Additive Effect of Twice Daily Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as an Adjunctive Therapy to a Prostaglandin Analogue
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
研究概览
简要总结
The purpose of this study is to evaluate the additive intraocular pressure (IOP) lowering effect of brinzolamide 1%/brimonidine 0.2% (dosed twice per day (BID)) when added to a prostaglandin analogue (PGA) in subjects with open-angle glaucoma or ocular hypertension.
详细描述
This study consisted of 2 sequential phases: Screening/Eligibility Phase, followed by a Masked Treatment Phase (Phase II). Subjects were assigned into one of 3 PGA therapy groups for the duration of the study, based upon commercial availability.
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
- •Diagnosis of either open-angle glaucoma or ocular hypertension;
- •Must sign an informed consent form;
- •Mean IOP measurements at both the Eligibility 1 and 2 visits, in at least 1 eye (the same eye[s]) ≥ 19 and < 32 mmHg at 09:
- •Willing and able to attend all study visits;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant, breast-feeding, intend to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study;
- •Any form of glaucoma other than open-angle glaucoma or ocular hypertension;
- •Ocular disease, trauma, infection, inflammation, pathology, or surgery as specified in the protocol;
- •Any other conditions including severe illness which would make the subject, in the opinion of the Investigator, unsuitable for the study;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
SIMBRINZA + PGA
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
干预措施: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension (Drug)
SIMBRINZA + PGA
Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
干预措施: Prostaglandin analogue (Drug)
Vehicle + PGA
Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
干预措施: Brinz/brim vehicle (Drug)
Vehicle + PGA
Brinz/brim vehicle, 1 drop instilled 2 times per day in affected eye(s) (09:00 and 21:00) plus designated prostaglandin analogue, 1 drop instilled in each eye once per day in the evening for 42 days
干预措施: Prostaglandin analogue (Drug)
结局指标
主要结局
Mean Change From Baseline (on PGA) in Diurnal IOP (Mean of 09:00 and 11:00 Time Points) at Week 6
时间窗: Baseline, Week 6
IOP (fluid pressure inside the eye) was measured using Goldmann applanation tonometry and averaged over the 09:00 AM and 11:00 AM time points. A more negative change from baseline indicates a greater improvement, i.e., a reduction of IOP. One eye (study eye) contributed to the analysis.
次要结局
- Mean Diurnal IOP at Week 6(Week 6)
- Mean Percentage Change From Baseline in Diurnal IOP at Week 6(Baseline, Week 6)
- Mean Change From Baseline in IOP at 11:00 at Week 6(Baseline, Week 6)
- Mean Percentage Change From Baseline in IOP at 11:00 at Week 6(Baseline, Week 6)
- Mean Change From Baseline in IOP at 09:00 at Week 6(Baseline, Week 6)
- Mean Percentage Change From Baseline at 09:00 at Week 6(Baseline, Week 6)