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

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 1 of 169 
 
 
 
 
Protocol Title: Evaluation of Visual Acuity with a Reusable Toric Multifocal Contact Lens 
Protocol Number: CR-6383 
Version: 4.0 
 
Date: 29 October 2021 
 
 
Test Articles: Bausch + Lomb Ultra® Multifocal for Astigmatism 
 
Key Words: Presbyopia, Multifocal, Astigmatism, Daily Wear, Dispensing, samfilcon A, 
logMAR visual acuity 
 
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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CR-6383, v 4.0 
JJVC CONFIDENTIAL 
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TABLE OF CONTENTS 
PROTOCOL TITLE, NUMBER, VERSION AND DATE ...................................................... 7 
SPONSOR NAME AND ADDRESS ....................................................................................... 7 
MEDICAL MONITOR ............................................................................................................. 7 
AUTHORIZED SIGNATURES ............................................................................................... 8 
CHANGE HISTORY ................................................................................................................ 9 
SYNOPSIS .............................................................................................................................. 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS 
................................................................................................................................................. 15 
1. 
INTRODUCTION AND BACKGROUND ................................................................... 17 
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products ................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 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 ............................................................................................ 21 
4.3. 
Enrollment Target and Study Duration .................................................................... 21 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking ........................................... 21 
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 ........................................................................................... 23 
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 
VISIT 2 ........................................................................................................................... 34 
VISIT 3 ........................................................................................................................... 40 
VISIT 4 ........................................................................................................................... 44 
FINAL EVALUATION .................................................................................................. 46 
7.3. 
Unscheduled Visits ................................................................................................... 47 
7.4. 
Laboratory Procedures ............................................................................................. 49 
8. 
SUBJECTS COMPLETION/WITHDRAWAL .............................................................. 49 
8.1. 
Completion Criteria .................................................................................................. 49 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 50 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 50 
9.1. 
Systemic Medications .............................................................................................. 50 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 51 
11. 
STUDY TERMINATION ........................................................................................... 52 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 53 
13. 
ADVERSE EVENTS ................................................................................................... 54 
13.1. 
Definitions and Classifications ............................................................................. 54 
13.2. 
Assessing Adverse Events .................................................................................... 56 
13.2.1. 
Causality Assessment .................................................................................... 57 
13.2.2. 
Severity Assessment ...................................................................................... 57 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 57 
13.4. 
Reporting Adverse Events .................................................................................... 59 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 59 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 

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60 
13.5. 
Event of Special Interest ....................................................................................... 60 
13.6. 
Reporting of Pregnancy ........................................................................................ 60 
14. 
STATISTICAL METHODS ........................................................................................ 60 
14.1. 
General Considerations ......................................................................................... 60 
14.2. 
Sample Size Justification ...................................................................................... 61 
14.3. 
Analysis Populations ............................................................................................ 61 
14.4. 
Level of Statistical Significance ........................................................................... 61 
14.5. 
Primary Analysis .................................................................................................. 61 
14.6. 
Secondary Analysis .............................................................................................. 62 
14.7. 
Other Exploratory Analyses ................................................................................. 62 
14.8. 
Interim Analysis ................................................................................................... 62 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 62 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 62 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 62 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 62 
15.2. 
Subject Record ...................................................................................................... 63 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 63 
16. 
DATA MANAGEMENT ............................................................................................. 63 
16.1. 
Access to Source Data/Document ........................................................................ 63 
16.2. 
Confidentiality of Information .............................................................................. 64 
16.3. 
Data Quality Assurance ........................................................................................ 64 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 64 
17. 
CLINICAL MONITORING ........................................................................................ 64 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................. 65 
18.1. 
Study-Specific Design Considerations ................................................................. 65 
18.2. 
Investigator Responsibility ................................................................................... 65 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 65 
18.4. 
Informed Consent ................................................................................................. 66 
18.5. 
Privacy of Personal Data ...................................................................................... 67 
19. 
STUDY RECORD RETENTION ................................................................................ 68 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 69 
21. 
PUBLICATION ........................................................................................................... 69 
22. 
REFERENCES ............................................................................................................ 69 

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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 71 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 94 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 95 
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE ...................................... 99 
APPENDIX E: OCULAR DOMINANCE ........................................................................... 100 
APPENDIX F: BINOCULAR OVER REFRACTION ........................................................ 101 
APPENDIX G: ...................................................................................................................... 102 
, DETERMINATION OF NEAR ADDITION .................................................... 103 
, NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE ....... 109 
, LENS FITTING CHARACTERISTICS ............................................................ 112 
, SUBJECT REPORTED OCULAR SYMPTOMS ............................................. 118 
, DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
............................................................................................................................................... 120 
, BIOMICROSCOPY SCALE ............................................................................. 126 
, KERATOMETRY .............................................................................................. 132 
, DISTANCE AND NEAR VISUAL ACUITY EVALUATION ........................ 134 
, TORIC FIT EVALUATION .............................................................................. 139 
,  DISTANCE  LOGMAR  VISUAL  ACUITY  MESAUREMENT PROCEDURE 
............................................................................................................................................... 144 
, VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 148 
APPENDIX H: GUIDELINES FOR COVID-19 RISK MITIGATION .............................. 157 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 169 
 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 14 
 
TABLE OF CONTENTS 
TABLE 1: TEST ARTICLES ................................................................................................. 22 
TABLE 2: ANCILLARY SUPPLIES .................................................................................... 23 
TABLE 3: TIME AND EVENTS ........................................................................................... 25 
TABLE 4: DISALLOWED SYSTEMIC MEDICATIONS ................................................... 51 
TABLE 5: EXAMPLES OF MAJOR AND MINOR PROTOCOL DEVIATIONS .............. 52 
 
Table 1: Test Articles .............................................................................................................. 22 

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Table 2: Ancillary Supplies .................................................................................................... 23 
Table 3: Time and Events ....................................................................................................... 25 
Table 4: Disallowed systemic medications ............................................................................. 51 

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CR-6383, v 4.0 
JJVC CONFIDENTIAL 
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PROTOCOL TITLE, NUMBER, VERSION AND DATE 
Protocol Title: Evaluation of Visual Acuity with a Reusable Toric Multifocal Contact Lens 
Protocol Number: CR-6383 
Version: 4.0 
Date: 29 October 2021 
 
 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC) 
7500 Centurion Parkway 
Jacksonville, FL 32256 
 
 
MEDICAL MONITOR 
 
 
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related questions 
should be directed towards your assigned clinical research associate. 
 
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File. 

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JJVC CONFIDENTIAL 
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AUTHORIZED SIGNATURES 
The signatures below constitutes the approval of this protocol and the attachments and provide 
the necessary assurances that this trial will be conducted according to all stipulations of the 
protocol, including all statements regarding confidentiality, and according to local legal and 
regulatory requirements and applicable U.S. federal regulations,4 ICH guidelines,2 ISO 
14155:2020,1 and the Declaration of Helsinki.3 
 
 
Author 
 See Electronic Signature Page 
      
 
DATE 
 
 
 
Clinical Operations 
Manager 
 See Electronic Signature Page 
 
  
 
DATE 
 
 
 
 
Biostatistician 
 See Electronic Signature Page 
 
  
 
DATE 
 
 
 
 
Data Management 
 See Electronic Signature Page 
 
  
 
DATE 
 
 
 
Medical Safety 
Officer 
 See Electronic Signature Page 
 
  
 
DATE 
 
 
Approver 
 See Electronic Signature Page 
 
  
 
DATE 

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JJVC CONFIDENTIAL 
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CHANGE HISTORY 
 
 
Version 
Originator 
Description of Change(s) and Section 
Number(s) Affected 
Date 
1.0 
 
Original Protocol 
29-Oct-2019 
2.0 
 
• Updated lens powers 
• Adapted to version 11 of protocol 
template 
• Updated disallowed medications 
• Changed lens care solution 
• COVID-19 appendix added 
28-Jan-2021 
3.0 
 
• Updated MRD questions 
• Updated Snellen visual acuity 
wording throughout Section 7.2 
• Changed criteria for unacceptable 
toric fit in Section 7.2 
28-Apr-2021 
4.0 
 
• Updated to v13 of protocol 
template 
• Increased cylinder eligibility range 
• Included luminance range in cd/m2 
and illuminance range in lux for 
logMAR acuity testing at Visits 3 
and 4 
• Made Visit 1 biomicroscopy 
consistent with inclusion criteria 
• Added updated lens label 
29-Oct-2021 

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CR-6383, v 4.0 
JJVC CONFIDENTIAL 
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SYNOPSIS 
 
Protocol Title 
Evaluation of Visual Acuity with a Reusable Toric Multifocal 
Contact Lens 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL 32256 
Clinical Phase 
Clinical trial phase: Post-market 
Design control phase: Not applicable. 
Trial Registration 
This study will be registered on ClinicalTrials.gov based on 
the following: The clinical trial is evaluating a U.S. FDA- 
regulated Device Product 
Test Article 
Marketed Product: Bausch + Lomb Ultra® Multifocal for 
Astigmatism contact lens manufactured in samfilcon A 
material. 
Wear and Replacement 
Schedules 
Wear Schedule: The lenses will be used on a daily reusable 
basis for approximately five weeks (1 week trial followed by 
4 week dispense of optimized pair). 
Replacement Schedule: The lenses will be replaced at the first 
follow-up visit only. 
Objectives 
Primary Objective 
The primary objective of this study is an evaluation of the 
logMAR visual performance with the study lenses after 4 
weeks of wear. 
Secondary Objective 
Not applicable. 
Exploratory Objective 
Not applicable. 
Study Endpoints 
Primary endpoints: logMAR visual acuity at distance (4 M), 
intermediate (64 cm) and near (40 cm). 
Study Design 
The study is a bilateral, single-masked, single-arm, 4-visit 
dispensing study. There will be one study treatment, with the 
subject being in the treatment for approximately five weeks. 
Approximately 90 eligible subjects will be enrolled, with the 
aim to complete at least 80 subjects. The subjects will be fit 
in the study lens and wear the study lenses for 5-9 days then 
undergo optimization and wear the optimized pair for 4 weeks 
(25-31 days), with an interim follow-up visit at 2 weeks (12-
16 days). The primary endpoint will be logMAR visual 
performance. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1). 

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Sample Size 
Approximately 50 myopic subjects with against-the-rule 
astigmatism will be enrolled, with the aim that at least 45 will 
complete the study. Approximately 40 hyperopic subjects 
with against-the-rule astigmatism will be enrolled, with the 
aim that at least 35 will complete the study. 
Study Duration 
The study will last approximately 2-3 months. 
Anticipated Study 
Population 
Healthy male and female volunteers with presbyopia, 
astigmatism and either myopia or hyperopia will be screened 
as per criteria outlined below. All volunteers will have 
baseline measurements taken to ensure eligibility. The 
baseline procedures will occur after informed consent has 
been obtained. 
For a detailed list of procedures see the time and events 
schedule listed below. 
Eligibility 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 if required for their 
distance vision. 
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 month). 
6. Be an existing wearer of a presbyopic contact lens 
correction (e.g., reading spectacles over contact lenses, 
multifocal or monovision contact lenses, etc.) or respond 
positively to at least one symptom on the “Presbyopic 
Symptoms Questionnaire”. 
Inclusion Criteria at Baseline 
The subject must: 
7. Have distance spherical component of refraction in the 
range of either -1.25 D to -3.75 D or +1.25 to +3.75 D in 
each eye. 

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JJVC CONFIDENTIAL 
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8. Have refractive cylinder in the range of -0.75 D to -1.75 D 
in each eye, with their cylinder axis 90°±25°. 
9. Have near ADD power requirement in the range of 
+0.75 D to +2.50 D in each eye. 
10. Have best corrected distance visual acuity of 20/20-3 or 
better in each eye. 
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, sodium 
fluorescein, or Biotrue® multipurpose solution. 
7. Have any previous, or planned, 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 

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The subject must not: 
14. Have clinically significant (Grade 2 or greater) corneal 
edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal or 
ocular abnormalities which would contraindicate contact 
lens wear. 
15. Have entropion, ectropion, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions. 
16. Have any current ocular infection or inflammation. 
17. Have any current ocular abnormality that may interfere 
with contact lens wear 
Disallowed 
Medications/Interventions 
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear. 
See section 9.1 for details regarding disallowed systemic 
medications. 
Measurements and 
Procedures 
The key measurements are logMAR visual acuity at distance 
(4 M), intermediate (64 cm) and near (40 cm) with the study 
lenses. See Section 7.2 for the detailed procedures. 
Microbiology or Other 
Laboratory Testing 
None 
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. Biotrue 
multi-purpose solution for lens care during dispensing period 
and for worn lens storage. Lens cases will be provided for 
temporary contact lens storage during study visits and for use 
during dispensing periods. 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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JJVC CONFIDENTIAL 
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Modifications 
(up to 2 attempts, 
if necessary) 
Yes 
No 
Modifications 
(if necessary) 
Yes 
No 
Final Evaluation 
• 
CLUE, MRD and CLDEQ-8 Questionnaires 
• 
Ocular Symptoms, Subjective Acceptance, Entrance VA, Over-Refraction 
• 
Toric Fitting Evaluation and Lens Fit Assessment 
• 
logMAR Visual Performance 
• 
Lens Removal 
Follow-up 3 (Visit 4) 
• 
Medical History and Concomitant Medication Review 
• 
Wear Time and Compliance 
• 
CLUE, MRD and CLDEQ-8 Questionnaires 
• 
Ocular Symptoms, Subjective Acceptance, Entrance VA, Over-Refraction 
• 
Toric Fitting Evaluation and Lens Fit Assessment 
• 
logMAR Visual Performance 
• 
Lens Removal and Temporary Storage 
• 
Biomicroscopy 
• 
Re-insert lenses, exit acuity, subject instructions. Schedule follow-up 25 to 31 days after Visit 2 date 
Follow-up 2 (Visit 3) 
• 
Medical History and Concomitant Medication Review 
• 
Wear Time and Compliance 
• 
Insertion of a New Pair of Study Lenses 
• 
Exit Visual Acuity, Dispensing Criteria, and Subject Instructions 
• 
Schedule Follow-up in 12 to 16 Days 
Dispensing 
• 
Lens Removal and Biomicroscopy 
Lens Optimization (up to 2 attempts allowed) 
• 
Lens Selection (Right, Left or Both) 
• 
Right Eye Lens Insertion and Lens Damage (if applicable) 
• 
Measure Rotation at 1 Minute and 3 Minutes (if applicable) 
• 
Left Eye Lens Insertion and Lens Damage (if applicable) 
• 
Measure Rotation at 1 Minute and 3 Minutes (if applicable) 
• 
Lens Settling, then Toric Fit Evaluation and Lens Fit Assessment 
• 
Visual Satisfaction, Visual Acuity, Over-Refraction 
• 
CLUE and MRD Questionnaire 
• 
Ocular Symptoms, Subjective Acceptance, Entrance Visual Acuity, and Over-Refraction 
• 
Toric Fit Evaluation and Lens Fit Assessment 
Follow-up 1 (Visit 2) 
• 
Medical History and Concomitant Medication Review 
• 
Wear Time and Compliance 
Dispensing
• 
Exit Visual Acuity 
• 
Dispensing Criteria, Subject Instructions 
• 
Schedule Follow-up in 5 to 9 Days 
 
Figure 1: Study Flowchart 
80 Subjects to Complete (45 myopes, 35 hyperopes) 
Potential Subjects Identified Based On: 
• 
Age: At least 40 and not greater than 70 at the time of consent 
• 
Habitual contact lens wearers with Presbyopic correction or symptoms 
• 
Refractive Spherical Component either -1.25D to -3.75D or +1.25D to +3.75D 
• 
Refractive Cylinder:-0.75D to -1.75D with a cylinder axis of 90° ± 25° 
• 
Near Add: +0.75D to +2.50D 
• 
Visual Acuity: Best corrected 20/20-3 or better in each eye 
Informed Consent (Visit 1) 
Eligibility Criteria 
Baseline Information 
• 
Habitual lens type, modality, and contact lens history. Wear Time 
• 
Baseline CLUE, MRD and CLDEQ-8 Questionnaire, Ocular symptoms, and Entrance Visual Acuity 
• 
Lens Removal, Keratometry, Subjective refraction, Add Determination, Ocular Dominance, Add Refinement, and 
Near Visual Acuity 
• 
Biomicroscopy 
Trial Fitting (Visit 1) 
• 
Lens Selection 
• 
Right Eye Lens Insertion and Lens Damage 
• 
Measure Rotation at 1 Minute and 3 Minutes 
• 
Left Eye Lens Insertion and Lens Damage 
• 
Measure Rotation at 1 Minute and 3 Minutes 
• 
Lens Settling, then Toric Fit Evaluation and Lens Fit Assessment 
• 
Visual Satisfaction, Visual Acuity, Over-Refraction 

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JJVC CONFIDENTIAL 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADD 
Plus Power Required For Near Use 
ADE 
Adverse Device Effect 
AE 
Adverse Event/Adverse Experience 
BCVA 
Best Corrected Visual Acuity 
BSCVA 
Best Spectacle Corrected Visual Acuity 
CFR 
Code of Federal Regulations 
CLUE 
Contact Lens User Experience 
COAS 
Complete Ophthalmic Analysis System 
COM 
Clinical Operations Manager 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CT 
Center Thickness 
D 
Diopter 
DMC 
Data Monitoring Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
ITT 
Intent-to-Treat 
JJVC 
Johnson & Johnson Vision Care, Inc. 
LC 
Limbus Center 
LogMAR 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NIH 
National Institutes of Health 
OD 
Right Eye 
OHRP 
Office for Human Research Protections 
OHSR 
Office for Human Subjects Research 
OS 
Left Eye 
OU 
Both Eyes 
PD 
Protocol Deviation 
PHI 
Protected Health Information 

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PI 
Principal Investigator 
PIG 
Patient Instruction Guide 
PQC 
Product Quality Complaint 
PRO 
Patient Reported Outcome 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis System 
SD 
Standard Deviation 
SOP 
Standard Operating Procedure 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect 
VA 
Visual Acuity 

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JJVC CONFIDENTIAL 
Page 17 of 169 
 
 
 
1. INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision launched 1-DAY ACUVUE® MOIST Multifocal in 2015 and 
ACUVUE® OASYS MULTIFOCAL in 2021. These lenses are 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 visual 
acuity achieved with one of these marketed lens types (Bausch + Lomb Ultra® Multifocal for 
Astigmatism). 
 
