Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cyclosporin
* Drug: Hydrocortisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone<br>Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye | Drug: Cyclosporin<br>* Cyclosporin eyedrops<br>Drug: Hydrocortisone<br>* Hydrocortisone eyedrops<br>|
| Experimental: left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone<br>Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye | Drug: Cyclosporin<br>* Cyclosporin eyedrops<br>Drug: Hydrocortisone<br>* Hydrocortisone eyedrops<br>|

What is the study measuring?
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Primary Outcome Measures

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