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

Completed

Conditions studied: Dry Eye

In brief

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.

Key facts

Study ID

NCT01313351

Run by

Rapid Pathogen Screening

People needed

206

Starts

2010-11-01

Expected to finish

2011-10-01

Last updated by the study team

2022-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients older than 18 years of age, who meet the following criteria related to the clinical history and signs will be enrolled:
• 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
• Schirmer's Tear Test (with anesthesia) < 10 mm over 5 minutes
• Tear Film Break Up Time (TBUT) < 10 seconds
• 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
• Schirmer's Tear Test (with anesthesia) ≥ 10 mm over 5 minutes
• Tear Film Break Up Time (TBUT) ≥ 10 seconds
• Total Corneal Staining = 0 [Appendix #1]

You may not qualify if…

• Patients with allergy to corn starch, talcum powder, or dacron
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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