RPS InflammaDry Detector™ to Determine MMP-9 Levels in Tears
NCT ID: NCT01313351
Last Updated: 2022-12-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
206 participants
OBSERVATIONAL
2010-11-30
2011-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Device testing
Tears were collected from subjects to apply to the RPS InflammaDry detector and were clinically evaluated.
RPS InflammaDry Detector™
A noninvasive immunoassay for detecting MMP-9 levels in tears
Interventions
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RPS InflammaDry Detector™
A noninvasive immunoassay for detecting MMP-9 levels in tears
Eligibility Criteria
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Inclusion Criteria
Group 1: Clinical Dry Eyes
Clinical History Criteria
An Ocular Surface Disease Index (OSDI) of greater than or equal to 13 - \[Appendix #2\]
Clinical Signs Criteria - All of the following must be present
1. Schirmer's Tear Test (with anesthesia) \< 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) \< 10 seconds
3. Total Corneal Staining ≥ 1 \[Appendix #1\]
* At least 1/2 of all patients enrolled will have a Schirmer's Tear Test \< 5 mm or demonstrate corneal staining ≥ 2 \[Appendix #1\]
Group 2: Clinical Normal Non-Dry Eyes
Clinical History Criteria
An Ocular Surface Disease Index (OSDI) of \< 7 - \[Appendix #2\]
Clinical Signs Criteria - All 3 of the following must be present
1. Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
2. Tear Film Break Up Time (TBUT) ≥ 10 seconds
3. Total Corneal Staining = 0 \[Appendix #1\]
Exclusion Criteria
* Patients with prior eye injury, trauma, or ocular surgery within the previous 3 months
* Patients with non-dry eye ocular inflammation, uveitis, history of herpetic keratitis or zoster keratitis
* Patients with history of a recent ocular infection within the prior 1 month
* Use of oral doxycycline or topical macrolides (AzaSite) within 1 month
* Patients currently receiving, or received in the last 2 weeks of the study , certain medications including topical or systemic corticosteroids, topical or systemic Nonsteroidal (NSAIDs) therapy, topical cyclosporine, or other immunosuppressive therapy
* Patients who are pregnant or lactating
* Before initialization of the study, patients must not have used any topical medications, including artificial tears during the previous 2 hours
* The use of Rigid-Gas permeable contact lenses or the use of soft-contact lenses within 1 month of the study
18 Years
ALL
Yes
Sponsors
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Rapid Pathogen Screening
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Sambursky, MD
Role: STUDY_DIRECTOR
Rapid Pathogen Screening, Inc.
Locations
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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
Countries
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References
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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.
Other Identifiers
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100310
Identifier Type: -
Identifier Source: org_study_id