Clinical Performance of Two Daily Disposable Silicone Hydrogel Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
Clinical performance of two daily disposable silicone hydrogel contact lenses (
) 
Protocol: CR-6495 
Version: 2.0 
Date: 1 August 2022 
Investigational Products: Acuvue® Oasys MAX 1-Day contact lenses, Dailies Total 1 contact 
lenses. 
Keywords: Contact lenses, daily wear, daily disposable, dispensing, senofilcon A, delefilcon 
A, subjective comfort, logMAR visual acuity, tear film stability. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155:2020 Clinical 
investigation of medical devices for human subjects – Good clinical practice1, and the 
Declaration of Helsinki2, and all applicable regulatory requirements. 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc. The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc. Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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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 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 ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 16 
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 ...................................................................................................... 18 
3.3. 
Exclusion Criteria ..................................................................................................... 18 
3.4. 
Enrollment Strategy.................................................................................................. 19 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 19 
4.1. 
Description of Study Design .................................................................................... 19 
4.2. 
Study Design Rationale ............................................................................................ 20 
4.3. 
Enrollment Target and Study Duration .................................................................... 20 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 20 
5.1. 
Test Article Allocation ............................................................................................. 20 
5.2. 
Masking .................................................................................................................... 21 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 21 
6.
STUDY INTERVENTION ............................................................................................. 21 
6.1. 
Identity of Test Articles............................................................................................ 21 
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6.2. 
Ancillary Supplies/Products ..................................................................................... 22 
6.3. 
Administration of Test Articles ................................................................................ 23 
6.4. 
Packaging and Labeling ........................................................................................... 23 
6.5. 
Storage Conditions ................................................................................................... 23 
6.6. 
Collection and Storage of Samples .......................................................................... 24 
6.7. 
Accountability of Test Articles ................................................................................ 24 
7.
STUDY EVALUATIONS .............................................................................................. 25 
7.1. 
Time and Event Schedule ......................................................................................... 25 
7.2. 
Detailed Study Procedures ....................................................................................... 25 
VISIT 1 ........................................................................................................................... 25 
VISIT 2 ........................................................................................................................... 30 
VISIT 3 ........................................................................................................................... 36 
FINAL EVALUATION .................................................................................................. 38 
7.3. 
Unscheduled Visits ................................................................................................... 39 
7.4. 
Laboratory Procedures ............................................................................................. 40 
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 40 
8.1. 
Completion Criteria .................................................................................................. 40 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 41 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 41 
9.1. 
Systemic Medications .............................................................................................. 42 
10.
DEVIATIONS FROM THE PROTOCOL .................................................................. 43 
11.
STUDY TERMINATION ........................................................................................... 43 
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 44 
13.
ADVERSE EVENTS ................................................................................................... 45 
13.1. 
Definitions and Classifications ............................................................................. 45 
13.2. 
Assessing Adverse Events .................................................................................... 47 
13.2.1. 
Causality Assessment .................................................................................... 48 
13.2.2. 
Severity Assessment ...................................................................................... 48 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 48 
13.4. 
Reporting Adverse Events .................................................................................... 50 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 50 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
51 
13.5. 
Event of Special Interest ....................................................................................... 51 
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13.6. 
Reporting of Pregnancy ........................................................................................ 51 
14.
STATISTICAL METHODS ........................................................................................ 51 
14.1. 
General Considerations ......................................................................................... 51 
14.2. 
Sample Size Justification ...................................................................................... 52 
14.3. 
Analysis Populations ............................................................................................ 52 
14.4. 
Level of Statistical Significance ........................................................................... 52 
14.5. 
Primary Analysis .................................................................................................. 52 
14.6. 
Secondary Analysis .............................................................................................. 52 
14.7. 
Other Exploratory Analyses ................................................................................. 52 
14.8. 
Interim Analysis ................................................................................................... 53 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 53 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 53 
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 53 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 53 
15.2. 
Subject Record ...................................................................................................... 54 
15.3. 
Trial Registration on ClinicalTrials.gov ............................................................... 54 
16.
DATA MANAGEMENT............................................................................................. 54 
16.1. 
Access to Source Data/Document ........................................................................ 54 
16.2. 
Confidentiality of Information.............................................................................. 55 
16.3. 
Data Quality Assurance ........................................................................................ 55 
16.4. 
Data Monitoring Committee (DMC) .................................................................... 55 
17.
CLINICAL MONITORING ........................................................................................ 55 
18.
ETHICAL AND REGULATORY ASPECTS ............................................................ 56 
18.1. 
Study-Specific Design Considerations ................................................................. 56 
18.2. 
Investigator Responsibility ................................................................................... 56 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 56 
18.4. 
Informed Consent ................................................................................................. 57 
18.5. 
Privacy of Personal Data ...................................................................................... 58 
19.
STUDY RECORD RETENTION................................................................................ 59 
20.
FINANCIAL CONSIDERATIONS ............................................................................ 60 
21.
PUBLICATION ........................................................................................................... 60 
22.
REFERENCES ............................................................................................................ 60 
APPENDIX A: PATIENT REPORTED OUTCOMES ......................................................... 61 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 66 
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Eligibility 
Criteria - 
Inclusion 
Potential subjects must satisfy all of the following criteria to be enrolled 
in the study:  
 
Inclusion Criteria following Screening: 
  
1. The subject must 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. Between 18 and 40 (inclusive) years of age at the time of screening. 
4. They agree not to participate in other clinical research while 
enrolled on this study. 
5. They have worn the same brand of soft daily disposable silicone 
hydrogel contact lenses at least eight hours per day for at least four 
days per week over the past 4 weeks. 
6. They own a wearable pair of spectacles if needed for distance 
vision correction (by self-report). 
 
