NCT02571712已完成4 期
Evaluation of the Safety of GANFORT® (Bimatoprost 0.03% Plus Timolol 0.5%) Ophthalmic Solution in Chinese 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
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 750
- 试验地点
- 15
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes
- •Is willing to stop other intraocular pressure (IOP)-lowering medications and switch to GANFORT® as a single agent in affected eye(s).
排除标准
- •Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease
- •Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.
研究组 & 干预措施
GANFORT®
Other
One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks.
干预措施: bimatoprost 0.03% plus timolol 0.5% (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 24 Weeks
次要结局
未报告次要终点
研究者
研究点 (15)
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