NCT00230763已完成3 期
Determination Of Predictive Factors Allowing To An Additional 10% Reduction Of Intra-Ocular Pressure After A 12-Week Treatment With Latanoprost 0.005% / Timolol 0.5% Fixed Combination (Xalacom) In Previously Treated Patients With Open Angle 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 396 人开始时间: 2005年9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
- 396
- 试验地点
- 1
- 主要终点
- A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
研究概览
简要总结
To determine the predictive factors of a positive response to latanoprost 0.005% / timolol 0.5% fixed combination (defined as a 10% IOP reduction from baseline), after 12 weeks of treatment (age, sex, ethnic origin, patient's medical history, family history of OAG or OHT, concomitant systemic treatment with beta-blockers, etiology, IOP at baseline, corneal thickness, compliance, and adverse events).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients,
- •Aged > than equal to 18 years,
- •Patient presenting with an OHT or OAG with an IOP � 21 mmHg,
- •Patient currently treated with ophthalmic beta-blockers monotherapy and requiring a change of the ophthalmic medication due to insufficient response to treatment,
排除标准
- •Patient currently treated by or having received within the last month any ophthalmic hypotensive agent other than a beta-blocker,
- •Patient presenting any contraindication to latanoprost or timolol,
- •Patient with history of asthma, obstructive broncho-pneumopathy, sinusal bradycardia (pulse rate < 60 bpm), auriculo-ventricular block, cardiac insufficiency, Raynaud disease or any other condition that would preclude the patient from taking the prescribed medication,
- •Patient with known intolerance to benzalkonium chloride or any excipient contained in the trial treatment,
研究组 & 干预措施
Active
Experimental
干预措施: LATANOPROST 0.005% / TIMOLOL 0.5% FIXED COMBINATION (Drug)
Procedure
Other
干预措施: GSS questionnaire (Procedure)
Procedure
Other
干预措施: IOP (Procedure)
Procedure
Other
干预措施: Visual acuity (Procedure)
结局指标
主要结局
A positive response defined as an additional IOP reduction over 10% after 12 weeks of treatment in the intent to treat (ITT) population.
时间窗: after 12 weeks of treatment
次要结局
- Percentage of patients achieving a target IOP value: under 18 mmHg and under 16 mmHg after 12 weeks of treatment,(week 12)
- Absolute and relative IOP change after 4 and 12 weeks of treatment(week 4 and 12)
研究者
研究点 (1)
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