Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 771
- 主要终点
- Mean Diurnal IOP Change From Baseline at Month 3
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.
详细描述
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 3 study drug groups: Brinz/Brim, Brinz, or Brim.
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
- •Diagnosed with open angle glaucoma or ocular hypertension, and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
- •Meet qualifying IOP entry criteria.
- •Able to understand and sign an informed consent form.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential if pregnant, test positive for pregnancy at Screening Visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- •Severe central visual field loss.
- •Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
- •Chronic, recurrent or severe inflammatory eye disease.
- •Ocular trauma within the preceding 6 months.
- •Ocular infection or ocular inflammation within the preceding 3 months.
- •Clinically significant or progressive retinal disease.
- •Other ocular pathology.
- •Intraocular surgery within the 6 months prior to entry.
- •Ocular laser surgery within the 3 months prior to entry.
- •Any abnormality preventing reliable applanation tonometry.
- •Any other conditions, including severe illness, which would make the subject, in the opinion of the Investigator, unsuitable for the study.
- •Recent use of high-dose (>1 gram daily) salicylate therapy.
- •Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
- •Concurrent use of glucocorticoid medications administered by any route.
- •Other protocol-specified exclusion crtieria may apply.
研究组 & 干预措施
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
干预措施: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug)
Brinz
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
干预措施: Brinzolamide 1% ophthalmic suspension (Drug)
Brim
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
干预措施: Brimonidine tartrate 0.2% ophthalmic solution (Drug)
结局指标
主要结局
Mean Diurnal IOP Change From Baseline at Month 3
时间窗: Baseline (Day 1), Month 3
Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
次要结局
未报告次要终点