NCT02798289

Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Oculeve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Detailed description

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Conditions

• Dry Eye Syndrome
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DEVICE	Oculeve Intranasal Neurostimulator	Neurostimulation device

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2016-06-14
• Last updated: 2017-10-25
• Results posted: 2017-10-25

Locations

2 sites across 1 country: United States