NCT01514734终止4 期
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Brazil
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
研究概览
简要总结
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years of age or older.
- •Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
- •Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
- •IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
- •Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
- •IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Presence of other primary or secondary glaucoma not listed in inclusion criteria #
- •History of ocular herpes simplex.
- •Abnormality preventing reliable applanation tonometry.
- •Corneal dystrophies.
- •Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- •Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
- •Risk of visual field or visual acuity worsening as a consequence of 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 which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
- •Pregnant or lactating.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AZARGA
Experimental
Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
干预措施: Brinzolamide/timolol maleate fixed combination (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
时间窗: 8 weeks
Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
次要结局
未报告次要终点
研究者
研究点 (1)
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