Study of Efficacy and Safety of Azithromycin T1225 1.5% in Children With Bacterial Conjunctivitis

Abstract

Purpose: : The purpose of the study was to analyze the efficacy and safety of azithromycin 1.5% eye-drops (T1225) in the treatment of purulent bacterial conjunctivitis versus tobramycin 0.3% in a subset of 150 children. The ocular pathogens in conjunctivitis were also aimed to be studied in the population.

Methods: : This multicenter, randomized, investigator-masked, parallel-group study, included 150 newborns, children and adolescent in a large study having enrolled 1,043 patients and compared T1225 twice daily for 3 days and tobramycin 0.3% 1 drop every two hours for 2 days then four times daily for 5 days. Signs and symptoms were evaluated and cultures obtained at baseline, Days 3 and 9. Primary efficacy variable was the clinical cure (score 0 for bulbar conjunctival injection and purulent discharge) at the test of cure visit (Day 9).

Results: : In the population, 58 patients had positive cultures at Day 0. Both treatments were effective with a clinical and microbiological cure of more than 80% of children on Day 9. T1225 provided a significantly quicker cure on Day 3 than tobramycin (p<0.001). Resistant species were resolved by T1225. No adverse effects were noted on the ocular surface. The involved ocular conjunctival pathogen flora in children was analyzed and cocci species were predominant.

Conclusions: : T1225 leads to a rapid clinical cure with negative microbiological control. The spectrum of azithromycin allow to treat frequent pathogen in children. This short-treatment course can be easily used in children, thus improving the quality of life.

Clinical Trial: : www.clinicaltrials.gov NCT00357773

Keywords: anatomy • conjunctivitis • keratitis