Clinical Evaluation of Delefilcon A and Verofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear
Phase: NA
Conditions: Ocular Physiology
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
Clinical Evaluation of Delefilcon A and Verofilcon A Daily Disposable Toric Soft Contact Lenses Over 
One Week of Wear 
Protocol CR-6493  
Version: 1.0  
Date: 22 July 2022  
Investigational Products: Alcon DAILIES TOTAL1® for Astigmatism Daily Contact Lenses, 
Alcon PRECISION1® for Astigmatism Daily Contact Lenses  
Keywords: Astigmatism, Alcon DAILIES TOTAL1® for Astigmatism, Alcon PRECISION1® 
for Astigmatism, delefilcon A, verofilcon A, daily wear, daily disposable, dispensing, Single 
use Eye-Cept® Rewetting Drops, LacriPure Saline Solution, ScleralFil Preservative Free Saline 
Solution, CLUE comfort, CLUE vision, CLUE handling, logMAR visual acuity, rotation 
performance. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This clinical trial will be conducted in compliance with ISO 14155:2020 Clinical investigation 
of medical devices for human subjects – Good clinical practice1 and the Declaration of 
Helsinki.2  
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE...................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS
................................................................................................................................................. 15 
1.
INTRODUCTION AND BACKGROUND ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 18 
3.
TARGETED STUDY POPULATION ........................................................................... 18 
3.1. 
General Characteristics ............................................................................................ 18 
3.2. 
Inclusion Criteria ...................................................................................................... 18 
3.3. 
Exclusion Criteria ..................................................................................................... 18 
3.4. 
Enrollment Strategy.................................................................................................. 19 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 19 
4.1. 
Description of Study Design .................................................................................... 19 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 20 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 21 
5.1. 
Test Article Allocation ............................................................................................. 21 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 22 
6.
STUDY INTERVENTION ............................................................................................. 22 
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6.1. 
Identity of Test Articles............................................................................................ 22 
6.2. 
Ancillary Supplies/Products ..................................................................................... 23 
6.3. 
Administration of Test Articles ................................................................................ 24 
6.4. 
Packaging and Labeling ........................................................................................... 24 
6.5. 
Storage Conditions ................................................................................................... 24 
6.6. 
Collection and Storage of Samples .......................................................................... 25 
6.7. 
Accountability of Test Articles ................................................................................ 25 
7.
STUDY EVALUATIONS .............................................................................................. 26 
7.1. 
Time and Event Schedule ......................................................................................... 26 
7.2. 
Detailed Study Procedures ....................................................................................... 27 
VISIT 1 ........................................................................................................................... 27 
VISIT 2 ........................................................................................................................... 33 
VISIT 3 ........................................................................................................................... 35 
VISIT 4 ........................................................................................................................... 36 
FINAL EVALUATION .................................................................................................. 37 
7.3. 
Unscheduled Visits ................................................................................................... 38 
7.4. 
Laboratory Procedures ............................................................................................. 39 
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 39 
8.1. 
Completion Criteria .................................................................................................. 39 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 40 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 40 
9.1. 
Systemic Medications .............................................................................................. 41 
10.
DEVIATIONS FROM THE PROTOCOL .................................................................. 42 
11.
STUDY TERMINATION ........................................................................................... 43 
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 44 
13.
ADVERSE EVENTS ................................................................................................... 45 
13.1. 
Definitions and Classifications ............................................................................. 45 
13.2. 
Assessing Adverse Events .................................................................................... 47 
13.2.1. 
Causality Assessment .................................................................................... 47 
13.2.2. 
Severity Assessment ...................................................................................... 48 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 48 
13.4. 
Reporting Adverse Events .................................................................................... 50 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 50 
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13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
51 
13.5. 
Event of Special Interest ....................................................................................... 51 
13.6. 
Reporting of Pregnancy ........................................................................................ 51 
14.
