NCT00760045已完成2 期
Clinical Pharmacological Study of AL-43546 Ophthalmic Product in Subjects With Shortened Tear Film Break Up Time
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
研究概览
简要总结
The purpose of the study is to observe lacrimal fluid condition (tear film break-up time) chronologically after a single dose of AL-43546 ophthalmic products（0.15%, 0.25% and vehicle）and 0.1% sodium hyaluronate ophthalmic solution and compare lacrimal fluid retention time between them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with NIBUT of either eye is 8 seconds or less and other eye is 10 seconds or less at screening test and NIBUT of either eye before instillation in Period I is 10 seconds or less.
排除标准
- •Diagnosis of severe Sjogren's syndrome (history of the use of punctal plug one time or more, etc.) in either eye.
- •Subjects who will use ophthalmic solutions (excluding the specified artificial tear) or ophthalmic ointment in either eye during the study period.
研究组 & 干预措施
1
Experimental
AL-43546 0.15%
干预措施: Hydroxypropyl Guar Galactomannan (Drug)
2
Experimental
AL-43546 0.25%
干预措施: Hydroxypropyl Guar Galactomannan (Drug)
3
Active Comparator
AL-43546 0%(Vehicle)
干预措施: Hydroxypropyl Guar Galactomannan (Drug)
4
Active Comparator
0.1% sodium hyaluronate ophthalmic solutio
干预措施: 0.1% sodium hyaluronate ophthalmic solution (Drug)
结局指标
主要结局
The change from baseline of non-invasive tear film break up time (ΔNIBUT: seconds).
时间窗: Up to 180 minutes
次要结局
- Ocular comfort(After installation)
研究者
研究点 (1)
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