Inclusion Criteria at Baseline Evaluation: 
 
7. They can attain a best-corrected logMAR distance visual acuity of 
at least 0.20 in each eye. 
8. They have spherical contact lens prescription in the range -1.00 to 
-6.00 DS (based on the calculated ocular refraction). 
9. They have up to maximum of 1.00 DC of refractive astigmatism 
(based on the calculated ocular refraction). 
Eligibility 
Criteria – 
Exclusion 
Potential subjects who meet any of the following criteria will be excluded 
from participating in the study:  
 
Exclusion Criteria following Screening: 
 
1. Currently pregnant or lactating. 
2. Any systemic disease (e.g., Sjögren’s Syndrome), allergies, 
infectious disease (e.g., hepatitis, tuberculosis), contagious 
immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. 
rheumatoid arthritis), or other diseases, by self-report, which are 
known to interfere with contact lens wear and/or participation in 
the study or may pose a risk to study personnel. 
3. They have an ocular disorder, which would normally 
contraindicate contact lens wear. 
4. They have had cataract surgery. 
5. They have had corneal refractive surgery. 
6. They are using any topical medications such as eye drops or 
ointments. 
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7. Any known hypersensitivity or allergic reaction to sodium 
fluorescein. 
8. Use of systemic medications (e.g., chronic steroid use) that are 
known to interfere with contact lens wear. See section 9.1 for 
additional details regarding excluded systemic medications. 
9. Participation in any contact lens or lens care product clinical trial 
within 2 weeks prior to study enrollment. 
10. Employee or immediate family member of an employee of clinical 
site (e.g., Investigator, Coordinator, Technician). 
 
Exclusion Criteria at Baseline Evaluation: 
 
11. They have any corneal distortion resulting from previous hard or 
rigid lens wear or have keratoconus. 
12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal abnormalities, 
conjunctival injection). 
13. They have a pre-corneal tear film break-up time less than five 
seconds when evaluated on the Digital Eye Strain Manchester 
Device (DESMD) tear film imaging system. 
Disallowed 
Medications / 
Interventions  
No ocular topical medications (including comfort drops) from 24 hours 
prior to study visits or during the wear of any study lenses. 
No systemic medications that in the view of the investigator may affect 
the ocular surface or contact lens wear from 24 hours prior to study 
visits.  
 
See section 9.1 for details regarding disallowed systemic medications. 
Measurements 
and Procedures 
Assessment of acceptable fit rate. Assessment of tear film stability using 
the DESMD tear film analysis system, slit lamp biomicroscopy, logMAR 
visual acuity assessment. 
Microbiology 
or Other 
Laboratory 
Testing 
None. 
Study 
Termination 
The occurrence of one or more Unanticipated Adverse Device Effect 
(UADE), or any SAE where relationship to study agent cannot be ruled 
out, 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 
Any Sponsor-approved saline pods and fluorescein strips 
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Principal 
Investigator(s) 
and Study 
Institution(s)/S
ite(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  
 
 
 
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
CVS  
 
Computer Vision Syndrome 
D 
 
 
Diopter 
DES 
 
 
Digital Eye Strain 
DESMD 
 
Digital Eye Strain Manchester Device 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
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PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
VA 
 
 
Visual Acuity 
DES 
 
 
Digital Eye Strain 
1. INTRODUCTION AND BACKGROUND 
Acuvue® Oasys MAX 1-Day is a new contact lens technology, which has been developed to 
offer improved clinical performance over existing contact lens designs. This study seeks to 
assess the clinical performance of this new lens type in comparison with the Dailies Total 1 
contact lens. This comparison will focus on acceptable fit rates, with other clinical metrics 
assessed including slit lamp biomicroscopy findings and tear film stability. 
1.1. Name and Descriptions of Investigational Products  
This clinical study will evaluate two soft contact lens types: Acuvue® Oasys MAX 1-Day 
(JJVC) daily disposable contact lenses, and Dailies Total 1 (Alcon) daily disposable contact 
lenses. These lens types are CE marked. Further details about the test articles are found in 
section 6 of this protocol. 
1.2. Intended Use of Investigational Products 
The intended use of the CE marked contact lens products is for correcting myopia. During the 
study, each study lens type will be worn bilaterally in daily wear, daily disposable modality 
for at least 8 hours per day for a period of 7 to 14 days.  No more than two days of missed lens 
wear are allowed on the days between fitting and follow-up. 
 
Subjects will wear Acuvue® Oasys MAX 1-day contact lenses for 7 to 14 days and Dailies 
Total 1 contact lenses for 7 to 14 days in a randomized order. 
 
 
1.3. Summary of Findings from Nonclinical Studies 
Not Applicable – Marketed product only. 
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1.4. Summary of Known Risks and Benefits to Human Subjects 
This study will use approved marketed products. The following risks/adverse events can be 
associated with the use of any marketed contact lens: 
x Discomfort, pain, watering or unusual secretions of the eyes 
x Redness of the eyes 
x Reduced vision and sensitivity to light 
x In very rare instances corneal infection, scarring or permanent loss of vision may occur 
 
The key invasive procedures in this work and their associated risks are outlined below: 
 
Staining of the ocular surface with sodium fluorescein 
x Some temporary discomfort on application 
x Very rarely, anaphylaxis with topical application 
 
There is no direct benefit to the subjects enrolled other than being able to try lens types that 
they have not had the opportunity to try before. The information obtained from this study 
may aid in the development of improved contact lenses in the future. 
In order to minimize the likelihood of adverse events, subjects will undergo an ocular 
examination before and after the clinical investigations. Subjects will also be trained on what 
to do if they develop ocular discomfort, redness, or reduced vision and what to do if they 
need to be seen outside of the Eurolens Research clinic opening hours. 
 
For the most comprehensive risk and benefit information regarding Acuvue® Oasys MAX 1-
Day, and Dailies Total 1 refer to the latest version of the package insert of the marketed 
products (Appendix C). 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
Acuvue® Oasys MAX 1-Day, and Dailies Total 1 are CE marked/approved and marketed 
products (APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT). 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Assess lens fit acceptance of the Acuvue® Oasys MAX 1-day contact lens and the Dailies Total 
1 daily disposable contact lens. 
2.2. Endpoints  
Primary Endpoint(s): 
Lens Fit Acceptance 
Lens fit acceptance will be assessed at dispensing and follow-up visits for each subject eye. 
Acceptable fit is a binary response where Y=1 if lens fit is deemed acceptable by the 
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investigator and Y=0 otherwise. An unacceptable fit is deemed by one or more of the following 
criteria: 
x limbal exposure at primary gaze or with extreme eye movement 
x edge lift 
x excessive movement with blink in primary gaze 
x insufficient movement with blink in upgaze 
x insufficient movement in push-up test 
 
 
Other Observations: 
Slit Lamp Findings 
The slit lamp findings (biomicroscopy) will be assessed for each subject eye across all study 
visits (including scheduled and unscheduled visits). The Efron grading scale will be used to 
quantify the slit lamp observations.  
 
Tear Film Stability 
Tear film stability (tear film surface quality) will be assessed in the left eye (OS) only. The 
Digital Eye Strain Manchester Device (DESMD) system uses an off-axis infrared ring 
projection illumination system to produce a reflected mire pattern on the tear film surface. 
Image processing will then be used to assess tear film surface quality and calculate the tear 
film break-up time. Tear film break-up time will be assessed three times, with a five-minute 
break between measurements. 
 
Patient Reported Outcomes 
Subjective impressions of the study lenses will be assessed using the CLDEQ-8 questionnaire, 
and two additional questions regarding the subject’s opinion of the lenses.  
 
CLDEQ-8 is a validated patient-reported outcome measure assessing patient-experience of 
symptoms relating to contact lens dryness.5 The sum of the item scores of CLDEQ-8 ranges 
from 0 to 37 where higher scores indicate more dryness with respect to contact lens wear.  
2.3. Hypotheses 
Primary Hypothesis: 
Lens Fit Acceptance 
Acceptable fit rate will be calculated by visit for each lens type. No statistical hypotheses will 
be tested. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
The study population will be healthy contact lens wearers aged 18-40 years of age from a single 
site in the United Kingdom (UK). 
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3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening: 
  
1. The subject must 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. Between 18 and 40 (inclusive) years of age at the time of screening. 
4. They agree not to participate in other clinical research while enrolled on this study. 
5. They have worn the same brand of soft daily disposable silicone hydrogel contact 
lenses at least eight hours per day for at least four days per week over the past 4 weeks. 
6. They own a wearable pair of spectacles if needed for distance vision correction (by 
self-report). 
 
Inclusion Criteria at Baseline Evaluation: 
 
7. They can attain a best-corrected logMAR distance visual acuity of at least 0.20 in each 
eye. 
8. They have spherical contact lens prescription in the range -1.00 to -6.00 DS (based on 
the calculated ocular refraction). 
9. They have up to maximum of 1.00 DC of refractive astigmatism (based on the 
calculated ocular refraction). 
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: 
 
1. Currently pregnant or lactating. 
2. Any systemic disease (e.g., Sjögren’s Syndrome), allergies, infectious disease (e.g., 
hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), 
autoimmune disease (e.g., rheumatoid arthritis), or other diseases, by self-report, which 
are known to interfere with contact lens wear and/or participation in the study or may 
pose a risk to study personnel. 
3. They have an ocular disorder which would normally contraindicate contact lens wear. 
4. They have had cataract surgery. 
5. They have had corneal refractive surgery. 
6. They are using any topical medications such as eye drops or ointments. 
7. Any known hypersensitivity or allergic reaction to sodium fluorescein. 
8. Use of systemic medications (e.g., chronic steroid use) that are known to interfere with 
contact lens wear. See section 9.1 for additional details regarding excluded systemic 
medications. 
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9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior 
to study enrollment. 
10. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
 
Exclusion Criteria at Baseline Evaluation: 
 
11. They have any corneal distortion resulting from previous hard or rigid lens wear or 
have keratoconus. 
12. Any Efron Grade 3 or greater slit lamp findings (e.g., edema, corneal 
neovascularization, corneal staining, tarsal abnormalities, conjunctival injection), 
13. They have a pre-corneal tear film break-up time less than five seconds when evaluated 
on the DESMD tear film imaging system. 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Eurolens Research (The University of Manchester) 
subject database and/or utilizing Independent Ethics Committee (IEC) or Institutional Review 
Board (IRB) approved materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a subject-masked, randomized, bilateral, 2x2 crossover dispensing clinical 
investigation.   
 
Visit 1 – Screening/Baseline/Lens Fitting #1 
Up to 16 subjects will be enrolled, with recruitment ceasing once 10 subjects have successfully 
completed the study. 
At study Visit 1, subjects will be consented and screened for inclusion/exclusion criteria. If a 
subject is found to meet all eligibility criteria, they will be fitted with the first study lens based 
on the randomization scheme; otherwise, the subject will be discontinued from the study. The 
subject will then be dispensed with the study lenses to wear on a daily disposable basis for a 
period of 7 to 14 days. 
Visit 2 - Assessment 1/Lens Fitting #2  
Subjects will attend after having worn the study lenses for at least 6 hours. At this visit,  
DESMD tear film stability will be assessed during a period of extended eye opening (three 
times on the left eye only, with a 5-minute break between measurements). The second lens 
type will then be fitted. The subject will then be dispensed with the study lenses to wear on a 
daily disposable basis for a period of 7 to 14 days. 
 
