Efficacy and safety of timolol/pilocarpine combination drops in glaucoma patients.
The aim of this randomized, double-blind study with two parallel groups was to examine the safety, efficacy and tolerability of two combination eye drops containing 0.5% timolol and 2% pilocarpine (Fotil, Leiras, Finland, and Timpilo, MSD, USA) in patients with glaucoma or ocular hypertension. Efficacy was determined based on daytime intraocular pressure curve and safety by examining visual fields, visual acuity, optic discs, by determining blood pressure and pulse rate, and by performing Schirmer and fluorescein tests. A total of 89 patients were enrolled, and 71 completed the 10-week treatment period. This study showed that the two combinations of 0.5% timolol maleate and 2% pilocarpine HCl compared in this study were equally effective in reducing intraocular 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 groups. 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 study groups. However, burning was more common in patients on Fotil, and blurring of vision and light sensitivity were more common in patients on Timpilo. In patients with no contraindication to beta-blockers, these drugs appeared to be safe.(ABSTRACT TRUNCATED AT 250 WORDS)
Uusitalo
R J
RJ
Department of Ophthalmology, Helsinki University Central Hospital, Finland.
Palkama
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005901:Glaucoma / Q000188:drug therapy*; D006439:Hemodynamics; D006801:Humans; D007429:Intraocular Pressure; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy; D009883:Ophthalmic Solutions; D010862:Pilocarpine / Q000009:adverse effects / Q000627:therapeutic use*; D013999:Timolol / Q000009:adverse effects / Q000627:therapeutic use*; D014792:Visual Acuity; D014794:Visual Fields
D009883:Ophthalmic Solutions; D010862:Pilocarpine; D013999:Timolol