Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03466086
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 18.1

Study Details

Study Description

Brief Summary

This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2 period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The study will last approximately 3 months.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: Test Eye Drops; Device: Control Eye Drops	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients
• Actual Study Start Date: Feb 9, 2018
• Actual Primary Completion Date: May 16, 2018
• Actual Study Completion Date: May 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test/Control Subjects between the ages of 18-69 years of age will sequentially try the Test and Control eye drops in a random order	Device: Test Eye Drops; blink® intensive TRIPLE ACTION 3 in 1 eye drops; Device: Control Eye Drops; Systane® BALANCE eye drops
Experimental: Control/Test Subjects between the ages of 18-69 years of age will sequentially try the Control and Test eye drops in a random order.	Device: Test Eye Drops; blink® intensive TRIPLE ACTION 3 in 1 eye drops; Device: Control Eye Drops; Systane® BALANCE eye drops

Outcome Measures

Primary Outcome Measures

1. Ocular Comfort [1-Week Follow-up]

   Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.

Secondary Outcome Measures

1. Subjective Dryness Rating [1-Week Follow-up]

   Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Potential subjects must satisfy all the following criteria to be enrolled in the study:

1. Subjects must be at least 18 years of age and no more than 69 years of age (inclusive)

2. Subjects must be non-contact lens wearers

3. Subjects must have a DEQ-5 score of >6 at either Visit 0 (pre-screen) and/or Visit 1 (screening).

4. Subjects must achieve visual acuity of 20/30 (equivalent to 0.18 logMAR) or better in each eye, either unaided or best corrected.

5. Subjects must possess a functional/usable pair of spectacles and bring them to every visit (only if applicable - to the investigators discretion).

6. Subjects must read, understand, and sign the Statement of Informed Consent.

7. Subjects must appear able and willing to adhere to the instructions set forth in this clinical protocol

Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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 investigator's discretion).

4. Any systemic disease, autoimmune disease, or use of medication which may interfere with the clinical trial (at the investigator's discretion).

5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report

6. Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA scale

7. Any active ocular abnormalities/conditions that may interfere with the clinical trial (this includes, but not limited to, chalazia, recurrent styles, pterygium, infection, etc)

8. Any corneal distortion due to previous rigid gas permeable lens wear, surgery or pathology

9. History of any ocular or corneal surgery (e.g. RK, PRK, LASIK)

10. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrollment.

11. History of binocular vision abnormality or strabismus.

12. Habitual wearers of soft contact lenses in the past 1 month or rigid gas permeable lens within the past 3 months

13. Current habitual use of Prescription Only Medicines (POM) 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).)

14. Employees of investigational clinic (investigator, coordinator, and technician etc) or family member of an employee of the clinical site by self-report.

In addition to the above criteria, patients with any allergy or sensitivity to ingredients that this product may contain (liposomes, sodium hyaluronate, vitamin E polyethylene glycol succinate (TPGS), polyethylene glycol 400 (PEG 400), disodium edetate, polyhexanide methylbiguanide, propylene glycol, boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 sterate, polyquaternium-1, sorbitan tristearate, sorbitol, hydrochloric acid and/or sodium hydroxide) should not participate in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Manchester	Manchester		United Kingdom

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 3, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03466086
• Other Study ID Numbers: CR-6013
• First Posted: Mar 15, 2018
• Last Update Posted: Jun 28, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	A total of 57 subjects were enrolled in this study, of which 55 subjects were assigned to receive at least 1 eye drop while, 2 subjects were screen failures and/or not assigned. Of the total assigned subjects, 53 subjects completed the study and 2 subjects discontinued the study.

Arm/Group Title	Test/Control	Control/Test
Arm/Group Description	Subjects randomized to this sequence received the Test eye drop during the first period and then received the Control eye drop during the second period.	Subjects randomized to this sequence received the Control eye drop during the first period and then received the Test eye drop during the second period.
Period Title: Period 1
STARTED	28	27
COMPLETED	26	27
NOT COMPLETED	2	0
Period Title: Period 1
STARTED	26	27
COMPLETED	26	27
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Dispensed Subjects
Arm/Group Description	All subjects dispensed at least one eye drop and 1 contact lens
Overall Participants	55
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	26.76 (11.273)
Sex: Female, Male (Count of Participants)
Female	37 67.3%
Male	18 32.7%
Race/Ethnicity, Customized (Number) [Number]
Asian	13 23.6%
Black Or African American	4 7.3%
White	34 61.8%
Other	4 7.3%
Region of Enrollment (Count of Participants)
United Kingdom	55 100%

Outcome Measures

1. Primary Outcome

Title	Ocular Comfort
Description	Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test eye drop during either the first or second period of the study.	All subjects that wore the control eye drop in either the first or second period of the study.
Measure Participants	52	52
Measure eyes	104	104
Mean (Standard Deviation) [Units on a scale]	81.96 (12.407)	82.49 (15.238)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments
	Type of Statistical Test	Superiority
	Comments	This was a pilot study and the sample size was not based on any empirical power calculation.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 95%; -2.35 to 2.59
	Parameter Dispersion	Type: Standard Deviation; Value: 1.238
	Estimation Comments	Mean Difference was calculated as Test minus Control.

2. Secondary Outcome

Title	Subjective Dryness Rating
Description	Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness
Time Frame	1-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Test	Control
Arm/Group Description	All subjects that wore the Test eye drop during either the first or second period of the study.	All subjects that wore the control eye drop in either the first or second period of the study.
Measure Participants	52	52
Mean (Standard Deviation) [Units on a Scale]	25.68 (10.162)	24.69 (10.609)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test, Control
	Comments	This was a pilot study and the sample size was not based on any empirical power calculation.
	Type of Statistical Test	Superiority
	Comments	Superiority will be declared if the lower bound of the 2-sided 95% credible interval of the difference between Test and Control is less than 0.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.49
	Confidence Interval	(2-Sided) 95%; -0.40 to 3.37
	Parameter Dispersion	Type: Standard Deviation; Value: 0.951
	Estimation Comments
Other Statistical Analysis		Mean difference was calculated as Test - Control

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 3 week per subject.
Arm/Group Title	Test		Control
Arm/Group Description	All subjects that wore the Test eye drop during either period 1 or period 2 during the study.		All subjects that wore the Control eye drop during either period 1 or period 2 during the study.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.