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 hypertensio
- Conditions
- Glaucoma
- Registration Number
- EUCTR2005-004060-24-AT
- Lead Sponsor
- Department of Clinical Pharmacology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Asthma
COPD
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
Pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of a 6 weeks treatment with 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.;Secondary Objective: ;Primary end point(s): Study treatment is stopped after 12 weeks
- Secondary Outcome Measures
Name Time Method