NCT02680158

A Study to Evaluate the Safety and Effectiveness of Oculeve Intranasal Lacrimal Neurostimulator in Participants With Dry Eye Syndrome

A Randomized, Controlled, Double-Masked, Multicenter Trial Designed to Evaluate Acute Tear Production With the Oculeve Intranasal Lacrimal Stimulator Compared to Two Control Applications in Patients With Aqueous Deficient Dry Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Oculeve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare acute tear production produced by the Oculeve Intranasal Lacrimal Neurostimulator with two control devices in participants with aqueous tear deficiency.

Detailed description

This is a prospective, randomized, controlled, double-masked, multicenter clinical trial in which participants with aqueous tear deficiency will receive three different device applications in a randomized sequence.

Conditions

• Dry Eye Syndrome
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DEVICE	Oculeve Intranasal	Oculeve device, intranasal (test) application for approximately 3 minutes.
DEVICE	Sham	Sham device (control), intranasal application for approximately 3 minutes.
DEVICE	Oculeve Extranasal	Oculeve device, extranasal (control) application for approximately 3 minutes.

Timeline

• Start date: 2016-01-31
• Primary completion: 2016-03-31
• Completion: 2016-03-31
• First posted: 2016-02-11
• Last updated: 2019-04-26
• Results posted: 2019-04-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study