Besifloxacin Ophthalmic Suspension 0.6% Administered Twice Daily for 3 Days in the Treatment of Bacterial Conjunctivitis in Adults and Children

Abstract

Registered at ClinicalTrials.gov as NCT00972777.

Clinical outcomes with besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis due to potentially consequential pathogens

“…56 In each of these studies, clinical efficacy was demonstrated for patients with culture-confirmed bacterial conjunctivitis when pooling infections by all causative pathogens (Table 1) and also in the following subsets: infections due to Gram-positive pathogens; infections due to Gram-negative infections; and infections due to H. influenzae, S. pneumoniae, S. aureus, or S. epidermidis, the most prevalent bacterial pathogens in these studies. Based on data from thrice-daily studies, besifloxacin ophthalmic suspension 0.6% was initially approved in 2009 for treatment of bacterial conjunctivitis due to these species as well as some less frequent causative species encountered in these studies, including CDC coryneform group G, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Moraxella lacunata, Staphylococcus hominis, Staphylococcus lugdunensis, Streptococcus mitis group, Streptococcus oralis, and Streptococcus salivarius.…”

“…Individual study results have been published previously. [53][54][55][56] The active comparator study 55 and two of the vehicle-controlled studies 53,54 employed a 5-day thrice-daily treatment regimen, while the third vehicle-controlled study 56 employed a 3-day twice-daily treatment regimen (Table 1).…”

“…[53][54][55][56] Briefly, eligible patients were aged $1 year with a diagnosis of bacterial conjunctivitis, as evidenced by a severity for both purulent ocular discharge and bulbar conjunctival injection of grade 1 or higher on a 4-point scale (0= absent, 1= mild, 2= moderate, and 3= severe) in at least one eye, and had a pinhole visual acuity (VA) of 20/200 or better in both eyes. The severity of bulbar conjunctival injection was determined using photographic standards (Ora Calibra TM Bacterial Conjunctivitis Bulbar Conjunctiva Redness Scale; Ora Inc., North Andover, MA, USA) employed in previous conjunctivitis research.…”

“…Patients were instructed to administer one drop of study medication in the affected eye(s) three times daily at approximately 6-hour intervals for 5 days, [53][54][55] or twice daily at approximately 8-hour intervals during waking hours for a total of 3 days. 56 Patients returned to the study site at or near the end of treatment (visit 2, day 5 [±1] 53,55 or day 4 or 5 54,56 ) and after treatment ended on days 7 through 9 (visit 3, day 8 or 9 [53][54][55] ) for clinical assessment of ocular signs and symptoms, VA testing, biomicroscopy, ophthalmoscopy (visit 3 only), and culture of infected eye(s). Ocular and non-ocular adverse events (AEs) were recorded at each visit.…”

“…69,70 The objective of this post hoc analysis was to assess the clinical efficacy of besifloxacin ophthalmic suspension 0.6% when used in the treatment of patients with conjunctivitis caused by the aforementioned group of potentially consequential bacterial pathogens across four clinical studies. [53][54][55][56] Case summaries for individual patients with P. aeruginosa conjunctival infections have been published previously, 48 and pooled outcomes for these patients repeated here. As expected, the number of infections due to P. aeruginosa, S. marcescens, and Neisseria spp.…”