NCT02526290

Six Month Study to Evaluate the Safety and Effectiveness of the Intranasal Lacrimal Neurostimulator

Single-Arm, Multicenter, Open-Label Study to Evaluate the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Participants With Aqueous Tear Deficient Dry Eye

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Oculeve, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

In this study, the safety and effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator after 180 days of use in participants with aqueous tear deficiency will be evaluated.

Detailed description

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the Oculeve Intranasal Lacrimal Neurostimulator to stimulate tear production for 180 days. Participants will have a Screening Visit within 60 days prior to the initial device application. Device application will be initiated at Day 0, at which time participants will receive training on the proper use of the device. Participants will receive follow-up visits at Days 7, 30, 90 and 180.

Conditions

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Interventions

Type	Name	Description
DEVICE	Intranasal Lacrimal Neurostimulator (Oculeve)	Neurostimulation device

Timeline

• Start date: 2015-08-31
• Primary completion: 2016-04-30
• Completion: 2016-04-30
• First posted: 2015-08-18
• Last updated: 2017-10-31
• Results posted: 2017-10-31

Locations

3 sites across 1 country: United States