24-hr Intraocular Pressure Control With Brinzolamide 1% / Brimonidine 0.2% Ophthalmic Suspension vs Vehicle
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 162
- 主要终点
- Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
研究概览
简要总结
The purpose of this study is to evaluate differences between treatments in mean change from baseline in 24-hr intraocular pressure (IOP) at Week 4.
详细描述
Subjects will undergo washout of pre-study IOP-lowering medications for the appropriate duration, then undergo 2 eligibility visits. Eligible subjects will be randomized 1:1, to receive masked SIMBRINZA ® or Vehicle for 4 weeks. Two 24-hour visits will be conducted (Day 0 and Week 4) during which intraocular pressure will be collected every 2 hours. The expected duration of subject participation in the study is 10 weeks.
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;
- •Able to attend all study related visits and be housed overnight at clinical site for the study assessments;
- •Willing and able to sign an informed consent form;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant, intend to become pregnant during the study, breast-feeding, or not using adequate birth control;
- •Diagnosed with any form of glaucoma other than open angle glaucoma or ocular hypertension;
- •Ocular surgeries or procedures excluded by the protocol;
- •Diseases, illnesses, infections, or ocular abnormalities excluded by the protocol;
- •Best-corrected visual acuity score less than 55 ETDRS letters (equivalent to approximately 20/80 Snellen) in either eye;
- •Other protocol-specific exclusion criteria may apply.
研究组 & 干预措施
SIMBRINZA
Brinzolamide 1% / Brimonidine 0.2% tartrate ophthalmic suspension, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
干预措施: Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension (Drug)
Vehicle
Vehicle, 1 drop 3 times per day in each eye at 8 AM, 3 PM, and 10 PM for 28 days
干预措施: Vehicle (Drug)
结局指标
主要结局
Least Squares Mean Change From Baseline in 24-hr Intraocular Pressure (IOP) at Week 4
时间窗: Baseline (Day 0), Week 4
IOP (fluid pressure inside the eye) was measured in millimeters of mercury (mmHg). Change was calculated by taking the change from baseline at each time point and averaging the available changes. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement. Only one eye (study eye) contributed to the analysis.
次要结局
- Least Squares Mean Change From Baseline in Daytime IOP at Week 4(Baseline (Day 0), Week 4)
- Least Squares Mean Change From Baseline in Nocturnal IOP at Week 4(Baseline (Day 0), Week 4)
- Least Squares Mean Change From Baseline in IOP for Each Time Point (8 AM Through 6 AM) at Week 4(Baseline (Day 0), Week 4)