A Safety Study of Bimatoprost in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 466
- 主要终点
- Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
研究概览
简要总结
This safety study will evaluate bimatoprost 0.01% and 0.03% in patients with glaucoma or ocular hypertension (OHT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Diagnosis of glaucoma or ocular hypertension
排除标准
- •Active ocular disease other than glaucoma or ocular hypertension
- •Require chronic use of ocular medications other than the study medication during the study (intermittent use of artificial tear solution will be permitted)
研究组 & 干预措施
Bimatoprost 0.01%
Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
干预措施: Bimatoprost 0.01% (Drug)
Bimatoprost 0.03%
Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
干预措施: Bimatoprost 0.03% (Drug)
结局指标
主要结局
Percentage of Patients With an Increase in Macroscopic Conjunctival Hyperemia in Either Eye
时间窗: Baseline, 6 Weeks
Macroscopic conjunctival hyperemia (eye redness) is graded in each eye on a 5-point scale (Scale 0 to +3: none, trace, mild, moderate, severe). An increase (worsening) in macroscopic conjunctival hyperemia is defined as an increase in macroscopic conjunctival hyperemia grade of at least 1 from baseline in either eye.
次要结局
未报告次要终点