NCT02970799

Tear Production by Nasal Neurostimulation Compared to Active Control

Randomized, Controlled, Crossover Study Comparing Tear Production by Nasal Neurostimulation Versus Active Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Oculeve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

Detailed description

In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.

Conditions

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DEVICE	Intranasal Neurostimulator	The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Timeline

• Start date: 2016-08-31
• Primary completion: 2016-10-31
• Completion: 2016-10-31
• First posted: 2016-11-22
• Last updated: 2021-10-19
• Results posted: 2021-10-19

Regulatory

• FDA-regulated device study