Effect of Ciclosporin Eyedrops on Sjögren Syndrome

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04597762
• Other study ID #: SiccaIkervis
• Status: Completed
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Hospital Hietzing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 31, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Sjogren's Syndrome
• Syndrome

Intervention

Drug:
• Cyclosporin
Cyclosporin eyedrops
• Hydrocortisone
Hydrocortisone eyedrops

Locations

Country	Name	City	State
Austria	Augenabteilung - Klinik Hietzing	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Hietzing

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tearfilm breakup time	tearfilm breakup time measured with Fluorescein	6 months
Primary	corneal fluorescein staining	corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)	6 months
Primary	corneal optical aberrations	corneal optical aberrations measured with iTrace aberrometry	6 months