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 Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.

NCT01244334 Phase 4 COMPLETED

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.

Details

Lead sponsor	Edward J. Holland
Phase	Phase 4
Status	COMPLETED
Enrolment	52
Start date	2009-03
Completion	2010-11

Conditions

• Cataracts
• Corneal Edema
• Retinal Structural Change, Deposit and Degeneration
• Visual Acuity Reduced Transiently

Interventions

• Difluprednate ophthalmic emulsion 0.05%
• Prednisolone acetate 1%

Primary outcomes

• Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1 — Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1

Countries

United States