Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

• Sponsor: Oculeve, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02385292
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10
• Patients Per Site: 11.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

The objectives of this study are:

• To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications

• To compare the goblet cell count following application between the intranasal and extranasal applications

• To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Device: Oculeve Intranasal Lacrimal Neurostimulator	N/A

Detailed Description

In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of:

• Active intranasal device application

• Active extranasal device application

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye
• Actual Study Start Date: May 31, 2015
• Actual Primary Completion Date: Mar 31, 2016
• Actual Study Completion Date: Mar 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal then Extranasal Application Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Device: Oculeve Intranasal Lacrimal Neurostimulator; The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.
Active Comparator: Extranasal then Intranasal Application Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Device: Oculeve Intranasal Lacrimal Neurostimulator; The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.

Outcome Measures

Primary Outcome Measures

1. Fluorescein Tear Clearance With Application [Day 1]

Other Outcome Measures

1. Level of Tear Proteins Pre and Post Administration [Day 1]

2. Level of Inflammatory Mediators Pre and Post Administration [Day 1]

3. Goblet Cell Count Following Application [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Bilateral dry eyes

• Capable of providing written informed consent

Exclusion Criteria:

• Chronic or recurring epistaxis (nosebleeds)

• Blood coagulation disorder

• Uncontrolled or poorly controlled diabetes

• Heart or pulmonary disease

• Females who are pregnant, planning a pregnancy or nursing

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grutzmacher, Lewis & Sierra	Sacramento	California	United States	95815
2	Baylor College of Medicine, Department of Ophthalmology	Houston	Texas	United States	77030

Sponsors and Collaborators

• Oculeve, Inc.

Investigators

• Principal Investigator: Richard Lewis, MD, Grutzmacher, Lewis & Sierra

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oculeve, Inc.
• ClinicalTrials.gov Identifier: NCT02385292
• Other Study ID Numbers: OCUN-003
• First Posted: Mar 11, 2015
• Last Update Posted: Oct 19, 2021
• Last Verified: Sep 1, 2021

• 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.: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Study Results

Participant Flow

Pre-assignment Detail	During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Arm/Group Title	Intranasal Then Extranasal Application	Extranasal Then Intranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Period Title: Overall Study
STARTED	0	0
COMPLETED	0	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intranasal Then Extranasal Application	Extranasal Then Intranasal Application	Total
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Total of all reporting groups
Overall Participants	0	0	0
Age (years) []
Sex: Female, Male (participants) []
Female
Male

Outcome Measures

1. Primary Outcome

Title	Fluorescein Tear Clearance With Application
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Arm/Group Title	Intranasal Application	Extranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Measure Participants	0	0

2. Other Pre-specified Outcome

Title	Level of Tear Proteins Pre and Post Administration
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Arm/Group Title	Intranasal Application	Extranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Measure Participants	0	0

3. Other Pre-specified Outcome

Title	Level of Inflammatory Mediators Pre and Post Administration
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Arm/Group Title	Intranasal Application	Extranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Measure Participants	0	0

4. Other Pre-specified Outcome

Title	Goblet Cell Count Following Application
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Arm/Group Title	Intranasal Application	Extranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Measure Participants	0	0

Adverse Events

Adverse Event Reporting Description	During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.
Arm/Group Title	Intranasal Application		Extranasal Application
Arm/Group Description	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.		Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
All Cause Mortality
	Intranasal Application		Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Intranasal Application		Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Intranasal Application		Extranasal Application
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

More Information

Certain Agreements

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

The investigator or other study-related personnel may not disclose to anyone or use any data, information, or materials related to this clinical trial without the express written consent of Oculeve.