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

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

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

Patients who were clinically determined by an ophthalmic clinician to meet enrollment criteria were included in the study.

20 Minutes

Regular monitoring by sponsor and mandatory reporting by investigator.