NCT00675207已完成4 期
Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs
Northwestern Ophthalmic Institute S.C.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.
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
- Single (Investigator)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary open-angle glaucoma or ocular hypertension.
- •Must be over 40 years of age.
- •Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost).
排除标准
- •History of angle closure or narrow angle.
- •Previous intraocular surgery.
- •Laser trabeculoplasty within 3 months prior to screening.
- •History of uveitis or intraocular inflammation.
- •Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study.
- •Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride.
- •Women of childbearing age who are pregnant or not using contraception.
研究组 & 干预措施
1
Active Comparator
Brimonidine purite 0.15%
干预措施: Brimonidine purite 0.15% (Drug)
2
Active Comparator
Dorzolamide 2%
干预措施: Dorzolamide 2% (Drug)
3
Active Comparator
Brinzolamide 1%
干预措施: Brinzolamide 1% (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
次要结局
未报告次要终点
研究者
研究点 (1)
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