EFFICACY AND SAFETY OF TIMOLOL PILOCARPINE COMBINATION DROPS IN GLAUCOMA PATIENTS

The aim of this randomized, double-blind study with two parallel group s cpas to examine the safety efficacy and tolerability of two combinat ion eye drops containing 0.5% timolol and 2% pilocarpine (Fotil(R), Le iras, Finland, and Timpilo(R), MSD, USA) in patients with glaucoma or ocular hypertension. Efficacy was determined based on daytime intraocu lar pressure curve and safety by examining visual fields, visual acuit y, optic discs, by determining blood pressure and pulse rate, and by p erforming Schirmer and fluorescein tests. A total of 89 patients were enrolled, and 71 completed the 10-week treatment period. This study sh owed that the two combinations of 0.5% timolol maleate and 2% pilocarp ine HCl compared in this study were equally effective in reducing intr aocular pressure. The decrease in mean daily intraocular pressure from 0 to 10 weeks was 7.48 mmHg for Fotil, and 6.31 for Timpilo. The mean decrease in mean daily intraocular pressure was 29.3% for Fotil, and 26.0% for Timpilo. No significant differences were found between the g roups. Adverse event were reported by 70 out of 89 patients by the end of 2 weeks, but were severe enough only in 11 for the treatment to be discontinued. In all others, adverse events were of transient nature and considered mild. In general, adverse events were similar in both s tudy groups. However, burning was more common in patients on Fotil, an d blurring of vision and light sensitivity were more common in patient s on Timpilo. In patients with no contraindication to beta-blockers, t hese drugs appeared to be safe. No significant changes were noticed in blood pressure during the follow-up period, while a decrease in pulse frequency was detected in both groups. No significant changes occurre d in visual acuity, visual fields or optic discs in either group.