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临床试验/JPRN-jRCT2080221632
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

发起方
Otsuka Pharmaceuticals Co., Ltd.

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