Three Month Efficacy and Safety Study 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
- 1,001
- 主要终点
- Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.
详细描述
This study consisted of 6 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 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.
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 patient, in the opinion of the Investigator, unsuitable for the study.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Brinzolamide/Brimonidine
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
干预措施: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug)
Brinzolamide
Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
干预措施: Brinzolamide ophthalmic suspension, 1% (Drug)
Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three 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 IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
时间窗: Month 3
At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. 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