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NCT02798289 Clinical Trial

Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Dry Eye Syndrome Clinical Trial

Official title:
A Single Arm, Multicenter, Open-Label Study Designed to Evaluate Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02798289
Other study ID # OCUN-014
Secondary ID
Status Completed
Phase N/A
First received June 9, 2016
Last updated September 27, 2017
Start date June 2016
Est. completion date August 2016

Study information
Verified date September 2017
Source Oculeve, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate acute tear production as measured by tear meniscus height (TMH) captured by optical coherence tomography (OCT) after single use of the Oculeve Intranasal Neurostimulator (OIN) in participants with dry eye.

Description:

This is a prospective, single-arm, multicenter, open-label clinical trial in which participants will use the OIN once following study enrollment.

Recruitment information / eligibility
Status Completed
Enrollment 55
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria:

- Subjects with dry eye disease

- Literate, able to speak English or Spanish, and able to complete questionnaires independently

- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol

Exclusion Criteria:

- Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding

- Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma

- Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

- Corneal transplant in either or both eyes

- Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

- Women who are pregnant, planning a pregnancy, or nursing at the Screening Visit

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Oculeve Intranasal Neurostimulator
Neurostimulation device

Locations
Country Name City State
United States Sall Research Medical Center Artesia California
United States Aesthetic Eyecare Institute Newport Beach California

Sponsors (1)
Lead Sponsor Collaborator
Oculeve, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tear Meniscus Height Captured by Optical Coherence Tomography Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography. Day 1
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