跳至主要内容
临床试验/NCT00621335
NCT00621335已完成不适用

A 12- Week Investigator Masked, Parallel Comparison of Tolerability of Combigan and Cosopt in the Treatment of Open Angle Glaucoma or Ocular Hypertension

DBYAN Medicine Professional Corporation1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2007年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension

研究概览

简要总结

The objective of this research study is to compare the tolerability and effectiveness of Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the treatment of open angle glaucoma or ocular hypertension.

详细描述

Patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have been receiving a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination are to be included in the study.Patients must have an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline.

Patients with any other form of glaucoma other than primary open angle glaucoma, with a gonioscopy measured angle grade of less than 2, with a visual field defect not of glaucomatous origen and previous cyclodestructive procedures will be excluded.The use of ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any of the study components also precludes involvement in the study. Any ocular laser therapy within the past three months, ocular inflammation or infection in the past three months or any history of trauma in the last six months will also exclude enrollment in the study.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • open angle glaucoma or ocular hypertension including pseudo-exfoliation and pigmentary glaucoma
  • definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss
  • a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination
  • an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline

排除标准

  • any other form of glaucoma other than primary open angle glaucoma
  • a gonioscopy measured angle grade of less than 2
  • a visual field defect not of glaucomatous origen
  • previous history of cyclodestructive procedures
  • the use of ocular non steroidal and anti-inflammatory topical agent that inhibit cyclooxygenase and prostaglandin analog synthesis
  • the use of glucocorticoid therapy
  • hypersensitivity to any of the study components
  • any ocular laser therapy within the past three months
  • ocular inflammation or infection in the past three months
  • any history of trauma in the last six months

结局指标

主要结局

Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
DBYAN Medicine Professional Corporation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. David Yan

Dr. David Yan M.D, F.R.C.S (c)

DBYAN Medicine Professional Corporation

研究点 (1)

Loading locations...

相似试验