Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial.

ABSTRACT:

Background

The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin^® SF), for management of postoperative inflammation and pain, after cataract surgery.

Methods

This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intent-to-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hy

SUBMITTER: Palacio-Pastrana C 

PROVIDER: S-EPMC7297453 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature