Purpose:
To assess the impact of different dosing regimens for topical treatment of patients with acute bacterial conjunctivitis, the microbiological efficacy of besifloxacin ophthalmic suspension, 0.6% dosed 2 times daily (BID) for 3 days was compared to dosing 3 times daily (TID) for 5 days.
Methods:
Results from three randomized, multi-center (U.S. only) double-masked, vehicle-controlled, parallel-group studies of patients ranging from 1 to 99 years old with culture-confirmed bacterial conjunctivitis were used to compare a 3 day BID regimen and a 5 day TID regimen. The TID dosing was administered at approximately 6 hour intervals while the BID dosing was administered at approximately 12 hour intervals. Assessments included quantitative bacteriology and antimicrobial susceptibility testing of all bacterial pathogens recovered at or above threshold from conjunctival swabs of qualified study eyes at each of 3 patient visits, including baseline (Visit 1), Visit 2 (End of Treatment), and Visit 3 (Test of Cure, at least 48 hours after last dose).
Results:
Microbiological eradication rates for culture-confirmed bacterial conjunctivitis infections (all bacterial species) for patients treated with besifloxacin or besifloxacin vehicle are summarized in the table below.
Conclusions:
Microbiological eradication rates of 85.7% at Visit 2 (day 4 or 5) and 90.1% at Visit 3 (day 7 +/- 1) following 3 days of BID dosing with besifloxacin ophthalmic suspension, 0.6% were similar to rates observed in two previous vehicle- controlled studies with 5 days of TID dosing.
Clinical Trial:
http://www.clinicaltrials.gov NCT00972777
Keywords: microbial pathogenesis: clinical studies • bacterial disease • antibiotics/antifungals/antiparasitics