The Efficacy and Safety of Brinzolamide 1%/Timolol 0.5% Fixed Combination Versus Dorzolamide 1%/Timolol 0.5% in Patients With Open-Angle Glaucoma and Ocular Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 218
- 试验地点
- 1
- 主要终点
- Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
研究概览
简要总结
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
详细描述
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand the nature of the study and sign informed consent.
- •Diagnosis of open angle glaucoma or ocular hypertension.
- •Currently on PGA monotherapy or PGA + alpha-1/beta blocker or PGA + alpha-2 agonist at screening visit, and allowed to instill only PGA for 4 weeks until the baseline visit.
- •Intraocular pressure (IOP) ≥ 15 mmHg (at least one same eye) at the baseline visit.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •History of bronchial asthma, bronchospasm, or serious chronic obstruction pulmonary disease.
- •Uncontrolled heart failure, sinus bradycardia, A-V block (II, III grade), cardiogenic shock, right heart failure due to pulmonary hypertension or congestive heart failure.
- •History of hypersensitivity to any of the excipients of the study medications.
- •Severe renal function disorders, diabetic ketoacidosis and metabolic acidosis, uncontrolled diabetes, or hepatic disorders.
- •Corneal disorder or history of chronic, recurrent or current severe inflammatory eye disease in either eye.
- •History of ocular trauma in either eye within 6 months prior to the screening examination.
- •Ocular infection or ocular inflammation in either eye.
- •History of or current clinically significant or progressive retinal disease in either eye.
- •Intraocular surgery in either eye within 6 months prior to the screening examination.
- •Ocular laser surgery in either eye within 3 months prior to the screening examination.
- •Any abnormality preventing reliable applanation tonometry of either eye.
- •Best-corrected visual acuity (BCVA) worse than 0.2 score (decimal visual acuity) in either eye.
- •Severe visual field loss in either eye.
- •Use of prohibited medication, as specified in the protocol.
- •Pregnant, lactating, or intending to become pregnant during the study period.
- •Currently on therapy or have been on therapy with another investigational agent within 30 days prior to the screening examination.
- •History of or current evidence of a severe illness or any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
BRI/TIM
Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
干预措施: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension (Drug)
BRI/TIM
Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
干预措施: Subject's habitual PGA monotherapy (Drug)
DOR/TIM
Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
干预措施: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution (Drug)
DOR/TIM
Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
干预措施: Subject's habitual PGA monotherapy (Drug)
结局指标
主要结局
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
时间窗: Baseline (Day 0), Week 4, Week 8 at 11 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
次要结局
- Least Squares Mean Change From Baseline in IOP at 9 AM(Baseline (Day 0), Week 4, Week 8 at 9 AM)