Clinical trial: Clinical Evaluation of the InflammaDry Device for Detecting Dry Eye (NCT01692964)

Eligibility 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
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Contradiction