
18.1. 
Study-Specific Design Considerations ................................................................. 75 
18.2. 
Investigator Responsibility ................................................................................... 75 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 75 
18.4. 
Informed Consent ................................................................................................. 76 
18.5. 
Privacy of Personal Data ...................................................................................... 77 
19. 
STUDY RECORD RETENTION ................................................................................ 78 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 78 
21. 
PUBLICATION ........................................................................................................... 79 
22. 
REFERENCES ............................................................................................................ 79 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 80 
APPENDIX B: PATIENT INSTRUCTION GUIDE (To be provided seperatley) .............. 109 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 110 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ..................................... 113 
APPENDIX F: OCULAR DOMINANCE ........................................................................... 115 
APPENDIX G: LENS FITTING GUIDE ............................................................................. 116 
APPENDIX H: CONTROL LENS FITTING GUIDE ......................................................... 118 
APPENDIX I: STRAYLIGHT WITH C-QUANT ............................................................... 149 
APPENDIX J: WAVEFRONT AND TOPOGRAPHY MEASUREMENT USING VISIONIX
............................................................................................................................................... 156 
APPENDIX K: 
) .................................... 166 
, Limbal & Conjunctival (Bulbar) Redness .......................................................... 167 
 Expanded Sodium Fluorescein Corneal Staining ............................................... 175 
 Determination of Near Addition ........................................................................ 180 
, Near LogMAR Visual Acuity Measurement Procedure .................................... 188 
 Lens Fitting Characteristics ................................................................................ 191 
 Subject Reported Ocular Symptoms/Problems .................................................. 198 
 Front and Back Surface Lens Deposit Grading Procedure ................................ 200 
 Determination of Distance Spherocylindrical Refractions ................................. 206 
 Biomicroscopy Scale .......................................................................................... 213 
Keratometry Procedure ...................................................................................... 219 
 Distance and Near Visual Acuity Evaluation ..................................................... 221 
 Distance LogMAR Visual Acuity Measurement Procedure .............................. 226 
 Patient Reported Outcomes ................................................................................ 230 
 White Light Lens Surface Wettability ............................................................... 232 
 Visual Acuity Chart Luminance and Room Illumination Testing ..................... 234 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 240 
TABLE OF CONTENTS  
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS  
Table 1: Test Articles .............................................................................................................. 22 
Table 2: Ancillary Supplies .................................................................................................... 24 
Table 3: Time and Events ....................................................................................................... 26 
Table 4: Disallowed systemic medications (less than 6 months of continual use). ................ 59
Table 5: Statistical Power Analysis to test for Non-inferiority of the Test relative to the Control
………………………………………………………………………………………………. 69 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Evaluation of a daily disposable novel multifocal contact lens in a myopic population  
Protocol Number: CR-6385 
Version: 4.0, Amendment 3 
Date: 05 March 2020 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, 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 ICH guidelines,2 ISO 14155,1
and the Declaration of Helsinki.3
Author
See Electronic Signature Page
Sr. Principal Research Optometrist, Clinical 
Sciences
DATE
Clinical Operations 
Manager
See Electronic Signature Page
Clinical Operations Manager, Clinical 
Operations
DATE
Biostatistician
See Electronic Signature Page
Biostatistician III, Clinical Science 
DATE
Data Management 
See Electronic Signature Page
Clinical Project Manager-Data and Systems,
Clinical Operations
DATE
Medical Safety 
Officer
See Electronic Signature Page
Medical Safety Officer, Global Medical Affairs
See Electronic Signature Page
DATE
Reviewer
Clinical Research Fellow, Clinical Sciences
See Electronic Signature Page
DATE
Approver
Presbyopia Platform Sr. Manager, Clinical 
Operations
DATE
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CHANGE HISTORY
Version
Originator
Description of Change(s) and Section 
Number(s) Affected
Date
1.0
Original Protocol
27 January 2020
2.0
Sections 7.1 and 7.2-added lens 
deposits and wettability evaluations 
at visits 3 and 6. 
Throughout document-updated 
version and date.
10 February 2020
3.0
Synopsis and Section 3.2-changed 
refraction inclusion criteria from -
1.25 to -1.50. 
Section 7.1-Indicated that binocular 
over refraction done at visit 6.
Sections 7.1 and 7.2-added C-Quant 
and wavefront/topography 
evaluations visits 3 and 6 (site 1036 
only). 
Section 9.1, synopsis and Section 
3.2-Updated disallowed medication 
table to match exclusion criteria.
Updated Flowchart (Figure 1)
Updated to V10 protocol template
Throughout document-updated 
version and date.
18 February 2020
4.0
Appendix J added and duplicate 
Appendix I deleted.
Throughout document-updated 
version and date.
05 March 2020
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SYNOPSIS 
Protocol Title
Evaluation of a daily disposable novel multifocal contact lens 
in a myopic population 
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 2b
Trial Registration
This study will be registered on ClinicalTrials.gov.
Test Article(s)
Investigational Product:  JJVC Investigational Multifocal 
Contact Lenses manufactured in senofilcon A C3 material 
Control Product: Dailies Total 1® Multifocal Contact Lenses 
manufactured in delefilcon A material
Wear and Replacement 
Schedules 
Wear Schedule: The Test and Control lenses will be used on a 
daily disposable basis.   
Replacement Schedule: The lenses will be replaced after one
day of wear.
Objectives 
This study is an evaluation of how the visual performance and 
subjective response of the JJVC Investigational Multifocal 
Contact Lens compares to the marketed Dailies Total 1®
Multifocal Contact Lens.
Study Endpoints
Primary endpoint: CLUE™vision scores
Secondary endpoint:  logMAR visual acuity scores
Study Design
This is a single-masked, crossover, randomized-controlled, 
dispensing clinical trial.  A total of approximately 70 myopic 
eligible subjects will be targeted to complete the study.  The 
subjects will be randomized and fit into their first study lens 
per the randomization schedule for a period of 3±1 days. 
Subjects will then undergo lens optimization and wear the
optimized pair for approximately 1 week (7±1 days). At the 
follow-up visit the endpoints will be measured and subjects 
will complete a 7±3 days washout period. At Visit 4 the 
subjects will be fit in the 2nd study lens and the testing that was 
done with the first study lens will be repeated.   
The primary endpoint will be CLUETM vision scores and the 
secondary endpoint will be visual performance. 
See the flow chart at the end of the synopsis for the schematic 
of the study visits and procedures of main observations 
(Figure 1).
Sample Size
A total of approximately 85 eligible subjects will be enrolled 
with 70 subjects targeted to complete.
Study Duration
The study will last approximately 2 to 4 months.
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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.  See the
detailed flowchart of procedures below.
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to 
the instructions set forth in this clinical protocol.
3. The subject must be at least 40 years of age and not 
greater than 70 years of age at the time of consent.
4. Subjects must own a wearable pair of spectacles if 
required for their distance vision.
5. The subject must be an adapted soft contact lens 
wearer in both eyes (i.e. worn lenses a minimum of 2 
days per week for at least 6 hours per wear day, for 1 
month or more duration).
6. The subject must either already be wearing a 
presbyopic contact lens correction (e.g., reading 
spectacles over contact lenses, multifocal or 
monovision contact lenses, etc.) or, if not respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”.
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction 
must be in the range of -1.50 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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Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies 
that may interfere with contact lens wear.  
3. Any active or ongoing systemic disease, autoimmune 
disease, or use of medication, which may interfere 
with contact lens wear. This may include, but not be 
limited to, diabetes, hyperthyroidism, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases 
or any infectious diseases (e.g. hepatitis, 
tuberculosis).
4. Any previous, or planned, ocular or intraocular 
surgery (e.g. radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.). 
5. A history of amblyopia, strabismus or binocular 
vision abnormality. 
6. Use of any of the following medications within 2 
weeks prior to enrollment: oral retinoids, oral 
tetracyclines, anticholinergics, systemic/topical 
steroids, oral phenothiazines.  See section 9.1 for 
additional details regarding excluded systemic 
medications.
7. Use of any ocular medication, with the exception of 
rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye. 
11. Participation in any contact lens or lens care product 
clinical trial within 30 days prior to study enrollment. 
12.  Employee or immediate family member of an 
employee of clinical site (e.g., Investigator, 
Coordinator, Technician). 
13. Any known hypersensitivity or allergic reaction to 
non-preserved rewetting drop solutions or sodium 
fluorescein.
Exclusion Criteria after Baseline:
14. Clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, 
tarsal abnormalities or bulbar injection, or any other 
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corneal or ocular abnormalities which would 
contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent 
styes, dry eye, glaucoma, history of recurrent corneal 
erosions. 
16. Any current ocular infection or inflammation.
17. Any current ocular abnormality that may interfere 
with contact lens wear.
Disallowed
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear. 
See section 9.1 for details regarding disallowed systemic 
medications.
Measurements and 
Procedures
logMAR Visual acuity and Subjective responses for vision 
using the CLUETM questionnaire. 
Microbiology or Other 
Laboratory Testing
None
Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any serious adverse event (SAE) where 
relationship to study agent cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Non-Preserved Rewetting drops, lens cases, glass vials, saline, 
ETDRS light cabinet, 4M logMAR charts, and Near logMAR 
charts.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.
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Figure 1: Study Flowchart 
70 Subjects to Complete
Potential Subjects Identified Based On:
x
Age: 40-70 yrs. (inclusive)
x
Habitual contact lens wearers with Presbyopic correction or symptoms
x
Refraction: Spherical Equivalent -1.25D to -3.75D
x
Cylinder: 0.75D
x
Add: +0.75D to +2.50D
x
Visual Acuity: Best corrected 20/20-3 or better in each eye 
Informed Consent 
Eligibility Criteria
Baseline Information
x
Habitual lens type, modality, and contact lens history. Wear Time
x
Baseline and CLDEQ-8 Questionnaire
x
Subjective refraction, Add Determination, Ocular Dominance, Add Refinement
x
Biomicroscopy
Modifications
(if necessary)
Yes
No
After 10 Minute Settling
x
Exit Visual Acuity
x
Post-Fit Questionnaire
x
Dispensing Criteria, Subject Instructions
x
Schedule Follow-up 3 ± 1 Day
Yes
Visit 1 Treatment 1 / Visit 4 Treatment 2
x
Lens Selection
x
Lens Insertion and Lens Damage
x
Lens Settling, Visual Satisfaction, Visual Acuity, Over-Refraction
x
Lens fit assessment
x
logMAR Visual Performance
Visit 2 Treatment 1 Follow-up 1 /Visit 5 Treatment 2 Follow-up 1
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
PRO Questionnaire
x
Visual Satisfaction, Entrance,  Visual Acuity, Over-Refraction
Modifications
(if necessary)
Yes
Yes
After 10 Minute Settling
x
Exit Visual Acuity, PRO Questionnaire
x
Dispensing Criteria. Subject Instructions
x
Biomicroscopy
x
Schedule Follow-up 7± 1 Day
No
Visit 3 Treatment 1 Follow-up 2 / Visit 6 Treatment 2 Follow-up 2
x
Medical History and Concomitant Medication Review
x
Wear Time and Compliance
x
PRO and CLDEQ-8 Questionnaire
x
Visual Satisfaction, Entrance Visual Acuity, Binocular Over Refraction, and logMAR Visual 
Performance
x
C Quant Straylight Meter Teating (Site 1036 only) and Corneal Topograohy / Wavefront (Site 
1036 only)
x
Lens Fitting Assessment, Lens Deposits, and Lens Wettability
x
Unworn Lens Collection (if applicable), and Lens Removal
x
Biomicroscopy
x
7± 3  Days Wash-out Period (Not applicable V6)
x
Exit Visual Acuity (Not Applicable V6
Final Evaluation
Crossover
The Subject will 
be fit with the 
2nd Test lens at 
Visit 4 and 
repeat the 
Process for Trial 
Fitting 2,
Visits 4-6
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required For Near Use
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information
PI 
 
 
Principal Investigator
PIG 
 
 
Patient Instruction Guide
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PQC 
 
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
1.
INTRODUCTION AND BACKGROUND  
The purpose of this study is to evaluate the visual performance and subjective response of the 
JJVC Investigational Multifocal Contact Lens and compare to the marketed Dailies Total 1®
Multifocal Contact Lenses manufactured in delefilcon A material.  
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1.1.
Name and Descriptions of Investigational Products 
Investigational Product:  JJVC Investigational Multifocal Contact Lenses manufactured in 
senofilcon A C3 material 
Control: Dailies Total 1® Multifocal Contact Lenses manufactured in delefilcon A material
1.2.
Intended Use of Investigational Products
All lenses are intended to correct spherical refractive error and presbyopia.  For this study both 
of the lenses will be worn as a daily disposable lens, with the lenses being discarded after a 
day of wear.  The Lenses will be fit in a randomized fashion.  After fitting, each subject will 
return for an optimization visit and then a follow-up.  The sequence will then be repeated with 
the other study lens type.  Each study lens type will be worn for a total of approximately 8-12 
days. 
1.3.
Summary of Findings from Nonclinical Studies
Not Applicable 
1.4.
Summary of Known Risks and Benefits to Human Subjects
Anticipated risks and adverse reactions with this lens are similar to those with other soft daily 
wear contact lenses used to correct presbyopia.  A listing of examples of adverse reactions is 
found in the Section 13 of this protocol.  The investigator should follow normal clinical 
guidelines regarding examination and care of subjects who participate in this trial.  Refer to 
study lens package insert for additional details for the control lens and the Investigational 
Brochure (IB) for the Investigational lens.
Both the study multifocal contact lenses are
designed for the correction of refractive spherical refractive error and presbyopia. The 
investigational study contact lens is manufactured in senofilcon A C3 and the control lens is 
manufactured in delefilcon A.  Both of the lenses will be worn in a daily wear, disposable 
modality. These lenses are not intended for extended wear in this study. 
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
The Test lenses have been previously tested in clinical studies
 however 
at the time of writing of this protocol there is not a completed report for 
30 subjects completed the study per the protocol.  The lenses displayed good 
clinical vision performance with binocular, distance, high luminance, high contrast logMAR 
visual acuity of -0.057 and 0.091 at distance and near respectively.  
There was one adverse event reported during the study.  The subject experienced mild upper 
respiratory virus and did not receive any treatment for this event.  The event resolved and the 
subject completed the study.  The investigator considered the event to be not related to study 
article/procedure.  
For information about the control product refer to study lens package insert for additional 
details (APPENDIX C)  and the Investigational Brochure (IB) for the Investigational product.
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2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The objective of this study is to evaluate the visual performance and subjective vision 
responses of the Investigational Multifocal Contact Lenses manufactured in senofilcon A C3 
material (Test) compares to the Dailies Total 1® Multifocal Contact Lenses (Control) 
manufactured in delefilcon A material. 
2.2.
Endpoints 
Primary Endpoint: 
Overall Quality of Vision
Overall quality of vision will be assessed using the Contact Lens User Experience (CLUE™) 
questionnaire at the 2-Week follow-up evaluation.  CLUE™ is a validated patient-reported 
outcomes questionnaire to assess patient-experience attributes of soft, disposable contact 
lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the 
US, ages 18-65.  Derived CLUE™ scores using Item Response Theory (IRT) follow a normal 
distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response with a range of 0-120.  A 5-point increase in an average CLUE™ 
score translates into 10% shift in the distribution of scores for population of soft contact lens 
wearers.6
Secondary Endpoint: 
Visual Acuity (logMAR) 
Multiple assessments of binocular and monocular visual acuity will be made during the study, 
but the binocular measurements made at the 2-week follow-up evaluation using high contrast 
letters in bright illuminance conditions will be the primary endpoint. 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. Visual acuity will be measured using high 
and low contrast charts in bright illuminance conditions. Visual acuity will also be measured 
using high contrast charts in dim illuminance conditions created by the use of goggles.
 
Other Endpoints: 
x
CLUETM Comfort 
x
CLUETM Handling  
x
Lens Optimization Summary 
x
Mechanical Lens Fit
x
Slit Lamp Findings  
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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 2 weeks of wear, the mean overall quality of vision score of the 
Test lens will be statistically better than 40 points on CLUE scale.  
2. After approximately 2 weeks of wear, the Test lens will be non-inferior to the Control 
lens with respect to the overall quality of vision score. A non-inferiority margin of 5 
points will be used.  
Secondary Hypotheses
1. After approximately 2 weeks of wear, the mean distance visual acuity score of the Test 
lens will be statistically lower than 0.00 on logMAR scale.
2. After approximately 2 weeks of wear, the mean intermediate visual acuity score of the 
Test lens will be statistically lower than 0.17 on logMAR scale. 
3. After approximately 2 weeks of wear, the mean near visual acuity score of the Test lens 
will be statistically lower than 0.17 on logMAR scale.  
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Healthy male and female subjects who are habitual soft contact lens wearers will be recruited.  
Subjects will be at least 40 years of age and not older than 70 years of age.  They will be 
myopic and have presbyopia.    
3.2.
Inclusion Criteria
Potential subjects must satisfy all the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol.
3. The subject must be at least 40 years of age and not greater than 70 years of age at the 
time of consent. 
4. Subjects must own a wearable pair of spectacles if required for their distance vision.
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5. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses 
a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more 
duration). 
6. The subject must either already be wearing a presbyopic contact lens correction (e.g., 
reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) 
or, if not respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire” (Appendix E). 
Inclusion Criteria after Baseline:
7. The subject’s distance spherical equivalent refraction must be in the range of -1.50 D
to -3.75 D in each eye. 
8. 7KHVXEMHFW¶VUHIUDFWLYHF\OLQGHUPXVWEH'LQHDFKH\H
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:
1. Currently pregnant or lactating. 
2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens 
wear.  
3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, Stevens-
Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. 
hepatitis, tuberculosis).
4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, 
LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
5. A history of amblyopia, strabismus or binocular vision abnormality. 
6. Use of any of the following medications within 2 weeks prior to enrollment: oral 
retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids,
oral 
phenothiazines.  See section 9.1 for additional details regarding excluded systemic 
medications.
7. Use of any ocular medication, with the exception of rewetting drops. 
8. History of herpetic keratitis.
9. History of irregular cornea.
10. History of pathological dry eye. 
11. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment. 
12.  Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
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13. Any known hypersensitivity or allergic reaction to non-preserved rewetting drop 
solutions or sodium fluorescein. 
Exclusion Criteria after Baseline:
14. Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear.
15. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history 
of recurrent corneal erosions.
16. Any current ocular infection or inflammation.
17. Any current ocular abnormality that may interfere with contact lens wear.
3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a 6-visit, subject-masked, multi-site, 2×2 crossover dispensing trial. A total of 
approximately 85 subjects will be enrolled with a target of 70 subjects to complete the study. 
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility criteria, 
they will be randomized to one of two lens wear sequences (Test/Control or Control/Test) in a 
bilateral fashion. 
If the subject is dispensed study lenses at the initial visit, five additional visits will be 
conducted. The first follow-up visit (Visit 2) will occur 3 ± 1 days after the initial visit. At visit 
2, subjects will undergo lens optimization if necessary. Subjects will wear the study lenses for 
7 ± 1 days and then will return for their second follow-up at Visit 3. After Visit 3, subjects 
will undergo a washout period of 7 ± 3 days, where subjects will wear their habitual contact 
lenses or spectacles. After the washout period subjects will return for Visit 4, where they will 
be dispensed their second study lens per the randomization schedule. Subjects will return for 
their first follow-up visit (Visit 5) 3 ± 1 days after Visit 4, for lens optimization. Subjects will 
return for their second follow-up visit and their final evaluation 7 ± 1 days after Visit 5.   
4.2.
Study Design Rationale
Crossover designs are a well-established study design in which subjects are exposed to multiple 
treatments during different time periods.  A 2×2 bilateral crossover design was considered to 
be the optimal design since the study period is relatively short the design can be cost effective 
and more efficient comparisons between treatments can be made than compared a parallel 
study since fewer subjects are required to achieve the same pre-specified statistical power. 
Each subject will act as their own control to reduce the influence of potential confounding factors 
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such as age, gender and vision correction. A 7±3 day washout between study lens wear will be 
implemented to help reduce any potential bias.   
4.3.
Enrollment Target and Study Duration
A total of approximately 85 eligible subjects will be enrolled with 70 targeted to complete the 
study. The study will last approximately 2-4 months.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
The study lenses will be worn in a bilateral and random fashion using a 2×2 crossover design. 
A computer-generated randomization scheme will be used to randomly assign subjects, in 
blocks of 2, to one of the two possible lens wear sequences: Test/Control or Control/Test. The 
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).
The study site must follow the randomization scheme provided and complete enrollment per 
the randomization list and not pre-select or assign subjects.  The randomized assignment of 
subjects will be performed at the first visit prior to the first fitting.  The following must have 
occurred prior to randomization: 
o
Informed consent has been obtained 
o
Subject meets all the inclusion / exclusion criteria
o
Subject history and baseline information has been collected.
5.2.
Masking
This is a single-masked study with the subjects being masked.  The term partial masking is 
being used as subjects will not be told any information regarding the optical designs of the 
lenses beyond that they are intended to correct for their refractive error and presbyopia, 
however there are slight differences in the tint of the lenses which is impossible to mask from 
the subject.    
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
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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
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. 
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
Dailies Total 1®
Multifocal Contact  
Lens
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6.2.
Ancillary Supplies/Products
The following solutions will be used in this study:
Manufacturer
Johnson & 
Johnson® Vision 
Care, Inc.
Alcon
Over-labeled 
(marketed product)
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 -4.00 D in 
0.25 D steps 
Nominal 
Cylinder Powers 
(D) and Axes
None
None
Nominal ADD 
Powers (D)
LOW, MID, HI
LO, MED, HI
Water Content 
38%
33%
Center Thickness 
@ -3.00 D
0.07 mm
@ -3.00 D
0.09 mm
@ -1.00 D
Oxygen 
Permeability (Dk)
103
156
@ -3.00 D
Wear Schedule in 
Current Study 
Daily Wear
Daily Wear
Replacement 
Frequency
Daily
Daily
Packaging Form
(vial, blister, etc.)
Blister
Blister
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Table 2: Ancillary Supplies
Single-Use Preservative-Free Rewetting 
Solutions (any one of these three 
rewetting solutions options may be 
supplied)
Solution 
Name/Description
Eye-Cept®
Rewetting 
Drops 
ScleralFil®
Preservative 
Free Saline 
Solution
LacriPure 
Saline 
Solution 
Manufacturer 
Optics 
Laboratory
B&L
Menicon
Preservative
Non-
Preserved
Non-
preserved
Non-
preserved
6.3.
Administration of Test Articles
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the Investigator and/or the Sponsor.
6.4.
Packaging and Labeling
The test articles will be packaged in blisters, as the primary packaging. The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic bags 
as the secondary packaging form. The sample study label is shown below:
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
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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.
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation. The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log. All test articles must be accounted. This includes:
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC.
If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
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7.
STUDY EVALUATIONS 
7.1.
Time and Event Schedule
Table 3: Time and Events 
Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Baseline
Treatment 2  
Visit 5
Treatment 2
Follow-up 1
Optimization
Visit 6
Treatment 2
Follow-up 2 
Time Point
Day 0
Day 3±1
from V1
Day 7±1
from V2
Complete
7±3 days 
washout before 
V4 (Day 0 for 
wash-out) 
Day 7±3
from V3
Day 0  
Day 3±1
from V4
Day 7±1
from V5 
Estimated Visit Duration
2.5 hours
1.0 hour
1.5 hour
1.5 hour
1.0 hour
1.5 hour
Statement of Informed 
Consent
x
Demographics
x
Medical 
History/Concomitant 
Medications
x
Adverse Events and 
Concomitant Medications 
Review
x
x
x
x
x
Compliance
x
x
x
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Baseline
Treatment 2  
Visit 5
Treatment 2
Follow-up 1
Optimization
Visit 6
Treatment 2
Follow-up 2 
Time Point
Day 0
Day 3±1
from V1
Day 7±1
from V2
Complete
7±3 days 
washout before 
V4 (Day 0 for 
wash-out) 
Day 7±3
from V3
Day 0  
Day 3±1
from V4
Day 7±1
from V5 
Estimated Visit Duration
2.5 hours
1.0 hour
1.5 hour
1.5 hour
1.0 hour
1.5 hour
Habitual Contact Lens 
Information
x
Contact Lens History
x
Wear Time and 
Comfortable Wear Time 
with Habitual lenses
x
Wear Time and 
Comfortable Wear Time 
with Study lenses
x
x
x
x
Screening
Inclusion/Exclusion 
Criteria
x
Subject Reported Ocular 
Symptoms
x
x
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
x
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Baseline
Treatment 2  
Visit 5
Treatment 2
Follow-up 1
Optimization
Visit 6
Treatment 2
Follow-up 2 
Time Point
Day 0
Day 3±1
from V1
Day 7±1
from V2
Complete
7±3 days 
washout before 
V4 (Day 0 for 
wash-out) 
Day 7±3
from V3
Day 0  
Day 3±1
from V4
Day 7±1
from V5 
Estimated Visit Duration
2.5 hours
1.0 hour
1.5 hour
1.5 hour
1.0 hour
1.5 hour
Lens Removal
x
x
x
x
x
x
Keratometry
x
Subjective Refraction and 
Distance Visual Acuity
x
Near ADD Determination
x
Ocular Dominance
x
ADD Refinement
x
Near Visual Acuity
x
Biomicroscopy
x
x
x
x
x
x
Baseline Inclusion/
Exclusion Criteria
x
Continuance
x
Lens Selection
x
x (if modified)
x
x (if modified)
Lens Insertion
x
x
x
x
10 Minute Settling
x
x
x
x
Visual Satisfaction /
Subjective Acceptance
x
x
x
x
x
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Baseline
Treatment 2  
Visit 5
Treatment 2
Follow-up 1
Optimization
Visit 6
Treatment 2
Follow-up 2 
Time Point
Day 0
Day 3±1
from V1
Day 7±1
from V2
Complete
7±3 days 
washout before 
V4 (Day 0 for 
wash-out) 
Day 7±3
from V3
Day 0  
Day 3±1
from V4
Day 7±1
from V5 
Estimated Visit Duration
2.5 hours
1.0 hour
1.5 hour
1.5 hour
1.0 hour
1.5 hour
Study Lens Distance and 
Near Visual Acuity 
x
x
x
x
x
x
Distance Over Refraction 
and Visual Acuity
x
x
x
x
Subjective Lens Fit 
Assessment
x
x
x
x
x
x
Lens Deposits
x
x
Lens Wettability
x
x
Binocular Over Refraction
x
x
C-Quant Straylight Meter 
Testing 
X
X
Corneal Topography and 
Wavefront measurement 
x
X
Compliance
x
x
x
x
Follow-up PRO (CLUE / 
MRD) Questionnaire
x
x
x
x
Visual Performance
x
x
Modifications
x
x
x
x
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Visit Information
Visit 1
Screening, 
Baseline, 
Treatment 1 
Visit 2
Treatment 1
Follow-up 1 
Optimization 
Visit 3
Treatment 1
Follow-up 2  
Visit 4
Baseline
Treatment 2  
Visit 5
Treatment 2
Follow-up 1
Optimization
Visit 6
Treatment 2
Follow-up 2 
Time Point
Day 0
Day 3±1
from V1
Day 7±1
from V2
Complete
7±3 days 
washout before 
V4 (Day 0 for 
wash-out) 
Day 7±3
from V3
Day 0  
Day 3±1
from V4
Day 7±1
from V5 
Estimated Visit Duration
2.5 hours
1.0 hour
1.5 hour
1.5 hour
1.0 hour
1.5 hour
Post-Fit PRO (MRD) 
Questionnaire
x
x
x
x
Distance and Near Exit 
Visual Acuity
x
x
x
x
x
Dispensing Criteria
x
x
x
x
Instructions
x
x
x
x
x
Schedule Follow-up
x
x
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.  
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
Keratometry 
Keratometry will be performed OD and OS 
and the steep and flat dioptric power and 
corresponding meridians recorded.
1.14
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.
1.15
Near ADD 
Determination
The near reading addition will be determined 
using the binocular crossed cylinder 
technique (BCC) at 40 cm followed by 
optimization in a trial frame in step 1.17
below.
1.16
Ocular Dominance
Determine the distance ocular dominance 
with the best distance correction in place 
using a +1.00-blur test. If the results are 
equivocal use the sighting dominance test to 
determine the dominant eye used for the 
study.
1.17
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses 
(or flippers) under binocular conditions. 
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1.18
Near Visual Acuity
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm.  Record the near 
visual acuity OD, OS and OU at 40 cm.
1.19
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If any of these slit lamp findings are Grade 2
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.  
1.20
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
1.21
Randomization 
Record the randomization ID.
1.22
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).  
1.23
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.
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1.24
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
1.25
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.  
1.26
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
1.27
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.   
1.28
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
1.29
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
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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. 
1.30
Post-Fit PRO 
(MRD) 
Questionnaire 
The subjects will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(MRD) questionnaire.
1.31
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. 
1.32
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to 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.
1.33
Patient Instructions
Instruct the Subject the following:
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x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
A patient instruction booklet will be 
provided. 
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.
1.34
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days. 
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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
Follow-Up PRO 
(CLUE) 
Questionnaire
The subject will respond to the Follow-Up 
PRO (CLUE) Questionnaire. 
2.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
2.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
2.7
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
Use the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm to measure the 
Near visual acuity
2.8
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 
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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.   
2.9
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.
2.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
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2.11
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.
2.12
Lens Removal
The study lenses will be removed and 
discarded.
2.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
2.14
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 2.12 above.  
2.15
Post-Fit PRO 
(MRD) 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(MRD) questionnaire.
2.16
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. 
2.17
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued.  
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
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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.
2.18
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.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for 
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
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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.
2.19
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) questionnaires.
3.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
3.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
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3.7
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
3.8
Visual Performance
Distance (4M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OD, OS, 
and OU for the following: 
Distance, Bright Illuminance 
High and Low Contrast ETDRS Charts        
4M- HC#1, HC#2, HC#3 and LC#1, LC#2, 
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#4, 
HC#5, HC#6 
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
NOTE:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597
lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
3.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
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Note: No lens changes are allowed based on 
the over-refraction.  
3.10
C-Quant Straylight 
Meter Testing (Site 
1036 only)
Ocular straylight will be measured using the 
C-Quant OD and OS and record the log (s), 
Esd and Q values to two decimal places. 
3.11
Corneal Topography 
and Wavefront 
measurement (Site 
1036 only) 
Using the VISIONIX corneal topography and 
wavefront will be measured over the contact 
lens OD and OS.  The simulated Ks will be 
recorded for the corneal topography and the 
RMS (day) value for the wavefront.
3.12
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
3.13
Lens Deposits
Grade and record the amount of front and 
back surface lens deposits for both eyes.
3.14
Lens Wettability
Grade the wettability of the lenses.
3.15
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject. 
3.16
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.
3.17
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
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Corneal Staining Assessment 
will be graded in 1.0 increments. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
3.18
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the subject’s 
habitual correction 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.
3.19
Schedule 
Follow-up 
The subject will be scheduled to return for 
their next appointment in 7±3 days. 
NOTE: Subject may wear their habitual 
spectacles or contact lenses during the 
washout period.
VISIT 4
The subjects may present to Visit 4 wearing their habitual spectacles or contact lenses, if 
required for their distance vision.
Visit 4: Baseline Treatment 2 
Step
Procedure
Details
4.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit.
Record any adverse events or medical history 
changes from the previous study visit.
4.2
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
4.3
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the subject’s 
habitual correction 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.  
4.4
Lens Removal (if 
applicable)
Have the subject remove their habitual lenses 
and store in an approved storage solution.
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4.5
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
4.6
Continuance
Determine whether the subject is eligible to 
continue in the study based on the 
examination findings.  
Visit 4: Treatment 2 Lens Fitting
Step
Procedure
Details
4.7
Lens Selection
Select the lens pair and power based on the 
randomization scheme, spherical equivalent 
refraction (measured at Visit 1 baseline) and 
fitting guide for each eye.  Record the Test 
lens parameters (power and lot number).  
4.8
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.
4.9
Lens Settling 
Allow the study lenses to settle for a 
minimum of 10 minutes.
4.10
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.  
4.11
Distance and Near 
Entrance Visual 
Acuity
Measure the distance and near visual acuity 
OD, OS and OU.  Record the results. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
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recorded to the nearest letter OD, OS and 
OU.
4.12
