Abstract
Abstract: :
Purpose:to test the efficacy of 0.03% bimatoprost QD in patients affected by ocular hypertension or primary open angle glaucoma and showing no response to 0.005% latanoprost QD Methods:prospective, randomised clinical trial with a cross-over design (two 30-day treatment phases with a 30-day washout phase in between). Random allocation to treatment to one eye only of every patient . n = 15 patients enrolled (5 Primary open angle glaucomas and 10 ocular hypertensives). Eligibility criteria: (a) IOP ≷ 22 mmHg in both eyes on current treatment (on three separate readings ≷ 24 hrs apart ) (b) angle wide open in both eyes (c) no pseudoexfoliation and/or pigment dispersion in both eyes (d) documented medical history consistent with < 10% IOP decrease in both eyes upon a 2 month-treatment with latanoprost 0.005% QD. The following variables were measured at each study visit: (a) IOP (Goldmann applanation tonometry, 5 readings, 8am, 12noon, 4pm, 8pm and 12midnight); (b) visual acuity (ETDRS chart, LogMAR); (c) estimate of conjunctival hyperemia based on 5 standard photographs, (graded as «none», «trace», «mild», «moderate» and «severe»). Main outcome: intra ocular pressure Results:IOP data (mean and standards deviation) were the following: baseline ( after washout) = 24.7 + 0.9 mmHg, after 30 days with latanoprost = 24.1+ 0.9 mmHg, after 30 days with bimatoprost = 18.1+ 1.7 mmHg. IOP upon bimatoprost proved lower than both baseline (p 20% IOP decrease with bimatoprost treatment. None of the 15 patients showed a ≷ 20% decrease of IOP after 30 days of latanoprost treatment. No significant IOP changes were observed in the fellow untreated eye in each patient through the study. Trace-to-mild conjunctival hyperemia was recorded more often with bimatoprost phase ( p = 0.035). Conclusion:patients non-responders to latanoprost 0.005% QD could be successfully treated with bimatoprost 0.03% QD. Bimatoprost treatment was associated with a higher incidence of trace-to-mild conjunctival hyperemia than latanoprost
Keywords: 514 pharmacology • 357 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials