Prospective, Randomized, Single-Center Study to Evaluate 24-hour Intraocular Pressure Control With Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Mean Nocturnal IOP at Week 4
研究概览
简要总结
The purpose of this study is to evaluate intraocular pressure (IOP) over a 24-hour period using Simbrinza™ topical ophthalmic suspension.
详细描述
This study consisted of two phases, a Screening/Eligibility Phase and a Treatment Phase. Both phases required the patient to complete an overnight stay.
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 (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
- •Clinical diagnosis of either open-angle glaucoma or ocular hypertension in both eyes.
- •Willing and able to attend all study-related visits and be housed overnight at clinical site for the study assessments.
- •Must sign an Informed Consent form.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential if pregnant, breastfeeding, or not using adequate birth control.
- •Severe central visual field loss in either eye.
- •Chronic, recurrent or severe inflammatory eye disease.
- •Ocular trauma or ocular surgery within the past 6 months.
- •Ocular infection or ocular inflammation within the past 3 months.
- •Clinically significant or progressive retinal disease.
- •Other ocular pathology, including severe dry eye, that may in the opinion of the investigator preclude the administration of study medication.
- •Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- •Any medical condition that would preclude the safe administration of a topical beta-blocker.
- •Cannot safely discontinue all glucocorticoids administered by any route.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
SIMBRINZA™
Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension, 1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
干预措施: Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension (Drug)
Timolol Maleate 0.5%
Timolol Maleate 0.5%, 1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
干预措施: Timolol Maleate 0.5% (Drug)
结局指标
主要结局
Mean Nocturnal IOP at Week 4
时间窗: Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). 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
- Mean 24-hour IOP at Week 4(Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AM)
- Mean Diurnal IOP at Week 4(Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM)