跳至主要内容
临床试验/NCT00140062
NCT00140062已完成4 期

A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension

Pfizer27 个研究点 分布在 2 个国家目标入组 329 人开始时间: 2002年2月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Pfizer
入组人数
329
试验地点
27
主要终点
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

研究概览

简要总结

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

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
None

入排标准

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

入选标准

  • Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
  • IOP of > 21 mm Hg on current treatment

排除标准

  • Any previous or current treatment with latanoprost or other prostaglandin analogues

结局指标

主要结局

Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

次要结局

  • Safety and the health care utilization in the two treatment groups over 36 months.

研究者

发起方
Pfizer
申办方类型
Industry

研究点 (27)

Loading locations...

相似试验