Additive Effect of Brinzolamide 1%/Brimonidine 0.2% Fixed Dose Combination as Adjunctive Therapy to a Prostaglandin Analogue
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 282
- 主要终点
- Mean Diurnal Intraocular Pressure (IOP) at Week 6
研究概览
简要总结
The purpose of this study is to demonstrate the additive effect of brinzolamide 1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
详细描述
This study was divided into 2 sequential phases. The Screening/Eligibility Phase included one Screening Visit and two Eligibility Visits, during which subjects washed out of all other intraocular pressure (IOP)-lowering medications and dosed with TRAVATAN Z®, XALATAN®, or LUMIGAN®, 1 drop instilled in each eye once daily for 28 days. Subjects who met all inclusion/exclusion criteria were randomized at the second Eligibility Visit. The Treatment Phase consisted of two on-therapy visits (Week 2 and Week 6).
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 open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension;
- •Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21 mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);
- •Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01% monotherapy for at least 28 days prior to the Screening Visit;
- •Able to understand and sign Informed Consent Document;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant, breastfeeding, or do not agree to use an adequate birth control method throughout the study;
- •Any form of glaucoma other than open angle glaucoma or ocular hypertension;
- •Severe central visual field loss;
- •Chronic, recurrent, or severe inflammatory eye disease;
- •Ocular trauma within the past 6 months;
- •Ocular infection or ocular inflammation within the past 3 months;
- •Best-corrected visual acuity score worse than approximately 20/80 Snellen;
- •Eye surgery within the past 6 months;
- •Any condition, including severe illness, which would make the subject unsuitable for the study in the opinion of the Investigator;
- •Use of any additional topical or systemic ocular hypertensive medication during the study;
- •Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering ocular medication(s) per the appropriate washout schedule prior to Eligibility 1 Visit;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
SIMBRINZA
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
干预措施: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension (Drug)
SIMBRINZA
Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
干预措施: Prostaglandin analogue (Drug)
Vehicle
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
干预措施: Vehicle (Drug)
Vehicle
Inactive ingredients, 1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
干预措施: Prostaglandin analogue (Drug)
结局指标
主要结局
Mean Diurnal Intraocular Pressure (IOP) at Week 6
时间窗: Week 6
Diurnal IOP was defined as the average of the four timepoints measured (8 AM, 10 AM, 3 PM, and 5 PM). IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in millimeters mercury (mmHg). One eye was chosen as the study eye and only data for the study eye were used for the 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 Diurnal IOP Percentage Change From Baseline to Week 6(Baseline, Week 6)
- Mean IOP at Week 6 for Each Time Point (8 AM, 10 AM, 3 PM, 5 PM)(Week 6)
- Mean Diurnal IOP Change From Baseline to Week 6(Baseline, Week 6)