Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 249
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient
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
- •Ocular hypertension or glaucoma in both eyes
- •Require IOP-lowering therapy in each eye
排除标准
- •Uncontrolled systemic disease
- •Known allergy or hypersensitivity to bimatoprost
研究组 & 干预措施
1
Bimatoprost 0.01% ophthalmic solution
干预措施: Bimatoprost 0.01% ophthalmic solution (Drug)
2
Bimatoprost 0.015% formulation 1 ophthalmic solution
干预措施: Bimatoprost 0.015% formulation 1 ophthalmic solution (Drug)
3
Bimatoprost 0.015% formulation 2 ophthalmic solution
干预措施: Bimatoprost 0.015% formulation 2 ophthalmic solution (Drug)
4
Bimatoprost 0.02% ophthalmic solution
干预措施: Bimatoprost 0.02% ophthalmic solution (Drug)
5
Bimatoprost 0.03% ophthalmic solution
干预措施: Bimatoprost 0.03% ophthalmic solution (Drug)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: Day 5
次要结局
- Patient Comfort(Days 1-4)
- Patient Satisfaction(Day 5)
- Treatment Preference(Day 5)