Abstract

OBJECTIVE

To compare the safety and efficacy of 1.5% azithromycin eye drops with 0.3% netilmicin ophthalmic solution in a paediatric population with purulent bacterial conjunctivitis.

METHODS

Patients received either azithromycin 1.5% (group 1) eye drops (twice daily for 3 days) or netilmicin 0.3% (group 2) eye drops (four times in a day for 7 days) to treat bacterial conjunctivitis. Clinical signs were evaluated on day 3 and 7. The primary variable was the clinical cure (absence of bulbar conjunctival injection and discharge) on day 3 for group 1 and day 7 for group 2.

RESULTS

A total of 92 patients were randomized, Both study medications were well tolerated. Clinical signs were evaluated on day 3 and 7. Clinical cure rate was similar between two groups (91.3% vs 89.3%, respectively). The most frequently observed ocular adverse events in the azithromycin group were eye irritation (15.2%) and conjunctival hyperemia (13.0%) in netilmicin%0.3 group.

CONCLUSION

Azithromycin 1.5% eye drops is safe and can be administered in a regimen of less frequent doses than netilmicin 0.3 %, while producing an equivalent clinical outcome in the treatment of purulent bacterial conjunctivitis in children, with a more convenient twice-a-day dosing regimen.