Evaluation of Rotation With a Multifocal Toric Contact Lens
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
Protocol Title: Evaluation of Rotation with a Multifocal Toric Contact Lens 
 
Protocol Number: CR-6491 
 
Version: 1.0  
                            
Date: 02 June 2022 
 
 
Test Articles: JJVC Investigational Multifocal Toric Contact Lenses manufactured in 
Senofilcon A (C3) material with UV/HEV filter 
 
Key Words: Presbyopia, Multifocal, Astigmatism, Daily Wear, Daily Disposable, Non-
Dispensing, senofilcon A, rotation, CLUE questionnaire 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155:2020,1 the 
International 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. 
 
 
 
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Clinical Study Protocol 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 18 
2.3. 
Hypotheses ............................................................................................................... 18 
3. 
TARGETED STUDY POPULATION ........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria ...................................................................................................... 19 
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 .................................................................................................................... 22 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6. 
STUDY INTERVENTION ............................................................................................. 22 
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6.1. 
Identity of Test Articles............................................................................................ 22 
6.2. 
Ancillary Supplies/Products ..................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 23 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 24 
7. 
STUDY EVALUATIONS .............................................................................................. 25 
7.1. 
Time and Event Schedule ......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 26 
VISIT 1 ........................................................................................................................... 26 
FINAL EVALUATION .................................................................................................. 35 
7.3. 
Unscheduled Visits ................................................................................................... 35 
7.4. 
Laboratory Procedures ............................................................................................. 37 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 37 
8.1. 
Completion Criteria .................................................................................................. 37 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 37 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 38 
9.1. 
Systemic Medications .............................................................................................. 38 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 38 
11. 
STUDY TERMINATION ........................................................................................... 39 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 40 
13. 
ADVERSE EVENTS ................................................................................................... 41 
13.1. 
Definitions and Classifications ............................................................................. 41 
13.2. 
Assessing Adverse Events .................................................................................... 43 
13.2.1. 
Causality Assessment .................................................................................... 43 
13.2.2. 
Severity Assessment ...................................................................................... 44 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 44 
13.4. 
Reporting Adverse Events .................................................................................... 46 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 46 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
47 
13.5. 
Event of Special Interest ....................................................................................... 47 
13.6. 
Reporting of Pregnancy ........................................................................................ 47 
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14. 
STATISTICAL METHODS ........................................................................................ 47 
14.1. 
General Considerations ......................................................................................... 47 
14.2. 
Sample Size Justification ...................................................................................... 47 
14.3. 
Analysis Populations ............................................................................................ 50 
14.4. 
Level of Statistical Significance ........................................................................... 50 
14.5. 
Primary Analysis .................................................................................................. 50 
14.6. 
Secondary Analysis .............................................................................................. 51 
14.7. 
Other Exploratory Analyses ................................................................................. 51 
14.8. 
Interim Analysis ................................................................................................... 51 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 51 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 51 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 52 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 52 
15.2. 
Subject Record ...................................................................................................... 52 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 53 
16. 
DATA MANAGEMENT............................................................................................. 53 
16.1. 
Access to Source Data/Document ........................................................................ 53 
16.2. 
Confidentiality of Information.............................................................................. 53 
16.3. 
Data Quality Assurance ........................................................................................ 53 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 54 
17. 
CLINICAL MONITORING ........................................................................................ 54 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 54 
18.1. 
Study-Specific Design Considerations ................................................................. 54 
18.2. 
Investigator Responsibility ................................................................................... 54 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 55 
18.4. 
Informed Consent ................................................................................................. 56 
18.5. 
Privacy of Personal Data ...................................................................................... 57 
19. 
STUDY RECORD RETENTION................................................................................ 58 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 58 
21. 
PUBLICATION ........................................................................................................... 59 
22. 
REFERENCES ............................................................................................................ 59 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 61 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 66 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 67 
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APPENDIX D: 
 ...................................... 68 
 LENS FITTING CHARACTERISTICS .............................................................. 69 
 SUBJECT REPORTED OCULAR SYMPTOMS ............................................... 75 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 77 
 BIOMICROSCOPY SCALE ............................................................................... 83 
 KERATOMETRY ................................................................................................ 89 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION .......................... 91 
 TORIC FIT EVALUATION ................................................................................ 96 
APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION............................... 101 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 113 
 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 14 
 
LIST OF TABLES 
Table 1 Randomization Scheme for 2x2 Crossover by Refraction Group and Toric Fit Type
................................................................................................................................................. 22 
Table 2: Test Articles .............................................................................................................. 22 
Table 3: Ancillary Supplies .................................................................................................... 23 
Table 4: Time and Events ....................................................................................................... 25 
Table 5: Disallowed systemic medications ............................................................................. 38 
Table 6 Summary of Historical Clinical Studies .................................................................... 48 
Table 7 Summary of Absolute Rotation by Lens – 15-Minutes After Insertion .................... 48 
Table 8 Statistical Power for 80 Subjects to complete by Reference Rate ............................. 49 
 
 
 
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SYNOPSIS  
Protocol Title 
Evaluation of Rotation with a Multifocal Toric Contact Lens 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Clinical trial phase: Confirmatory 
Design control phase: phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov based on 
the following: The clinical trial is evaluating a prototype 
contact lens with the finalized design. 
Test Article 
Investigational Product: JJVC Investigational Multifocal 
Toric Contact Lenses manufactured in Senofilcon A (C3) 
material with UV/HEV filter 
Wear and Replacement 
Schedules 
Wear Schedule: The lenses will be used once for a brief period 
within the study visit in this non-dispensing study. 
Replacement Schedule: Not applicable. 
Objectives  
Primary Objective: 
The primary objective of this study is to evaluate absolute 
rotation of the investigational multifocal toric lenses 15-
minutes after insertion.   
 
