NCT00966576已完成4 期
The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
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
- 47
- 主要终点
- The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent.
- •21 years of age or older.
- •Able to follow instructions and willing to attend required study visits.
- •Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
- •Intra-ocular pressure (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 trial.
- •Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Presence of other primary or secondary glaucomas not listed in inclusion criterion.
- •Presence of corneal dystrophies.
- •Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- •Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit
- •Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
- •Women of childbearing potential not using reliable means of birth control.
- •Women who are pregnant or lactating.
- •Participation in any other investigational study within 30 days prior to Visit
- •Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
- •Severe allergic rhinitis
- •History of ocular herpes simplex.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Brinzolamide/Timolol Maleate Fixed Combination
Experimental
干预措施: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) (Drug)
结局指标
主要结局
The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline
时间窗: 12 weeks
次要结局
- Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success(Week 4 and Week 12)
研究者
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