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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00712777 |
Topical brimonidine is a recently introduced alpha 2 receptor agonist which is used in the therapy of intraocular pressure (IOP) reduction in patients with open angle glaucoma. Although adequate IOP reduction is achieved in many patients there is a considerable degree of variability in IOP reduction among subjects. The reason for this interindividual variability is not entirely clear. Obviously differences in pharmacokinetic properties due to variable penetration of the drug through the cornea may be responsible. Alternatively, polymorphisms of the alpha-2 receptor may account for the differences in IOP-lowering efficacy of topical brimonidine. This hypothesis is tested in the present study. Polymorphisms of the alpha-2 receptor have been described in a number of previous studies. In addition, polymorphisms in the alpha-2 receptor gene have been shown to be functionally important, particularly a polymorphism of the alpha-2B receptor, which has a high allele frequency in caucasians.
Condition | Intervention |
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Ocular Physiology Intraocular Pressure |
Drug: Brimonidine 0.2 % |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Relation Between Intraocular Pressure Lowering Effects of Topical Brimonidine and Alpha 2 Receptor Polymorphism |
Estimated Enrollment: | 80 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
homozygote mutant: Insertion/Insertion (40 patients)
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Drug: Brimonidine 0.2 %
Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye
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2: Active Comparator
homozygote mutant: Deletion/Deletion (40 patients)
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Drug: Brimonidine 0.2 %
Brimonidine 0.2 % (Alphagan, Irvine, CA, USA), dose: 1 drop per eye
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Ages Eligible for Study: | 19 Years to 35 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerhard Garhofer, MD | 0043 1 40400 ext 2981 | klin-pharmakologie@meduniwien.ac.at |
Austria | |
Department of Clinical Pharmacology | Recruiting |
Vienna, Austria, 1090 |
Responsible Party: | Department of Clinical Pharmacology ( Gabriele Fuchsjäger-Mayrl, MD ) |
Study ID Numbers: | OPHT-230408 |
Study First Received: | July 8, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00712777 |
Health Authority: | Austria: Agency for Health and Food Safety |
Brimonidine alpha 2 receptor polymorphism Intraocular Pressure |
Brimonidine |
Neurotransmitter Agents Adrenergic alpha-Agonists Molecular Mechanisms of Pharmacological Action Adrenergic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Adrenergic Agonists |