NCT01488396已完成4 期
Efficacy of 0.05% Cyclosporin Eye Drop in Stevens Johnson Syndrome Patient With Chronic Dry Eye
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- dry eyes symptoms : dryness, gritty, photophobia, burning and pain
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of 0.05% cyclosporin ophthalmic emulsion (Restasis) in patients with Stevens-Johnson syndrome that have dry eyes by subjective symptoms and signs.
详细描述
Stevens-Johnson syndrome patients in chronic stage who have dry eys symptoms and signs will be treated with 0.05%cyclosporin ophthalmic emulsion(Restasis)twice a day for 6 months, compare results at 0,2,4,6 months include dry eye symptoms, corneal staining (Fluorescein, Rose Bengal), Schirmer I,FCT and impression cytology
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, of legal age of consent
- •Patient with Stevens-Johnson syndrome in chronic stage or has symptoms more than 3 months and has dry eye symptoms
- •Dry eye symptoms are defined as
- •has dry eye symptom everyday for more than 3 months
- •has foreign body sensation frequently
- •use tear substitutes more than 3 times per day
- •Tear test shaw abnormalities at least 1 of 2 of following:
- •Schirmer test without anesthesia is not more than 5 millimeters in 5 minutes
- •Fluorescein clearance test at first 10 minutes is not more than 3 millimeters and has at least 1 of 3 of the following:
- •2.1.Rose Bengal score is not less than 4 2.2.Fluorescein stain at cornea 2.3.Impression cytology is consistent to dry eye
- •Patent punctum
排除标准
- •Age < 18 years old
- •Patients with Steven Johnson syndrome without dry eye
- •Patients used oral cyclosporine or anticholinergic drug within past 2 months
- •Patients with HIV or immunocompromise status
- •Patients with active ocular infections and patients with a history of herpes keratitis
- •Patients with known or suspected hypersensitivity to any of the ingredients in the formula (cyclosporine, glycerin, castor oil, polysorbate 80, carbomer 1342)
- •Female patients are pregnant or nursing
研究组 & 干预措施
0.05%cyclosporin eye drop
Experimental
干预措施: 0.05%cyclosporin eye drop (Drug)
结局指标
主要结局
dry eyes symptoms : dryness, gritty, photophobia, burning and pain
时间窗: 0, 2, 4, 6 months
次要结局
- Corneal staining(0, 2, 4, 6 months)
- Schirmer I test(0, 6 months)
- Fluorescein tear break up time(0, 2. 4. 6 months)
- Fluorescein clearance test (FCT)(0, 6 month)
研究者
Pinnita Prabhasawat
Associated professor
Mahidol University
研究点 (1)
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