NCT01101984已完成不适用
A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -
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
- 400
- 试验地点
- 2
- 主要终点
- Changes in the fluorescein and rose bengal staining score
研究概览
简要总结
Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.
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
- 21 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who show:
- •Keratoconjunctival disorder confirmed with vital dye staining
- •Abnormal Schirmer score results
排除标准
- •Eye disease that needs therapy other than that for dry eye
- •Those who need to wear contact lenses during the clinical study
研究组 & 干预措施
DE-089
Experimental
DE-089 ophthalmic solution
干预措施: diquafosol ophthalmic solution (Drug)
DE-089
Experimental
DE-089 ophthalmic solution
干预措施: 0.1% sodium hyaluronate ophthalmic solution. (Drug)
HA
Active Comparator
0.1% sodium hyaluronate ophthalmic solution
干预措施: 0.1% sodium hyaluronate ophthalmic solution. (Drug)
结局指标
主要结局
Changes in the fluorescein and rose bengal staining score
时间窗: 2 weeks and 4 weeks from baseline.
1. Changes in the fluorescein staining score at Week 4 / at the time of discontinuation (non-inferiority) 2. Changes in the rose bengal staining score at Week 4 / at the time of discontinuation (superiority)
次要结局
- Changes in tear film breakup time (second)(2 weeks and 4 weeks from baseline.)
研究者
研究点 (2)
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