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.   
4.13
Lens Fit Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement; 
x
edge lift;
x
excessive movement in primary and 
up gaze; or  
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up. 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
4.14
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 
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the fitting guide allowing for at least 10 
minutes of settling time between each lens 
modification attempted.   
If modifications are required steps 4.7-4.13 
will be repeated for each modification. 
4.15
Post-Fit PRO (MRD) 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of the study lenses using the PRO (MRD) 
questionnaire.
4.16
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. 
4.17
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort of 
the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
4.18
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. 
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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.
4.19
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 3±1 days. 
NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 5
The subjects must present to Visit 5 wearing the study lenses. To be counted as a day of wear 
the lenses need to have been worn for at least six (6) hours prior to the visit. 
Visit 5: Treatment 2 Follow-up 1
Step
Procedure
Details
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5.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit. 
Record any adverse events or medical history 
changes from the previous study visit.
5.2
Wear time and 
Comfortable Wear 
time with Study 
lenses Wear Time
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
5.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
NOTE: Subjects must have worn lenses for 
at least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
5.4
Follow-Up PRO 
(CLUE) 
Questionnaire
The subject will respond to the Follow-Up 
PRO (CLUE) Questionnaire. 
5.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
5.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
5.7
Distance and Near 
Entrance Visual 
Acuity
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
5.8
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. 
5.9
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.  
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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 4.7-4.13 in 
Visit 4 Fitting allowing for at least 10 
minutes of settling time between each lens 
modification.
5.10
Lens Fit Assessment
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test).
x
The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
x
presence of limbal exposure (appearance 
of clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up). 
NOTE: If lens fit is unacceptable subject 
will be discontinued from the study. Remove 
the lenses, and complete the Final 
Evaluation forms.
5.11
Collection of
unworn lenses (if 
applicable) 
Collect unworn lenses returned by the subject 
when lens power has been optimized. 
If lens power was not changed allow the
subject to use the unworn lenses dispensed at 
Visit 4 and dispense enough lenses of the
same power to last the subject until their next
visit.
5.12
Lens Removal
The study lenses will be removed and 
discarded.
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5.13
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
5.14
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 5.12 above.  
5.15
Post-Fit PRO 
(MRD) 
Questionnaire 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(MRD) questionnaire.
5.16
Distance and Near 
Exit Visual Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU.
NOTE: The distance visual acuity must be 
at least 20/30 OU for the lenses to be 
dispensed. 
5.17
Dispensing Criteria
The following criteria must be met for lenses 
to be dispensed and if not all are met subject 
to be discontinued. 
x
Distance Snellen acuity equal to or 
better than 20/30 OU 
x
Subject must indicate that the vision is 
acceptable.
x
Subject must indicate that the comfort 
of the lenses is acceptable.
x
Lenses must have an acceptable general 
lens fit.
5.18
Patient Instructions
Instruct the Subject the following:
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x
The lenses will be worn on a daily wear 
basis. 
x
Only enough lenses will be dispensed to 
the subject to wear for the required 
number of days until their follow-up visit. 
No additional lenses will be dispensed.
x
A new lens will be opened and worn each 
day. 
x
Instruct the subject to bring back all 
unworn study lenses. 
x
Instruct the subject no cleaning or 
disinfecting solutions will be used for this 
lens type.  
x
If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness.
x
Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. 
x
Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses.
x
Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
NOTE: In the event a lens is lost or damaged, 
the subject will return to the clinical site for
replacement.  As much as reasonably 
possible, a damaged lens and packaging 
should be returned to the clinical site (wet, if 
possible) and then returned to the Sponsor.  
If lens damage is present, complete the 
Product Quality Complaint Form.  The lens 
will be stored in labeled vial with saline, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor.
5.19
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 7±1 days. 
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NOTE: To count the follow-up visit as a day 
of wear the Subject must have worn the 
study lenses for 6 hours prior to the visit.
VISIT 6
The subjects must present to Visit 6 wearing the study lenses.  To be counted as a day of 
wear the lenses need to have been worn for at least six (6) hours prior to the visit.
Visit 6: Treatment 2 Follow-up 2
Step
Procedure
Details
6.1
Adverse Events and 
Concomitant 
Medications Review
Review the subject’s concomitant 
medications and record any changes from the 
previous study visit. 
Record any adverse events or medical history 
changes from the previous study visit.
6.2
Wear time and 
Comfortable Wear 
time with Study 
lenses 
Record the hours the subject has worn the 
study lenses and the comfortable wear time 
on the day of follow-up. 
6.3
Compliance
Record the subject’s compliance with 
wearing the study lenses.  
NOTE: Subjects must have worn lenses for 
at least 6 hours per day  
To be counted as a day of wear at this visit 
the Subject must have worn the study lenses 
for 6 hours prior to the visit.
6.4
PRO (CLUE and 
MRD) and CLDEQ-
8 Questionnaires   
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual 
symptoms of the study lenses using the PRO 
(CLUE and MRD) questionnaires.
6.5
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire
6.6
Subjective 
Acceptance
Record whether the subject’s distance and 
near vision with the lenses is acceptable.
6.7
Distance and Near 
Entrance Visual 
Acuity
Distance and near Snellen visual acuity will 
be measured for each eye with the study 
contact lenses in place. 
For near measures use the ETDRS 2000 
Series Chart 1 or 2. The acuity will be 
recorded to the nearest letter OD, OS and 
OU. 
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6.8
Visual Performance
Distance (4M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OD, OS, 
and OU for the following: 
Distance, Bright Illuminance 
High and Low Contrast ETDRS Charts        
4M- HC#1, HC#2, HC#3 and LC#1, LC#2, 
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#4, 
HC#5, HC#6 
Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
High Contrast Intermediate (64 cm) and Near 
(40 cm).
NOTE:
x
The room illuminance must be
between 7.3 and 7.9 EV (394-597
lux).
x
Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
x
Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
x
Do not use the Mesopic filter for 
Dim luminance (Dim luminance will 
be simulated by using the goggles)
6.9
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity.  
Note: No lens changes are allowed based on 
the over-refraction.   
6.10
C-Quant Straylight 
Meter Testing (Site 
1036 only)
Ocular straylight will be measured using the 
C-Quant OD and OS and record the log (s), 
Esd and Q values to two decimal places. 
6.11
Corneal Topography 
and Wavefront 
Using the VISIONIX corneal topography and 
wavefront will be measured over the contact 
lens OD and OS.  The simulated Ks will be 
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measurement (Site 
1036 only)
recorded for the corneal topography and the 
RMS (day) value for the wavefront.
6.12
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.
6.13
Lens Deposits
Grade and record the amount of front and 
back surface lens deposits for both eyes.
6.14
Lens Wettability
Grade the wettability of the lenses.
6.15
Collection of
unworn lenses (if 
applicable)
Collect unworn lenses returned by the
subject. 
6.16
Lens Removal
Have the subject remove the study lenses and 
store in saline in a labeled glass vial.
NOTE: Lenses do not need to be stored in a 
refrigerator.
6.17
Biomicroscopy
Perform biomicroscopy OD and OS. Slit 
Lamp Classification Scales will be used to 
grade the findings.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled.  
FINAL EVALUATION
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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
Distance Subjective 
Sphero-cylindrical 
Refraction and 
Distance Exit Visual 
Acuity
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.   
Record the refraction and distance visual 
acuity to the nearest letter.
F.2
Subject Disposition
Indicate if the subject completed the study 
successfully.  If subject discontinued from the 
study indicate the reason.
7.3.
Unscheduled Visits
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected at a minimum:
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. 
Unscheduled Visit
Step
Procedure
Details
U.1
Chief Complaints
Record the subject’s chief complaints for 
reasons for the unscheduled visit
U.2
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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Unscheduled Visit
U.3
Subject Reported Ocular 
Symptoms
Subjects will respond to a verbal open-
ended symptoms questionnaire.
U.4
Entrance VA
Record the entrance distance and near 
visual acuity (OD, OS and OU) to the 
nearest letter. 
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.  
U.5
Subjective Sphero-
cylindrical Refraction
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed.   
Record the refraction and distance visual 
acuity to the nearest letter.
U.6
Biomicroscopy
FDA Slit Lamp Classification Scale will 
be used to grade the findings and 
determine eligibility.  
For the conjunctival redness 
 
0.5 unit increments will be used in the 
grading.  
Corneal Staining Assessment 
will be graded in 1.0 increments.
If the clearance of the fluorescein needs to 
be expedited, preservative-free rewetting 
drops may be instilled.  
U.7
Lens Dispensing
Additional study lenses may be dispensed 
when required.
U.8
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
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Unscheduled Visit
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.
U.9
Exit Visual Acuity 
Record the subject’s exit distance and 
near visual acuity (OD, OS and OU) to 
the nearest letter.
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.  
7.4.
Laboratory Procedures 
Not Applicable 
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 death during the study period 
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 causing discontinuation of study 
lens wear 
x
Subjects who have experienced a Corneal Infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x
Subject missed any study visits
x
Subject not compliant with study lens wear schedule 
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x
Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit 
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled). 
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study.
x
Record the spherocylindrical refraction with best corrected distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2.
x
Collect all unused test article(s) from the subject. 
x
Make arrangements for subject care, if needed, due to their study participation
An additional subject may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear. 
9.1.
Systemic Medications
A summary of disallowed medications is shown in Table 4.  
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 Tetracylines
Urinary tract infection, acne, 
chlamydia,  gonorrhea
Sumycin, Actisite, Achromycin 
V, etc., … 
Systemic/Topical 
Corticosteroids
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions 
Cortisone, Prednisone, 
Hydrocortisone, Medrol, 
Kenalog etc.,.…
Oral
Phenothiazines 
Antipsychotic disorders 
(schizophrenia, mania) 
Compazine, Mellarill, 
Thorazine, Phenagran, etc. 
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Class of Drug
Common Indication(s)
Common Examples
Oral Retinoids
Seborrhoea, acne
Isotretinoin, Acitretin,
Alitretinoin, 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" .
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation. 
Protocol waivers are prohibited. 
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.
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
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x
Eye Care Provider objective (slit lamp) findings if applicable. 
x
Confirmation of product availability for return (and tracking information, if available),
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
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 devices1
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. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following: 
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization 
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x
Chronic disease 
x
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
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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)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
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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: to entry: 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 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – 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; 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; severe for all events - 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;
unknown. 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
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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. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
x
Adverse event (diagnosis not symptom). 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size,
location, and depth, etc.). 
x
Date the clinical site was notified. 
x
Date and time of onset. 
x
Date and time of resolution. 
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x
Adverse event classification, severity, and relationship to test articles, as applicable. 
x
Treatment regimen instituted, 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. 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
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hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately. 
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines. 
13.4.3. Event of Special Interest
None 
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13.5. 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. At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data will 
not be collected as part of the clinical study database. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
 
