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H.R. Katz, S. Lane, S. Masket, K. Sall, S. Orr, R. Faulkner, S.M. Robertson, D.C. Dahlin; Human Aqueous Concentrations of Moxifloxacin and Gatifloxacin Following Two Multiple–Dose Topical Ocular Dosing Regimens With VIGAMOXTM and ZYMARTM . Invest. Ophthalmol. Vis. Sci. 2005;46(13):4907.
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Purpose: To evaluate the ocular absorption of moxifloxacin HCl ophthalmic solution, 0.5% (VIGAMOXTM) and gatifloxacin ophthalmic solution, 0.3% (ZYMARTM) by measuring the concentration of moxifloxacin (Moxi) and gatifloxacin (Gati) in the aqueous humor (AH) of patients undergoing cataract surgery following two different topical ocular dosing regimens. Methods: In an open–label, 2–arm, multiple–dose study, 120 cataract patients received either VIGAMOXTM or ZYMARTM according to one of two dosing regimens: operative eye treated with one drop every 15 minutes x 4 doses on day of surgery (regimen 1), or operative eye treated with one drop 4 times daily on the day prior to surgery, and one drop every 15 minutes x 4 doses on the day of surgery (regimen 2). Patients in both arms were randomized to one of 5 sampling times with the last dose administered 0.25, 0.50, 1, 2 or 3 hours prior to AH sampling. At the time of surgery, approximately 0.15 mL of AH was collected from the anterior chamber using a tuberculin syringe and stored frozen until analysis. AH samples were assayed using a validated HPLC–fluorescence method which simultaneously measured Moxi and Gati. Results: For regimens 1 and 2, Moxi AH Cmax was 3.1– and 2.3–fold higher than Gati, respectively. Moxi AH AUC0–3 was significantly (p<0.05) higher (>2–fold) than Gati for both regimens and exceeded the minimum bactericidal concentration (MBC) and mutant prevention concentration (MPC) for both S. epidermidis and S. aureus over the entire 3–hour sampling period. Conclusions: Findings showed that the ocular penetration of moxifloxacin is at least two–fold greater than for gatifloxacin with either regimen. These concentrations also demonstrate over an extended period of time that moxifloxacin exceeded the MIC, MBC, and MPC of pathogens that typically cause endophthalmitis.
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