Objective To determine the efficacy of Dorzolamide, a topmical carbonic anhydrase inhibitor (CAI), in preventing patients affected by ocular hypertension from developing glaucoma. To validate a surrogate, end-point (for visual function) such as intra-ocular pressure (IOP) reduction to be used in clinical trials about glaucoma. Ocular hypertension has been recognized as the most important risk factor for the development of primary open-angle glaucoma (POAG). A number of drugshave been proved to be effective in lowering the intra-ocular pressure (IOP). Among those, traditional categories include beta-blockers, parasympathetic agonists, systemic CAI and sympathetic agonists. New categories effective in reducing IOP, and probably devoid of undesirable side effects, include topic CAI such as Dorzolamide. Although these new drugs are capable of reducing the IOP, as of today, a study demonstrating their efficacy in reducing the incidence of glaucoma does not exist. A randomized controlled clinical trial would allow to assess the efficacy in preventing patients affected by ocular hypertension from developing glaucoma. Our project needs the collaboration of more centres in order to enrol the adequate number of patients according to statistical requirements. The project is based on the analysis of visual function impairment in patients affected by ocular hypertension followed up to three years. Half of the sample will be treated with topic Dorzolamide and half with placebo. The occurrence of visual field defects and optic disc changes during the three years of the study will be the primary endpoints. Several inclusion and exclusion criteria will identify only patients with a primary increase of ocular pressure, normal visual function and without ocular or systemic major diseases.The patients will undergo visual field and optic disc analysis every six months as well as complete ophthalmological examination.A central co-ordinating centre will provide for randomization, lecture of visual fields and analysis of optic disc photographs. At the end of the study and periodically during the study itself,. statistical analysis will be performed by means of survival tables analysis. Fields of science medical and health sciencesclinical medicineophthalmologyglaucoma Programme(s) FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998 Topic(s) 1.3 - Clinical trials Call for proposal Data not available Funding Scheme CSC - Cost-sharing contracts Coordinator Università degli Studi di Milano EU contribution No data Address Via di Rudini 20142 Milano Italy See on map Total cost No data Participants (3) Sort alphabetically Sort by EU Contribution Expand all Collapse all Johannes Gutenberg Universität Mainz Germany EU contribution No data Address 1,Langenbeckstrasse 55131 Mainz See on map Total cost No data Universidade de Coimbra Portugal EU contribution No data Address Azinhaga de Santa Comba - Celas 3000 Coimbra See on map Total cost No data Universitaire Instelling Antwerpen - Universiteit Antwerpen Belgium EU contribution No data Address Universiteitsplein 2610 Wilrijk See on map Total cost No data
