This article is more than 5 years old. Information may no longer be current.
InSite Vision to conduct phase 3 trial of blepharitis treatment
ALAMEDA, Calif. — InSite Vision has received a special protocol assessment from the U.S. Food and Drug Administration to conduct a phase 3 clinical trial of two blepharitis treatments, the company announced in a press release.
The DOUBle (Dual ophthalmic agents used in blepharitis) study will evaluate the safety and efficacy of AzaSite Plus (ISV-502) and DexaSite (ISV-305) in patients with blepharitis.
AzaSite Plus, a combination of dexamethasone 0.1% with AzaSite (azithromycin 1% ophthalmic solution), is administered with the DuraSite drug delivery system. DexaSite combines dexamethasone 0.1% with DuraSite.
The controlled, masked, multicenter trial will randomize 900 patients to receive either AzaSite Plus, DexaSite, AzaSite or the DuraSite vehicle for 14 days. Patients will be assessed with a proprietary scoring tool, digital photography and a quality-of-life questionnaire.
Follow-up will be conducted for 6 months.
"Based on our clinical experience with AzaSite Plus and DexaSite, including a completed phase 3 study in blepharoconjunctivitis, we believe that the design of the DOUBle phase 3 program provides us with a unique opportunity to advance two promising products for the treatment of this disease in a single study," Timothy Ruane, CEO of InSite, said in the release.