Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-03-31

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.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Cyclosporin

Intervention Type DRUG

Cyclosporin eyedrops

Hydrocortisone

Intervention Type DRUG

Hydrocortisone eyedrops

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

Group Type EXPERIMENTAL

Cyclosporin

Intervention Type DRUG

Cyclosporin eyedrops

Hydrocortisone

Intervention Type DRUG

Hydrocortisone eyedrops

Interventions

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Cyclosporin

Cyclosporin eyedrops

Intervention Type DRUG

Hydrocortisone

Hydrocortisone eyedrops

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No