Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
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 brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).
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
- •Willing to sign an Informed Consent form.
- •Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
- •Be on a stable IOP lowering regimen within 30 days of Screening Visit.
- •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.
- •Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit
- •IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
- •Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
- •Willing to follow instructions and able to attend required study visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known history of hypersensitivity to any component of the preparations used in this study.
- •Presence of primary or secondary glaucoma not listed in inclusion criterion #
- •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 3 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.
- •Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
- •Pregnant or lactating.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
AZARGA
Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
干预措施: Brinzolamide 1% / timolol 0.5% maleate fixed combination (Drug)
结局指标
主要结局
Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
时间窗: Baseline, Week 8
IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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)(Week 8)