Trials / Completed
CompletedNCT03719885
TrueTear in Sjogren's Disease Patients
Prospective Controlled Study of Intranasal Tear Neurostimulation for Sjogrens Patients With Dry Eye Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2019-04-25
- Completion
- 2019-12-31
- First posted
- 2018-10-25
- Last updated
- 2023-07-07
- Results posted
- 2020-08-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03719885. Inclusion in this directory is not an endorsement.