Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Oculeve

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: Oculeve Intranasal Lacrimal Neurostimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02385292

OCUN-003

Details and patient eligibility

About

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

Full 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

Enrollment: 23 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Intranasal then Extranasal Application

Experimental group

Description:

Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Treatment:

Device: Oculeve Intranasal Lacrimal Neurostimulator

Extranasal then Intranasal Application

Active Comparator group

Description:

Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator.

Treatment:

Device: Oculeve Intranasal Lacrimal Neurostimulator