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

Completed

• Conditions: Dry Eye

• Registration Number: NCT01313351
• Lead Sponsor: Rapid Pathogen Screening

Brief 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2022-01-11
• Results First Posted: 2022-03-16
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.	15 minutes	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.

Trial Locations

Locations (8)

Manatee Sarasota Eye Clinic; 🇺🇸 Bradenton, Florida, United States

Center for Excellence in Eye Care; 🇺🇸 Miami, Florida, United States

St. John's Clinics; 🇺🇸 Springfield, Missouri, United States

Ophthalmic Consultants of Long Island; 🇺🇸 Lynbrook, New York, United States

Physician Eyecare of NY; 🇺🇸 New York, New York, United States

Weill-Cornell Medical College; 🇺🇸 New York, New York, United States

Black Hills Regional Eye Institute; 🇺🇸 Rapid City, South Dakota, United States

William F. Davitt, III, MD; 🇺🇸 El Paso, Texas, United States