A Study of LUMIGAN® RC in the Clinical Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 1,137
- 主要终点
- Percentage of Treatment-Naive Patients With Ocular Hyperemia
研究概览
简要总结
This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.
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
- •Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
- •Determined by the treating physician to require treatment with LUMIGAN® RC
排除标准
- 未提供
研究组 & 干预措施
Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
干预措施: Bimatoprost 0.01% (Drug)
结局指标
主要结局
Percentage of Treatment-Naive Patients With Ocular Hyperemia
时间窗: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Naive patients did not use glaucoma medication prior to study entry.
Percentage of Previously Treated (Switched) Patients With Ocular Hyperemia
时间窗: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and were switched from their previous therapy to study treatment.
Percentage of Patients Treated With Adjunctive Therapy With Ocular Hyperemia
时间窗: Week 12
Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia is graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness). Previously treated patients used glaucoma medication prior to study entry and added study treatment as adjunctive therapy.
次要结局
- Percent Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy(Baseline, 12 Weeks)
- Change From Baseline in IOP in the Study Eye of Treatment-Naive Patients(Baseline, Week 6, Week 12)
- Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients(Baseline, Week 6, Week 12)
- Change From Baseline in IOP in the Study Eye of Patients Treated With Adjunctive Therapy(Baseline, Week 6, Week 12)
- Percent Change From Baseline in Intraocular Pressure (IOP) in the Study Eye of Treatment-Naive Patients(Baseline, 12 Weeks)
- Percent Change From Baseline in IOP in the Study Eye of Previously Treated (Switched) Patients(Baseline, 12 Weeks)
- Percentage of Patients Discontinuing Due to Ocular Adverse Events(12 Weeks)