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NCT01692964 · ClinicalTrials.gov registry record
Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye
A clinical trial of Dysfunctional Tear Syndrome, sponsored by Rapid Pathogen Screening.
- Completed
- Registry status
- 237
- Enrollment target
- 4
- Study locations
NCT01692964: Completed study of Dysfunctional Tear Syndrome, sponsored by Rapid Pathogen Screening.
NCT01692964 is a study of Dysfunctional Tear Syndrome that has completed, run by Rapid Pathogen Screening. The registered enrollment target is 237 participants. The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01692964, a study of Dysfunctional Tear Syndrome, has completed, sponsored by Rapid Pathogen Screening.
- COMPLETED
- Registry status
- 237 participants
- Enrollment target
- 4
- Study locations
Study Summary
InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Primary Outcome
Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
Conditions Studied
Interventions
- DEVICE InflammaDry
Study Locations (4)
Florida
- Manatee-Sarasota Eye Clinic - Bradenton
Missouri
- Mercy Clinic - Eye Specialists - Springfield
New York
- Ophthalmic Associates - Johnson City
Texas
- Ophthalmology Diagnostics & Clinical Research - El Paso
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-05 |
What the finished NCT01692964 record still lists
NCT01692964 is an observational study that tracks outcomes without assigning an intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Dysfunctional Tear Syndrome appearing as the primary indexed condition, and to 1 intervention - of which InflammaDry is the first listed.
NCT01692964 reports a single indexed study location in Florida, Missouri, New York.
Frequently Asked Questions
What is clinical trial NCT01692964 about?
NCT01692964 is a clinical study titled "Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye". InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
What is the current status of trial NCT01692964?
This trial is currently completed. The enrollment target is 237 participants. The study started on 2012-10. Estimated completion is 2013-05.
What conditions does trial NCT01692964 study?
This clinical trial studies the following conditions: Dysfunctional Tear Syndrome.
What interventions are being tested in trial NCT01692964?
The interventions under investigation include: InflammaDry (DEVICE).
Who is sponsoring clinical trial NCT01692964?
This trial is sponsored by Rapid Pathogen Screening, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01692964 being conducted?
This trial has 4 study locations across Florida, Missouri, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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