0.12% Isopropyl unoprostone與0.5% Timolol於青光眼病患的療效及安全性之比較試驗研究

Abstract

This clinical trial evaluated the intraocular pressure lowering effect of 0.12% isopropyl unoprostone compared with 0.5% timolol in patients with primary open-angle glaucoma or ocular hypertension. Fifty two patients with primary open-angle glaucoma or ocular hypertension were randomly assigned to receive either 0.12% isopropyl unoprostone or 0.5% timolol twice daily for a period of eight weeks. Both drugs showed sustained ocular hypotensive efficacy in the period of study. At each visit, in 76.7%, 76.7% and 73.3% of cases in the isopropyl unoprostone group and 85.7%, 90.9%, and 81.8% in the timolol group respectively, both drugs were rated as ”extremely effective” achieving TOP reduction of 5 mmHg or more. 83.3%, 86.7% and 83.3% of cases in isopropyl unoprostone group and 90.5%, 86.4%, 8 1.8% in the timolol group respectively were considered as ”extremely improved” in overall improvement rate scaled by the mean values of IOP reduction rate in outflow pressure. No statistically significant difference in IOP reduction efficacy between the two groups after 8 week of administration. All of these cases reporting to have adverse effects were graded as ”mild” and did not require any change or discontinuation of treatment in both groups. There were also no systemic side effects noted in both groups. Topically applied twice daily for 8 weeks, 0.12% isopropyl unoprostone has a clinical effectiveness equivalent to 0.5% timolol in patients with primary open-angle glaucoma or ocular hypertension. Isopropyl unoprostone is safe and generally well tolerated in our studied patients.