1.1. Name and Descriptions of Investigational Products 
Test Article: Bausch + Lomb Ultra® Multifocal for Astigmatism manufactured in samfilcon 
A material. 
Refer to Table 1: Test Articles in Section 6.1 of the protocol. 
 
1.2. Intended Use of Investigational Products 
According to the package insert, the Bausch + Lomb ULTRA® (samfilcon A) Multifocal for 
Astigmatism Contact Lens is indicated for daily wear for the correction of refractive ametropia 
(myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons 
with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters (D) and require an add 
power ranging from +0.75 D to +5.00 D. In this study, a limited range of refractive corrections 
(spheres, cylinders and axes) will be evaluated (see section 3.2). 
 
1.3. Summary of Findings from Nonclinical Studies 
Not applicable for studies of marketed contact lenses. 
 
1.4. Summary of Known Risks and Benefits to Human Subjects 
Not applicable for studies of marketed contact lenses. 
 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Information about the Bausch + Lomb Ultra® Multifocal for Astigmatism may be found in the 
package insert (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT). 
 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
 
2.1. Objectives 
Primary Objective 
The primary objective of this study is to assess the clinical performance of the study lenses 
with respect to visual acuity (logMAR) after 4-weeks of lens wear. 
 
Secondary Objective 
Not applicable. 

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2.2. Endpoints 
Primary Endpoint 
Visual Acuity (logMAR) 
Multiple assessments of binocular and monocular visual acuity will be made during the study, 
but the binocular measurements made at the 4-week follow-up evaluation using high contrast 
letters in bright illuminance conditions will be the primary endpoint. At distance (4 meters), 
VA is assessed using ETDRS Charts; while near (40 cm) and intermediate (64 cm) assessments 
will be made using reduced Guillon-Poling charts. Visual acuity will be measured using high 
and low contrast charts in bright illuminance conditions. Visual acuity will also be measured 
using high contrast charts in dim illuminance conditions created by the use of goggles. See 
in Appendix  G for details regarding the  collection  of 
visual acuity (logMAR). 
 
Secondary Endpoint 
Not applicable. 
 
Other Exploratory Endpoint 
Not applicable. 
 
2.3. Hypotheses 
 
Primary Hypotheses 
1. After 25-31 days of wear, the binocular, high-luminance, high-contrast distance (4 M) 
logMAR visual acuity of the test lens will be statistically better than 0.00 logMAR. 
This will be determined using ETDRS LogMAR acuity testing charts. 
 
2. After 25-31 days of wear, the binocular, high-luminance, high-contrast intermediate 
(64 cm) logMAR visual acuity of the test lens will be statistically better than +0.17 
logMAR. This will be determined using Guillon/Poling LogMAR acuity testing charts. 
 
3. After 25-31 days of wear, the binocular, high-luminance, high-contrast near (40 cm) 
logMAR visual acuity of the test lens will be statistically better than +0.17 logMAR. 
This will be determined using Guillon/Poling LogMAR acuity testing charts. 
 
3. TARGETED STUDY POPULATION 
 
3.1. General Characteristics 
The population to be studied will consist of adapted contact lens wearers who have astigmatism 
in both eyes. Approximately 90 eligible subjects (50 myopes with against-the-rule astigmatism 
and 40 hyperopes with against-the-rule astigmatism) will be enrolled with at least 80 targeted 
to complete. Subjects to be enrolled will have -0.75 D to -1.75 D of astigmatism in both eyes 
with 90°±25° axis. 

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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 if required for their distance vision. 
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 month). 
6. Be an existing wearer of a presbyopic contact lens correction (e.g., reading spectacles over 
contact lenses, multifocal or monovision contact lenses, etc.) or respond positively to at 
least one symptom on the “Presbyopic Symptoms Questionnaire”. 
 
Inclusion Criteria at Baseline 
The subject must: 
 
7. Have distance spherical component of refraction in the range of either -1.25 D to -3.75 D 
or +1.25 to +3.75 D in each eye. 
8. Have refractive cylinder in the range of -0.75 D to -1.75 D in each eye, with their cylinder 
axis 90°±25°. 
9. Have near ADD power requirement in the range of +0.75 D to +2.50 D in each eye. 
10. Have best corrected distance visual acuity of 20/20-3 or better in each eye. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
 
Exclusion Criteria 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. 

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6. Have any known hypersensitivity or allergic reaction to single use preservative free 
rewetting drops, sodium fluorescein, or Biotrue® multipurpose solution. 
7. Have any previous, or planned, 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 2 or greater) corneal edema, corneal vascularization, 
corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear. 
15. Have entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal 
erosions. 
16. Have any current ocular infection or inflammation. 
17. Have any current ocular abnormality that may interfere with contact lens wear 
 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
 
4. STUDY DESIGN AND RATIONALE 
 
4.1. Description of Study Design 
The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. Approximately 
90 subjects will be enrolled with target completion of at least 80 subjects. 
The study begins with an initial visit (Visit 1). If a subject is found to meet all eligibility 
criteria, they will be dispensed the study lens in a bilateral fashion. 
 
If the subject is dispensed study lenses at the initial visit, then three follow-up visits will occur. 
The first follow-up visit will occur approximately one week after the initial visit. If necessary, 
the lens power may be modified at Visit 2, then a new pair of lenses with the final lens power 
will be dispensed. The second follow-up (Visit 3) will occur approximately 14 days after Visit 
2 and the third and final follow-up evaluation (Visit 4) will occur approximately 28 days after 
Visit 2. 

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4.2. Study Design Rationale 
A single-arm study was chosen to assess the clinical performance with respect to objective 
vision for the marketed contact lens Bausch + Lomb Ultra® Multifocal for Astigmatism. This 
study design and the clinical measurements involved are similar to recent studies of a JJVC 
prototype toric multifocal lens.6,7 Data from these studies will be compared by creating tables 
and graphs of aggregate data after the study databases are all hard-locked. 
 
4.3. Enrollment Target and Study Duration 
Approximately 50 eligible myopes with against-the-rule astigmatism and 40 eligible hyperopes 
with against-the-rule astigmatism will be enrolled with at least 80 targeted to complete. The 
study will last approximately 2-3 months. 
 
 
5. TEST ARTICLE ALLOCATION AND MASKING 
 
5.1. Test Article Allocation 
This is a single-arm study. All subjects will be dispensed the study lens in a bilateral fashion. 
 
5.2. Masking 
Subjects will be masked to the study lens to help reduce potential bias. Subjects will be 
unaware of the identity of the investigational product. Investigators and clinical site personnel 
involved in the data collection will not be masked as to the identity of the investigational 
product. 
 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor. In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel. 
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued may be replaced. 
 
5.3. Procedures for Maintaining and Breaking the Masking 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject. The Sponsor must be notified before 
the mask is broken. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 

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1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
 
6. STUDY INTERVENTION 
 
6.1. Identity of Test Articles 
The following contact lenses will be used in this study: 
 
Table 1: Test Articles 
 
Test Lens 
Name 
Bausch + Lomb Ultra® Multifocal for 
Astigmatism 
Manufacturer 
Bausch + Lomb 
Lens Material 
Samfilcon A 
Nominal Base Curve 
8.6 
Nominal Diameter 
14.5 
Nominal Distance Powers (D) 
-1.00 to -4.00 in 0.25D steps, 
+1.00 to +4.00 in 0.25D steps 
Nominal Cylinder Powers (D) 
-0.75, -1.25 
Cylinder axes (º) 
70, 80, 90, 100, 110 
Nominal ADD Power (D) 
Low, High 
Water Content 
46% 
Oxygen Permeability (Dk) 
114.0 
Wear Schedule in Current Study 
Daily Reusable 
Replacement Frequency 
Monthly 
Packaging Form (vial, blister, etc.) 
Blister 
 
Estimated number of lenses needed = 48 per SKU (90 axis) and 24 per SKU (other axes). 

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6.2. Ancillary Supplies/Products 
The following solutions will be used in this study: 
 
Table 2: Ancillary Supplies 
 
Single-Use Preservative-Free Rewetting Solutions 
(any of these three options may be supplied) 
Multipurpose 
Disinfecting and 
Storing Solution 
Solution 
Name/Description 
Eye-Cept® 
Rewetting 
Drops 
ScleralFil® 
Preservative 
Free Saline 
Solution 
LacriPure 
Saline Solution 
Biotrue® 
multipurpose 
solution 
Manufacturer 
Optics 
Laboratory 
Bausch + 
Lomb 
Menicon 
Bausch + Lomb 
Preservative 
Non- 
Preserved 
Non- 
Preserved 
Non-Preserved 
Polyquaternium 
0.0001% and 
polyaminopropyl 
biguanide 
0.00013% 
 
Lens cases which are compatible with Biotrue® multipurpose solution will be provided to 
participants for temporary storage of contact lenses during Visits 1 and 3 and for use during 
dispensing periods. Stopwatches will be provided to research sites to help with managing the 
timing of toric fit assessments and lens settling. 
 
6.3. Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any 
dispensing requirements set forth in this clinical protocol. Subjects will be dispensed an 
adequate supply of test articles to complete the study. Test articles which are lost or damaged 
in the period up to and including Visit 2 may be replaced at the discretion of the Investigator 
and/or the Sponsor. 
 
6.4. Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging. The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in plastic 
bags as the secondary packaging form. The sample study label is shown below: 

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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, to wear out of the office, or issued 
for the subject to replace appropriately between visits. 
2. What was returned to the Investigator unused, including expired or malfunctioning 
product. 
3. The number and reason for unplanned replacements. 
 
The Investigator will collect all unused test articles from the subjects at the end of the subject’s 
participation. Subject returned unused test articles must be separated from the clinical study 
inventory of un-dispensed test articles and must be labeled with the subject number and date 
of return. Following final reconciliation of test articles by the monitor, the Investigator or 
monitor will return all unused test articles to JJVC. 

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If there is a discrepancy between the shipment documents and the contents, contact the study 
monitor immediately. 
 
 
7. STUDY EVALUATIONS 
 
7.1. Time and Event Schedule 
 
Table 3: Time and Events 
 
Visit Information 
Visit 1 
Screening, 
Baseline, 
Treatment 1 
Visit 2 
Treatment 1 
Follow-up 1 
Visit 3 
Treatment 1 
Follow-up 2 
Visit 4 
Treatment 1 
Follow-up 3 
Time Point 
Day 0 
7 ± 2 days 
after Visit 1 
14 ± 2 days 
after Visit 2 
28 ± 3 days 
after Visit 2 
Estimated Visit Duration 
2.5 hours 
1.0 hours 
1.0 hours 
1.5 hours 
Statement of Informed 
Consent 
x 
Demographics 
x 
Medical History/Concomitant 
Medications/Review 
x 
x 
x 
x 
Current Habitual Correction 
x 
Habitual Contact Lens 
Information 
x 
Contact Lens History 
x 
Habitual Lens Wear Time 
x 
Presbyopic Symptoms 
Questionnaire 
x 
Screening 
Inclusion/Exclusion Criteria 
x 
Ocular Symptoms 
x 
x 
x 
x 
Entrance Distance and near 
Visual Acuity 
x 
x 
x 
x 
Lens Removal 
x 
x 
x 
x 
Keratometry 
x 
Subjective Sphero-Cylindrical 
Refraction 
x 
Near ADD Determination 
x 
Ocular Dominance 
x 
ADD Refinement 
x 
Near Visual Acuity 
x 
Slit Lamp Biomicroscopy 
x 
x 
x 
x 
Baseline Inclusion/ Exclusion 
x 
Lens Selection 
x 
x (if optimized) 
Right Lens Insertion 
x 
x (if optimized) 
Right Lens 1 Minute and 3 
Minute Rotation 
x 
x (if optimized) 

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Visit Information 
Visit 1 
Screening, 
Baseline, 
Treatment 1 
Visit 2 
Treatment 1 
Follow-up 1 
Visit 3 
Treatment 1 
Follow-up 2 
Visit 4 
Treatment 1 
Follow-up 3 
Time Point 
Day 0 
7 ± 2 days 
after Visit 1 
14 ± 2 days 
after Visit 2 
28 ± 3 days 
after Visit 2 
Estimated Visit Duration 
2.5 hours 
1.0 hours 
1.0 hours 
1.5 hours 
Left Lens Insertion 
x 
x (if optimized) 
Left Lens 1 Minute and 3 
Minute Rotation 
x 
x (if optimized) 
Lens Settling 
x 
x (if optimized) 
Toric Fit Assessment 
x 
x 
x 
x 
Subjective Lens Fit 
Assessment 
x 
x 
x 
Visual Satisfaction 
x 
x (if optimized) 
Subjective Acceptance 
x 
x 
x 
Study Lens Distance and Near 
Visual Acuity 
x 
x 
x 
x 
Over Refraction and Visual 
Acuity 
x 
x 
Lens Power Modification (if 
applicable) 
x 
x 
Determination of Lens 
Optimization 
x 
x 
Lens Optimization (if 
required) 
x 
x 
Insertion of Study Lenses 
x 
x 
Exit Snellen Distance and 
Near Visual Acuity 
x 
x 
Dispensing Criteria 
x 
x 
Subject Instructions 
x 
x 
Instruction Guide 
x 
Lens Dispensing 
x 
x 
Schedule Follow-Up 
x 
x 
Compliance 
x 
x 
x 
Study Lens Wear Time 
x 
x 
x 
PRO (CLUE and MRD) 
Questionnaires 
x 
x 
x 
x 
CLDEQ-8 Questionnaire 
x 
x 
x 
Binocular Over Refraction 
x 
Distance, Intermediate, and 
Near ETDRS LogMAR 
Visual Acuity 
x 
Final Evaluation 
x 
 
 
7.2. Detailed Study Procedures 
 
VISIT 1 

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Subjects must report to the visit wearing their habitual contact lenses to accurately assess 
baseline PRO (CLUE and MRD) performance. If the subject is not wearing their lenses they 
must be rescheduled. 
 
Visit 1: Screening 
Step 
Procedure 
Details 
 
1.1 
Statement of 
Informed Consent 
Each subject must read, understand, and sign 
the Statement of Informed Consent before 
being enrolled into the study. The Principal 
Investigator or his/her designee conducting 
the informed consent discussion must also 
sign the consent form. 
Note: The subject must be provided a signed 
copy of this document. 
1.2 
Demographics 
Record the subject’s year of birth, age, 
gender, race and ethnicity. 
1.3 
Medical History and 
Concomitant 
Medications 
Questions regarding the subjects’ medical 
history and concomitant medications. 
1.4 
Habitual Contact 
Lens Information 
Questions regarding the subject’s habitual 
lens type and parameters. 
1.5 
Habitual Contact 
Lens Wear Schedule 
Record the duration of wearing this contact 
lens type and power (number of years and 
months). 
During the past month, what is the minimum 
number of days per week that the subject has 
worn their lenses for at least 8 hours. 
1.6 
Contact Lens History Record the subject’s correction type (i.e. 
monovision, multifocal, sphere with readers, 
etc.). 
1.7 
Wear time and 
Comfortable Wear 
time with Habitual 
lenses 
Record the subjects wear time and 
comfortable wear time with their habitual 
contact lenses. 
1.8 
Presbyopic 
Symptoms 
Questionnaire 
Subjects will be asked if they are wearing a 
presbyopic correction and whether they are 
experiencing any of five common symptoms 
of presbyopia. 
Appendix 
D 
1.9 
Eligibility after 
Screening 
All responses to Screening Inclusion Criteria 
questions must be answered “yes” and all 
responses to Exclusion Criteria must be 
answered “no” for the subject to be 
considered eligible. 

