Effect of Ciclosporin eyedrops on symptoms of the eye and visual quality in patients with dry eye syndrome and primary or secondary Sjögren syndrome

Phase 1

• Conditions: primary or secondary Sjögren Syndrome; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-004929-33-AT
• Lead Sponsor: KH Hietzing, Department of Ophthalmology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-27
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Diagnosis of severe keratoconjunctivitis sicca defined by:
1) Staining of the cornea = Grade III according to the Oxford scale
2) OSDI value = 12
- Age between 18 and 90 years
- Primary or secondary Sjögren syndrome (defined according to the American-European Consensus Group criteria)
- Stable course of the underlying rheumatic disease and unchanged systemic treatment for 6 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Pregnancy
- Children and adolescents up to the age of 18
- Eye surgery in the last 6 months
- Simultaneous participation in another study
- Regular use of eye drops except for tear substitutes
- Use of Ciclosporin-containing or Corticosteroid-containing eye drops in the last 6 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified