TrueTear in Sjogren's Disease Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate acute tear production produced by the intranasal tear neurostimulator in participants with Sjögrens syndrome and aqueous tear deficiency. Our primary goal is to evaluate whether Sjögrens patients respond to this intervention and whether there is a baseline tear production level below which these patients do not respond.

Official Title
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Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease

Conditions
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Dry Eye Syndromes, Sjogren's Syndrome

Intervention / Treatment
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* Device: TrueTear Intranasal Tear Neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG) American College of Rheumatology (ACR), or American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value (during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline value Baseline Ocular Surface Disease Index® (OSDI) total score ≥13 Age greater than or equal to 22 years old Able to complete questionnaires independently Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol Exclusion Criteria: Use of any topical ophthalmic medication, including artificial tears, within 4 hours of either visit Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the investigator, may lead to clinically significant increased bleeding Use of systemic anticoagulants Nasal or sinus surgery including nasal cautery or significant trauma Severely deviated septum Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device Have an active implanted metallic or active implanted electronic device in the head, a cardiac demand pacemaker, or an implanted defibrillator Known hypersensitivity to any of the procedural agents or materials in the study device that contact the nasal mucosa Corneal transplant in either or both eyes Participation in any clinical trial within 30 days of the Screening Visit A woman who is pregnant, planning a pregnancy, or nursing at 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br> | Device: TrueTear Intranasal Tear Neurostimulator<br>* This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Schirmer Testing | Tear production measured immediately following intranasal tear neurostimulation. For this measurement, Schirmer strips (small strips of paper with measurements on them) are placed in the corner of each eye. The amount of wetting of the Schirmer strips is measured in millimeters. Wetting of less than 5 mm is indicative of deficient tear production. | Immediately following the procedure (ie immediately following use of the device) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Changes in Visual Acuity | Clinically significant change in Best corrected visual acuity (BCVA)- this measurement was taken to determine if a significant change in BCVA was noted for participants. If a clinically significant change was noted (greater or equal to 2 lines of vision) then a subject would be listed in the data table below. | Immediately following the procedure (ie immediately following use of the device) | 
| Clinically Significant Changes in Slit Lamp Exam | Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below. | Immediately following the procedure (ie immediately following use of the device) | 
| Number of Adverse Events | Pain, headache, nosebleed, etc felt to be associated with use of the device | Immediately following the procedure (ie immediately following use of the device) |