Tear Production by Nasal Neurostimulation Compared to Active Control

Randomized, Controlled, Crossover Study Comparing Tear Production by Nasal Neurostimulation Versus Active Control

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.

Study Overview

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

Detailed Description

In this randomized, controlled study, participants will receive two applications of approximately a three-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence at Visit 2 (Day 1). At Visits 3 (Day 15) and 4 (Day 29), participants will undergo two applications of approximately an eight-minute duration, one intranasal (active) and one extranasal (control), in randomized sequence. The Schirmer test is a clinically relevant and accepted measure to assess tear production over a specified time interval, generally five minutes. Tear meniscus height (TMH) and, to a lesser extent, tear meniscus area (TMA) have been reported as measures of tear quantity and/or production and have been used to diagnose dry eye disease (DED). One reliable means of measuring TMH and TMA is via use of optical coherence tomography (OCT), an established medical imaging technique that uses light to capture micrometer-resolution images from within optical scattering media such as biological tissue. Due to the non-invasive nature of the technique, this study was designed to explore the utility of TMH and TMA captured by OCT as a means of evaluating stimulated tear production following use of the study device.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

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:

• Mild to severe dry eye disease
• Have not worn contact lenses for at least seven days prior to the Screening Visit and willing to forego the use of contact lenses for the duration of the study
• Literate, able to speak English or Spanish, and able to complete questionnaires independently

Exclusion Criteria:

• Previously used the Intranasal Neurostimulator at any time
• Used commercial lid hygiene product within 14 days of the Screening Visit or plan to use at any time during the study
• Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to the risk of clinically significant increased bleeding
• Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
• Severe nasal airway obstruction (e.g. severe septal deviation or inferior turbinate hypertrophy) or vascularized polyp as confirmed by nasal endoscopic examination at the Screening Visit
• Have an implanted metallic or other electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator
• Participation in any clinical trial with a new active substance or a new device within 30 days of the Screening Visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal then Extranasal Application; Intranasal Neurostimulator applied intranasally (active) followed by extranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence for Days 15 and 29.	Device: Intranasal Neurostimulator; The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
Experimental: Extranasal then Intranasal Application; Intranasal Neurostimulator applied extranasally (control) followed by intranasal application on Day 1. Participants were randomized to determine the intranasal and extranasal sequence at Days 15 and 29.	Device: Intranasal Neurostimulator; The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Acute Tear Production by Jones Schirmer Test	Day 1

Other Outcome Measures

Outcome Measure	Time Frame
Tear Meniscus Height	Pre and Post Application on Days 15 and 29
Tear Meniscus Area	Pre and Post Application Days 15 and 29
Number of Secreting Meibomian Glands	Day 1
Tear Film Lipid Layer Thickness by Tearscope	Pre and Post Application on Days 15 and 29
Lower Lid Margin Temperature	Pre and Post Application on Days 15 and 29
Tear Film Temperature	Pre and Post Application on Days 15 and 29
Number of Participants With Adverse Events	Up to 41 days

Collaborators and Investigators

• Sponsor: Oculeve, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2016
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye Disease
• 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-016B

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes