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NCT01313351 · ClinicalTrials.gov registry record
RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
A clinical trial, sponsored by Rapid Pathogen Screening.
- Completed
- Registry status
- 206
- Enrollment target
NCT01313351: Completed study, sponsored by Rapid Pathogen Screening.
NCT01313351 is a clinical trial that has completed, run by Rapid Pathogen Screening. The registered enrollment target is 206 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313351 has completed, sponsored by Rapid Pathogen Screening.
- COMPLETED
- Registry status
- 206 participants
- Enrollment target
Study Summary
The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
Primary Outcome
Patients were assessed for signs and Symptoms of Dry Eye using OSDI (Ocular Surface Disease Index), TBUT (Fluorescein Tear Break-up Time), Corneal fluorescein staining and Schirmer Tear Test and compared to the results of the tested device. Sensitivity is the percentage of true positive cases correctly identified by the test, compared to clinical assessment. Specificity is the percentage of true negative cases correctly identified by the test, compared to clinical assessment.
Interventions
- DEVICE RPS InflammaDry Detector™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-10 |
What the finished NCT01313351 record still lists
NCT01313351 is an observational study that tracks outcomes without assigning an intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which RPS InflammaDry Detector™ is the first listed.
NCT01313351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313351 about?
NCT01313351 is a clinical study titled "RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears". The RPS InflammaDry Detector™ is intended to detect elevated MMP-9 in human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.
What is the current status of trial NCT01313351?
This trial is currently completed. The enrollment target is 206 participants. The study started on 2010-11. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01313351?
The interventions under investigation include: RPS InflammaDry Detector™ (DEVICE).
Who is sponsoring clinical trial NCT01313351?
This trial is sponsored by Rapid Pathogen Screening, which has 5 total clinical trials registered on ClinicalTrials.gov.
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