Abstract
Purpose::
To compare the aqueous penetration of ketorolac tromethamine 0.4% (Acular LS) and bromfenac 0.09% (Xibrom) at peak and trough time points in patients scheduled for phacoemulsification.
Methods::
Sixty two phacoemulsification patients were randomized to receive ketorolac 0.4% (n=30) or bromfenac 0.09% (n=32). On label dosing of ketorolac 0.4% QID and bromfenac 0.09% BID was given 3 days prior to surgery. On the day of surgery each patient received 4 additional doses 90 minutes prior to surgery. Thirty two additional patients were randomized and analyzed (ketorolac 0.4%, n=16/bromfenac 0.09%, n=16) for on label trough drug levels. Aqueous samples were collected on label 12 hours after a single dose of bromfenac and 6 hours after a single dose of ketorolac. Trough patients received no pulse dosing prior to surgery. Following collection of 0.15cc of aqueous trough with a 30 gage needle through peripheral clear cornea, samples were stored at T-60°C prior to analysis. Drug concentrations were analyzed by liquid chromatography tandem mass spectrometry using positive turbo-ionspray ionization and multiple reaction monitoring mode for quantification.
Results::
Aqueous concentrations were significantly higher for ketorolac than bromfenac at both the peak and trough drug effect. At peak, mean concentrations were 772.5 ± 537.0 ng/mL for ketorolac and 39.5 ± 32.4 ng/mL for bromfenac (P<.001). At trough, mean concentrations were 130.5 ± 159.4 ng/mL for ketorolac and 6.2 ± 3.1 ng/mL for bromfenac (P=.004).
Conclusions::
In cataract patients just prior to phacoemulsification, ketorolac achieved significantly greater concentrations in the aqueous than did bromfenac at both peak and trough.
Clinical Trial::
www.clinicaltrials.gov NCT00347503
Keywords: inflammation • cataract • anterior chamber