Safety and Efficacy of LUMIGAN® RC Versus DuoTrav® in Patients Who Require Further Intraocular Pressure (IOP) Reduction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 135
- 主要终点
- Mean Diurnal Intraocular Pressure (IOP)
研究概览
简要总结
This non-inferiority study will assess safety and efficacy of LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) versus DuoTrav® (travoprost 0.004%/timolol 0.5% combination ophthalmic solution) in patients previously on Travatan® Z (travoprost ophthalmic solution 0.004%) monotherapy.
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
- Single (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
- •Open angle glaucoma or ocular hypertension
- •Best corrected visual acuity of 20/100 or better in both eyes
排除标准
- •Ocular surgery within 3 months, or anticipated ocular surgery within 12 weeks
- •Previous treatment with LUMIGAN® RC or DuoTrav®
- •History of LASIK, LASEK, RK or PRK in the study eye(s)
- •Active ocular inflammation
研究组 & 干预措施
LUMIGAN® RC
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
干预措施: travoprost ophthalmic solution 0.004% (Drug)
LUMIGAN® RC
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
干预措施: Bimatoprost ophthalmic solution 0.01% (Drug)
DuoTrav®
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
干预措施: travoprost ophthalmic solution 0.004% (Drug)
DuoTrav®
Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
干预措施: travoprost 0.004% / timolol 0.5% combination ophthalmic solution (Drug)
结局指标
主要结局
Mean Diurnal Intraocular Pressure (IOP)
时间窗: Week 12
IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye (worse eye) at Week 12 measured at 8 AM, 12 Noon and 4 PM. For each study eye, IOP was either the average of 2 measurements, or, if a third measurement was required, the average of 3 measurements.
次要结局
- Change From Baseline in Mean IOP at Week 12(Baseline, Week 12)
- Percentage of Participants With ≥15% Reduction in Mean Diurnal IOP From Baseline(Baseline, Week 12)
- Percentage of Participants With Mean Diurnal IOP Less Than 18 mmHg(Week 12)
- Change From Baseline in Mean IOP at Week 6(Baseline, Week 6)