NCT01292460已完成3 期
A Phase III, Randomized, Double-masked 6-month Trial to Compare the Efficacy and Safety of the Preservative-free Fixed-dose Combination of Tafluprost and Timolol Eye Drops to Those Given Individually in 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
- 发起方
- Santen Oy
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin.
The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Aged 18 years or more
- •A diagnosis of ocular hypertension or open-angle glaucoma and prior use of timolol or prostaglandin.
- •Meet specific IOP level at visit 1 (screening), visit 2 (run-in) and visit 3 (baseline).
- •Meet specific visual acuity score
- •Are willing to follow instructions
- •Have provided a written informed consent
排除标准
- •Females who are pregnant, nursing or planning pregnancy
- •IOP of 35 mmHg or greater
- •Diagnosis of angle-closure glaucoma or secondary glaucoma other than capsular or pigmentary glaucoma in either eye
- •Suspected contraindication or hypersensitivity to study medications tafluprost or timolol (e.g. asthma, low pulse)or to wash-out medication brinzolamide
- •Glaucoma filtration surgery or any other ocular surgery (including ocular laser procedures) within 6 months prior to Screening
- •Use of contact lenses at Screening or during the study
- •Presence of any abnormality or significant illness that could be expected to interfere with the patient safety or study parameters
- •Current participation in another clinical trial within the last 30 days
研究组 & 干预措施
Preservative-free timolol
Active Comparator
干预措施: Timolol/ FDC/ Placebo/ Tafluprost (Drug)
Preservative-free FDC and placebo
Experimental
干预措施: Timolol/ FDC/ Placebo/ Tafluprost (Drug)
Preservative-free tafluprost
Active Comparator
干预措施: Timolol/ FDC/ Placebo/ Tafluprost (Drug)
Preservative-free FDC
Experimental
干预措施: Timolol/ FDC/ Placebo/ Tafluprost (Drug)
结局指标
主要结局
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
时间窗: At 3 months
次要结局
- Change from baseline in average diurnal IOP(At 2 and 6 weeks and 6 months)
- Change from baseline in timewise IOPs(At 2 weeks, 6 weeks, 3 months and 6 months)
研究者
研究点 (2)
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