title: The safety of besifloxacin ophthalmic suspension 0.6 % used three times daily for 7 days in the treatment of bacterial conjunctivitis.
abstract: BACKGROUND
  Besifloxacin ophthalmic suspension 0.6 % (Besivance(®); Bausch & Lomb, Rochester, NY, USA) was approved by the FDA in 2009 for the treatment of bacterial conjunctivitis, with a recommended 7-day dosing regimen.
  
  
  OBJECTIVE
  The objective of this study was to compare the safety of besifloxacin ophthalmic suspension 0.6 %, administered three times a day for 7 days, with that of its vehicle.
  
  
  METHODS
  This randomized, multicenter, double-masked, vehicle-controlled, parallel-group study involved 518 patients ≥1 year of age with a clinical diagnosis of bacterial conjunctivitis. Patients were randomized 2:1 to treatment with besifloxacin 0.6 % ophthalmic suspension or vehicle, one drop in the infected eye(s) TID for 7 days. Main outcomes included the incidence and types of adverse events reported by the subject or observed by the investigator at each study visit.
  
  
  RESULTS
  Thirty-one ocular treatment-emergent adverse events (TEAEs) were reported by 28 subjects in the study eye; 19 occurred in 17/344 (4.9 %) besifloxacin patients, and 12 occurred in 11/170 (6.5 %) vehicle patients (p = 0.5362). Only two ocular events (mild instillation site reaction, one case in each group) were considered "definitely related" to study treatment. One event of self-limited dysgeusia in the besifloxacin group was considered definitely related to treatment; there were no other nonocular TEAEs considered related to treatment. There were no serious adverse events, and other safety outcomes (visual acuity, biomicroscopy, ophthalmoscopy) were unremarkable.
  
  
  CONCLUSIONS
  These findings indicate that besifloxacin ophthalmic suspension 0.6 % is safe in patients aged 1 year and older when used TID for 7 days.
authors.affiliation: Ophthalmology Associates, Cornea and Laser Vision Institute, 12990 Manchester Road, Suite 200, St. Louis, MO, 63131, USA, ranjan.malhotra@youreyedoc.com.
authors.forename: Ranjan
authors.initials: R
authors.lastname: Malhotra
authors.forename: Stacey
authors.initials: S
authors.lastname: Ackerman
authors.forename: Lynne S
authors.initials: LS
authors.lastname: Gearinger
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Morris
authors.forename: Catherine
authors.initials: C
authors.lastname: Allaire
mesh_terms: D060433:Administration, Ophthalmic; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001381:Azepines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D013535:Suspensions; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D001381:Azepines; D024841:Fluoroquinolones; D013535:Suspensions; C522124:besifloxacin