JPRN-jRCT2080221632已完成1 期
Safety Study of OPC-12759 Ophthalmic Solution
Otsuka Pharmaceuticals Co., Ltd.0 个研究点目标入组 100 人开始时间: 2011年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
2% OPC-12759 ophthalmic solution had no particular safety problems in the treatment for dry eye.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable(—)
- 性别
- All
入选标准
- •1.Gender: Male or Female
- •2.Age: 20 years and older (at the time of informed consent)
- •3.BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4 kg/m2
排除标准
- •1.Presence of ocular disorder
- •2.Intraocular pressure of 21mmHg or higher
- •3.Corrected visual acuity of less than 1.0
- •4.Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or eye lid which affects the nasolacrimal outflow
- •5.History of refractive surgery
- •6.History of other ocular surgeries within 12 months
- •7.Those who cannot discontinue the use of contact lenses from the 1st dose to 5-hour-post-dose.
研究者
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