Safety and Efficacy of Different Formulations of Bimatoprost 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
- 597
- 主要终点
- Average Eye IOP at Week 12
研究概览
简要总结
This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) 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 0.03% Formulation B Ophthalmic Solution
Bimatoprost 0.03% Formulation B Ophthalmic Solution
干预措施: Bimatoprost 0.03% Formulation B Ophthalmic Solution (Drug)
Bimatoprost 0.03% Ophthalmic Solution
Bimatoprost 0.03% Ophthalmic Solution
干预措施: Bimatoprost 0.03% Ophthalmic Solution (Drug)
结局指标
主要结局
Average Eye IOP at Week 12
时间窗: Baseline, Week 12
Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only.
Average Eye IOP at Week 6
时间窗: Week 6
Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12
时间窗: Baseline, Week 12
Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP.
Average Eye IOP at Week 2
时间窗: Week 2
Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported.
次要结局
未报告次要终点