Status:
COMPLETED
Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
Lead Sponsor:
Pavly Moawd
Conditions:
Dry Eye
Sjogren Syndrome
Eligibility:
All Genders
20-70 years
Phase:
PHASE3
Brief 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.
Detailed Description
Sjogren syndrome is a chronic autoimmune disorder characterized by immune cell infiltration of exocrine glands (exocrinopathy or epitheliitis) and systemic complications due to autoantibody production...
Eligibility Criteria
Inclusion
- 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
- Any inflammation or active structural changes in the iris or anterior chamber.
- Patients receiving or who had received systemic cyclosporine or tacrolimus.
- Patients receiving any systemic drug that can cause dry eye as some antidepressants , antihistaminic drugs , hormonal therapy…etc
- Glaucoma.
- Previous ocular surgery.
- Use of any topical medication other than artificial tears.
- Contact lens wearers.
- Presence of any corneal infection.
- Any corneal diseases (ulcer, opacity, scar, bullous keratopathy, symblepharon or tumors).
- Deforming structural lid or conjunctival abnormality.
- Pregnancy.
- 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
Key Trial Info
Start Date :
October 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03865888
Start Date
October 30 2018
End Date
April 30 2019
Last Update
May 22 2019
Active Locations (1)
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1
Pavly Moawad
Cairo, Egypt, 11421