A Six-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Hypotensive Efficacy and Safety of 2%Dorzolamide vs Placebo Ophthalmic Solution

ABSTRACT

Two percent dorzolamide, a topical carbonic anhydrase inhibitor (CAI), was developed to reduce the side effects associated with systemic CAI such as fatigue, anorexia, dysesthesia, etc. and to effectively reduce the elevat-ed intraocular pressure(IOP). This study was designed to evaluate the effectiveness and safety of 2%dorzolamide in Korean patients with primary open-angle glaucoma or ocular hypertension. In this randomized, double-blind, placebo-controlled clinical study, 2%dorzolamide or placebo was given three times a day to the patients with primary open-angle glaucoma or ocular hypertension (22mmHg < or =IOP < or =30mmHg)to evaluate the hypotensive effect and safety of dorzolamide during the period of 6 weeks. After 1,3, and 6 weeks treatment, the mean percent decrease of IOP from baseline in the dorzolamide group (16.3 +/-8.9%,17.9 +/- 9.8%,and 18.2 +/-8 .7 %, respectively) was significantly larger (p<0.01)than that in the placebo group (7.5 +/- 6.8%, 8.5 +/-9.5%, 10.4 +/-10.4%, respectively). The decrease of IOP was also significant in each group(p<0.01)compared to the pre-treatment IOP. During the period of treatment, burning sensation was more frequent in the dorzolamide group (p<0.05). In conclusion,this study has shown that the topical application of 2% dorzolamide effectively reduces IOP without serious adverse effects in Korean patients with primary open-angle glaucoma or ocular hypertension.