Summaries will be presented by study lens type and will be performed separately by 
completion status (Safety Population, Per-Protocol Population or Intent-to-Treat Population).  
14.2. Sample Size Justification
This study was not designed or powered to test non-inferiority of the Test lens relative to the 
Control lens. Instead the sample size was chosen by the study responsible clinician. Historical 
data for the Control lens from 
 at the 1-week follow-up was utilized in the power 
calculation. The mean and standard deviation for the Control was 60.1 and 19.58, respectively.
Assuming that the Test and Control will have similar performance with respect to CLUE vision 
scores, the table below provide the power for different scenarios of effect size and intra-class 
correlation.  
Table 5: Statistical Power Analysis to test for Non-inferiority of the Test relative to the Control
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14.3. Analysis Populations
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file. 
Intent-to-Treat (ITT) Population:
All subjects regardless of actual treatment and subsequent withdrawal from study or deviation 
from protocol.  At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analysis  
All primary analysis will be conducted on the Per-protocol population.  
CLUE Vision
CLUE vision scores at the 2-week follow-up will be analyzed using a linear mixed model 
adjusting for baseline values as a covariate. Sequence of lens wear, study period, lens type will 
be included as fixed effects. Other factors such as, race, gender or ADD power may be included 
in the model as covariates when appropriate. Site will be included as a random effect (G-side). 
The covariance between residual errors from the same subject across study periods will be 
modeled using either homogenous compound symmetry (CS) or unstructured (UN). The 
Effect Size
Intra-class 
correlation
Power
0
0.3
0.675
0
0.6
0.871
0
0.8
0.989
1
0.3
0.809
1
0.6
0.954
1
0.8
0.999
2
0.3
0.902
2
0.6
0.987
2
0.8
>.999
3
0.3
0.957
3
0.6
0.997
3
0.8
>.999
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structure that returns the lowest finite-sample corrected Akaike’s Information criterion7 will 
be selected as the structure that best fits the model. The Kenward and Roger method, (Kenward 
and Roger, 1997)8 will be used for the denominator degrees of freedom.  
Comparisons between the Test and Control lens at the 2-week follow-up evaluation will be 
carried out using two-sided 95% confidence intervals constructed for the least-square mean 
difference (Test minus Control).      
Primary hypothesis 1: 
The null and alternative hypothesis for CLUE vision to test for superiority of the Test lens 
relative to the pre-defined threshold of 40 is as follows: 
ܪ௢: ߤ்௘௦௧൑ 40 
ܪ஺: ߤ்௘௦௧> 40 
Superiority will be declared if the lower limit of the 95% confidence interval of the adjusted 
mean for the Test lens is greater than 40. i.e. P(ߤ்௘௦௧> 
Primary Hypothesis 2:
The null and alternative hypothesis for CLUE vision to test for non-inferiority of the Test lens 
relative the Control lens is as follows: 
ܪ௢: ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟൑ -5 
ܪ஺: ߤ்௘௦௧െߤ஼௢௡௧௥௢௟> -5 
Non-inferiority will be declared if the lower limit of the 95% confidence interval for the least-
square mean difference is greater than -5. i.e. P(ߤ்௘௦௧െ ߤ஼௢௡௧௥௢௟>-5
14.6. Secondary Analysis  
Visual Performance (logMAR)
Binocular, high luminance, high contrast visual performance (logMAR) will be analyzed using 
a linear mixed model. Sequence of lens wear, study period, lens type, distance (4m, 64cm and 
40cm) and the lens by distance interaction as fixed effects. Other characteristics including, age, 
gender and race and ADD power may be included when appropriate. Site will be included as 
a random effect (G-side). The covariance between residual errors from the same subject and 
distance across study periods will be modeled using either homogenous compound symmetry 
(CS) or unstructured (UN) covariance structure. The structure that returns the lowest finite-
sample corrected Akaike’s Information criterion7 will be selected as the structure that best fits 
the model. The Kenward and Roger method8 will be used for the denominator degrees of 
freedom.
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Comparisons between the Test and Control lenses will be carried out at each distance (4m, 
64cm and 40cm) using 2-sided 95% confidence intervals constructed of least square means 
(LSM) differences (Test minus Control) at the 2-week follow-up evaluation. 
Secondary hypothesis 1:  
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0 logMAR is as follows: 
ܪ௢: ߤ்௘௦௧൒ 0 logMAR 
ܪ஺: ߤ்௘௦௧< 0 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0 logMAR. i.e. P(ߤ்௘௦௧< 0
Secondary hypothesis 2:  
The null and alternative hypothesis for binocular near HLHC visual performance to test for 
superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as follows: 
ܪ௢: ߤ்௘௦௧൒ 0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧< 0.17
Secondary hypothesis 3:  
The null and alternative hypothesis for binocular distance HLHC visual performance to test 
for superiority of the Test lens relative to the pre-defined threshold of 0.17 logMAR is as 
follows: 
ܪ௢: ߤ்௘௦௧൒ 0.17 logMAR 
ܪ஺: ߤ்௘௦௧< 0.17 logMAR 
Superiority will be declared if the upper limit of the 95% confidence interval of the adjusted 
mean for the Test lens is below 0.17 logMAR. i.e. P(ߤ்௘௦௧< 0.17
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14.7. Other Exploratory Analyses 
CLUETM comfort and handling scores. 
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 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 15 imputations. 
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). 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 Date 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 
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Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification 
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol 
x
a record of all adverse events
x
follow-up of adverse events 
x
medical history and concomitant medication 
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. ClinicalTrials.gov  
This study will be registered on ClincalTrials.gov. 
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
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16.2. Confidentiality of Information
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
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. 
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x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 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 
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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
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 ICH2 and ISO 141551
guidelines, applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
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that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully. 
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x
adequate, relevant, and not excessive in relation to said purposes. 
x
accurate and, where necessary, kept current. 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
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should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC
management representative prior to study initiation. 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
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x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html
2.
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html
3.
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR
5.
Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
6.
Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales. 
Optom Vis Sci. 2016;93(8):801-808.  
7. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. Communications in Statistics—Simulation and Computation.
1998;27:591-604. 
8. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983–997. 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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APPENDIX B: PATIENT INSTRUCTION GUIDE (TO BE PROVIDED 
SEPERATLEY) 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
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APPENDIX D: BINOCULAR OVER REFRACTION
   
APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE
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Presbyopic Symptoms Questionnaire
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APPENDIX F: OCULAR DOMINANCE
  
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APPENDIX G: LENS FITTING GUIDE
   
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APPENDIX H: CONTROL LENS FITTING GUIDE
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APPENDIX I: STRAYLIGHT WITH C-QUANT
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Work Aid: Optical Scatter Measurement (C-Quant)
  
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Work Aid: Optical Scatter Measurement (C-Quant)
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Work Aid: Optical Scatter Measurement (C-Quant)
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Work Aid: Optical Scatter Measurement (C-Quant)
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Work Aid: Optical Scatter Measurement (C-Quant)
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Work Aid: Optical Scatter Measurement (C-Quant)
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APPENDIX J: WAVEFRONT AND TOPOGRAPHY MEASUREMENT USING 
VISIONIX
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
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Work Aid: Wavefront and Topography Measurement using Visionix VX118 instrument
DOCUMENT CHANGE HISTORY
Originator
Change Description
Effective Date
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APPENDIX K:
 
 
x
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
x
EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
x
DETERMINATION OF NEAR ADD
x
NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE
x
 LENS FITTING CHARACTERISTICS
x
SUBJECT REPORTED OCULAR SYMPTOMS
x
FRONT AND BACK SURFACE LENS DEPOSIT GRADING 
PROCEDURE
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
x
 BIOMICROSCOPY SCALE
x
KERATOMETRY
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
 PATIENT REPORTED OUTCOMES
x
 WHITE LIGHT LENS SURFACE WETTABILITY
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS
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Limbal & Conjunctival (Bulbar) Redness
 
 
  
  
 
 
 
  
 
 
  
  
 
 
 
  
 
 
 
  
 
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EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING
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Expanded Sodium Fluorescein Corneal Staining 
 
 
   
 
 
  
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DETERMINATION OF NEAR ADDITION
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Determination of Near Addition
     
         
           
           
                                 
           
                                
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Page 3 of 7
o 
 o
o 
 o 
 
o
o
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Page 5 of 7
 
  
                        
           
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NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE
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Page 1 of 2 
 
Near LogMAR Visual Acuity Measurement Procedure 
  
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LENS FITTING CHARACTERISTICS
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Lens Fitting Characteristics 
  
 
 
 
  
  
  
 
 
  
  
 
 
  
 
 
  
 
 
 
  
  
 
  
  
 
   
  
 
  
 
 
 
 
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Page 2 of 6 
  
  
  
   
 
  
 
 
 
 
 
 
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) 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS
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Subject Reported Ocular Symptoms/Problems
  
 
 
  
 
  
 
  
 
 
 
   
 
 
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FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE
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Front and Back Surface Lens Deposit Grading Procedure 
   
  
   
 
 
      
  
 
 
 
 
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Page 2 of 5
 
 
 
 
 
  
 
 
 
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DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
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  Determination of Distance Spherocylindrical Refractions
 
 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
 
 
 
 
 
  
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Page 5 of 6
 
 
   
  
 
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Page 6 of 6
 
 
  
  
   
 
 
 
 
 
 
 
 
  
  
  
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 BIOMICROSCOPY SCALE  
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Biomicroscopy Scale
 
 
  
  
 
  
  
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Page 2 of 5
  
  
  
 
    
                                        
                                         
  
                        
 
  
   
  
  
 
  
 
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Page 4 of 5
  
 
   
 
 
 
 
 
                       
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Page 5 of 5
 
  
  
 
 
 
 
 
 
  
 
 
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 KERATOMETRY PROCEDURE
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Keratometry Procedure
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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Title:
Distance and Near Visual Acuity Evaluation
Document Type:
Document Number: 
Revision Number: 3
Page 1 of 4
  
    
 
  
 
 
 
 
  
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Title:
Distance and Near Visual Acuity Evaluation
Document Type:
Document Number: 
Revision Number: 3
Page 2 of 4
  
   
 
 
  
 
  
  
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Title:
Distance and Near Visual Acuity Evaluation
Document Type:
Document Number: 
Revision Number: 3
Page 3 of 4
   
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Title:
Distance and Near Visual Acuity Evaluation
Document Type:
Document Number: 
Revision Number: 3
Page 4 of 4
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DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 
PROCEDURE
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 1 of 3 
 
  
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 2 of 3 
 
 
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Title: 
Distance LogMAR Visual Acuity Measurement Procedure 
Document Type: 
 
Document Number:  
 
Revision Number: 4 
 
Page 3 of 3 
 
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PATIENT REPORTED OUTCOMES
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Title:
Patient Reported Outcomes
Document Type:
Document Number:
Revision Number: 
2
Page 1 of 1
  
                       
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WHITE LIGHT LENS SURFACE WETTABILITY
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White Light Lens Surface Wettability  
 
 
  
 
 
 
 
  
 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION
TESTING
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
Page 1 of 5 
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
CTP-2059
Revision Number: 3
 
Page 2 of 5 
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
CTP-2059
Revision Number: 3
 
Page 3 of 5 
 
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
Page 4 of 5 
 
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Title:
Visual Acuity Chart Luminance and Room Illumination Testing
Document Type:
Work Instructions
Document Number: 
Revision Number: 3
 
Page 5 of 5 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6385 Evaluation of a daily disposable novel multifocal contact 
lens in a myopic population  
Version and Date: 4.0, Amendment 3 05 March 2020 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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