Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385292
• Other study ID #: OCUN-003
• Status: Completed
• Phase: N/A
• Start date: May 31, 2015
• Est. completion date: March 31, 2016

Study information

• Verified date: September 2021
• Source: Oculeve, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine, Department of Ophthalmology	Houston	Texas
United States	Grutzmacher, Lewis & Sierra	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of Tear Proteins Pre and Post Administration		Day 1
Other	Level of Inflammatory Mediators Pre and Post Administration		Day 1
Other	Goblet Cell Count Following Application		Day 1
Primary	Fluorescein Tear Clearance With Application		Day 1