TrueTear in Sjogren's Disease Patients
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|ClinicalTrials.gov Identifier: NCT03719885|
Recruitment Status : Completed
First Posted : October 25, 2018
Results First Posted : August 25, 2020
Last Update Posted : August 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Syndromes Sjogren's Syndrome||Device: TrueTear Intranasal Tear Neurostimulator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||July 25, 2019|
|Actual Study Completion Date :||November 1, 2019|
Device: TrueTear Intranasal Tear Neurostimulator
This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
- Schirmer Testing [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]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.
- Clinically Significant Changes in Visual Acuity [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]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.
- Clinically Significant Changes in Slit Lamp Exam [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]Clinically significant changes in slit lamp examination . Subjects who experienced clinically significant changes would be represented in the data table below.
- Number of Adverse Events [ Time Frame: Immediately following the procedure (ie immediately following use of the device) ]Pain, headache, nosebleed, etc felt to be associated with use of the device
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719885
|United States, Pennsylvania|
|Scheie Eye Institute, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Giacomina Massaro-Giordano, MD||Scheie Eye Insitute, University of Pennsylvania|