Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of Wear
Phase: NA
Conditions: Ocular Physiology
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over Two Weeks of 
Wear 
 
Protocol CR-6553  
 
Version: 3.0  
                            
Date: 27 November 2023   
 
 
Investigational Products: The Test product will be rotationally stabilized, astigmatic, soft contact lenses in 
senofilcon A with a chromophore to filter High-Energy Visible Light (HEVL). The Control product will be Alcon 
DAILIES TOTAL1® for Astigmatism Daily Contact Lenses (DT1fA). 
 
Keywords: Astigmatism, toric contact lenses, senofilcon A, RTY-1 chromophore, High-Energy Visible Light, 
Alcon DAILIES TOTAL1® for Astigmatism, delefilcon 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, rotational 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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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE.................................................................................... 6 
SPONSOR NAME AND ADDRESS ..................................................................................................................... 6 
MEDICAL MONITOR .......................................................................................................................................... 6 
AUTHORIZED SIGNATURES ............................................................................................................................. 7 
CHANGE HISTORY ............................................................................................................................................. 8 
SYNOPSIS ............................................................................................................................................................. 9 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS .......................... 14 
1. 
INTRODUCTION AND BACKGROUND ................................................................................................ 15 
1.1. 
Name and Descriptions of Investigational Products ........................................................................... 15 
1.2. 
Intended Use of Investigational Products............................................................................................ 15 
1.3. 
Summary of Findings from Nonclinical Studies ................................................................................. 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .............................................................. 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study .......... 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ................................................................... 16 
2.1. 
Objectives ........................................................................................................................................... 16 
2.2. 
Endpoints ............................................................................................................................................ 16 
2.3. 
Hypotheses .......................................................................................................................................... 17 
3. 
TARGETED STUDY POPULATION ....................................................................................................... 17 
3.1. 
General Characteristics ....................................................................................................................... 17 
3.2. 
Inclusion Criteria ................................................................................................................................ 17 
3.3. 
Exclusion Criteria ............................................................................................................................... 18 
3.4. 
Enrollment Strategy ............................................................................................................................ 18 
4. 
STUDY DESIGN AND RATIONALE ...................................................................................................... 18 
4.1. 
Description of Study Design ............................................................................................................... 18 
4.2. 
Study Design Rationale ....................................................................................................................... 19 
4.3. 
Enrollment Target and Study Duration ............................................................................................... 19 
5. 
TEST ARTICLE ALLOCATION AND MASKING ................................................................................. 19 
5.1. 
Test Article Allocation ........................................................................................................................ 19 
5.2. 
Masking .............................................................................................................................................. 20 
5.3. 
Procedures for Maintaining and Breaking the Masking ...................................................................... 20 
6. 
STUDY INTERVENTION ......................................................................................................................... 20 
6.1. 
Identity of Test Articles ...................................................................................................................... 20 
6.2. 
Ancillary Supplies/Products ................................................................................................................ 21 
6.3. 
Administration of Test Articles ........................................................................................................... 22 
6.4. 
Packaging and Labeling ...................................................................................................................... 22 
6.5. 
Storage Conditions .............................................................................................................................. 22 
6.6. 
Collection and Storage of Samples ..................................................................................................... 22 
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6.7. 
Accountability of Test Articles ........................................................................................................... 22 
7. 
STUDY EVALUATIONS .......................................................................................................................... 23 
7.1. 
Time and Event Schedule ................................................................................................................... 23 
7.2. 
Detailed Study Procedures .................................................................................................................. 25 
VISIT 1 ....................................................................................................................................................... 25 
VISIT 2 ....................................................................................................................................................... 31 
VISIT 3 ....................................................................................................................................................... 33 
VISIT 4 ....................................................................................................................................................... 35 
VISIT 5 ....................................................................................................................................................... 35 
VISIT 6 ....................................................................................................................................................... 35 
FINAL EVALUATION .............................................................................................................................. 37 
7.3. 
Unscheduled Visits ............................................................................................................................. 37 
7.4. 
Laboratory Procedures ........................................................................................................................ 38 
8. 
SUBJECTS COMPLETION/WITHDRAWAL .......................................................................................... 39 
8.1. 
Completion Criteria ............................................................................................................................ 39 
8.2. 
Withdrawal/Discontinuation from the Study ...................................................................................... 39 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .............................................. 39 
9.1. 
Systemic Medications ......................................................................................................................... 39 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................................................. 40 
11. 
STUDY TERMINATION........................................................................................................................... 41 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS.............................................. 42 
13. 
ADVERSE EVENTS .................................................................................................................................. 43 
13.1. 
Definitions and Classifications ........................................................................................................... 43 
13.2. 
Assessing Adverse Events .................................................................................................................. 44 
13.2.1. 
Causality Assessment............................................................................................................. 45 
13.2.2. 
Severity Assessment .............................................................................................................. 45 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................................................ 45 
13.4. 
Reporting Adverse Events .................................................................................................................. 46 
13.4.1. 
Reporting Adverse Events to Sponsor ................................................................................... 46 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities ................... 47 
13.5. 
Event of Special Interest ..................................................................................................................... 47 
13.6. 
Reporting of Pregnancy ...................................................................................................................... 47 
14. 
STATISTICAL METHODS ....................................................................................................................... 48 
14.1. 
General Considerations ....................................................................................................................... 48 
14.2. 
Sample Size Justification .................................................................................................................... 48 
14.3. 
Analysis Populations ........................................................................................................................... 48 
14.4. 
Level of Statistical Significance.......................................................................................................... 49 
14.5. 
Primary Analysis ................................................................................................................................. 49 
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14.6. 
Secondary Analysis ............................................................................................................................. 49 
14.7. 
Exploratory Analyses .......................................................................................................................... 49 
14.8. 
Interim Analysis .................................................................................................................................. 50 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................................................ 50 
14.10. Procedure for Reporting Deviations from Statistical Plan .................................................................. 50 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................................................... 50 
15.1. 
Electronic Case Report Form/Data Collection .................................................................................... 50 
15.2. 
Subject Record .................................................................................................................................... 51 
15.3. 
Trial Registration on ClinicalTrials.gov.............................................................................................. 51 
16. 
DATA MANAGEMENT ............................................................................................................................ 51 
16.1. 
Access to Source Data/Document ....................................................................................................... 51 
16.2. 
Confidentiality of Information ............................................................................................................ 51 
16.3. 
Data Quality Assurance ...................................................................................................................... 51 
16.4. 
Data Monitoring Committee (DMC) .................................................................................................. 52 
17. 
CLINICAL MONITORING ....................................................................................................................... 52 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................................................ 52 
18.1. 
Study-Specific Design Considerations ................................................................................................ 52 
18.2. 
Investigator Responsibility ................................................................................................................. 52 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) ......................................... 53 
18.4. 
Informed Consent ................................................................................................................................ 53 
18.5. 
Privacy of Personal Data ..................................................................................................................... 54 
19. 
STUDY RECORD RETENTION ............................................................................................................... 55 
20. 
FINANCIAL CONSIDERATIONS............................................................................................................ 55 
21. 
PUBLICATION .......................................................................................................................................... 55 
22. 
REFERENCES ........................................................................................................................................... 55 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ................................... 57 
APPENDIX B: PATIENT INSTRUCTION GUIDE  .......................................................................................... 79 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................................................... 80 
APPENDIX D: 
..................................................................... 83 
 LENS FITTING CHARACTERISTICS ............................................................................................ 84 
 SUBJECT REPORTED OCULAR SYMPTOMS ............................................................................. 90 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS......................... 92 
 BIOMICROSCOPY SCALE ............................................................................................................. 98 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ................................... 104 
 TORIC FIT EVALUATION ............................................................................................................ 109 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE ............................ 114 
 PATIENT REPORTED OUTCOMES ............................................................................................ 118 
 LENS INSERTION AND REMOVAL ........................................................................................... 120 
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 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION TESTING ............. 123 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ...................................................... 132 
 
LIST OF TABLES 
Table 1: Test Articles ........................................................................................................................................... 21 
Table 2: Ancillary Supplies .................................................................................................................................. 21 
Table 3: Time and Events ..................................................................................................................................... 23 
Table 4: Disallowed systemic medications ........................................................................................................... 40 
Table 5: Disallowed systemic antihistamines ....................................................................................................... 40 
Table 6: Examples of major and minor protocol deviations ................................................................................. 41 
Table 7: Half-Width of the 95% Confidence Intervals for Proportion of Eyes with Grade 3+ SLFs ................... 48 
 
LIST OF FIGURES 
Figure 1: Study Flowchart .................................................................................................................................... 13 
 
 
 
 
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Clinical Study Protocol 
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SYNOPSIS  
Protocol Title 
Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft 
Contact Lenses Over Two Weeks of Wear 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Clinical Trial Phase: Confirmatory  
Design control phase: Confirmatory phase, phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov by the Sponsor. 
Test Articles 
Investigational Product (Test lens): The test product will be rotationally 
stabilized astigmatic soft contact lenses in senofilcon A with a chromophore 
to filter High-Energy Visible Light (HEVL). 
Approved Product (Control lens): The control product will be DAILIES 
TOTAL1® for Astigmatism Contact Lenses (DT1fA). 
Wear and Replacement 
Schedules 
Wear Schedule: Daily wear 
Replacement Schedule: Daily disposable 
Objectives  
Primary Objective: 
The primary objective of this study is to estimate the incidence rate 
(percentage) of eyes with clinically significant slit-lamp findings (Grade 3 
or 4) related to each study lens (Test lens and Control lens) after 
approximately 2-weeks of lens wear.  
 
Exploratory Objectives: 
The exploratory objectives of this study include the estimation of the mean 
difference between study lenses (Test lens and Control lens) with respect to 
distance monocular high luminance, high contrast (HLHC), logMAR visual 
acuity (at the 1-week follow-up visit), and CLUE comfort, vision, and 
handling scores (at the fitting, 1- and 2-week follow-up visits). Additional 
exploratory objectives of the study are to estimate the mean and standard 
deviation of the mean settled toric orientation of each study lens (Test lens 
and Control lens) following lens settling and after 1- and 2-weeks of lens 
wear, and to assess the toric lens orientation of each study lens, 1- and 3-
minutes after lens insertion. Adverse events will also be monitored and 
collected.  
 
Study Endpoints 
Primary endpoint: 
x 
Indicidence (percentage) of eyes with Grade 3 or 4 slit lamp 
findings related to the study lenses (Test lens and Control lens) 
after 2-week of lens wear. 
 
