Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (Nepafenac Ophthalmic Suspension) 0.3% QD With Extra (Pulse) Dose on Day of Surgery for Treatment of Ocular Inflammation Associated With Cataract Surgery in a Randomized, Single Masked Clinical Trial

NCT03886779 Phase 4 COMPLETED

Clinical Outcomes of Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD vs. Ilevro (nepafenac Ophthalmic Suspension) 0.3% QD with extra (pulse) dose on day of surgery for Treatment of Ocular Inflammation Associated with Cataract Surgery

Details

Lead sponsor	Silverstein Eye Centers
Phase	Phase 4
Status	COMPLETED
Enrolment	57
Start date	2013-10-30
Completion	2019-03

Conditions

• Treatment of Ocular Inflammation Associated With Cataract Surgery

Interventions

• Bromfenac
• Nepafenac

Primary outcomes

• Outcome Change measured by Summed Ocular Inflammation Score (SOIS) — Day 1 through Day 15
  50 Subjects are planned, 25 per treatment group who are undergoing planned cataract extraction with posterior chamber intraocular lens implantation to evaluate the non-inferiority of Prolensa and Ilevro when administering a pulse dose in each arm 1 hour prior to surgery. Outcome measure is defined as SIOS score of zero (no cell or flare) on day 15 (day one being the day prior to surgery, and for 14 days following surgery