Multicenter Trial Evaluating Quality of Tears Produced by Nasal Neurostimulation

Study Overview
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Brief Summary
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The objectives of this study are: To compare the change in levels of tear proteins and inflammatory mediators pre and post administration between the intranasal and extranasal applications To compare the goblet cell count following application between the intranasal and extranasal applications To compare fluorescein tear clearance with the application of the device intranasally and extranasally applications

Detailed Description
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In this study, subjects will participate for three study days during up to a 44 day period, consisting of a screening examination to determine eligibility on one day and study applications on two different days. There are two applications, intranasal and extranasal. Subjects will receive both applications, in random sequence, one at each of the two application days (Visit 2 and Visit 3). The two applications consist of: Active intranasal device application Active extranasal device application

Official Title
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Randomized, Controlled, Crossover, Multicenter Trial Comparing Quality of Tears Produced by Nasal Neurostimulation Versus Sham for Dry Eye

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Oculeve Intranasal Lacrimal 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) Blood coagulation disorder Uncontrolled or poorly controlled diabetes Heart or pulmonary disease Females who are pregnant, planning a pregnancy or nursing

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal then Extranasal Application<br>Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. | Device: Oculeve Intranasal Lacrimal Neurostimulator<br>* The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate the body's natural tear production system.<br>|
| Active Comparator: Extranasal then Intranasal Application<br>Extranasal application of the Oculeve Intranasal Lacrimal Neurostimulator followed by Intranasal application of the Oculeve Intranasal Lacrimal Neurostimulator. | Device: Oculeve Intranasal Lacrimal Neurostimulator<br>* The Oculeve Intranasal Lacrimal Neurostimulator applies a small electrical current to gently activate 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 |
| --- | --- | --- |
| Fluorescein Tear Clearance With Application |  | Day 1 |