Exploratory Objectives: 
Exploratory objectives include evaluations of absolute 
rotation at 1-, 3-, 7- and, 25-minutes and rotational stability 
with blink at 15- and 25-minutes. Additionally, initial comfort 
and handling scores will be assessed.  
 
Study Endpoints 
Primary endpoint:  
 
x Absolute rotation less than or equal to 10° 15-minutes 
after insertion 
 
Exploratory endpoints: 
x Summary of Rotation 1-, 3-, 7- and, 25-minutes after 
insertion 
x Rotational stability with blink 15- and 25-minutes 
after insertion 
x Comfort scores approximately 30-minutes after 
insertion 
x Handling scores approximately 30-minutes after 
insertion 
 
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Study Design 
The study is a bilateral, single-masked, single-visit, non-
dispensing 2x2 crossover study.  There will be eight study lens 
types, however, each subject will only be randomized to 
receive two study lens types. 
x 
Myopes with against-the-rule astigmatism will wear -
3.00/-1.00 x 90 and -3.00/-1.75 x 90 
x 
Myopes with with-the-rule astigmatism will wear -
3.00/-1.00 x 180 and -3.00/-1.75 x 180 
x 
Hyperopes with against-the-rule astigmatism will 
wear +3.00/-1.00 x 90 and +3.00/-1.75 x 90 
x 
Hyperopes with with-the-rule astigmatism will wear 
+3.00/-1.00 x 180 and +3.00/-1.75 x 180 
 
The two lens powers that each subject wears are unlikely to be 
an exact match to their refractive error (ie. They may under-
correct or over-correct the sphere and/or cylinder) and will 
therefore provide sub-optimal vision correction during the 
brief wearing period while rotation and comfort are evaluated.  
The wear period will be approximately forty (40) minutes per 
lens type. 
 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 
Sample Size 
Approximately 90 subjects who habitually wear soft contact 
lenses will be enrolled, with the aim that at least 80 will 
complete the study (40 myopes and 40 hyperopes).     
Study Duration 
The study will last approximately 2 months. 
Anticipated Study 
Population 
Healthy male and female volunteers in the age range of 40 to 
70 with either myopia or hyperopia will be screened as per 
criteria outlined below.  The study will aim to enroll at least 
15 subjects in each of these four groups: 
x 
Myopes with against-the-rule astigmatism  
x 
Myopes with with-the-rule astigmatism  
x 
Hyperopes with against-the-rule astigmatism  
x Hyperopes with with-the-rule astigmatism  
All volunteers will have baseline measurements taken to 
ensure eligibility.  The baseline procedures will occur after 
informed consent has been obtained.   
For a detailed list of procedures see the time and events 
schedule listed below.     
Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
 
Inclusion Criteria following Screening 
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The subject must: 
  
1. Read, understand, and sign the STATEMENT OF 
INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol. 
3. Be at least 40 and not more than 70 years of age at the time 
of screening. 
4. Own a wearable pair of spectacles with distance vision 
correction. 
5. Be an adapted soft contact lens wearer in both eyes (i.e. 
has worn lenses a minimum of 2 days per week for at least 
8 hours per wear day, for the past four weeks). 
 
Inclusion Criteria at Baseline 
The subject must: 
6. Have distance spherical equivalent refraction in the range 
of either –1.00 D to -6.00 D or +1.00 to +6.00 D in each 
eye. 
7. Have distance cylinder refraction in the range of -0.75 to -
2.50 D in each eye, with the axis being in the range of 
either 90 ± 30° or 180 ± 30°. 
8. Have best corrected distance visual acuity of 20/25 or 
better in each eye. 
 
Eligibility Criteria - 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic allergies 
that may interfere with contact lens wear. 
3. Have any active or ongoing systemic disease, 
autoimmune disease, or use of medication, which may 
interfere with contact lens wear. This may include, but 
not be limited to, diabetes, hyperthyroidism, Sjögren’s 
syndrome, xerophthalmia, acne rosacea, Stevens- 
Johnson syndrome, and immunosuppressive diseases or 
any infectious diseases (e.g. hepatitis, tuberculosis). 
4. Use systemic medications that may interfere with contact 
lens wear or cause blurred vision. See section 9.1 for 
additional 
details 
regarding 
excluded 
systemic 
medications.  
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5. Currently use ocular medication with the exception of 
rewetting drops. 
6. Have any known hypersensitivity or allergic reaction to 
single use preservative free rewetting drops, or sodium 
fluorescein. 
7. Have had any previous ocular or intraocular surgery (e.g. 
radial keratotomy, PRK, LASIK, lid procedures, cataract 
surgery, retinal surgery, etc.). 
8. Have a history of amblyopia or strabismus. 
9. Have a history of herpetic keratitis. 
10. Have a history of irregular cornea. 
11. Have a history of pathological dry eye. 
12. Have participated in any contact lens or lens care product 
clinical trial within 14 days prior to study enrollment. 
13. Be an employee or immediate family member of an 
employee of clinical site (e.g., Investigator, Coordinator, 
Technician). 
 
Exclusion Criteria at Baseline 
The subject must not: 
14. Have clinically significant (Grade 3 or greater) corneal 
edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact 
lens wear. 
15. Have entropion, ectropion, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions. 
16. Have any current ocular infection or inflammation. 
17. Have any other 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 
The key measurements are contact lens rotation assessment, 
requiring the availability of a slit lamp biomicroscope with an 
adjustable beam orientation and axis dial, or an eyepiece 
reticle with axis protractor. 
Subjective questionnaire responses will be recorded by 
computer-based direct data entry. 
Microbiology or Other 
Laboratory Testing 
None 
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Study Termination 
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any SAE where relationship to study agent 
cannot be ruled out, may result in stopping further dispensing 
investigational product.  In the event of a UADE or SAE, the 
Sponsor Medical Monitor may unmask the treatment regimen 
of subject(s) and may discuss this with the Principal 
Investigator before any further subjects are enrolled. 
Ancillary Supplies/ Study-
Specific Materials 
Rewetting drops for optional use during lens wear.  
Stopwatches will be provided to the site for use during visits. 
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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COVID-19 
 
Coronavirus Disease 2019 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
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 
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 
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VA 
 
 
Visual Acuity 
1. INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision launched their most recent multifocal contact lens called 
ACUVUE® OASYS MULTIFOCAL in March, 2021.  The lens is recommended for 
presbyopes who have up to -0.75 D of refractive cylinder.  There is a considerable population 
of presbyopic patients who have greater than -0.75 D of cylinder, in one or both eyes.  Currently 
there are a limited number of soft toric multifocal lenses available.  This study will evaluate 
the performance of prototype daily disposable multifocal toric lenses with a similar optical 
design to ACUVUE® OASYS MULTIFOCAL which are manufactured in senofilcon A (C3) 
material with an added high energy visible (HEV) light filter.     
1.1. Name and Descriptions of Investigational Products 
Test Article:  JJVC Investigational Multifocal Toric Contact Lenses manufactured in 
Senofilcon A (C3) material with UV/HEV filter  
Refer to Table 2 in Section 6.1 the protocol.    
1.2. Intended Use of Investigational Products 
The Investigational Test lens is indicated for daily wear for the optical correction of refractive 
ametropia (myopia, hyperopia) and presbyopia in phakic or aphakic persons with non-diseased 
eyes who may need up to +2.50 D of ADD power and have astigmatism in the range of  -0.75 
D to -2.50 D.   In this study, the lenses will be used in a population of presbyopes with spherical 
equivalent refraction in the range of +1.00 D to +6.00 D or -1.00 D to -6.00 D, and -0.75 D to 
-2.50 D of cylinder with axis within 90°±30° or 180 ± 30° (see Section 3.2).  In this 
non-dispensing study, study lenses will be available in eight lens powers, and each subject will 
wear two powers that are unlikely to be an exact match to their refractive error, since vision is 
not being evaluated. 
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding JJVC 
Multifocal Toric Contact Lenses manufactured in senofilcon A material refer to the latest 
version of the CR-6491 Investigator's Brochure.5 
1.4. Summary of Known Risks and Benefits to Human Subjects 
For the most comprehensive risk and benefit information regarding JJVC Multifocal Toric 
Contact Lenses manufactured in senofilcon A material refer to the latest version of the CR-
6491 Investigator’s Brochure and Informed Consent.5 
 
As each study participant will wear two contact lens powers that may over-correct or under-
correct the sphere and/or cylinder, there is a risk that they may experience blurred vision, 
headaches or nausea during wear.  It is recommended that subjects remain seated in the 
examination chair if they experience blurred vision due to the lens power being dissimilar to 
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their refractive needs.  Subjects will need to be monitored by research staff during the brief 
period of lens wear due to this potential mismatch between the lens power and their refraction.  
If subjects experience unacceptable headaches or nausea during study lens wear, the lenses 
should be removed and the subject will need to be discontinued from the study. 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Investigational multifocal toric lenses with similar designs and materials have been evaluated 
in three other clinical studies prior to this study.   A summary of these studies is shown below, 
and relevant safety information for these studies is included in the CR-6491 Investigator’s 
Brochure. 
 
