NCT00751049已完成3 期
A 6-month, Randomized, Double-masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United Kingdom
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 294 人开始时间: 1992年12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
- 294
- 试验地点
- 1
- 主要终点
- to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
研究概览
简要总结
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
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
- 40 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.
- •Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- •IOP of 22mmHg or higher obtained during the pre-study period.
- •Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
- •3 weeks for B-adrenergic antagonists
- •2 weeks for adrenergic agonists
- •5 days for cholinergics and oral carbonic anhydrase inhibitors.
排除标准
- •History of acute angle closure.
- •Severe trauma at any time.
- •Intraocular surgery or argon laser trabeculoplasty within 6 months.
- •Current use of contact lenses.
- •History of severe dry eye syndrome.
- •Ocular inflammation/infection with three months of inclusion.
- •Any condition preventing reliable applanation tonometry.
- •Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
- •In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
- •Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
- •Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
- •Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- •Having participated in any other clinical study within the last month.
研究组 & 干预措施
PhXA41
Experimental
干预措施: PhXA41 (Drug)
timolol
Active Comparator
干预措施: timolol (Drug)
结局指标
主要结局
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
时间窗: 6 mos
次要结局
- to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.(6 mos)
研究者
研究点 (1)
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