Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation
2010年12月10日 更新者：Santen Oy
Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation in Patients With Open-angle Glaucoma or Ocular Hypertension
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.
研究概览
研究类型
介入性
注册 (实际的)
43
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Tafluprost 0.0015% preserved formulation
|
Eye drops, 0.015 mg/ml, once daily to affected eye(s)
|
|
实验性的：Tafluprost 0.0015% unpreserved formulation
|
Eye drops, 0.015 mg/ml, once daily to affected eye(s)
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Intraocular Pressures (IOPs) at Baseline
大体时间：Baseline
|
IOPs at baseline: mean IOP values at four timepoints (worse eye)
|
Baseline
|
|
Intraocular Pressures (IOPs) at Week 1
大体时间：Week 1
|
IOPs at week 1: mean IOP values at four timepoints (worse eye)
|
Week 1
|
|
Intraocular Pressures (IOPs) at Week 4
大体时间：Week 4
|
IOPs at week 4: mean IOP values at four timepoints (worse eye)
|
Week 4
|
|
Primary Pharmacodynamic Variable Intention to Treat Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
大体时间：Baseline - Week 4
|
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurements analysis of covariance (RM ANCOVA) model.
|
Baseline - Week 4
|
|
Primary Pharmacodynamic Variable Per Protocol Efficacy Dataset: Change From Baseline in the Overall Diurnal Intraocular Pressure (IOP) at Week 4 (Worse Eye)
大体时间：Baseline - Week 4
|
Overall treatment difference at 4 weeks (unpreserved-preserved) evaluated using a repeated measurments analysis of covariance (RM ANCOVA) model.
|
Baseline - Week 4
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall and Time-wise Comparisons of IOP at Week 1
大体时间：Baseline - Week 1
|
The overall and time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 1 (diurnal IOP and IOP value at given timepoint at 1 week minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
|
Baseline - Week 1
|
|
Change From Baseline in Time-wise IOPs at Week 4
大体时间：Baseline - Week 4
|
The time-wise, i.e. at 8:00, 12:00, 16:00 and 20:00, comparisons of IOP at week 4 (IOP value at given timepoint at 4 weeks minus corresponding value at baseline: unpreserved-preserved) were done using the RM ANCOVA model.
|
Baseline - Week 4
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Juhani Airaksinen, Prof.、University Hospital of Oulu
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年9月1日
初级完成 (实际的)
2006年3月1日
研究完成 (实际的)
2006年4月1日
研究注册日期
首次提交
2009年6月9日
首先提交符合 QC 标准的
2009年6月10日
首次发布 (估计)
2009年6月11日
研究记录更新
最后更新发布 (估计)
2010年12月28日
上次提交的符合 QC 标准的更新
2010年12月10日
最后验证
2010年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.