Clinical Trial: Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolo

Brief Summary: The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.

Detailed Summary:
Sponsor: Edward J. Holland

Current Primary Outcome: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1 [ Time Frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1 ]

Original Primary Outcome: Assess the efficacy on visual acuity, corneal edema, and retinal thickness [ Time Frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Days 1, 15, 30 ]

Current Secondary Outcome: Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 [ Time Frame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 ]

Original Secondary Outcome:

Information By: Cincinnati Eye Institute Northern Kentucky

Dates:
Date Received: November 18, 2010
Date Started: March 2009
Date Completion:
Last Updated: August 6, 2012
Last Verified: August 2012