Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery

Purpose To assess the efficacy and safety of a sustained-release intracanalicular dexamethasone insert for the treatment of postoperative ocular inflammation and pain in patients having cataract surgery. Setting Twenty-one United States sites. Design Prospective multicenter randomized parallel-arm double-masked vehicle-controlled phase 3 study. Methods Patients with planned clear corneal cataract surgery were randomized (1:1) to receive dexamethasone insert or placebo, and the treatment was placed in the canaliculus of the eye immediately after surgery (Day 1). The primary efficacy endpoints were complete absence of anterior chamber cells at Day 14 and complete absence of pain at Day 8. Results The study comprised 438 adult patients (216 in the treatment arm and 222 in the placebo arm). At Day 14, significantly more patients had an absence of anterior chamber cells in the dexamethasone insert arm compared with placebo (52.3% versus 31.1%; P P Conclusions Both primary endpoints were successfully met. In addition, patients receiving the dexamethasone insert experienced a decrease in inflammation after surgery as early as Day 4 through Day 45, and a decrease in pain as early as one day after surgery (Day 2) through Day 45. The dexamethasone insert was well-tolerated, and the adverse events profile was similar to placebo.