STATISTICAL METHODS ........................................................................................ 52 
14.1. 
General Considerations ......................................................................................... 52 
14.2. 
Sample Size Justification ...................................................................................... 52 
14.3. 
Analysis Populations ............................................................................................ 52 
14.4. 
Level of Statistical Significance ........................................................................... 52 
14.5. 
Primary Analysis .................................................................................................. 53 
14.6. 
2.3 Secondary Analysis ........................................................................................ 53 
14.7. 
Other Exploratory Analysis .................................................................................. 53 
14.8. 
Interim Analysis ................................................................................................... 53 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 53 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 53 
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 53 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 53 
15.2. 
Subject Record ...................................................................................................... 54 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 55 
16.
DATA MANAGEMENT............................................................................................. 55 
16.1. 
Access to Source Data/Document ........................................................................ 55 
16.2. 
Confidentiality of Information.............................................................................. 55 
16.3. 
Data Quality Assurance ........................................................................................ 55 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 55 
17.
CLINICAL MONITORING ........................................................................................ 56 
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 56 
18.1. 
Study-Specific Design Considerations ................................................................. 56 
18.2. 
Investigator Responsibility ................................................................................... 56 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 56 
18.4. 
Informed Consent ................................................................................................. 58 
18.5. 
Privacy of Personal Data ...................................................................................... 58 
19.
STUDY RECORD RETENTION................................................................................ 59 
20.
FINANCIAL CONSIDERATIONS ............................................................................ 60 
21.
PUBLICATION ........................................................................................................... 60 
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22.
REFERENCES ............................................................................................................ 60 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 61 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 74 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 75 
APPENDIX D: 
 ...................................... 80 
LENS FITTING CHARACTERISTICS ............................................................... 81 
SUBJECT REPORTED OCULAR SYMPTOMS ................................................ 87 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 89 
BIOMICROSCOPY SCALE ................................................................................ 95 
DISTANCE AND NEAR VISUAL ACUITY EVALUATION ......................... 101 
TORIC FIT EVALUATION ............................................................................... 106 
DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 111 
PATIENT REPORTED OUTCOMES................................................................ 115 
LENS INSERTION AND REMOVAL .............................................................. 117 
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING .............................................................................................................................. 120 
APPENDIX E: 
Guidelines for COVID-19 Risk Mitigation ............................... 129 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 141 
LIST OF TABLES 
Table 1: Test Articles .............................................................................................................. 23 
Table 2: Ancillary Supplies .................................................................................................... 24 
Table 3: Time and Events ....................................................................................................... 26 
Table 4: Disallowed systemic medications ............................................................................. 41 
Table 5: Disallowed systemic antihistamines ......................................................................... 42 
Table 6: Examples of major and minor protocol deviations ................................................... 43 
LIST OF FIGURES 
Figure 1: Study Flowchart ...................................................................................................... 14 
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Johnson & Johnson Vision Care, Inc. 
SYNOPSIS 
Protocol Title 
Clinical Evaluation of Delefilcon A and Verofilcon A Daily 
Disposable Toric Soft Contact Lenses Over One Week of Wear 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Descriptive study phase: Post-market  
Design control phase: Post-market, phase 4 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the 
Sponsor. 
Test Article(s) 
Approved Products:  
Test: DAILIES TOTAL1® for Astigmatism Contact Lenses 
(DT1fA) 
Control: PRECISION1™ for Astigmatism Contact Lenses 
(P1fA) 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily disposable 
Objectives 
Primary Objective: 
To evaluate the incidence of grade 3 or higher biomicroscopy 
findings following a 7(±2) day wear period for DAILIES 
TOTAL1® for Astigmatism Contact Lenses (DT1fA) relative to 
PRECISION1™ for Astigmatism Contact Lenses (P1fA) as 
control.  
Exploratory Objectives: 
To evaluate the subjective comfort, vision and handling, visual 
acuity, and rotational performance over a 7(±2) day wear period 
for DT1fA relative to P1fA as control. 
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Study Endpoints 
Primary endpoint: 
x Incidence of grade 3 or higher biomicroscopy findings 
using the FDA grading scale following a 7(±2) day wear 
period  
 
