Safety and Efficacy of a New Formulation of Bimatoprost/Timolol Ophthalmic Solution Compared With Bimatoprost/Timolol Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 561
- 主要终点
- Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost/timolol formulation A ophthalmic solution with Ganfort® (bimatoprost 0.03%/timolol 0.5% ophthalmic solution) once daily for 12 weeks 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
- Double (Participant, Investigator)
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
- •Patient has ocular hypertension or glaucoma in both eyes
- •Requires IOP-lowering therapy in each eye
排除标准
- •Active or recurrent eye disease that would interfere with interpretation of study data in either eye
- •History of any eye surgery or laser in either eye within 6 months
- •Required chronic use of other eye medications during the study
- •Anticipated wearing of contact lenses during the study.
- •Intermittent use of oral, intramuscular, or intravenous corticosteroids within 21 days
研究组 & 干预措施
bimatoprost/timolol formulation A
One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
干预措施: bimatoprost /timolol formulation A fixed combination ophthalmic solution (Drug)
bimatoprost/timolol fixed combination ophthalmic solution
One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
干预措施: bimatoprost/timolol fixed combination ophthalmic solution (Drug)
结局指标
主要结局
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 2
时间窗: Week 2
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 2 at Hour 0, Hour 2 and Hour 8.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
时间窗: Baseline, Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. IOP was evaluated at Baseline and Week 12 at Hour 0, Hour 2 and Hour 8 in the worse eye, defined as the eye with the worse (higher) IOP at baseline. A negative number change from baseline indicates a reduction in IOP (improvement).
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 6
时间窗: Week 6
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 6 at Hour 0, Hour 2 and Hour 8.
Average Eye Intraocular Pressure (IOP) at Each Hour Evaluated at Week 12
时间窗: Week 12
Intraocular pressure (IOP) is a measurement of the fluid pressure inside the eye. Average eye IOP is the average IOP of both eyes and was evaluated at Week 12 at Hour 0, Hour 2 and Hour 8.
次要结局
- Change From Baseline in Average Eye IOP at Each Hour Evaluated at Week 12(Baseline, Week 12)
- Change From Baseline in Worse Eye IOP at Each Hour Evaluated at Week 12(Baseline, Week 12)