Abstract
Purpose: :
To determine the aqueous humor concentrations of commercially available moxifloxacin 0.5% ophthalmic solution and besifloxacin 0.6% ophthalmic suspension following routine preoperative topical dosing in patients undergoing cataract surgery.
Methods: :
A prospective, randomized, parallel, double-masked clinical trial was performed. Subjects were given one drop of moxifloxacin 0.5% ophthalmic solution (n = 23) or besifloxacin 0.6% ophthalmic suspension (n = 25) which was administered every 10 minutes for a total of 4 doses beginning 1 hour prior to routine cataract surgery. Aqueous humor was sampled via paracentesis and antibiotic concentrations were determined using validated high performance liquid chromatography (HPLC) procedures.
Results: :
The aqueous concentration of antibiotic was detectable in 100% (23/23) of the subjects who received moxifloxacin compared to 40% (10/25) of the subjects who received besifloxacin (p < 0.0001, Pearson’ chi-square test). The mean aqueous drug concentration for moxifloxacin (1.6108µg/ml) was 50-fold higher (p < 0.0001, Wilcoxon test) than for besifloxacin (0.0319µg/ml). When comparing the subset of aqueous samples with detectable levels of antibiotic, the mean moxifloxacin concentration (1.6108µg/ml) was 38-fold higher (p < 0.0001) than that of besifloxacin (0.0422µg/ml).
Conclusions: :
After preoperative topical administration, moxifloxacin 0.5% ophthalmic solution achieved a 50-fold higher concentration in aqueous humor compared with besifloxacin 0.6% ophthalmic suspension. Besifloxacin was undetectable in more than half of the aqueous humor samples.
Clinical Trial: :
www.clinicaltrials.gov NCT00924729
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • antibiotics/antifungals/antiparasitics