NCT00643669已完成2 期
24 Hour IOP Lowering Efficacy of AL-3789
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure (IOP)
研究概览
简要总结
The objective of this study was to describe the intraocular pressure-lowering efficacy of AL-3789 over a 24-hour period in patients with open-angle glaucoma compared to an untreated control. Patients received one treatment of AL-3789. Twenty-eight days after treatment, IOP was measured every 4 hours, beginning at 8 AM for 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma and treated for at least 30 days prior to Screening Visit with a topical prostaglandin analog as monotherapy.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant, intend to become pregnant, breastfeeding.
- •Difference in IOP greater than 3 mm Hg between eyes at Screening Visit.
- •Any form of glaucoma other than open-angle glaucoma.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AL-3789
Experimental
AL-3789 Sterile Suspension, single depot administration of 0.8 mL in the study eye
干预措施: AL-3789 Sterile Suspension (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP)
时间窗: Day 28, Up to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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