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A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.

2021年2月1日 更新者：Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.

To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

139

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。

学习地点

  • 乌克兰
      • Kharkiv、乌克兰、61000
        • Pfizer Investigational Site
      • Kyiv、乌克兰
        • Pfizer Investigational Site
      • Kyiv、乌克兰、04050
        • Pfizer Investigational Site
      • Kyiv、乌克兰、01135
        • Pfizer Investigational Site
      • Odesa、乌克兰、65061
        • Pfizer Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、119331
        • Pfizer Investigational Site
      • St. Petersburg、俄罗斯联邦、194100
        • Pfizer Investigational Site
  • 南非
      • Myfair West、南非、2109
        • Pfizer Investigational Site
  • 印度
    • Andhra Pradesh
      • Hyderabad、Andhra Pradesh、印度、500034
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad、Gujarat、印度、380004
        • Pfizer Investigational Site
    • Tamilnadu
      • Coimbatore、Tamilnadu、印度、641 014
        • Pfizer Investigational Site
  • 哥伦比亚
    • Antioquia
      • Medellín、Antioquia、哥伦比亚、0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota、Cundinamarca、哥伦比亚、0000
        • Pfizer Investigational Site
  • 塞尔维亚
      • Belgrade、塞尔维亚、11000
        • Pfizer Investigational Site
  • 德国
      • Regenstauf、德国、93128
        • Pfizer Investigational Site
      • Schorndorf、德国、73614
        • Pfizer Investigational Site
  • 意大利
      • Catania、意大利、95123
        • Pfizer Investigational Site
      • Milano、意大利、20162
        • Pfizer Investigational Site
  • 捷克语
      • Praha 5、捷克语、150 06
        • Pfizer Investigational Site
  • 斯洛伐克
      • Bratislava、斯洛伐克、83340
        • Pfizer Investigational Site
  • 斯洛文尼亚
      • Ljubljana、斯洛文尼亚、1000
        • Pfizer Investigational Site
  • 比利时
      • Leuven、比利时、3000
        • Pfizer Investigational Site
  • 法国
      • Lille Cedex、法国、59037
        • Pfizer Investigational Site
      • Lyon、法国、69437
        • Pfizer Investigational Site
    • Cedex 1
      • Amiens、Cedex 1、法国、80054
        • Pfizer Investigational Site
  • 波兰
      • Bialystok、波兰、15-274
        • Pfizer Investigational Site
      • Gdansk、波兰、80-211
        • Pfizer Investigational Site
      • Wroclaw、波兰、50-368
        • Pfizer Investigational Site
  • 罗马尼亚
    • Cluj
      • Cluj-Napoca、Cluj、罗马尼亚、400006
        • Pfizer Investigational Site
  • 美国
    • Florida
      • Pembroke Pines、Florida、美国、33028
        • Pfizer Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • Pfizer Investigational Site
    • Nevada
      • Henderson、Nevada、美国、89052
        • Pfizer Investigational Site
      • Henderson、Nevada、美国、89074
        • Pfizer Investigational Site
      • Las Vegas、Nevada、美国、89148
        • Pfizer Investigational Site
  • 英国
      • Birmingham、英国、B18 7QH
        • Pfizer Investigational Site
      • London、英国、EC1V 2PD
        • Pfizer Investigational Site
  • 菲律宾
      • Makati City、菲律宾、1200
        • Pfizer Investigational Site
      • Mandaluyong City、菲律宾、1500
        • Pfizer Investigational Site
  • 葡萄牙
      • Coimbra、葡萄牙、3000-548
        • Pfizer Investigational Site
      • Lisboa、葡萄牙、1649-035
        • Pfizer Investigational Site
      • Lisboa、葡萄牙、1169-019
        • Pfizer Investigational Site
      • Lisboa、葡萄牙、1169-097
        • Pfizer Investigational Site
      • Porto、葡萄牙、4099-001
        • Pfizer Investigational Site
  • 西班牙
      • Madrid、西班牙、28040
        • Pfizer Investigational Site
      • Sevilla、西班牙、41013
        • Pfizer Investigational Site
    • Barcelona
      • Esplugues de Llobregat、Barcelona、西班牙、08950
        • Pfizer Investigational Site

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

8个月 至 18年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Male or female of 18 years of age or under
  • Diagnosis of glaucoma
  • IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

  • Require surgery for acute angle closure
  • Have had prior cyclodestructive procedures
  • Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit

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：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：噻吗洛尔
药品：Timolol
Timolol 0.5% dosed twice-daily
实验性的：latanoprost
药品：latanoprost
Latanoprost 0.005% ophthalmic solution dosed once-daily

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
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
大体时间：Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12

次要结果测量

结果测量
措施说明
大体时间
Reduction From Baseline in Mean IOP at Week 1
大体时间：Baseline, Week 1
Calculated as Baseline IOP minus Week 1 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 1
Reduction From Baseline in Mean IOP at Week 4
大体时间：Baseline, Week 4
Calculated as Baseline IOP minus Week 4 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4
Reduction From Baseline in Mean IOP at Week 12 (Observed)
大体时间：Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP (observed). IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 12
Mean IOP at Baseline
大体时间：Baseline
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline
Mean IOP at Week 1
大体时间：Week 1
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 1
Mean IOP at Week 4
大体时间：Week 4
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 4
Mean IOP at Week 12
大体时间：Week 12
IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Week 12
Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12
大体时间：Baseline, Week 4, and Week 12
Participants with ≥15% IOP reduction from baseline at both Week 4 and Week 12. Calculated as (post baseline IOP minus baseline IOP) divided by IOP, multiplied by 100%. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were ≤ 2 mmHg of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
Baseline, Week 4, and Week 12
Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience
大体时间：Baseline through Week 12
An investigator's causality assessment was the determination of whether there existed a reasonable possibility that the investigational product caused or contributed to an adverse event (AE). If the investigator did not know whether or not investigational product caused the event, then the event was handled as "related to investigational product" for reporting purposes.
Baseline through Week 12

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

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

2008年7月1日

初级完成 (实际的)

2009年11月1日

研究完成 (实际的)

2009年11月1日

研究注册日期

首次提交

2008年7月14日

首先提交符合 QC 标准的

2008年7月14日

首次发布 (估计)

2008年7月16日

研究记录更新

最后更新发布 (实际的)

2021年2月3日

上次提交的符合 QC 标准的更新

2021年2月1日

最后验证

2011年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • A6111137

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.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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