NCT01379144已完成2 期
A 4 Week, Dose-Ranging, Multi-Center, Randomized, Double-Masked, Parallel Study Comparing The Efficacy, Safety, And Tolerability Of Latanoprost 75, 100 And 125 ug/ml To Xalatan In The Treatment Of Primary Open-Angle Glaucoma Aand Ocular Hypertension
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.25 个研究点 分布在 8 个国家目标入组 282 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 25
- 主要终点
- The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
研究概览
简要总结
The primary objective of this study was to compare the change in intraocular pressure (IOP) of three different doses of latanoprost (75, 100 and 125 ug/ml) to that of the marketed 50 ug/ml dose, in a dose ranging study.
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
- •Male or female, 18 years of age or older.
- •Primary open angle glaucoma (POAG) or ocular hypertension (OHT) requiring unilateral or bilateral administration of intraocular pressure (IOP) lowering treatment, including patients who were naïve to IOP lowering treatment.
- •IOP between ≥ 24 mmHg and ≤ 36 mmHg in at least one eye at the 8 AM time point at baseline/randomization.
排除标准
- •Closed/barely open anterior chamber angle or a history of acute angle closure.
- •A history of discontinued prostaglandin IOP lowering treatment, unless the reason for discontinuation was participation in a clinical study.
- •Ocular surgery or argon laser trabeculoplasty in one or both eyes within 3 months prior to the screening visit.
- •Use or anticipated requirement during the study of any topical medication that was known to affect IOP.
- •Anticipated need to modify systemic medication known to affect IOP (eg, beta-adrenergic antagonists, alpha-adrenergic agonists, calcium channel blockers, angiotension converting enzyme inhibitors, and angiotension II receptor antagonists) during the study period.
研究组 & 干预措施
latanoprost 75 ug
Experimental
干预措施: latanoprost 75 ug (Drug)
latanoprost 100 ug
Experimental
干预措施: latanoprost 100 ug (Drug)
latanoprost 125 ug
Experimental
干预措施: latanoprost 125 ug (Drug)
latanoprost 50 ug
Active Comparator
干预措施: latanoprost 50 ug (Drug)
结局指标
主要结局
The primary endpoint was the change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline to Week 4 (Day 28).
时间窗: Baseline and Day 28
次要结局
- The change in intraocular pressure (IOP) at 8 AM and 4 PM from baseline across all clinic visits; comparisons were made by separate analyses for each time point and visit.(Baseline and Day 28)
- The percentage change in IOP from baseline at 8 AM to Week 4 (Day 28).(Baseline and Day 28)
- Ocular safety assessments (ie, ocular adverse events, assessment of conjunctival hyperemia, and ocular symptom evaluations) across all clinic visits.(Baseline and Day 28)
研究者
研究点 (25)
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