Observational endpoints (efficacy): 
x Subjective comfort, vision and handling at fitting and 
following a 7(±2) day wear period using the CLUE 
questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity in 
logMAR measured using ETDRS charts at follow-up 
x Lens orientation at 1 minute and 3 minutes following 
insertion at fitting 
x Mean and standard deviation of settled lens orientation 
calculated from repeated measures of settled lens 
orientation at fitting and follow-up visits  
 
Observational endpoints (safety): 
x Adverse events 
 
All endpoints will be summarized using descriptive statistics 
only; no formal hypothesis testing is planned. 
Study Design 
This is a bilateral, dispensing, randomized, controlled, double 
masked, 2×2 cross-over study. Each subject will be randomly 
assigned to one of two wear sequences (test followed by control 
or control followed by test). Each wear period will be 7(±2) 
days, with a 7(±2) day washout period between wear periods.  
 
There will be a total of 4 visits: 
Visit 1: Screening, baseline evaluation and lens fit #1  
Visit 2: Follow-up evaluation for first lens 
Visit 3: Continuance, lens fit #2 
Visit 4: Follow-up evaluation for second lens 
 
See the flow chart at the end of the synopsis table for a 
schematic of the study visits and procedures ( 
Figure 1). 
Sample Size 
This study will have an enrollment target of approximately 66 
subjects, with a target of at least 60 to complete (assuming a 
dropout rate of 10%). 
Study Duration 
Total study duration including the enrollment period is 
anticipated to be approximately 8 weeks. 
Anticipated Study 
Population 
Subjects will be habitual soft contact lens wearers with bilateral 
astigmatism who are between 18 and 39 years of age 
(inclusive). 
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Eligibility Criteria - 
Inclusion 
Potential subjects must satisfy of all 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 between 18 and 39 (inclusive) years of age at the time of 
screening. 
4. By self-report, habitually wear soft contact lenses in both 
eyes in a daily reusable or daily disposable wear modality 
(i.e., not extended wear modality). Habitual wear is defined 
as a minimum of 6 hours of wear per day, for a minimum of 
2 days per week during the past month. 
5. Possess a wearable pair of spectacles that provide correction 
for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. Have the spherical component of their vertex-corrected 
distance refraction must be between -0.875 to -4.625 DS 
(inclusive) in each eye. 
7. Have the magnitude of the cylindrical component of their 
vertex-corrected distance refraction between 0.625 DC and 
1.625 DC in both eyes. 
8. Have the cylinder axis of their distance refraction between 
165° and 15° (i.e., 180±15°, inclusive) or between 75° and 
105° (i.e., 90±15°, inclusive) in each eye.   
9. Have best corrected monocular distance visual acuity of 
20/30 or better in each eye. 
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Eligibility Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be diabetic. 
3. Be currently using any ocular medications or have any 
ocular infection of any type. 
4. By self-report, have any ocular or systemic disease, 
allergies, infection, or use of medication that might 
contraindicate or interfere with contact lens wear, or 
otherwise 
compromise 
study 
endpoints, 
including 
infectious disease (e.g., hepatitis, tuberculosis), contagious 
immunosuppressive 
disease 
(e.g., 
Human 
Immunodeficiency Virus [HIV]), autoimmune disease (e.g., 
rheumatoid arthritis, Sjögren’s syndrome), or history of 
serious mental illness or seizures. See section 9.1 for 
additional details regarding excluded systemic medications.  
5. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, 
SoftPerm) within the past 6 months. 
6. Be currently wearing monovision or multifocal contact 
lenses. 
7. Be currently wearing lenses in an extended wear modality. 
8. Have a history of strabismus or amblyopia. 
9. Be 
an 
employee 
(e.g., 
Investigator, 
Coordinator, 
Technician) or immediate family member of an employee 
(including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site. 
10. Have participated in a contact lens or lens care product 
clinical trial within 7 days prior to study enrollment. 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
11. Have clinically significant (grade 3 or higher on the FDA 
grading scale) slit lamp findings (e.g., corneal edema, 
neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or 
abnormalities that contraindicate contact lens wear or may 
otherwise 
compromise 
study 
endpoints 
(including 
entropion, ectropion, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, aphakia, moderate or 
above corneal distortion, herpetic keratitis).  
12. Have fluctuations in vision due to clinically significant dry 
eye or other ocular conditions.  
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13. Have had or have planned (within the study period) any 
ocular or intraocular surgery (e.g., radial keratotomy, PRK, 
LASIK, iridotomy, retinal laser photocoagulation, etc.). 
Disallowed 
Medications/Interventions  
Subjects will not be eligible to enroll if they are taking any 
ocular medications, or any systemic medications that would 
normally contraindicate contact lens wear or may otherwise 
compromise study endpoints. See section 9.1 for details 
regarding disallowed systemic medications. 
Measurements and 
Procedures 
The key procedures associated with the observational endpoints 
for this study will be: 
- Grading of ocular physiology by slit lamp biomicroscopy 
using the FDA grading scale 
- Completion of the CLUE questionnaire at fitting and follow-
up 
- Measurement of HLHC VA using ETDRS charts at follow-
up 
- Measurement of toric lens orientation using a slit lamp 
biomicroscope 
Microbiology or Other 
Laboratory Testing 
Not applicable for this study. 
Study Termination 
The occurrence of an Unanticipated Adverse Device Effect 
(UADE) or Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in 
stopping further dispensing investigational product. In the 
event of a UADE or SAE, the Sponsor Medical Monitor may 
unmask the treatment regimen of subject(s) and may discuss 
this with the Principal Investigator before any further subjects 
are enrolled. 
Ancillary Supplies/ 
Study-Specific Materials 
Lens cases, fluorescein strips and preservative-free rewetting 
drops / artificial tears will be supplied for use as needed.   
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File. 
 
