NCT01562795已完成不适用
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- tear osmolarity
研究概览
简要总结
This clinical trial is to investigate whether nonsteroid anti-inflammatory drops have therapeutic effect on moderate to severe dry eye patients.And compare the efficacy of the two nonsteroid anti-inflammatory drops with 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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe dry eye syndrome
- •tear film breakup time >0 second and ≤5 seconds,or schirmer test(no anaesthesia)≥2mm/5min and ≤5mm/5min
- •corneal staining≥3 scores
排除标准
- •allergic to any composition of the drugs under experiment
- •previous use of anti-inflammatory drugs or immunosuppressive agent
- •viral,bacterial or fungal infection of the eye
- •eyelid anomaly
- •glaucoma or high IOP
- •significant meibomian gland dysfunction
研究组 & 干预措施
group 1
Experimental
干预措施: nonsteroid anti-inflammatory drops (Drug)
group 2
Experimental
干预措施: nonsteroid anti-inflammatory drops (Drug)
group 3
Experimental
干预措施: corticosteroids (Drug)
group 4
Other
干预措施: artificial tear substitute (Drug)
结局指标
主要结局
tear osmolarity
时间窗: Day 0, Day 14
次要结局
- corneal staining(0 day,7th day and 14th day after treatment)
- Schirmer test(without anaesthesia)(0 day,7th day,14th day after treatment)
- tear film breakup time(TBUT)(0 day,7th day and 14th day after treatment)
- meibomian gland function(0 day,7th day and 14th day after treatment)
研究者
Xiangtian Zhou
MD
Wenzhou Medical University
研究点 (1)
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