 was a single-arm dispensing evaluation of multifocal toric investigational lenses in a 
myopic population with against-the-rule astigmatism.  Lenses used in this study had a slightly 
different material formulation than the lenses being used in the current 
 study.  The 
study lenses were worn for approximately 2 weeks (with a first follow-up visit after 6-8 days, 
and second follow-up visit after a further 6-8 days).  Forty subjects were enrolled in the study 
and thirty-seven completed it.    No adverse events were reported.6,7   
 
 was a single-arm dispensing evaluation of multifocal toric investigational lenses in a 
hyperopic population with against-the-rule astigmatism.  This study tested lenses with an older 
formulation (same as the one used in 
) in comparison with a newer formulation.  In 
the 2x3 crossover study design involving 6 visits, subjects wore one of the study lens types for 
approximately 2 weeks, and the other study lens type for approximately 3 weeks.  Of the 35 
subjects enrolled, 32 were dispensed study lenses, and 28 completed the study per protocol.    
Two non-significant ocular adverse events were reported.  One ocular adverse event was 
determined to be not related to the study article or procedure.  One ocular adverse event 
(blepharitis) was considered unlikely to be related to the study article.6,8 
  
 was a bilateral, single-masked, single-arm, 4-visit dispensing study.  Study 
participants wore the study lenses for a period of approximately three weeks.  Of the 95 
subjects enrolled, 86 were dispensed study lenses, and 83 completed the study per protocol.    
No adverse events were reported during the study.7 
 
In addition to these multifocal toric studies, a series of studies have been performed on a non-
toric multifocal version of the study lens.  Further details of the safety profile of these related 
lens types are included in the Investigator’s Brochure.5 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
 Primary Objective: 
The primary objective of this study is to evaluate absolute rotation of the investigational 
multifocal toric contact lens 15-minutes after insertion. 
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Exploratory Objectives: 
Exploratory objectives include evaluations of absolute rotation at 1-, 3-, 7- and, 25-minutes 
and rotational stability with blink at 15- and 25-minutes. Additionally, initial comfort and 
handling scores will be assessed.  
2.2. Endpoints  
Primary endpoint:  
Absolute rotation 10° (Acceptable Absolute Rotation) 
Absolute rotation will be assessed at 1-, 3-, 7-, 15- and 25-minutes after insertion for each 
subject eye. However, absolute rotation at 15-minutes will be the primary endpoint. Acceptable 
absolute rotation is a binary response where Y=1 if absolute rotation is less than or equal to 
10° and Y=0 otherwise (absolute rotation greater than 10°).  See 
 in Appendix D for 
additional details on the collection of absolute rotation.   
 
Exploratory endpoints: 
x Summary of Rotation 1-, 3-, 7- and, 25-minutes after insertion 
x Rotational stability with blink 15- and 25-minutes after insertion 
x Comfort scores approximately 30-minutes after insertion 
x Handling scores approximately 30-minutes after insertion 
 
Comfort and handling scores will be assessed using the Contact Lens User Experience 
(CLUE™) questionnaire approximately 30-minutes after lens insertion. 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.9 
 
2.3. Hypotheses 
 
Primary Hypothesis 
1. Approximately 15-minutes after lens insertion, the percentage of lens fits with absolute 
rotation less than or equal to 10 degrees will be superior to 80%. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
The population to be studied will consist of adapted contact lens wearers with presbyopia, 
ametropia (hyperopia or myopia) and astigmatism.  
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3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be at least 40 and not more than 70 years of age at the time of screening. 
4. Own a wearable pair of spectacles with distance vision correction. 
5. Be an adapted soft contact lens wearer in both eyes (i.e. has worn lenses a minimum of 2 
days per week for at least 8 hours per wear day, for the past four weeks). 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. Have distance spherical equivalent refraction in the range of either –1.00 D to -6.00 D or 
+1.00 to +6.00 D in each eye. 
7. Have distance cylinder refraction in the range of -0.75 to -2.50 D in each eye, with the axis 
being in the range of either 90 ± 30° or 180 ± 30°. 
8. Have best corrected distance visual acuity of 20/25 or better in each eye. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Have any active or ongoing ocular or systemic allergies that may interfere with contact 
lens wear. 
3. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, 
which may interfere with contact lens wear. This may include, but not be limited to, 
diabetes, hyperthyroidism, Sjögren’s syndrome, xerophthalmia, acne rosacea, Stevens- 
Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. 
hepatitis, tuberculosis). 
4. Use systemic medications that may interfere with contact lens wear or cause blurred vision. 
See section 9.1 for additional details regarding excluded systemic medications.  
5. Currently use ocular medication with the exception of rewetting drops. 
6. Have any known hypersensitivity or allergic reaction to single use preservative free 
rewetting drops, or sodium fluorescein. 
7. Have had any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, 
lid procedures, cataract surgery, retinal surgery, etc.). 
8. Have a history of amblyopia or strabismus. 
9. Have a history of herpetic keratitis. 
10. Have a history of irregular cornea. 
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11. Have a history of pathological dry eye. 
12. Have participated in any contact lens or lens care product clinical trial within 14 days prior 
to study enrollment. 
13. Be an employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
14. Have clinically significant (Grade 3 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear. 
15. Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal 
erosions. 
16. Have any current ocular infection or inflammation. 
17. Have any other 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 
The study is a bilateral, single-masked, single-visit, non-dispensing 2x2 crossover study. Up 
to 90 (45 Hyperopes and 45 Myopes) subjects will be enrolled with the aim of 80 subjects (40 
Hyperopes and 40 Myopes) to complete the study. 
 
Eligible subjects will be randomized to receive two investigational multifocal toric lenses in a 
random order at the single study visit. Subjects will be fitted, and evaluations of toric and 
mechanical lens fit will be conducted as well as assessment of subjects’ initial comfort and 
handling. Each lens will be worn for approximately forty (40) minutes. Lens powers fit on 
subjects during this study are unlikely to be an exact match to their refractive error (ie., They 
may under-correct or over-correct the sphere and/or cylinder) and will therefore provide sub-
optimal vision correction during the brief wearing period while rotation and comfort are 
evaluated.       
 
4.2. Study Design Rationale 
A non-dispensing, single-visit,  2×2 bilateral crossover design was considered to be the optimal 
design to evaluate the primary objective of absolute rotation of the investigational lenses 15-
minutes after insertion. The lens design of the investigational multifocal toric lenses in this 
study was modified after reviewing the results from a previous study 
 Since the 
primary objective is to assess the absolute rotation, a limited number of lens powers were 
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chosen to be included in this study, as rotation and lens power are expected to be independent. 
Lens powers in combinations of plus and minus sphere powers (-3.00, +3.00 DS), low and high 
cylinder powers (-1.00, -1.75 DC), and cylinder axes (90°, 180°) were chosen to approximately 
represent the range of possible refractive errors. A 2x2 Crossover design is more cost effective 
compared to a parallel study as fewer subjects are required to achieve the same pre-specified 
statistical power. A washout period of 15-minutes will be used between study treatments. Due 
to the objective nature of the primary endpoint a washout of 15-minutes is considered sufficient  
to minimize any effects from the previous treatment.  
 
4.3. Enrollment Target and Study Duration 
Approximately 90 subjects who habitually wear soft contact lenses will be enrolled, with the 
aim that at least 80 will complete the study (40 myopes and 40 hyperopes).   The study will 
aim to enroll at least 15 subjects in each of these four groups: 
 
x 
Myopes with against-the-rule astigmatism  
x 
Myopes with with-the-rule astigmatism  
x 
Hyperopes with against-the-rule astigmatism  
x Hyperopes with with-the-rule astigmatism  
 
It is anticipated that 4 or 5 sites will participate, with each site targeting 20 to 28 completed 
subjects.   
Each study subject will participate in a single visit.  Study enrollment is expected to take 2 
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 to one 
of the two possible lens wear sequences (-1.00/-1.75 or -1.75/-1.00 DC) within each refraction 
and toric fit type group. See Table 1 below for additional details regarding the randomization 
for this study. 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).10 
 
Randomization will be performed prior to the first lens fitting.  The following must have 
occurred prior to randomization: 
o Informed consent must have been obtained.  
o The subject must have met all eligibility criteria. 
o The subject’s screening and baseline information must have been collected. 
 
 
 
 
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6.4.
Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging with an investigational 
lens label. The test articles will be in plastic bags as the secondary packaging form. The sample 
study label is shown below: 
 
Primary Packaging 
Secondary Packaging 
 
 
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Event and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return to JJVC. 
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 
2. The number and reason for unplanned replacements. 
Following final reconciliation of test articles by the monitor, the Investigator or monitor will 
return all unused test articles to JJVC. 
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7.4. Laboratory Procedures  
None 
8. SUBJECTS COMPLETION/WITHDRAWAL  
8.1. Completion Criteria 
Subjects are considered to have completed the study if they:  
x provided informed consent. 
x are eligible. 
x completed the study visit 
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 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). 
 
 
 
 
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 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.  
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deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB.   This is a "Major Deviation". Deviations 
that contradict the information contained in the Informed Consent/Assent forms will be 
considered Major Deviations. 
 
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature.  
 
Protocol waivers are prohibited. 
11. STUDY TERMINATION 
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(e.g., definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC Safety Management 
Team, the study may be terminated. This potential stopping rule is established based on our 
trial involving approximately 200 subjects wearing the investigational soft contact lens for up 
to 3 years with an assumed MK rate that is below 0.2% per patient-year. The rate of 0.2% per 
patient year is the established rate for extended wear lenses in adults, which was requested by 
the FDA as a criterion for evaluating a contact lens for pediatric use in an FDA response to a 
pre-IDE submission. To be conservative, 200 independent patient years were used in the 
calculation. The probability of observing 2 cases or more incidents of MK is 0.061, and 3 cases 
or more incidents of MK is 0.007 (given an MK rate of 0.2% per patient year).  
 
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.”  
NOTE: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1  
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
NOTE: Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x Death 
x Serious deterioration in the health of the subject that resulted in any of the following: 
x Life-threatening illness or injury 
x Permanent or persistent impairment of a body structure or a body function 
x Hospitalization or prolongation of patient hospitalization 
x Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x Chronic disease 
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x Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of > 2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
x Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x Asymptomatic Corneal Scar 
x Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x Non-significant Infiltrative Event (NSIE) 
x Contact Lens Papillary Conjunctivitis (CLPC) 
x Superficial Punctate Keratitis (SPK) 
x Conjunctivitis: Bacterial, Viral, Allergic 
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x Blepharitis 
x Meibomianitis 
x Contact Dermatitis 
x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
NOTE 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device.9  
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x Seriousness/Classifications (see definition in section 13.1). 
x Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in Section 13.2.1). 
x Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in 
Section 13.2.2). 
x Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
x Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
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x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x Adverse event (diagnosis not symptom). 
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x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
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13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
x Notify the Sponsor immediately. 
x Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
x Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
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13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 or higher (SAS Institute, Cary, NC).11 Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will be summarized. 
 
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. Summary tables will be summarized by timepoint, group and 
lens. 
14.2. Sample Size Justification 
This study was designed and powered to test that the percentage of lens fit with absolute 
rotation for both study lenses is superior to 80% 15-minutes after insertion. The sample size 
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was calculated using a 2-sided type I error rate of 5% with at least 80% statistical power. 
Historical data from 
 and 
 was both utilized in estimation of the sample 
size.7,12 Table 6 below provides details regarding each clinical study and Table 7 summarizes 
the absolute rotation for each study and lens for all lens fits (including any modifications).    
 
Table 6 Summary of Historical Clinical Studies  
 
Study ID 
Design 
Population 
Age Range 
(years) 
Number 
Enrolled 
Number 
Dispensed  
Number 
Completed 
 
Single 
arm 
Hyperopes 
+ Myopes 
40 to 70 
95 
86 
84 
 
2x2 
crossover 
Myopes 
18 to 39 
103 
98 
93 
  
 
Table 7 Summary of Absolute Rotation by Lens – 15-Minutes After Insertion  
 
 
AOfA 
N=202 
Aurora A 
Hyperopes 
N=114 
Myopes  
N=136 
Total  
N=250  
Absolute rotation 
n(%) 
 
 
 
 
0 to 5 
174 (86.1) 
85 (74.6) 
96 (70.6) 
181 (72.4) 
>5 to 10 
19 (9.4) 
14 (12.3) 
21 (15.4) 
35 (14.0) 
>10 to 15 
8 (4.0) 
7 (6.1) 
11 (8.1) 
18 (7.2) 
>15 
1 (0.5) 
8 (7.0) 
8 (5.9) 
16 (6.4) 
Total  
202 
114 
136 
250 
 
 
 
 
 
Absolute rotation 
< 10°  n(%) 
 
 
 
 
Yes 
193 (95.6) 
99 (86.8) 
117 (86.0) 
216 (86.4) 
No 
9 (4.5) 
15 (13.2) 
19 (14.0) 
34 (13.6) 
Total  
202 
114 
136 
250 
N=Number of lens fits.  
 
Based on the results from 
, the lens design was modified to improve the absolute 
rotation. The changes implemented into the lens design are more closely aligned with the 
Acuvue Oasys for Astigmatism lens design utilized in 
. However, as indicated in 
Table 5, 
 enrolled non-presbyopic myopic subjects only. In general, presbyopic subjects 
have been found to more contact lens rotation compared to non-presbyopic subjects, therefore, 
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results from both studies were considered when choosing different scenarios of reference 
rates.7,12 
 
Shown in Table 6 above, 
 had rates of 86% and 96%, respectively. Therefore, 
different scenarios used for the sample size and power calculations were chosen within that 
range. Furthermore, taking into consideration that this study will enroll subjects aged 40 to 70, 
more conservative rates of 88%, 89% and 90% were used.7,12  
 
Sample size estimates were carried out using Monte Carlo methods. A total of 2000 boot-strap 
samples were simulated using different scenarios for the reference rate for event Y and 
interclass correlations of 0.80 to model the covariance between the left and right eyes within 
the same treatment, and 0.50 to model both the covariance between treatments within the same 
eye as well as between eyes and treatments. Each boot-strap sample was analyzed using a 
generalized linear mixed model with a binary distribution and the logit and the link function. 
Lens was included as the only fixed effect. Errors between measurements within the same 
subject and period were modeled using a variance component covariance structure (VC). The 
Kenward and Roger Method was used for the denominator degrees of freedom.13  The 
percentage of lens fits with absolute rotation less than 10° was constructed using 95% 
confidence intervals for the least-square mean. Success for each boot-strap sample was 
declared if the lower limit of the 95% CI was above 80%. Table 8 below displays the number 
of subjects required to test superiority for the primary hypothesis for each study lens.    
 
While subjects will wear the study lenses in a random order data collected during evaluations 
in period 2 are not expected to be influenced by the lenses worn during period 1 since a wash-
out 15 -minutes will be utilized between study lenses and, subjects’ absolute rotation depends 
on the study lens on eye at that moment of data collection. 
 
