NCT00586625已完成3 期
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 861
- 主要终点
- Ocular Comfort
研究概览
简要总结
Safety study for bepotastine besilate ophthalmic solution in normal volunteers
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
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be at least 3 years of age, and have ocular health within normal limits
排除标准
- •No active ocular disease
研究组 & 干预措施
Bepreve
Experimental
bepotastine besilate ophthalmic solution 1.5%
干预措施: Bepreve (Drug)
Placebo
Placebo Comparator
vehicle
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Comfort
时间窗: Day 8 & Day 22
A 4-step grading scale with half unit (1-step) increments allowed: 0=Comfortable;discomfort absent; 1.0=Generally comfortable; mild discomfort; 2.0=Some discomfort but tolerable; moderate comfort; 3.0=Severely uncomfortable or intolerable
次要结局
未报告次要终点
研究者
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