Evaluation of the Safety and Effectiveness of the Oculeve Intranasal Lacrimal Neurostimulator in Patients With Dry Eye

Study Overview
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Brief Summary
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The purpose of this study was to evaluate the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally compared with the same device applied extranasally (control) in treating the symptoms of dry eye exacerbated by the Controlled Adverse Environment (CAE) Model.

Official Title
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A Single Center, Randomized, Controlled, Single-Masked, Cross-Over Clinical Pilot Study to Evaluate the Reduction in the Exacerbation of the Symptoms of Dry Eye Upon Exposure to a Controlled Adverse Environment (CAESM) With Treatment by the Oculeve Nasal Lacrimal TENS Unit

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Intranasal Tear Neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral dry eyes Capable of providing written informed consent Exclusion Criteria: Chronic or recurring epistaxis (nosebleeds) Uncontrolled systemic disease Blood coagulation disorder Females who are pregnant, nursing or planning a pregnancy

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Application<br>Intranasal Tear Neurostimulator device, intranasal application for approximately 3 minutes on Day 0 when the participant experienced an Ocular Discomfort Score (ODS) ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure. | Device: Intranasal Tear Neurostimulator<br>* Neurostimulation applied intranasally and extranasally.<br>|
| Sham Comparator: Extranasal Application<br>Intranasal Tear Neurostimulator device, extranasal application for approximately 3 minutes on Day 0 when the participant experienced an ODS ≥3 at 2 or more consecutive time points in at least one eye during CAE exposure. | Device: Intranasal Tear Neurostimulator<br>* Neurostimulation applied intranasally and extranasally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-Application to Post-Application in the Ora Calibra Ocular Discomfort Scale (ODS) Score | The participant graded their eye discomfort prior to CAE entry, during CAE exposure to threshold, then starting 1 minute after treatment application every 5 minutes in each eye separately using the Ora Calibra ODS where: 0=no discomfort to 4=constant discomfort. Data from the analysis eye was used to determine effectiveness. The analysis eye was defined as the first eye that reached the threshold and resulted in the device application. If both eyes reached the threshold at the same time point, the analysis eye was the eye with the lowest baseline Schirmer test score (a test to determine if the eye produces enough tears to keep it moist; >10 mm is normal) or, if the Schirmer test scores were equal, the right eye. A negative change from Baseline indicates improvement. | Pre-application to Post-application on Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Pre-Application to Post-Application in Dry Eye Symptoms (DES) Using a Visual Analog Scale (VAS) | The participant rated their eye dryness (both eyes simultaneously) at all visits and every 5 minutes during CAE exposure by placing a vertical mark on the 100 mm horizontal line to indicate the level of eye dryness. 0 corresponds to no dryness and 100 corresponds to maximal dryness. A negative change from Baseline indicates improvement. | Pre-application to Post-application on Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye syndrome, keratoconjunctivitis, ophthalmic, eye disease, corneal disease, keratitis