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L. M. Amico, F. A. Bucci, Jr., R. Evans, D. Waterbury; Aqueous Penetration of Ketorolac Tromethamine 0.45%, Bromfenac 0.09%, and Nepafenac 0.1% in Patients Undergoing Phacoemulsification. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2456.
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To compare the peak aqueous penetration of ketorolac tromethamine 0.45% (Acuvail), bromfenac 0.09% (Xibrom), nepafenac 0.1% (Nevanac), and amfenac (the active metabolite of nepafenac) in patients undergoing phacoemulsification.
A single center, double-masked study randomized 122 patients to receive one of three treatment arms. On label dosing of ketorolac BID, bromfenac BID, and nepafenac TID was given 1 day prior to surgery. Each patient was instructed to instill one drop the morning of surgery. The patients received 4 additional doses 1 hour prior to phacoemulsification. After completion of the paracentesis site with a super blade, aqueous humor (0.15cc) was collected through the peripheral clear cornea with a 30 gauge needle attached to a TB syringe. Following collection, aqueous samples were stored at -60° C prior to analysis. Drug concentrations were analyzed by liquid chromatography tandem mass spectrometry using positive turbo-ion spray ionization and multiple reaction monitoring mode for quantification. An independent samples Student’s t test was used to detect between group differences.
The peak aqueous concentration of ketorolac 0.45% was approximately 10X the concentration of bromfenac 0.09%, 5X the concentration of the metabolically active amfenac, and 54% greater than the metabolically inactive nepafenac 0.1%. The peak aqueous concentration of ketorolac 0.45% was 688.87 +/-749.6 ng/ml. Bromfenac achieved a peak aqueous concentration of 67.64 +/-62.4 ng/ml. The peak aqueous concentrations of nepafenac and amfenac were 447.10 +/-225.7 ng/ml and140.37 +/-56.6 ng/ml respectively. The peak concentration of ketorolac was statistically significantly greater than bromfenac (p=0<0.0005), nepafenac (p=<0.05), and amfenac (p=<0.005).
Ketorolac 0.45% (Acuvail) has a lower pH(6.8), a higher concentration than previous ketorolac compounds, and contains carboxymethylcellulose with no preservatives. This new ketorolac compound achieved dramatically greater aqueous concentrations when compared to bromfenac 0.07% and the active metabolite of nepafenac 0.1% (amfenac) in patients undergoing phacoemulsification.
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