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

Phase 4 Completed 52 enrolled Edward J. Holland Alcon Research · collab Parsons Medical Communications · collab Sirion Therapeutics, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2009-03
Primary completion: 2010-06
Completion: 2010-11

Publications

Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Difluprednate	Small molecule	0.05 %	Topical
Comparator	Prednisolone	Other / unclassified	1 %	Topical

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

Summary

Timeline

Publications

Drugs

Indications