Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
研究概览
简要总结
The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Sign Informed Consent.
- •Diagnosis of open-angle glaucoma in at least one eye.
- •Requires more than one IOP-lowering medication.
- •IOP measurements at Screening, Safety, and Eligibility/Period 1 Baseline Visits as specified in protocol.
- •Able to discontinue all IOP-lowering medication prior to Eligibility Visit and for 4 weeks between treatment periods.
- •Willing to complete all required study visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Female of child-bearing potential if pregnant, lactating, or not using highly effective birth control measures.
- •Severe central visual field loss in either eye.
- •Previous glaucoma surgery in the study eye.
- •Intraocular surgery in the study eye within 3 months prior to the Screening Visit.
- •Wears contact lenses.
- •Allergy/hypersensitivity to study medication.
- •Cannot safely discontinue use of glucocorticoid medication.
- •Uses medication that could affect IOP or blood pressure.
- •Recent use of high-dose aspirin.
- •Bronchial asthma or severe chronic obstructive pulmonary disease.
- •Diabetic retinopathy.
- •Any abnormality preventing reliable tonometry.
- •Any severe illness or condition unsuitable for the study, in the opinion of the investigator.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AZARGA/COMBIGAN
AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
干预措施: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension (Drug)
AZARGA/COMBIGAN
AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
干预措施: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution (Drug)
COMBIGAN/AZARGA
COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
干预措施: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension (Drug)
COMBIGAN/AZARGA
COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
干预措施: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution (Drug)
结局指标
主要结局
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
时间窗: Week 0, Week 6 (period-based)
Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
次要结局
- Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Diastolic Blood Pressure at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Systolic Blood Pressure at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks(Week 0, Week 6 (period-based))
- Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6(Week 0, Week 6 (period-based))
- Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6(Week 0, Week 6 (period-based))