NCT00061542已完成3 期
Safety and Efficacy Study of BETOPTIC S 0.25% and Timolol Gel-forming Solution 0.25% and 0.5% in Pediatric Patients With Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Mean change from baseline in IOP
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of BETOPTIC S and Timolol Gel-forming solution in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.
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
入排标准
- 年龄范围
- 1 Week 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Betaxolol
Experimental
Two doses daily for 12 weeks
干预措施: BETOPTIC S (betaxolol HCl) (Drug)
TGFS 0.25%
Experimental
Two doses daily for 12 weeks
干预措施: Timolol Gel-forming Solution (TGFS) (Drug)
TGFS 0.5%
Experimental
Two doses daily for 12 weeks
干预措施: Timolol Gel-forming Solution (TGFS) (Drug)
结局指标
主要结局
Mean change from baseline in IOP
时间窗: Up to Week 12
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Timolol Option for Ulcerated Hemangiomas (TOUCH Trial)Infantile HemangiomasNCT01408056Children's Hospital of Philadelphia
招募中
3 期
Efficacy and Safety of Timolol for TKI Induced ParonychiaParonychiaNCT06140186Queen Mary Hospital, Hong Kong40
已完成
3 期
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients Wtih Glaucoma or Ocular HypertensionOcular HypertensionNCT00332072Allergan541
已完成
3 期
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionOcular HypertensionNCT00332059Allergan445
已完成
3 期
Safety and Efficacy Study of Bimatoprost/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionOcular HypertensionNCT00332540Allergan520