 
 
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Figure 1: Study Flowchart 
Visit 1: Screening 
Subjects must wear habitual lenses to visit 
Statement of Informed Consent 
Demographics 
Medical History & Concomitant Medications 
Habitual Contact Lens Information 
Eligibility at Screening 
Baseline Evaluation 
Subject Reported Ocular Symptoms 
Entrance visual acuity 
Spherocylindrical refraction and distance visual acuity 
Slit lamp biomicroscopy findings 
Eligibility after Baseline 
Baseline CLUE questionnaire (habitual lenses) 
Lens Fitting (#1 through #2) 
Lens assignment and insertion 
Timed rotation assessments, lens settling 
Toric and general fit assessment 
Spherical over-refraction, modification if required 
CLUE post-fit questionnaire 
Additional samples of toric lens orientation  
Lenses dispensed for 7r2 days 
Follow-up (#1 through #2) 
Subjects must wear study OHQVHVIRUKUSULRUWRYLVLW 
CLUE follow-up questionnaire 
HLHC visual acuity using ETDRS charts 
Record lens orientation 
Additional samples of toric lens orientation  
Lens removal 
Biomicroscopy 
Schedule next visit 
Continuance 
Review med history and medications 
Subject reported ocular symptoms 
Entrance VA and biomicroscopy 
Confirm continuing eligibility 
Final Evaluation 
Spherocylindrical refraction 
Completion status 
Biomicroscopy (if discontinued early) 
After follow-up #1 
al Evaluation
After follow-up #2 
Washout Period 
A washout period of 7r2 days duration 
will be observed between wear periods 
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COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF 
TERMS 
ADE 
 
 
Adverse Device Effect 
ADHD  
 
Attention Deficit Hyperactivity Disorder 
AE 
 
 
Adverse Event/Adverse Experience 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience 
COM  
 
Clinical Operations Manager 
COVID-19 
 
Coronavirus Disease 2019 
CRA 
 
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO 
 
 
Contract Research Organization 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC 
 
 
Electronic Data Capture 
ETDRS  
Early Treatment Diabetic Retinopathy Study 
FDA 
 
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice 
HIPAA  
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICH 
 
 
The International Council for Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC 
 
 
Johnson & Johnson Vision Care, Inc. 
LASIK  
 
Laser-Assisted in Situ Keratomileusis 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
OD 
 
 
Right Eye 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PIG 
 
 
Patient Instruction Guide 
PQC 
 
 
Product Quality Complaint 
PRK 
 
 
Photorefractive Keratectomy 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
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1. INTRODUCTION AND BACKGROUND 
DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA) and PRECISION1® 
(verofilcon A) for Astigmatism Contact Lenses (P1fA) are daily disposable lenses indicated 
for the correction of astigmatism and associated ametropia in persons with non-diseased 
eyes. The purpose of this study is to evaluate the ocular physiological response following 
wear of DT1fA relative to P1fA as control.  
1.1. Name and Descriptions of Investigational Products  
The test lens in this study will be DT1fA. DT1fA contact lenses are made from a lens material 
that is 33% water and 67% (delefilcon A) polymer, a silicone containing hydrogel with added 
phosphatidylcholine. DT1fA lenses also contain a handling tint (color additive copper 
phthalocyanine). 
 
The control lens in this study will be P1fA. P1fA soft contact lenses are made from a lens 
material that is 51% water and 49% verofilcon A, a silicone containing hydrogel. The color 
additive Reactive Blue 247 is added to the lens material to create a light blue edge-to-edge 
color to make it easier to see when handling. In addition, P1fA lenses contain a benzotriazole 
UV-absorbing monomer to block UV radiation. The transmittance characteristics are less than 
1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 316 to 380 
nm for the entire power range. 
 
Further details about the test articles are found in section 6.1 of this protocol and in the DT1fA 
and P1fA package inserts (Appendix C). 
1.2. Intended Use of Investigational Products 
The intended use of the investigational products is the correction of astigmatism and associated 
myopic refractive error. Study lenses will be worn bilaterally in a daily wear, daily disposable 
modality for at least 8 hours per day. Each wear period will be 7±2 (i.e., 5 to 9) days in duration, 
and subjects will be instructed to wear lenses for at least 5 days per week during each wear 
period. Two wear periods will be completed, with a washout period of 7±2 days between the 
wear periods. 
1.3. Summary of Findings from Nonclinical Studies 
Not Applicable – marketed product only. 
1.4. Summary of Known Risks and Benefits to Human Subjects 
The anticipated clinical benefit of the investigational lenses will be the correction of refractive 
error. The risks associated with use of the investigational lenses are considered to be equivalent 
to those associated with other marketed soft contact lenses worn in the same modality (i.e., 
daily disposable).   
 
Comprehensive risk and benefit information regarding the study lenses are included in the 
DT1fA and P1fA package inserts (Appendix C). 
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1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Both DT1fA and P1fA are approved in the US for the correction of astigmatism and associated 
ametropia in persons with non-diseased eyes.  
 
