NCT03450629已完成3 期
A Randomized, Multi-Center, Investigator-Masked, Parallel Group, Equivalence Study of Once Daily Brimonidine Tartrate Ophthalmic Suspension Compared With Three Times Daily ALPHAGAN-P® in Subjects With Open Angle Glaucoma, or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 682
- 试验地点
- 47
- 主要终点
- Change From Baseline in Mean Intraocular Pressure
研究概览
简要总结
The study will be conducted to evaluate the efficacy and safety of topical administration of PDP-716 compared with brimonidine tartrate ophthalmic solution.
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
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female, of 2 years of age or older
- •Have open-angle glaucoma or ocular hypertension in both the eyes
- •Be able and willing to follow study instructions and complete all required visits.
排除标准
- •Females who are pregnant/lactating.
- •Have uncontrolled systemic disease which might interfere with the study
- •Any known allergy or sensitivity to the study medications or their components
- •Any other clinically relevant abnormality
研究组 & 干预措施
PDP-716
Experimental
干预措施: Brimonidine Tartrate Ophthalmic Suspension (Drug)
Brimonidine Tartrate Ophthalmic Solution
Active Comparator
干预措施: Brimonidine Tartrate Ophthalmic Solution (Drug)
结局指标
主要结局
Change From Baseline in Mean Intraocular Pressure
时间窗: Week 12 8 AM, 10 AM and 4 PM
次要结局
未报告次要终点
研究者
研究点 (47)
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