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Bacterial conjunctivitis antibiotic trial set to begin
ALAMEDA, Calif. — A pivotal clinical trial of a broad-spectrum antibiotic will commence in the third quarter of this year, the drug’s developer announced.
The protocol for a phase 3 clinical study of ISV-401 in the treatment of bacterial conjunctivitis has been completed, according to InSite Vision.
The trial of ISV-401, an antibiotic that combines azithromycin with a patented vehicle, will follow the same formulation and dosing regimen as previous trials. A phase 2 trial showed clinical resolution and bacterial eradication of both gram positive and gram negative strains of acute bacterial conjunctivitis when six drops of the drug were administered over a 5-day period. According to InSite, results with ISV-401 were comparable to those seen when patients received 35 drops of currently marketed antibiotics administered over a 7-day period.
Initially, InSite will be testing the drug for treatment of bacterial conjunctivitis, but the trial may be expanded to include trachoma.