Acute Tear Production Following Single Use of the Oculeve Intranasal Neurostimulator

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

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.

Study Overview

• Status: Completed
• Conditions: Keratoconjunctivitis Sicca; Dry Eye Syndrome
• Intervention / Treatment: Device: Oculeve Intranasal Neurostimulator

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Newport Beach, California, United States, 92663
      • Aesthetic Eyecare Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active - Device; The Oculeve Intranasal Neurostimulator will be administered once to induce aqueous tear production once following study enrollment.	Device: Oculeve Intranasal Neurostimulator; Neurostimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oculeve, Inc.
• Investigators: Study Director: Neil Friedman, MD, Mid-Peninsula Ophthalmology Medical Group

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Keratoconjunctivitis
• Other Study ID Numbers: OCUN-014