NCT02154217已完成3 期
Comparison of the Effects of Bimatoprost and a Fixed Combination of Latanoprost and Timolol on 24-hour Blood and Ocular Perfusion Pressures
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Difference in mean diastolic and systolic perfusion pressures
研究概览
简要总结
This is a data revision with a focus on 24 hour perfusion pressures of data from a previous randomized, double masked, multicenter clinical trial.
The aim was to compare the effect of bimatoprost and the fixed combination of latanoprost and timolol (LTFC) on 24-hour mean intraocular pressure (IOP) after patients are switched from a nonfixed combination of latanoprost and timolol.
The main findings of the original trial had been published on Ophthalmology [2007;114: 2244-2251].
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients diagnosed as having POAG (primary open-angle glaucoma) or ocular hypertension and 18 years or older who fulfilled the eligibility requirements detailed below and signed an informed consent at the screening visit were included.
- •Two different groups of patients were potentially eligible:
- •Those patients who were controlled (IOP< 21 mmHg) on the nonfixed combination of latanoprost and timolol (twice daily or once daily morning administration) for at least 3 months prior to the baseline visit.
- •Patients on monotherapy either with latanoprost or timolol who were eligible for dual therapy being not satisfactorily controlled (IOP < 21 mmHg, or, as judged by the physician, target IOP was not reached).
- •Pseudoexfoliation glaucomas and patients with diabetes were not excluded.
排除标准
- •All patients in whom beta-blockers were contraindicated were excluded. Ocular Condition.
- •Closed/barely open anterior chamber angles (ACAs) or history of acute angle closure. The ACA was viewed by means of the Goldmann 1-mirror lens. Shaffer grading was used, and grades II, III, and IV were included. Grades 0 and I were excluded.
- •Ocular surgery or argon laser trabeculoplasty within the last 3 months.
- •Ocular inflammation/infection occurring within 3 months before the pretrial visit.
- •Neovascular glaucomas.
- •Hypersensitivity to benzalkonium chloride or to any other component of the trial drug solutions.
- •Other abnormal ocular condition or symptom preventing the patient from entering the trial, according to the investigator's judgement.
- •Patients on either bimatoprost or the LTFC.
- •Patients who had undergone refractive surgery. General
- •Inability to adhere to treatment/visit plan.
- •Participation in any other clinical trial (i.e., requiring in- formed consent) within 1 month before the prestudy visit.
- •Pregnancy, nursing, or, if applicable, nonuse of adequate contraception.
- •Any drug known to affect IOP.
研究组 & 干预措施
Bimatoprost
Experimental
once daily
干预措施: Bimatoprost (Drug)
Latanoprost/Timolol
Experimental
once daily
干预措施: Latanoprost/Timolol (Drug)
结局指标
主要结局
Difference in mean diastolic and systolic perfusion pressures
时间窗: Baseline - Week 2 - Week 6 - Week 12
The Primary outcome was the difference in mean diastolic and systolic perfusion pressures after bimatoprost and the LTFC
次要结局
未报告次要终点
研究者
研究点 (8)
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