Clinical Investigation of Visual Acuity in Contact Lens Wearers After Instillation of a Lipid- Based Lubricating Eye Drop
Phase: PHASE1
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
Clinical Investigation of Visual Acuity in Contact Lens Wearers after Instillation of a Lipid-
Based Lubricating Eye Drop
Protocol CR-6371
Version: 4.0
Date: 19 August 2020
Investigational Products: Investigational lipid eye drops and blink® Tears Eye Drops 
Key Words: artificial tears, blink® Tears, logMAR Visual Acuity, contact lenses, non-
dispensing 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. This study will be conducted as a non-
significant risk device investigation per 21 CFR 812.2 (b) IDE Abbreviated Requirements and 
per U.S. FDA GUIDANCE FOR INDUSTRY -- Premarket Notification (510[k]) Guidance 
Document for Contact Lens Care Products dated May 1 1997). 
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........................................................................... 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 ................................................................... 16 
1.1. 
Name and Descriptions of Investigational Products ................................................ 16 
1.2. 
Intended Use of Investigational Products................................................................. 16 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 16 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 16 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 17 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 17 
2.1. 
Objectives ................................................................................................................. 17 
2.2. 
Endpoints .................................................................................................................. 17 
2.3. 
Hypotheses ............................................................................................................... 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 ............................................................................................ 19 
4.3. 
Enrollment Target and Study Duration .................................................................... 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 20 
5.1. 
Test Article Allocation ............................................................................................. 20 
5.2. 
Masking .................................................................................................................... 20 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 20 
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 ................................................................................ 22 
6.4. 
Packaging and Labeling ........................................................................................... 22 
6.5. 
Storage Conditions ................................................................................................... 23 
6.6. 
Collection and Storage of Samples .......................................................................... 23 
6.7. 
Accountability of Test Articles ................................................................................ 23 
7. 
STUDY EVALUATIONS .............................................................................................. 24 
7.1. 
Time and Event Schedule ......................................................................................... 24 
7.2. 
Detailed Study Procedures ....................................................................................... 25 
VISIT 1 ........................................................................................................................... 25 
FINAL EVALUATION .................................................................................................. 27 
7.3. 
Unscheduled Visits ................................................................................................... 28 
7.4. 
Laboratory Procedures ............................................................................................. 29 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 29 
8.1. 
Completion Criteria .................................................................................................. 29 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 29 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 30 
9.1. 
Systemic Medications .............................................................................................. 30 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 30 
11. 
STUDY TERMINATION ........................................................................................... 31 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 32 
13. 
ADVERSE EVENTS ................................................................................................... 33 
13.1. 
Definitions and Classifications ............................................................................. 33 
13.2. 
Assessing Adverse Events .................................................................................... 35 
13.2.1. 
Causality Assessment .................................................................................... 35 
13.2.2. 
Severity Assessment ...................................................................................... 36 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 36 
13.4. 
Reporting Adverse Events .................................................................................... 37 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 38 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
38 
13.4.3. 
Event of Special Interest ............................................................................... 39 
13.5. 
Reporting of Pregnancy ........................................................................................ 39 
14. 
STATISTICAL METHODS ........................................................................................ 39 
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14.1. 
General Considerations ......................................................................................... 39 
14.2. 
Sample Size Justification ...................................................................................... 39 
14.3. 
Analysis Populations ............................................................................................ 39 
14.4. 
Level of Statistical Significance ........................................................................... 40 
14.5. 
Primary Analysis .................................................................................................. 40 
14.6. 
Secondary Analysis .............................................................................................. 40 
14.7. 
Other Exploratory Analyses ................................................................................. 40 
14.8. 
Interim Analysis ................................................................................................... 40 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 40 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 40 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 41 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 41 
15.2. 
Subject Record ...................................................................................................... 41 
15.3 ClinicalTrials.gov........................................................................................................ 42 
16. 
DATA MANAGEMENT............................................................................................. 42 
16.1. 
Access to Source Data/Document ........................................................................ 42 
16.2. 
Confidentiality of Information.............................................................................. 42 
16.3. 