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Visit 1: Screening 
Step 
Procedure 
Details 
If subject is deemed to be ineligible after 
screening, proceed to Final Evaluation and 
complete Subject Disposition. Refraction and 
Biomicroscopy forms are not required. 
 
 
Visit 1: Baseline 
Step 
Procedure 
Details 
1.10 
Baseline PRO 
(CLUE and MRD) 
and CLDEQ-8 
Questionnaires 
The subject will evaluate the vision 
characteristics, comfort characteristics, 
handling characteristics, and visual symptoms 
of their habitual lenses using the PRO (CLUE 
and MRD) and CLDEQ-8 questions. 
1.11 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
1.12 
Entrance Distance 
and Near Visual 
Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the subject’s habitual contact lenses in place. 
For near measurements use the ETDRS 2000 
Series Chart 1 or 2. If the subject habitually 
wears reading glasses over their contact 
lenses, these may be worn for near acuity. 
 
1.13 
Lens Removal 
Have the subject remove their habitual lenses 
and store in an approved storage solution. 
1.14 
Keratometry / SimK 
Keratometry/SimK will be performed OD 
and OS and the steep and flat dioptric power 
and corresponding meridians recorded. 
 
1.15 
Subjective Sphero- 
cylindrical 
Refraction 
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed. Record the refraction and 
distance visual acuity (OD, OS, OU) to the 
nearest letter. 
Note: Best distance visual acuity with 
sphero-cylindrical refraction must be at least 
20/20-3 in each eye for the subject to be 
eligible in the study. 
 
1.16 
Near ADD 
Determination 
The near reading addition will be determined 
using the binocular crossed cylinder 
technique (BCC) at 40 cm 
 
1.17 
Ocular Dominance 
Determine the distance ocular dominance 
with the best distance correction in place 
using a +1.00-blur test. If the results are 
Appendix 
E 

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Visit 1: Baseline 
Step 
Procedure 
Details 
equivocal use the sighting dominance test to 
determine the dominant eye used for the 
study. 
1.18 
ADD Refinement 
Place the BCC result in the trial frame and 
refine the near prescription with trial lenses 
(or flippers) under binocular conditions. 
 
1.19 
Near Visual Acuity 
Using the ETDRS 2000 Series Chart 1 or 2 
near card placed at 40 cm. Record the near 
visual acuity (OD, OS, OU). 
1.20 
Biomicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility. 
If any of these slit lamp findings are Grade 2 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
may be instilled. 
 
1.21 
Eligibility after 
Baseline 
All responses to Inclusion Criteria questions 
must be answered “yes” and all responses to 
Exclusion Criteria questions must be 
answered “no” for the subject to be 
considered eligible. 
If subject is deemed to be ineligible after 
baseline, proceed to Final Evaluation and 
complete all forms. 
 
Visit 1: Treatment 1 Lens Fitting 
Step 
Procedure 
Details 
1.22 
Lens Selection 
Select the lens power and axis based on the 
refraction and fitting guide for each eye. 
Record the test lens parameters (power and 
lot number). 
Appendix 
C 
1.23 
Right Lens Insertion 
Subjects will insert the right lens themselves. 
If the lens is uncomfortable, inspect for 
damage and remove, reinsert or replace as 
necessary. 

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Damaged lenses will be stored in labeled vial 
with Biotrue® multipurpose solution, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor. Complete the Quality Product 
Complaint form. 
1.24 
Timed Settling for 
Right Lens 
The investigator will start a stopwatch as 
soon as the right lens is inserted. 
Note: All lenses in this study have a toric 
orientation mark at the 6 o’clock position. 
Rotation measurements are made relative 
to a vertical reference line. 
Record base nasal or base temporal rotation 
to the nearest degree. 
At one (1) minute after insertion: Record: 
1. The rotational position to the nearest 
degree 
At three (3) minutes after insertion: Record: 
1. The rotational position to the nearest 
degree 
1.25 
Left Lens Insertion 
Subjects will insert the left lens themselves. If 
the lens is uncomfortable, inspect for damage 
and remove, reinsert or replace as necessary. 
Damaged lenses will be stored in labeled vial 
with Biotrue® multipurpose solution, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor. Complete the Quality Product 
Complaint form. 
1.26 
Timed Settling for 
Left Lens 
The investigator will start a stopwatch as 
soon as the left lens is inserted. 
Note: All lenses in this study have a toric 
orientation mark at the 6 o’clock position. 
Rotation measurements are made relative 
to a vertical reference line. 
Record base nasal or base temporal rotation 
to the nearest degree. 
At one (1) minute after insertion: Record: 
1. The rotational position to the nearest 
degree 

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At three (3) minutes after insertion: Record: 
1. The rotational position to the nearest 
degree 
1.27 
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes. 
1.28 
Toric Fit Evaluation 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
 
1.29 
Lens Fit Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
 
1.30 
Determine Visual 
Satisfaction 
Determine if the subject’s vision is acceptable 
with the lenses. Allow the subject to look 
down a hallway or out of a window for 
distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision. 

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1.31 
Study Lens Distance 
and Near Visual 
Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 2000 
Series Chart 1 or 2. 
 
1.32 
Distance Over- 
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and 
OS using loose lenses outside of the 
phoropter under ambient room illumination. 
The distance over-refraction may also be 
refined under binocular conditions. 
Record the results. The results of the 
distance over-refraction may also be checked 
for the impact on near vision under 
monocular and/or binocular conditions. 
1.33 
Lens Power 
Modification (if 
applicable) 
If the subject reports unsatisfactory vision, 
or is unable to obtain 20/30 distance visual 
acuity OU with the lenses than a modification 
must be attempted. If the subject reports 
satisfactory vision with the lenses a 
modification is not required however may at 
the Investigators discretion based upon their 
findings on the measured visual acuity and/or 
over- refraction. 
Note: switching to a non-multifocal lens per 
section 5 of the Fitting Guide is not an 
available option in this study. 
Select the reason(s) for lens change (select 
all that apply): 
• The settled lens rotation is such that one of 
the other available lens cylinder axis would 
be better (use LARS rule to determine the 
replacement lens cylinder axis) 
• Power Modification needed 
• Unsatisfactory Vision 
• Other (specify reason) 
If one or both lenses are modified, repeat 
steps 1.22 through 1.32 for one or both eyes 
as appropriate. 
A maximum of two lens modifications are 
allowed. 
Appendix 
C: 
Fitting 
Guide 
1.34 
Exit Distance and 
Near Visual Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
 

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For near measurements use the ETDRS 2000 
Series Chart 1 or 2. 
1.35 
Dispensing 
Criteria 
The lenses may be dispensed for 5-9 days, if 
the following criteria are met: 
• Distance Snellen acuity equal to or 
better than 20/30 OU 
• Subject must indicate that the vision 
is acceptable. 
• Subject  must indicate   that the 
comfort of the lenses is acceptable. 
• Lenses must have an acceptable toric 
and general lens fit. 
1.36 
Subject Instructions 
Instruct the Subject on the following: 
• The lenses will be worn on a daily wear 
basis. 
• After each lens removal, use a 
rub/rinse/soak lens care regimen with 
Biotrue® multipurpose solution (per 
manufacturer’s instructions). 
• If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. One missed day of 
lens wear per week is acceptable. 
• Subjects will be instructed to wear their 
glasses when not wearing the study 
lenses. 
• A patient instruction booklet will be 
provided. 
Note: In the event a lens is lost or damaged, 
the subject will return to the investigator site 
for a determination of whether the lens will be 
replaced 
or 
if 
the 
subject 
will 
be 
discontinued. 
As 
much 
as 
reasonably 
possible, a damaged lens should be returned 
to the investigational site and then returned to 
the   Sponsor.    If   lens   damage   is present, 
complete the Product Quality Complaint 
Form.  The lens will be stored in labeled vial 

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with 
Biotrue® multipurpose solution and 
returned to the Sponsor. 
1.37 
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 7±2 days. 
 
 
 
 
 
 
VISIT 2 
The subjects must present to Visit 2 wearing the study lenses. 
 
Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
2.1 
Adverse Events and 
Concomitant 
Medications Review 
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events. 
2.2 
Wear time and 
Comfortable Wear 
time (Study Lenses) 
Record the average wearing time and 
comfortable wearing time with the study 
lenses. 
2.3 
Compliance 
Confirm compliance with the prescribed wear 
schedule. 
2.4 
PRO (CLUE and 
MRD) 
Questionnaires 
The subject will respond to the Follow-Up 
PRO (CLUE and MRD). 
2.5 
Subject Reported 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
2.6 
Subjective 
Acceptance 
Record whether the subject’s distance and 
near vision with the lenses is acceptable. 
2.7 
Entrance Distance 
and Near Visual 
Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 
2000 Series Chart 1 or 2. 
 
2.8 
Distance Over- 
Refraction and 
Distance Visual 
Acuity 
Perform a distance over-refraction OD and 
OS using loose lenses outside of the phoropter 
under ambient room illumination. The 
distance over-refraction may also be refined 
under binocular conditions. 
Record the results. The results of the distance 
over-refraction may also be checked for the 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
impact on near vision under monocular and/or 
binocular conditions. 
2.9 
Toric Fit Evaluation 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
 
2.10 
Lens Fit Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
 
2.11 
Determination of 
Lens Optimization 
If the subject’s vision is unacceptable for at 
least one distance or the Investigator 
determines that the visual acuity or over- 
refraction are not acceptable then a lens 
modification must be made. If modifications 
are not needed, proceed to step 2.23. 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
Up to two attempts at changes are permitted if 
necessary, in order to achieve an acceptable 
distance and near binocular performance for 
the subject. 
Follow the fitting guide allowing for at least 
10 minutes of settling time between lens 
changes. Note: switching to a non-multifocal 
lens per section 5 of the Fitting Guide is not 
an available option in this study. 
2.12 
Lens Optimization (if 
required) 
Select the reason(s) for lens change (select 
all that apply): 
• The settled lens rotation is such that one of 
the other available lens cylinder axis would be 
better (use LARS rule to determine the 
replacement lens cylinder axis). 
• Power Modification needed 
• Unsatisfactory Vision 
• Other (specify reason) 
2.13 
Lens Selection (if 
required) 
Select the lens power, based on the Fitting 
Guide for each eye needing optimization. 
Record the test lens parameters (power and 
lot number). 
Appendix 
C 
2.14 
Lens Insertion (if 
required) 
Subjects will insert the lens themselves. If the 
lens is uncomfortable, inspect for damage and 
remove, reinsert or replace as necessary. 
Damaged lenses will be stored in labeled vial 
with Biotrue® multipurpose solution, and 
clearly differentiated from the other worn 
lenses that will be shipped back to the 
Sponsor. Complete the Quality Product 
Complaint form. 
2.15 
Timed Settling for 
Lens (if required) 
The investigator will start a stopwatch as 
soon as the lens is inserted. 
Note: All lenses in this study have a toric 
orientation mark at the 6 o’clock position. 
Rotation measurements are made relative 
to a vertical reference line. 
Record base nasal or base temporal rotation to 
the nearest degree. 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
At one (1) minute after insertion: Record: 
1. The rotational position to the nearest 
degree 
At three (3) minutes after insertion: Record: 
1. The rotational position to the nearest 
degree 
2.16 
Lens Settling (if 
required) 
Allow the study lenses to settle for a 
minimum of 15 minutes. 
2.17 
Toric Fit Evaluation 
(if required) 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Lens stability with eye versions 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
 
2.18 
Lens Fit Assessment 
(if required) 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
2.19 
Determine Visual 
Satisfaction (if 
required) 
Determine if the subject’s vision is acceptable 
with the lenses. Allow the subject to look 
down a hallway or out of a window for 
distance vision assessments, and for them to 
read a book, magazine or similar for near 
vision. 
2.20 
Study Lens Distance 
and Near Visual 
Acuity (if required) 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 2000 
Series Chart 1 or 2. 
2.21 
Distance Over- 
Refraction and 
Distance Visual 
Acuity (if required) 
Perform a distance over-refraction OD and 
OS using loose lenses outside of the phoropter 
under ambient room illumination. The 
distance over-refraction may also be refined 
under binocular conditions. 
Record the results. The results of the distance 
over-refraction may also be checked for the 
impact on near vision under monocular and/or 
binocular conditions. 
2.22 
Additional Lens 
Power Optimization 
(if required) 
If the subject reports unsatisfactory vision, 
or is unable to obtain 20/30 distance visual 
acuity OU with the lenses than a modification 
must be attempted. If the subject reports 
satisfactory vision with the lenses a 
modification is not required however may at 
the Investigators discretion based upon their 
findings on the measured visual acuity and/or 
over- refraction. Note: switching to a non- 
multifocal lens per section 5 of the Fitting 
Guide is not an available option in this study. 
Select the reason(s) for lens change (select 
all that apply): 
• The settled lens rotation is such that one of 
the other available lens cylinder axis would be 
better (use LARS rule to determine the 
replacement lens cylinder axis) 
• Power Modification needed 
• Unsatisfactory Vision 
• Other (specify reason) 
Appendix 
C: Fitting 
Guide 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
 
If one or both lenses are modified, repeat 
steps 2.13 through 2.21 for one or both eyes 
as appropriate. 
2.23 
Lens Removal 
Have the subject remove the study lenses. 
Temporarily store the worn lenses until 
Biomicroscopy has been completed. If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded. 
2.24 
Biomicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
 
2.25 
Insertion of Study 
Lenses 
Provide the subject with a new set of lenses 
that match the power of the lenses that were 
removed in step 2.23 above. 
2.26 
Exit Distance and 
Near Visual Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 2000 
Series Chart 1 or 2. 
 
2.27 
Dispensing 
Criteria 
The lenses will be dispensed for 12-16 days if 
the following criteria are met: 
• Distance Snellen acuity equal to or 
better than 20/30 OU 
• Subject must indicate that the vision 
is acceptable. 
• Subject  must indicate   that the 
comfort of the lenses is acceptable. 
• Lenses must have an acceptable toric 
and general lens fit. 
2.28 
Subject Instructions 
Instruct the Subject on the following: 
• The lenses will be worn on a daily wear 
basis. 
• After each lens removal, use a 
rub/rinse/soak lens care regimen with 
Biotrue® multipurpose solution (per 
manufacturer’s instructions). 

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Visit 2: Treatment 1 Follow-Up 1 
Step 
Procedure 
Details 
• If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. One missed day of 
lens wear per week is acceptable. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 
Note: In the event a lens is lost or damaged 
after Visit 2, the subject will return to the 
investigator site for discontinuation and Final 
Evaluation. As much as reasonably possible, 
a damaged lens should be returned to the 
investigational site and then returned to the 
Sponsor. If lens damage is present, complete 
the Product Quality Complaint Form. The 
lens will be stored in labeled vial with 
Biotrue® multipurpose solution and returned 
to the Sponsor. 
2.29 
Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment in 14±2 days. 
 
 
 
VISIT 3 
The subjects must present to Visit 3 wearing the study lenses. 
 
Visit 3: Treatment 1 Follow-Up 2 
Step 
Procedure 
Details 
3.1. 
Adverse Events and 
Concomitant 
Medications Review 
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events. 

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Visit 3: Treatment 1 Follow-Up 2 
Step 
Procedure 
Details 
 
3.2. 
Wear time and 
Comfortable Wear 
time (Study Lenses) 
Record the average wearing time and 
comfortable wearing time with the study 
lenses. 
3.3. 
Compliance 
Confirm compliance with the prescribed wear 
schedule. 
3.4. 
PRO (CLUE and 
MRD) and CLDEQ- 
8 Questionnaires 
The subject will respond to the Follow-Up 
PRO (CLUE and MRD) and Dry Eye 
Questionnaires. 
3.5. 
Subject Reported 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
3.6. 
Subjective 
Acceptance 
Record whether the subject’s distance and 
near vision with the lenses is acceptable. 
3.7. 
Entrance Distance 
and Near Visual 
Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 
2000 Series Chart 1 or 2. 
 
