Journal of Clinical and Experimental Ophthalmology
Open Access
ISSN: 2155-9570
ISSN: 2155-9570
Joseph Gira
Tanzania
Research Article
Efficacy and Safety of Sustained Release Dexamethasone for the Treatment of Ocular Pain and Inflammation after Cataract Surgery: Results from Two Phase 3 Studies
Author(s): Thomas Walters, Shamik Bafna, Steven Vold, Gary Wortz, Paul Harton, Jeffrey Levenson, John Hovanesian, Francis Mah, Joseph Gira, David Vroman, Reginald Sampson, John Berdahl, Thomas Elmer and Robert J. NoeckerThomas Walters, Shamik Bafna, Steven Vold, Gary Wortz, Paul Harton, Jeffrey Levenson, John Hovanesian, Francis Mah, Joseph Gira, David Vroman, Reginald Sampson, John Berdahl, Thomas Elmer and Robert J. Noecker
Background: These studies evaluated the safety and efficacy of a single-dose sustained release dexamethasone depot (DEXTENZA™, Intracanalicular Depot) for the treatment of pain and inflammation following cataract surgery. Methods: Patients were randomized (2:1) on Day 1 to receive a sustained release dexamethasone depot, (0.4 mg; Study 1, n=164; Study 2, n=161) or placebo vehicle depot (Study 1, n=83; Study 2, n=80) in the inferior canaliculus. Results: A significantly greater proportion of patients in the dexamethasone groups (Study 1, 80.4% [131/164] vs. 43.4% [36/83], P<0.0001; Study 2, 77.5% [124/161] vs. 58.8% [47/80], P=0.0025) had an absence of ocular pain at Day 8. At Day 14 more patients in the dexamethasone groups had an absence of anterior chamber cells (Study 1, 33.1% [54/164] vs. 14.5% [12/83], P=0.0018; Study 2, 39.4% [63/161] vs. 31.3% [25/80], P=0.2182). Stati.. View More»
DOI:
10.4172/2155-9570.1000572