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

May 20, 2019 updated by: Pavly Moawd

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

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt, 11421
        • Pavly Moawad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cyclosporins 0.05 % treated eyes
Topical Cyclosporins 0.05% eye drops twice in one eye for 3 months
Cyclosporins eye drops to be administered in dry eyes
Other Names:
  • Restasis
Active Comparator: Tacrolimus 0.03% treated eyes
Topical Tacrolimus 0.03% eye drops twice in one eye for 3 months
Tacrolimus eye drops to be administered in dry eyes
Other Names:
  • FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
3 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Omar El Zawahry, Cairo University
  • Principal Investigator: Gaafar Ragab, Cairo University
  • Principal Investigator: Rehab Shamma, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

April 30, 2019

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

March 5, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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