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Visit 3 – Assessment 2 
Subjects will attend after having worn the study lenses for at least 6 hours. At this visit,  
DESMD tear film stability will be assessed during a period of extended eye opening (three 
times on the left eye only, with a 5-minute break between measurements).  Subjects will then 
be exited from the study.  
4.2. Study Design Rationale 
The purpose of this study is to evaluate the performance of Acuvue® Oasys MAX 1-Day daily 
disposable contact lenses compared to Dailies Total 1 daily disposable contact lenses. A 2×2 
crossover design is used. Crossover designs are a well-established study design in which 
subjects are exposed to multiple treatments during different time periods. This design is cost 
effective and more efficient since it eliminates part of the inter-subject variability from the 
treatment comparisons. Subjects will be randomized into the two lens wear sequences. 
Randomization eliminates the selection bias and balances both the known and unknown 
confounding factors that may affect the study outcomes.  
4.3. Enrollment Target and Study Duration 
Up to 16 subjects will be enrolled, with a target of 10 subjects successfully completing the 
study.  
The study will last approximately 3 months. Once the informed consent has been signed the 
subject will be considered enrolled. Subjects who are discontinued prior to the final evaluation 
will be replaced.  Study recruitment will cease once 10 subjects have completed all study visits. 
5. TEST ARTICLE ALLOCATION AND MASKING 
Subjects will wear Acuvue® Oasys MAX 1-day contact lenses for 7 to 14 days and Dailies 
Total 1 contact lenses for 7 to 14 days in a randomized order. 
 
5.1. Test Article Allocation  
Subjects will wear Acuvue® Oasys MAX and Dailies Total 1 sequentially in a random order. 
Subjects will be randomly assigned to one of the two lens wear sequences: Acuvue® Oasys 
MAX 1-Day/Dailies Total 1 or Dailies Total 1/Acuvue® Oasys MAX 1-Day.  
The randomization scheme will be provided by the study responsible biostatistician and will 
be generated using the Statistical Analysis System (SAS) software Version 9.4 or higher (SAS 
Institute, Cary, NC).4 
The clinical site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. 
 
Randomization will be performed at visit 1.  The following must have occurred prior to 
randomization: 
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• Informed consent must have been obtained.  
• The subject must have met all eligibility criteria. 
• The subject’s screening and baseline information must have been collected. 
 
5.2. Masking 
This is a single masked study where subjects are masked to the identity of the study contact 
lenses during the study. The investigators and technical personnel involved in the data 
collection may be aware of the study lenses based on a slight difference in lens color (the Test 
lens will be slightly more turquoise in color than the Control lens).  
5.3. Procedures for Maintaining and Breaking the Masking 
The identity of the investigational products will be masked by over labelling the contact lens 
blister packs with a label containing the study number and expiration date.  
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.  
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations. Subjects who are discontinued will be replaced. 
When conducting the visit, the following steps should be followed to maintain randomization 
codes: 
1. Investigator or designee (documented on the Delegation Log) will consult 
randomization scheme to obtain the test sequence assignment for that subject prior to 
DESMD system assessment. 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme. 
3. Investigator or designee will pull the appropriate test articles from the study supply. 
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
6. STUDY INTERVENTION 
6.1. Identity of Test Articles  
 
The following contact lenses will be used in this study: 
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x Have completed all study visits. 
x Have not withdrawn/discontinued from the study for any reason described in 
Section 8.2. 
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 including use of non-study lenses or not reaching the 
required wear times. 
x Subject lost to follow-up. 
x Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant). 
x Subject develops significant or serious adverse events causing discontinuation of study 
lens wear (more than 7 days). 
x Subjects who have experienced a Corneal Infiltrative Event (CIE). 
x Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment). 
x Subject missed two consecutive 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 will be enrolled if a subject discontinues from the study prematurely.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt.  
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study. 
Disallowed medications for this study include: any ocular topical medications (including 
comfort drops) and any systemic medications that in the view of the investigator may affect 
the ocular surface or contact lens wear from 24 hours prior to study visits.  
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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). 
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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. 
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 and whether 
anticipated or unanticipated”.  
Note: This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices.1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study. 
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states. 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event. 
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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: 
o Life-threatening illness or injury. 
o Permanent or persistent impairment of a body structure or a body function. 
o Hospitalization or prolongation of patient hospitalization. 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 
o Chronic disease. 
o Foetal distress, foetal death, or a congenital physical or mental impairment of 
birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
x Microbial Keratitis (MK) 
x Iritis (including cells in the anterior chamber) 
x Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
x Central Corneal Opacity 
x Central Corneal Neovascularization 
x Uveitis 
x Endophthalmitis 
x Hypopyon 
x Hyphemia 
x Penetration of Bowman’s Membrane 
x Persistent Epithelial Defect 
x Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x Contact Lens Induced Peripheral Ulcer (CLPU) 
x Significant Infiltrative Events (SIE) 
x Superior Epithelial Arcuate Lesions (SEALs) 
x Any Temporary Loss of > 2 Lines of BSCVA 
x Other grade 3 or higher corneal findings, such as abrasions or edema 
x Non-contact lens related corneal events - e.g., Epidemic Keratoconjunctivitis (EKC) 
x Asymptomatic Corneal Scar 
x Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
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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 temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
NOTE 1: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2 : This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”  
 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly. Elements of categorization will include: 
x Seriousness/Classifications (see definition in Section 13.1). 
x Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly 
related; related - see definition in Section 13.2.1). 
x Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2). 
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x Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; 
unknown. 
x Actions Taken – none; temporarily discontinued; permanently discontinued; other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
x Not Related - An adverse event that is not related to the use of the test article, study 
treatment, or study procedures. 
x Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g., concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely. 
x Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g., 
concomitant 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. 
 
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Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following: 
x Adverse event (diagnosis not symptom). 
x Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.). 
x Date the clinical site was notified. 
x Date and time of onset. 
x Date and time of resolution. 
x Adverse event classification, severity, and relationship to test articles, as applicable. 
x Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
x Any referral to another health care provider if needed. 
x Outcome, ocular damage (if any). 
x Likely etiology. 
x Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event. 
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF. Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
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events related to the test article, study treatment, or study procedures as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the Sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
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. 
 
