NCT01284166撤回3 期
Safety and Efficacy of Triple Combination Therapy With Dorzolamide Hydrochloride / Brimonidine Tartrate / Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Allergan
- 主要终点
- Change from Baseline in Intraocular Pressure (IOP)
研究概览
简要总结
This study will investigate the safety and efficacy of Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution in patients with glaucoma or ocular hypertension who have elevated IOP on dorzolamide hydrochloride/timolol maleate combination therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ocular hypertension or glaucoma in each eye
- •Requires IOP-lowering treatment in both eyes
排除标准
- •Use of dorzolamide or carbonic anhydrase within 4 weeks
- •Any other active ocular disease other than ocular hypertension or glaucoma (eg, uveitis, ocular infections or severe dry eye)
- •Required chronic use of ocular medications other than study medication during the study (intermittent use of certain products eg, artificial tears are permitted)
- •Use of oral, injectable or topical ophthalmic steroids within 21 days
- •Any eye laser surgery within 3 months
- •Any intraocular surgery (eg cataract surgery) within 6 months
研究组 & 干预措施
Triple Combination Therapy
Experimental
Triple Combination Therapy with dorzolamide hydrochloride/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
干预措施: dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution (Drug)
结局指标
主要结局
Change from Baseline in Intraocular Pressure (IOP)
时间窗: Baseline, Week 12
次要结局
未报告次要终点
研究者
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