Conditions: Visual Acuity
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 46
Healthy volunteers: yes

Brief summary:
This will be a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2X2 crossover study.

Detailed description:

Arms:
arm 1: Eligible subjects who are habitual soft contact lens wearers will be randomized into the Test/Control sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (test then control). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated. arm 2: Eligible subjects who are habitual soft contact lens wearers will be randomized into the Control/Test sequence, to receive 1-2 drops on each eye (right eye followed by left eye) over soft spherical contact lenses, over two wear periods (control then test). A washout period of 90 minutes between eyedrop instillations will occur. The second eyedrop as per the randomization schedule will follow the same procedure as previously stated.

Interventions: intervention 1: Blink® Tears eye drops in a multidose bottle intervention 2: Preservative-free investigational lubricating eye drops in a Novelia® eyedropper
Intervention descriptions: intervention 1: Control intervention 2: Test

Protocol document:
Prot_SAP_000.pdf: 
Protocol Title: Clinical Investigation of Visual Acuity in Contact Lens Wearers after Instillation of Investigational 
Lubricating Eye Drops 
 
Protocol CR-6503  
 
Version: 2.0  
 
Date: 24 April 2023  
 
 
Investigational Products: Product 
 (Investigational Lubricating Eye Drop 
 in a Novelia® 
Multidose Eyedropper) 
 
Approved Products: Blink® Tears lubricating eyedrops in a multidose bottle   
 
Keywords: artificial tears, non-dispensing, visual acuity, dry eye 
 
 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
 
This clinical trial will be conducted in compliance with ISO 14155:2020 Clinical investigation of medical devices 
for human subjects – Good clinical practice,1 International Council for Harmonization Good Clinical Practice 
ICH E6(R2) (ICH GCP)4 guidelines, and the Declaration of Helsinki.2 
 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, released or published 
without written approval from Johnson & Johnson Vision Care, Inc. The information may not be disclosed to 
others except to the extent necessary to obtain Institutional Review Board/Independent Ethics Committee 
approval and informed consent, or as required by International, Federal and State Laws, as applicable. Persons to 
whom this information is disclosed must be informed that this information is privileged and confidential and that 
it should not be further disclosed without the written permission of Johnson & Johnson Vision Care, Inc. Any 
supplemental information that may be added to this document is also confidential and proprietary to Johnson & 
Johnson Vision Care, Inc. and must be kept in confidence in the same manner as the contents of this document. 
 
 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION AND DATE.................................................................................... 6 
SPONSOR NAME AND ADDRESS ..................................................................................................................... 6 
MEDICAL MONITOR .......................................................................................................................................... 6 
AUTHORIZED SIGNATURES ............................................................................................................................. 7 
CHANGE HISTORY ............................................................................................................................................. 8 
SYNOPSIS ........................................................................................................................................................... 10 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS .......................... 13 
1. 
INTRODUCTION AND BACKGROUND ............................................................................................ 15 
1.1. 
Name and Descriptions of Investigational Products ........................................................................... 15 
1.2. 
Intended Use of Investigational Products............................................................................................ 16 
1.3. 
Summary of Findings from Nonclinical Studies ................................................................................. 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .............................................................. 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study .......... 16 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ............................................................... 17 
2.1. 
Objectives ........................................................................................................................................... 17 
2.2. 
Endpoints ............................................................................................................................................ 17 
2.3. 
Hypotheses .......................................................................................................................................... 17 
3. 
TARGETED STUDY POPULATION .................................................................................................... 17 
3.1. 
General Characteristics ....................................................................................................................... 17 
3.2. 
Inclusion Criteria ................................................................................................................................ 17 
3.3. 
Exclusion Criteria ............................................................................................................................... 17 
3.4. 
Enrollment Strategy ............................................................................................................................ 18 
4. 
STUDY DESIGN AND RATIONALE ................................................................................................... 18 
4.1. 
Description of Study Design ............................................................................................................... 18 
4.2. 
Study Design Rationale ....................................................................................................................... 19 
4.3. 
Enrollment Target and Study Duration ............................................................................................... 19 
5. 
TEST ARTICLE ALLOCATION AND MASKING .............................................................................. 19 
5.1. 
Test Article Allocation ........................................................................................................................ 19 
5.2. 
Masking .............................................................................................................................................. 20 
5.3. 
Procedures for Maintaining and Breaking the Masking ...................................................................... 20 
6. 
STUDY INTERVENTION ..................................................................................................................... 20 
6.1. 
Identity of Test Articles ...................................................................................................................... 20 
6.2. 
Ancillary Supplies/Products ................................................................................................................ 21 
6.3. 
Administration of Test Article ............................................................................................................ 21 
6.4. 
Packaging and Labeling ...................................................................................................................... 21 
6.5. 
Storage Conditions .............................................................................................................................. 22 
6.6. 
Collection and Storage of Samples ..................................................................................................... 22 
6.7. 
Accountability of Test Articles ........................................................................................................... 22 
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7. 
STUDY EVALUATIONS ...................................................................................................................... 22 
7.1. 
Time and Event Schedule ................................................................................................................... 22 
7.2. 
Detailed Study Procedures .................................................................................................................. 23 
VISIT 1 ....................................................................................................................................................... 23 
FINAL EVALUATION .............................................................................................................................. 27 
7.3. 
Unscheduled Visits ............................................................................................................................. 27 
7.4. 
Laboratory Procedures ........................................................................................................................ 28 
8. 
SUBJECTS COMPLETION/WITHDRAWAL ...................................................................................... 28 
8.1. 
Completion Criteria ............................................................................................................................ 28 
8.2. 
Withdrawal/Discontinuation from the Study ...................................................................................... 29 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION .......................................... 29 
9.1. 
Systemic Medications ......................................................................................................................... 29 
10. 
DEVIATIONS FROM THE PROTOCOL .............................................................................................. 30 
11. 
STUDY TERMINATION ....................................................................................................................... 31 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .......................................... 32 
13. 
ADVERSE EVENTS .............................................................................................................................. 32 
13.1. 
Definitions and Classifications ........................................................................................................... 32 
13.2. 
Assessing Adverse Events .................................................................................................................. 34 
13.2.1. 
Causality Assessment............................................................................................................. 34 
13.2.2. 
Severity Assessment .............................................................................................................. 34 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................................................ 35 
13.4. 
Reporting Adverse Events .................................................................................................................. 36 
13.4.1. 
Reporting Adverse Events to Sponsor ................................................................................... 36 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities ................... 36 
13.5. 
Event of Special Interest ..................................................................................................................... 36 
13.6. 
Reporting of Pregnancy ...................................................................................................................... 36 
14. 
STATISTICAL METHODS ................................................................................................................... 37 
14.1. 
General Considerations ....................................................................................................................... 37 
14.2. 
Sample Size Justification .................................................................................................................... 37 
14.3. 
Analysis Populations ........................................................................................................................... 38 
14.4. 
Level of Statistical Significance.......................................................................................................... 38 
14.5. 
Primary Analysis ................................................................................................................................. 38 
14.6. 
Secondary Analysis ............................................................................................................................. 39 
14.7. 
Other Exploratory Analysis ................................................................................................................ 39 
14.8. 
Interim Analysis .................................................................................................................................. 39 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................................................ 39 
14.10. Procedure for Reporting Deviations from Statistical Plan .................................................................. 39 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................................................ 39 
15.1. 
Electronic Case Report Form/Data Collection .................................................................................... 39 
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15.2. 
Subject Record .................................................................................................................................... 40 
15.3. 
Trial Registration on ClinicalTrials.gov.............................................................................................. 40 
16. 
DATA MANAGEMENT ........................................................................................................................ 40 
16.1. 
Access to Source Data/Document ....................................................................................................... 40 
16.2. 
Confidentiality of Information ............................................................................................................ 40 
16.3. 
Data Quality Assurance ...................................................................................................................... 40 
16.4. 
Data Monitoring Committee (DMC) .................................................................................................. 41 
17. 
CLINICAL MONITORING .................................................................................................................... 41 
18. 
ETHICAL AND REGULATORY ASPECTS ........................................................................................ 41 
18.1. 
Study-Specific Design Considerations ................................................................................................ 41 
18.2. 
Investigator Responsibility ................................................................................................................. 41 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) ......................................... 42 
18.4. 
Informed Consent ................................................................................................................................ 42 
18.5. 
Privacy of Personal Data ..................................................................................................................... 43 
19. 
STUDY RECORD RETENTION ........................................................................................................... 44 
20. 
FINANCIAL CONSIDERATIONS ........................................................................................................ 44 
21. 
PUBLICATION ...................................................................................................................................... 44 
22. 
REFERENCES ........................................................................................................................................ 44 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ................................... 46 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................................................... 47 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................................................... 48 
APPENDIX D: 
..................................................................... 50 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING .................................................. 51 
 LENS FITTING CHARACTERISTICS ............................................................................................ 58 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ....................................................... 64 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE ERROR ............. 66 
 BIOMICROSCOPY SCALE ............................................................................................................. 72 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ..................................... 78 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE .............................. 83 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION ..................................... 87 
APPENDIX E: 
 GUIDELINES FOR COVID-19 RISK MITIGATION............................................. 96 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ...................................................... 108 
 
