Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Sponsor

Hospital Hietzing (Other)

Overall Status

Completed

CT.gov ID

NCT04597762

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Cyclosporin Drug: Hydrocortisone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 31, 2020

Actual Primary Completion Date :

Mar 30, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

tearfilm breakup time [6 months]
tearfilm breakup time measured with Fluorescein
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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