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The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the Sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according to 
the written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  
 
Pregnant participants are not discontinued from contact lens or solution related studies for 
safety concerns but due to general concerns relating to pregnancy and contact lens use. 
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or 
visual acuity that occur secondary to systemic hormonal changes and not due to unforeseen 
health risks to the mother or fetus. 
14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the Sponsor or under the authority of the Sponsor. 
A general description of the statistical methods to be implemented in this clinical trial is 
outlined below.  
 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC).4 Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis. 
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis. 
 
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Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables, and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, SD, median, minimum and maximum). 
Frequency count and percentage of subjects or eyes within each category will be provided for 
categorical data. 
14.2. Sample Size Justification 
The plan is to complete 10 eligible subjects. This is an early feasibility study and no statistical 
hypothesis will be tested. Therefore, the sample size was not based on any empirical power 
analysis. Targeting 10 subjects to complete the study is considered sufficient to assess lens fit 
acceptance and descriptive summaries of other observations. The data collected for this study 
may be used to design future clinical trials.  
14.3. 5Analysis Populations 
Safety Population: 
All subjects who are administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who successfully complete all visits and do not substantially deviate from the 
protocol as determined by the trial cohort review committee prior to database hard lock (Per-
Protocol Population). Justification of excluding subjects with protocol deviations in the per-
protocol population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
No statistical hypothesis will be tested. All planned analysis for this study will be descriptive.  
14.5. Primary Analysis  
Lens Fit Acceptance 
Acceptable fit rate will be calculated by visit and lens type for the safety population. No 
statistical hypotheses will be tested. 
14.6. Secondary Analysis  
Not Applicable. 
14.7. Other Exploratory Analyses 
All other observations will be summarized descriptively by study lens and timepoint. 
 
Further exploratory analysis may be conducted at the discretion of the study responsible 
clinician.  
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database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
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 based on the following: although the study 
is a pilot study of a new type of clinical measurement, it involves the use of marketed contact 
lenses and it is being conducted in the United Kingdom. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents. Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
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16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data, or other pertinent information is confidential and remains the property of JJVC. The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites, and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
 
16.4. Data Monitoring Committee (DMC) 
Not applicable. 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel. The monitor’s responsibilities will include: 
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. 
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x Ensuring that protocol deviations are documented with corrective action plans, as 
applicable. 
x Ensuring that the clinical site has sufficient test article and supplies. 
x Clarifying questions regarding the study. 
x Resolving study issues or problems that may arise. 
x Reviewing of study records and source documentation verification in accordance with 
the monitoring plan. 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP)2, and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP)2, and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x Final protocol. 
x Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects). 
x Investigator’s Brochure (or equivalent information). 
x Sponsor-approved subject recruitment materials. 
x Information on compensation for study-related injuries or payment to subjects for 
participation in the study. 
x Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB). 
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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 
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both the Sponsor and by the reviewing IEC/IRB. The informed consent is in accordance with 
principles that originated in the Declaration of Helsinki3, current ICH2 and ISO 14155:20201 
guidelines, applicable regulatory requirements, and Sponsor Policy. 
 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
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 General Data Protection Regulation6 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. 
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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/her personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel, whose responsibilities require access to 
personal data, agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines2, the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
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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 
This is a pilot study of a novel measurement of contact lens wettability.  Examples of these 
new types of study measurements may be published, at the discretion of the study sponsor.  
22. REFERENCES 
1. ISO 14155:2020: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/71690.html 
2. 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). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
4. SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. Cary, NC: SAS 
Institute Inc; 2014.  
5. Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye 
Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis 
Sci. 2012 Oct;89(10):1435-42. doi: 10.1097/OPX.0b013e318269c90d. PMID: 
22960615. 
6. Data Protection Act. Available at: 
http://www.legislation.gov.uk/ukpga/1998/29/contents   
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES  
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
N/A 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Acuvue® Oasys MAX 1-Day / Dailies Total 1 Contact Lenses 
 
 
 
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APPENDIX D: 
 
 
 Lens Fitting Assessment 
 Subject Reported Ocular Symptoms/Problems 
 Determination of Distance Spherocylindrical Refractions 
 Distance and Near Snellen Visual Acuity Evaluation 
 Patient Reported Outcomes  
 
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 LENS FITTING ASSESSMENT 
 
 
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Title:                          Lens Fitting Characteristics 
Document Type:       
 
Document Number:  
 
Revision Number:  6 
Page 4 of 5 
 
 
 
 
 
 
 
 
 
 
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Title:                          Lens Fitting Characteristics 
Document Type:       
 
Document Number:  
 
Revision Number:  6 
Page 5 of 5 
 
 
 
 
 
 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
 
 
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
 
 
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Title:                           Determination of Distance Spherocylindrical Refractive Error 
Document Type:        
 
Document Number:  
 
Revision Number:  5 
Page 2 of 5 
 
  
 
 
 
 
 
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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 
Page 2 of 4 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation 
Document Type:       
 
Document Number:  
 
Revision Number:  5 
Page 4 of 4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
 
 
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APPENDIX E: EUROLENS RESEARCH SOP #12A LOGMAR ACUITY  
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
 
 
APPENDIX F: EUROLENS RESEARCH SOP #13 SLIT LAMP BIOMICROSCOPY 
 
 
 
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
 
 
APPENDIX G: EUROLENS RESEARCH DESMD SYSTEM SETUP AND 
MEASUREMENT PROCEDURES  
 
 
 
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APPENDIX *: DESMD SYSTEM SETUP AND MEASUREMENT PROCEDURES 
Authors: Michael Read and Maria Nascues-Cornago 
Date: 11th July, 2022 
Version 3.0 
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Table of contents 
 
