NCT00800267已完成3 期
A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 418 人开始时间: 1997年7月最近更新:
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
- 入组人数
- 418
- 试验地点
- 1
- 主要终点
- The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
研究概览
简要总结
Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
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
- 18 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, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- •Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).
排除标准
- •History of acute angle closure or closed/barely open anterior chamber angle.
- •Current use of contact lenses.
- •Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
- •Ocular inflammation/infection occurring within three months prior to pre-study visit.
- •Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
- •Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
- •Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
- •Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- •Inability to adhere to treatment/visit plan.
- •Have participated in any other clinical study within one month prior to pre-study visit.
研究组 & 干预措施
Fixed combination of latanoprost 0.005% and timolol 0.5%
Experimental
干预措施: fixed combination latanoprost-timolol (Drug)
latanoprost 0.005%
Active Comparator
干预措施: latanoprost 0.005% (Drug)
Timolol - 0.5%
Active Comparator
干预措施: timolol 0.5% (Drug)
结局指标
主要结局
The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
时间窗: 6 months
Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
时间窗: 6 months
次要结局
- To follow the safety variables throughout the study periods.(6 months)
- To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26(6 months)
- To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups(6 months)
- To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination(6 months)
- To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol(6 months)
- To describe the IOP development from baseline to Week 26 for all treatment groups(6 months)
- To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52(6 months)
研究者
研究点 (1)
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Crossover comparative study of latanoprost/timolol fixed combination with combined therapy comprised of latanoprost and timololglaucoma, ocular hypertensionJPRN-UMIN000005426Department of Ophthalmology, Gifu University Graduate School of Medicine40