A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,062
- 主要终点
- Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.
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
- Quadruple (Participant, Care Provider, 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
- •Sign Informed Consent document.
- •Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
- •Any form of glaucoma other than open-angle glaucoma.
- •Severe central vision loss in either eye.
- •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 such as retinal degeneration, diabetic retinopathy, or retinal detachment.
- •Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
- •Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
- •Ocular surgery within the preceding 6 months.
- •Ocular laser surgery within the preceding 3 months.
- •Any abnormality preventing reliable applanation tonometry.
- •Any other conditions, including severe illness, which could 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
Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
干预措施: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug)
Brinzolamide
Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
干预措施: Brinzolamide ophthalmic suspension, 1% (Drug)
Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
干预措施: Brimonidine tartrate ophthalmic solution, 0.2% (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3
时间窗: Month 3
The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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