NCT00767481终止3 期
1 Year Study Trav/Brinz QD Fixed Combination Versus COSOPT
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 主要终点
- Mean IOP
研究概览
简要总结
Parallel, Multi-Center, Double-masked, Active controlled, three arm study comparing the IOP lowering efficacy and safety over 12 months of morning or evening instillations of Travoprost/Brinzolamide vs. Cosopt dosed in the morning and evening in patients with open-angle glaucoma or ocular hypertension.
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, Investigator, Outcomes Assessor)
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
- •IOP at screening visit <18mmHg in at least one eye Mean IOP in same eye (at both eligibility 1 &2 visits)
- •24 and ≤ 36 mmHg at 9:00
- •21 and ≤ 36 mmHg at 11:00 and 16:00
排除标准
- •Severe central visual field loss Angle Shaffer grade < 2 C/D ratio > 0.8 (horizontal or vertical measurement)
研究组 & 干预措施
Cosopt
Active Comparator
Cosopt BID
干预措施: Cosopt (Drug)
Travoprost/Brinzolamide PM, Vehicle AM
Experimental
Travoprost/Brinzolamide PM, Vehicle AM
干预措施: Travoprost/Brinzolamide (Drug)
Travoprost/Brinzolamide AM, Vehicle PM
Experimental
Travoprost/Brinzolamide AM, Vehicle PM
干预措施: Travoprost/Brinzolamide (Drug)
结局指标
主要结局
Mean IOP
时间窗: 9:00,11:00, and 1600 time points at month 12
次要结局
- Percent change in IOP, IOP change from baseline, patients with IOP <18mmHg. BSCVA, Ocular signs, Dilated fundus, perimetry, pachymetry, cardiovascular parameters(pulse, BP and AEs at W2, W3, M6, M9 and M12.(All on therapy time points not included in primary efficacy)
研究者
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