Exploratory endpoints: 
x 
Distance Monocular HLHC logMAR at 4m at the 1-week follow-
up visit 
x 
Contact Lens User Experience (CLUE) comfort scores at the 
fitting, 1-, and  2-week follow-up visits  
x 
CLUE vision scores at the fitting, 1-, and  2-week follow-up visits   
x 
CLUE handling scores at the fitting, 1-, and  2-week follow-up 
visits   
x 
Lens orientation at 1 minute and 3 minutes following insertion at 
fitting 
x 
Mean Settled Lens Orientation at the fitting, 1-, and 2-week follow-
up visits  
x 
Adverse events 
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Study Design 
This will be a multi-site, bilateral, dispensing, randomized, controlled, 
double-masked, 2×2 crossover study. Eligible subjects will be randomly 
assigned to one of two lens wear sequences (Test/Control or Control/Test). 
Each lens will be worn for a period of 14(±4) days. There will be a 7(±2) 
days washout period between study lenses.  
 
There will be a total of 6 visits: 
Visit 1: Screening, baseline evaluation and lens fit #1  
Visit 2: Follow-up evaluation #1 (for first lens dispensed) 
Visit 3: Follow-up evaluation #2 (for first lens dispensed) 
Visit 4: Continuance, lens fit #2 
Visit 5: Follow-up evaluation #3 (for second lens dispensed) 
Visit 6: Follow-up evaluation #4 (for second lens dispensed) 
 
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 10 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). 
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 four weeks. 
5. Possess a wearable pair of spectacles that provide correction for 
distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
6. In both eyes, have refractive error suitable for correction with the toric 
contact lens powers available in this study: 
a. 
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 
b. 
Cylinder powers (DC) -0.75 and -1.25 
c. 
Axes (°) 170, 180, 10, 80, 90, 100 
7. 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.  
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. 
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Measurements and Procedures 
The key procedures associated with the endpoints for this study will be: 
- Examination of the anterior segment using a slit lamp biomicroscope and 
grading findings using the FDA grading scale 
- Measurement of HLHC VA using ETDRS charts  
- Measurement of toric lens orientation and rotational stability using a slit 
lamp biomicroscope 
- Overseeing completion of the CLUE questionnaires 
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 PRO 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 
Post-fit PRO questionnaire 
Additional samples of toric lens orientation  
Lenses dispensed for 7r2 days 
Follow-up (#1 and #3) 
Subjects must wear study OHQVHVIRUKUSULRUWRYLVLW 
Follow-up PRO questionnaire 
HLHC visual acuity using ETDRS charts 
Record lens orientation 
Lens removal 
Biomicroscopy 
Lenses dispensed for 7r2 days 
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 #2 
After follow-up #4
Washout Period 
A washout period of 7r2 days 
duration will be observed between 
wear periods 
Follow-up (#2 and #4) 
6XEMHFWVPXVWZHDUVWXG\OHQVHVIRUKUSULRUWRYLVLW 
Follow-up PRO questionnaire 
Record lens orientation 
Additional samples of toric lens orientation  
Lens removal 
Biomicroscopy 
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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 
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 
HEVL  
 
High Energy Visible Light 
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 
SLF 
 
 
Slit Lamp Finding 
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) are single-use, 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 a daily disposable, toric lens design in 
senofilcon A incorporating a HEVL-filtering chromophore (RTY-1) relative to DT1fA as Control. 
1.1. 
Name and Descriptions of Investigational Products  
The Test lens in this study will be a toric contact lens design in senofilcon A containing a HEVL-filtering 
chromophore (RTY-1). 
 
The Control 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). 
 
Further details about the Test and Control articles are found in section 6.1 of this protocol, the Investigator’s 
Brochure4 and in the DT1fA package insert (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 14±4 (i.e., 10 to 18) 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 
All previous pre-clinical findings for the test lens were deemed satisfactory prior to proceeding with clinical trials 
on humans. For the most comprehensive nonclinical information regarding the test design refer to the 
Investigator's Brochure.4  
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. No adverse 
device effects are anticipated. The risks associated with use of the investigational lenses are considered to be the 
same as those for other marketed soft contact lens worn in the same modality (i.e., daily disposable wear). No 
additional risks associated with participation in this investigation are anticipated.  
 
Comprehensive risk and benefit information regarding the investigational (test lens) design and the DT1fA control 
lens are included in the Investigator's Brochure4 and the DT1fA package insert (Appendix C), respectively.  
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
Prototype toric lens designs featuring the RTY-1 chromophore have previously been evaluated in several JJVC-
sponsored clinical trials. Safety data from these trials suggest the investigational lenses have a safety profile 
equivalent to currently marketed soft contact lens products; a review of literature references and prior clinical 
data related to the test designs is given in the Investigator’s Brochure.4  
 
DT1fA contact lenses are approved in the US for the correction of astigmatism and associated ametropia in 
persons with non-diseased eyes. For further details regarding the DT1fA control lens, refer to the DT1fA package 
insert (Appendix C). 
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2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. 
Objectives  
Primary Objective: 
The primary objective of this study is to estimate the incidence rate (percentage) of eyes with clinically significant 
slit-lamp findings (Grade 3 or 4) related to each study lens (Test lens and Control lens) after approximately 2-
weeks of lens wear.  
 
Exploratory Objectives: 
The exploratory objectives of this study include the estimation of the mean difference between study lenses (Test 
lens and Control lens) with respect to distance monocular high luminance, high contrast (HLHC), logMAR visual 
acuity (at the 1-week follow-up visit), and CLUE comfort, vision, and handling scores (at the fitting, 1- and 2-
week follow-up visits). Additional exploratory objectives of the study are to estimate the mean and standard 
deviation of the settled toric roation of each study lens (Test lens and Control lens) following lens settling and 
after 1- and 2-weeks of lens wear, and to assess the toric lens orientation of each study lens, 1- and 3-minutes 
after lens insertion. Adverse events will also be monitored and collected.  
 
2.2. 
Endpoints  
Primary endpoint: 
 
1. Percentage of Eyes with slit-lamp findings (Grade 3 or 4) related to study lens wear  
Slit Lamp Findings (Grade 3 or higher) will be assessed for each subject eye at all study visits (scheduled and 
unscheduled). However, the primary endpoint will be the percentage of eyes with Grade 3 or higher SLFs related 
to study lens wear, after approximately 2 weeks of lens wear.  
SLFs will be evaluated and classified using the FDA Grading scale rating from 0 to 4, where Grade 0 represents 
the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1=trace, Grade 2= mild, 
Grade 3=moderate and Grade 4= severe).  
 
Exploratory Endpoints: 
 
1. Distance Monocular HLHC logMAR Visual Acuity  
Visual acuity (VA) will be assessed monocularly at the 1-week follow-up visits under high-luminance 
high contrast (HLHC) conditions at a test distance of 4 meters using ETDRS Charts. The logMAR VA 
score is a continuous endpoint. 
 
2. CLUE Comfort Scores 
Subjective comfort will be assessed using the Contact Lens User Experience (CLUE) questionnaire. 
CLUE will be assessed at the fitting, 1- and 2-week follow-up visits. The CLUE comfort score is a 
conintuous endpoint.  
 
CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of 
soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing 
population in the US, ages 18-65.  Derived CLUE™ scores using Item Response Theory (IRT) follow a 
normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more 
favorable/positive response with a range of 0-120.  A 5-point increase in an average CLUE™ score 
translates into 10% shift in the distribution of scores for population of soft contact lens wearers.5  
 
3. CLUE Vision Scores at the fitting, 1-, and  2-week follow-up visits. The CLUE vision score is a 
conintuous endpoint.  
 
4. CLUE Handling Scores at the fitting, 1-, and  2-week follow-up visits. The CLUE handling score is a 
conintuous endpoint.  
  
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5. Toric Lens Orientation  
Toric lens orientation (scribe mark position relative to 6 o’clock) will be assessed for each eye at 1, 3 
and at least 15 minutes after lens insertion at the fitting visit, and at the 1- and 2-week follow-up visits. 
However, toric lens orientation at 1- and 3-minutes after lens insertion at the fitting visit is the 
exploratory endpoint. The endpoint is the distribution (counts, percentages) of eyes for the toric 
Orientation (in degrees).  
 
6. Mean Settled Lens Orientation 
Lens orientation (scribe mark position relative to 6 o’clock) will be assessed for each eye at 1 minute, 3 
minutes, at least 15 minutes after lens insertion; 2 additional measurements per eye following settling 
will also be collected. The exploratory endpoint is the lens orientation assessed at the fitting, 1-, and 2-
week follow-up visits. Mean settled lens orientation is a continuous response where the mean is 
calculated by eye by averaging across all lens orientation measurements collected at least 15-minutes 
after lens insertion. The standard deviation of average settled lens orientation will also be calculated. See 
 in Appendix D for details regarding the collection of lens orientation. 
  
7. Adverse events (AEs) - including ocular and non-ocular. Details for AEs will be provided through 
listings.  
 
2.3. 
Hypotheses 
Not applicable, there is no planned hypothesis testing for any endpoints in this study.   
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 four weeks. 
5. Possess a wearable pair of spectacles that provide correction for distance vision. 
 
Inclusion Criteria at Baseline Evaluation 
The subject must: 
 
6. In both eyes, have refractive error suitable for correction with the toric contact lens powers available in 
this study: 
a. 
Sphere powers (DS) -1.50 through -4.00 in 0.25 steps 
b. 
Cylinder powers (DC) -0.75 and -1.25 
c. 
Axes (°) 170, 180, 10, 80, 90, 100 
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7. 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. 
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 mulit-site, 6-visit, randomized, controlled, double-masked, bilateral wear, dispensing  2×2 
crossover study.  
 
At the initial visit (Visit 1),  if a subject is deemed eligible, the subject will be randomized into one of two unique 
sequences of lens wear (Test/Control or Control/Test), otherwise, the subject will be deemed ineligible and exited 
from the study.  
 
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Subjects will wear each study lens (Test lens and Control lens) in a daily wear, daily disposable modality for 
approximately 2 weeks. There will be a washout period of 7r2 days between wear periods. Subjects will not have 
access to the study lenses following completion of the protocol.  
 
Subjects will be advised to wear the study lenses for a minimum of 8 hours per day for at least 5 days during each 
wear period. Unscheduled visits may be conducted, if appropriate, and lost or damaged lenses may be replaced 
when necessary.  
 
4.2. 
Study Design Rationale 
A 6-visit, double-masked, 2×2 crossover study design was chosen to demonstrate the study objectives. In this 
design, each subject will act as their own control to reduce the influence of potential confounding factors such as 
age, gender, race, and vision correction. To help further reduce the potential for carryover effects, a washout 
period of approximately 1-week (7±2 days) between study will be used. 
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 6 clinical sites, where the enrollment target for each site will be approximately 
11 subjects. A subject will be considered enrolled upon signing of the informed consent form.  
 
There will be 6 visits in total per subject. The total study duration including the enrollment period is expected to 
be approximately 10 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. 
5. 
TEST ARTICLE ALLOCATION AND MASKING 
5.1. 
Test Article Allocation  
 The study lenses will be worn bilaterally in a randomized fashion using a 2×2 crossover design with 2 lens types 
and 2 periods.  
 