LIST OF TABLES 
Table 1: Target number of subjects by site ........................................................................................................... 19 
Table 2. Subject assignment to treatments (eye drops) ........................................................................................ 20 
Table 3: Test Articles ........................................................................................................................................... 20 
Table 4: Ancillary Supplies .................................................................................................................................. 21 
Table 5: Time and Events ..................................................................................................................................... 22 
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Table 6: Systemic medications list ....................................................................................................................... 29 
Table 7: Disallowed systemic antihistamines ....................................................................................................... 30 
Table 8: Examples of major and minor protocol deviations ................................................................................. 31 
Table 9: Descriptive Summary of Monocular LogMAR Visual Acuity from 
 – Per Protocol Population
 .............................................................................................................................................................................. 37 
Table 10: Power for the Primary Endpoint ........................................................................................................... 38 
 
LIST OF FIGURES 
Figure 1: Study Flowchart .................................................................................................................................... 13 
Figure 2: The mechanism for dispensing drops in the Novelia® system .............................................................. 15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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minimum of 6 hours per day, for a minimum of 2 days per week 
during the last 30 days. 
 
Inclusion Criteria at Baseline Evaluation 
 
5. Subjects must achieve visual acuity of 20/30 or better in each eye, 
with their habitual contact lenses. 
 
Eligibility Criteria - Exclusion 
Potential subjects who meet any of the following criteria will be excluded 
from participating in the study:  
 
Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be diabetic.  
3. Be currently using any ocular medications or have any ocular 
infection of any type which may interfere with the clinical trial 
(at the investigator’s discretion). 
4. By self-report, have any ocular or systemic disease, allergies, 
infection, or use of medication that might contraindicate or 
interfere with the clinical trial, or otherwise compromise study 
endpoints, 
including 
infectious 
disease 
(e.g., 
hepatitis, 
tuberculosis), contagious immunosuppressive disease (e.g., 
Human Immunodeficiency Virus [HIV]), autoimmune disease 
(e.g., rheumatoid arthritis, Sjögren’s syndrome), or history of 
serious mental illness or seizures. See section 9.1 for additional 
details regarding excluded systemic medications. 
5. Have habitually worn rigid gas permeable (RGP) lenses, 
orthokeratology lenses, or hybrid lenses (e.g., SynergEyes, 
SoftPerm) within the past 3 months.  
6. Have participated in any pharmaceutical or medical device 
related clinical trial within 14 days prior to study enrollment.  
7. Be an employee (e.g., Investigator, Coordinator, Technician) or 
immediate family member of an employee (including partner, 
child, parent, grandparent, grandchild or sibling of the employee 
or their spouse) of the clinical site. 
8. Be a current habitual user of prescription medication to treat dry 
eye and ocular discomfort, ocular steroids, or any medication (RX 
or OTC) except artificial tears, that would interfere with the 
clinical study (at the discretion of the investigator).  
9. Have any known allergy or sensitivity to ingredients that the 
investigational product may contain (e.g., Sodium Chlorite, Boric 
Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium 
Chloride, Calcium Chloride Dihydrate, Magnesium Chloride 
Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate and 
Purified Water). 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
10. Have clinically significant (grade 3 or higher on the FDA grading 
scale) slit lamp findings (e.g., corneal edema, neovascularization 
or staining, tarsal abnormalities, or bulbar injection) or other 
corneal or ocular disease or abnormalities that contraindicate 
participation or may otherwise compromise study endpoints 
(including entropion, ectropion, chalazia, recurrent styes, 
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glaucoma, history of recurrent corneal erosions, aphakia, 
moderate or above corneal distortion, herpetic keratitis). 
11. Have a history of strabismus or amblyopia. 
12. Have had or have planned (within the study period) any ocular or 
intraocular surgery (e.g., radial keratotomy, PRK, LASIK, 
iridotomy, cataract removal, retinal laser photocoagulation, etc.). 
13. Have any significant corneal distortion due to previous contact 
lens wear, surgery, or pathology (At the discretion of the 
investigator).  
Disallowed 
Medications/Interventions 
Current habitual use of Prescription Medicines to treat dry eye or ocular 
discomfort, ocular steroids, or any medication (RX or OTC) that would 
interfere with the clinical study (at the discretion of the investigator). 
Measurements and Procedures 
LogMAR visual acuity, slit lamp finding using FDA scale, Snellen visual 
acuity, subject reported ocular symptoms 
Microbiology or Other 
Laboratory Testing 
None 
Study Termination 
The occurrence of a Serious Adverse Event (SAE) for which a causal 
relationship to a test article cannot be ruled out, will result in stopping 
further dispensing investigational product. In the event of a 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 
ScleralFil (Bausch + Lomb), Fluorescein (Akorn, Inc.) or another country-
specific alternative approved by the sponsor. 
Principal Investigator(s) and 
Study Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and institutions is kept 
separately from the Study Protocol and is included in the study Trial 
Master File. 
 
 
 
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Figure 1: Study Flowchart 
COMMONLY USED ABBREVIATIONS, ACRONYMS AND DEFINITIONS OF TERMS 
Add 
 
 
Near addition; the additional power required for near vision correction  
ADR 
 
 
Adverse Drug Reaction 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA  
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
COM 
 
 
Clinical Operations Manager 
COVID-19 
 
Coronavirus Disease 2019 
CRA 
 
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO 
 
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC 
 
 
Data Monitoring Committee 
eCRF 
 
 
Electronic Case Report Form 
EDC 
 
 
Electronic Data Capture 
ETDRS  
 
Early Treatment Diabetic Retinopathy Study 
FDA 
 
 
Food and Drug Administration 
GCP 
 
 
Good Clinical Practice 
HIPAA  
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council for Harmonization 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intention-to-Treat 
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JJVC 
 
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP 
 
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
PQC 
 
 
Product Quality Complaint 
PRO 
 
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
VA 
 
 
Visual Acuity 
 
 
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1. 
INTRODUCTION AND BACKGROUND 
It is estimated that Dry Eye Diseases (DED) affect approximately 16 million patients over 18 years of age in the 
United States.5 Topical artificial tears or tear supplements are often used to treat the symptoms of dryness and 
discomfort associated with the condition6. Toxic effects of preservatives used in topical ocular formulations have 
been documented to induce conjunctival inflammation and tear-film instability in human and animal studies, 
highlighting the need for preservative-free options in topical preparations7. Given the potential of additional 
benefit of preservative-free topical tear supplements, JJV CEH has already introduced Blink® Tears Preservative 
Free lubricating eye drops in single dose vials. However, JJV CEH currently does not offer preservative-free 
topical tear supplements in a multidose dropper.   
 
This study will investigate a new investigational product 
 which contains the marketed formulation 
 in a Novelia® eyedropper, along with the marketed Blink® Tears (Johnson & Johnson Surgical Vision, 
Santa Ana, CA) as a control in up to 3 clinical sites in the US. 
 
Figure 2: The mechanism for dispensing drops in the Novelia® system 
 
Figure 2 above shows the mechanism of drug delivery system utilized by a Novelia® (Nemera Inc, France) 
eyedropper where the squeezing action of the bottle/eyedropper opens a valve which facilitates the dispensing 
of a single drop. The intricate system of valves closes immediately which stops the potential backflow of the 
drop which comes into contact with air/external environment, hence maintaining sterility of the formulations 
contained in the bottle. 
1.1. 
Name and Descriptions of Investigational Products  
The products which will be used in this clinical study is listed below: 
 
x 
Investigational Eye Drops 
 in a Novelia® eyedropper, Product 
 (Test) 
x 
Approved Products: Blink® Tears eye Drops (Control) 
 
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Blink® Tears is a marketed product with preservatives while the investigational lubricating eye drops do not 
contain any preservatives and are maintained sterile in a multi-dose Novelia® eyedropper.  
1.2. 
Intended Use of Investigational Products 
The investigational eye drops are developed as preservative-free lubricating eye drops, and the other product, 
the control drop is CE approved and is a marketed eye drop, available over the counter (without a prescription) 
in the US.  
 
The intended use of the study artificial tears is treatment of subjects with symptoms of ocular dryness. The 
indications for the investigational eyedrops are consistent with 21 CFR Part 349.60 pertaining to the demulcent 
eyedrops as per the FDA OTC monograph8. The following are the indications: 
x 
For the temporary relief of burning and irritation due to dryness of the eye. 
x 
For the temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or 
sun. 
x 
For use as a protectant against further irritation or to relieve dryness of eye. 
x 
For use as a lubricant to prevent further irritation or relieve dryness of the eye. 
 
In this study, the test articles will be used over the soft spherical contact lenses in a non-dispensing modality 
to assess visual acuity after instillation to support EU registration. In the EU, the eyedrops will be intended to 
be used with contact lens wear.  
1.3. 
Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical trials on humans. 
For the most comprehensive nonclinical information regarding the investigational eye drops in a Novelia® 
eyedropper, refer to the latest version of the Investigator’s Brochure9. 
1.4. 
Summary of Known Risks and Benefits to Human Subjects 
The following risks/adverse events can be associated with using artificial tears, in general: 
x 
There may be less comfort than when the drop was first placed on the eye. 
x 
The eyes may burn, sting and/or itch. 
x 
There may be a feeling of something in the eye (foreign body, scratched area). 
x 
There may be the potential for some temporary impairment due to peripheral infiltrates, peripheral 
corneal ulcers, and corneal erosion. 
x 
There may be the potential for other physiological observations, such as local or generalized edema, 
corneal neovascularization, corneal staining, injection, tarsal abnormalities, iritis, and conjunctivitis, 
some of which are clinically acceptable in low amounts. 
x 
There may be excessive watering, unusual eye secretions, or redness of the eye. 
x 
Poor visual acuity, blurred vision, rainbows or halos around objects, photosensitivity, or dry eyes may 
also occur if the drops are used continuously or for too long a time. 
 
There is no direct benefit to the subject for participating in the study, although they will be able to try out new 
artificial tears. The information from this study will aid in the further development and design of new 
preservative free artificial tears. 
 
For the most comprehensive clinical information regarding the control eyedrops refer to the package insert 
(Appendix C). 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
Refer to the Investigator’s Brochure9 and package insert for control eyedrops (Appendix C) for additional 
information.  
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2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. 
Objectives  
The objective of this study will be to demonstrate that visual acuity after instillation of the test eyedrops is non-
inferior to visual acuity after instillation of the control eye drops in habitual soft spherical contact lens wearers.   
 
