NCT03886779

Study Title: 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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Silverstein Eye Centers · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

Detailed description

Name of Finished Product: Prolensa (Bromfenac Ophthalmic Solution) 0.07% Bausch and Lomb, Rochester, NJ Dose: Subjects will instill one drop into the study (operative) eye once daily for a maximum of 16 days. Dosing will begin one days prior to surgery (Day 1), continue on the day of surgery plus 1 hour before surgery and for 14 days after surgery. 2\) Ilevro® (nepafenac ophthalmic suspension ) 0.3% This is a single-center, randomized, investigator and subject-masked, parallel group, and active-comparator controlled study. Subjects will be screened for this study between 1 and 21 days prior to the initiation of dosing with the test article. Subjects who sign the informed consent form and meet all inclusion/exclusion criteria will be randomized to receive either Prolensa (Bromfenac Ophthalmic Solution) 0.07% QD or Ilevro (nepafenac Ophthalmic Suspension) 0.3% (1:1) for 14 days after cataract extraction.

Conditions

• Treatment of Ocular Inflammation Associated With Cataract Surgery

Interventions

Type	Name	Description
DRUG	Bromfenac	0.7 MG/ML \[Prolensa\]
DRUG	Nepafenac	3 MG/ML \[Ilevro\]

Timeline

• Start date: 2013-10-30
• Primary completion: 2017-02-15
• Completion: 2019-03-01
• First posted: 2019-03-22
• Last updated: 2019-04-01

Regulatory

• FDA-regulated drug study