跳至主要内容
临床试验/NCT01156012
NCT01156012已完成3 期

Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients

Laboratoires Thea1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2009年9月最近更新:
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
404
试验地点
1
主要终点
Change From Baseline in Intraocular Pressure (IOP)

研究概览

简要总结

The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients diagnosed with glaucoma

排除标准

  • Under 18.

研究组 & 干预措施

T2345

Experimental

One drop of T2345

干预措施: T2345 (Drug)

Prostaglandin

Active Comparator

One drop

干预措施: Prostaglandin (Drug)

结局指标

主要结局

Change From Baseline in Intraocular Pressure (IOP)

时间窗: Day 0 and Day 84

The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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