NCT00651859已完成2 期
Safety and Efficacy Study of Bimatoprost in Ethnically Japanese Patients With Open-Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 111
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
This study evaluates the safety and efficacy of once-daily bimatoprost 0.03% and 0.01% ophthalmic solutions compared with once-daily administered bimatoprost vehicle ophthalmic solution for 2 weeks in ethnically Japanese patients with open-angle glaucoma or ocular hypertension
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
- •Ethnically Japanese patients with glaucoma or ocular hypertension in each eye who require IOP-lowering therapy in both eyes
排除标准
- •Uncontrolled systemic disease
- •Use of bimatoprost or an ocular prostaglandin (eg, latanoprost, travoprost) within 6 weeks prior to baseline (Day 0)
研究组 & 干预措施
1
Experimental
Bimatoprost 0.01% Ophthalmic Solution
干预措施: Bimatoprost 0.01% Ophthalmic Solution (Drug)
2
Experimental
Bimatoprost 0.03% Ophthalmic Solution
干预措施: Bimatoprost 0.03% Ophthalmic Solution (Drug)
3
Placebo Comparator
Bimatoprost Vehicle Ophthalmic Solution
干预措施: Bimatoprost Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: Day 14
次要结局
- IOP(Days 2 and 7)
研究者
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