Table 8 Statistical Power for 80 Subjects to complete by Reference Rate  
 
 
 
Reference Rate 
88% 
89% 
90% 
Statistical Power (%)  
87.7 
95.1 
98.3 
 
Up to 90 subjects (45 Hyperopes and 45 Myopes) will be enrolled with the target of 80 subjects 
(40 Hyperopes and 40 Myopes) to complete the study. Since this is a single-visit, non-
dispensing study, a high rate (> 10%) of subject drop-out is not expected to occur. However, 
subject drop-out rate will be monitored. If an unexpectedly high dropout rate is observed, then 
enrollment maybe be increased to ensure the minimum number of subjects required to test the 
primary hypothesis complete the study.  
 
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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 randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
The primary analyses will be conducted with a 2-sided type I error rate of 5%. 
14.5. Primary Analysis  
The primary analysis will be conducted on the ITT population.  
 
Absolute Rotation 10° 
Absolute rotation data collected 15-minutes after insertion will be dichotomized as Y=1 if the 
absolute rotation is less than 10° and Y=0 otherwise for the purpose of analysis. Y will be 
analyzed using a generalized linear mixed model with a binary distribution and the logit as the 
link function. Sequence of lens wear, period and lens type will be included in the model as 
fixed effects. Other characteristics such as age may be included as covariates in the model.  
Site and subject will be included as random effects (G-side). The covariance measurements 
within the same subject (between eyes) across study periods will be modeled using an 
unstructured (UN) covariance structure. The Kenward and Roger method7 will be used for the 
denominator degrees of freedom. If none of the fixed effects are significant, the percentage of 
lens fits with absolute rotation less than 10° will be estimated by combining data from both 
lenses using 2-sided 95% confidence intervals. 
 
The Model: 
Let ݕ௜௝௞௟௠௡ denote the absolute rotation for the ݊௧௛ eye from the ݉௧௛ subject at the ݈௧௛ site 
assigned to the ݇௧௛ sequence during the ݆௧௛ period for  the ݅௧௛ lens (i=1,2,; j=1,2; k=1, 2,; 
l=1…,݈௠݊= 1,2). The likelihood will be constructed as follows:  
 
݈݋݃݅ݐ൫ݕ௜௝௞௟௠௡൯= ߚ଴ + ߚଵܮ݁݊ݏ௜[௝,௞] + ߚଶܲ݁ݎ݅݋݀௝+ ߚଷܵ݁ݍݑ݁݊ܿ݁௞+ ߜ௟+ ߛ௟೘+ ߝ௜௝௞௟௠௡ 
 
Where: 
x ߚ଴: Intercept 
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x ܮ݁݊ݏ௜: ܮ݁݊ݏ௜=1 if Lens=’-1.00DC’; otherwise ܮ݁݊ݏ௜=0 
x ܲ݁ݎ݅݋݀௝: ܲ݁ݎ݅݋݀௝=1 if period=1; otherwise ܲ݁ݎ݅݋݀௝=0  
x ܵ݁ݍݑ݁݊ܿ݁௞: ܵ݁ݍݑ݁݊ܿ݁௞=1 if sequence=-1.00/-1.75; otherwise ܵ݁ݍݑ݁݊ܿ݁௞=0 
x ߜ௟: effect of the ݈௧௛ site, a random effect 
x ߛ௟೘: effect of the ݉௧௛ subject from the ݈௧௛ site, a random effect  
x ߝ௜௝௞௟௠௡: Random error associated between eyes (left and right) for the ݉௧௛ subject 
from the ݈௧௛ site assigned to the  ݇௧௛ sequence during the ݆௧௛ period for the ݅௧௛ lens 
 
Assume ߜ௟,  ߛ௟೘ and ߝ௜௝௞௟௠௡ are independent and   
x ߜ௞~ ܰ(0, ߪ௦௜௧௘
ଶ
) 
x ߛ௟೘~ ܰ(0, ߪ௦௨௕௝௘௖௧(௦௜௧௘)
ଶ
) 
x ቂ
ߝ௜௝௞௟௠_௅௘௙௧
ߝ௜௝௞௟௠_ோ௜௚௛௧ቃ= ቆቂ0
0ቃ, ൤ߪଵଵ
ଶ
ߪଵଶ
ଶ
ߪଶଵ
ଶ
ߪଶଶ
ଶ൨ቇ 
 
 
Primary Hypothesis 
The null and alternative hypothesis to test for superiority are as follows:  
  
ܪ௢: ்ܲ൑  80% 
ܪ஺: ்ܲ>  80% 
 
Where ்ܲ is the probability of the event (i.e., the probability of having absolute rotation less 
than 10° 15-minutes after insertion). Superiority will be concluded if the lower limit of the 
95% confidence interval is above 80%(i.e., P(݌்௘௦௧> 80% 
14.6. Secondary Analysis  
Not applicable. 
14.7. Other Exploratory Analyses 
Exploratory endpoints will be descriptively summarized. 
14.8. Interim Analysis 
No interim analysis will be conducted 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.  
 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
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a change is made, the change will be documented in the study report along with a justification 
for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using 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. 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1  
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x subject identification 
x eligibility 
x study identification 
x study discussion 
x provision of and date of informed consent 
x visit dates 
x results of safety and efficacy parameters as required by the protocol 
x a record of all adverse events 
x follow-up of adverse events 
x medical history and concomitant medication 
x test article receipt/dispensing/return records 
x date of study completion 
x reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
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The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
 
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: The purpose of the 
study is for design confirmation, not feasibility. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
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Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
x Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x Ensuring the rights and wellbeing of subjects are protected. 
x Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test article and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. 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 
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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 
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 
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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 14155:20201 
guidelines,  applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
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. 
 
