Clinical trial: Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study (NCT04714099)

Eligibility criteria:
Inclusion Criteria:

          -  We included all patients with moderate to severe dry eye disease (grade 3 or grade 4)
             with the following criteria: The tear film break up time ≤5 seconds for grade 3 and
             immediate for grade 4, schirmer test with anesthetic is ≤5 millimeters for grade 3 and
             ≤2 millimeters for grade 4, corneal or conjunctival staining pattern with fluorescein
             is abnormal and consistent with an abnormal tear film. Oxford grade II or more,
             meibomian gland dysfunction is documented (inspissation of the meibomian gland
             orifices, pitting and neovascularization of the eyelid margins) and one or more
             moderate (≥2+) dry eye related symptoms; including itching, burning, blurred vision,
             foreign body sensation, photophobia, veiling, and soreness or pain

        Exclusion Criteria:

          -  Exclusion criteria included Post LASIK patients, Post radiation fibrosis of lacrimal
             gland, Vitamin A deficiency, Conjunctival scarring (advanced trachoma, chemical burn,
             OCP), Drugs (anti-histaminics, anti-cholinergic, anti-psychotics, selective serotonin
             uptake inhibitors), Patients with familial dysautonomia (Riley-Day syndrome), Use of
             systemic or topical CsA in the previous 90 days.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

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