For further details regarding literature references and prior data relevant to these lenses, refer 
to the DT1fA and P1fA package inserts (Appendix C). 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Primary Objective: 
To evaluate the incidence of grade 3 or higher biomicroscopy findings following a 7(±2) day 
wear period for DAILIES TOTAL1® for Astigmatism Contact Lenses (DT1fA) relative to 
PRECISION1® for Astigmatism Contact Lenses (P1fA) as control.  
 
Exploratory Objectives: 
To evaluate the subjective comfort, vision and handling, visual acuity, and rotational 
performance over a 7(±2) day wear period for DT1fA relative to P1fA as control. 
2.2. Endpoints  
Primary endpoint: 
x Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period  
 
Observational endpoints (efficacy): 
x Subjective comfort, vision, and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity in logMAR measured using 
ETDRS charts at follow-up 
x Lens orientation at 1 minute and 3 minutes following insertion at fitting 
x Mean and standard deviation of settled lens orientation calculated from repeated 
measures of settled lens orientation at fitting and follow-up visits  
 
Observational endpoints (safety): 
x Adverse events 
 
All endpoints will be summarized using descriptive statistics only; no confirmatory hypothesis 
testing is planned.   
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2.3. Hypotheses 
Not applicable; no confirmatory hypothesis testing for the primary endpoint is planned with 
respect to data collected in this study. Therefore, any hypothesis testing will be exploratory in 
nature. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
The target population for this study will be healthy adult soft contact lens wearers between 18 
and 39 years of age with binocular myopic astigmatism.   
3.2. Inclusion Criteria 
Potential subjects must satisfy all 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 between 18 and 39 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear soft contact lenses in both eyes in a daily reusable or 
daily disposable wear modality (i.e., not extended wear modality). Habitual wear is 
defined as a minimum of 6 hours of wear per day, for a minimum of 2 days per week 
during the past month. 
5. Possess a wearable pair of spectacles that provide correction for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. Have the spherical component of their vertex-corrected distance refraction must be 
between -0.875 to -4.625 DS (inclusive) in each eye. 
7. Have the magnitude of the cylindrical component of their vertex-corrected distance 
refraction between 0.625 DC and 1.625 DC in both eyes. 
8. Have the cylinder axis of their distance refraction between 165° and 15° (i.e., 180±15°, 
inclusive) or between 75° and 105° (i.e., 90±15°, inclusive) in each eye.   
9. Have best corrected monocular distance visual acuity of 20/30 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. 
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2. Be diabetic. 
3. Be currently using any ocular medications or have any ocular infection of any type. 
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of 
medication that might contraindicate or interfere with contact lens wear, or otherwise 
compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), 
contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), 
autoimmune disease (e.g., rheumatoid arthritis, Sjögren’s syndrome), or history of 
serious mental illness or seizures. See section 9.1 for additional details regarding 
excluded systemic medications.  
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or 
hybrid lenses (e.g., SynergEyes, SoftPerm) within the past 6 months. 
6. Be currently wearing monovision or multifocal contact lenses. 
7. Be currently wearing lenses in an extended wear modality. 
8. Have a history of strabismus or amblyopia. 
9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family 
member of an employee (including partner, child, parent, grandparent, grandchild or 
sibling of the employee or their spouse) of the clinical site. 
10. Have participated in a contact lens or lens care product clinical trial within 7 days prior 
to study enrollment. 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
11. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp 
findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or 
bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate 
contact lens wear or may otherwise compromise study endpoints (including entropion, 
ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, 
aphakia, moderate or above corneal distortion, herpetic keratitis).  
12. Have fluctuations in vision due to clinically significant dry eye or other ocular 
conditions.  
13. Have had or have planned (within the study period) any ocular or intraocular surgery 
(e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.). 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This will be a 4-visit, randomized, controlled, double-masked, bilateral wear, dispensing, 2×2 
crossover study. Each subject will be randomized into one of two unique sequences to wear 
two different study lenses one at a time over two wear periods (test followed by control or 
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control followed by test). During each wear period the lenses will be worn bilaterally for 1 
week (7r2 days) in a daily disposable modality. Study lenses will be worn for a minimum of 
8 hours per day and at least 5 days per week during the wear period. Subjective comfort, vision, 
and handling will be assessed using the CLUE questionnaire at both fitting and follow-up visits 
for each wear period. HLHC VA will be assessed at the follow-up evaluation using ETDRS 
charts. Ocular health will be assessed by slit lamp biomicroscopy and graded using the FDA 
grading scale at fitting and follow-up visits. There will be a washout period of 7(r2) days 
duration between wear periods. Subjects will not have access to the study lenses following 
completion of the protocol. 
 
