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RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears

Dry Eye Clinical Trial

Official title:
A Clinical Evaluation of the RPS InflammaDry Detector's Sensitivity and Specificity Compared to the Clinical Diagnosis for Confirming Dry Eyes.

Clinical Trial 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.

Clinical Trial Description

The purpose of this clinical trial was to determine the sensitivity and specificity of InflammaDry compared with the clinical assessment of dry eyes. Patients were screened using clinical history and signs. Clinical history was performed using the Ocular Surface Disease Index (OSDI) and evaluated for clinical signs: - positive vital staining of the ocular surface, - decreased tear breakup time (TBUT), - reduced corneal sensitivity, and - decreased functional visual acuity Last, an independent health care professional masked to the clinical evaluation was asked to analyze each InflammaDry test result, independently confirming each result. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01313351
Study type Observational
Source Lumos Diagnostics
Contact
Status Completed
Phase
Start date November 2010
Completion date October 2011
View Details
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