Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

• Sponsor: Oculeve, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02798289
• Collaborator: (none)
• Enrollment: 55
• Locations: 2
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 27.5
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome; Keratoconjunctivitis Sicca	Device: Oculeve Intranasal Neurostimulator	N/A

Detailed Description

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active - Device The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.	Device: Oculeve Intranasal Neurostimulator; Neurostimulation device

Outcome Measures

Primary Outcome Measures

1. Tear Meniscus Height Captured by Optical Coherence Tomography [Day 1]

   Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subjects with dry eye disease

• Literate, able to speak English or Spanish, and able to complete questionnaires independently

• Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding

• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma

• Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

• Corneal transplant in either or both eyes

• Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

• Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center	Artesia	California	United States	90701
2	Aesthetic Eyecare Institute	Newport Beach	California	United States	92663

Sponsors and Collaborators

• Oculeve, Inc.

Investigators

• Study Director: Neil Friedman, MD, Mid-Peninsula Ophthalmology Medical Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oculeve, Inc.
• ClinicalTrials.gov Identifier: NCT02798289
• Other Study ID Numbers: OCUN-014
• First Posted: Jun 14, 2016
• Last Update Posted: Oct 25, 2017
• Last Verified: Sep 1, 2017

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis

Study Results

Participant Flow

Arm/Group Title	Active - Device
Arm/Group Description	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
Period Title: Overall Study
STARTED	55
COMPLETED	55
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Active - Device
Arm/Group Description	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
Overall Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.2 (15.3)
Sex: Female, Male (Count of Participants)
Female	18 32.7%
Male	37 67.3%
Region of Enrollment (participants) [Number]
United States	55 100%

Outcome Measures

1. Primary Outcome

Title	Tear Meniscus Height Captured by Optical Coherence Tomography
Description	Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Safety population included all subjects who received device intervention.

Arm/Group Title	Active - Device
Arm/Group Description	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
Measure Participants	55
Pre-stimulation TMH	238.4 (16.7)
Post-stimulation TMH	634.9 (60.8)

Adverse Events

Time Frame	Day 0 to Day 22
Arm/Group Title	Active - Device
Arm/Group Description	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment. Oculeve Intranasal Neurostimulator: Neurostimulation device
All Cause Mortality
	Active - Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Active - Device
	Affected / at Risk (%)	# Events
Total	0/55 (0%)
Other (Not Including Serious) Adverse Events
	Active - Device
	Affected / at Risk (%)	# Events
Total	0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The data provided by this clinical trial, and all related information and any materials containing such data and information, are the exclusive property of Oculeve and are confidential to Oculeve. 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.