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M.B. Abelson, E.E. Protzko, A.M. Shapiro, AzaSite Clinical Study Group; A Randomized Trial Assessing Microbial Eradication and Clinical Efficacy of 1% Azithromycin Ophthalmic Solution vs. Tobramycin in Adult Subjects With Bacterial Conjunctivitis . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3589.
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To evaluate the efficacy of azithromycin ophthalmic solution 1.0% in DuraSite (AzaSite) compared to tobramycin ophthalmic solution USP, 0.3% in pediatric and adult patients with bacterial conjunctivitis.
Seven hundred forty–six subjects, aged one year or older, with presumptive bacterial conjunctivitis were dosed two times daily (BID) for 2 days followed by once a day (QD) for 3 days with AzaSite 1% or four times a day for 5 days with tobramycin 0.3% in a, multi–center, double–masked, randomized, active–controlled study. The primary clinical efficacy variable was clinical resolution rate. Clinical resolution was attained when the score of the three ocular signs (palpebral and bulbar conjunctival redness, conjunctival discharge) was zero at the test–of–cure visit (Day 6 and 7). Anti–microbial efficacy was evaluated as bacterial eradication rate at each of 3 clinic visits.
Three hundred and sixteen subjects had positive bacterial cultures. In this pivotal phase 3 clinical trial powered to demonstrate equivalency, the results show that the clinical resolution rate of AzaSite is equivalent to tobramycin even though Azasite was dosed less frequently. The bacterial eradication rates were similarly equivalent. Prominent organisms eradicated by both tobramycin and AzaSite were Streptococcus pneumoniae, Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, and other viridans Streptococcus .
The results indicate that clinical resolution of bacterial conjunctivitis and eradication of bacterial species prevalent in acute bacterial conjunctivitis can be accomplished with a 5–day dosing of AzaSite 1.0% instilled BID on days 1 and 2 and QD on days 3–5. This regimen of reduced dosing frequency was just as effective as tobramycin dosed QID for 5 days.
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