Sponsor study identifier
observational
206
1 country
8
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 3, 2011
Actual (reported)March 11, 2011
Actual (reported)October 2011
Actual (reported)October 2011
Actual (reported)March 16, 2022
Actual (reported)Sensitivity and Specificity of InflammaDry Detector Compared to Clinical Assessment at Confirming a Diagnosis of Dry Eyes.
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.
15 minutes
Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.
A noninvasive immunoassay for detecting MMP-9 levels in tears
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Only patients who met the inclusion criteria were included in the study.
Manatee Sarasota Eye Clinic
Bradenton, Florida, 34208, United States
Center for Excellence in Eye Care
Miami, Florida, 33176, United States
St. John's Clinics
Springfield, Missouri, 65804, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563, United States
Physician Eyecare of NY
New York, New York, 10016, United States
Weill-Cornell Medical College
New York, New York, 10021, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Sambursky R, Davitt WF 3rd, Latkany R, Tauber S, Starr C, Friedberg M, Dirks MS, McDonald M. Sensitivity and specificity of a point-of-care matrix metalloproteinase 9 immunoassay for diagnosing inflammation related to dry eye. JAMA Ophthalmol. 2013 Jan;131(1):24-8. doi: 10.1001/jamaophthalmol.2013.561.
Robert Sambursky, MD
Rapid Pathogen Screening, Inc.
206 participants (actual enrollment reported by the registry).
First Submitted
March 3, 2011
First Posted
March 11, 2011
Study Start
November 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
William F. Davitt, III, MD
El Paso, Texas, 79904-2037, United States
Primary Completion
October 2011
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
December 12, 2022
Results First Posted
March 16, 2022
Record last verified: 2022-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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