Purpose: To compare the efficacy of azithromycin 1.5% versus tobramycin 0.3% eyedrops on clinical ocular signs and symptoms of bacterial conjunctivitis in children and to assess the parents' satisfaction regarding the dosing regimen.
Patients and methods: An international, multicenter, randomized, investigator-masked, controlled clinical trial conducted in children (1 day to 18 years old) with bulbar conjunctival hyperemia and purulent discharge. Azithromycin 1.5% was administered as 1 drop twice daily for 3 days, and tobramycin 0.3% as 1 drop every 2 hours for 2 days, then 4 times daily for 5 days.
Results: A total of 286 patients (mean age: 3.2 years) were enrolled. In children with bacteriologically positive cultures (N=203), azithromycin produced a significantly greater improvement in conjunctival discharge (P<0.01) and a trend (P=0.054) toward improvement in conjunctival hyperemia at day 7 than did tobramycin. Complete resolution of conjunctival discharge was significantly more frequent at day 3 on azithromycin than tobramycin (P=0.005). More parents found azithromycin easier to use (in terms of treatment duration, total number of instillations, instilling drops during the day, and difficulty in performing daily activities) than tobramycin.
Conclusion: The azithromycin 1.5% regimen produced a rapid resolution of cardinal signs of purulent bacterial conjunctivitis with a more convenient dosage regimen. Such improved convenience is likely to improve compliance and lessen the burden of illness for patients and carers.
Keywords: QOL; acceptability; azithromycin; bacterial conjunctivitis; children; compliance; topical antibiotics.