NCT01692964|CompletedResults
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Sponsor study identifier
observational
237
1 country
4
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
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.
September 19, 2012
Actual (reported)September 26, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)May 2013
Actual (reported)October 12, 2020
Actual (reported)Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes
Negative agreement is the percentage of true negative cases compared to clinical assessment (specificity). Positive agreement is the percentage of true positive cases compared to clinical assessment (sensitivity). The InflammaDry test was compared with the clinical assessment of tear break-up time, Schirmer tear testing, and corneal staining for the confirmation of dry eye, both with and without the inclusion of the Ocular Surface Disease Index (OSDI), as a confirmatory test.
20 minutes
Patients suspected of having dry eye will be tested with the InflammaDry.
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.
Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.
Manatee-Sarasota Eye Clinic
Bradenton, Florida, 34208, United States
Mercy Clinic - Eye Specialists
Springfield, Missouri, 65804, United States
Ophthalmic Associates
Johnson City, New York, 13790, United States
Ophthalmology Diagnostics & Clinical Research
El Paso, Texas, 79904-2037, United States
Sambursky R, Davitt WF 3rd, Friedberg M, Tauber S. Prospective, multicenter, clinical evaluation of point-of-care matrix metalloproteinase-9 test for confirming dry eye disease. Cornea. 2014 Aug;33(8):812-8. doi: 10.1097/ICO.0000000000000175.
237 participants (actual enrollment reported by the registry).
First Submitted
September 19, 2012
First Posted
September 26, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
October 12, 2020
Results First Posted
October 12, 2020
Record last verified: 2020-09
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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