1. Experimental setup 
3 
2. DESMD preparation and testing 
5 
3. DESMD analysis metrics 
6 
3.1 Blink and palpebral aperture height analysis 
6 
3.2 Tear film surface quality (TFSQ) 
7 
3.3 Tear meniscus height (TMH) 
7 
3.4 Symptomatic events 
7 
3.5 Tear film stability during extended eye opening 
8 
3.6 Subjective comfort analogue slider during extended eye opening 
8 
3.7 Continuous acuity testing during extended eye opening 
8 
3.8 Pupil size and Interpupillary distance 
8 
4 Visual tasks 
9 
4.1 Maltese cross 
9 
4.2 Documentary video 
9 
4.3 Tetris-type game 
9 
4.4 Continuous VA test 
9 
 
 
 
 
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1. Experimental setup 
The Digital Eye Strain Manchester Device (DESMD) is designed to assess contact lens 
performance in a non-invasive manner during use of a digital display. The instrument aims to 
allow control over environmental conditions (including airflow and humidity), whilst the study 
participant engages in a range of digital device tasks. The DESMD system is shown in Figure 
1. The system is based on an optical breadboard (B6090AX, Thorlabs UK Ltd) mounted on a 
height adjustable table (Topcon GB). A chin rest (Head Support, SR Research Ltd., Ottawa, 
Canada) is mounted to one end of the table, to accommodate the study participant who is 
seated on an office chair. A 7-inch LCD display (FW279S, Wex Photographic Ltd, UK) is 
mounted on an adjustable arm, at a 60 cm working distance from the participant. The 
resolution of tKHGLVSOD\LV௘î௘SL[HOVDQGEULJKWQHVVVHWDWWKHVHWWLQJV are 
otherwise the default monitor settings). The monitor is connected via a HDMI cable to a 
workstation computer (DELL T3620, DELL UK Ltd.), with the visual tasks displayed using 
MATLAB software (Mathworks Inc., Natick).  
 
The system comprises three digital cameras, with one camera just below the digital display 
which captures images of both eyes (termed the central camera), one camera imaging the 
study participant’s left eye from the side (termed the side camera) and a third camera capturing 
the digital display (termed the display camera). These cameras all feed into the Dell 
workstation, where the three video streams are synchronized for later analysis.  
 
 
Figure 1. The Digital Eye Strain (DESMD) system 
 
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Figure 2. Photograph of the DESMD system. 
 
The central monochromatic camera (MX022RG-CM, Ximea GMbH, Munster, Germany) 
captures a video feed at 500 frames per second (FPS), with a resolution of 1600௘î௘400 pixels 
and is sensitive to infrared light. The camera is used in conjunction with a MVL50TM23 50mm 
C-Mount lens (Kowa GmbH, Dusseldorf, Germany) at a working distance of 600mm, giving a 
horizontal field of view of around 80mm, allowing both of the participants' eyes to be imaged. 
The camera assembly is mounted on a Manfrotto tripod head (MHXPRO-3W X-PRO, Vitec 
Imaging Solutions, Cassola, Italy), to allow the camera position to be optimised for video 
capture. 
 
 
 
 
 
The side camera (MQ042MG-CM, Ximea GMbH, Munster, Germany) captures a video feed 
at 30 frames per second, with a resolution of 2048௘î௘ pixels and is sensitive to infrared 
light. The camera assembly is mounted on a Manfrotto tripod head (MHXPRO-3W X-PRO, 
Vitec Imaging Solutions, Cassola, Italy), itself mounted on a height adjustable 1.5” post holder 
(LPH200, Thorlabs Inc., New Jersey, US) to allow the camera position to be optimised for 
video capture. 
 
The display camera (GS3-U3-23S6M-C, PointGrey Inc, Canada) captures a video feed at 15 
frames per second, with a resolution of 1920௘î௘1080 pixels. The camera assembly is mounted 
on a Manfrotto tripod head (MHXPRO-3W X-PRO, Vitec Imaging Solutions, Cassola, Italy) 
allowing the camera position to be optimised for video capture of the digital display. 
 
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The DESMD has two LED infrared light sources. The first light source is an infrared LED light 
(Thorlabs LIU850A) which is diffused by a piece of paper (100GSM) and a custom emulsion 
film photomask target (JD Photodata Ltd, UK), comprising of multiple concentric rings. The 
LED lamp is mounted on a height and angle adjustable mount allowing it to be positioned near 
to the participant's left eye (at a 45-degree angle from the visual axis). The side camera is 
used to view a reflection of the concentric ring target in the tear film. This light also acts to 
illuminate the participants left eye for the central camera. The participant's right eye is 
illuminated with a similar LED lamp on the other side, with the intensity adjusted to create even 
illumination of the subject's eye on the central camera. This LED is also on an adjustable 
mount to optimise alignment with the participant’s eyes.  
 
Where required, a handheld pendant button (CompuPhase, Bussum, Netherlands) is also 
connected to the workstation via a USB cable. Each button press is logged by custom software 
(see Section 3.4). A linear slide (Motorised linear potentiometer, Tinkerforge GMbH, Germany) 
is also connected to the workstation via USB. Custom MATLAB software tracks subjective 
comfort during extended eye opening (see Section 3.6). 
 
Where required, a small USB-powered desk fan (RS PRO Desk Fan, RS Components Ltd., 
Corby, UK) is positioned in front and below of the participant at a distance of 50cm. When the 
fan is switched on the airflow is approximately 1.5 meter per second at the participants face. 
 
