Primary endpoint
Complete clearance of cells and flare*
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Study design: Clinical efficacy evaluated in 2 randomized, double-masked, vehicle-controlled trials of patients undergoing cataract surgery. Each randomized patient received PROLENSA® or vehicle starting with one drop into the surgical eye the day prior to and the day of surgery, and for 14 days post-surgery. Study endpoints were clearing of ocular inflammation (SOIS=0) by Day 15 (primary) and the number of subjects pain free on Day 1 after surgery (secondary).1,2
*Ocular inflammation was assessed by the Summed Ocular Inflammation Score (SOIS). Complete clearance of inflammation was defined as the proportion of patients who achieved an SOIS of grade 0 (0 cells and absence of flare).5
†0-5 cells.