Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Hospital Hietzing12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

tearfilm breakup time

tearfilm breakup time measured with Fluorescein

Time frame: 6 months

corneal fluorescein staining

corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)

Time frame: 6 months

corneal optical aberrations

corneal optical aberrations measured with iTrace aberrometry

Time frame: 6 months

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes