BACKGROUND: New effective hypotensive agents have been recently introduced into clinical practice, but often more than one drug has to be used to prevent further visual field loss. The aim of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.03% compared with the association of timolol 0.5% and latanoprost 0.005% in open-angle glaucoma patients. METHODS: In this 6-month, prospective, parallel, randomised, investigator-masked clinical trial, 61 glaucomatous patients treated withtimolol0.5% twice in both eyes were enrolled. The timolol 0.5% was replaced by bimatoprost 0.03% once daily (group I) or by latanoprost 0.005% plus timolol 0.5% (group II). IOP measurements were performed at the baseline visit and at days 15, 30, 60, 90, 120 and 180. Digital colour photography was used to evaluate topical side effects. RESULTS:Fifty-six of the 61 patients were included for the intent-to-treat analysis (28 in group I and 28 in group II). Baseline mean IOP was similar in the two groups (p=0.5). Both treatments lowered the mean IOP at every visit significantly compared with the baseline (p<0.01). Comparing the IOP reductions obtained by the two treatments, no significant differences were found at any time during the study. Conjunctival hyperaemia, skin pigmentation and eyelash growth in group I and headache in group II were the most common side effects observed during the study. CONCLUSIONS: Bimatoprost and the association of latanoprost plus timolol were equally effective in lowering the IOP in glaucomatous patients previously treated withtimolol. Latanoprost plus timolol showed a better ocular safety profile.
RCT Entities:
BACKGROUND: New effective hypotensive agents have been recently introduced into clinical practice, but often more than one drug has to be used to prevent further visual field loss. The aim of this study was to evaluate the intraocular pressure (IOP)-lowering efficacy and safety of bimatoprost 0.03% compared with the association of timolol 0.5% and latanoprost 0.005% in open-angle glaucomapatients. METHODS: In this 6-month, prospective, parallel, randomised, investigator-masked clinical trial, 61 glaucomatouspatients treated with timolol 0.5% twice in both eyes were enrolled. The timolol 0.5% was replaced by bimatoprost 0.03% once daily (group I) or by latanoprost 0.005% plus timolol 0.5% (group II). IOP measurements were performed at the baseline visit and at days 15, 30, 60, 90, 120 and 180. Digital colour photography was used to evaluate topical side effects. RESULTS: Fifty-six of the 61 patients were included for the intent-to-treat analysis (28 in group I and 28 in group II). Baseline mean IOP was similar in the two groups (p=0.5). Both treatments lowered the mean IOP at every visit significantly compared with the baseline (p<0.01). Comparing the IOP reductions obtained by the two treatments, no significant differences were found at any time during the study. Conjunctival hyperaemia, skin pigmentation and eyelash growth in group I and headache in group II were the most common side effects observed during the study. CONCLUSIONS:Bimatoprost and the association of latanoprost plus timolol were equally effective in lowering the IOP in glaucomatouspatients previously treated with timolol. Latanoprost plus timolol showed a better ocular safety profile.
Authors: Eve J Higginbotham; Joel S Schuman; Ivan Goldberg; Ronald L Gross; Amanda M VanDenburgh; Kuankuan Chen; Scott M Whitcup Journal: Arch Ophthalmol Date: 2002-10