BleQOLITY Information

In pursuit of a Special Protocol Assessment (SPA) designation for the DOUBle Phase 3 study, InSite Vision developed its proprietary BleQOLITY (Blepharitis Quality Of Life In TherapY) instrument, to be used by patients, in conjunction with the scheduled BleSSSED evaluations by the ophthalmologist investigators. This numeric scoring instrument was developed with the goal of objectively measuring the way patients feel (their Quality of Life) as related to the severity of their disease and how it affects their daily life. BleQOLITY is the first Quality of Life instrument to be employed in a Phase 3 study of blepharitis.

Participating in the DOUBle Phase 3 study will evaluate the severity of blepharitis in each patient suffering from the disease.

Like BleSSSED, the BleQOLITY instrument will be used in the DOUBle study to:

• Establish each patients baseline Quality of Life in the pre-treatment period (Day 0)
• Evaluate each patients Quality of Life post-treatment (Day 15)
• Evaluate each patients Quality of Life in the follow-up period (upon investigator determination of recurrence and / or exacerbation, when the patients come off study).