Data Quality Assurance ........................................................................................ 42 
17. 
CLINICAL MONITORING ........................................................................................ 43 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 43 
18.1. 
Study-Specific Design Considerations ................................................................. 43 
18.2. 
Investigator Responsibility ................................................................................... 43 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 44 
18.4. 
Informed Consent ................................................................................................. 45 
18.5. 
Privacy of Personal Data ...................................................................................... 45 
19. 
STUDY RECORD RETENTION................................................................................ 46 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 47 
21. 
PUBLICATION ........................................................................................................... 47 
22. 
REFERENCES ............................................................................................................ 48 
APPENDIX A: PATIENT INSTRUCTION GUIDE ............................................................. 49 
APPENDIX B: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 50 
APPENDIX C: 
 ....................................... 52 
 SUBJECT REPORTED OCULAR SYMPTOMS ............................................... 53 
 BIOMICROSCOPY SCALE ............................................................................... 55 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION .......................... 61 
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE .... 66 
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING ................................................................................................................................ 70 
APPENDIX D: 
 Guidelines for COVID-19 Risk Mitigation ................................ 76 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE .......................... 86 
TABLE OF CONTENTS
Figure 1: Study Flowchart ...................................................................................................... 13 
TABLE OF CONTENTS
Table 1: Lubricating eye drops ……………………………………………………………... 21
Table 2: Ancillary Supplies .................................................................................................... 22 
Table 3: Time and Events ....................................................................................................... 24 
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SYNOPSIS 
Protocol Title
Clinical Investigation of Visual Acuity in Contact Lens 
Wearers after Instillation of a Lipid-Based Eye Drop
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Confirmatory, Phase 1
Trial Registration
This study will be registered on ClinicalTrials.gov based on 
the following: this study is being conducted after final 
formulation lock.
Test Article(s)
Two lubricating eye drop products: 
x
Investigational lipid eye drops – 
 (Test)
x
Blink® Tears eye drop (Control)
Wear and Replacement 
Schedules
Not applicable
Objectives 
The objective of this study is to assess visual acuity after the 
instillation of a lipid-based eye drop compared to a marketed 
lubricating eye drop while wearing habitual contact lenses.
Study Endpoints
Primary endpoint(s):
x
Change in logMAR visual acuity after the instillation 
of the eyedrop.    
Other Endpoint(s) 
x
Slit Lamp Findings using FDA scale
x
Snellen best corrected distance visual acuity
x
Subject reported ocular symptoms 
x
Adverse Events
x
Number and reasons for discontinuation will be 
monitored.
Study Design
This is a single visit, randomized, double masked, bilateral, 
non-dispensing, 2×2 crossover study.
Sample Size
Approximately 30 subjects will be enrolled and approximately 
25 subjects are targeted to complete the study.
Study Duration
The study will last approximately 6 weeks and include a 6-
week enrollment period.
Anticipated Study 
Population
Habitual spherical contact lens wearers 18-69 years of age.
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Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria after 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 69 (inclusive) years of age at the time 
of screening. 
4. Subjects must be habitual spherical soft contact lens 
wearers. 
Inclusion Criteria after Baseline: 
5. Subjects must achieve visual acuity of 20/30 or better 
in each eye with their habitual contact lenses.
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
Exclusion Criteria after Screening:
1. Currently pregnant or breast-feeding. 
2. Diabetes. 
3. Any ocular or systemic allergies or disease which may 
interfere with the clinical trial (at the discretion of the 
investigator).  
4. Any systemic disease, autoimmune disease, or use of 
medication which may interfere with the clinical trial 
(at the discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or 
a contagious immunosuppressive disease (e.g. HIV), 
by self-report.
6. History of any ocular or corneal surgery (e.g. RK, 
PRK, LASIK) 
7. Participation in any pharmaceutical or medical device 
related clinical trial within 14 days prior to study
enrollment.
8. History of binocular vision abnormality or strabismus.
9. Habitual wearers of rigid gas permeable lens within 
the past 3 months
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10. Current habitual use of Prescription Medication 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)
11. Employees of investigational clinic (investigator, 
coordinator, and technician etc) or family members of 
an employee of the clinical site by self-report. 
Exclusion Criteria after Baseline: 
12. Any Grade 3 or greater biomicroscopy findings (this 
includes, corneal edema, corneal staining, corneal 
vascularization, 
conjunctival 
injection, 
tarsal 
abnormalities, 
bulbar 
injection) 
on 
the 
FDA
classification scale. 
13. Any active ocular abnormalities/conditions that may 
interfere with the clinical trial (this includes, but not 
limited to, chalazia, recurrent styles, pterygium, 
infection, etc.). 
14. Any corneal distortion due to previous rigid gas 
permeable lens wear, surgery or pathology. 
In addition to the above criteria, patients with any allergy 
or sensitivity to ingredients that this product may contain
should not participate in the study (Castor Oil, Polyoxyl 
40 Hydrogenated Castor Oil, Sodium Chlorite, Boric 
Acid, Sodium Borate Decahydrate, Sodium Chloride, 
Potassium Chloride, Calcium Chloride Dihydrate, 
Magnesium Chloride Hexahydrate, Polyethylene Glycol 
400, Sodium Hyaluronate, Purified Water).
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, subjective reported ocular symptoms.
Microbiology or Other 
Laboratory Testing
None
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Study Termination
The occurrence of one or more Unanticipated Adverse Device 
Effect (UADE), or any serious adverse event (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
ScleralFil 
(Bausch 
+ 
Lomb), 
LacriPure 
(Menicon), 
Fluorescein (Akorn, Inc.) or other 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 
18-69-year-old habitual 
soft CL wearers with dry 
eye symptoms
Visit 1:
Screening: Medical History/Dry Eye symptoms 
Baseline: LogMAR VA, Slit Lamp
Treatment 1: Insert 1 drop OU, LogMAR VA (3 and 10minutes) 
Washout 90 minutes 
Treatment 2: Insert 1 drop OU, LogMAR VA (3 and 10minutes) 
Final evaluation
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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 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Conference on Harmonization 
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc.
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OTC  
 
Over the Counter 
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 
RX 
 
 
Prescription
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
Lubricating eye drops are often used to treat symptoms of ocular dryness and discomfort.  Most 
of the major lubricating eye drop manufacturing companies have some type of lipid product to 
address lipid deficient tear films, however JJV CEH does not currently have a lipid-like 
lubricating drop in our portfolio.  
This study will be conducted at one clinical site in the United States and will include one 
investigational lipid eye drop (
) and one marketed lubricating eye drop (blink® Tears).  
By developing a lipid-like drop addition to the CEH portfolio it would continue to support JJV 
Eye Health Mission.
1.1.
Name and Descriptions of Investigational Products  
The products used in this clinical study are listed below:  
x
Investigational lipid eye drops 
 (Test) 
x
Blink® Tears (Control) 
1.2.
Intended Use of Investigational Products
One of the products is an investigational, preserved lipid drop, and the other product is a 
marketed eye drop in the U.S. and the EU, available over the counter (without a prescription).  
Subjects will be required to use the 1 drop in both eyes.  
The intended use of the study lubricating drops is treatment of subjects with symptoms of 
ocular dryness. 
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 
Investigational lipid eye drops 
refer to the latest version of the Investigator’s Brochure.
1.4.
Summary of Known Risks and Benefits to Human Subjects
The following risks/adverse events can be associated with using lubricating eye drops and 
contact lenses, 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. 
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x
Poor visual acuity, blurred vision, rainbows or halos around objects, photo-phobia, 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 lubricating eye drops.  The information from this study will aid if the further 
development and design of new lubricating eye drops.   
For the most comprehensive clinical information regarding the lubricating eye drops refer to 
the package inserts (Appendix B) and the latest version of the Investigator Brochure.
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
Refer to the Investigator’s Brochure and package insert (APPENDIX B).
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The objective of this study is to assess visual acuity after the instillation of a lipid-based eye 
drop compared to a marketed lubricating eye drop while wearing habitual contact lenses. 
