Clinical trial: Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome (NCT03865888)

Eligibility criteria:
Inclusion Criteria:

          -  Patients diagnosed as Secondary Sjogren syndrome according to the 2002 American
             European consensus group (AECG) criteria, which require the presence of well defined
             major connective tissue disease (such as rheumatoid arthritis and systemic lupus
             erythematosus.

          -  All patients show chronic symptoms of burning, foreign body sensation, itching in both
             eyes, abnormal Schirmer test <5 mm wetting of the paper after 5 minutes, and abnormal
             tear breakup time (TBUT) < 10 seconds.

          -  Wash out period of 30 days before start of the immunomodulatory eye drops included in
             the investigator's study

        Exclusion Criteria:

          1. Any inflammation or active structural changes in the iris or anterior chamber.

          2. Patients receiving or who had received systemic cyclosporine or tacrolimus.

          3. Patients receiving any systemic drug that can cause dry eye as some antidepressants ,
             antihistaminic drugs , hormonal therapy…etc

          4. Glaucoma.

          5. Previous ocular surgery.

          6. Use of any topical medication other than artificial tears.

          7. Contact lens wearers.

          8. Presence of any corneal infection.

          9. Any corneal diseases (ulcer, opacity, scar, bullous keratopathy, symblepharon or
             tumors).

         10. Deforming structural lid or conjunctival abnormality.

         11. Pregnancy.

         12. Prior diagnosis of any of the following conditions would exclude participation in AECG
             study :

        Past head and neck radiation treatment Hepatitis C infection Acquired immunodeficiency
        disease (AIDS) Pre-existing lymphoma Sarcoidosis Graft versus host disease
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 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