Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 15
- 主要终点
- Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
研究概览
简要总结
A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30 years or older.
- •Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
- •Best corrected visual acuity at least 20/40 in at least one eye.
排除标准
- •History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- •History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- •History or signs of intraocular trauma.
- •Any abnormality preventing reliable applanation tonometry.
- •Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- •Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
研究组 & 干预措施
Combigan®
Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
干预措施: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Drug)
Cosopt®
Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
干预措施: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution (Drug)
结局指标
主要结局
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
时间窗: 1 Month
Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery
时间窗: 1 Month
End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
时间窗: 1 Month
Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
时间窗: 1 Month
Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery
时间窗: 1 Month
End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery
时间窗: 1 Month
End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
时间窗: 1 Month
Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery
时间窗: 1 Month
End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).
次要结局
未报告次要终点