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has been 
fully explained. The assent and consent forms must be signed before performance of any study-
related activity. The assent and consent forms that are used must be approved by both the 
Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms should be in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH2 and 
GCP guidelines, applicable regulatory requirements, and Sponsor policy. Before entry into the 
study or pre-screening, the Investigator or an authorized member of the clinical site personnel 
must explain to the potential subject and parent and/or legal guardian the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study or pre-screening, and any 
discomfort it may entail. Subjects and parent and/or legal guardian will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. They 
will be informed that choosing not to participate will not affect the care the subject will receive. 
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Finally, they will be told that the Investigator will maintain a subject identification register for 
the purposes of long-term follow-up if needed and that their records may be accessed by health 
authorities and authorized Sponsor personnel without violating the confidentiality of the 
subject, to the extent permitted by the applicable law(s) or regulations. By signing the assent 
and informed consent form, the subject is authorizing such access and agrees to be contacted 
after study completion by health authorities and authorized Sponsor personnel for the purpose 
of obtaining consent for additional safety evaluations if needed. 
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 States  and other applicable personal data protection and security laws and regulations.14 
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. 
 
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The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
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: 
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Johnson & Johnson Vision Care, Inc. 
 
x Continuing an ineligible subject in the study. 
x Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x Query resolution. 
x Case Report Form signature. 
x Completion of any follow-up action items. 
21. PUBLICATION 
There is no plan to publish the outcome of this investigation. 
22. REFERENCES 
 
1. 
ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. 
2. 
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html  
3. 
Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html. 
4. 
United States (US) Code of Federal Regulations (CFR). . 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. 
Franklin R, Investigator Brochure CR-6491 
 JJVC Investigational 
Multifocal Toric Contact Lenses manufactured in Senofilcon A (C3) material with UV 
blocker/HEV filter. May 19, 2022 
6. 
Franklin R, Clinical Study Report 
 Pilot Evaluation of a 
Silicone Hydrogel Daily Disposable Toric Multifocal Contact Lens. March 15, 2021 
7. 
Franklin R, Clinical Study Report 
 Evaluation of Daily 
Disposable Silicone Hydrogel Multifocal Toric Contact Lenses. March 04, 2022 
8. 
Franklin R, Clinical Study Report 
 Evaluation of 
Silicone Hydrogel Multifocal Toric Contact Lenses in a Hyperopic Population. 
October 20, 2021 
9. 
Wirth RJ, Edwards MC, Henderson M, Henderson T, Olivares G, Houts CR. 
Development of the Contact Lens User Experience: CLUE Scales. Optom Vis Sci. 
2016;93(8):801-808. 
10. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC SAS 
Institute Inc; 2014. 
11. 
SAS Institute Inc: SAS® 9.4 Statements: Reference TEC, NC: SAS Institute Inc; 
2014. 
12. 
Straker B, Clinical Study Report 
 Evaluation of 
Subjective Vision, Comfort and Handling of Toric Lenses with RTY-1 Chromophore. 
May 01, 2020 
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13. 
Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53(3):983. 
14. 
Health Information Portability and Accountability Act (HIPAA). 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
The patient instruction guide (PIG) will be provided separately.  
 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Not Applicable, as this study uses Investigational Products  
 
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APPENDIX D: 
 
 
x 
 LENS FITTING CHARACTERISTICS 
x 
 SUBJECT REPORTED OCULAR SYMPTOMS 
x 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
x 
 BIOMICROSCOPY SCALE 
x 
  KERATOMETRY 
x 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
x 
 TORIC FIT EVALUATION 
x 
 PATIENT REPORTED OUTCOMES 
 
 
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LENS FITTING CHARACTERISTICS 
 
 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6 
Page 4 of 5 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6 
Page 5 of 5 
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SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 5 
  
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 BIOMICROSCOPY SCALE 
 
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 KERATOMETRY 
 
 
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DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
Page 2 of 4 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
Page 4 of 4 
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TORIC FIT EVALUATION 
 
 
 
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Title:                          Toric Fit Evaluation
Document Type:  
Document Number:
Revision Number:  7 
Page 2 of 4 
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Title:                          Toric Fit Evaluation
Document Type:  
Document Number:
Revision Number:  7 
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APPENDIX E: GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6491 Evaluation of Rotation with a Multifocal Toric Contact Lens 
 
Version and Date: 1.0,  02 June 2022 
 
I have read and understand the protocol specified above and agree on its content.   
 
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the Declaration 
of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual 
country laws/regulations and to comply with its obligations, subject to ethical and safety considerations. 
The Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
 
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all 
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix E of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
Principal Investigator:  
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
 
Institution/Site: 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
Institution/Site Address 
 
 
 
 
 
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