A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 1,553
- 主要终点
- Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
研究概览
简要总结
The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with primary open-angle glaucoma or ocular hypertension
- •Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons
排除标准
- 未提供
研究组 & 干预措施
Patients with POAG or OHT
Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
干预措施: Fixed Combination Bimatoprost and Timolol (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
时间窗: Baseline, Final Visit (Week 8 to 12)
IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).
次要结局
- Patient Assessment of Tolerability on a 4-Point Scale(Final Visit (Week 8 to 12))
- Percentage of Patients Who Discontinued Treatment(12 Weeks)
- Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale(Baseline, Final Visit (Week 8 to 12))
- Physician Assessment of Tolerability on a 4-Point Scale(Final Visit (Week 8 to 12))
- Percentage of Patients Prescribed by the Physician to Continue Treatment(Final Visit (Week 8 to 12))
- Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale(Final Visit (Week 8 to 12))