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

NCT02680158 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-04-26

Study results available
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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.

Conditions

  • Dry Eye Syndrome
  • Keratoconjunctivitis Sicca

Interventions

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.

Sponsors & Collaborators

  • Oculeve, Inc.

    lead INDUSTRY

Principal Investigators

  • Michelle Senchyna · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-03-31
Completion
2016-03-31
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 NCT02680158 on ClinicalTrials.gov