Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Santen Oy
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Intraocular Pressures (IOPs) at Week 4
研究概览
简要总结
The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure [IOP]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension.
The primary aim of this study is to show that IOP reduction between the two formulations is equivalent at the end of the 4 week treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (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
- •Age 18 years or more
- •A diagnosis of open angle glaucoma or ocular hypertension
- •Prior use of prostaglandin(s)
- •Intra ocular pressure of 22-34 mmHg in at least one eye
排除标准
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception
- •Previous participation in any clinical trial in which tafluprost was an investigational drug or use of contact lenses at screening or during the study
- •Presence of any abnormality or significant illness that could be expected to interfere with the study
研究组 & 干预措施
Tafluprost 0.0015% unpreserved formulation
干预措施: Tafluprost 0.0015% (Drug)
Tafluprost 0.0015% preserved formulation
干预措施: Tafluprost 0.0015% (Drug)
结局指标
主要结局
Intraocular Pressures (IOPs) at Week 4
时间窗: Week 4
IOPs at week 4: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Baseline
时间窗: Baseline
IOPs at baseline: mean IOP values at four timepoints (worse eye)
Intraocular Pressures (IOPs) at Week 1
时间窗: Week 1
IOPs at week 1: mean IOP values at four timepoints (worse eye)
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
时间窗: Baseline - Week 4
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
时间窗: Baseline - Week 4
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
次要结局
- Overall and Time-wise Comparisons of IOP at Week 1(Baseline - Week 1)
- Change From Baseline in Time-wise IOPs at Week 4(Baseline - Week 4)