Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye

Rapid Pathogen Screening

Status: Completed

Conditions: Dysfunctional Tear Syndrome

Treatments: Device: InflammaDry

Study type: Observational

Funder types: Industry

Identifiers

NCT01692964

12-0615

Details and patient eligibility

About

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

Full description

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

Enrollment: 237 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

  1. Burning or stinging
  2. Sandy or gritty feeling
  3. Foreign body sensation
  4. Tearing
  5. Light sensitivity
  6. Intermittent or fluctuating vision
  7. 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

Trial design

237 participants in 1 patient group

InflammaDry

Description:

Patients suspected of having dry eye will be tested with the InflammaDry.

Treatment:

Device: InflammaDry