4.2. Study Design Rationale 
A 2×2 crossover study design was chosen to allow each subject to act as their own active 
control. A washout period will be included to mitigate any carryover effects.  
 
The prescribed wear schedule (7r2 days, minimum of 8 hours per day, minimum of 5 days per 
week) was chosen as this is representative of a typical wear schedule for contact lens wearers. 
 
Slit lamp biomicroscopy was selected as the method for assessing ocular health, on the basis 
that it is the most commonly used instrument for comprehensive examination of the anterior 
eye. The FDA slit lamp findings classification scale was selected for grading ocular health on 
the basis that it is widely used and is part of the FDA regulatory guidance for contact lenses 
(FDA 510(k) guidance).  
 
The investigational lenses will be fitted by optometrists who are experienced at fitting toric 
soft contact lenses and will be evaluated by habitual contact lens wearers in their standard 
wearing environment.  
4.3. Enrollment Target and Study Duration 
This study will have an enrollment target of approximately 66 subjects, with a target of at least 
60 to complete.  The study will be conducted at up to 5 clinical sites, where the enrollment 
target for each site will be approximately 14 subjects. A subject will be considered enrolled 
upon signing of the informed consent form.   
 
There will be 4 visits in total per subject. The total study duration including the enrollment 
period is expected to be approximately 8 weeks. Subjects who are discontinued prior to the 
final evaluation may be replaced at the discretion of the study sponsor. The investigation will 
end at the time that the study data is hard locked. 
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5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
This study will be a randomized, double-masked, 2×2 crossover design. Subjects will be 
randomized into one of 2 unique sequence groups in a 1:1 allocation ratio to wear two different 
study lens designs (test and control designs) one at a time bilaterally over 2 wear periods.  
 
Use of the test articles will be randomized using a randomization scheme supplied by the study 
biostatistician.  The randomized assignment of subjects will be performed at the first visit prior 
to the first fitting. Clinical sites will follow the randomization scheme provided and will not 
pre-select or assign subjects. The following must have occurred prior to randomization: 
x Informed consent must have been obtained 
x The subject must have met all inclusion and exclusion criteria 
x The subject history and baseline information must have been collected 
 
Randomly permuted block randomization will be used to avoid bias in the assignment of 
subjects to treatment and to enhance the validity of statistical comparisons across treatment 
groups. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme (lens fitting schedule) to obtain the test article assignment for 
that subject prior to dispensing. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme (lens fitting schedule).  
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
5.2. Masking 
To reduce the possibility of bias, this will be a double-masked trial. Subjects will not be aware 
of the identity of the assigned lenses. The identity of the study lenses will be masked by having 
the blister packs labeled with the study number, lot number, sphere power, cylinder power, 
axis, expiration date and randomization code. While clinical trial personnel (including 
investigators, site technicians, data management, the study biostatistician, and clinical 
operations personnel) will be aware of the brand and type of lenses included in the study, every 
attempt will be made to ensure they are not made aware of the corresponding randomization 
codes for the test and control lenses. Only the unmasked Biostatistician generating the 
randomization scheme (lens fitting schedule) will have access to the decode information that 
allows matching of the randomization codes to the investigational articles. The medical 
monitor will also have access to the decode information in case breaking the mask is necessary 
for the urgent medical treatment of a subject. 
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5.3. Procedures for Maintaining and Breaking the Masking 
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 at the 
discretion of the study sponsor. 
6. STUDY INTERVENTION 
6.1. Identity of Test Articles  
The following contact lenses will be used in this study: 
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x completed all visits through the final visit (visit 4).    
x If all visits were completed but an additional visit is considered necessary for subject 
care, follow the requirements for unscheduled visits in section 7.3. 
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
x Subject withdrawal of consent. 
x Subject not compliant to protocol. 
x Subject lost to follow-up. 
x Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x Subject develops significant or serious adverse events necessitating discontinuation of 
study lens wear. 
x Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x Subject misses any study visits. 
x Subject not compliant with study lens wear schedule. 
x Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit. 
 
For discontinued subjects, the Investigator will: 
x Complete the current visit (scheduled or unscheduled). 
x Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study. 
x Record the spherocylindrical refraction with best corrected distance visual acuity. 
x Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in section 7.2. 
x Collect all unused test article(s) from the subject. 
x Make arrangements for subject care, if needed, due to their study participation. 
 
