Goblet Cell Degranulation Produced by Intranasal Tear Neurostimulator (ITN) in Dry Eye Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate goblet cell degranulation following acute use of the Intranasal Tear Neurostimulator in participants with dry eye.

Official Title
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Goblet Cell Degranulation Produced by Nasal Neurostimulation: A Randomized, Controlled Study in Patients With Dry Eye Disease

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving verbal and signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol Have not worn contact lenses for at least 7 days prior to the screening visit and are willing to forego the use of contact lenses for the duration of the study The participant should be 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 clinically significant increased bleeding Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device Corneal transplant in either or both eyes Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study Women who are pregnant, planning a pregnancy, or nursing throughout the study

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITN [TrueTear®] - Intranasal Application<br>Intranasal application of the ITN. Single application at application visit. | Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]<br>* The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.<br>|
| Experimental: ITN [TrueTear®] - Extranasal Application<br>Extranasal application of the ITN. Single application at application visit. | Device: Intranasal Tear Neurostimulator (ITN) [TrueTear®]<br>* The ITN applies a small electrical current to the nasal cavities 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 |
| --- | --- | --- |
| Difference in Ratio of Degranulated Goblet Cells. | Mean change from Screening to Application Visit in ratio of goblet cell degranulation post-intranasal use of the Intranasal Tear Neurostimulator (ITN) at the Application visit compared to without use of the ITN at the Screening visit | Screening (Day -60 to Day -30) to Application Visit (Day 0) | 

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