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临床试验/CTRI/2009/091/000578
CTRI/2009/091/000578已完成3 期

A Multicenter, Open Label, Active Control, Parallel-Group Randomized Study to Demonstrate Non Inferiority of Brinzolamide 1% Ophthalmic Suspension compared With Dorzox (Dorzolamide) 2% Ophthalmic Solution in Treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Alcon Laboratories India Pvt Ltd7 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年11月2日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
200
试验地点
7
主要终点
IOP reduction from baseline

研究概览

简要总结

This is a multicenter, open label, active control, parallel-group randomized study to compare the reduction of elevated intra-ocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. 200 patients with primary open angle glaucoma or ocular hypertension will be randomized to receive either the test or the comparator drug, instilled in the eye three times daily for a period of 12 weeks. The primary outcome measure is to demonstrate IOP reduction from baseline and demonstrate non inferiority of brinzolamide (test) 1% ophthalmic suspension compared with Dorzox (dorzolamide - comparator) 2% ophthalmic solution.

研究设计

分配方式
Computer generated randomization
盲法
Open Label

入排标准

入选标准

  • 1.Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.2.IOP measurements ≥ 24 ≤ 36 mm Hg, in atleast one eye, at 9.00 am and ≥ 21 ≤ 36 mm Hg in atleast one eye (the same eye) at 11.00 am measurement.

排除标准

  • Patients with one sighted eye or amblyopia, history of chronic or recurrent inflammatory eye disease, ocular infections (3 months), ocular trauma, severe or progressive retinal or optic nerve disease, severe ocular pathology, intraocular surgery (last 12 months), laser surgery (last 3 months), current use of steroids or presence of any other form of glaucoma other than primary open angle glaucoma.

结局指标

主要结局

IOP reduction from baseline

时间窗: 12 weeks

次要结局

  • IOP reduction from baseline(4 and 8 weeks)

研究者

发起方
Alcon Laboratories India Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (7)

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