A computer-generated randomization scheme will be used to randomly assign subjects to one of two unique 
sequences of lens wear. The randomization scheme will be provided by an internal independent unmasked 
Biostatistician who is independent of the study team and not involved in the study conduct or analyses, beyond 
the randomization codes and schedule generation. The randomization scheme will be generated using the PROC 
PLAN procedure from Statistical Analysis System (SAS) Software Version 9.4 or higher (SAS Institute, Cary, 
NC).6  
 
The assignment of subjects will be performed at the first visit prior to the first fitting. Clinical sites must follow 
the randomization scheme provided. 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 
 
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. 
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5.2. 
Masking 
To reduce the possibility of bias, this will be a double-masked trial. Subjects and investigators and clinical site 
personel will not be aware of the identity of the assigned lenses. While every effort will be made to maintain 
masking of study investigators, due to differences in the lens designs, it is possible that investigators may 
determine the identity of the designs during study procedures. 
5.3. 
Procedures for Maintaining and Breaking the Masking 
Every attempt will be made to keep the clinical trial personnel involved in the study (e.g., data management, 
project biostatistician, and clinical operations) unaware of the identity of the assigned study 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. During study execution, only the 
independent unmasked biostatistician generating the lens fitting schedule will have access to the decode 
information that allows matching of the randomization codes to the test 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. All personnel involved in the study will be unmasked once the study database is locked. 
 
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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6.3. 
Administration of Test Articles 
Test articles will be dispensed to subjects meeting all eligibility requirements, including any dispensing 
requirements set forth in this clinical protocol. Subjects will be dispensed an adequate supply of test articles to 
complete the study. Lost or damaged test articles may be replaced at the discretion of the investigator and/or the 
sponsor.  
6.4. 
Packaging and Labeling 
The test articles will be supplied in blister packages as the primary packaging and placed into plastic bags as 
secondary packaging. Test and Control blister packages will be physically over-labeled with permanent labels. 
Representative sample labels for the primary and secondary packaging are shown below:  
 
Primary Packaging 
Secondary Packaging 
 
 
6.5. 
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must be kept under secure 
conditions. 
6.6. 
Collection and Storage of Samples 
No samples will be collected as part of the study procedures. When possible, any lens or test article associated 
with an Adverse Event and/or a Product Quality Complaint must be retained and stored in a glass vial with 
moderate solution pending directions from the sponsor for potential return to JJVC. 
6.7. 
Accountability of Test Articles 
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to complete the 
investigation. The Investigator is asked to retain all lens shipment documentation for the test article accountability 
records.  
 
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the Investigator for 
dispensing. The Investigator may delegate this activity to authorized study site personnel listed on the Site 
Delegation Log. All test articles must be accounted for. This includes: 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued for the subject to 
replace appropriately between visits.  
2. What was returned to the Investigator unused, including expired or malfunctioning product. 
3. The number and reason for unplanned replacements. 
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8. 
SUBJECTS COMPLETION/WITHDRAWAL  
8.1. 
Completion Criteria 
Subjects are considered to have completed the study if they:  
x 
provided informed consent. 
x 
they are eligible. 
x 
have not withdrawn/discontinued from the study for any reason described in section 8.2. 
x 
completed all visits through the final visit (visit 6).  
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. 
9.1. 
Systemic Medications 
Certain systemic medications are known to have a higher likelihood to interfere with contact lens wear, chiefly 
by disrupting the tear film.  
 
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The Sponsor will determine when a study will be stopped. The Principal Investigator always has the discretion to 
initiate stopping the study based on patient safety or if information indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the IEC/IRB reserves the 
right to terminate the study if an unreasonable risk is determined. The study can be terminated by the Principal 
Investigator at the individual clinical site due to specific clinical observations, if in their opinion, after a discussion 
with JJVC, it is determined that it would be unwise to continue at the clinical site. 
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is determined that an adverse 
event presents an unreasonable risk, the investigation, or that part of the investigation presenting the risk, will be 
terminated as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will notify the IEC/IRB and 
Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of test 
articles after they have been released for clinical trial use.  
 
Potential complaints may come from a variety of sources including but not limited to subjects, clinical research 
associates (CRA), clinical operations managers (COM), medical monitors, and site personnel, etc. The following 
are not considered product quality complaints: 
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.). 
x 
Eye Care Provider objective (slit lamp) findings if applicable. 
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x 
Confirmation of product availability for return (and tracking information, if available), or rationale if 
product is not available for return 
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel to determine if it is 
an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint results in an AE/SAE, the COM/CRA, or 
trained site personnel will follow section 13 of this protocol. If the AE/SAE was potentially the result of a product 
quality related deficiency, these procedures also apply and will be executed in parallel.  
 
