NCT00758342终止4 期
A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Mean IOP (Intraocular Pressure)
研究概览
简要总结
To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.
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
- •≥ 18 years;
- •CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
- •have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
- •clinical stability of VA (Visual Acuity) and optic nerve throughout the study
排除标准
- •Abnormality restricts exam of the fundus or anderior chamber
- •conjunctivitis, keratitis or uveitis
- •unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
- •ocular surgery prior to the study
研究组 & 干预措施
Travoprost 0.004% + Brinzolamide 1.0%
Experimental
Travoprost 0.004% (once daily) + Brinzolamide 1.0% (twice daily)
干预措施: Travoprost 0.004% + Brinzolamide 1.0% (Drug)
Travoprost 0.004% + Tears Natural
Active Comparator
Travoprost 0.004% (once daily) + Tears Naturale (twice daily)
干预措施: Travoprost 0.004% + Tears Natural (Drug)
结局指标
主要结局
Mean IOP (Intraocular Pressure)
时间窗: Screening: Week 12; (At 9 am and 4 pm time points)
次要结局
未报告次要终点
研究者
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