Effect of Ciclosporin Eyedrops on Sjögren Syndrome

April 6, 2021 updated by: Prof. Dr. Pia Vécsei-Marlovits, Hospital Hietzing

Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome

Keratoconjunctivitis sicca, also known as dry eye syndrome, is one of the most common ophthalmological diseases and is treated with tear substitutes to moisten the surface of the eye and, in more severe cases of this disease, with local anti-inflammatory therapy with corticosteroids or ciclosporin A. In patients with rheumatological diseases, such as Sjögren's syndrome, dry eye syndrome of severe extent occurs particularly frequently, which is why topical anti-inflammatory therapy is often necessary in these patients.

Aim of this study is to evaluate the treatment of severe dry eye syndrome with topical cyclosporin eyedrops with and without topical corticosteroids at the beginning of the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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

  • Austria
      • Vienna, Austria, 1130
        • Augenabteilung - Klinik Hietzing

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

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of severe keratoconjunctivitis sicca defined by:
  • Staining of the cornea ≥ grade III according to the Oxford scale
  • OSDI value ≥ 12
  • Age between 18 and 90 years
  • Primary or secondary Sjogren's syndrome (defined according to the American-European Consensus Group criteria) with a stable course and unchanged treatment for 6 months

Exclusion criteria:

  • Pregnancy (excluded with a pregnancy test in patients of childbearing potential)
  • Children and young people up to the age of 18
  • Eye surgery in the past 6 months
  • Simultaneous participation in another study
  • Regular use of eye drops, with the exception of tear substitutes
  • Use of eye drops containing ciclosporin or glucocorticoids in the last 6 months

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
Experimental: right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye
Drug: Cyclosporin
Cyclosporin eyedrops
Drug: Hydrocortisone
Hydrocortisone eyedrops
Experimental: left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye
Drug: Cyclosporin
Cyclosporin eyedrops
Drug: Hydrocortisone
Hydrocortisone eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tearfilm breakup time
Time Frame: 6 months
tearfilm breakup time measured with Fluorescein
6 months
corneal fluorescein staining
Time Frame: 6 months
corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)
6 months
corneal optical aberrations
Time Frame: 6 months
corneal optical aberrations measured with iTrace aberrometry
6 months

Collaborators and Investigators

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

Sponsor

Hospital Hietzing

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)

August 31, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SiccaIkervis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

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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