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the PQC forms will be 
marked “Intentionally Left Blank” or “ILB.” Justification for ILB must be documented. 
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related 
to the investigational medical device.”  
Note: This definition includes events related to the investigational medical device or the comparator, and to the 
procedures involved. For users or other persons, this definition is restricted to events related to investigational 
medical devices.  
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of the study. 
2. Was present prior to the study but worsened during the study. This would include any condition resulting 
from concomitant illnesses, reactions to concomitant medications, or progression of disease states. 
Note: Pregnancy must be documented as an adverse event and must be reported to the clinical monitor and to the 
Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x 
Death 
x 
Serious deterioration in the health of the subject that resulted in any of the following: 
x 
Life-threatening illness or injury 
x 
Permanent or persistent impairment of a body structure or a body function 
x 
Hospitalization or prolongation of patient hospitalization 
x 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 
a body structure or a body function. 
x 
Chronic disease 
x 
Foetal distress, foetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not limited to: 
x 
Microbial Keratitis (MK) 
x 
Iritis (including cells in the anterior chamber) 
x 
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or greater 
x 
Central Corneal Opacity 
x 
Central Corneal Neovascularization 
x 
Uveitis 
x 
Endophthalmitis 
x 
Hypopyon 
x 
Hyphemia 
x 
Penetration of Bowman’s Membrane 
x 
Persistent Epithelial Defect 
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x 
Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant discontinuation (temporary 
or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but not limited to the 
following: 
x 
Contact Lens Induced Peripheral Ulcer (CLPU) 
x 
Significant Infiltrative Events (SIE) 
x 
Superior Epithelial Arcuate Lesions (SEALs) 
x 
Any Temporary Loss of > 2 Lines of BSCVA 
x 
Other grade 3 or higher corneal findings, such as abrasions or edema 
x 
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x 
Asymptomatic Corneal Scar 
x 
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic and usually do not 
warrant discontinuation of contact lens wear but may cause a reduction in wear time. However, the Investigator 
may choose to prescribe treatment as a precautionary measure.  
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, but not limited to 
the following: 
x 
Non-significant Infiltrative Event (NSIE) 
x 
Contact Lens Papillary Conjunctivitis (CLPC) 
x 
Superficial Punctate Keratitis (SPK) 
x 
Conjunctivitis: Bacterial, Viral, Allergic 
x 
Blepharitis 
x 
Meibomianitis 
x 
Contact Dermatitis 
x 
Localized Allergic Reactions 
x 
Any corneal event not explicitly defined as serious or significant adverse event, which necessitates 
WHPSRUDU\OHQVGLVFRQWLQXDWLRQ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.  
 
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). 
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x 
Adverse Event Severity – Adverse event severity is used to assess the degree of intensity of the adverse 
event (mild, moderate, or severe - see definition in section 13.2.2). 
x 
Outcome – not recovered or not resolved, recovering or resolving, recovered or resolved with sequelae, 
recovered or resolved, death related to adverse event, or unknown. 
x 
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the test article. The 
test article relationship for each adverse event should be determined by the investigator using these explanations: 
x 
Not Related- An adverse event that is not related to the use of the test article, study treatment or study 
procedures. 
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.  
 
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It is the Investigator’s responsibility to maintain documentation of each reported adverse event. All adverse events 
will be followed in accordance with applicable licensing requirements. Such documentation will include the 
following: 
x 
Adverse event (diagnosis not symptom). 
x 
Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, and depth, etc.). 
x 
Date the clinical site was notified. 
x 
Date and time of onset. 
x 
Date and time of resolution. 
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. 
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 
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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. 
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. 
 
Descriptive statistics will be reported for all key variables as appropriate. Continuous data will be summarized 
descriptively by sample size (n), mean, standard deviation (SD), median, minimum (Min) and maximum (Max). 
Categorical data will be summarized descriptively by frequency count (n) and percentage (%) of subjects or eyes 
within each category level. Summary tables will be presented by event (Baseline, Fitting, 1-week follow-up, 2-
week follow-up, Unscheduled and Final Evaluations) and study lens type (Test and Control)  as applicable, for 
the analysis set of interest. The denominator for all percentages will be the number of subjects (or eyes as 
applicable) with available data in the lens group under consideration. Unscheduled visits and tele-visits will be 
summarized separately and will be excluded from the primary and secondary analysis. 
 
All available data collected at scheduled visits will be used in the statistical summaries and analyses, with no 
imputation of missing data. Unscheduled visits will be summarized separately and will be excluded from the 
statistical analysis. All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).6  
 
14.2. Sample Size Justification 
This study was not designed or powered to test any statistical hypotheses with respect to incidence (percentage) 
of study lens-related grade 3 or higher SLFs after approximately 2-weeks of lens wear. Instead, the sample size 
and study design were based on clinical considerations and operational feasibility. A sample size of 60 subjects 
(120 eyes) to complete (through Visit 6), will provide adequate precision around the estimate of the percentage 
of eyes with study lens related grade 3 or higher SLFs as measured by the half-width of a 95% CI. Percision 
estimates were provided using difference scenarios for the percentage of events and are displayed in Table 7 
below. 
 
Table 7: Half-Width of the 95% Confidence Intervals for Proportion of Eyes with Grade 3+ SLFs 
Sample Size (number of 
subject to complete) 
Proportion of Grade 3 + 
SLFs  
Confidence Interval 
Half-Width 
Estimated Upper Limit 
60 (120 eyes) 
0 (no events) 
0.02466 
0.02466 
0.0083 (1 event) 
0.03057 
0.03887 
0.0167 (2 events) 
0.03488 
0.05158 
  
A total of 60 subjects are targeted to complete the study. To account for subject drop-out approximately 66  (based 
on a drop-out rate of 10%) subjects will be enrolled in this study to ensure that at least 60 subject complete the 
study.  
14.3. Analysis Populations 
Safety Population: 
All subjects who are administered at least one treatment (study lens). Subject will be analyzed per actual treatment 
received.  
 
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. 
 
