Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Completed

Conditions studied: Dysfunctional Tear Syndrome

In brief

InflammaDry is a rapid diagnostic test for the detection of elevated levels of Matrix Metalloproteinase-9 (MMP-9) protein in tear fluid.

Key facts

Study ID

NCT01692964

Run by

Rapid Pathogen Screening

People needed

237

Starts

2012-10-01

Expected to finish

2013-05-01

Last updated by the study team

2020-10-12

Who can join

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

You may qualify if…

• 18 years of age or older
• Patient voluntarily reported at least 1 episode of any of the following ocular symptoms during the last month:
• Burning or stinging
• Sandy or gritty feeling
• Foreign body sensation
• Tearing
• Light sensitivity
• Intermittent or fluctuating vision
• Tired eyes

You may not qualify if…

• Allergy to cornstarch or Dacron
• Allergy to topical anesthetic or fluorescein dye
• Prior eye injury, trauma, or ocular surgery within the last 3 months
• Known blockage of the lacrimal drainage system
• Contact lens wear in the last month
• Previous corneal refractive surgery including RK, LASIK or PRK surgery
• Have an active ocular infection or history of a recent ocular infection in the last month
• Have active intraocular inflammation or history of intraocular inflammation, e.g. Uveitis
• Use of oral doxycycline, corticosteroids, or immunomodulators in the last month
• Have received topical ocular corticosteroids, topical Nonsteroidal (NSAIDs) therapy, or topical ocular cyclosporine in the last month
• Pregnant or lactating
• Use of any topical ophthalmic medications, including artificial tears 2 hours prior to enrollment

Where it is running

• Manatee-Sarasota Eye Clinic — Bradenton, Florida, United States
• Mercy Clinic - Eye Specialists — Springfield, Missouri, United States
• Ophthalmic Associates — Johnson City, New York, United States
• Ophthalmology Diagnostics & Clinical Research — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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