NCT00449956已完成3 期
Multicenter, Double-Blind, Active Comparator-controlled Study to Evaluate the Safety and Efficacy of MK0507A in Patients With Glaucoma and Ocular Hypertension Who Are Inadequately Controlled on Beta-Blockers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 474
- 主要终点
- Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
研究概览
简要总结
The clinical study compares safety and efficacy of MK0507A (dorzolamide 1.0% / timolol 0.5%) with 1) timolol 0.5% and with 2) concomitant therapy with dorzolamide 1.0% / timolol 0.5% in patients with glaucoma and 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with glaucoma and ocular hypertension
排除标准
- •History of ocular surgery within 3 months
- •Administration contradiction to timolol and dorzolamide
研究组 & 干预措施
1
Experimental
combination of dorzolamide hydrochloride and timolol maleate
干预措施: dorzolamide hydrochloride (+) timolol maleate (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) From Baseline at 8 Weeks
时间窗: 8 weeks
Change from baseline to 8 weeks in Intraocular Pressure (IOP) assessed 2 hours after ocular instillation (at Hour 2)
次要结局
- Percent Change From Baseline in Intraocular Pressure (IOP) at 8 Weeks(8 Weeks)
- Percent Change From Baseline in Outflow Pressure Reduction Rate at 8 Weeks(8 weeks)
研究者
相似试验
已完成
不适用
Multicentre comparative clinical trial of the safety and efficacy of a 0.5% timolol-2% dorzolamide-0.2% brimonidine ophthalmic solution in fixed combination (formulated by Laboratorios Sophia S.A. de C.V.) versus Cosopt® in open angle glaucoma or ocular hypertensioISRCTN26988657aboratorios Sophia S.A de C.V. (Mexico)100
已完成
不适用
Evaluation of dorzolamide/timolol fixed combination therapy for the patients who need more IOP reduction under PG analoguesprimary open angle glaucoma, ocular hypertensionJPRN-UMIN000004596Department of Ophthalmology, Kyoto Prefectural University of Medicine40
已完成
不适用
Evaluation of the Efficacy and Safety of DM05 Versus Optive™ on the Treatment of Moderate to Severe Ocular DrynessDry EyeNCT03517748Horus Pharma80
已完成
3 期
A Clinical Study of Remimazolam Tosilate Compared to Propofol for General Anesthesia During Elective SurgeryAnesthesia for Elective Surgery PatientsNCT03921775Jiangsu HengRui Medicine Co., Ltd.330
已完成
4 期
Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418)AsthmaNCT00394355Organon and Co566