NCT00647101已完成4 期
Open Multicenter Study on the Efficacy of Xalatan at 3 Months as First-line Therapy in Naive Patients With Ocular Hypertension (OH) or Open Angle Glaucoma (OAG), Based on Initial Intraocular Pressure (IOP): 20 mmHg Less Than or Equal to IOP Less Than 24 mmHg, IOP Greater Than or Equal to 24 mmHg
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2003年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
研究概览
简要总结
The purpose of this study is to evaluate the effect of latanoprost on intraocular pressure reduction in patients with ocular hypertension or open-angle glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A patient with an IOP greater than or equal to 20 mmHg related to unilateral or bilateral OH or OAG (primary open angle glaucoma, pseudo-exfoliative glaucoma, and pigmentary glaucoma), after a visual field exam
- •Naive patients (i.e. never having been treated) and requiring treatment initiation
排除标准
- •A patient with OH or OAG currently on treatment
- •A patient with OH or OAG previously treated (regardless of the date treatment was discontinued)
- •A patient with traumatic, inflammatory, or neovascular glaucoma
研究组 & 干预措施
Latanoprost group
Experimental
干预措施: Latanoprost (Drug)
结局指标
主要结局
Change in IOP after 3 months of treatment in absolute values (mmHg) compared to baseline IOP
时间窗: 3 months
次要结局
- Change in IOP after 3 months of treatment in relative values (percentage of decrease) compared to baseline IOP(3 months)
- Proportion of patients after 3 months of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%(3 months)
- Change in IOP after 1 month of treatment in absolute (mmHg) and relative values (percentage of decrease) relative to baseline IOP(1 month)
- Proportion of patients after 1 month of treatment with a relative reduction in IOP of greater than or equal to 30%, and greater than or equal to 10%(1 month)
- Proportion of patients after 3 months of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg(3 months)
- Proportion of patients after 1 month of treatment achieving the following target IOP values: IOP less than or equal to 21 mmHg, IOP less than or equal to 18 mmHg, IOP less than or equal to 15 mmHg(1 month)
- Occurrence of adverse events on latanoprost, local tolerability analysis by clinical exam(3 months)
研究者
研究点 (1)
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