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Michele Figus, Stefano Lazzeri, Chiara Posarelli, Luca Martini, Marco Nardi; A twelve-months, randomized, prospective, open-label, parallel-group of in vivo confocal microscopic findings in glaucoma patients treated with bimatoprost 0.01% or bimatoprost 0.03%. Invest. Ophthalmol. Vis. Sci. 2013;54(15):780.
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To evaluate the safety of two commercially available formulations of bimatoprost eye drops: 0.03% and 0.01% ophthalmic solutions.
Randomized, prospective, open-label, parallel-group cohort study. A total of 60 glaucoma patients (60 eyes) in monotherapy with bimatoprost 0.03% since at least one year. After a baseline visit, qualified subjects were randomized to receive a single drop of bimatoprost 0.01% (n = 30) or bimatoprost 0.03% (n= 30) ophthalmic solutions once per day for 12 months. Statistical analyses were performed using paired t-test and repeated measures ANOVA. Main outcome measures: primary end point was comparison between groups in laser-scanning microscope parameters (corneal epithelium and endothelium cells, goblet cells and conjunctival epithelium). Secondary endpoint was to evaluate and compare changes in functional parameters (meniscus tear, Schirmer test and BUT).
Goblet cells density showed significant increase in bimatoprost 0.01% group from baseline 351.8 ± 192.3 cells/µm2 to 425.6 ± 178.5 cells/µm2 (P < 0.001; mean difference = 73.8 cells/µm2; 95% CI 42.88 to 104.7) and to 428.5 ± 171 cells/µm2 (P < 0.001; mean difference = 76.7 cells/µm2, 95% CI 47.17 to 106.1) at 6- and 12-months follow-up, respectively. Significant differences were also found between the two groups (p<0.001). Correspondingly, all functional parameters improved in bimatoprost 0.01% group (P < 0.05) with significant differences between groups (meniscus tear P = 0.043, Schirmer test P = 0.010, and break-up time P < 0.001). No differences between groups in lowering IOP (P > 0.05).
Bimatoprost 0.01% demonstrated an increase in conjunctival goblet cells density and functional parameters compared to bimatoprost 0.03% eye drop.
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