InSite Vision Incorporated (OTCBB: INSV) today announced that patient enrollment has been completed in the DOUBle Phase 3 clinical trial of AzaSite Plus (ISV-502) and DexaSite (ISV-305) for the treatment of blepharitis. The DOUBle (Dual Ophthalmic agents Used in Blepharitis) study enrolled more than 900 patients with moderate-to-severe blepharitis in less than ten months in a four-arm trial designed to evaluate the efficacy and safety of both product candidates simultaneously.
“The DOUBle Phase 3 trial is the largest and most extensive quantitative clinical study ever conducted for blepharitis. In addition to testing two promising therapeutics simultaneously, the DOUBle study is designed to significantly improve the understanding of the disease and make an important contribution to improving patient care”
More than 1,100 patients at 44 sites entered the study screening process after being diagnosed with blepharitis. After using twice-daily lid scrubs for seven days, 81% of those patients were determined to have moderate-to-severe blepharitis and were randomized into the DOUBle clinical trial. The remaining patients, or 19%, were largely determined to have mild blepharitis, which was adequately controlled by lid scrubs alone, and were not enrolled into the trial. Currently, about 450 patients remain on-study. InSite Vision expects that the DOUBLe clinical trial will be complete and top-line data available in early 2013.
"The DOUBle Phase 3 trial is the largest and most extensive quantitative clinical study ever conducted for blepharitis. In addition to testing two promising therapeutics simultaneously, the DOUBle study is designed to significantly improve the understanding of the disease and make an important contribution to improving patient care," said Kamran Hosseini, M.D., PhD, Vice President and Chief Medical Officer of InSite Vision. "We are committed to make AzaSite Plus and DexaSite available for the more than 34 million blepharitis sufferers in the United States who currently have no approved drug therapies available to them. While all data are blinded, during the study to date there have been no serious adverse events related to the study drugs and the drugs have been well tolerated."
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