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NCT03719885 · ClinicalTrials.gov registry record · NA
TrueTear in Sjogren's Disease Patients
A NA study of Sjogren's Syndrome and Dry Eye Syndromes, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03719885: Completed NA study of Sjogren's Syndrome and Dry Eye Syndromes, sponsored by University of Pennsylvania.
NCT03719885 is a NA study of Sjogren's Syndrome and Dry Eye Syndromes that has completed, run by University of Pennsylvania. The registered enrollment target is 55 participants, below the 286-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03719885, a NA study of Sjogren's Syndrome and Dry Eye Syndromes, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE TrueTear Intranasal Tear Neurostimulator
Study Locations (1)
Pennsylvania
- Scheie Eye Institute, University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-12-01 |
| Est. Completion | 2019-12-31 |
| Phase | NA |
What the finished NCT03719885 record still lists
NCT03719885 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 286-participant average among 20 other Sjogren's Syndrome trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Sjogren's Syndrome appearing as the primary indexed condition, and to 1 intervention - of which TrueTear Intranasal Tear Neurostimulator is the first listed.
NCT03719885 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03719885 about?
NCT03719885 is a clinical study titled "TrueTear in Sjogren's Disease Patients". 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 te...
What is the current status of trial NCT03719885?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2018-12-01. Estimated completion is 2019-12-31.
What conditions does trial NCT03719885 study?
This clinical trial studies the following conditions: Sjogren's Syndrome, Dry Eye Syndromes.
What interventions are being tested in trial NCT03719885?
The interventions under investigation include: TrueTear Intranasal Tear Neurostimulator (DEVICE).
Who is sponsoring clinical trial NCT03719885?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03719885 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03719885's enrollment target sits among peer trials
55 13th of 20 higher than 8 of 20 other Sjogren's Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sjogren's Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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