Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation

Study Overview
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Brief Summary
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This study evaluates the safety and effectiveness of the Intranasal Tear Neurostimulator applied intranasally (active) compared with the same device applied extranasally (control) relating to symptoms of dry eye exacerbated by the Controlled Adverse Environment model.

Detailed Description
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Participants will be randomized to a single application sequence, either sequence A (intranasal application followed by control application) or sequence B (control application followed by intranasal application) using the device. Upon entering the CAE, participants will complete dry eye questionnaires every five minutes and will administer the device either intranasally or extranasally in randomized sequence when a certain level of ocular discomfort has been reached.

Official Title
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Multicenter, Randomized, Controlled, Single-Masked, Cross-Over Clinical Trial to Evaluate Dry Eye Symptoms With Application of the Oculeve Intranasal Tear Neurostimulator During Exposure to a Controlled Adverse Environment (CAE®)

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: Moderate to severe dry eye disease Normal lid/lash anatomy, blinking function and closure as determined by the Investigator Literate, able to speak English, and able to complete questionnaires independently Exclusion Criteria: Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas Implanted metallic or electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator Corneal transplant in either or both eyes A woman who is pregnant, nursing an infant, or planning a pregnancy at the Screening Visit Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal Application<br>Intranasal Tear Neurostimulator applied intranasally device (active), intranasal 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 the CAE exposure. | Device: Intranasal Tear Neurostimulator<br>* The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.<br>|
| Sham Comparator: Extranasal Application<br>Intranasal Tear Neurostimulator device applied extranasally (control) 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 the CAE exposure. | Device: Intranasal Tear 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 |
| --- | --- | --- |
| Change From Pre-Application to Post-Application in Eye Dryness Score (EDS) 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. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect. | 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 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 eye that reached the threshold triggering the first application or if both eyes reach the threshold at the same time, the eye with the higher discomfort score or if both eyes are the same, the right eye was used. A negative change from Baseline indicates improvement. A cross-over linear model was used with symptom relief as the response variable; sequence, application location, period, and the application location by period interaction as fixed effects; and participant (sequence) as a random effect. | Pre-application to Post-application on Day 0 |