title: A randomized trial assessing the clinical efficacy and microbial eradication of 1% azithromycin ophthalmic solution vs tobramycin in adult and pediatric subjects with bacterial conjunctivitis.
abstract: OBJECTIVE
  The study was designed to evaluate the efficacy of an ophthalmic formulation of 1% azithromycin in DuraSite((R)) (AzaSite, InSite Vision, Alameda CA, USA) and demonstrate equivalence with 0.3% tobramycin ophthalmic solution, USP, for the treatment of bacterial conjunctivitis as defined by the resolution of clinical signs and the eradication of pathogens.
  
  
  METHODS
  Prospective, randomized, active-controlled, double-masked, phase 3 trial conducted at 47 US sites between 6 August 2004 and 6 October 2005.
  
  
  METHODS
  Subjects aged 1 year or older with diagnosis of acute bacterial conjunctivitis.
  
  
  METHODS
  Bacteriologically confirmed participants received either 1% azithromycin in Dura-Site (n = 159) or tobramycin (n = 157). Masked study medications were dosed 4 times a day for 5 days. Participants in the 1% azithromycin in DuraSite group were dosed twice a day with active drug on days 1 and 2 and once daily on days 3 through 5. The other doses were vehicle. Clinical signs and bacterial cultures were evaluated at visit 3 (day 6 + 1).
  
  
  RESULTS
  Clinical resolution was observed in 79.9% of participants in the 1% azithromycin in DuraSite group, as compared with 78.3% of those in the tobramycin group (95% CI: -7.4-10.5). Bacterial eradication was 88.1% in the 1% azithromycin in DuraSite group vs 94.3% in the tobramycin group (95% CI: -12.4-0.0). Analyses of resistance confirmed that 1% azithromycin in DuraSite eradicated Staphylococci and Streptococci strains that are commonly resistant to azithromycin, erythromycin, and fluoroquinolones.
  
  
  CONCLUSIONS
  The efficacy of 1% azithromycin in DuraSite and tobramycin are equivalent; however, this formulation of azithromycin also permits effective dosing intervals of twice a day on days 1 and 2 followed by once daily on the last 3 days of therapy, for a total of 65% fewer doses. In vitro, the killing spectrum of 1% azithromycin in DuraSite appears to be enhanced relative to 1% azithromycin without DuraSite.
authors: Ophthalmic Research Associates, Clinical Research and Development, 863 Turnpike Street, North Andover, MA, USA. abelson@vision.eri.harvard.edu
authors: Mark
authors: M
authors: Abelson
authors: Eugene
authors: E
authors: Protzko
authors: Aron
authors: A
authors: Shapiro
authors: Ana
authors: A
authors: Garces-Soldana
authors: Lyle
authors: L
authors: Bowman