2.2.
Endpoints 
Primary Endpoint 
Change in logMAR visual acuity after the instillation of a lipid-based eye drop.  
Other Exploratory Endpoints  
x
Slit Lamp Findings using FDA scale
x
Snellen best corrected distance visual acuity
x
Subject reported ocular symptom 
x
Adverse Events
x
Number and reasons for discontinuation will be monitored. 
.
2.3.
Hypotheses
This is a descriptive feasibility study to assess the change in logMAR visual acuity after the 
instillation of a lipid-based eye drop. No formal hypothesis testing will be performed. 
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
Habitual contact lens wearers 18-69 years of age.
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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 after 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 69 (inclusive) years of age at the time of screening. 
4. Subjects must be habitual spherical soft contact lens wearers. 
Inclusion Criteria after Baseline: 
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:  
Exclusion Criteria after Screening:
1. Currently pregnant or breast-feeding. 
2. Diabetes. 
3. Any ocular or systemic allergies or disease which may interfere with the clinical trial
(at the discretion of the investigator).  
4. Any systemic disease, autoimmune disease, or use of medication which may interfere 
with the clinical trial (at the discretion of the investigator). 
5. Any 
infectious 
diseases 
(e.g. 
hepatitis, 
tuberculosis) 
or 
a 
contagious 
immunosuppressive disease (e.g. HIV), by self-report. 
6. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)  
7. Participation in any pharmaceutical or medical device related clinical trial within 14 
days prior to study enrollment. 
8. History of binocular vision abnormality or strabismus. 
9. Habitual wearers of rigid gas permeable lens within the past 3 months 
10. Current habitual use of Prescription Medication 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) 
11. Employees of investigational clinic (investigator, coordinator, and technician etc) or 
family members of an employee of the clinical site by self-report. 
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Exclusion Criteria after Baseline: 
12. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal 
staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar 
injection) on the FDA classification scale. 
13. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this 
includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc.). 
14. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or 
pathology. 
In addition to the above criteria, patients with any allergy or sensitivity to ingredients that 
this product may contain should not participate in the study (Castor Oil, Polyoxyl 40 
Hydrogenated Castor Oil, Sodium Chlorite, Boric Acid, Sodium Borate Decahydrate, 
Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride 
Hexahydrate, Polyethylene Glycol 400, Sodium Hyaluronate, Purified Water). 
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, randomized, double-masked, bilateral, controlled, 2×2 crossover study.
Approximately 30 subjects will be screened and randomly assigned to either Test or Control 
group.  The goal is for a sample size of 25 after subjects who withdraw or are lost-to-follow-
up.
At Visit 1, subjects will be consented and screened for inclusion/exclusion criteria.  Baseline 
logMAR visual acuity will be measured in their habitual contact lenses.  If a subject is found 
to meet all eligibility criteria, the first lubricating eye drops will be instilled based on the 
randomization scheme; otherwise, the subject will be discontinued from the study. Three
minutes and ten minutes after OD drop instillation logMAR visual acuity will be measured.  
There will then be a 90 minutes washout period.  After the washout, the second artificial tear 
eye drop will be instilled.  Three minutes and ten minutes after instillation logMAR visual 
acuity will be measured.  The subject will then complete the final evaluation.  
4.2.
Study Design Rationale 
Randomized, double masked, controlled designs are the gold standard to perform scientifically 
sound evaluations of the intervention by reducing bias associated with the conduct and 
interpretation of a clinical trial and avoiding confounding from other factors.  Crossover study 
design was chosen to allow more efficient comparison of the test articles.
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4.3.
Enrollment Target and Study Duration
Up to 30 subjects will be enrolled (informed consent signed) and randomized from up to 2 sites
in the US.  The goal is for a sample size of 25 subjects after subjects who withdraw or are lost 
to follow-up. 
