Trial intelligence / Profile preview

Prolensa vs Ilevro for Ocular Inflammation in Cataract Surgery

NCT03886779Phase 4

Key facts

Status
Completed
Start
Oct 2013
Primary completion
Feb 2017
Sponsor
Silverstein Eye Centers
Modality
Small Molecules
Conditions
ocular inflammation
01

Overview

Phase 4, randomised, double-blind trial of bromfenac sodium in ocular inflammation (2 arms), sponsored by Silverstein Eye Centers. Primary endpoint: Summed Ocular Inflammation Score. Started Oct 2013; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Prolensa

    Bromfenac 0.07% QD + pulse dose

  • Ilevro

    Nepafenac 0.3% QD + pulse dose

03

Who it enrols

Adult patients scheduled for unilateral cataract surgery with BCVA 20/200 or better and IOP 5-22 mmHg, excluding those with active inflammation, corneal pathology, or recent use of NSAIDs/steroids.

04

Endpoints

Primary

  • Summed Ocular Inflammation Score

Secondary

  • Adverse Events

  • Slit Lamp Biomicroscopy

  • Intraocular Pressure

  • Funduscopic Examination (Dilated)

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