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Intention-to-Treat (ITT) Population: 
All randomized subjects. Subject will be analyzed per planned randomized treatment.  
14.4. Level of Statistical Significance 
Not applicable, there is no planned hypothesis testing for any endpoints in this study.   
14.5. Primary Analysis 
The summary of the primary endpoint will be conducted on the safety population.  
The distribution of eyes (n, %) with SLF grade level will be summarized by study lens type. The grading SLFs 
scale is from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse 
findings (i.e., Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). 
14.6. Secondary Analysis  
Not applicable. 
14.7. Exploratory Analyses  
Summary for exploratory endpoints will be provided for both the ITT and the Per-Protocol populations. However, 
all analyses for exploratory endpoints will be conducted on the ITT population.  
 
Distance Monocular HLHC logMAR visual acuity  
Distance monocular HLHC logMAR visual acuity at the 1-week follow-up will be summaried and presented only 
descriptively by lens type accompanied with the 2-sided 95% CIs. Summary statistics are described in section 
14.1.  
 
CLUE Comfort, Vision, and Handling Scores  
The analysis of exploratory endpoints of CLUE comfort, vision and handling at the fitting, 1-, and 2-week follow-
up visits will be conducted separately for each CLUE domain. The exploratory analysis of each CLUE score 
endpoints will include the estimation of mean CLUE scores and associated 95% CIs for each study lens (Test lens 
and Control lens). Additionally, the mean difference between the Test and Control lens paired with the 95% CI 
will be calculated.   
 
CLUE scores will be analyzed using a linear mixed model, adjusting for baseline scores as a covariate. Sequence 
of lens wear, study period,  lens type (Test and Control), timepoint (fitting, 1-week, and 2-week follow-up visit), 
and the ineraction lens type by timepoint will be included as fixed effects. Other baseline characteristics such age, 
gender, and/or race will be included as fixed covariates when appropriate. Site and subject nested within site will 
be included as random effects (G-side). Residual errors from measurements within the same subject  and timepoint 
across study period will be modeled using an unstructured covariance structure (UN). If the model does not 
converge, other covariance structures will be considered. The Kenward and Roger method will be used for the 
denominator degree of freedom.7 Estimates for each study lens and between study lenses (Test lens and Control 
lens) will be carried out using two-sided 95% CIs for the least-square mean and/or mean difference. 
 
Toric Lens Orientation  
The distribution (counts, percentages) of eyes for the toric Orientation (in degrees) at 1- and 3-minutes after lens 
insertion will be summarized by timepoint (fitting, 1-, and 2-week follow-up) and lens type.   
 
Mean Settled Lens Orientation 
Mean settled lens orientation will be summarized separately for each timepoint (fitting, 1-, and 2-week follow-up 
visits) and lens type (Test and Control). Mean settled lens orientation is calculated by eye by averaging across all 
lens orientation measurements collected at least 15-minutes after lens insertion. The standard deviation of average 
settled lens orientation will also be calculated.  
 
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The exploratory analysis of this exploratory endpoint will include the estimation of the mean settled rotation by 
study lens paired with the corresponding two-sided 95% CIs for each lens, and the point estimate with the two-
sided 95% CI for the mean difference. 
 
Mean settled rotation will be analyzed using a linear mixed model. Sequence of lens wear, period, lens type, and 
first order carryover effect will be included in the model as fixed effects. Other baseline characteristics may be 
included, such as, race and age. Subject will be included as a random effect. Residual errors between 
measurements within a subject across periods will be modeled using an unstructured (UN) covariance structure. 
The Kenward and Roger Method will be used for the calculation of denominator degrees of freedom.7  Estimates 
will be calculated using two-sided 95% confidence intervals constructed for the least-square mean and/or least-
square mean difference. 
 
  
Adverse Events 
All Adverse Events reported during this study will be provided in a listing. This listing will include subject 
demographic information, treatment information (associated with the time of the reported AE), AE type (ocular 
or non-ocular), seriousness / classification, causality or relatedness, adverse event severity, outcome, actions taken 
and the associated start and end date / time for each AE. 
 
Additional exploratory analyses may be considered at the discretion of the study sponsor. 
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 Sitero EDC system. An 
authorized data originator will enter study data into the eCRFs using the EDC system. Data collected on 
equipment that is not captured in EDC will be formatted to the specification of the JJVC database manager and 
sent to JJVC for analysis.  
 
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 
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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. 
 
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 
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Investigator, in turn, must ensure that all Sub-Investigators and clinical site personnel are familiar with the 
protocol and all study-specific procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the start of the study. 
The Sponsor will review case report forms for accuracy and completeness remotely during the conduct of the 
study, during monitoring visits, and after transmission to data management. Any data discrepancies will be 
resolved with the Investigator or designee, as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced during the study 
and to access compliance with applicable regulations pertaining to the conduct of clinical trials. The clinical sites 
will provide direct access to study-related source data/documents and reports for the purpose of monitoring and 
auditing by JJVC and for inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the Investigator’s designated 
clinical site personnel. The monitor’s responsibilities will include: 
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, according to ISO 14155:20201 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 20132 and that the clinical study data are credible. The 
Investigator must maintain clinical study files in accordance with ISO 14155:20201 and applicable regulatory 
requirements. 
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18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the IEC/IRB with current 
and complete copies of the following documents (where applicable): 
x 
Final protocol. 
x 
Sponsor-approved informed consent form (and any other written materials to be provided to the 
subjects). 
x 
Investigator’s Brochure (or equivalent information). 
x 
Sponsor-approved subject recruitment materials. 
x 
Information on compensation for study-related injuries or payment to subjects for participation in the 
study. 
x 
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not required, as 
documented by IEC/IRB). 
x 
Information regarding funding, name of the Sponsor, institutional affiliations, other potential conflicts 
of interest, and incentives for subjects. 
x 
Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, the informed 
consent form, applicable recruiting materials, and subject compensation programs, and the Sponsor has received 
a copy of this approval. This approval letter must be dated and must clearly identify the documents being 
approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following documents to the IEC/IRB 
for their review and approval, where appropriate: 
x 
Protocol revisions 
x 
Revision(s) to informed consent form and any other written materials to be provided to subjects 
x 
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x 
Revisions to compensation for study-related injuries or payment to subjects for participation in the study 
x 
Investigator’s Brochure revisions  
x 
Summaries of the status of the study (at least annually or at intervals stipulated in guidelines of the 
IEC/IRB) 
x 
Reports of adverse events that are serious, unanticipated, and associated with the test articles, according 
to the IRB’s requirements 
x 
New information that may adversely affect the safety of the subjects or the conduct of the study 
x 
Major protocol deviations as required by the IEC/IRB 
x 
Report of deaths of subjects under the Investigator's care 
x 
Notification if a new Investigator is responsible for the study at the clinical site 
x 
Any other requirements of the IEC/IRB 
 
