NCT01111890已完成4 期
Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
研究概览
简要总结
Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.
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
- Single (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
- •Must be at least 18 years of age.
- •Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- •Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- •Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
- •Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
- •For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
排除标准
- •Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
- •Presence of other primary or secondary glaucoma not listed in inclusion criterion #
- •Any abnormality preventing reliable applanation tonometry in study eye(s).
- •Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
- •Progressive retinal or optic nerve disease from any cause.
- •Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
- •A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
- •Participation in any other investigational study within 30 days prior to Visit 1.
研究组 & 干预措施
Azarga
Experimental
Azarga (brinzolamide 1% / timolol 0.5%)
干预措施: Azarga (brinzolamide 1% / timolol 0.5%) (Drug)
Cosopt
Active Comparator
Cosopt (dorzolamide 2% / timolol 0.5%)
干预措施: Cosopt (dorzolamide 2% / timolol 0.5%) (Drug)
结局指标
主要结局
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing
时间窗: 12 weeks
次要结局
- Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)(12 weeks)
研究者
相似试验
已完成
4 期
Patient Preference Comparison of AZARGA Versus COSOPT in Patients With GlaucomaGlaucomaNCT01471158Alcon Research120
进行中（未招募）
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进行中（未招募）
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Patient Preference Comparison of Azarga versus Cosopt, after Single Doses in Patients with Open-Angled Glaucoma or Ocular Hypertension - not applicableOpen-angle glaucoma or ocular hypertensionEUCTR2009-015796-27-SIAlcon d.o.o.
进行中（未招募）
不适用
Patient Preference Comparison of Azarga versus Cosopt, in Patients with Open-Angle Glaucoma or Ocular Hypertension.Open-Angle Glaucoma and Ocular HypertensionMedDRA version: 14.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2010-024244-15-DEALCON Research Ltd112
进行中（未招募）
不适用
Patient Preference Comparison of Azarga versus Cosopt, in Patients with Open-Angled Glaucoma or Ocular Hypertension.Open-Angle Glaucoma and Ocular HypertensionMedDRA version: 13.1Level: HLGTClassification code 10018307Term: Glaucoma and ocular hypertensionSystem Organ Class: 10015919 - Eye disordersEUCTR2010-024244-15-GBALCON Research Ltd112