title: Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.
abstract: OBJECTIVE
  Besifloxacin ophthalmic suspension 0.6% given thrice daily for 5 days is safe and effective in the treatment of patients with bacterial conjunctivitis. This study evaluated the safety and efficacy of besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days compared with vehicle in the treatment of bacterial conjunctivitis.
  
  
  METHODS
  This was a multicenter, double-masked, randomized, vehicle-controlled, parallel-group study.
  
  
  METHODS
  A total of 474 patients aged ≥1 year with bacterial conjunctivitis were randomized in a 1 : 1 ratio to receive either besifloxacin ophthalmic suspension 0.6% or vehicle administered twice daily for 3 days. There were three study visits: day 1 (the baseline visit), day 4/5 (visit 2), and day 7 ± 1 (visit 3). The co-primary efficacy endpoints were bacterial eradication and clinical resolution at day 4/5 in designated study eyes of patients with culture-confirmed bacterial conjunctivitis. Secondary efficacy endpoints were bacterial eradication and clinical resolution at day 7 ± 1, individual clinical outcomes of ocular discharge and bulbar conjunctival injection at all visits; and microbial and clinical outcomes for overall bacterial species and individual Gram-positive and Gram-negative bacterial species at each follow-up visit. Safety endpoints included adverse events (AEs), changes in visual acuity and biomicroscopy findings at each visit, and changes in ophthalmoscopy findings at day 7 ± 1.
  
  
  RESULTS
  Bacterial eradication and clinical resolution rates were significantly higher in the besifloxacin group than in the vehicle group (115/135 [85.2%] vs 77/141 [54.6%], p < 0.001, and 89/135 [65.9%] vs 62/141 [44.0%], p < 0.001, respectively) at day 4/5. Rates of bacterial eradication continued to be significantly greater in the besifloxacin group (115/135 [85.2%] vs 91/141 [64.5%], respectively; p < 0.001) at day 7 ± 1; however, the rates of clinical resolution did not differ significantly between the groups (103/135 [76.3%] and 94/141 [66.7%], p = 0.209) at this visit. Ocular discharge and bulbar conjunctival injection at each visit were consistent with the primary outcomes. Clinical resolution and bacterial eradication with Gram-positive or Gram-negative organisms were consistent with the overall findings. All AEs in both groups were of mild or moderate severity and were considered unrelated to the treatment.
  
  
  CONCLUSIONS
  Treatment with besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days was effective and safe in adults and children with bacterial conjunctivitis.
  
  
  BACKGROUND
  Registered at ClinicalTrials.gov as NCT00972777.
authors.affiliation: Center for Clinical Trials, LLC, Paramount, CA, USA.
authors.forename: Jesse
authors.initials: J
authors.lastname: DeLeon
authors.forename: Bruce E
authors.initials: BE
authors.lastname: Silverstein
authors.forename: Catherine
authors.initials: C
authors.lastname: Allaire
authors.forename: Lynne S
authors.initials: LS
authors.lastname: Gearinger
authors.forename: Kirk M
authors.initials: KM
authors.lastname: Bateman
authors.forename: Timothy W
authors.initials: TW
authors.lastname: Morris
authors.forename: Timothy L
authors.initials: TL
authors.lastname: Comstock
mesh_terms: D060433:Administration, Ophthalmic; D000293:Adolescent; D000328:Adult; 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; D005500:Follow-Up Studies; D006090:Gram-Negative Bacteria / Q000302:isolation & purification; D006094:Gram-Positive Bacteria / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009887:Ophthalmoscopy; D013535:Suspensions; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D001381:Azepines; D024841:Fluoroquinolones; D013535:Suspensions; C522124:besifloxacin