To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01\% ophthalmic solutions.This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03\% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01\% (n=30) or bimatoprost 0.03\% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test.Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01\% group from baseline 4.7 ± 3.8 to 2.9 ± 2.3 (P < 0.001) and 2.5 ± 2.0 (P < 0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P = 0.003 and P < 0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01\% group compared with the bimatoprost 0.03\% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01\% group at each follow-up visit (P < 0.05) and in comparison with bimatoprost 0.03\% (P < 0.05).The results of this trial suggest that bimatoprost 0.01\% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03\% eye drops.

Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients.

M. Figus;NARDI, MARCO;P. Piaggi;
2014

Abstract

To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01\% ophthalmic solutions.This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucoma patients (60 eyes) under bimatoprost 0.03\% monotherapy since at least 1 year were enrolled. Selected patients were randomized to receive a single drop of bimatoprost 0.01\% (n=30) or bimatoprost 0.03\% (n=30) ophthalmic solutions for 12 months. Statistical analysis was performed using paired t-test and repeated measures ANOVA test.Global clinical score (the sum of pruritus, stinging/burning, blurred vision, sticky eye sensation, eye dryness sensation, and foreign body sensation) significantly decreased in the bimatoprost 0.01\% group from baseline 4.7 ± 3.8 to 2.9 ± 2.3 (P < 0.001) and 2.5 ± 2.0 (P < 0.001) at 6-month and 12-month follow-ups, respectively. Comparison between groups showed differences at both follow-up visits (P = 0.003 and P < 0.001, respectively). In vivo confocal microscopy revealed a significant increase in goblet cell density in the bimatoprost 0.01\% group compared with the bimatoprost 0.03\% group (P<0.001 at both follow-up visits). All functional parameters and conjunctival hyperemia improved in the bimatoprost 0.01\% group at each follow-up visit (P < 0.05) and in comparison with bimatoprost 0.03\% (P < 0.05).The results of this trial suggest that bimatoprost 0.01\% eye drops seem to decrease the ocular discomfort with respect to bimatoprost 0.03\% eye drops.
Figus, M.; Nardi, Marco; Piaggi, P.; Sartini, M.; Guidi, G.; Martini, L.; Lazzeri, S.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11568/514477
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