A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study Evaluating The Efficacy And Safety Of Latanoprost And Timolol In Pediatric Subjects With Glaucoma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
研究概览
简要总结
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 36 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of 18 years of age or under
- •Diagnosis of glaucoma
- •IOP of 22 mmHg or above in at least 1 eye
排除标准
- •Require surgery for acute angle closure
- •Have had prior cyclodestructive procedures
- •Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit
研究组 & 干预措施
Timolol
干预措施: Timolol (Drug)
latanoprost
干预措施: latanoprost (Drug)
结局指标
主要结局
Reduction From Baseline in Mean IOP at Week 12, Last Observation Carried Forward (LOCF)
时间窗: Baseline, Week 12
Calculated as Baseline IOP minus Week 12 IOP, LOCF. IOP measured using 1 of 3 methods: Goldmann applanation tonometry (preferred method, if feasible), Perkins tonometry, or TonoPen. IOP was measured twice and if the measurements were less than or equal to (≤) 2 millimeters of mercury (mmHg) of each other, the mean of the 2 readings was recorded as the IOP at that time point. Otherwise, a third IOP measurement was taken and the median IOP recorded.
次要结局
- Reduction From Baseline in Mean IOP at Week 12 (Observed)(Baseline, Week 12)
- Reduction From Baseline in Mean IOP at Week 1(Baseline, Week 1)
- Mean IOP at Baseline(Baseline)
- Mean IOP at Week 4(Week 4)
- Reduction From Baseline in Mean IOP at Week 4(Baseline, Week 4)
- Percentage of Participants With Greater Than or Equal to (≥) 15% IOP Reduction From Baseline at Both Weeks 4 and 12(Baseline, Week 4, and Week 12)
- Percentage of Participants Discontinuing Therapy Due to a Drug-related Adverse Experience(Baseline through Week 12)
- Mean IOP at Week 1(Week 1)
- Mean IOP at Week 12(Week 12)