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
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Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. The main focus of glaucoma is still directed towards a decrease in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan® (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as their ocular hemodynamic effects.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Double-masked Randomized Cross-over Study Comparing of 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
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men and women over 18 years
Unilateral or bilateral primary open angle glaucoma, ocular hypertension, exfoliation glaucoma, pigmentary glaucoma with IOP between 22 -35mmHg
At least 3 reliable visual field testings
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
History of acute angle closure
Closed or barely open anterior chamber angle
Mean 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
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 systematically/oral therapy with steroids
History of non-IOP responder to beta-blockers, alpha-2 adrenergic or prostaglandin analogues