The Investigator is responsible for ensuring that all subjects entering the study conform to 
subject selection criteria.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
Subjects will be randomly assigned to one of two unique sequence groups to bilaterally receive 
two different test articles one at a time over two study periods. The randomization scheme will 
be generated using the PROC PLAN procedure from the Statistical Analysis System (SAS) 
Software version 9.4 or higher.7
The study site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects.  The assignment 
of the subjects must be performed at the first baseline visit (Visit 1). The following must have 
occurred prior to randomization: 
x
Informed consent has been obtained 
x
Subject meets all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected 
5.2.
Masking
This is a double masked study where subjects and the investigators are masked to the identity 
of the eye drops during the study period.  Every attempt will be made to keep the other clinical 
trial personnel involved in the study (e.g., Data management, Biostatistician) unaware of the 
identity of the test articles.
The identity of the investigational products will be masked by over labeling the eye drop bottles
with a label containing the study number, expiration date and the randomization codes.  Only 
the personnel involved in the over labeling and the unmasked Statistician generating the 
randomization scheme will have access to the decode information translating the 
randomization codes into Test and Control eye drops.  The medical monitor will also have 
access to the decode information in case breaking the mask is necessary for the urgent medical 
treatment of a subject.
5.3.
Procedures for Maintaining and Breaking the Masking
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
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subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the 
randomization scheme to obtain the test article assignment for that subject prior to 
dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply.  
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section. 
6.
STUDY INTERVENTION
6.1.
Identity of Test Articles 
Table 1: Lubricating eye drops   
Test
Control
Solution 
Name/Description
Investigational lipid eye drops 
Blink® Tears
Manufacturer
Johnson & Johnson Vision, Inc
Johnson & Johnson Vision, Inc
Ingredients
Castor Oil, Polyoxyl 40
Hydrogenated Castor Oil, 
Sodium Chlorite, Boric Acid, 
Sodium Borate Decahydrate, 
Sodium Chloride, Potassium 
Chloride, Calcium Chloride 
Dihydrate, Magnesium Chloride 
Hexahydrate, Polyethylene 
Glycol 400, Sodium 
Hyaluronate, Purified Water
See package insert
Packaging Form
Over-Labeled
Over-Labeled
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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 
drop  
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 not successfully dispensed due to lack of efficacy or safety. 
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 
An additional subject may be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal. The measures taken to follow 
up must be documented including two written attempts and a certified letter (or equivalent) as 
the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.
Disallowed medications for this study include: Current habitual use of Prescription Only 
Medicines for 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).
9.1.
Systemic Medications
Due to the nature of the study and endpoints being assessed, medications will be allowed 
provided they did not interfere with contact lens wear, which will be at the discretion of the 
investigator.  
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked and corrective actions implemented as appropriate.  
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If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study then it must be reported to IEC/IRB. This is a "Major Deviation".
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study.  They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation. 
Visual performance assessments started at 2 minutes, or between 4 and 5 minutes after OD 
drop insertion will be considered minor deviations. Visual performance assessments started 1 
minute or less, or 6 minutes or more after OD drop insertion will be considered major 
deviations for the 3-minute LogMAR procedure (Steps 1.19 and 1.25).  
Visual performance assessments started at 8 minutes, or between 11 and 12 minutes after OD
drop insertion will be considered minor deviations. Assessments started 7 minutes or less, or 
13 minutes or more after OD drop insertion will be considered major deviations for the 10-
minute LogMAR procedure (Steps 1.20 and 1.26).  
Protocol waivers are prohibited. 
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
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. 
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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
Test article replacements that occur due to missed drops. 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency, only in situations where there is no deficiency 
alleged by the subject. 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness). 
x
Who received the complaint. 
x
Study number. 
x
Clinical site information (contact name, site ID, telephone number). 
x
Lot number(s). 
x
Unique Subject Identifier(s). 
x
Indication of who first observed complaint (site personnel or subject). 
x
OD/OS indication, along with whether the lens was inserted. 
x
Any related AE number if applicable. 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.). 
x
Eye Care Provider objective (slit lamp) findings if applicable. 
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x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies 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.  
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 devices1
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. 
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
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
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Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber) 
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA 
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
Non-Significant Adverse Events – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment as a precautionary 
measure.   
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
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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: to entry: 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 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
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). 
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. 
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x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive. The relationship in time is 
reasonable. Therefore, the causal relationship cannot be excluded. 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s). The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge. 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities. 
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. 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.). 
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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 
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. 
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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.
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 the 
written guidelines, including reporting timelines.  
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13.4.3. Event of Special Interest
None 
13.5. 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)7. Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization. Unscheduled visits will be 
summarized separately.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate. Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD]), median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data.
14.2. Sample Size Justification
Approximately 30 subjects will be enrolled in this study to attain a minimum of 25 completed 
subjects. This is a feasibility descriptive study to evaluate the visual acuity after the instillation 
of a lipid-based eye drop. Sample size is not based on the empirical power analysis, and the 
data collected for this study may be used in future study design if applicable. 
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
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Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock. 
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 inferential statistics are planned to be performed in this study; hence, the level of statistical 
significance is not a concern. In the event that exploratory analysis is conducted, an overall 
type I error rate of 5% will be used.
14.5. Primary Analysis  
Change in logMAR visual acuity will be descriptively summarized. 
14.6. Secondary Analysis  
Not applicable.
14.7. Other Exploratory Analyses 
The following study endpoints will be disruptively summarized: 
x
Slit Lamp Findings using FDA scale
x
Snellen best corrected distance visual acuity
x
Subject reported ocular symptoms 
x
Adverse Events
x
Number and reasons for discontinuation will be monitored. 
14.8. Interim Analysis
Not applicable.
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of observed values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
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15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica 5.5). 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 include: 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.  
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 ISO14155:2011.1
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
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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 ClinicalTrials.gov  
This pilot study is being conducted after final formulation and meets the criteria for 
registration.
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 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 
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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. 
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. 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. 
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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).
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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 Helsinki,3 current ICH2 and ISO 141551
guidelines, applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
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 
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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. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
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If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports.  
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement. The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation.
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study. 
x
Scheduling a study visit outside the subject’s acceptable visit range. 
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution. 
x
Case Report Form signature. 
x
Completion of any follow-up action items. 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov based on the following: this study is being 
conducted after final formulation lock.
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22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-subjects/
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. EU MDR 2017/745 
7. SAS Institute Inc. 2016 SAS/STAT® 14.3 User’s Guide. Cary, NC: SAS Institute 
Inc.
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APPENDIX A: PATIENT INSTRUCTION GUIDE  
 
A Clinic Only Wear Patient Instruction Guide will be provided separately. 
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APPENDIX B: 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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APPENDIX C: 
 
 
x
 SUBJECT REPORTED OCULAR SYMPTOMS
x
 BIOMICROSCOPY SCALE 
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
x
ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE
x
VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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SUBJECT REPORTED OCULAR SYMPTOMS
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BIOMICROSCOPY SCALE
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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Title:                          Distance and Near Snellen Visual Acuity Evaluation
Document Type:  
Document Number:
Revision Number:  4 
Page 2 of 4 
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ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
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VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING
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APPENDIX D:
GUIDELINES FOR COVID-19 RISK MITIGATION
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6371 Clinical Investigation of Visual Acuity in Contact Lens Wearers 
after Instillation of a Lipid-Based Eye Drop
Version and Date: 4.0 19 August 2020
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the Declaration of 
Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the pertinent individual country 
laws/regulations and to comply with its obligations, subject to ethical and safety considerations. The 
Principal Investigator is responsible for ensuring that all clinical site personnel, including Sub-
Investigators adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and 
after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior agreement 
from the Sponsor and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere to all
ICH2 regulations and GCP guidelines regarding clinical trials during and after study completion. 
All clinical site personnel involved in the conduct of this study have completed Human Subjects 
Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this study 
without written authorization.
I have read the suggested guidance provided by JJVCI pertaining to the COVID-19 risk mitigation,
(COVID-19 Work Instruction in the Appendix of this protocol). I agree to conduct the study in 
compliance with all local, state, and governmental guidelines for COVID-19 risk mitigation.
Principal Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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