Abstract
Purpose: :
A multi–center, double–masked, randomized, active–controlled study to compare the safety and tolerability of a new ophthalmic formulation of azithromycin 1.0% in a polymer vehicle of DuraSite® (AzaSite) with tobramycin ophthalmic solution USP, 0.3% in subjects with acute bacterial conjunctivitis.
Methods: :
In this phase 3 pivotal study, a total of 746 pediatric and non–pediatric subjects were exposed to either AzaSite or tobramycin and evaluated for safety. The subjects ranged in age from 1–93 years of age. The entire population consisted of 59% pediatric (age range 1–18 years) and 41% adult (19–93 years).
Results: :
The most frequent adverse events in the AzaSite group were eye irritation (1.9 %) and unrelated upper respiratory tract infection (2.2 %), which were similar in incidence to the tobramycin group. No severe adverse events were observed in the trial. Overall, no clinically relevant differences or statistically significant differences in adverse events were observed between the AzaSite group and the tobramycin group. Additionally, there were no safety concerns based on changes in visual acuity, biomicroscopic and ophthalmoscopic measurements.
Conclusions: :
AzaSite is an ophthalmic solution of 1.0% azithromycin in DuraSite, a polymeric vehicle which permits sustained release of azithromycin to the ocular surface. AzaSite was safe and well tolerated in children and adults. In comparison, subjects tolerated AzaSite just as well as tobramycin.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • antibiotics/antifungals/antiparasitics • bacterial disease