Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: Oculeve Intranasal Lacrimal Neurostimulator

• Registration Number: NCT02385292
• Lead Sponsor: Oculeve, Inc.

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

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 Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Study Start: 2015-05-31
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2021-09
• Results First Submitted: 2021-09-22
• Results First Submitted QC: 2021-09-22
• Last Update Submitted: 2021-09-22
• Results First Posted: 2021-10-19
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intranasal then Extranasal Application	Oculeve Intranasal Lacrimal Neurostimulator	Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.
Extranasal then Intranasal Application	Oculeve Intranasal Lacrimal Neurostimulator	Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Primary Outcome Measures

Name	Time	Method
Fluorescein Tear Clearance With Application	Day 1

Trial Locations

Locations (2)

Grutzmacher, Lewis & Sierra; 🇺🇸 Sacramento, California, United States

Baylor College of Medicine, Department of Ophthalmology; 🇺🇸 Houston, Texas, United States