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 Latin America
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
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 participants 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
- •Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
- •On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
- •IOP considered safe in both eyes in order to 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.
- •History of ocular herpes simplex.
- •Any 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 Screening Visit.
- •Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
- •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 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®
Brinzolamide/timolol maleate fixed combination, 1 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
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
时间窗: Baseline, Week 8
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
次要结局
- Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8(Week 8)