Effect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome

KH Hietzing, Department of Ophthalmology0 个研究点目标入组 20 人开始时间: 2018年11月27日最近更新: 2019年1月7日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

KH Hietzing, Department of Ophthalmology