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www.fdanews.com/articles/81303-insite-vision-completes-enrollment-in-azasite-study

INSITE VISION COMPLETES ENROLLMENT IN AZASITE STUDY

September 30, 2005

InSite Vision has completed enrollment for one of its two Phase III clinical studies with AzaSite for the treatment of bacterial conjunctivitis. The clinical study was a randomized, double blind, active-controlled study evaluating the safety and efficacy of AzaSite in patients with bacterial conjunctivitis. The randomized patients were treated for five days with either AzaSite or tobramycin ophthalmic solution. The goal of the study was to show equivalent efficacy between AzaSite and tobramycin-treated patients.

There are a total of 69 study sites involved in the study; 58 in the U.S. and 11 in three Latin American countries. A wide variety of bacteria was encountered in the trial, including both gram-positive organisms such as Streptococcus pneumoniae and gram-negative organisms such as Haemophilus influenzae.