3.8. 
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity. 
Note: No lens changes are allowed based on 
the over-refraction. 
Appendix 
F 
3.9. 
Toric Fit Evaluation 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
 
3.10. Lens Fit Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
 

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JJVC CONFIDENTIAL 
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Visit 3: Treatment 1 Follow-Up 2 
Step 
Procedure 
Details 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
3.11. Visual Performance 
Distance (4 M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OD, OS, 
and OU for the following: 
Distance, Bright Illuminance 
ETDRS Charts 4 M-HC#1, HC#2, HC#3 and 
LC#1, LC#2 and LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts High Contrast 
and Low Contrast Intermediate (64 cm) and 
Near (40 cm). 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 4 M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64 cm) and Near (40 cm). 
Note: 
• The room illuminance must be between 
7.3 and 7.9 EV (or 400 to 600 lux) 
• Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7 (or 180 
to 210 cd/m2) 
• Guillon-Poling, Near Chart Luminance 
Acceptable EV Range 10.8-11.1 (or 220 
to 280 cd/m2) 
 

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Visit 3: Treatment 1 Follow-Up 2 
Step 
Procedure 
Details 
 
• Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles). 
3.12. Lens Removal 
Have the subject remove the study lenses and 
temporarily store them in a lens case with 
Biotrue® multipurpose solution. 
3.13. Biomicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
 
3.14. Insertion of Study 
Lenses 
Have the subject re-insert the lenses which 
had been removed at step 3.12. 
3.15. Exit Distance and 
Near Visual Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 2000 
Series Chart 1 or 2. 
 
3.16. Subject Instructions 
Instruct the Subject on the following: 
• The lenses will be worn on a daily wear 
basis. 
• After each lens removal, use a 
rub/rinse/soak lens care regimen with 
Biotrue® multipurpose solution (per 
manufacturer’s instructions). 
• If determined necessary by the 
Investigator sterile non-preserved 
rewetting drops may be dispensed to be 
used as needed for dryness. 
• Subjects will be instructed to wear lenses 
for a minimum of 6 hours a day, every 
day during the study. One missed day of 
lens wear per week is acceptable. 
• Subjects will be instructed to wear their 
glasses when not wearing the study lenses. 
• Subjects will be instructed to bring their 
habitual contacts or spectacles to the next 
visit. 

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Visit 3: Treatment 1 Follow-Up 2 
Step 
Procedure 
Details 
Note: In the event a lens is lost or damaged 
after Visit 3, the subject will return to the 
investigator site for discontinuation and Final 
Evaluation. As much as reasonably possible, 
a damaged lens should be returned to the 
investigational site and then returned to the 
Sponsor. If lens damage is present, complete 
the Product Quality Complaint Form. The 
lens will be stored in labeled vial with 
Biotrue® multipurpose solution and returned 
to the Sponsor. 
3.17. Schedule 
Follow-up 
The subject will be scheduled to return for 
their follow-up appointment which should be 
25 to 31 days after Visit 2. 
 
 
 
VISIT 4 
The subjects must present to Visit 4 wearing the study lenses. 
 
Visit 4: Treatment 1 Follow-Up 3 
Step 
Procedure 
Details 
4.1. 
Adverse Events and 
Concomitant 
Medications Review 
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events. 
4.2. 
Wear time and 
Comfortable Wear 
time (Study Lenses) 
Record the average wearing time and 
comfortable wearing time with the study 
lenses. 
4.3. 
Compliance 
Confirm compliance with the prescribed wear 
schedule. 
4.4. 
PRO (CLUE and 
MRD) and CLDEQ- 
8 Questionnaires 
The subject will respond to the Follow-Up 
PRO (CLUE and MRD) and Dry Eye 
Questionnaires. 
4.5. 
Subject Reported 
Ocular Symptoms 
Subjects will respond to a verbal open-ended 
symptoms questionnaire. 
 
4.6. 
Subjective 
Acceptance 
Record whether the subject’s distance and 
near vision with the lenses is acceptable. 
4.7. 
Entrance Distance 
and Near Visual 
Acuity 
Record the distance and near Snellen visual 
acuity (OD, OS, OU) to the nearest letter with 
the study contact lenses in place. 
For near measurements use the ETDRS 
2000 Series Chart 1 or 2. 
 

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Visit 4: Treatment 1 Follow-Up 3 
Step 
Procedure 
Details 
4.8. 
Binocular Distance 
Over-refraction and 
Distance Visual 
Acuity 
Perform a binocular over-refraction and 
record the OD and OS results and distance 
visual acuity. 
Note: No lens changes are allowed based on 
the over-refraction. 
Appendix 
F 
4.9. 
Toric Fit Evaluation 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
 
4.10. Lens Fit Assessment 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
 
4.11. Visual Performance 
Distance (4M) 
Intermediate (64 cm) 
Near (40 cm) 
Visual performance will be recorded OD, OS, 
and OU for the following: 
Distance, Bright Illuminance 
ETDRS Charts 4M-HC#1, HC#2, HC#3 and 
LC#1, LC#2 and LC#3 
 

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Visit 4: Treatment 1 Follow-Up 3 
Step 
Procedure 
Details 
 
Near, Bright Illuminance 
Reduced Guillon-Poling Charts High Contrast 
and Low Contrast Intermediate (64 cm) and 
Near (40 cm). 
Distance, Dim Illuminance (with Distance 
goggles) 
ETDRS Charts 4M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64 cm) and Near (40 cm). 
Note: 
• The room illuminance must be between 
7.3 and 7.9 EV (or 400 to 600 lux) 
• Distance, HC-1 Chart luminance 
Acceptable EV Range 10.5-10.7 (or 180 
to 210 cd/m2) 
• Guillon-Poling, Near Chart Luminance 
Acceptable EV Range 10.8-11.1 (or 220 
to 280 cd/m2) 
• Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
simulated by using the goggles). 
4.12. Lens Removal 
Have the subject remove the study lenses. 
Temporarily store the worn lenses until 
Biomicroscopy has been completed. If no 
adverse event or PQC was recorded, the worn 
lenses may be discarded. 
 
 
 
FINAL EVALUATION 
The final evaluation will ordinarily take place immediately following the last scheduled 
follow-up visit per the study protocol. It may also take place at any point the subject 
discontinues the study or is terminated from the study. 

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Final Evaluation 
Step 
Procedure 
Details 
F.1 
Final Exam Form 
Indicate if the subject completed the study 
successfully. If subject discontinued from the 
study, indicate the reason. 
F.2 
Biomicroscopy 
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility. 
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
 
F.3 
Subjective 
spherocylindrical 
Refraction 
An optimal, binocular balanced distance 
sphero-cylindrical refraction will be 
performed. Record the refraction and 
distance visual acuity (OD, OS, OU) to the 
nearest letter. 
 
F.4 
Exit Distance Visual 
Acuity 
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (habitual 
lenses, distance spectacles or unaided). 
 
 
7.3. 
Unscheduled Visits 
If, during the investigation, a subject requires an unscheduled visit to the clinical site, the 
following information will be collected at a minimum: 
• Chief complaint prompting the visit. If the reason is an adverse event, the applicable 
eCRF for the adverse event must be completed and subject record completed as 
appropriate 
• Date and time of the visit and all procedures completed at the unscheduled visit 
• Review of adverse event and concomitant medications 
• Documentation of any test article dispensed or collected from the subject, if applicable 
• Slit lamp findings (using the Slit Lamp Classification Scale) 
 
If the Investigator withdraws a subject from the study, the final study visit case report forms 
must be completed indicating the reason(s) why the subject was withdrawn. The subject record 
must be completed documenting the date and primary reason for withdrawal and the study 
CRA notified. 
 
Any ocular and non-ocular Adverse Events that are ongoing at the time of the study visit will 
be followed by the Investigator, within licensure, until they have resolved, returned to pre- 
treatment status, stabilized, or been satisfactorily explained. If further treatment i.e., beyond 
licensure is required, the subject will be referred to the appropriate health care provider. 
 
The following information will be collected during an unscheduled visit. 

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Unscheduled Visit 
Step 
Procedure 
Details 
U.1 
Reason for 
unscheduled visit 
Indicate if the only reason for the visit is that 
the subject requires additional test articles. If 
the reason is other than resupply of 
previously dispensed lenses, specify the 
reason for the visit. 
U.2 
Chief Complaints (if 
applicable) 
Record the subject’s chief complaints for 
reasons for the unscheduled visit. 
U.3 
Adverse Events and 
Concomitant 
Medications Review 
(if applicable) 
Review any changes to the subject’s medical 
history or concomitant medications from the 
previous study visit. Record any changes, and 
any adverse events. 
U.4 
Entrance VA (if 
applicable) 
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided). 
 
U.5 
Subjective Sphero- 
cylindrical 
Refraction (if 
applicable) 
Perform bare-eye subjective spherocylindrical 
refraction with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS). 
 
U.6 
Slit Lamp 
Biomicroscopy (if 
applicable) 
FDA Slit Lamp Classification Scale will be 
used to grade the findings. If the clearance of 
the fluorescein needs to be expedited, 
preservative-free rewetting drops may be 
instilled. 
 
U.7 
Dispensing (if 
applicable) 
If the subject requires additional lenses to 
complete the wear period and is eligible to do 
so, provide additional lenses per the 
dispensing instructions given in the detailed 
study procedures. 
U.8 
Toric Fit 
Evaluation (if 
applicable) 
After lens settling, record: 
• The rotational position to the nearest 
degree 
• Lens stability with blink 
• Lens stability with eye versions 
• Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 30 degrees, or lens 
stability is worse than 5 degrees movement 
 

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Unscheduled Visit 
Step 
Procedure 
Details 
 
with blink. If toric fit is unacceptable, 
remove, store, and label the lenses, and 
proceed to final evaluation. 
U.9 
Lens Fit 
Assessment (if 
applicable) 
Evaluate and grade lens centration, primary 
gaze movement, upgaze movement and 
tightness (push-up test). 
• The subject should not proceed to wear 
the lenses if any of the following is 
observed: 
• presence of limbal exposure (appearance 
of clear cornea) in any gaze 
• presence of edge lift 
• presence of unacceptable movement 
(excessive or insufficient) in all three 
movement categories (primary gaze, 
upgaze, and push-up). 
If either lens is deemed unacceptable, the 
subject will be discontinued from the study. 
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final 
Evaluation form. 
 
U.10 Exit Visual Acuity 
(if applicable) 
Record the distance Snellen visual acuity 
(OD, OS, OU) to the nearest letter, and the 
type of visual correction being worn (study 
lenses, habitual lenses, distance spectacles or 
unaided). 
 
 
 
7.4. Laboratory Procedures 
None 
 
8. SUBJECTS COMPLETION/WITHDRAWAL 
 
8.1. Completion Criteria 
Subjects are considered to have completed the study if they: 
• provided informed consent. 
• are eligible. 
• completed all visits 

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8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
• Subject death during the study period. 
• Subject withdrawal of consent. 
• Subject not compliant to protocol 
• Subject lost to follow-up. 
• Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
• Subject develops significant or serious adverse events causing discontinuation of study 
lens wear. 
• Subjects who have experienced a Corneal Infiltrative Event (CIE). 
• Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
• Subject missed any study visit. 
• Subject not compliant with study lens wear schedule. 
• Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
 
For discontinued subjects, the Investigator will: 
• Complete the current visit (scheduled or unscheduled). 
• Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
• Record the spherocylindrical refraction with best corrected distance visual acuity. 
• Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2. 
• Collect all unused test article(s) from the subject. 
• Make arrangements for subject care, if needed, due to their study participation 
 
An additional subject may be enrolled if a subject discontinues from the study prematurely. 
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
 
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications and therapies are medications or therapies that contraindicate contact 
lens wear. See the Exclusion criteria for specific details. 
 
9.1. Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact 
lens wear, chiefly by disrupting the tear film. A summary of disallowed medications is shown 

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in Table 4. Subjects with a history of taking these medications will be allowed to enroll only 
if: 
• The medications have been taken on a continual or routine basis for at least 6 months 
and the subject has demonstrated successful contact lens wear during this time. 
Or 
• The subject previously used these medications on a temporary basis and has ceased that 
medication at least 1 week prior to signing the informed consent. 
 
Table 4: Disallowed systemic medications 
 
Class of Drug 
Common Indication(s) 
Common Examples 
Anticholinergics 
Irritable bowel syndrome, 
Parkinson’s disease, peptic ulcer, 
cystitis, nasal congestion, cold 
symptoms, overactive bladder, 
COPD 
Bentyl, Spiriva, Atrovent, 
Hyosyne, Levsin, Symax 
Fastab, Symax SL, Homax SL, 
Cogentin, Transderm Scop, etc. 
Oral Phenothiazines 
Antipsychotic disorders 
(schizophrenia, mania) 
Compazine, Mellarill, 
Thorazine, Phenagran, etc. 
Oral/Inhaled 
Corticosteroids 
Arthritis, colitis, asthma, 
bronchitis, allergic or 
inflammatory conditions 
Cortisone, Prednisone, 
Hydrocortisone, Medrol, 
Kenalog, Flonase etc. 
Oral Retinoids 
Seborrhea, acne 
Isotretinoin, Acitretin, 
Alitretinoin, etc. 
Oral Tetracycline 
Urinary Tract Infection, acne, 
chlamydia, gonorrhea 
Sumycin, Achromycin V, etc. 
 
 
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked, and corrective actions implemented as appropriate. 
 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
 
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study, then it must be reported to IEC/IRB. This is a "Major Deviation". Deviations 
that contradict the information contained in the Informed Consent/Assent forms will be 
considered Major Deviations. 

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Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. 
 
Protocol waivers are prohibited. 
 
Table lists examples of deviations that will constitute major and minor protocol deviations for 
this study. 
 
Table 5: Examples of major and minor protocol deviations 
 
Deviation category 
Major deviation 
Minor deviation 
Out-of-window visit 
Visit attended 3 or more days 
out of visit window defined 
in study procedures 
Visit attended 2 or fewer 
days out of visit window 
defined in study procedures 
Insufficient wear of study 
lenses 
Subject does not wear study 
lenses for at least 6 hours per 
day for 3 or more days out of 
any 
week 
through 
the 
dispensing period. 
Subject does not wear study 
lenses for at least 6 hours per 
day for 2 days out of any 
week through the dispensing 
period. 
 
 
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 Review 
committee, 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. 

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The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use. 
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
• Lens replacements that occur due to drops/fall-outs. 
• 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: 
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 

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• Who received the complaint. 
• Study number. 
• Clinical site information (contact name, site ID, telephone number). 
• Lot number(s). 
• Unique Subject Identifier(s). 
• Indication of who first observed complaint (site personnel or subject). 
• OD/OS indication, along with whether the lens was inserted. 
• Any related AE number if applicable. 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
• Eye Care Provider objective (slit lamp) findings if applicable. 
• Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also apply and will be executed in parallel. 
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”. Justification for ILB must be 
documented. 
 
13. ADVERSE EVENTS 
 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.” 
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.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: 

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• Death 
• Serious deterioration in the health of the subject that resulted in any of the following: 
• Life-threatening illness or injury 
• Permanent or persistent impairment of a body structure or a body function 
• Hospitalization or prolongation of patient hospitalization 
• Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
• Chronic disease 
• 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: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• 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: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• 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 

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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: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.” 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device. 
Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device.1 
 
Unanticipated Adverse Device Effect (UADE) – A UADE is any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, the test 
article, if that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan, Investigator’s Brochure or protocol, or any 
other unanticipated serious problem associated with the test article that relates to the rights, 
safety and welfare of subjects. 
 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
• Seriousness/Classifications (see definition in section 13.1). 
• 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). 
• 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). 
• Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 

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• 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: 
• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
• 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. 
• 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. 
• 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: 
• Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
• Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
• 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. 

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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: 
• Adverse event (diagnosis not symptom). 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
• Date the clinical site was notified. 
• Date and time of onset. 
• Date and time of resolution. 
• Adverse event classification, severity, and relationship to test articles, as applicable. 
• Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
• Any referral to another health care provider if needed. 
• Outcome, ocular damage (if any). 
• Likely etiology. 
• 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 

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record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
• Notify the Sponsor immediately. 
• 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. 
• 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. 
• 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. 

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The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according 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). Throughout the 
analysis of data, the results for each subject/eye will be used when available for summarization 
and statistical analysis. Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis. 
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 

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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. 
 
14.2. Sample Size Justification 
This is a pilot study assessing the clinical performance of a marketed contact lens Bausch + 
Lomb Ultra® Multifocal for Astigmatism with respect to objective vision. This is the first time 
the sponsor will be assessing this study lens; therefore, historical data is not available to 
perform any statistical power calculation. The sample size was chosen by the study responsible 
clinician and was determined based on previous studies on other multifocal toric contact lenses 
with similar study endpoints. 
 
