Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye

Oculeve, Inc.2 sites in 1 country23 target enrollmentMay 31, 2015

ConditionsDry Eye Syndromes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Syndromes
Sponsor: Oculeve, Inc.
Enrollment: 23
Locations: 2
Primary Endpoint: Fluorescein Tear Clearance With Application
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 31, 2015

End Date

March 31, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover