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Kamran Hosseini, Judith Hutcheson, Lyle Bowman; Aqueous humor concentration of Bromfenac 0.09% (Bromday) compared with Bromfenac in DuraSite 0.075% (Bromsite) in cataract patients undergoing phacoemulsification after 3 days dosing. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5061.
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To compare the aqueous humor penetration of two different formulations of Bromfenac, namely commercial Bromday (0.09%) with Bromfenac in Durasite (0.075%).
A multi center, double-masked study randomized 60 patients requiring cataract extraction. Patients were to receive one of two treatment arms. Once a day dosing of Bromday and Bromfenac in Durasite was instructed for 2 day prior to surgery. Patients were instructed to instill the last (third) dose in the morning of surgery. After completion of the paracentesis site, aqueous humor was collected through the peripheral clear cornea with a 30-gauge needle. Following collection, aqueous samples were frozen and stored prior to analysis. Drug concentrations were analyzed by a validated liquid chromatography tandem mass spectrometry method from extracted tissue samples using an internal standard. The comparison of means between groups was performed using an F-test.
The average aqueous humor concentration of Bromfenac in Durasite 0.075% was 2 times the concentration of Bromday 0.09%. Bromfenac in Durasite achieved a mean peak aqueous humor concentration of 49.33 compared with 23.64 ng/ml for Bromday.
Bromfenac in Durasite 0.075% achieved significantly greater aqueous humor concentrations when compared to Bromfenac 0.09% in patients undergoing phacoemulsification.
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