This study is being conducted to support product registration in the European Union. 
2.2. 
Endpoints  
Primary Endpoint: 
x 
Monocular distance (4 m) High Luminance, Low Contrast (HLLC) logMAR visual acuity under high 
illumination 
 
Exploratory endpoints: 
The exploratory endpoints in this study are: 
x 
Slit lamp findings using FDA scale 
x 
Snellen best corrected distance visual acuity 
x 
Subject reported ocular symptoms 
x 
Number of adverse events 
x 
Number and reasons for discontinuation will be monitored 
x 
Contact lens fitting assessment 
2.3. 
Hypotheses 
Primary Hypothesis: 
x 
Monocular distance (4 m) High Luminance, Low Contrast (HLLC) logMAR visual acuity at 10-minute 
after instillation of the Preservative-free investigational lubricating eye drops in a Novelia® eyedropper 
will be non-inferior to the monocular distance (4m) HLLC logMAR at 10-minutes after the installation 
of Blink® Tears eye drops in a multidose bottle. A non-inferiority margin of 0.05 logMAR will be used. 
 
3. 
TARGETED STUDY POPULATION 
3.1. 
General Characteristics  
Habitual soft spherical contact lens wearers of 18-69 years of age.  
3.2. 
Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
 
Inclusion Criteria following Screening 
The subject must: 
1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed 
copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Be between 18 and 69 (inclusive) years of age at the time of screening. 
4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily reusable or daily 
disposable wear modality (i.e., not extended wear modality). Habitual wear is defined as a minimum of 
6 hours per day, for a minimum of 2 days per week during the last 30 days. 
 
Inclusion Criteria at Baseline Evaluation 
5. Subjects must achieve visual acuity of 20/30 or better in each eye, with their habitual contact lenses. 
3.3. 
Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating in the study:  
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Exclusion Criteria following Screening 
The subject must not: 
1. Be currently pregnant or lactating. 
2. Be diabetic.  
3. Be currently using any ocular medications or have any ocular infection of any type which may 
interfere with the clinical trial (at the investigator’s discretion). 
4. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might 
contraindicate or interfere with the clinical trial, or otherwise compromise study endpoints, including 
infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human 
Immunodeficiency Virus [HIV]), autoimmune disease (e.g., rheumatoid arthritis, Sjögren’s syndrome), 
or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded 
systemic medications. 
5. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g., 
SynergEyes, SoftPerm) within the past 3 months.  
6. Have participated in any pharmaceutical or medical device related clinical trial within 14 days prior to 
study enrollment.  
7. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an 
employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their 
spouse) of the clinical site. 
8. Be a current habitual user of prescription medication to treat dry eye and ocular discomfort, ocular 
steroids, or any medication (RX or OTC) except artificial tears, that would interfere with the clinical 
study (at the discretion of the investigator).  
9. Have any known allergy or sensitivity to ingredients that the investigational product may contain (e.g., 
Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, Sodium Chloride, Potassium Chloride, 
Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Polyethylene Glycol 400, Sodium 
Hyaluronate and Purified Water). 
 
Exclusion Criteria at Baseline Evaluation 
The subject must not: 
10. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal 
edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular 
disease or abnormalities that contraindicate participation or may otherwise compromise study endpoints 
(including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal 
erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). 
11. Have a history of strabismus or amblyopia. 
12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial 
keratotomy, PRK, LASIK, iridotomy, cataract removal, retinal laser photocoagulation, etc.). 
13. Have any significant corneal distortion due to previous contact lens wear, surgery, or pathology (At the 
discretion of the investigator). 
3.4. 
Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or utilizing Independent 
Ethics Committee (IEC) or Institutional Review Board (IRB) approved materials.  
 
4. 
STUDY DESIGN AND RATIONALE 
4.1. 
Description of Study Design 
This is a single-visit, multi-site, randomized, single-masked, bilateral, active-controlled, non-dispensing, 2x2 
crossover study. Approximately 45 subjects will be screened and assigned to both the test and control drops in a 
random order. The goal is for a sample size of 38 after subjects who withdraw or discontinue.  The subjects will 
present wearing their habitual contact lenses on. 
At Visit 1, subjects will be consented and screened for inclusion and exclusion criteria. Baseline High Luminance, 
Low Contrast (HLLC) logMAR visual acuity under high illumination will be measured with their habitual contact 
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lenses. If a subject is found to meet all eligibility criteria, the subjects will be assigned to receive the eyedrops in 
a randomized order. A single drop (Eyedrops #1) will first be placed on the right eye followed by the left eye. 
LogMAR visual acuity will then be recorded 3 minutes and 10 minutes post eyedrop application on the right eye. 
This will be followed by a washout of 90 minutes. The second eyedrop (Eyedrops#2) as per the randomization 
schedule will then be placed on the right eye followed by the left eye. LogMAR visual acuity will be recorded 3 
minutes and 10 minutes post the eyedrop application on the right eye. The subject will then complete the final 
evaluation.      
4.2. 
Study Design Rationale 
 
The single-masked, randomized 2x2 cross-over design will be used to allow for each subject to be his/her own 
control. Furthermore, it is also desirable that the study encompass a variety of subjects wearing diverse brands or 
materials as well as different modalities of soft, spherical contact lenses, as the investigational product is intended 
to be compatible with all soft contact lens materials. Given a large distribution of possible types or brands, or 
materials of contact lenses, a crossover study was deemed to be more relevant and applicable to investigate the 
potential outcomes.    
In addition to visual acuity investigation, this study will also be useful to explore the impact of the artificial tears 
to the fitting of subjects’ own habitual contact lenses which also merits a crossover design. Moreover 
 
a previous study using the same marketed eyedrop as a control, employed a crossover design with a 90-minute 
washout to document the effects of lubricating eyedrops on low contrast LogMAR visual acuity.   
4.3. 
Enrollment Target and Study Duration 
 
A total of up to 45 subjects will be enrolled (informed consent signed) and the eyedrop application randomized 
in up to 3 clinical sites in the US. The goal is for a sample size of 38 subjects after subjects who withdraw or are 
discontinued. The Investigator is responsible for ensuring that all subjects entering the study conform to subject 
selection criteria. The number of subjects targeted for randomization and completion are as follows: 
Table 1: Target number of subjects by site 
 
Total 
Randomization 
45 
Completion 
38 
Number of sites 
3 
Number of subjects per site 
15 
 
The study will last approximately 1.5 months and includes an approximately 1-month enrollment period. Once 
the informed consent has been signed the subject will be considered enrolled. An additional subject may be 
enrolled if a subject discontinues from the study prematurely. Subjects who are discontinued prior to the final 
evaluation may be replaced at the discretion of the study sponsor. The investigation will end at the time that the 
study data is hard locked. 
 
5. 
TEST ARTICLE ALLOCATION AND MASKING 
5.1. 
Test Article Allocation  
Subjects will be randomly assigned to one of two unique sequence groups (Test/Control and Control/Test) to 
bilaterally receive two different test articles i.e., one investigational formulation in a Novelia® eyedropper and 
another marketed Blink® Tears eyedrops, one at a time over the same visit (Table 2).  
 
