A Six-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Hypotensive Efficacy and Safety of 2%Dorzolamide vs Placebo Ophthalmic Solution.
- Author:
Dong Myung KIM
1
;
Byung Heon AHN
;
Ki Ho PARK
;
Changwon KEE
Author Information
1. Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article ; Controlled Clinical Trial
- Keywords:
Carbonic anhydrase inhibitor;
Dorzolamide;
Intraocular pressure;
Ocular hypertension;
Primary open-angle glaucoma
- MeSH:
Anorexia;
Burns;
Carbonic Anhydrases;
Fatigue;
Glaucoma, Open-Angle;
Humans;
Intraocular Pressure;
Ocular Hypertension;
Paresthesia;
Sensation
- From:Journal of the Korean Ophthalmological Society
1999;40(9):2575-2582
- CountryRepublic of Korea
- Language:Korean
-
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.
