Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome

• Status: Completed
• Trial end date: 2019-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pavly Moawd
• Treatments: Cyclosporine; Cyclosporins; Ophthalmic Solutions; Tacrolimus

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