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W. C. Stewart, C. S. Crean, R. C. Zink, R. Haque, D. G. Hwang; Pharmacokinetics of Azithromycin and Moxifloxacin in Human Conjunctiva and Aqueous Humor During and After the Approved Dosing Regimens. Invest. Ophthalmol. Vis. Sci. 2009;50(13):2670.
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To evaluate the pharmacokinetics (PK) of azithromycin and moxifloxacin in human conjunctiva and aqueous humor throughout and following the labeled dosing regimens of azithromycin 1% ophthalmic solution (AzaSite®) and moxifloxacin HCl 0.5% ophthalmic solution (Vigamox®).
This study was a multi-center, randomized, open-label clinical trial in subjects undergoing routine cataract surgery. Conjunctival biopsy and aqueous humor samples were obtained from subjects immediately prior to cataract surgery at one of ten time points ranging from 1 to 14 days (1-312 hours) during or following an approved dosing regimen of either azithromycin 1% ophthalmic solution (twice daily on days 1 and 2; once daily on days 3-7) or moxifloxacin 0.5% ophthalmic solution (three times daily on days 1-7). Drug concentrations were determined using liquid chromatography-mass spectrometry (LC/MS/MS).
The mean concentration of azithromycin in the conjunctiva was 40.4 µg/g after the first dose and was 269.46 µg/g one hour after the final dose on Day 7. By contrast, the mean concentration of moxifloxacin in the conjunctiva was 5.7 µg/g one hour after the first dose and 5.4 µg/g one hour after the final dose on Day 7. Mean azithromycin concentration in the aqueous humor was 0.022 µg/g one hour after the first dose and 0.052 µg/g one hour after the last dose. Mean concentrations of moxifloxacin in the aqueous humor were 0.58 µg/g one hour after the first dose, and 0.67 µg/g one hour after the final dose.
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