Additional subjects 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 concomitant interventions for this study include ocular medications of any kind, 
or any systemic medications that would normally contraindicate contact lens wear or may 
otherwise compromise study endpoints. 
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JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).” 
x Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site. 
x Lens replacements that occur due to drops/fall-outs. 
x Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
x Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x Who received the complaint. 
x Study number. 
x Clinical site information (contact name, site ID, telephone number). 
x Lot number(s). 
x Unique Subject Identifier(s). 
x Indication of who first observed complaint (site personnel or subject). 
x OD/OS indication, along with whether the lens was inserted. 
x Any related AE number if applicable. 
x Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
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x Eye Care Provider objective (slit lamp) findings if applicable. 
x Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also 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: 
x Death 
x Serious deterioration in the health of the subject that resulted in any of the following: 
x Life-threatening illness or injury 
x Permanent or persistent impairment of a body structure or a body function 
x Hospitalization or prolongation of patient hospitalization 
x Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
x Chronic disease 
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x Foetal distress, foetal death or a congenital physical or mental impairment of birth 
defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of > 2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
x Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x Asymptomatic Corneal Scar 
x Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x Non-significant Infiltrative Event (NSIE) 
x Contact Lens Papillary Conjunctivitis (CLPC) 
x Superficial Punctate Keratitis (SPK) 
x Conjunctivitis: Bacterial, Viral, Allergic 
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x Blepharitis 
x Meibomianitis 
x Contact Dermatitis 
x Localized Allergic Reactions 
x Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuatioQZHHNV 
 
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: 
x Seriousness/Classifications (see definition in section 13.1). 
x Causality or Relatedness – i.e., the relationship between the test article, study treatment 
or study procedures, and the adverse event (not related, unlikely related, possibly 
related, or related - see definition in section 13.2.1). 
x Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild, moderate, or severe - see definition in section 0). 
x Outcome – not recovered or not resolved, recovering or resolving, recovered or 
resolved with sequelae, recovered or resolved, death related to adverse event, or 
unknown. 
x Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures. 
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x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g., concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g., 
concomitant treatment, concomitant disease(s), is inconclusive. The relationship in 
time is reasonable. Therefore, the causal relationship cannot be excluded. 
x Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g., 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g., it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x Mild – Event is noticeable to the subject but is easily tolerated and does not interfere 
with the subject’s daily activities. 
x Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities. 
x Severe – Event is intolerable, necessitates additional therapy or alteration of therapy, 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment, or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study, it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs and complete the Adverse Event eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
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x Adverse event (diagnosis not symptom). 
x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted (where appropriate), including concomitant medications 
prescribed, in accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event, if the AE is related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or 
study procedures (whether related to the visual system or not), an AE review form 
 
must be completed. Additional dated and initialed entries should be made at follow-up 
evaluations. Separate forms must be completed for each eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
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13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail or telephone, but no later than 24 hours 
following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
x Notify the Sponsor immediately. 
x Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject. 
x Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article. 
x Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations. 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
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13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
 
 
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14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).5 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
 
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables, and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation (SD), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
14.2. Sample Size Justification 
Approximately 66 subjects will be enrolled in this study to attain a minimum of 60 completed 
subjects. All endpoints will be summarized using descriptive statistics only; no confirmatory 
hypotheses will be tested. This is a descriptive study to evaluate the clinical performance of 
the DT1fA and P1fA lenses. Sample size is not based on the empirical power analysis. The 
data collected for this study may be used for designing future studies if applicable. 
14.3. Analysis Populations 
Safety Population: 
All subjects who are 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 successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock. 
Justification for the exclusion of subjects with protocol deviations from 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 the 
study or deviation from the protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
No confirmatory hypothesis testing is planned for this study; hence, the level of statistical 
significance is not applicable. All planned analyses for this study will be descriptive. 
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14.5. Primary Analysis 
Descriptive summary tables by Lens Type (DT1fA vs. P1fA) for the following safety and 
efficacy endpoints will be provided.  
x Incidence of grade 3 or higher biomicroscopy findings using the FDA grading scale 
following a 7(±2) day wear period 
14.6. 2.30Secondary Analysis  
Not applicable. 
14.7. Other Exploratory Analysis  
Descriptive summary tables by Lens Type (DT1fA vs. P1fA) for the following exploratory 
endpoints will be provided: 
x Subjective comfort, vision, and handling at fitting and following a 7(±2) day wear 
period using the CLUE questionnaire 
x High-luminance, high-contrast (HLHC) visual acuity in logMAR measured using 
ETDRS charts at follow-up 
x Lens orientation at 1 minute and 3 minutes following insertion at fitting 
x Mean and standard deviation of settled lens orientation calculated from repeated 
measures of settled lens orientation at fitting and follow-up visits 
Other exploratory analyses will be determined after reviewing the descriptive summary at the 
discretion of the study responsible clinician and project team. They may be performed on study 
endpoints between lens type (DT1fA vs. P1fA) or on endpoints collected in previous JJVC-
sponsored studies to generate hypotheses for future confirmatory studies. 
14.8. Interim Analysis 
Not applicable. 
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 the 
BioClinica EDC system. An authorized data originator will enter study data into the eCRFs 
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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.  
 
