NCT01230736已完成4 期
Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 主要终点
- Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
研究概览
简要总结
The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- •Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
- •Must be willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- •Women who are pregnant or lactating.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- •Corneal dystrophies in either eye.
- •Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- •Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- •History of severe allergic rhinitis.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DuoTrav
Experimental
One drop in study eye(s) once daily for 8 weeks
干预措施: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®) (Drug)
结局指标
主要结局
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)
时间窗: 8 weeks
Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.
次要结局
- Percentage of subjects who reach target IOP (≤18 mmHg)(8 weeks)
研究者
相似试验
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Efficacy of Changing to DUOTRAV® From Prior TherapyPigment Dispersion GlaucomaOcular HypertensionOpen-Angle GlaucomaNCT01327599Alcon Research60
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Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior TherapyGlaucomaNCT01514721Alcon Research37
撤回
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Assessing the Efficacy of DuoTrav as a Replacement Therapy in Glaucoma Patients in RussiaGlaucomaOcular HypertensionNCT01696383Alcon Research
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