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Efficacy of hypotensive therapy with the topical carbonic anhydrase inhibitor dorzolamide for the prevention of glaucoma in ocular hypertensive patients

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.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Università degli Studi di Milano
Address
Via Di Rudini
20142 Milano
Italy

Participants (3)

Johannes Gutenberg Universität Mainz
Germany
Address
1,Langenbeckstrasse
55131 Mainz
Universidade de Coimbra
Portugal
Address
Azinhaga De Santa Comba - Celas
3000 Coimbra
Universitaire Instelling Antwerpen - Universiteit Antwerpen
Belgium
Address
Universiteitsplein
2610 Wilrijk