PURPOSE: To evaluate the safety and efficacy of @entity619 as a sustained-release drug depot when placed in the canaliculus for the treatment of @entity32 and @entity158 in @entity231 surgery @entity1 . SETTING: Four private practice sites in the United States. DESIGN: Multicenter randomized double-masked clinical trial. METHODS: @entity1 were randomized (1:1) to receive either the sustained-release @entity619 or a placebo vehicle punctum plug inserted into the inferior distal canaliculus of the operated eye intraoperatively during @entity231 surgery. The primary endpoints were the proportions of @entity1 with absence of cells or @entity158 in the anterior chamber at 8 days. Secondary endpoints included cells, flare, @entity158 , and the presence of the device at various timepoints through 30 days. RESULTS: Approximately one fifth (20.7%) of @entity1 in the sustained-release @entity619 group had an absence of anterior chamber cells at 8 days compared with 10.0% in the placebo group (P  =  .1495). A higher proportion of @entity1 in the sustained-release @entity619 group (79.3%) than in the placebo group (30.0%) had an absence of @entity3856 at 8 days (P  <  .0001) and at all other timepoints (P  <  .0002). There were significantly higher proportions of @entity1 in  the sustained-release @entity619 group than in the placebo group with an absence of anterior chamber cells, anterior chamber flare, and @entity158 at several timepoints through 30 days (P   <=  .0251). CONCLUSION: Sustained-release @entity619 provided elution of drug for up to 1  month after @entity231 surgery, providing clinically significant reductions in @entity32 and @entity158 . FINANCIAL DISCLOSURE: Dr. Masket is a consultant to and shareholder in Ocular Therapeutix, Inc. No other author has a financial or proprietary interest in any material or method mentioned.

Sustained-release @entity619 for the  treatment of @entity32 and  @entity158 after XXXX surgery.

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation', 'ocular inflammation'] @entity231 :: ('MESH:D002386', 'Disease') :: ['cataract'] @entity619 :: ('MESH:D003907', 'Chemical') :: ['dexamethasone'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity3856 :: ('MESH:D058447', 'Disease') :: ['ocular pain']
@entity231 :: (MESH:D002386,Disease) :: ['cataract']
