title: Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of gatifloxacin 0.5% ophthalmic solution administered twice daily for treatment of acute bacterial conjunctivitis.
  
  
  METHODS
  Two identically designed, double-masked, multicenter studies in the United States and India enrolled patients 1 year or older with acute bacterial conjunctivitis. Patients were randomized to gatifloxacin 0.5% or vehicle treatment for 5 days. Clinical success in clearing conjunctival hyperemia and discharge at day 6 (primary endpoint) and day 4 and microbiological cure were determined. Isolates from positive conjunctival samples were tested for sensitivity and susceptibility. Safety measures included adverse events (AEs). Data from these 2 studies were pooled for these analyses.
  
  
  RESULTS
  Of the 1437 randomized patients, 658 constituted the modified intent-to-treat population. Patient characteristics were similar between the pooled treatment groups. Clinical success occurred for 58.0% of gatifloxacin 0.5%-treated versus 45.5% vehicle-treated patients at day 6 (P=0.001) and for 23.7% versus 15.4% in the respective groups at day 4 (P=0.007). Microbiological cure was higher with gatifloxacin 0.5% than vehicle at days 4 and 6 (P<0.001 for both time points). The combined minimum inhibitory concentration required to inhibit 90% of isolates for gatifloxacin 0.5% was 2.0 μg/mL for gram-positive and gram-negative organisms. AEs were reported by 11.6% and 13.3% of patients in the gatifloxacin 0.5% and vehicle safety populations, respectively. One patient in each treatment group experienced a serious AE; neither was treatment related.
  
  
  CONCLUSIONS
  The 0.5% concentration of gatifloxacin ophthalmic solution was safe and effective for treatment of acute bacterial conjunctivitis with twice-daily administration for 5 days.
authors.affiliation: 1 Arizona Center for Clinical Trials , Phoenix, Arizona.
authors.forename: Warren
authors.initials: W
authors.lastname: Heller
authors.forename: Marilou
authors.initials: M
authors.lastname: Cruz
authors.forename: Yasmin Rusi
authors.initials: YR
authors.lastname: Bhagat
authors.forename: Jesse M
authors.initials: JM
authors.lastname: De Leon
authors.forename: Carlos
authors.initials: C
authors.lastname: Felix
authors.forename: Linda
authors.initials: L
authors.lastname: Villanueva
authors.forename: David A
authors.initials: DA
authors.lastname: Hollander
authors.forename: Harold
authors.initials: H
authors.lastname: Jensen
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D003234:Conjunctivitis, Bacterial / Q000188:drug therapy*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D024841:Fluoroquinolones / Q000008:administration & dosage* / Q000009:adverse effects; D000077734:Gatifloxacin; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; D000077734:Gatifloxacin