Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 47
- 主要终点
- Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
详细描述
This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.
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, primary open angle (including pigment dispersion) glaucoma in both eyes.
- •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.
- •Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit
- •Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit
- •At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
- •Best corrected visual acuity of 1.0 LogMAR or better in each eye.
- •In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
- •Willing to sign an informed consent form.
- •Able to follow instructions and willing and able to attend required study visits.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
- •A history of, or at risk for uveitis or cystoid macular edema (CME).
- •History of ocular herpes simplex.
- •Corneal dystrophies in either eye.
- •Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
- •Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to 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 apart from glaucoma.
- •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 Visit 1 or an anticipated change in the dosage during the course of the study.
- •Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
- •Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •History of severe allergic rhinitis.
- •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.
- •Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]).
- •Severely impared renal function.
- •History of an allergy to sulphonamides.
- •Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
- •Any clinically significant, serious, or severe medical condition.
- •Participation in any other investigational study within 30 days prior to the screening/baseline visit.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Azarga
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
干预措施: Brinzolamide 1% / timolol 0.5% Fixed Combination (Drug)
Azarga
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
干预措施: Habitual prostaglandin monotherapy (Drug)
结局指标
主要结局
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
时间窗: Baseline, Week 12
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. Only one eye (study eye) contributed to the mean.
次要结局
- Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12(Baseline, Week 12)
- Mean Change From Baseline in IOP at Week 4(Baseline, Week 4)
- Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)(Week 12)