M Figus1, M Nardi1, P Piaggi2, M Sartini1, G Guidi1, L Martini1, S Lazzeri1. 1. Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology, and Critical Area, University of Pisa, Pisa, Italy. 2. Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.
Abstract
PURPOSE: To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions. METHODS: 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. RESULTS: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). CONCLUSION: 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.
RCT Entities:
PURPOSE: To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03 and 0.01% ophthalmic solutions. METHODS: This was a randomized, prospective, parallel-group, open-label, cohort study. A total of 60 glaucomapatients (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. RESULTS: 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). CONCLUSION: 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.
Authors: M De Saint Jean; F Brignole; A F Bringuier; A Bauchet; G Feldmann; C Baudouin Journal: Invest Ophthalmol Vis Sci Date: 1999-03 Impact factor: 4.799
Authors: John S Cohen; Ronald L Gross; Janet K Cheetham; Amanda M VanDenburgh; Paula Bernstein; Scott M Whitcup Journal: Surv Ophthalmol Date: 2004-03 Impact factor: 6.048