 
 
 
 
 
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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 
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, breakages, etc.), only in situations where there is no deficiency alleged 
by the subject. 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be recorded in the 
EDC system, which will trigger an automatic email notification to the appropriate COM/CRA and Clinical QA 
representative. In cases where the EDC system in use is not configured to send automatic notifications or when 
an EDC system is not used, the COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC 
has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect additional information 
which will include:  
x 
Date the complaint was received/recorded in the EDC System (Date of Sponsor Awareness). 
x 
Who received the complaint. 
x 
Study number. 
x 
Clinical site information (contact name, site ID, telephone number). 
x 
Lot number(s). 
x 
Unique Subject Identifier(s). 
x 
Indication of who first observed complaint (site personnel or subject). 
x 
OD/OS indication, along with whether the eyedrop was used. 
x 
Any related AE number if applicable. 
x 
Detailed complaint description (scheduled/unscheduled visit, time of eyedrop usage, 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 in a patient or clinical investigation subject 
administered a pharmaceutical product and which does not necessarily have a causal relationship with this 
treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal 
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laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) 
product, whether or not related to the medicinal (investigational) product.”  
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study but appeared or reappeared following initiation of the study. 
2. Was present prior to the study but worsened during the study. This would include any condition resulting 
from concomitant illnesses, reactions to concomitant medications, or progression of disease states. 
NOTE: Pregnancy must be documented as an adverse event and must be reported to the clinical monitor 
and to the Sponsor immediately upon learning of the event. 
 
Serious Adverse Event (SAE) – An SAE is any adverse event that led to any of the following: 
x 
Death 
x 
Serious deterioration in the health of the subject that resulted in any of the following: 
x 
Life-threatening illness or injury 
x 
Permanent or persistent impairment of a body structure or a body function 
x 
Hospitalization or prolongation of patient hospitalization 
x 
Medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to 
a body structure or a body function. 
x 
Chronic disease 
x 
Foetal distress, foetal death or a congenital physical or mental impairment of birth defect. 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not limited to: 
x 
Microbial Keratitis (MK) 
x 
Iritis (including cells in the anterior chamber) 
x 
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines or greater 
x 
Central Corneal Opacity 
x 
Central Corneal Neovascularization 
x 
Uveitis 
x 
Endophthalmitis 
x 
Hypopyon 
x 
Hyphemia 
x 
Penetration of Bowman’s Membrane 
x 
Persistent Epithelial Defect 
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 test articles (excluding Serious Adverse Events). 
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but not limited to the 
following: 
x 
Significant Infiltrative Events (SIE) 
x 
Any Temporary Loss of > 2 Lines of BSCVA 
x 
Other grade 3 or higher corneal findings, such as abrasions or edema 
x 
Corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x 
Asymptomatic Corneal Scar 
x 
Any corneal event which necessitates temporary eyedrop discontinuation > 2 weeks 
 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic and usually do not 
warrant discontinuation of tear supplement use but may cause further symptoms.  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) 
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x 
Papillary Conjunctivitis 
x 
Superficial Punctate Keratitis (SPK) 
x 
Conjunctivitis: Bacterial, Viral, Allergic 
x 
Blepharitis 
x 
Meibomianitis 
x 
Contact Dermatitis 
x 
Localized Allergic Reactions or infections 
x 
Any corneal event not explicitly defined as serious or significant adverse event, which necessitates 
temporary eyedrop discontinuation < 2 weeks 
 
Adverse Drug Reaction (ADR): An ADR is referred to all “noxious and unintended responses to a drug 
product related to any dose where a causal relationship between a medical product and an adverse event is at 
least a reasonable possibility, i.e., the relationship cannot be ruled out.”  
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure the events are 
categorized correctly. Elements of categorization will include: 
x 
Seriousness/Classifications (see definition in section 13.1). 
x 
Causality or Relatedness – i.e. the relationship between the test article, study treatment or study 
procedures and the adverse event (not related, unlikely related, possibly related, or related - see definition 
in section 13.2.1). 
x 
Adverse Event Severity – Adverse event severity is used to assess the degree of intensity of the adverse 
event (mild, moderate, or severe - see definition in section 13.2.2). 
x 
Outcome – not recovered or not resolved, recovering, or resolving, recovered, or resolved with sequelae, 
recovered, or resolved, death related to adverse event, or unknown. 
x 
Actions Taken – none, temporarily discontinued, permanently discontinued, or other. 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the test article. The 
test article relationship for each adverse event should be determined by the investigator using these explanations: 
x 
Not Related- An adverse event that is not related to the use of the test article, study treatment or study 
procedures. 
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. 
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x 
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy and interferes with 
the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the subjects are exposed 
to the test article, study treatment or study procedure.  Adverse events reported before the use of test article, start 
of study treatment, or study procedures will be recorded as medical history. However, if the condition deteriorates 
at any time during the study, it will be recorded and reported as an AE. Untoward medical events reported after 
the subject’s exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the subject record and 
in the eCRFs and complete the Adverse Event eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All Adverse Events including 
local and systemic reactions not meeting the criteria for “serious adverse events” shall be captured on the 
appropriate case report form or electronic data system. All adverse events occurring while the subject is enrolled 
in the study must be documented appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. All adverse events 
will be followed in accordance with applicable licensing requirements. Such documentation will include the 
following: 
x 
Adverse event (diagnosis not symptom). 
x 
Drawings or photographs (where appropriate) that detail the finding (e.g., size, location, and depth, etc.). 
x 
Date the clinical site was notified. 
x 
Date and time of onset. 
x 
Date and time of resolution. 
x 
Adverse event classification, severity, and relationship to test articles, as applicable. 
x 
Treatment regimen instituted (where appropriate), including concomitant medications prescribed, in 
accordance with applicable licensing requirements. 
x 
Any referral to another health care provider if needed. 
x 
Outcome, ocular damage (if any). 
x 
Likely etiology. 
x 
Best corrected visual acuity at the discovery of the event and upon conclusion of the event, if the AE is 
related to the visual system. 
 
Upon discovery of an AE that is deemed ‘possibly related’ or ‘related’ to the test article or study procedures 
(whether related to the visual system or not), an AE review form 
 must be completed. Additional 
dated and initialed entries should be made at follow-up evaluations. Separate forms must be completed for each 
eye if the AE is bilateral.  
 
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment eCRF. Where 
necessary, a culture of the corneal lesion will be collected to determine if the infection is microbial in nature. If 
cultures are collected, the date of culture collection and laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration of the event at each 
level of intensity to be performed. Adverse events characterized as intermittent require documentation of the onset 
and duration of each episode. Changes in the assessment of relationship to the Test Article shall also be clearly 
documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within licensure, until all signs 
and symptoms have returned to pre-treatment status, stabilized, or been satisfactorily resolved. If further treatment 
beyond licensure is required, the patient will be referred to the appropriate health care provider. The Investigator 
will use his/her clinical judgment as to whether a subject reporting with an adverse event will continue in the 
study. If a subject is discontinued from the study, it will be the responsibility of the Investigator to record the 
reason for discontinuation. The Investigator will also document the adverse event appropriately and complete the 
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Adverse Event eCRF. Any subjects with ongoing adverse events related to the test article, study treatment or 
study procedures, as of the final study visit date, should be followed to resolution of the adverse event or until 
referral to an appropriate health care provider, as recommended by the Investigator. Non-ocular adverse events 
that are not related to the test article, study treatment, or study procedures may be recorded as “ongoing” without 
further follow-up. 
 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone as soon as possible 
and no later than 24 hours from discovery for any serious /significant adverse events, and 2 days from discovery 
for any non-significant adverse event. In addition, a written report will be submitted by the Principal Investigator 
to the IEC/IRB according to their requirements (section 13.4.2). The report will comment whether the adverse 
event was considered to be related to the test article, study treatment or study procedures. 
 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring during the study period 
as soon as possible by e-mail or telephone, but no later than 24 hours following discovery of the event. The 
Investigator is obligated to pursue and obtain information requested by the Sponsor in addition to that information 
reported on the eCRF. All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine the identity of the 
treatment that the subject received. The Sponsor and study monitor should be notified prior to unmasking the test 
articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
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. 
 
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 artificial tear solution related studies for safety 
concerns, but due to general concerns relating to pregnancy and solution use. Specifically, pregnant women are 
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Hypothesis Testing 
The null and alternative hypotheses for testing non-inferiority of the Preservative-free investigational lubricating 
eye drops compared to Blink® Tears eye drops with respect to monocular logMAR visual acuity are as follows: 
ܪ଴: ߤ்െߤ஼൒0.05 
 ܪ஺: ߤ்െߤ஼< 0.05 
 
Where, ߤ் represents the mean logMAR score for the Preservative-free investigational lubricating eye drops, and 
ߤ஼ represents the mean logMAR score for the Blink® Tears eye drops. Non-inferiority will be declared if the 
upper bound of the 2-sided 95% confidence interval of the difference (the Preservative-free investigational 
lubricating eye drops – Blink® Tears eye drops) is less than the non-inferiority margin of 0.05 logMAR. .  
 
The primary hypothesis must be met for the study to be successful. 
14.6. Secondary Analysis  
There are no secondary analyses.  
14.7. Other Exploratory Analysis  
Summary statistical analysis will be provided for the following other observations: 
x 
Slit lamp findings using FDA scale 
x 
Snellen best corrected distance visual acuity 
x 
Subject reported ocular symptoms 
x 
Number of Adverse events 
x 
Number and reasons for discontinuation 
x 
Lens fitting assessments  
14.8. Interim Analysis 
No interim analysis is planned in this study.  
14.9. Procedure for Handling Missing Data and Drop-Outs 
All efficacy analyses will be performed on observed case data. Missing values will not be imputed. The count of 
missing values will be included in the summary tables and listings. However, as this is a single visit study, subject 
dropout is not expected. In the event that more than 10% (4 subjects) have missing data, a sensitivity analysis will 
be conducted for the primary endpoint. using multiple imputation method. Full details regarding methods for the 
imputations will be outlined in SAP. 
14.10.  Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no known reasons for 
which it is planned to deviate from these analysis methods. If for any reason a change is made, the change will be 
documented in the study report along with a justification for the change. 
 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using the Clario EDC system. 
An authorized data originator will enter study data into the eCRFs using the EDC system. Data collected on 
equipment that is not captured in EDC will be formatted to the specification of the JJVC database manager and 
sent to JJVC for analysis. External data sources for this study are not applicable. 
 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the study procedures for 
each visit. Only specifically delegated staff can enter data on a CRF.  Once completed, the eCRFs will be reviewed 
for accuracy and completeness and signed by the Investigator. The sponsor or sponsor’s representatives will be 
authorized to gain access to the subject recordation for the purposes of monitoring and auditing the study.  
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Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and complete data 
collection. Data will be transmitted from the clinical site to a secure central database as forms are completed or 
updated, ensuring information accuracy, security, and confidentiality. After the final database lock, the 
Investigator will be provided with Individual Patient Profiles (IPP) including the full audit trail on electronic 
media in PDF format for all of the study data. The IPP must be retained in the study files as a certified copy of 
the source data for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2020.1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
x 
subject identification 
x 
eligibility 
x 
study identification 
x 
study discussion 
x 
provision of and date of informed consent 
x 
visit dates 
x 
results of safety and efficacy parameters as required by the protocol 
x 
a record of all adverse events 
x 
follow-up of adverse events 
x 
medical history and concomitant medication 
x 
test article receipt/dispensing/return records 
x 
date of study completion 
x 
reason for early discontinuation of test article or withdrawal from the study, if applicable 
 
The subject record is the eCRF or an external record. The author of an entry in the subject record must be 
identifiable. The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
15.3. Trial Registration on ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov by the Sponsor.  
 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and regulatory 
inspection(s) by providing direct access to source data/documents. Should the clinical site be contacted for an 
audit by an IEC/IRB or regulatory authority, JJVC must be contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific data or other 
pertinent information is confidential and remains the property of JJVC. The Investigator may use this information 
for the purposes of the study only. It is understood by the Investigator that JJVC will use information developed 
in this clinical study in connection with the development of the investigational product and therefore may disclose 
it as required to other clinical investigators and to regulatory agencies. In order to allow the use of the information 
derived from this clinical study, the Investigator understands that he/she has an obligation to provide complete 
test results and all data developed during this study to the Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of qualified investigators 
and appropriate clinical sites and review of protocol procedures with the Principal Investigator. The Principal 
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Investigator, in turn, must ensure that all Sub-Investigators and clinical site personnel are familiar with the 
protocol and all study-specific procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the start of the study. 
The Sponsor will review case report forms for accuracy and completeness remotely during the conduct of the 
study, during monitoring visits, and after transmission to data management. Any data discrepancies will be 
resolved with the Investigator or designee, as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced during the study 
and to access compliance with applicable regulations pertaining to the conduct of clinical trials. The clinical sites 
will provide direct access to study-related source data/documents and reports for the purpose of monitoring and 
auditing by JJVC and for inspection by local and regulatory authorities. 
16.4. Data Monitoring Committee (DMC) 
Not applicable 
 
