Treatment of Ocular Inflammation Associated With Cataract Surgery Clinical Trial
Official 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
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.
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