NCT01484951已完成4 期
Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
研究概览
简要总结
The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- •Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
- •Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
- •Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- •Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
- •Any abnormality preventing reliable applanation tonometry in either eye.
- •Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
- •Pregnant or lactating.
- •Participation in any other investigational study within 30 days of screening visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AZARGA
Experimental
Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
干预措施: Brinzolamide 1% and timolol 0.5% fixed combination eye drops (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
时间窗: Baseline, Week 8
As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.
次要结局
- Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy(Week 8)
研究者
研究点 (1)
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