No external data sources will be included in this study. 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x subject identification 
x eligibility 
x study identification 
x study discussion 
x provision of and date of informed consent 
x visit dates 
x results of safety and efficacy parameters as required by the protocol 
x a record of all adverse events 
x follow-up of adverse events 
x medical history and concomitant medication 
x test article receipt/dispensing/return records 
x date of study completion 
x reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
 
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15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, including 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. 
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17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
x Ensuring that the investigation is being conducted according to the protocol, any 
subsequent versions, and regulatory requirements are maintained. 
x Ensuring the rights and wellbeing of subjects are protected. 
x Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel. 
x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test articles and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study, and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Subjects will only be enrolled if the subject is fully 
able to understand the risks, benefits, and potential adverse events of the study and provide 
their consent voluntarily. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, section 4 of the ICH E6(R2) 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with section 8 of the ICH E6(R2) guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x Final protocol. 
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x Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects). 
x Investigator’s Brochure (or equivalent information). 
x Sponsor-approved subject recruitment materials. 
x Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
x Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects. 
x Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x Protocol revisions 
x Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
x If applicable, new or revised subject recruitment materials approved by the Sponsor 
x Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
x Investigator’s Brochure revisions  
x Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
x Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
x New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x Major protocol deviations as required by the IEC/IRB 
x Report of deaths of subjects under the Investigator's care 
x Notification if a new Investigator is responsible for the study at the clinical site 
x Any other requirements of the IEC/IRB 
 
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. 
 
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At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject or their representative must give written consent according to local requirements 
after the nature of the study has been fully explained. The consent form must be signed before 
performance of any study-related activity. The consent form that is used must be approved by 
both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki,3 current ICH GCP2 and ISO 
14155:20201 guidelines, applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA)6 and 
other applicable personal data protection and security laws and regulations. Appropriate 
measures will be employed to safeguard these data, to maintain the confidentiality of the 
person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to 
their personal data and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
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These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x processed fairly and lawfully. 
x collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes. 
x adequate, relevant, and not excessive in relation to said purposes. 
x accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
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If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
x Continuing an ineligible subject in the study. 
x Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x Query resolution. 
x Case Report Form signature. 
x Completion of any follow-up action items. 
21. PUBLICATION 
There is no plan to publish the outcome of this investigation. 
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html 
2. International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). 
Available at: https://www.ich.org/page/efficacy-guidelines 
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. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute 
Inc. 
6. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
A Patient Instruction Guide (PIG) will be provided separately.  
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
Alcon DAILIES TOTAL1® for Astigmatism (delefilcon A) soft contact lenses for Daily 
Disposable Wear. 
 
Alcon PRECISION1® for Astigmatism (verofilcon A) soft contact lenses for Daily Disposable 
Wear. 
 
 
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APPENDIX D: 
 
 
x 
 LENS FITTING CHARACTERISTICS 
x 
 SUBJECT REPORTED OCULAR SYMPTOMS 
x 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS  
x 
 BIOMICROSCOPY SCALE  
x 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
x 
 TORIC FIT EVALUATION 
x 
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE 
x 
 PATIENT REPORTED OUTCOMES 
x 
 LENS INSERTION AND REMOVAL 
x 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
 
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 LENS FITTING CHARACTERISTICS 
 
 
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Title:                          Lens Fitting Characteristics 
Document Type:       
 
Document Number:  
 
Revision Number:  6 
Page 5 of 5 
 
 
 
 
 
 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS  
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error 
Document Type:        
 
Document Number:  
 
Revision Number:  5 
Page 2 of 5 
 
  
 
 
 
 
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 BIOMICROSCOPY SCALE  
 
 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
 
 
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Clinical Study Protocol 
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 TORIC FIT EVALUATION 
 
 
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Clinical Study Protocol 
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 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 PATIENT REPORTED OUTCOMES 
 
 
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Clinical Study Protocol 
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LENS INSERTION AND REMOVAL 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
APPENDIX E: 
GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6493 Clinical Evaluation of Delefilcon A and Verofilcon A 
Daily Disposable Toric Soft Contact Lenses Over One Week of Wear 
Version and Date: 1.0 22 July 2022 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155:2020,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk 
mitigation, (COVID-19 Work Instruction in the Appendix E of this protocol). I agree to 
conduct this study in compliance with local, state, governmental guidance for COVID-19 risks. 
Principal Investigator: 
Signature 
Date 
Name and Professional Position (Printed) 
Institution/Site: 
Institution/Site Name 
Institution/Site Address 
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