A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
研究概览
简要总结
The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
- •Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
- •Other protocol-defined inclusion criteria applied.
- •Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
- •Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
- •Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
- •Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
- •History of uveitis or previous intraocular inflammation (other than post-operatively).
- •Hypersensitivity to sulfa, or benzalkonium chloride.
- •History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).
- •Other protocol-defined exclusion criteria applied.
排除标准
- 未提供
研究组 & 干预措施
Xalatan + Azopt
Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
干预措施: Brinzolamide 1% ophthalmic solution (Azopt) (Drug)
Xalatan + Azopt
Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
干预措施: Latanoprost 0.005% ophthalmic solution (Xalatan) (Drug)
Xalatan + Placebo
Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
干预措施: Placebo eye drops (Drug)
Xalatan + Placebo
Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
干预措施: Latanoprost 0.005% ophthalmic solution (Xalatan) (Drug)
结局指标
主要结局
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
时间窗: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
时间窗: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
时间窗: Day 0, 3 months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
时间窗: Day 0, 3 months
Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM \& 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.
次要结局
未报告次要终点