June 18, 2008
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Ophthalmic solution successfully treats bacterial conjunctivitis, is well-tolerated

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Azithromycin 1% ophthalmic solution showed statistically significant results in treating bacterial conjunctivitis in both adults and children, a multicenter prospective study found.

The solution, delivered with the drug delivery system DuraSite (InSite Vision), "eradicated" 88.5% of acute bacterial conjunctivitis, including pathogens resistant to azithromycin in vitro, by the patient's third visit, study authors said. Adverse events were similar to a control vehicle, they found.

"Azithromycin 1% ophthalmic solution in DuraSite showed statistically significant differences in clinical resolution and bacterial eradication rates when compared with vehicle. Because it was well-tolerated in this population, it may be a viable treatment option for children and adults with bacterial conjunctivitis," Mark B. Abelson, MD, and colleagues said.

They conducted the prospective, randomized, vehicle-controlled, parallel-group and double-masked clinical study of 279 patients from ages 1 to 96 years, all of whom were diagnosed with acute bacterial conjunctivitis. Patients were randomized to either azithromycin 1% or a control vehicle, both used for 5 days. The infected eyes were dosed twice daily on the first and second day, and once daily, from the third to fifth day.

Dr. Abelson and colleagues collected conjunctival cultures at baseline, the second visit and the third visit. The third visit was typically 6 or 7 days following initial treatment, they said. They measured the primary end point as clinical resolution of signs and symptoms at the third visit. They examined safety by adverse events, slit-lamp findings and ophthalmoscopy.

The study was published in the June issue of American Journal of Ophthalmology.