A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 800
- 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 study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
排除标准
- 未提供
研究组 & 干预措施
Bimatoprost 0.01% (Naive Monotherapy)
1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
干预措施: Bimatoprost 0.01% (Drug)
Bimatoprost 0.01% (Switched Monotherapy)
1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
干预措施: Bimatoprost 0.01% (Drug)
Bimatoprost 0.01% (with Adjunctive Therapy)
1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
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: Week 12
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 participants in each severity grade are presented.
次要结局
- Change From Baseline in Intraocular Pressure (IOP)(Baseline, Week 6, Week 12)
- Overall Percent Change From Baseline in IOP(Baseline, Week 6, Week 12)