NCT00457795已完成4 期
24-hour IOP-lowering Effect of Brimonidine 0.1%
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
- Allergan
- 入组人数
- 15
- 主要终点
- Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
研究概览
简要总结
This study will evaluate the efficacy and safety of brimonidine 0.1% three-times daily in patients with glaucoma or ocular hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with open-angle glaucoma or ocular hypertension
排除标准
- •allergy to brimonidine
- •inability to complete 24 hour stay for monitoring
研究组 & 干预措施
brimonidine 0.1%
Experimental
brimonidine 0.1%
干预措施: brimonidine 0.1% (Alphagan® P) (Drug)
结局指标
主要结局
Intraocular Pressure (IOP) for a 24-Hour Period at Week 4
时间窗: Week 4
IOP for a 24-hour period separated into diurnal(7AM-11PM or awake period) and nocturnal (11PM-7AM or sleep period) at week 4. IOP is a measurement of the fluid pressure inside the eye. Measurements of IOP were taken in the sitting and supine (laying down face up) body positions during the 16-hour diurnal (awake) period and in the supine position during the 8-hour nocturnal (sleep) period.
次要结局
- Change From Baseline in Intraocular Pressure (IOP) for a 24-Hour Period at Week 4(Baseline, Week 4)
- Ocular Perfusion Pressure (OPP) for a 24-Hour Period at Week 4(Week 4)
- Change in Ocular Perfusion Pressure (OPP) Over a 24-Hour Period at Week 4(Week 4)
研究者
相似试验
已完成
4 期
24-hour IOP-lowering Effect of 0.01% BimatoprostIntraocular PressureGlaucomaOcular HypertensionNCT01271686University of California, San Diego16
已完成
3 期
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular HypertensionOcular HypertensionOpen-Angle GlaucomaNCT01310777Alcon Research771
已完成
4 期
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension SubjectsGlaucomaOcular HypertensionNCT00811564Allergan148
已完成
3 期
Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular HypertensionGlaucomaOcular HypertensionNCT00652483Allergan433
已完成
2 期
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric SubjectsOcular RednessNCT01675609Eye Therapies, LLC57