title: Besifloxacin Ophthalmic Suspension 0.6% Compared with Gatifloxacin Ophthalmic Solution 0.3% for the Treatment of Bacterial Conjunctivitis in Neonates.
abstract: OBJECTIVE
  The aim of this study was to evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension 0.6% compared with gatifloxacin ophthalmic solution 0.3% in the treatment of bacterial conjunctivitis in neonates.
  
  
  METHODS
  This was a multicenter, randomized, double-masked, parallel group study. Subjects ≤31 days of age with severity grade ≥1 (scale 0-3) for both conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled three times daily for 7 days, and completed five study visits (three clinic visits and two phone calls). Primary endpoints included clinical resolution (absence of both conjunctival discharge and conjunctival hyperemia) at visit 5 (day 8 or 9) and ocular and non-ocular treatment-emergent adverse events (AEs). Bacterial eradication was a secondary endpoint.
  
  
  RESULTS
  Thirty-three subjects were included in the intent-to-treat (ITT) population. All were aged <28 days, with a mean (standard deviation) age of 15.5 days (6.0), and 57.6% were female. Twenty-two subjects had culture-confirmed conjunctivitis in at least one eye (modified ITT [mITT] population), most often with Gram-positive bacteria. Visit 5 clinical resolution and bacterial eradication rates were comparable among besifloxacin- and gatifloxacin-treated study eyes (clinical resolution: 12/16 [75.0%] vs. 12/17 [70.6%] for the ITT population, and 11/13 [84.6%] vs. 7/9 [77.8%] for the mITT population; bacterial eradication: 12/13 [92.3%] vs. 8/9 [88.9%] for the mITT population, respectively). No AEs were reported in the besifloxacin treatment group, and AEs reported in the gatifloxacin group were considered not treatment-related.
  
  
  CONCLUSIONS
  In this small study in neonates, both besifloxacin and gatifloxacin appeared effective and safe in the treatment of bacterial conjunctivitis. Larger studies are warranted.
authors.affiliation: Bausch & Lomb, 1400 North Goodman Street, Rochester, NY, 14609, USA. Christine.sanfilippo@bausch.com.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Sanfilippo
authors.affiliation: , 38, rue de Villiers, 92300 , Levallois Perret, France.
authors.forename: Catherine M
authors.initials: CM
authors.lastname: Allaire
authors.affiliation: Bausch & Lomb, 1400 North Goodman Street, Rochester, NY, 14609, USA.
authors.forename: Heleen H
authors.initials: HH
authors.lastname: DeCory
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D001381:Azepines / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000494:pharmacology / Q000627:therapeutic use*; D000077734:Gatifloxacin; D006094:Gram-Positive Bacteria / Q000187:drug effects; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008826:Microbial Sensitivity Tests; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D001381:Azepines; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; C522124:besifloxacin; D000077734:Gatifloxacin