Tear Production by Nasal Neurostimulation Compared to Active Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dry Eye, Dry Eye Syndromes, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Device: Intranasal Neurostimulator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal then Extranasal Application<br>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<br>* The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.<br>|
| Experimental: Extranasal then Intranasal Application<br>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<br>* The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Disease