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

NCT02526290 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2017-10-31

Study results available
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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.

Conditions

  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca

Interventions

DEVICE

Intranasal Lacrimal Neurostimulator (Oculeve)

Neurostimulation device

Sponsors & Collaborators

  • Oculeve, Inc.

    lead INDUSTRY

Principal Investigators

  • Edward Holland, MD · Cincinnati Eye Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-04-30
Completion
2016-04-30

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 NCT02526290 on ClinicalTrials.gov