NCT01313351

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Rapid Pathogen Screening · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DEVICE	RPS InflammaDry Detector™	A noninvasive immunoassay for detecting MMP-9 levels in tears

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-03-11
• Last updated: 2022-12-12
• Results posted: 2022-03-16

Locations

8 sites across 1 country: United States