If required, the environmental humidity surrounding the DESMD device can be modified. To 
assess the impact of environmental humidity on clinical performance, the environment 
surrounding the DESMD system can be controlled using either a dehumidifier or humidifier. 
Two dehumidifiers (2 x Meaco Platinum dehumidifier, Meaco Ltd., Guildford, UK) allow the 
humidity within the testing environment to be maintained at a relatively low humidity (RH of 
- ). Use of the humidifier (Levoit LV600HH, Levoit Inc., Anaheim, CA) allows the 
testing environment to be maintained at a relatively high humididty (RH RI- ). Both 
the humidifier and dehumidifier have a humidity feedback system to maintain the desired 
relative humidity. To allow sufficient time for the room to reach the required humidity, testing 
days will be allocated to either high or low humidity testing and the required system activated 
on the evening before clinical testing. To confirm the environmental conditions are at the 
correct level, a humidity sensor (Humidity and Temperature sensor, Tinkerforge GMbH, 
Germany) will continuously measure humidity and temperature during testing via custom 
MATLAB software. 
2. DESMD preparation and testing 
Prior to testing, any surfaces which the investigator or study participant will be touching or in 
close proximity with will be wiped down with alcohol wipes. The participant will be seated at 
the instrument and the height of the chair, table and chin rest carefully adjusted to obtain a 
comfortable position for the participant. The test will be carefully explained to the participant. 
If required, the response pad and subjective feedback button will be demonstrated, and their 
use carefully explained to the study participant. The side and central camera will have their 
position adjusted to centre the region of interest and the focusing will be optimised. The 
investigator will start the video recording first and then initialise the visual task. Following 
completion of each task, the participant will be asked to sit back from the instrument. The video 
filenames will include details of subject ID, visit, vision correction, humidity, airflow and visual 
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task. Data files of measurements recorded by Matlab software (such as visual acuity, 
symptomatic events and analogue subjective comfort data) will also include this information. 
Similarly, output files generated from image analysis of captured videos will include these 
identification details.  
3. DESMD analysis metrics 
Below are several metrics which can be captured using the DESMD system: 
3.1 Blink and palpebral aperture height analysis 
The videos captured will be processed using MATLAB image analysis software. For the blink 
analysis and palpebral aperture height, only data from the left eye will be processed and 
analysed.  
 
This software loads the central camera video file and identifies the pupil location. The software 
extracts a single column of pixels from the video frame, which crosses through the pupil centre, 
and the automated process is repeated on subsequent frames, with the columns of pixel 
values concatenated across all of the frames in the video to produce a space-time plot. From 
this plot the eyelid blinking episodes can be readily visualised as downward spikes and 
subsequently marked by the investigator to determine blink frequency. Once this process is 
completed, a video frame corresponding to the first blinking time point marked on the space-
time plot is loaded and the investigator uses the mouse scroll wheel to scroll through the video 
frames until the point of maximum closure of the eyelid can be identified. The investigator then 
marks the position of the upper and lower eyelids (in line with pupil centre) at maximum closure 
to determine the gap between lids (closed palpebral aperture). This process is repeated for 
the remaining blinks identified. To determine the average palpebral aperture height (PAH), the 
position of the eyelids is assessed at any interblink interval longer than 2 seconds where no 
detectable lid movement is observed. The closed palpebral aperture is expressed as a 
percentage of the average PAH to evaluate blink completeness (with 10 LQGLFDWLQJ
complete lid closure on the blink). 
 
For the 10 most complete blinks, the blink velocity and duration will also be assessed. The 
blink cycle is divided into a closing phase and opening phase. The investigator marks the 
position of the upper lid on three specific video frames: (i) 100 frames (0.2 seconds) prior to 
maximum eyelid closure (ii) at the point of maximum eyelid closure and (iii) 500 frames (1 
second) after maximum eyelid closure. The custom software then returns to the space-time 
plot, with the position of the upper lid prior to the blink and at maximum closure highlighted, in 
DGGLWLRQWROLQHVLQGLFDWLQJWKHDQGFRPSOHWHQHVVRIOLGFORVure. The investigator 
then marks on the space-WLPHSORWWKHSRLQWDWZKLFKWKHXSSHUOLGUHDFKHVDQGRI
total closing amplitude. The relevant video frames are then displayed and the actual position 
of the upper lid at these time points is accurately marked. The software is then able to calculate 
the average closing velocity. This process is then repeated for the opening phase. The 
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DQGRIRSHQLQJDPSOLWXde. The total duration of the blink is defined as the time interval 
EHWZHHQWKHRIFORVLQJDPSOLWXGHDQGRIRSHQLQJDPSOLWXGH 
 
The software will extract the following metrics: 
Ɣ Blink rate  
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Ɣ Interblink interval (seconds) 
Ɣ Blink completeness (mm) 
Ɣ &ORVLQJDQGRSHQLQJEOLQNVSHHGPPV 
Ɣ Total blink duration (ms) 
Ɣ Closed phased duration (ms) 
Ɣ Palpebral aperture height (mm) 
 
Blink rate, interblink interval, blink completeness and palpebral aperture height metrics will be 
determined across the 5 minutes and at 1-minute increments. Blink speed and duration 
metrics will be determined for the 10 most complete blinks.  
3.2 Tear film surface quality (TFSQ) 
The infrared light next to the participants' left eye projects a pattern of concentric rings onto 
WKHFRUQHDOWHDUILOPVXUIDFHZKLFKLVLPDJHGE\WKHVLGHFDPHUD:KHQWKHUHIOHFWHGGLVF
pattern is regular, the tear film is considered to be smooth and stable. When the tear film 
becomes unstable, the reflection of the rings is disturbed. The custom MATLAB algorithm 
developed for the DESMD system, characterises tear film dynamics by the morphological 
changes of the reflected pattern reflections, based on the methodology described in Downie 
et al. (Automated Tear Film Surface Quality Breakup Time as a Novel Clinical Marker for Tear 
Hyperosmolarity in Dry Eye Disease. IOVS 2015). Prior to analysis of the images, any frames 
affected by blinking or large eye movements will be detected and removed from the analysis. 
The central circular ring is then detected allowing the analysis to be centred relative to the 
reflected mires. The image is then transformed from Cartesian to polar coordinates, converting 
the concentric rings into broadly horizontal lines. The background of the polar coordinates is 
then subtracted from the polar image using morphological operations. Global thresholding is 
then performed to enhance the morphology of the reflected mires. The video is then processed 
and an index (Tear film Surface Quality -TFSQ) extracted at 1 second intervals. The average 
and SD of TFSQ will be determined across the 5 minutes and at 1-minute increments.  
3.3 Tear meniscus height (TMH) 
The videos captured will be processed using MATLAB image analysis software. This software 
loads the side camera video file which captures the inferior tear meniscus of the left eye. 
Following spatial calibration, a video frame is loaded and the investigator is instructed to mark 
the upper and lower border of the reflected line of the tear meniscus at approximately 6 o’clock 
position. The software determines the tear meniscus height and this process is repeated every 
30 frames (i.e. 1 second). The average and SD of the tear meniscus height will be determined 
across the 5 minutes and at 1-minute increments.  
3.4 Symptomatic events 
Subjects will be asked to report episodes of discomfort or lens awareness while undertaking 
the visual tasks by pressing a handheld subjective feedback button, which will record a time-
stamped event. Subjects will be instructed to press the button again after 10 seconds if the 
symptom is still present. Each button press is logged by custom software, which will extract 
the number and time of symptomatic events.  
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3.5 Tear film stability during extended eye opening 
This test is performed with the right eye closed (either by the participant gently holding their 
eyelid closed, or with the use of an eye patch). The participant is asked to fixate a Maltese 
cross displayed on the DESMD screen. The participant is then instructed to take two natural 
blinks and then avoid blinking for as long as possible (up to a maximum of 30 seconds). During 
this time the side camera will capture a video of the reflected concentric ring mire pattern. The 
participant will then sit back from the DESMD and rest for 5 minutes. The testing process will 
then be repeated on two further occasions with a five-minute recovery period between each 
test. The video captured by the side camera will subsequently be analysed to extract the TFSQ 
over the 30 second period. The tear film break-up time will then be calculated for each of the 
three periods of extended eye opening.  
3.6 Subjective comfort analogue slider during extended eye opening 
A linear slide potentiometer will be used to record subjective discomfort during an extended 
eye-opening period. After training, subjects will be asked to rate the ocular discomfort with the 
potentiometer while they look at a visual target and keep the left eye open as long as possible. 
This test will be performed with the right eye closed, so that the observation relates only to the 
left eye. The subjective discomfort data will be processed using a custom MATLAB software, 
which extracts the level of discomfort on a 0 to 10 scale (10 = no discomfort; 0 = very 
uncomfortable) at approximately 0.1-second intervals for the recorded period. The discomfort 
data will be plotted against time for visual inspection. The rate of comfort change will be 
determined. Three measurements of subjective comfort (using the analogue slider) during 
extended eye opening will be captured.  
3.7 Continuous acuity testing during extended eye opening 
The continuous acuity testing during extended eye-opening task is similar to the continuous 
VA testing visual task (see Section 10), although once a threshold visual acuity has been 
reached, the participant is asked to avoid blinking for as long as possible whilst continuing to 
assess visual acuity. This test is performed with the right eye closed, so that the observation 
relates only to the left eye. The custom MATLAB software will automatically calculate the 
moving average and SD of visual acuity prior to and during the extended eye-opening period. 
Three measurements of continuous acuity testing during extended eye opening will be 
captured.  
3.8 Pupil size and Interpupillary distance 
The central camera video will be processed using custom MATLAB image analysis software. 
This software loads the video file and, following spatial calibration, automatically detects the 
pupil, fitting a circle to the right and left eye pupil. This process is repeated every 50 frames 
(i.e., 0.1 seconds). The software extracts the pupil diameter for the right and left eye pupil and 
interpupillary distance in millimetres. The average and SD of pupil diameter and interpupillary 
distance will be determined across the 5 minutes and at 1-minute increments. 
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4 Visual tasks  
4.1 Maltese cross 
For simple fixation tasks, such as tear film stability testing (see Section 3.5), a Maltese cross 
is displayed on the DESMD monitor.  
4.2 Documentary video  
Subjects will be instructed to watch a 5-minute video, a wildlife documentary film, whilst the 
central and side camera capture a video of the participants eyes. All subjects will watch the 
same wildlife documentary videos during the study, which will be specifically selected to 
minimise any emotional reaction or changes in emotional state during the video recording. 
During this task, subjects will be asked to report symptomatic events using the handheld 
device, as described in Section 8. 
4.3 Tetris-type game 
Subjects will be required to play a MATLAB version of the classic Tetris game during a 5-
minute period. Subjects will be instructed to use their dominant hand to press the arrow keys 
on a keyboard to move the pieces and the non-dominant hand to use the handheld feedback 
button to report symptomatic events during the task. All subjects will start playing the game on 
level 1. If the game is over before the 5-minute time point, the game will be restarted. 
4.4 Continuous VA test 
Custom MATLAB software will be used to assess continuous visual acuity during a 5-minute 
period. During the test, the software presents a rotating optotype Landolt ‘C’. The subject is 
instructed to track the orientation of the ‘C’ by pressing the arrow keys on a keyboard. The 
starting optotype size is 0.5 LogMAR and increases by 0.02 with a correct response and 
decreases by 0.02 with an incorrect response. Once a response is made the result is logged 
by the custom software and a new target is presented. The custom MATLAB software will 
automatically calculate the moving average and SD of visual acuity will be determined 
across the 5 minutes and at 1-minute increments. During this task, subjects will be asked to 
report symptomatic events using the handheld device, as described in Section  
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Clinical Study Protocol 
Johnson & Johnson Vision Care, Inc. 
 
 
 
 
APPENDIX H: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
 
 
 
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