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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
Outcome Change measured by Summed Ocular Inflammation Score (SOIS)
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
Time frame: Day 1 through Day 15
Adverse Events
Adverse Events reported, elicited, and observed
Time frame: 42 Days
Slit Lamp Biomicroscopy
Slit Lamp Biomicroscopy evaluated and observed within normal limits
Time frame: 42 Days
Intraocular Pressure
Intraocular Pressure evaluated and observed within normal limits
Time frame: 42 Days
Funduscopic Examination (Dilated)
Funduscopic Examination (Dilated) evaluated and observed within normal limits
Time frame: 42 Days
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