Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

Not Applicable

Completed

• Conditions: Keratoconjunctivitis Sicca; Dry Eye Syndrome
• Interventions: Device: Oculeve Intranasal Neurostimulator

• Registration Number: NCT02798289
• Lead Sponsor: Oculeve, Inc.

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-14
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-09
• Results First Submitted: 2017-09-27
• Results First Submitted QC: 2017-09-27
• Last Update Submitted: 2017-09-27
• Results First Posted: 2017-10-25
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active - Device	Oculeve Intranasal Neurostimulator	The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.

Primary Outcome Measures

Name	Time	Method
Tear Meniscus Height Captured by Optical Coherence Tomography	Day 1	Tear meniscus Height was measured before and after stimulation with Oculeve Intranasal Neurostimulator using Optical Coherence Tomography.

Trial Locations

Locations (2)

Aesthetic Eyecare Institute; 🇺🇸 Newport Beach, California, United States

Sall Research Medical Center; 🇺🇸 Artesia, California, United States