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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03865888
Date of registration: 16/12/2018
Prospective Registration: Yes
Primary sponsor: Pavly Moawd
Public title: Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
Scientific title: 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
Date of first enrolment: October 30, 2018
Target sample size: 60
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03865888
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  Phase 3
Countries of recruitment
Egypt
Contacts
Name:     Gaafar Ragab
Address: 
Telephone:
Email:
Affiliation:  Cairo University
Name:     Omar El Zawahry
Address: 
Telephone:
Email:
Affiliation:  Cairo University
Name:     Rehab Shamma
Address: 
Telephone:
Email:
Affiliation:  Cairo University
Key inclusion & exclusion 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



Age minimum: 20 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Dry Eye
Sjogren Syndrome
Intervention(s)
Drug: Cyclosporins
Drug: Tacrolimus
Primary Outcome(s)
Comparison between the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on tear film volume in dry eyes in Secondary Sjogren Syndrome patients. [Time Frame: 3 months follow up]
Evaluating the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on ocular surface damage in dry eyes in Secondary Sjogren Syndrome patients. [Time Frame: 3 months follow up]
Studying the effect of cyclosporine and tacrolimus eye drops on tear film stability in dry eyes in Secondary Sjogren Syndrome patients. [Time Frame: 3 months follow up]
Secondary Outcome(s)
Evaluating the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on meibomian glands secretion in dry eyes of Secondary Sjogren Syndrome patients. [Time Frame: 3 months follow up]
Studying the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on expressibility of meibomian glands in dry eyes of Secondary Sjogren Syndrome patients. [Time Frame: 3 months follow up]
Secondary ID(s)
N-75-2018
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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