A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 6
- 主要终点
- Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital, juvenile glaucoma
- •Requires treatment with IOP-lowering medication in one or both eyes
排除标准
- •Surgical intervention is indicated or planned to lower IOP
- •Abnormally low body weight (below 5th percentile)
- •Any active eye infection or disease
- •Anticipated use of contact lenses during the study
- •Topical ocular steroid use within 2 months
- •History of ocular trauma in either eye
- •Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
研究组 & 干预措施
bimatoprost ophthalmic solution formulation A and vehicle
1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
干预措施: bimatoprost ophthalmic solution formulation A (Drug)
bimatoprost ophthalmic solution formulation A and vehicle
1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
干预措施: bimatoprost vehicle (Drug)
timolol ophthalmic solution
1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
干预措施: timolol ophthalmic solution (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
时间窗: Baseline, Week 6
IOP is a measure of the fluid pressure inside the study eye. A negative number change from baseline indicates a reduction in IOP (improvement) and a positive change from baseline indicates an increase in IOP (worsening). Due to lack of enrollment, analysis was not performed for this outcome measure.
次要结局
未报告次要终点