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

Oculeve, Inc.2 sites in 1 country55 target enrollmentJune 2016

ConditionsDry Eye Syndrome Keratoconjunctivitis Sicca

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Syndrome
Sponsor: Oculeve, Inc.
Enrollment: 55
Locations: 2
Primary Endpoint: Tear Meniscus Height Captured by Optical Coherence Tomography
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

August 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Oculeve, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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