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OpenTrials
Completed

NCT Number: NCT01692964

Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manatee-Sarasota Eye Clinic, Bradenton, Florida, United States

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About this study

The InflammaDry test will be used to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

InflammaDry

Device

A noninvasive immunoassay for detecting MMP-9 levels in tears.

Primary outcomes

  1. Negative and Positive Agreement of the InflammaDry at Diagnosis of Dry Eyes

    Time frame: 20 minutes

    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.

Sponsors and collaborators

Lead sponsor

Rapid Pathogen Screening

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2012
Registry last updated
Oct 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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