Purpose:
To compare the microbiological eradication rates of two dosing regimens (BID 3-day treatment vs. TID 5-day treatment), as well as to assess consistency of microbiological eradication rates over a seven year time period (2004 - 2010) for patients treated with besifloxacin ophthalmic suspension, 0.6% in bacterial conjunctivitis (BC) clinical trials.
Methods:
Randomized, multi-center (US only) double-masked, vehicle-controlled, parallel-group studies including 784 total patients ranging from 1 to 98 years old with culture-confirmed BC were compared. Two 3-day BID analyses (Part A cohort, 2009-2010 and Part B cohort, 2010) and previous 5-day TID studies (2004 - 2007) were compared. Patients were dosed at ~12 hr intervals in the BID studies and ~6 hr intervals in the TID studies. Assessments included quantitative bacteriology 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), 1st follow-up (Visit 2, at or near end of treatment), and 2nd follow-up (Visit 3, day 7 to 9).
Results:
For patients treated with besifloxacin, microbial eradication rates for BID and TID dosing regimens were >86% for Gram-positive pathogens and ≥80% for Gram-negative pathogens at both follow-up visits.
Conclusions:
Besifloxacin ophthalmic suspension, 0.6% yielded similar microbiological eradication rates in both BID 3-day treatment and TID 5-day treatment studies. Additionally, microbiological eradication rates have remained consistent over a seven year period regardless of dosing regimen.
Keywords: microbial pathogenesis: clinical studies • bacterial disease • antibiotics/antifungals/antiparasitics