A Study of Bimatoprost 0.01% in the Clinical Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 312
- 主要终点
- Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
研究概览
简要总结
This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of primary open-angle glaucoma or ocular hypertension
- •Determined by the treating physician to require treatment with bimatoprost 0.01%.
排除标准
- •Previous use of Lumigan® 0.01%
研究组 & 干预措施
Pts with POAG or OH (Previously Treatment Naive)
Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
干预措施: Bimatoprost 0.01% (Drug)
Pts with POAG or OH (Switched Monotherapy)
Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
干预措施: Bimatoprost 0.01% (Drug)
结局指标
主要结局
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale
时间窗: 12 Weeks
Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5-point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of patients in each severity grade are presented.
次要结局
- Percentage of Patients Who Discontinue Due to an Adverse Event(12 Weeks)
- Overall Percent Change From Baseline in IOP(Baseline, Week 12)
- Change From Baseline in Intraocular Pressure (IOP) in the Study Eye(Baseline, Week 12)