NCT00856622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.
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 436 人开始时间: 1997年8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
- 436
- 试验地点
- 1
- 主要终点
- To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
研究概览
简要总结
The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
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 (two 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.
- •Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
- •Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
- •Pregnancy
- •Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
- •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: i. Fixed combination of latanoprost 0.005% and timolol 0.5% (Drug)
timolol 0.5% ophthalmic solution
Active Comparator
one drop in the morning and evening
干预措施: timolol 0.5% ophthalmic solution (Drug)
latanoprost 0.005% ophthalmic solution
Active Comparator
placebo in the morning and latanoprost .005% in the evening
干预措施: latanoprost 0.005% ophthalmic solution (Drug)
结局指标
主要结局
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 compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups(6 Months)
- To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26(6 Months)
- 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 compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26(6 Months)
- To describe the IOP development from baseline to Week 26 for all 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 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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