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NCT04597762 | COMPLETED | Dry Eye Syndromes

Effect of Ciclosporin Eyedrops on Sjögren Syndrome
Sponsor:

Hospital Hietzing

Information provided by (Responsible Party):

Prof. Dr. Pia Vécsei-Marlovits

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

Dry Eye Syndromes

Intervention/treatment

Cyclosporin

Hydrocortisone

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 12 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome
Actual Study Start Date : 2020-08-31
Estimated Primary Completion Date : 2021-03-30
Estimated Study Completion Date : 2021-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Location Details

NCT04597762

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How to Participate

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Locations

Not yet recruiting

Austria,

Eye department - Hietzing Clinic

Vienna, Austria, 1130