17. CLINICAL MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the Investigator’s designated 
clinical site personnel. The monitor’s responsibilities will include: 
x 
Ensuring that the investigation is being conducted according to the protocol, any subsequent versions, 
and regulatory requirements are maintained. 
x 
Ensuring the rights and wellbeing of subjects are protected. 
x 
Ensuring adequate resources, including facilities, laboratories, equipment, and qualified clinical site 
personnel. 
x 
Ensuring that protocol deviations are documented with corrective action plans, as applicable. 
x 
Ensuring that the clinical site has sufficient test 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. Subjects will only be enrolled 
if the subject is fully able to understand the risks, benefits, and potential adverse events of the study and provide 
their consent voluntarily. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in accordance with the 
signed agreement, the investigational plan, according to ISO 14155:2020,1  ICH GCP E6 (R2)4 and applicable 
regulatory requirements. GCP is an international ethical and scientific quality standard for designing, conducting, 
recording, and reporting studies that involve the participation of human subjects. Compliance with this standard 
provides public assurance that the rights, safety, and well-being of study subjects are protected, consistent with 
the principles of the Declaration of Helsinki 64th WMA General Assembly 20132 and that the clinical study data 
are credible. The Investigator must maintain clinical study files in accordance with applicable regulatory 
requirements.   
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18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the IEC/IRB with current 
and complete copies of the following documents (where applicable): 
x 
Final protocol. 
x 
Sponsor-approved informed consent form (and any other written materials to be provided to the subjects) 
x 
Investigator’s Brochure (or equivalent information). 
x 
Sponsor-approved subject recruitment materials. 
x 
Information on compensation for study-related injuries or payment to subjects for participation in the 
study. 
x 
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not required, as 
documented by IEC/IRB). 
x 
Information regarding funding, name of the Sponsor, institutional affiliations, other potential conflicts 
of interest, and incentives for subjects. 
x 
Any other documents that the IEC/IRB requests to fulfill its obligation. 
 
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, the informed 
consent form, applicable recruiting materials, and subject compensation programs, and the Sponsor has received 
a copy of this approval. This approval letter must be dated and must clearly identify the documents being 
approved. 
 
During the study, the Investigator (or Sponsor when applicable) will send the following documents to the IEC/IRB 
for their review and approval, where appropriate: 
x 
Protocol revisions 
x 
Revision(s) to informed consent form and any other written materials to be provided to subjects 
x 
If applicable, new, or revised subject recruitment materials approved by the Sponsor 
x 
Revisions to compensation for study-related injuries or payment to subjects for participation in the study 
x 
Investigator’s Brochure revisions  
x 
Summaries of the status of the study (at least annually or at intervals stipulated in guidelines of the 
IEC/IRB) 
x 
Reports of adverse events that are serious, unanticipated, and associated with the test articles, according 
to the IRB’s requirements 
x 
New information that may adversely affect the safety of the subjects or the conduct of the study 
x 
Major protocol deviations as required by the IEC/IRB 
x 
Report of deaths of subjects under the Investigator's care 
x 
Notification if a new Investigator is responsible for the study at the clinical site 
x 
Any other requirements of the IEC/IRB 
 
For protocol revisions that increase subject risk, the revisions and applicable informed consent form revisions 
must be submitted promptly to the IEC/IRB for review and approval before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request should be documented 
in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB about the study 
completion. Documentation of this notification must be retained at the clinical site and a copy provided to the 
CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject or their representative, must give written consent according to local requirements after the nature of 
the study has been fully explained. The consent form must be signed before performance of any study-related 
activity. The consent form that is used must be approved by both the Sponsor and by the reviewing IEC/IRB. The 
informed consent is in accordance with principles that originated in the Declaration of Helsinki2, International 
Committee on Harmonization  E6(R2)4 and ISO 14155:20201 guidelines.  
 
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Before entry into the study, the Investigator or an authorized member of the clinical site personnel must explain 
to potential subject the aims, methods, reasonably anticipated benefits, and potential hazards of the study, and 
any discomfort it may entail. Subjects will be informed that their participation is voluntary and that they may 
withdraw consent to participate at any time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity to ask questions. 
After this explanation and before entry into the study, consent should be appropriately recorded by means of the 
subject's dated signature. After having obtained the consent, a copy of the informed consent form must be given 
to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to the Study Subject, 
and personal data related to Principal Investigator and any clinical site personnel (e.g., name, clinic address and 
phone number, curriculum vitae) is subject to compliance with the Health Information Portability and 
Accountability Act (HIPAA) in the United States13  and other applicable personal data protection and security 
laws and regulations.13  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the concerned persons 
about the collection and processing of their personal data, to grant them reasonable access to their personal data 
and to prevent access by unauthorized persons. 
 
All information obtained during the course of the investigation will be regarded as confidential. All personal data 
gathered in this trial will be treated in strictest confidence by Investigators, monitors, Sponsor’s personnel, and 
IEC/IRB. No data will be disclosed to any third party without the express permission of the subject concerned, 
with the exception of Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context 
of their investigation related activities that, as part of the investigation will have access to the CRFs and subject 
records. 
 
The collection and processing of personal data from subjects enrolled in this study will be limited to those data 
that are necessary to investigate the efficacy, safety, quality, and utility of the investigational product(s) used in 
this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality and compliance 
with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x 
processed fairly and lawfully. 
x 
collected for specified, explicit, and legitimate purposes and not further processed in a way incompatible 
with these purposes. 
x 
adequate, relevant, and not excessive in relation to said purposes. 
x 
accurate and, where necessary, kept current. 
 
Explicit consent for the processing of personal data will be obtained from the participating subject before 
collection of data. Such consent should also address the transfer of the data to other entities and to other countries. 
 
The subject has the right to request through the Investigator access to his personal data and the right to request 
rectification of any data that are not correct or complete. Reasonable steps should be taken to respond to such a 
request, taking into consideration the nature of the request, the conditions of the study, and the applicable laws 
and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against unauthorized disclosures 
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place. Sponsor 
personnel whose responsibilities require access to personal data agree to keep the identity of study subjects 
confidential. 
 
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19. STUDY RECORD RETENTION 
In compliance with the ISO 14155:20201 guidelines, the Investigator/Institution will maintain all CRFs and all 
subject records that support the data collected from each subject, as well as all study documents as specified in 
ISO 14155:2020,1 and all study documents as specified by the applicable regulatory requirement(s)14. The 
Investigator/Institution will take measures to prevent accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a marketing application 
in an ICH region and until there are no pending or contemplated marketing applications in an ICH region or until 
at least two (2) years have elapsed since the formal discontinuation of clinical development of the investigational 
product. These documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the responsibility of keeping 
the study records, custody must be transferred to a person who will accept the responsibility. The Sponsor must 
be notified in writing of the name and address of the new custodian. Under no circumstance shall the Investigator 
relocate or dispose of any study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any documentation 
relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact JJVC. 
 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research Agreement. The 
Research Agreement will be signed by the Principal Investigator and a JJVC management representative prior to 
study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations such as: 
x 
Continuing an ineligible subject in the study. 
x 
Scheduling a study visit outside the subject’s acceptable visit range. 
 
