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OpenTrials
Completed

NCT Number: NCT04597762

Effect of Ciclosporin Eyedrops on Sjögren Syndrome

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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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augenabteilung - Klinik Hietzing

Vienna, 1130, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporin

Drug

Cyclosporin eyedrops

Hydrocortisone

Drug

Hydrocortisone eyedrops

Primary outcomes

  1. tearfilm breakup time

    Time frame: 6 months

    tearfilm breakup time measured with Fluorescein

  2. corneal fluorescein staining

    Time frame: 6 months

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

  3. corneal optical aberrations

    Time frame: 6 months

    corneal optical aberrations measured with iTrace aberrometry

Sponsors and collaborators

Lead sponsor

Hospital Hietzing

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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