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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03865888 |
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Date of registration:
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16/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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October 30, 2018 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03865888 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 3
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Rehab Shamma |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Gaafar Ragab |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Name:
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Omar El Zawahry |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cairo University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Dry Eye
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Sjogren Syndrome
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Intervention(s)
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Drug: Tacrolimus
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Drug: Cyclosporins
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Primary Outcome(s)
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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]
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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]
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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]
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Secondary Outcome(s)
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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]
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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]
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Secondary ID(s)
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N-75-2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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