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 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
 
14.5. Primary Analysis 
LogMAR Visual Acuity 
Binocular, high luminance, high contrast visual performance on logMAR scale will be 
analyzed using a linear mixed model. Each model will include the experimental design factors: 
distance (distance/intermediate/near) as fixed effect. Site will be included as random covariate 
when appropriate. Other baseline characteristics known of importance such as age, gender 
and/or add power will be included as fixed covariates when appropriate. The covariance 
between residual errors from the same subject across different distances will be selected based 
on the finite-sample corrected Akaike’s Information Criterion (Keselman et al. 1998).8 
Covariance structures considered may include: Homogenous compound symmetry (CS) and 
Unstructured covariance structure (UN). The structure that returns the lowest Akaike 
Information Criteria Corrected (AICC) will be selected as the structure that best fit the data. 

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The Kenward and Roger method will be used for the calculation of the denominator of degrees 
of freedom.9 
 
Comparisons will be carried out using 95% confidence intervals constructed of least-square 
means (LSM) from the linear mixed models. Statistically superiority will be concluded if the 
upper limits of the confidence intervals are below the thresholds for corresponding distances. 
 
14.6. Secondary Analysis 
Not Applicable 
 
14.7. Other Exploratory Analyses 
Not Applicable 
 
14.8. Interim Analysis 
An interim analysis will not be performed on this study. 
 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
 
14.10. 
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted to 
the specification of the JJVC database manager and sent to JJVC for analysis. 
 
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 

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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: 
• subject identification 
• eligibility 
• study identification 
• study discussion 
• provision of and date of informed consent 
• visit dates 
• results of safety and efficacy parameters as required by the protocol 
• a record of all adverse events 
• follow-up of adverse events 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
 
15.3. Trial Registration on ClinicalTrials.gov 
This study will be registered on ClinicalTrials.gov based on the following: The clinical trial is 
evaluating a U.S. FDA-regulated Device Product. 
 
16. DATA MANAGEMENT 
 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 

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16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub- 
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
 
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: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
• Ensuring the rights and wellbeing of subjects are protected. 
• Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 

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• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
• Ensuring that the clinical site has sufficient test article and supplies. 
• Clarifying questions regarding the study. 
• Resolving study issues or problems that may arise. 
• Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
 
18. ETHICAL AND REGULATORY ASPECTS 
 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled. 
 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol. 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information). 
• Sponsor-approved subject recruitment materials. 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 

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• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
• 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: 
• Protocol revisions 
• Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
• If applicable, new or revised subject recruitment materials approved by the Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure revisions 
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of 
the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• 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 

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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. 
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 States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 

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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: 
• processed fairly and lawfully. 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
• adequate, relevant, and not excessive in relation to said purposes. 
• accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,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. 

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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: 
• Continuing an ineligible subject in the study. 
• 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: 
• Query resolution. 
• Case Report Form signature. 
• Completion of any follow-up action items. 
 
21. PUBLICATION 
There is no plan to publish the outcome of this investigation. 
 
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html 

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2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy- 
guidelines.html 
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of- 
helsinki-ethical-principles-for-medical-research-involving-human-subjects/ 
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR 
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html 
6. Franklin R. 
Clinical Study Protocol. Pilot Evaluation of a Silicone Hydrogel 
Daily Disposable Toric Multifocal Contact Lens. August 06, 2020. 
7. Franklin  R. 
Clinical Study Protocol. Evaluation of Silicone Hydrogel 
Multifocal Toric Contact Lenses in a Hyperopic Population. January 11, 2021. 
8. Keselman HJ, Algina J, Kowalchuk RK, Wolfinger RD. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated Measures. 
Communications in Statistics—Simulation and Computation. 1998;27(3):591-604. 
9. Kenward MG, Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997;53:983-997. 

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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 

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APPENDIX B: PATIENT INSTRUCTION GUIDE 
Will be provided separately. 

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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 

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UltraMFA DW PIFG Ins / US / FITSET 
8184600 
n/a 
5573 
BLACK 
PMS 
320 

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2
  
PACKAGE INSERT / FITTING GUIDE 
 
 
 
 
 
 
 
 
 
 
SYMBOL REFERENCE GUIDE 
For labels and cartons: 
 
Meets EU 
 
Packaging 
Directive 
 
Sterilized 
Using Steam 
 
            Caution 
Diameter 
EXP 
Use-By Date 
Batch Code 
 
 
 
 
Base Curve 
 
Single Vision 
Spherical 
 
Add Power 
Cylinder Axis 
Cylinder Power 
Sphere Power 
Temperature 
Limit 
TABLE OF CONTENTS 
Important ......................................................................................... 2 
Description ...................................................................................... 3 
Lens Parameters Available ................................................................ 4 
How the Lens Works (Actions) ........................................................... 4 
Indications ....................................................................................... 4 
Contraindications (Reasons Not To Use) ........................................... 5 
Warnings .......................................................................................... 6 
Precautions....................................................................................... 7 
Adverse Reactions ...........................................................................................11 
Selection of Patients ................................................................................ 13 
Practitioner Fitting Sets ........................................................................... 14 
General Fitting Procedure ............................................................... 14 
Pre-Fitting Examination ................................................................... 14 
Lens Power Selection ............................................................... 14 
Lens Fitting ...................................................................................... 14 
To Refine Near Vision ............................................................... 15 
To Refine Distance Vision ........................................................ 15 
Patient Education ............................................................................. 16 
Lens Evaluation ................................................................................ 16 
Criteria of a Well-Fitted Lens .................................................... 16 
Characteristics of a Tight (Steep) Lens ..................................... 17 
Characteristics of a Loose (Flat) Lens ....................................... 17 
CAUTION 
Federal law restricts this device to sale by or on the order of a licensed practitioner. 
IMPORTANT 
This package insert and fitting guide has been developed to provide practitioners 
with information covering characteristics of the Bausch + Lomb ULTRA 
(samfilcon A) Multifocal for Astigmatism Contact Lens and to illustrate fitting 
procedures. It is effective as of revision date on cover and supersedes all prior 
fitting guides for the product described. Please read carefully and keep this 
information for future use. 
This package insert and fitting guide is intended for the eye care practitioner, but 
should be made available to patients upon request. The eye care practitioner 
should provide the patient with the patient instructions that pertain to the patient’s 
prescribed lens and the recommended wearing schedule. 
 
 
 
 
 
 
 
 
 
 
 
CAUTION: Federal law restricts this device to 
sale by or on the order of a licensed practitioner. 
®/TM are trademarks of Bausch & Lomb Incorporated or its affiliates. 
© 2019 Bausch & Lomb Incorporated 
Bausch & Lomb Incorporated 
1400 North Goodman Street 
Rochester, NY 14609 USA 
Printed in the USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Rev. 2019-02 
8184600 
Prescription 
Only (USA) 
 
Power 
YYYY-MM-DD 
Effective Date 
 
Manufacturer 
Follow-Up Care ........................................................................ 18 
Monovision Fitting Guidelines ................................................................ 19 
Patient Selection ...................................................................... 19 
Eye Selection....................................................................... 20 
Special Fitting Considerations ................................................. 20 
Near Add Determination .................................................... 20 
Trial Lens Fitting ............................................................................... 21 
Adaptation ....................................................................................... 21 
Other Suggestions .................................................................. 22 
Wearing Schedule ...................................................................... 23 
Handling of Lens ............................................................................ 23 
Patient Lens Care Directions .................................................... 23 
Frequent/Planned Replacement Wear ......................................... 23 
Disposable Wear ............................................................................. 24 
Care for a Sticking (Nonmoving) Lens ............................................. 25 
Emergencies .............................................................................. 26 
Reporting of Adverse Reactions ...................................................... 26 
How Supplied ................................................................................. 26 
2 
 
DESCRIPTION 
The Bausch + Lomb ULTRA® (samfilcon A) Multifocal for Astigmatism Contact 
Lens material, samfilcon A, is a hydrophilic copolymer of a siloxane methacrylate 
and N-vinyl pyrrolidone, and is 46% water by weight when immersed in a sterile 
borate buffered saline with poloxamine solution. This lens is tinted with up to 
200 ppm of Reactive Dye 246. The Bausch + Lomb ULTRA (samfilcon A) 
Multifocal for Astigmatism Contact Lenses utilizes MoistureSeal® Technology 
which creates a unique material and a hydrophilic surface. 
The physical/optical properties of the lens are: 
Specific Gravity: 
1.048 
Refractive Index: 
1.411 
Light Transmittance: 
C.I.E. value—at least 95% 
Water Content: 
46% 
Oxygen Permeability: 
114 x 10–11 [cm3O (STP) x cm]/(sec x cm2 x mmHg) 
@ 35°C Polarographic Method (Boundary and 
Edge Corrected) 
The Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism Contact 
Lens features both a 3-Zone Progressive™ Design and an OpticAlign® Design. 
 
LENS PARAMETERS AVAILABLE 
The Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens is 
a hemispherical shell of the following dimensions: 
Diameter: 
14.5mm 
Center Thickness: 
0.05mm to 0.50mm 
Base Curve: 
8.6mm 
Powers: 
+4.00D to -6.00D in 0.25D steps 
Add Powers: 
Low (+0.75D to +1.50D) and 
High (+1.75D to +2.50D) 
Cylinder Powers: 
-0.75D, -1.25D and -1.75D 
Axis: 
10° to 180° in 10° increments 
*Additional powers may be introduced over time, check periodically for product availability. 
 
HOW THE LENS WORKS (ACTIONS) 
In its hydrated state, the Bausch + Lomb ULTRA (samfilcon A) Multifocal for 
Astigmatism Contact Lens, when placed on the cornea, acts as a refracting medium to 
focus light rays on the retina. 
INDICATIONS 
Multifocal for Astigmatism Vision Correction 
The Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism Contact 
Lens is indicated for daily wear for the correction of refractive ametropia (myopia, 
hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons 
with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require 
an add power ranging from +0.75D to +5.00D. 
Frequent/Planned Replacement Wear 
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens is to be cleaned, rinsed 
and disinfected each time it is removed from the patient’s eye and discarded after the 
recommended wearing period prescribed by the eye care practitioner. The lens may 
be disinfected using a chemical disinfection system. 
Disposable Wear 
When prescribed for Disposable Wear, the Bausch + Lomb ULTRA (samfilcon A) 
Multifocal for Astigmatism Contact Lens is to be discarded after each removal. 
 
CONTRAINDICATIONS 
(REASONS NOT TO USE) 
DO NOT USE the Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens when any of the following conditions exist: 
• 
Acute and subacute inflammation or infection of the anterior chamber of the eye 
• 
Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, 
or eyelids 
• 
Severe insufficiency of lacrimal secretion (dry eyes) 
• 
Corneal hypoesthesia (reduced corneal sensitivity) 
• 
Any systemic disease that may affect the eye or be exaggerated by wearing 
contact lenses 
• 
Allergic reactions of ocular surfaces or adnexa (surrounding tissue) that may be 
induced or exaggerated by wearing contact lenses or use of contact lens solutions 
• 
Allergy to any ingredient, such as mercury or Thimerosal, in a solution which is 
to be used to care for the Bausch + Lomb ULTRA (samfilcon A) Multifocal for 
Astigmatism Contact Lens 
• 
Any active corneal infection (bacterial, fungal, or viral) 
• 
If eyes become red or irritated 
 
WARNINGS 
After a thorough eye examination, including appropriate medical background, 
patients should be fully apprised by the prescribing professional of all the risks 
with contact lens wear. Patients should be advised of the following warnings 
pertaining to contact lens wear: 
• 
Problems with contact lenses and lens care products could result in serious 
injury to the eye. It is essential that patients follow their eye care practitioner’s 
direction and all labeling instructions for proper use of lenses and lens care 
products, including the lens case. Eye problems, including corneal ulcers, can 
develop rapidly and lead to loss of vision. 
• 
Daily wear lenses are not indicated for overnight wear, and patients should 
be instructed not to wear lenses while sleeping. Clinical studies have 
shown that the risk of adverse reactions is increased when daily wear lenses 
are worn overnight. 
• 
When prescribed for Frequent/Planned Replacement Wear, the need for 
strict compliance with the care regimen including cleaning of the lens case, 
wearing restrictions, wearing schedule, and follow-up visit schedule should be 
emphasized to the patient. 
• 
Studies have shown that contact lens wearers who are smokers have a higher 
incidence of adverse reactions than nonsmokers. 
• 
If a patient experiences eye discomfort, excessive tearing, vision changes, or 
redness of the eye, the patient should be instructed to immediately remove 
the lenses and promptly contact his or her eye care practitioner. 
 
 
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PRECAUTIONS 
Special Precautions for Eye Care Practitioners 
• 
Due to the small number of patients enrolled in clinical investigation of lenses, 
all refractive powers, design configurations, or lens parameters available in the 
lens material are not evaluated in significant numbers. 
Consequently, when selecting an appropriate lens design and parameters, 
the eye care practitioner should consider all characteristics of the lens that 
can affect lens performance and ocular health, including oxygen permeability, 
wettability, central and peripheral thickness, and optic zone diameter. 
• 
The potential impact of these factors on the patient’s ocular health should 
be carefully weighed against the patient’s need for refractive correction; 
therefore, the prescribing eye care practitioner should carefully monitor the 
continuing ocular health of the patient and lens performance on eye. 
• 
Eye care practitioners should instruct the patient to REMOVE A LENS 
IMMEDIATELY if an eye becomes red or irritated. 
• 
Fluorescein, a yellow dye, should not be used while the lenses are on the eyes. 
The lenses absorb this dye and become discolored. Whenever fluorescein 
is used in eyes, the eyes should be flushed with sterile saline solution that is 
recommended for in-eye use. 
• 
The patient should be instructed to always discard disposable lenses 
and lenses worn on a frequent/planned replacement schedule after the 
recommended wearing schedule prescribed by the eye care practitioner. 
• 
As with any contact lens, follow-up visits are necessary to assure the 
continuing health of the patient’s eyes. The patient should be instructed as to 
a recommended follow-up schedule. 
• 
Aphakic patients should not be fitted with Bausch + Lomb ULTRA 
(samfilcon A) Multifocal for Astigmatism Contact Lenses until the 
determination is made that the eye has healed completely. 
• 
Patients who wear aspheric contact lenses, such as the Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens, to correct 
presbyopia may not achieve the best corrected visual acuity for either far 
or near vision. Visual requirements vary with the individual and should be 
considered when selecting the most appropriate type of lens for each patient. 
• 
Eye care practitioners should carefully instruct patients about the following 
lens care and safety precautions. It is strongly recommended that patients be 
provided with a copy of the Bausch + Lomb ULTRA (samfilcon A) Multifocal 
for Astigmatism Contact Lens Patient Information Booklet available from 
Bausch + Lomb and understand its contents prior to dispensing the lenses. 
Handling Precautions 
• 
Always wash and rinse hands before handling lenses. Do not get cosmetics, 
lotions, soaps, creams, deodorants, or sprays in the eyes or on the lenses. It is best 
to put on lenses before putting on makeup. Water-based cosmetics are less likely 
to damage lenses than oil-based products. 
• 
Be sure that before leaving the eye care practitioner’s office, the patient is able to 
remove lenses promptly or have someone else available to remove them. 
• 
Be certain that the fingers or hands are free of foreign materials before touching 
lenses, as microscopic scratches of the lenses may occur, causing distorted vision 
and/or injury to the eye. 
• 
Always handle lenses carefully and avoid dropping them. 
• 
Do not touch the lens with fingernails. 
• 
Carefully follow the handling, insertion, removal, cleaning, disinfecting, storing and 
wearing instructions in the Patient Information Booklet for the Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens and those 
prescribed by the eye care practitioner. 
• 
Never use tweezers or other tools to remove lenses from the lens container unless 
specifically indicated for that use. Pour the lens into the hand. 
Lens Wearing Precautions 
• 
Never wear lenses beyond the period recommended by the eye care practitioner. 
• 
If the lens sticks (stops moving) on the eye, follow the recommended directions on 
Care for a Sticking (Nonmoving) Lens. The lens should move freely on the eye for 
the continued health of the eye. If nonmovement of the lens continues, the patient 
should be instructed to immediately consult his or her eye care practitioner. 
• 
Avoid, if possible, all harmful or irritating vapors and fumes while wearing lenses. 
• 
If aerosol products are used while wearing lenses, exercise caution and keep eyes 
closed until the spray has settled. 
Solution Precautions 
Eye injury due to irritation or infection may result from lens contamination. To reduce 
the risk of contamination, review the appropriate manufacturer’s labeled lens care 
instructions with the patient. 
• 
Always use fresh, unexpired lens care solutions. 
• 
Always follow directions in the package inserts for the use of contact 
lens solutions. 
• 
Sterile unpreserved solutions, when used, should be discarded after the time 
specified in the labeling directions. 
• 
You should fill your lens case with fresh solution every time you store your 
lenses and never “top-off” or re-use solution. You should discard your solution 
immediately after your lenses have been removed from the lens case. 
• 
Always keep the lenses completely immersed in the recommended storage 
solution when lenses are not being worn (stored). Prolonged periods of drying 
will damage lenses. Follow the lens care directions for Care for a Dried Out 
(Dehydrated) Lens in the Patient Information Booklet if lens surface does become 
dried out. 
• 
Do not use saliva or anything other than the recommended solution for lubricating 
or wetting lenses. 
• 
Tap water, distilled water or homemade saline should not be used as a substitute 
for any component in the lens care regimen since they have been associated with 
an Acanthamoeba keratitis infection. 
• 
Never use conventional hard contact lens solutions that are not also 
recommended for use with prescribed lenses. 
• 
Do not mix or alternate lens care systems or solutions unless indicated in the lens 
care system labeling. 
• 
Do not heat the chemical disinfection solution or lenses. 
Lens Case Precautions 
• 
Contact lens cases can be a source of bacterial growth. To prevent 
contamination and to help avoid serious eye injury, always empty and rinse 
the lens case with fresh, sterile rinsing solution and allow to air-dry. 
• 
Lens cases should be replaced at least every three months or as 
recommended by the lens case manufacturer or eye care practitioner. 
Topics to Discuss with the Patient 
• 
As with any contact lens, follow-up visits are necessary to assure the 
continuing health of the eyes. The patient should be instructed as to a 
recommended follow-up schedule. 
• 
Patients should be advised about wearing lenses during sporting and water 
related activities. Exposure to water while wearing contact lenses in activities 
such as swimming, water skiing and hot tubs may increase the risk of ocular 
infection including, but not limited to, Acanthamoeba keratitis. 
• 
Certain medications, such as antihistamines, decongestants, diuretics, muscle 
relaxants, tranquilizers, and those for motion sickness may cause dryness of 
the eye, increased lens awareness, or blurred vision. Should such conditions 
exist, proper remedial measures should be prescribed. Depending on the 
severity, this could include the use of lubricating drops that are indicated for 
use with soft contact lenses or temporary discontinuance of contact lens wear 
while such medication is being used. 
• 
Oral contraceptive users could develop visual changes or changes 
in lens tolerance when using contact lenses. Patients should be 
cautioned accordingly. 
Who Should Know That the Patient is Wearing Contact Lenses 
• 
Patients should inform their doctor (health care professional) about being a 
contact lens wearer. 
• 
Patients should always inform their employer of being a contact lens wearer. 
Some jobs may require the use of eye protection equipment or may require 
that you do not wear lenses. 
 
