A double-masked randomized cross-over study comparing the effect of Xalacom (latanoprost/timolol) and Combigan (brimonidine/timolol) fixed combination on intraocular pressure and ocular blood flow in patients with primary open angle glaucoma or ocular hypertension

Department of Clinical Pharmacology0 个研究点开始时间: 2005年10月20日最近更新: 2013年6月3日

研究概览

暂无简介。

•Men and women >= 18 years
•Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP >= 22 -35mmHg
•At least 3 reliable visual field testings
•Washout period: 4 weeks for ß adrenergic receptor antagonists and prostaglandin analogues, 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•History of acute angle closure
•Closed or barely open anterior chamber angle
•Standard deviation of visual field testing > 10
•Intraocular surgery or argon laser trabeculoplasty within the last six months
•Ocular inflammation or infection within the last three months
•Contact lenses
•Patients with bradycardia (heart rate < 50 beats/min)
•Second and third degree heart block
•Congestive heart failure
•Severe renal impairment (creatinine clearance < 1.8 L/h)
•History of hypersensitivity to one of the study drugs or drugs with similar chemical structure
•Topical or systemical/oral therapy with steroids
•History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues

发起方

Department of Clinical Pharmacology