Efficacy and Safety of Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 493
- 主要终点
- Mean Diurnal IOP Change From Baseline at Month 3
研究概览
简要总结
The purpose of this study is to compare the fixed combination (BID) [Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL eyes drops, suspension] to the unfixed combination (BID) [Brinzolamide 10 mg/mL eye drops, suspension plus Brimonidine 2 mg/mL eyes drops, solution] with respect to intraocular pressure (IOP)-lowering efficacy.
详细描述
This study is divided into 2 phases conducted in sequence for a total of 6 visits: Phase I (Screening/Eligibility) which includes a Screening Visit, followed by 2 Eligibility Visits (E1 and E2) and Phase II (Treatment/Follow-up) which includes 3 visits at Week 2, Week 6, and Month 3. Following washout of any IOP-lowering medication, subjects who meet all inclusion/exclusion criteria at both Eligibility visits and had IOP measurements within the specified range during this period will be randomized to Phase II.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of open-angle glaucoma or ocular hypertension insufficiently controlled on monotherapy or currently on multiple IOP-lowering medications;
- •Mean IOP measurements within guidelines specified in the protocol. Must not be > 36 mmHg at any time point;
- •Able to understand and sign an informed consent form;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Women of childbearing potential who are pregnant, test positive for pregnancy, intend to become pregnant during the study period, breast-feeding, or not in agreement to use adequate birth control methods throughout the study;
- •Severe central visual field loss in either eye;
- •Unable to safely discontinue all IOP-lowering ocular medication(s) for a minimum of 5 (± 1) to 28 (± 1) days prior to E1 Visit;
- •Chronic, recurrent or severe inflammatory eye disease;
- •Ocular trauma within the past 6 months;
- •Ocular infection or ocular inflammation within the past 3 months;
- •Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment;
- •Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal);
- •Other ocular pathology (including severe dry eye) that may preclude the administration of α-adrenergic agonist and/or topical carbonic anhydrase inhibitor (CAI);
- •Intraocular surgery within the past 6 months;
- •Ocular laser surgery within the past 3 months;
- •Any abnormality preventing reliable applanation tonometry;
- •Any conditions including severe illness which would make the Subject, in the opinion of the Investigator, unsuitable for the study;
- •History of active, severe, unstable or uncontrolled cardiovascular, cerebrovascular, hepatic, or renal disease that would preclude safe administration of a topical α-adrenergic agonist or CAI;
- •Recent (within 4 weeks of the E1 Visit) use of high-dose (> 1 g daily) salicylate therapy;
- •Current or anticipated treatment with any psychotropic drugs that augment adrenergic response (eg, desipramine, amitriptyline);
- •Concurrent use of monoamine oxidase inhibitors (MAOI);
- •Concurrent use of glucocorticoids administered by any route;
- •Therapy with another investigational agent within 30 days prior to the Screening Visit;
- •Hypersensitivity to α-adrenergic agonist drugs, topical or oral CAIs, sulfonamide derivatives, or to any component of the study medications;
- •Less than 30 days stable dosing regimen before the Screening Visit of any medications (excluding IOP-lowering treatments) or substances administered by any route and used on a chronic basis that may affect IOP, including but not limited to β-adrenergic blocking agents;
- •Use of any additional topical or systemic ocular hypotensive medication during the study;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Brinz/Brim
Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
干预措施: Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension (Drug)
Brinz/Brim
Vehicle solution, 1 drop, followed by Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) twice daily (BID) for 3 months
干预措施: Vehicle (Drug)
Brinz+Brim
Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
干预措施: Brinzolamide 10 mg/mL eye drops, suspension (Drug)
Brinz+Brim
Brimonidine 2 mg/mL eye drops, solution, 1 drop, followed by Brinzolamide 10 mg/mL eye drops, suspension, 1 drop, administered at least 5 minutes apart in the treated eye(s) BID for 3 months
干预措施: Brimonidine 2 mg/mL eye drops, solution (Drug)
结局指标
主要结局
Mean Diurnal IOP Change From Baseline at Month 3
时间窗: Baseline (Day 0), Month 3
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and reported in mmHg. Diurnal IOP was defined as the average of the three timepoints measured: 9 AM, +2 Hrs and +7Hrs. Baseline was the average of the values for 2 eligibility visits. If one of the values was missing, the other non-missing value was taken as the baseline. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates greater improvement, ie, a reduction of IOP. Only one eye (study eye) contributed to the analysis.
次要结局
未报告次要终点