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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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ClinicalTrials.gov Identifier: NCT03865888
Recruitment Status : Completed
First Posted : March 7, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pavly Moawd, Cairo University

Tracking Information
First Submitted Date  ICMJE December 16, 2018
First Posted Date  ICMJE March 7, 2019
Last Update Posted Date May 22, 2019
Actual Study Start Date  ICMJE October 30, 2018
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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 ]
    Tear film volume will be evaluated using Schirmer I test in millimetres in seconds in dry eyes before and after prescribing either cyclosporine or tacrolimus eye drops in Secondary Sjogren Syndrome patients.
  • 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 ]
    Ocular surface damage will be assessed in term of calculating ocular surface staining score in dry eyes of Secondary Sjogren Syndrome patients before start and at end of treatment in cyclosporine and tacrolimus treated eyes.
  • 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 ]
    Tear film stability will be described in form of tear film break up time in seconds in treated dry eyes of Secondary Sjogren Syndrome patients before and after adminstration of cyclosporine and tacrolimus eye drops.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03865888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • 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 ]
    Comparing between effect of topical cyclosporine 0.05% and tacrolimus 0.03 % on meibomian glands secretions quality score in dry eyes of Secondary Sjogren Syndrome patients.
  • 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 ]
    Evaluating the effect of topical cyclosporine 0.05% and tacrolimus 0.03 % on meibomian glands expressibility score in dry eyes of Secondary Sjogren Syndrome patients.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome
Official Title  ICMJE 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
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, immune complex deposition and lymphocytic infiltration of many organs .The loss of aqueous tear flow in Sjogren syndrome is a result of inflammatory cell infiltration of the lacrimal glands.The principal ocular manifestation of which is decreased tear production leading to chronic irritation and damage to the corneal and conjunctival epithelium. Dry eye associated with Sjogren syndrome (SS dry eye) is often more severe than non-Sjogren dry eye (non-SS dry eye). Rose bengal staining, fluorescein staining, impression cytology, and brush cytology show greater changes in SS dry eye owing to a lack of both basic tearing and reflex tearing resulting from lacrimal gland destruction, which is the hallmark of deteriorating clinical conditions.

The initial tear film ocular surface society dry eye workshop report noted the importance of ocular surface inflammation not only in the development of, but as a downstream effect and propagator of dry eye disease , and reviewed a range of therapies that function, at least in part, by anti-inflammatory mechanisms of action. Thus understanding the link between inflammation and dry eye validates the utilization of anti-inflammatory therapy in everyday practice.

Cyclosporine is understood to be an immunomodulatory drug with anti-inflammatory properties, as well as having other actions relevant to managing dry eye disease . Topical cyclosporine was approved by the FDA for the treatment of moderate-to-severe dry eye disease in 2003, based on an improvement in tear production.

Tacrolimus, a macrolide produced by Streptomyces tsukubaensis,was discovered in 1984 in Japan while searching for new immunosuppressive and cancer chemotherapeutic agents. The use of tacrolimus is of special interest in ophthalmology because it is indicated to be effective in the treatment of immune-mediated diseases Thus, the investigators performed this study to evaluate the effect of two different immunomodulatory eye drops on the ocular surface which are topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Dry Eye
  • Sjogren Syndrome
Intervention  ICMJE
  • Drug: Cyclosporins
    Cyclosporins eye drops to be administered in dry eyes
    Other Name: Restasis
  • Drug: Tacrolimus
    Tacrolimus eye drops to be administered in dry eyes
    Other Name: FK506
Study Arms  ICMJE
  • Active Comparator: Cyclosporins 0.05 % treated eyes
    Topical Cyclosporins 0.05% eye drops twice in one eye for 3 months
    Intervention: Drug: Cyclosporins
  • Active Comparator: Tacrolimus 0.03% treated eyes
    Topical Tacrolimus 0.03% eye drops twice in one eye for 3 months
    Intervention: Drug: Tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 30, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03865888
Other Study ID Numbers  ICMJE N-75-2018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pavly Moawd, Cairo University
Study Sponsor  ICMJE Pavly Moawd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Omar El Zawahry Cairo University
Principal Investigator: Gaafar Ragab Cairo University
Principal Investigator: Rehab Shamma Cairo University
PRS Account Cairo University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP