BleSSSED Information

In pursuit of a Special Protocol Assessment (SPA) designation for the DOUBle Phase 3 study, InSite Vision developed its proprietary BleSSSED (Blepharitis Signs & Symptoms Scoring for Evaluating Disease) instrument. This numeric scoring instrument was developed with the goal of objectively standardizing the way ophthalmologist investigators participating in the DOUBle Phase 3 study will evaluate the severity of blepharitis in each patient suffering from the disease.

The BleSSSED instrument will be used in the DOUBle study to:

• Evaluate patient eligibility to participate in the study
• Establish baseline disease severity in the pre-treatment period (Day 0)
• Evaluate response to therapy post-treatment (Day 15)
• Evaluate disease severity in the follow-up period (every 30 Days until patients are off-study)