NCT01306461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 of Tafluprost and Timolol Eye Drops Given Concomitantly 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
- 401
- 主要终点
- Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 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-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol.
This study will enroll patients who have ocular hypertension or glaucoma.
The study schedule includes seven visits to the study site and three stages:
- washout of 5 days to 4 weeks depending on current glaucoma medication (if any)
- 6-month study treatment period
- 1-3 weeks post-study period
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
- •Meet specific IOP level at visit 1 (screening)and visit 2 (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 greater than 36 mmHg at any time point at screening or baseline
- •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
Timolol and Tafluprost
Active Comparator
Concomitant administration of preservative-free timolol and tafluprost eye drops
干预措施: Timolol and Tafluprost (Drug)
Fixed Dose Combination of tafluprost and timolol
Experimental
Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops
干预措施: Fixed Dose Combination of tafluprost and timolol (Drug)
结局指标
主要结局
Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months
时间窗: 6 months
次要结局
- Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months(2 weeks, 6 weeks and 3 months)
- Change from baseline in timewise IOPs(2 weeks, 6 weeks, 3 months and 6 months)
研究者
相似试验
已完成
3 期
Tafluprost-Timolol Preservative-free Fixed Dose Combination (FDC) Superiority Study Against MonotherapiesOpen-angle GlaucomaOcular HypertensionNCT01292460Santen Oy600
已完成
3 期
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil AloneEssential HypertensionNCT01456169Takeda507
已完成
3 期
A HIV Study Of A Fixed-Dose Combination Tablet In Antiretroviral Experienced PatientsInfection, Human Immunodeficiency Virus IHIV InfectionNCT00046176ViiV Healthcare240
已完成
3 期
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic MyopiaVisual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM)NCT01922102Novartis Pharmaceuticals457
已完成
3 期
Pyronaridine Artesunate 3:1 Granule Formulation vs. Coartem© Crushed Tablets in P. Falciparum Malaria Pediatric PatientsMalariaNCT00541385Medicines for Malaria Venture535