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
- 64
- 主要终点
- 24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of AL-54478 0.005% compared with Latanoprost 0.005% and AL-54478 Vehicle in patients with open-angle glaucoma or ocular hypertension.
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
- Triple (Participant, Investigator, 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
- •Patients diagnosed with either OAG or OHT.
- •Patients who are able to comply with the scheduled visits.
- •Patients who have had a physical exam within 6 months of the Screening Visit.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Females of childbearing potential who meet any 1 of the following conditions: a) Currently pregnant; b) Positive urine pregnancy test; c)Intend to become pregnant; d) Breast feeding; e) Not using highly effective birth control measures.
- •Patients with extreme narrow angle with complete or partial closure.
- •Patients with a cup to disc ratio more than 0.
- •Patients with a severe central visual field loss in either eye.
- •Patients with chronic or recurrent inflammatory eye disease or acute ocular infection or inflammation.
- •Patients who have had ocular trauma within the past 6 months or have had intraocular surgery within the past 6 months or have had ocular laser surgery within the past 3 months.
- •Patients with best-correct visual acuity less than 20/
- •Patients who have had ocular infection or inflammation within the past 3 months.
- •Patients who have clinically relevant progressive retinal disease.
- •Patients who have severe illness or conditions.
- •Patients who have hypersensitivity to a prostaglandin analogu.e
- •Patients who are unable to safely discontinue all IOP-lowering medications during washout.
- •Patients who are currently on therapy with another investigational agent within 30 days prior to the Screening Visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Vehicle
Placebo Comparator
AL-54478 Vehicle, single dose, followed 7 days later with 14 days of once daily dosing
干预措施: AL-54478 Vehicle (Drug)
AL-54478
Experimental
AL-54478 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
干预措施: AL-54478 0.005% (Drug)
Latanoprost
Active Comparator
Latanoprost 0.005%, single dose, followed 7 days later with 14 days of once daily dosing
干预措施: Latanoprost 0.005% (Drug)
结局指标
主要结局
24-hour Area Under the Curve (AUC) for IOP Change from Baseline after 14 Days of Once Daily Dosing
时间窗: Day 14
次要结局
未报告次要终点
研究者
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