Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Not Applicable

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: Cyclosporin; Drug: Hydrocortisone

• Registration Number: NCT04597762
• Lead Sponsor: Hospital Hietzing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-31
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-06
• Last Update Posted: 2021-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone	Cyclosporin	Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye
left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone	Cyclosporin	Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye
left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone	Hydrocortisone	Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye
right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone	Hydrocortisone	Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye

Primary Outcome Measures

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

Trial Locations

Locations (1)

Augenabteilung - Klinik Hietzing; 🇦🇹 Vienna, Austria