NCT00872651已完成3 期
Travoprost 0.004%/Timolol 0.5% Versus Latanoprost 0.005%/Timolol in Chinese Patients With Open-Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
Eligible patients will be randomized in a 1.1 ratio to receive Travoprost 0.004%/timolol 0.5% once daily or Latanoprost 0.005%/Timolol 0.5% once a day for 8 Weeks. The study treatments will be compared for mean diurnal intraocular pressure (IOP) change from baseline at Week 8.
Safety parameters measured at 4 study visits: ocular signs, visual acuity, dilated fundus, cardiovascular parameters (blood pressure and pulse), and adverse events.
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
- Single (Outcomes Assessor)
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
- •Patients of either sex and any race, 18 years of age or older, diagnosed with open angle glaucoma or ocular hypertension who are not sufficiently responsive to topical beta-blockers or prostaglandin analogues.
- •Patients must meet the following IOP criteria in at least one eye. For each qualifying eye, the mean IOP should be ≥21 mmHg at 9 AM and 11 AM time points at the eligibility visit
- •The mean IOP in either eye at the eligibility visit must not be greater than 35 mmHg at any time point.
排除标准
- •Patients with any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or ocular hypertension.
- •Patients with iridocorneal angle Shaffer grade < 2 (extreme narrow angle with complete or partial closure) angle in either eye, as measured by gonioscopy
- •Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
- •Patients with severe central visual field loss in either eye. Severe central field loss is defined as a sensitivity of ≤ 10 dB in at least 2 of the 4 visual field test points closest to the point of fixation.
- •Current chronic, recurrent or severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis), or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
- •History of ocular trauma within the past 6 months.
- •Intraocular surgery within the past 3 months.
- •Ocular laser surgery within the past 3 months.
- •Best-corrected visual acuity score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal)
- •Current ocular infection or inflammation, or history of ocular infection or inflammation within the past 3 months, as determined by patients' history and/or examination.
- •History of or current clinically relevant or progressive retinal disease, such as retinal degeneration, diabetic retinopathy or retinal detachment.
- •Any abnormality preventing reliable applanation tonometry.
研究组 & 干预措施
Travoprost 0.004%/Timolol 0.5%
Experimental
Travoprost 0.004%/Timolol 0.5%
干预措施: Travoprost 0.004%/Timolol 0.5% (Drug)
Latanoprost 0.005% / Timolol 0.5%
Active Comparator
Latanoprost 0.005% / Timolol 0.5%
干预措施: Latanoprost 0.005% / Timolol 0.5% (Drug)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 8 weeks
Mean Diurnal Intraocular Pressure (IOP) (averaged at 9 AM, 11 AM and 4 PM) change from baseline at Week 8.
次要结局
- Intraocular Pressure (IOP)(8 weeks)
研究者
研究点 (1)
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