NCT00143208已完成4 期
Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom (Fixed Combination Of Latanoprost And Timolol) In Patients With Poag Or Oh. A 6-Month, Open, Multi-Center Trial In Italy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2003年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 22
- 主要终点
- IOP change from baseline to the 6-month visit.
研究概览
简要总结
This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP >= 21 mmHG).
- •Visual acuity >= 20/200.
排除标准
- •Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
- •Hystory of ALT within 3 months prior to the baseline visit.
- •History of any ocular filtering surgical intervention.
- •Ocular surgery or inflammation/infection within 3 months prior to the baseline visit.
结局指标
主要结局
IOP change from baseline to the 6-month visit.
次要结局
- Proportion of pts who reach specific IOP levels at the end of treatment(eg:16,17,18,19 mmHg,etc).
- % reduction of IOP change from baseline to the 6-month visit.
- Proportion of pts achieving different levels of mean % of IOP reduction at the end of the treatment(eg:0%,10%,15%,20%,etc).
研究者
研究点 (22)
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