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

Dry Eye Syndromes Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02526290
Study type Interventional
Source Oculeve, Inc.
Contact
Status Completed
Phase N/A
Start date August 31, 2015
Completion date April 30, 2016
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