NCT00383019已完成3 期
A 8-WEEK, RANDOMIZED, DOUBLE-MASKED, PARALLEL GROUP, PHASE III STUDY COMPARING THE EFFICACY AND SAFETY OF XALACOM AND XALATAN IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA (POAG) OR OCULAR HYPERTENSION (OH)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.54 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年11月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 54
- 主要终点
- Change of Intraocular Pressure (IOP) From Baseline to Week 8
研究概览
简要总结
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intraocular pressure is 18 mmHg or more at baseline after treatment with Xalatan for 4 weeks or more.
排除标准
- •History of no-response to timolol
- •History of trabeculectomy
- •History of other ocular surgery including ALT, SLT,and trabeculotomy within 6 months
研究组 & 干预措施
Xalatan
Experimental
干预措施: Xalatan (Drug)
Xalacom
Experimental
干预措施: Xalacom (Drug)
结局指标
主要结局
Change of Intraocular Pressure (IOP) From Baseline to Week 8
时间窗: Baseline to Week 8
Value at Week 8 minus value at baseline
次要结局
- Change of IOP From Baseline to Week 4(Baseline to Week 4)
- Number of Subjects With an IOP of <=15 mmHg at Week 8(Week 8)
- Number of Subjects With an IOP of <=16 mmHg at Week 8(Week 8)
- Number of Subjects With an IOP Reduction of >=3 mmHg From Baseline to Week 8(Baseline to Week 8)
- Percent Change of IOP From Baseline to Week 8(Baseline to Week 8)
- Number of Subjects With an IOP Reduction of >=2 mmHg From Baseline to Week 8(Baseline to Week 8)
- Number of Subjects With an IOP of <=18 mmHg at Week 8(Week 8)
- Number of Subjects With an IOP of <=17 mmHg at Week 8(Week 8)
研究者
研究点 (54)
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