MedTrace Logo

Tear Production by Nasal Neurostimulation Compared to Active Control

NCT02970799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-10-19

Study results available
· View outcomes & findings →

Summary

This crossover design study evaluates the effectiveness of the Oculeve Intranasal Neurostimulator comparing the effect of intranasal (active) versus extranasal (control) stimulation on tear production as measured by the Jones Schirmer test in participants with dry eye disease.

Conditions

  • Dry Eye
  • Dry Eye Syndromes
  • Keratoconjunctivitis Sicca

Interventions

DEVICE

Intranasal Neurostimulator

The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

Sponsors & Collaborators

  • Oculeve, Inc.

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · Andover Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-10-31
Completion
2016-10-31
FDA Device
Yes

More Related Trials

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 NCT02970799 on ClinicalTrials.gov