For protocol revisions that increase subject risk, the revisions and applicable informed consent form revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request should be documented 
in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about the study 
completion. Documentation of this notification must be retained at the clinical site and a copy provided to the 
CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject or their representative must give written consent according to local requirements after the nature of 
the study has been fully explained. The consent form must be signed before performance of any study-related 
activity. The consent form that is used must be approved by both the Sponsor and by the reviewing IEC/IRB. The 
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informed consent is in accordance with principles that originated in the Declaration of Helsinki2 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)8 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality of the person’s 
related health and medical information, to properly inform the concerned persons about the collection and 
processing of their personal data, to grant them reasonable access to their personal data and to prevent access by 
unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. All personal data 
gathered in this trial will be treated in strictest confidence by Investigators, monitors, Sponsor’s personnel and 
IEC/IRB. No data will be disclosed to any third party without the express permission of the subject concerned, 
with the exception of Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context 
of their investigation related activities that, as part of the investigation will have access to the CRFs and subject 
records. 
 
The collection and processing of personal data from subjects enrolled in this study will be limited to those data 
that are necessary to investigate the efficacy, safety, quality, and utility of the investigational product(s) used in 
this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality and compliance 
with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x 
processed fairly and lawfully. 
x 
collected for specified, explicit, and legitimate purposes and not further processed in a way incompatible 
with these purposes. 
x 
adequate, relevant, and not excessive in relation to said purposes. 
x 
accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating subject before 
collection of data. Such consent should also address the transfer of the data to other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the right to request 
rectification of any data that are not correct or complete. Reasonable steps 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 
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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 ISO 14155:2020,1 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 ISO 
14155:20201 and all study documents as specified by the applicable regulatory requirement(s). The 
Investigator/Institution will take measures to prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a marketing application 
in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or until 
at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational 
product. These documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the responsibility of keeping 
the study records, custody must be transferred to a person who will accept the responsibility. The Sponsor must 
be notified in writing of the name and address of the new custodian. Under no circumstance shall the Investigator 
relocate or dispose of any study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any documentation 
relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research Agreement. The 
Research Agreement will be signed by the Principal Investigator and a JJVC management representative prior to 
study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations such as: 
x 
Continuing an ineligible subject in the study. 
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.  
CR-6553, v3.0
 
 
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2. 
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/  
3. 
United States (US) Code of Federal Regulations (CFR). Ophthalmic Drug Products for over-the-counter 
human 
use,Section 
349.1. 
Available 
at: 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=349.1.  
4. 
Straker B. Investigator's Brochure CR-6553. (VIS-CSIB-'DLO\GLVSRVDEOHWRULFFRQWDFWOHQVHV
manufactured in senofilcon A with a blue light-filtering chromophore. October, 2023. 
5. 
RJ Wirth, MC Edwards, Henderson M, et a. Development of the contact lens user experience: CLUE 
scales. 
. 
Optometry 
and 
Vision 
Science. 
2016;93(8):801. 
Available 
at: 
https://pubmed.ncbi nlm nih.gov/27383257/ 
6. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC SAS Institute Inc; 2014. 
7. 
MG Kenward, Roger J. Small Sample Inference for Fixed Effects from Restricted Maximum Likelihood. 
Biometrics. 1997;53(3):983. Available at: http://dx.doi.org/10.2307/2533558 
8. 
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. 
 
 
 
 
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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 SNELLEN VISUAL ACUITY EVALUATION  
x 
 TORIC FIT EVALUATION 
x 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT 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 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6 
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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 
  
 
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 BIOMICROSCOPY SCALE 
 
 
 
 
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 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
 
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
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 TORIC FIT EVALUATION 
 
 
 
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Document Type:  
Document Number:
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DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
 
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 LENS INSERTION AND REMOVAL 
 
 
 
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION TESTING 
 
 
 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
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Revision Number:  4 
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Document Type:  
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Revision Number:  4 
DEL
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6553 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft 
Contact Lenses Over Two Weeks of Wear 
Version and Date: 3.0 27 November 2023 
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 the Declaration of Helsinki,2 United States (US) 
Code of Federal Regulations (CFR),3 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 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. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects Protection 
Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about their 
obligations in meeting the above commitments. 
I shall not disclose the information contained in this protocol or any results obtained from this study without 
written authorization. 
Principal Investigator: 
Signature 
Date 
Name and Professional Position (Printed) 
Institution/Site: 
Institution/Site Name 
Institution/Site Address 
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