临床试验/NCT00061516

NCT00061516已完成3 期

Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Alcon Research0 个研究点目标入组 78 人开始时间: 2003年1月最近更新: 2016年11月18日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Alcon Research
入组人数: 78
主要终点: Mean Change from Baseline IOP

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

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

入排标准

年龄范围: 1 Week 至 5 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

Brinzolamide suspension, 1%

Experimental

Dosed twice daily for 12 weeks

干预措施: AZOPT (brinzolamide) (Drug)

Levobetaxolol suspension, 0.5%

Experimental

Dosed twice daily for 12 weeks

干预措施: BETAXON (levobetaxolol HCl) (Drug)

结局指标

主要结局

Mean Change from Baseline IOP

时间窗: Up to Week 12

次要结局

未报告次要终点

研究者

发起方

Alcon Research

申办方类型

Industry

责任方

Sponsor

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