NCT00348335已完成4 期
Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea
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
- 35
- 试验地点
- 1
- 主要终点
- hyperemia
研究概览
简要总结
The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea
详细描述
The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient at least 18 years old, but younger than 65
- •Diagnosis of acne rosacea
- •Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+
- •Schirmers test of greater than 5mm in at least 1 eye
- •If patient currently using lid hygiene must maintain regimen during study
- •Stop oral antibiotics at least 4 weeks prior
排除标准
- •Use of topical cyclosporin within last 90 days
- •Visual acuity of 20/100 or better in both eyes
- •Pregnant or lactating females
- •Active ocular infection
- •Scarring of central cornea
- •Eyelid defects,abnormal lid positioning or lagophthalmos
- •Flax seed or Fish oil supplements within last 30 days
研究组 & 干预措施
1: Restasis
Active Comparator
干预措施: Cyclosporine 0.05% (Drug)
2: Refresh Endura
Active Comparator
干预措施: Ocular lubricant (Drug)
结局指标
主要结局
hyperemia
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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