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Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye

NCT02313454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-01-31

Study results available
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Summary

The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.

Conditions

  • Dry Eye Syndromes

Interventions

DEVICE

Intranasal Tear Neurostimulator

Neurostimulation applied intranasally and extranasally.

Sponsors & Collaborators

  • ORA, Inc.

    collaborator INDUSTRY

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Michelle Senchyna · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2015-04-08
Completion
2015-04-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02313454 on ClinicalTrials.gov