JJVC reserves the right to withhold final remuneration until all study related activities have been completed, such 
as: 
x 
Query resolution. 
x 
Case Report Form signature. 
x 
Completion of any follow-up action items. 
x 
 
21. PUBLICATION 
There is currently no plan to publish this outcome of this investigation. 
 
22. REFERENCES 
 
1. 
ISO 14155:2020: Clinical investigation of medical devices for human subjects — Good clinical practice. 
Available at: 
https://www.iso.org/standard/71690.html 
2. 
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. 
International Council for Harmonization Good Clinical Practice E6(R2) (ICH GCP). Available at: 
https://www.ich.org/page/efficacy-guidelines  
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5. 
Ferrand K et al. Prevalence of diagnosed dry eye disease in the united States among adults aged 18 years 
and older. AJO. 2017;(182):90-98.  
6. 
Clayton JA. 2018. New England Journal of Medicine. 378(23):2212-2223.  
7. 
M Figus, L Agnifili, M Lanzini, al e. Topical preservative-free ophthalmic treatments: An unmet clinical 
need. Expert Opinion on Drug Delivery. 2021 Jun 3;18(6):655-72. Expert Opinion on Drug Delivery. 
2021 Jun 3;18(6):655-72.  
8. 
AD Pucker, SM Ng, Nichols J. Over the counter (OTC) artificial tear drops for dry eye syndrome. 
Cochrane Database of Systematic Reviews. 2016;(2) 
9. 
Joshi N. Investigator's Brochure: Product 
 in a Novelia eyedropper. Version 1.0. 2023. 
10. 
SAS Institute Inc: SAS® 9.4 Statements: Reference, Third Edition. SAS Institute Inc; 2014. 
11. 
Bishop M. 
 Study report for Clinical Investigation of Visual Acuity in Contact Lens Wearers 
after Instillation of a Lipid-Based Lubricating Eye Drop. 
12. 
Stroup W. Mixed model procedures to assess power, precision, and sample sizes. American Statistical 
Association. 1999; 
13. 
Health 
Information 
Portability 
and 
Accountability 
Act 
(HIPAA). 
Available 
at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
14.         Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices,  http://data.europa.eu/eli/reg/2017/745/2017-05-05 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
Not Applicable.  
 
 
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APPENDIX B: PATIENT INSTRUCTION GUIDE   
Patient instruction guides (PIG) will be provided separately. 
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
 
 
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Drug Facts
Active Ingredient  
Purpose
Polyethylene Glycol 400 0.25% . . . . . . . Eye lubricant
Uses  ■  For the temporary relief of burning, 
irritation, and discomfort due to dryness of the eye or 
exposure to wind or sun.
■  May be used as a protectant against further irritation. 
Warnings
■  For external use only.
■  To avoid contamination, do not touch tip of 
container to any surface. Replace cap after using. 
■  Do not use if solution changes color or becomes cloudy.
Stop use and ask a doctor if:
You experience eye pain, changes in vision, continued 
redness or irritation of the eye, or if the condition 
worsens or persists for more than 72 hours.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison 
Control Center right away. 
Directions
Instill 1 or 2 drops in the affected eye(s) as needed or 
as directed by your eye care professional.
Inactive Ingredients 
Boric Acid; Calcium Chloride; Magnesium Chloride; 
Potassium Chloride; Puriﬁed Water; Sodium Borate; 
Sodium Chloride; Sodium Chlorite (OcuPure® brand) 
as a preservative; Sodium Hyaluronate. 
Other Information
Use only if tape seals on top and bottom ﬂaps are intact.
RETAIN THIS CARTON FOR FUTURE REFERENCE.
Lubricating Eye Drops
blink
ting Eye Drops
Tears
Tears
Discard solution 90 days after opening
Product of China made in accordance with US FDA guidelines
Blink is a trademark of Johnson & Johnson Surgical Vision, Inc.
No. 93286BT
© Johnson & Johnson 
Surgical Vision, Inc. 2017
Santa Ana, CA 92705
AM60870US12C
9587X
Revision Date: 07/2018
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Clinical Study Protocol 
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APPENDIX D: 
 
 
x 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
x 
 LENS FITTING CHARACTERISTICS  
x 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
x 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE ERROR 
x 
 BIOMICROSCOPY SCALE 
x 
 DISTANCE AND NEAR SNELLEN VISUAL ACUITY EVALUATION 
x 
 DISTANCE LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
x 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION TESTING 
 
 
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Title:                        Expanded Sodium Fluorescein Corneal Staining
Document Type:       
Document Number:
Revision Number:  6 
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 LENS FITTING CHARACTERISTICS 
 
 
 
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Title:                          Lens Fitting Characteristics
Document Type:  
Document Number:
Revision Number:  6 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS  
 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIVE 
ERROR 
 
 
 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  5 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
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Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
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Revision Number:  4 
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Title:                          Visual Acuity Chart Luminance and Room Illumination Testing 
Document Type:  
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Revision Number:  4 
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APPENDIX E: 
 GUIDELINES FOR COVID-19 RISK MITIGATION 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6503 Protocol Title: Clinical Investigation of Visual Acuity in Contact Lens 
Wearers after Instillation of Investigational Lubricating Eye Drops 
 
Version and Date: 2.0 24 April 2023 
 
I have read and understand the protocol specified above and agree on its content. 
 
I agree to conduct this study according to ISO 14155:2020,1 International Council for Harmonization Good 
Clinical Practice E6(R2) (ICH GCP),4 the Declaration of Helsinki,2 United States (US) Code of Federal 
Regulations (CFR)3, and the pertinent individual country laws/regulations and to comply with its obligations, 
subject to ethical and safety considerations. I, as the Principal Investigator, am responsible for ensuring that all 
clinical site personnel, including Sub-Investigators, adhere to all regulations and GCP guidelines regarding 
clinical trials during and after study completion. 
 
I will assure that no deviation from or changes to the protocol will take place without prior agreement from the 
Sponsor and documented approval from the Institutional Review Board (IRB), except where necessary to 
eliminate an immediate hazard(s) to the trial participants. 
 
All clinical site personnel involved in the conduct of this study have completed Human Subjects Protection 
Training.  
 
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about their 
obligations in meeting the above commitments. 
 
I shall not disclose the information contained in this protocol or any results obtained from this study without 
written authorization. 
 
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation, (COVID-19 
Work Instruction in the Appendix E of this protocol). I agree to conduct this study in compliance with local, state, 
governmental guidance for COVID-19 risks. 
 
 
Principal 
Investigator: 
 
 
 
 
Signature 
 
 
 
Date 
 
Name and Professional Position (Printed) 
 
 
 
Institution/Site: 
 
 
 
 
Institution/Site Name 
 
 
 
 
 
 
Institution/Site Address 
 
 
 
 
 
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