Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- corneal fluorescein staining
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye
干预措施: Cyclosporin (Drug)
right eye: Ciclosporin, left eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the right eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the left eye
干预措施: Hydrocortisone (Drug)
left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye
干预措施: Cyclosporin (Drug)
left eye: Ciclosporin, right eye: Ciclosporin + Hydrocortisone
Patients receive treatment with Ciclosporin eyedrops for the left eye and Ciclosporin eyedrops + Hydrocortisone eyedrops for the right eye
干预措施: Hydrocortisone (Drug)
结局指标
主要结局
corneal fluorescein staining
时间窗: 6 months
corneal fluorescein staining staged with Oxford grading scale, ranging from 0 (no staining) to 5 (maximal staining)
corneal optical aberrations
时间窗: 6 months
corneal optical aberrations measured with iTrace aberrometry
tearfilm breakup time
时间窗: 6 months
tearfilm breakup time measured with Fluorescein
次要结局
未报告次要终点
研究者
Prof. Dr. Pia Vécsei-Marlovits
Pro. Dr. Pia Vécsei-Marlovits
Hospital Hietzing