NCT01471093已完成1 期
Safety Study of OPC-12759 Ophthalmic Solution in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Subjects With Blurred Vision After Instillation
研究概览
简要总结
The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
排除标准
- •Presence of ocular disorder
- •Intraocular pressure of 21mmHg or higher
- •Corrected visual acuity of less than 1.0
- •Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
- •History of refractive surgery
- •History of other ocular surgeries within 12 months
- •Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose
研究组 & 干预措施
Solution
Experimental
A single dose of OPC-12759 Ophthalmic solution for two-day treatment
干预措施: OPC-12759 Ophthalmic solution (Drug)
Suspension
Active Comparator
A single dose of OPC-12759 Ophthalmic suspension for two-day treatment
干预措施: OPC-12759 Ophthalmic suspension (Drug)
结局指标
主要结局
Number of Subjects With Blurred Vision After Instillation
时间窗: The first and second instillation
The number of subjects with white blurred vision after first and/or second instillation was calculated for subjects.
Number of Subjects With Bitter Taste
时间窗: The first and second instillation
The number of subjects with bitter taste on first and/or second instillation was calculated for subjects.
次要结局
未报告次要终点
研究者
研究点 (1)
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