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Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

NCT02385292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-19

Study results available
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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

Conditions

  • Dry Eye Syndromes

Interventions

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.

Sponsors & Collaborators

  • Oculeve, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Lewis, MD · Grutzmacher, Lewis & Sierra

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-03-31
Completion
2016-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02385292 on ClinicalTrials.gov