 
 
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ADVERSE REACTIONS 
The patient should be informed that the following problems may occur: 
• 
Eyes stinging, burning, itching (irritation), or other eye pain 
• 
Comfort is less than when lens was first placed on eye 
• 
Abnormal feeling of something in the eye (foreign body, scratched area) 
• 
Excessive watering (tearing) of the eyes 
• 
Unusual eye secretions 
• 
Redness of the eyes 
• 
Reduced sharpness of vision (poor visual acuity) 
• 
Blurred vision, rainbows, or halos around objects 
• 
Sensitivity to light (photophobia) 
• 
Dry eyes 
If the patient notices any of the above, he or she should be instructed to: 
• 
Immediately remove the lenses. 
• 
If the discomfort or problem stops, the patient should look closely at the lens. 
If the lens is in any way damaged, do not put the lens back on the eye. Place 
the lens in the storage case and contact the eye care practitioner. If the lens 
has dirt, an eyelash, or other foreign body on it, or the problem stops and 
the lens appears undamaged, the patient should thoroughly clean, rinse, 
and disinfect the lenses; then reinsert them. After reinsertion, if the problem 
continues, the patient should immediately remove the lenses and consult 
his or her eye care practitioner. 
If the above symptoms continue after removal of the lens, or upon reinsertion 
of a lens, or upon insertion of a new lens, the patient should immediately 
remove the lenses and contact his or her eye care practitioner or 
physician, who must determine the need for examination, treatment or 
referral without delay. (See Important Treatment Information for Adverse 
Reactions.) A serious condition such as infection, corneal ulcer, corneal 
vascularization, or iritis may be present, and may progress rapidly. 
Less serious reactions such as abrasions, epithelial staining or bacterial 
conjunctivitis must be managed and treated carefully to avoid more serious 
complications. 
Important Treatment Information for Adverse Reactions 
Sight-threatening ocular complications associated with contact lens wear can develop 
rapidly, and therefore early recognition and treatment of problems are critical. 
Infectious corneal ulceration is one of the most serious potential complications, 
and may be ambiguous in its early stage. Signs and symptoms of infectious corneal 
ulceration include discomfort, pain, inflammation, purulent discharge, sensitivity to 
light, cells and flare, and corneal infiltrates. 
Initial symptoms of a minor abrasion and an early infected ulcer are sometimes 
similar. Accordingly, such epithelial defect, if not treated properly, may develop into an 
infected ulcer. In order to prevent serious progression of these conditions, a patient 
presenting symptoms of abrasions or early ulcers should be evaluated as a potential 
medical emergency, treated accordingly, and be referred to a corneal specialist when 
appropriate. Standard therapy for corneal abrasions such as eye patching or the use 
of steroids or steroid/antibiotic combination may exacerbate the condition. If the 
patient is wearing a contact lens on the affected eye when examined, the lens should 
be removed immediately and the lens and lens care products retained for analysis 
and culturing. 
SELECTION OF PATIENTS 
The eye care practitioner should not fit patients who cannot or will not adhere to a 
recommended care or replacement regimen, or are unable to place and remove 
the lenses should not be provided with them. Failure to follow handling and cleaning 
instructions could lead to serious eye infections which might result in corneal ulcers. 
Patient communication is vital because it relates not only to patient selection but also 
to ensure compliance. It is also necessary to discuss the information contained in the 
Patient Information Booklet with the patient at the time of the initial examination. 
Patients selected to wear Bausch + Lomb ULTRA (samfilcon A) Multifocal for 
Astigmatism Contact Lenses should be chosen for their motivation to wear contact 
lenses, general health and cooperation. The eye care practitioner must take care 
in selecting, examining and instructing contact lens patients. Patient hygiene and 
willingness to follow practitioner instructions are essential to their success. 
A detailed history is crucial to determining patient needs and expectations. Your 
patient should be questioned regarding vocation, desired lens wearing time (full or 
part time), and desired lens usage (reading, recreation or hobbies). 
Initial evaluation of the trial lens should be preceded by a complete eye examination, 
including visual acuity with and without correction at both distance and near, 
keratometry and slit lamp examination. 
It is normal for the patient to experience mild symptoms such as lens awareness, 
variable vision, occasional tearing (watery eyes) and slight redness during the 
adaptation period. Although the adaptation period varies for each individual, generally 
within one week these symptoms will disappear. 
If these symptoms persist, the patient should be instructed to contact his or her eye 
care practitioner. 
PRACTITIONER FITTING SETS 
Lenses must be discarded after a single use and must not be used from patient 
to patient. 
GENERAL FITTING PROCEDURE 
1. Pre-Fitting Examination 
A pre-fitting patient history and examination are necessary to: 
• 
Determine whether a patient is a suitable candidate for contact lenses 
(consider patient hygiene and mental and physical state), 
• 
Make ocular measurements for initial contact lens parameter selection, and 
• 
Collect and record baseline clinical information to which post-fitting 
examination results can be compared. 
A pre-fitting examination should include spherocylinder refraction and VA, 
keratometry, and biomicroscopic examination. 
2. Lens Power Selection 
a. Update spectacle refraction and Add power. 
b. Determine ocular dominance. 
c. 
Select toric lens power, adjusting for vertex distance if necessary. 
d. Select Add power for both eyes, following the guidance below. 
• 
Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens Low Add: +0.75D to +1.50D 
• 
Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens High Add: +1.75D to +2.50D 
3. Lens Fitting 
a. 
Allow lens to equilibrate for at least 10 minutes before assessing fit and vision. 
b. Confirm axis orientation. 
c. 
Evaluate distance and near vision binocularly in normal room illumination. 
d. If vision at distance and near are satisfactory, dispense lenses and schedule 
follow-up exam within 1-2 weeks. 

CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 98 of 169 
 
 
4. To Refine Near Vision 
If patient is wearing two Low Add lenses: 
• 
Refinement 1: 
Place Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens High Add in non-dominant eye while keeping 
Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens Low Add in dominant eye. 
• 
Refinement 2: 
If vision is still unsatisfactory, continue adding +0.25D at a time to the 
non-dominant eye using handheld lenses. Adjust contact lens power 
when vision is satisfactory. 
If patient is wearing two High Add lenses: 
• 
Refinement 1: 
Add +0.25D to the non-dominant eye. 
• 
Refinement 2: 
If vision is still unsatisfactory, continue adding +0.25D at a time to the 
non-dominant eye using handheld lenses. 
5. To Refine Distance Vision 
If patient is wearing two Low Add lenses: 
• 
Refinement 1: 
Fit Bausch + Lomb ULTRA for Astigmatism in dominant eye while 
keeping Bausch + Lomb ULTRA (samfilcon A) Multifocal for 
Astigmatism Contact Lens Low Add in non-dominant eye. 
• 
Refinement 2: 
If vision is still unsatisfactory, add -0.25D at a time to dominant eye using 
hand held lenses. Adjust contact lens power when vision is satisfactory. 
If patient is wearing two High Add lenses: 
• 
Refinement 1: 
Fit with Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lens Low Add in dominant eye while keeping Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens Add in 
non-dominant eye. 
• 
Refinement 2: 
If vision is still unsatisfactory, add -0.25D at a time to dominant eye using 
hand held lenses. Adjust contact lens power when vision is satisfactory. 
6. Patient Education 
All patients do not function equally well with multifocal correction. Patients may not 
perform as well for certain tasks with this correction as they have with multifocal 
reading glasses. Each patient should understand that multifocal correction can create 
a vision compromise that may reduce visual acuity and depth perception for distance 
and near tasks. During the fitting process it is necessary for the patient to realize the 
disadvantages as well as the advantages of clear near vision in straight ahead and 
upward gaze that multifocal contact lenses provide. 
7. Lens Evaluation 
a. 
To determine proper lens parameters, observe the lens relationship to the eye 
using a slit lamp. 
• 
Movement: The lens should provide discernible movement with: 
— Primary gaze blink 
— Upgaze blink 
— Upgaze lag 
• 
Centration: The lens should provide full corneal coverage 
b. Lens evaluation allows the contact lens fitter to evaluate the lens/cornea 
relationship in the same manner as would be done with any soft lens. If after the 
lens has settled on the eye, the patient reports lens sensation, or if the lens is 
moving or decentering excessively, the lens should not be dispensed. Alternatively, 
if the patient reports variable vision, or if the lens shows insufficient movement, the 
lens should not be dispensed. 
8. Criteria of a Well-Fitted Lens 
If the lens fully covers the cornea, provides discernible movement after a blink, is 
comfortable for the patient and provides satisfactory visual performance, it is a 
well-fitted lens and can be dispensed. 
9. Characteristics of a Tight (Steep) Lens 
A lens which is much too steep may subjectively and objectively cause distortion which 
will vary after a blink. However, if a lens is only marginally steep, the initial subjective 
and objective vision and comfort findings may be quite good. A marginally steep lens 
may be differentiated from a properly fitted lens by having the patient gaze upward. 
A properly fitted lens will tend to slide downward approximately 0.5mm while a steep 
lens will remain relatively stable in relationship to the cornea, particularly with the blink. 
Toric Lens: With your finger, gently rotate the lens approximately 45° to the temporal 
side. It should reorient with 5 to 10 blinks back to the same stabilized position. 
10. Characteristics of a Loose (Flat) Lens 
A lens that is too flat will decenter, especially on post-blink, have a tendency to edge 
lift inferiorly and sit on the lower lid, rather than positioning between the sclera and 
palpebral conjunctiva. A flat fitted lens will have a tendency to be uncomfortable and 
irritating with fluctuating vision. A flat fitted lens has a tendency to drop or lag greater 
than 2.0mm on upgaze post-blink. 
11. Follow-Up Care 
a. 
Follow-up examinations are necessary to ensure continued successful contact 
lens wear. From the day of dispensing, the following schedule is a suggested 
guideline for follow-up. 
• 
24 hours 
• 
1 to 2 weeks 
• 
Every six months thereafter 
At the initial follow-up evaluations the eye care practitioner should again 
reassure the patient that any of the previously described adaptive symptoms 
are normal, and that the adaptation period should be relatively brief. 
Depending on the patient’s prior experience with contact lenses and/or 
continuous wear, the eye care practitioner may consider prescribing a one 
week period of daily wear adaptation prior to beginning continuous wear. 
b. Prior to a follow-up examination, the contact lenses should be worn for at 
least 4 continuous hours and the patient should be asked to identify any 
problems which might be occurring related to contact lens wear. If the patient 
is wearing the lenses for continuous wear, the follow-up examination should 
be conducted as early as possible the morning after overnight wear. 
c. 
With lenses in place on the eyes, evaluate fitting performance to assure that 
Criteria of a Well-Fitted Lens continue to be satisfied. Examine the lenses 
closely for surface deposition and/or damage. 
d. After the lens removal, instill sodium fluorescein [unless contraindicated] into 
the eyes and conduct a thorough biomicroscopy examination. 
1. 
The presence of vertical corneal striae in the posterior central cornea 
and/or corneal neovascularization may be indicative of excessive 
corneal edema. 
2. 
The presence of corneal staining and/or limbal-conjunctival hyperemia 
can be indicative of an unclean lens, a reaction to solution preservatives, 
excessive lens wear, and/or a poorly fitting lens. 
3. 
Papillary conjunctival changes may be indicative of an unclean and/or 
damaged lens. 
If any of the above observations are judged abnormal, various professional 
judgments are necessary to alleviate the problem and restore the eye to 
optimal conditions. If the Criteria of a Well-Fitted Lens are not satisfied 
during any follow-up examination, the patient should be re-fitted with a more 
appropriate lens. 
 
 
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MONOVISION FITTING GUIDELINES 
1. Patient Selection 
a. Monovision Needs Assessment 
For a good prognosis the patient should have adequately corrected 
distance and near visual acuity in each eye. The amblyopic patient or the 
patient with significant astigmatism (greater than one [1] diopter) in one 
eye may not be a good candidate for monovision with the Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lenses. 
Occupational and environmental visual demands should be considered. 
If the patient requires critical vision (visual acuity and stereopsis) it should 
be determined by trial whether this patient can function adequately with 
monovision. 
Monovision contact lens wear may not be optimal for such activities as: 
1. 
Visually demanding situations such as operating potentially dangerous 
machinery or performing other potentially hazardous activities; and 
2. 
Driving automobiles (e.g., driving at night). Patients who cannot pass their 
state driver’s license requirements with monovision correction should be 
advised to not drive with this correction, OR may require that additional 
over-correction be prescribed. 
b. Patient Education 
All patients do not function equally well with monovision correction. 
Patients may not perform as well for certain tasks with this correction as 
they have with bifocal reading glasses. Each patient should understand 
that monovision can create a vision compromise that may reduce visual 
acuity and depth perception for distance and near tasks. During the fitting 
process it is necessary for the patient to realize the disadvantages as well as 
the advantages of clear near vision in straight ahead and upward gaze that 
monovision contact lenses provide. 
2. Eye Selection 
Generally, the non-dominant eye is corrected for near vision. The following test for eye 
dominance can be used. 
a. Ocular Preference Determination Methods 
• 
Method 1—Determine which eye is the “sighting dominant eye”. Have the 
patient point to an object at the far end of the room. Cover one eye. If the 
patient is still pointing directly at the object, the eye being used is the dominant 
(sighting) eye. 
• 
Method 2—Determine which eye will accept the added power with the least 
reduction in vision. Place a trial spectacle near add lens in front of one eye 
and then the other while the distance refractive error correction is in place for 
both eyes. Determine whether the patient functions best with the near add 
lens over the right or left eye. 
b. Refractive Error Method 
For anisometropic corrections, it is generally best to fit the more hyperopic (less 
myopic) eye for distance and the more myopic (less hyperopic) eye for near. 
c. 
Visual Demands Method 
Consider the patient’s occupation during the eye selection process to determine 
the critical vision requirements. If a patient’s gaze for near tasks is usually in one 
direction correct the eye on that side for near. 
Example: 
A secretary who places copy to the left side of the desk will usually function best 
with the near lens on the left eye. 
3. Special Fitting Considerations 
Unilateral Lens Correction 
There are circumstances where only one contact lens is required. As an example, 
an emmetropic patient would only require a near lens while a bilateral myope may 
require only a distance lens. 
Example: 
A presbyopic emmetropic patient who requires a +1.75 diopter add would have a 
+1.75 diopter lens on the near eye and the other eye left without a lens. 
A presbyopic patient requiring a +1.50 diopter add who is –2.50 diopters myopic 
in the right eye and –1.50 diopters myopic in the left eye may have the right eye 
corrected for distance and the left uncorrected for near. 
4. Near Add Determination 
Always prescribe the lens power for the near eye that provides optimal near acuity at 
the midpoint of the patient’s habitual reading distance. However, when more than one 
power provides optimal reading performance, prescribe the least plus (most minus) 
of the powers. 
5. Trial Lens Fitting 
A trial fitting is performed in the office to allow the patient to experience monovision 
correction. Lenses are fit according to the directions in the general fitting guidelines. 
Case history and standard clinical evaluation procedure should be used to determine 
the prognosis. Determine which eye is to be corrected for distance and which eye is 
to be corrected for near. Next determine the near add. With trial lenses of the proper 
power in place observe the reaction to this mode of correction. 
Immediately after the correct power lenses are in place, walk across the room and 
have the patient look at you. Assess the patient’s reaction to distance vision under 
these circumstances. Then have the patient look at familiar near objects such as a 
watch face or fingernails. Again assess the reaction. As the patient continues to look 
around the room at both near and distant objects, observe the reactions. Only after 
these vision tasks are completed should the patient be asked to read print. Evaluate 
the patient’s reaction to large print (e.g., typewritten copy) at first and then graduate to 
newsprint and finally smaller type sizes. 
After the patient’s performance under the above conditions is completed, tests of 
visual acuity and reading ability under conditions of moderately dim illumination should 
be attempted. 
An initial unfavorable response in the office, while indicative of a guarded prognosis, 
should not immediately rule out a more extensive trial under the usual conditions in 
which a patient functions. 
6. Adaptation 
Visually demanding situations should be avoided during the initial wearing period. 
A patient may at first experience some mild blurred vision, dizziness, headaches, and 
a feeling of slight imbalance. You should explain the adaptational symptoms to the 
patient. These symptoms may last for a brief minute or for several weeks. The longer 
these symptoms persist, the poorer the prognosis for successful adaptation. 
To help in the adaptation process the patient can be advised to first use the lenses in a 
comfortable familiar environment such as in the home. 
Some patients feel that automobile driving performance may not be optimal during 
the adaptation process. This is particularly true when driving at night. Before driving a 
motor vehicle, it may be recommended that the patient be a passenger first to make 
sure that their vision is satisfactory for operating an automobile. During the first several 
weeks of wear (when adaptation is occurring), it may be advisable for the patient to 
only drive during optimal driving conditions. After adaptation and success with these 
activities, the patient should be able to drive under conditions with caution. 
7. Other Suggestions 
The success of the monovision technique may be further improved by having your 
patient follow the suggestions below. 
• 
Having a third contact lens (distance power) to use when critical distance 
viewing is needed. 
• 
Having a third contact lens (near power) to use when critical near viewing 
is needed. 
• 
Having supplemental spectacles to wear over the monovision contact lenses 
for specific visual tasks may improve the success of monovision correction. 
This is particularly applicable for those patients who cannot meet state 
licensing requirements with a monovision correction. 
• 
Make use of proper illumination when carrying out visual tasks. 
Success in fitting monovision can be improved by the following suggestions: 
• 
Reverse the distance and near eyes if a patient is having trouble adapting. 
• 
Refine the lens powers if there is trouble with adaptation. Accurate lens power 
is critical for presbyopic patients. 
• 
Emphasize the benefits of the clear near vision in straight ahead and upward 
gaze with monovision. 
• 
The decision to fit a patient with a monovision correction is most 
appropriately left to the eye care practitioner in conjunction with the 
patient after carefully considering the patient’s needs. 
• 
All patients should be supplied with a copy of the Bausch + Lomb 
ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens Patient 
Information Booklet. 
 
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WEARING SCHEDULE 
The wearing and replacement schedules should be determined by the eye care 
practitioner. Regular checkups, as determined by the eye care practitioner, are 
extremely important. 
Daily Wear 
There may be a tendency for the daily wear patient to over wear the lenses initially. 
Therefore, the importance of adhering to a proper, initial daily wearing schedule 
should be stressed to these patients. The wearing schedule should be determined 
by the eye care practitioner. The wearing schedule chosen by the eye care 
practitioner should be provided to the patient. 
Disposable Lens Wear 
No lens care is needed. The lenses are discarded every time they are removed 
from the eye. Lenses should only be cleaned, rinsed and disinfected on an 
emergency basis when replacement lenses are not available. 
Frequent/Planned Replacement Wear 
When removed between replacement periods, lenses must be cleaned and 
disinfected before reinsertion, or be discarded and replaced with a new lens. 
HANDLING OF LENS 
Patient Lens Care Directions 
When lenses are dispensed, the patient should be provided with appropriate 
and adequate instructions and warnings for lens care handling. The eye care 
practitioner should recommend appropriate and adequate procedures and 
products for each individual patient in accordance with the particular lens wearing 
schedule and care system selected by the professional, the specific instructions for 
such products and the particular characteristics of the patient. 
Frequent/Planned Replacement Wear 
For complete information concerning the care, cleaning and disinfection of 
contact lenses refer to the Bausch + Lomb ULTRA (samfilcon A) Multifocal for 
Astigmatism Contact Lens Patient Information Booklet. 
Disposable Wear 
For complete information concerning emergency lens care, refer to the 
Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism Contact Lens 
Patient Information Booklet. 
a. Soaking and Storing Lenses 
Instructions for Use: 
Use only fresh contact lens disinfecting solution each time you soak (store) your lenses. 
WARNING: 
Do not reuse or “top-off” old solution left in lens case since solution reuse reduces 
effective lens disinfection and could lead to severe infection, vision loss or blindness. 
“Topping-off” is the addition of fresh solution to solution that has been sitting in 
the case. 
b. Rub and Rinse Time 
Instructions for Use: 
Follow the complete recommended lens rubbing and rinsing times in the labeling of 
the solution used for cleaning, disinfecting and soaking lenses to adequately disinfect 
lenses and reduce the risk of contact lens infection. 
WARNING: 
• 
Rub and rinse lenses for the recommended amount of time to help prevent 
serious eye infections. 
• 
Never use water, saline solution, or rewetting drops to disinfect lenses. These 
solutions will not disinfect lenses; not using the recommended disinfectant can 
lead to serious infection, vision loss or blindness. 
c. Lens Case Care 
Instructions for Use: 
• 
Clean contact lens cases with digital rubbing using fresh, sterile disinfecting 
solution/contact lens cleaner. Never use water. Cleaning should be followed by 
rinsing with fresh, sterile disinfecting solutions (never use water) and wiping the 
lens cases with fresh, clean tissue is recommended. Never air-dry or recap the 
lens case lids after use without any additional cleaning methods. If air-drying, be 
sure that no residual solution remains in the case before allowing it to air-dry. 
• 
Replace lens case at least every three months, or as directed by your eye 
care practitioner. 
• 
Contact lens cases can be a source of bacterial growth. 
WARNING: 
Do not store lenses or rinse lens case with water or any non-sterile solution. Only 
use fresh solution so you do not contaminate lenses or lens case. Use of non-sterile 
solution can lead to severe infection, vision loss or blindness. 
d. Water Activity 
Instructions for Use: 
Do not expose contact lenses to water while wearing them. 
WARNING: 
Water can harbor microorganisms that can lead to severe infection, vision loss or 
blindness. If your lenses have been submersed in water when swimming in pools, 
lakes, or oceans, discard them and replace them with a new pair. Ask your eye 
care practitioner for recommendations about wearing lenses during any activity 
involving water. 
e. Discard Date on Solution Bottle 
Instructions for Use: 
Discard any remaining solution after the recommended time period indicated on the 
bottle of the solution used for disinfecting and soaking contact lenses. 
WARNING: 
Using solution beyond the discard date could result in contamination of the solution 
and can lead to severe infection, vision loss or blindness. 
CARE FOR A STICKING (NONMOVING) LENS 
If the lens sticks (stops moving), the patient should be instructed to use a lubricating or 
rewetting solution in their eye. The patient should be instructed to not use plain water, 
or anything other than the recommended solutions. The patient should be instructed 
to contact the eye care practitioner if the lens does not begin to move upon blinking 
after several applications of the solution, and to not attempt to remove the lens except 
on the advice of the eye care practitioner. 
EMERGENCIES 
If chemicals of any kind (household products, gardening solutions, laboratory 
chemicals, etc.) are splashed into your eyes, you should: FLUSH EYES 
IMMEDIATELY WITH TAP WATER AND THEN REMOVE LENSES 
PROMPTLY. CONTACT YOUR EYE CARE PRACTITIONER OR VISIT 
A HOSPITAL EMERGENCY ROOM WITHOUT DELAY. 
REPORTING OF ADVERSE REACTIONS 
All serious adverse experiences and adverse reactions observed in patients 
wearing Bausch + Lomb ULTRA (samfilcon A) Multifocal for Astigmatism 
Contact Lenses or experienced with the lenses should be reported to: 
Bausch & Lomb Incorporated 
1400 North Goodman Street 
Rochester, New York 14609 USA 
Toll Free Telephone Number 
In the Continental U.S., Alaska, Hawaii 
1-800-553-5340 
In Canada 
1-888-459-5000 (Option 1 – English, Option 2 – French) 
HOW SUPPLIED 
Each sterile lens is supplied in a plastic blister package containing borate buffered 
saline with poloxamine solution. The container is marked with the manufacturing 
lot number of the lens, the base curve, sphere, diameter and expiration date. 
 
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APPENDIX E: OCULAR DOMINANCE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX F: BINOCULAR OVER REFRACTION 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX G: 
• 
DETERMINATION OF NEAR ADDITION 
• 
NEAR logMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
• 
LENS FITTING CHARACTERISTICS 
• 
SUBJECT REPORTED OCULAR SYMPTOMS 
• 
 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
• 
BIOMICROSCOPY SCALE 
• 
KERATOMETRY 
• 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
• 
TORIC FIT EVALUATION 
• 
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
• 
 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
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APPENDIX H: GUIDELINES FOR COVID-19 RISK MITIGATION 

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1.0 
PURPOSE 
 
The purpose of this document is to provide guidelines for the re-opening or initiation of clinical study sites 
participating in Johnson & Johnson Vision Care, Inc. (JJVCI) clinical studies during the COVID-19 
pandemic. 
 
2.0 
SCOPE 
 
This document provides guidelines for Johnson & Johnson Vision Care (JJVCI) to address the potential risks 
from COVID-19 to study subjects, investigators, study site staff, and monitors at study sites. The guidance 
provided in this document is in effect from the date of approval through the date of retirement of this Work 
Instruction. At a minimum, this Work Instruction will be reviewed and updated on a quarterly basis, as 
appropriate. 
 
NOTE: Re-opening of sites outside of the US will be evaluated on a country by country basis subject 
to local health authority guidance. 
 
3.0 
DEFINITIONS 
 
American Academy of Optometry (AAO): The American Academy of Optometry is an organization of 
optometrists based in Orlando, Florida. Its goal is to maintain and enhance excellence in optometric 
practice, by both promoting research and the dissemination of knowledge. The AAO holds an annual 
meeting, publishes a monthly scientific journal, gives credentials to optometrists through the fellowship 
process and publishes position statements. 
 
American Optometric Association (AOA): The American Optometric Association, founded in 1898, is 
the leading authority on quality care and an advocate for our nation's health, representing more than 44,000 
Doctors of Optometry (O.D.), optometric professionals, and optometry students. Doctor of Optometry take 
a leading role in patient care with respect to eye and vision care, as well as general health and well-being. 
As primary health care providers, Doctor of Optometry have extensive, ongoing training to examine, 
diagnose, treat and manage ocular disorders, diseases and injuries and systemic diseases that manifest in the 
eye. The American Optometric Association is a federation of state, student, and armed forces optometric 
associations. Through these affiliations, the AOA serves members consisting of optometrists, students of 
optometry, paraoptometric assistants and technicians. The AOA and its affiliates work to provide the public 
with quality vision and eye care. 
Centers for Disease Control and Prevention (CDC): The Centers for Disease Control and Prevention is a 
national public health institute in the United States. It is a United States federal agency, under the 
Department of Health and Human Services, and is headquartered in Atlanta, Georgia. 
COVID-19: Current outbreak of respiratory disease caused by a novel coronavirus. The virus has been 
named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID- 
19). 
Clinical Study: Voluntary research studies conducted in people and designed to answer specific questions 
about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing 
treatments. May also be called clinical trials, studies, research, trials, or protocols. 
Clinical Study Site: Location where a clinical study is conducted, such as a doctor’s office, university, or 
laboratory. Clinical studies are conducted by Investigators who are individual(s) responsible for the 
conduct of the clinical study at a study site. If a study is conducted by a team of individuals, the 
Investigator is the responsible leader of the team and may be called the Principal Investigator. 
Clinical Operations Manager (COM): The Johnson & Johnson Vision Care (JJVCI) individual 
responsible for the overall management of a clinical trial. 
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Monitor: An individual designated to oversee the progress of a clinical study and ensure that it is 
conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), 
Good Clinical Practice (GCP), and applicable regulatory requirements. 
 
Medical Safety Officer (MSO): Physician who has primary accountability in their product portfolio for 
product health and safety, and who serves as an independent medical voice for patient safety. 
 
Safety Management Team (SMT): A cross-functional, collaborative team responsible for review, 
assessment and evaluation of medical safety data arising from any source throughout the product life cycle. 
 
4.0 
GUIDANCE FOR STUDY DOCUMENTS 
 
In alignment with recent health authority guidance, JJVCI is providing recommendations for study-related 
management in the event of disruption to the conduct of the clinical study. This guidance does not supersede 
any local or government requirements or the clinical judgement of the investigator to protect the health, safety 
and well-being of participants and site staff. If, at any time, a participant’s safety is considered to be at risk, 
study intervention will be discontinued, and study follow-up will be conducted as outlined in the protocol. 
 
During the COVID-19 pandemic, the additional risks listed below need to be considered for study participants 
and study personnel: 
 
Additional Risks Related to the COVID-19 Pandemic: 
• 
The possible transmission of the Coronavirus infection and consequent complications, beyond the 
risk of adverse events due to the investigational device and/or procedures. 
• 
The risk may be higher in an optometric clinical study because of the close contact the subject will 
have with health care professionals during the procedures and assessments (since the investigator 
must make the measurements close to the subject’s face) and, in addition the need for multiple 
follow-up visits/exams which may expose the subject to other patients and/or healthcare 
professionals who might be transmitting the virus, even if they do not have symptoms. 
• 
Potential disruptions to the study may be necessary due to current or future pandemic-related 
emergency restrictions, which may lead to delays in scheduled follow-up visits. 
• 
Subjects experiencing an adverse event related to contact lens wear may receive delayed treatment 
due to COVID-19 restrictions. In this event, all assessments that can be conducted virtually will be 
completed by the investigator to determine the best course of treatment for the subject, including 
an unscheduled visit, up to discontinuation from the study, as appropriate. 
 
If a study subject is found to have contracted COVID-19 during participation in a study, he/she will be 
discontinued from the study and followed until COVID-19 Adverse Event (AE) resolution. 
 
To help minimize the above potential risks, JJVCI recommend reviewing/complying with local, state, 
and governmental guidance for COVID-19 risks. 
 
JJVCI will provide the following study specific documents with language pertaining to COVID-19 risks: 
 
4.1.1 
Informed Consent: 
 
Will include information concerning the study-associated risks related to the COVID-19 pandemic 
in bold font and/or boxed on the first page of the Informed Consent document: 
Document Type: 
Document Number: 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 160 of 169 
 
 
 
STUDY ASSOCIATED RISKS RELATED TO COVID-19 (CORONAVIRUS) PANDEMIC 
 
It is important to note that this study will be conducted, at least in part, during the COVID-19 pandemic. As such, 
additional risks associated with the infection with COVID-19 exist for you. This is particularly important for this 
study due, in part, to the closeness of the doctor during the study examinations. 
 
The potential effects of the disease are not fully known, at this time, and may include long-term serious health 
consequences. In severe cases, this may result in hospitalization and/or death. Based on current knowledge from the 
Centers for Disease Control and Prevention (CDC), those at high-risk for severe illness from COVID-19 include 
older adults and people with underlying medical conditions. 
 
During this study, all appropriate measures will be taken to minimize risks including the use of personal protective 
equipment such as masks and gloves, as well as proper sanitization. This is in conformance to guidance from the 
CDC, local health departments, and the state and county in which the study doctor’s office is located. However, 
these measures may not completely eliminate the risks associated with contracting COVID-19. 
 
