title: Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: a retrospective safety surveillance study.
abstract: OBJECTIVE
  The objective of this study was to collect and evaluate retrospective safety information about the use of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial keratitis.
  
  
  METHODS
  This was a retrospective, postmarketing surveillance study conducted at 10 clinical centers in the United States. The study population included 142 patients treated with besifloxacin ophthalmic suspension 0.6% for bacterial keratitis in one or both eyes. For perspective, data on 85 patients treated at these centers with moxifloxacin ophthalmic solution 0.5% for bacterial keratitis were also included. The analysis was designed to measure the types and rates of adverse events (AEs) reported during the treatment of bacterial keratitis with besifloxacin ophthalmic suspension 0.6%. Other treatment outcomes of interest included the development of corneal scarring and corneal neovascularization, measured or presumed bacterial eradication, ending visual acuity, and duration of pain before and after treatment.
  
  
  RESULTS
  There was one reported AE of mild superficial punctate keratitis in a patient using besifloxacin ophthalmic suspension 0.6%. The difference in AE frequencies between groups was not significant (P>0.999). Additional treatment outcomes were similar for both groups. Limitations of this report include the retrospective nature of the study.
  
  
  CONCLUSIONS
  These retrospective data suggest that besifloxacin ophthalmic suspension 0.6% was well tolerated when included in the treatment of bacterial keratitis; no serious AEs were reported. A prospective clinical trial is needed to better isolate the contribution of besifloxacin to the therapeutic outcome and to confirm these observations.
authors.affiliation: 1 Florida Eye Microsurgical Institute , Boynton Beach, Florida.
authors.forename: Barry A
authors.initials: BA
authors.lastname: Schechter
authors.forename: Jai G
authors.initials: JG
authors.lastname: Parekh
authors.forename: William
authors.initials: W
authors.lastname: Trattler
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D001381:Azepines / Q000008:administration & dosage* / Q000009:adverse effects*; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans; D007634:Keratitis / Q000188:drug therapy* / Q000382:microbiology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D001381:Azepines; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; C522124:besifloxacin