NCT01244334

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Edward J. Holland · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Difluprednate ophthalmic emulsion 0.05%	Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
DRUG	Prednisolone acetate 1%	Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2010-11-01
• First posted: 2010-11-19
• Last updated: 2012-08-08

Locations

3 sites across 1 country: United States