If you are found to have contracted COVID-19 or feel ill with flu-like symptoms during participation in the study, 
you will not be permitted to continue in-office study follow-up visits, but you will receive instructions and your 
condition will be monitored by the doctor and/or study staff. 
 
4.1.2 
COVID-19 Risk Control Checklist (Attachment-B): 
 
Will include COVID-19 risk control methods that are required by a site to conduct JJVCI clinical 
studies. The risk controls are consistent with CDC, AOA, AAO Guidance. The Principal 
Investigator will review/sign the study specific checklist prior to the Site Initiation Meeting. 
 
 
4.1.3 
Protocol Compliance Investigator(s) Signature Page: 
 
Will include a statement indicating that the Principal Investigator (PI) agrees to conduct the study 
in compliance with all local, state, and governmental guidance’s for COVID-19 risk mitigation. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, 
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct this study in 
compliance with local, state, governmental guidance for COVID-19 risks. 
 
4.1.4 
Study Site Initiation Training Slides: 
 
Will include suggestions to help mitigate potential transmission of COVID-19. Suggestions may 
include maintaining social distancing in the clinical site by staggered scheduling of study patients, 
wearing proper PPEs, frequent disinfection, and installing shields on the slit lamp and other 
applicable equipment. 
 
5.0 
GUIDANCE FOR REMOTE SUBJECT VISITS 
 
Potential disruptions to the study may be necessary due to current or future pandemic-related emergency 
restrictions. Possible disruption of the study as a result of COVID-19 control measures may lead to delays 
in scheduled follow-up visits. 
 
Subjects may be delayed in being seen for study follow up visit(s), for example due to COVID-19 control 
measures or due to the subject’s concerns or fears about COVID-19 risk. When appropriate, the remote 
assessment will be conducted to the extent possible. Discussions with the subject during remote assessments 
may include: 
Document Type: 
Document Number: 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 161 of 169 
 
 
Document Type: 
Document Number: 
  
 
  
Revision Number: 5  
 
 
 
Procedure 
Details 
Subject Reported Ocular 
Symptoms 
Subjects will respond to a verbal open-ended symptoms questionnaire 
regarding the test article when applicable and feasible. 
Change of Medical History 
(Adverse Events) and 
Concomitant Medications / 
Therapies Review 
Record any adverse events or medical history changes from the 
previous study visit with the subject/parents. 
Review the subject’s concomitant medications/therapies and record 
any changes from the previous study visit. 
Wearing Time and 
Compliance 
Record the average wearing time (including number of hours per day 
during weekdays and weekends, and number of days per week). 
Confirm compliance with the prescribed wear schedule. 
• 
Record and discuss the lens wear compliance based on the 
subject’s self-report. For example, the subjects will be asked the 
time of the day the subject typically puts on the study lenses in the 
morning and takes off in the evening, the number of days per week 
lenses were worn, and the number of consecutive days the subject 
didn’t wear the study lenses, etc. 
 
The discussion with the subject will be documented in EDC under Tele-Visit and a minor protocol deviation 
will be noted. If during the telephone consultation, a subject states he/she wishes to discontinue participating 
in the study, instruct the subject to stop wearing the study lenses and schedule the subject to return to the 
clinic for a Final Evaluation at the at earliest possible time. Subjects should return all unused lenses to the 
clinic at the last visit. 
 
Changes in study visit schedules, missed visits, or participant discontinuations may lead to missing data, 
including data related to protocol-specified procedures. Case report forms should capture specific 
information regarding the basis of missing data, including the relationship to the COVID-19 pandemic. 
 
6.0 
STUDY CONDUCT DURING PANDEMIC 
 
It is recognized that the Coronavirus Disease 2019 (COVID-19) pandemic may have an impact on the conduct 
of this clinical study due to, for example, self-isolation/quarantine by participants and study-site personnel; 
travel restrictions/limited access to public places, including Optometry Clinics; and changes in clinic 
procedures required to address the COVID-19 challenge. 
 
Every effort should be made to adhere to protocol-specified assessments for study participants, including 
follow-up. However, if scheduled visits cannot be conducted in person at the study site it is suggested that 
assessments be performed to the extent possible remotely/virtually or delayed until such time that on-site 
visits can be resumed in order to continue participant monitoring in accordance with the protocol where 
possible. At each contact, participants will be interviewed to collect safety data. Key efficacy endpoint 
assessments should be performed if required and as feasible. 
 
Modifications to protocol-required assessments may be permitted via COVID-19 Appendix after consultation 
with the participant, investigator, and the sponsor. Missed assessments/visits will be captured in the clinical 
trial management system for protocol deviations. Interruptions of test article wear or discontinuations of 
study interventions and withdrawal from the study should be documented with the prefix “COVID-19- 
related” in the case report form (CRF). 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 162 of 169 
 
 
 
The sponsor will continue to monitor the conduct and progress of the clinical study, and any changes will be 
communicated to the sites and to the health authorities according to local guidance. 
 
If a participant has tested positive for COVID-19, the investigator should contact the sponsor’s responsible 
medical monitor to discuss initial plans for study intervention and follow-up. The medical monitor will 
notify the Safety Management Team of any subject(s) that have reported “COVID-19”, “Asymptomatic 
COVID-19”, or “Suspected COVID-19” adverse events within 24 hours of the notification. 
 
Modifications made to the study conduct as a result of the COVID-19 pandemic will be summarized in the 
clinical study report. 
 
COVID-19 screening procedures that may be mandated by local healthcare systems do not need to be 
reported as an amendment to the protocol even if done during clinical study visits. 
 
Monitoring Visits 
 
When on-site monitoring by the sponsor is not feasible, the sponsor’s site monitor will contact the study 
site to schedule remote visits. In such cases, on-site monitoring visits will resume when feasible, with 
increased frequency to address the source data verification backlog. 
 
Even with staffing limitations during this COVID-19 pandemic, all routine operations related to clinical 
trials should be well-documented and archived as part of standard process. When conditions permit, all 
parties involved in this clinical trial should communicate relevant information in a timely manner so that 
all relevant parties remain sufficiently informed. 
 
6.1.1 
Study Site Initiation: 
 
During the period that this Work Instruction is in effect, Site Initiation Meetings and training of 
study site staff will be conducted remotely. The JJVCI study team will conduct training via Skype, 
Zoom, Microsoft Teams or similar software as well as utilize online training materials, as applicable. 
Study site training will be documented utilizing Site Initiation Report 
 
On-site visits may be considered when, for example, hands-on training or evaluation of site facilities 
is required. While on site, the Clinical Research Associate (CRA) will follow all local, state, and 
governmental policies for COVID-19 Risk Mitigation, including social distancing, wearing of PPE, 
etc. as applicable for the location of the study site. 
 
6.1.2 
Interim Monitoring Visits (if applicable): 
 
During the period that this Work Instruction is in effect, Interim Monitoring On-site visits will be 
kept to a minimum and include only those tasks that the CRA cannot perform remotely (e.g., source 
document verification, test article reconciliation, etc.). 
 
To ensure data integrity during the conduct of all JJVC studies, clinical study teams will follow the 
study specific Clinical Monitoring Plan 
 
While on site, the CRA will follow all local, state, and governmental policies for COVID-19 Risk 
Mitigation, including social distancing, wearing of PPE, etc. as applicable for the location of the 
study site. 
Document Type: 
Document Number: 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 163 of 169 
 
 
 
6.1.3 
Study Site Closure: 
 
During the period that this Work Instruction is in effect, the duration of the Study Site Closure Visit 
will be limited to tasks that the CRA cannot perform remotely (e.g., source document verification, 
test article final reconciliation and return, etc.). 
Document Type: 
Document Number: 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 164 of 169 
 
 
 
Attachment A: Study Site Correspondence 
 
XXXX XX, 2020 
 
 
Re: COVID-19 Mitigation Plan, <<CR-xxxx/protocol title>> 
 
 
Dear <<Principal Investigator>> and Study Team, 
 
Coronavirus (COVID-19) has impacted several communities and business activities over the past several months. 
While we work toward the successful conduct of clinical studies, our commitment continues to be the safety of 
patients, healthcare professionals, and to our communities. 
 
Therefore, we would like to share the following revisions/additions related to the above referenced Johnson & 
Johnson Vision Care company sponsored clinical trial(s) you are currently working on or considering participation 
within. 
 
Protocol: 
 
• 
Guidelines for COVID-19 Risk Mitigation provided in the Appendix section. 
 
Protocol Signature Page: 
 
• 
Will include a statement indicating the Principal Investigator agrees to conduct the study in compliance 
with all local, state, and governmental guidelines for COVID-19 risk mitigation. 
 
Informed Consent: 
 
• 
Will include information concerning the study-associated risks related to the COVID-19 pandemic in bold 
font and/or boxed on the first page of the Informed consent document. 
 
COVID-19 Risk Control Checklist for Clinical Studies: 
 
• 
Will include COVID-19 risk control measures that are required to ensure the safety and health of subjects, 
site staff and monitors during the pandemic. 
 
We want to encourage the need for open lines of communication about potential challenges you may foresee as the 
result of the current COVID-19 situation. Therefore, we encourage you to regularly connect with your respective 
Johnson & Johnson clinical study team (Clinical Research Associate (CRA), Lead CRA or Study Managers). 
 
Thank you for your continued engagement, collaboration, and dedication to your study subjects during this 
challenging time. 
 
 
Please file this letter in your site file study correspondence. 
Document Type: 
Document Number: 

Title: 
Document Type: 
Document Number: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 165 of 169 
 
 
 
 
COVID-19 Risk Control Checklist (Attachment-B): 
 
 
Study Number 
Site Number 
Principal Investigator (PI) Name 
 
The following COVID-19 risk control methods are required to conduct Johnson & Johnson Vison Care clinical 
studies. Please review the following requirements and Initial each requirement. 
 
PI Initials 
General Site Safety Planning Measures 
Signage within site describing Risk Control methods 
Social Distancing practices throughout site (waiting rooms, lobby, exam rooms, etc.) 
Non-contact thermometer available to assess temperatures of staff and patients 
Training on patient flow and physical distancing in waiting room 
Establish longer time frame between patient appointments to reduce persons in the site 
Staff should receive job-specific training on PPE and demonstrate competency with selection and 
proper use of PPE and wear at all times during interactions with subjects (e.g., putting on and 
removing without self-contamination) 
 
 
PI Initials 
Site Staff Daily Safety Measures 
As part of routine practice, site staff should regularly monitor themselves for fever and symptoms 
of COVID-19, including temperature checks 
Any staff member (including non-study clinic staff and Investigators) showing signs of being sick 
or testing positive for COVID-19 must not be permitted to work on activity that may expose study 
related staff and subject and the Sponsor shall be informed 
NOTE: Inform JJVC in 24 hours of any COVID-19 cases and all potential exposure during 
the clinical study. 
Ensure that all staff wear a mask 
Gloves should be required when working directly with patients and changed between each patient 
Have staff thoroughly wash hands for at least 20 seconds or use an alcohol-based hand sanitizer 
when they arrive, before and after each patient, before eating and after using the bathroom. 
Cleaning and disinfection procedures for exam rooms and instruments or equipment between 
patients with gloves. 
Cleaning and disinfection procedures for commonly touched surfaces (doors, chairs, computers, 
phones, etc.) with gloves. 
 
 
PI Initials 
Before a Patient or Study Visit: 
Patients should be asked prior to entering the site about fever and respiratory illness and whether 
they or a family member have had contact with another person with confirmed COVID-19 in the 
past 14 days. Patients exhibiting signs of being sick should be rescheduled when their symptoms 
resolve. 
Instruct patients that companions should remain outside of the facility and not accompany the 
patient into the facility unless they are a parent/guardian of the patient or if they are a true 
caregiver and need to assist the patient 
Request the patient to call or text the office upon arrival so entrance to and movement through 
facility can be coordinated by site staff 

Title: 
Document Type: 
Document Number: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 166 of 169 
 
 
 
PI Initials 
Patients Entering the site: 
Temperature checks utilizing a non-contact thermometer for all patients and companions entering 
the site. 
All patients and companions must wear cloth or disposable mask at all times in the site 
Maintain social distancing. Waiting rooms or lobbies should be as empty as possible. Advise 
seated patients to remain at least 6 feet from one another. 
Communal objects in (e.g. toys, reading materials, etc.) should be removed or cleaned regularly. 
 
 
 
I certify that I have read and agree to implement all the listed COVID-19 Risk Control Measures required for the 
conduct of Johnson & Johnson Vision Care studies. 
 
 
 
 
 
 
 
Principal Investigator Signature and Date 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
CR-6383, v 4.0 
JJVC CONFIDENTIAL 
Page 167 of 169 
 
 
 
RESOURCE LINKS 
 
US Resource Links 
 
• 
OSHA Training 
https://www.osha.gov/SLTC/covid-19/controlprevention.html 
 
Personal Protective Equipment (PPE) Training 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html 
 
• 
I&R Training 
ACUVUE® LensAssist: https://www.acuvue.com/lensassist 
 
• 
Clinic Preparedness Guides 
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinic-preparedness.html 
AOA: https://aoa.uberflip.com/i/1240437-aoa-guidance-for-re-opening-practices-covidꞏ19/1?m4= 
American Optometric Association: https://www.aoa.org/optometry-practice-reactivation-preparedness- 
guide 
 
• 
ln-Office Disinfection of Multi-Patient Use Diagnostic Contact Lenses 
https://www.gpli.info/wp-content/uploads/2020/03/2020-01-15-in-office-disinfecting-of-diagnostic- 
lenses.pdf 
 
OUS Resource Links 
 
• 
Updates on local regulations in Hong Kong 
https://www.coronavirus.gov.hk/eng/index.html 
 
• 
Resumption of optical services in England: Letter from Matt Neligan and Poonam Sharma 
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0601-reopening-of-optical- 
services-letter-17-june-2020.pdf 
 
• 
NHS Optical Letter 
https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2020/04/C0127-optical-letter-1-april- 
2020.pdf 
 
• 
The College of Optometrists primary eye care COVID-19 guidance: Red phase 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-covid-19-guidance- 
for-optometrists.html 
 
• 
The College of Optometrists COVID-19: College updates 
https://www.college-optometrists.org/the-college/media-hub/news-listing/coronavirus-2019-advice-for- 
optometrists.html#CollegeGuidelines 
 
• 
Infection Control Guidelines. (n.d.). Retrieved from Canadian Association Of Optometrists: 
https://opto.ca/sites/default/files/resources/documents/infection_control_guidelines_2016.pdf 
• 
Infection prevention and control for COVID-19: Interim guidance for outpatient and ambulatory care 
settings. (2020, May 23 May). Retrieved from Government of Canada: https://www.canada.ca/en/public- 
health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/interim-guidance- 
outpatient-ambulatory-care-settings.html 
Document Type: 
Document Number: 

Title: 
Guidelines for COVID-19 Risk Mitigation 
 
  
 
  
Revision Number: 5 
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JJVC CONFIDENTIAL 
Page 168 of 169 
 
 
 
• 
Information for Members On Coronavirus (COVID-19). (n.d.). Retrieved from Canadian Association Of 
Optometrists: 
https://opto.ca/sites/default/files/resources/documents/information_for_members_on_coronavirus.pdf 
• 
Coronavirus (COVID-19) resources for health professionals, including aged care providers, pathology 
providers and health care managers. (2020, September 24). Retrieved from Australian Government 
Department of Health: 
https://www.health.gov.au/resources/collections/coronavirus-covid-19-resources-for-health-professionals- 
including-aged-care-providers-pathology-providers-and-health-care-managers 
 
• 
Environmental Cleaning and Disinfection Principles for COVID-19. (n.d.). Retrieved from Australian 
Government Department of Health: 
https://www.health.gov.au/sites/default/files/documents/2020/03/environmental-cleaning-and-disinfection- 
principles-for-covid-19.pdf 
• 
Infection control guidelines and advice. (n.d.). Retrieved from Optometry Australia : 
https://www.optometry.org.au/practice-professional-support/coronavirus-covid-19-what-optometrists-need- 
to-know/covid-19-clinical-advice/infection-control-guidelines-and-advice/ 
Document Type: 
Document Number: 

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JJVC CONFIDENTIAL 
Page 169 of 169 
 
 
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6383 Evaluation of Visual Acuity with a Reusable Toric 
Multifocal Contact Lens 
 
Version and Date: 4.0, 29 October 2021 
 
I have read and understand the protocol specified above and agree on its content. 
 
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
 
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
 
Principal 
Investigator: 
  
 
 
 
Signature 
 
Date 
 
 
Name and Professional Position (Printed) 
 
Institution/Site: 
  
 
Institution/Site Name 
 
 
Institution/Site Address