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.

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.

Inclusion Criteria:

• Healthy male or female 21 years of age or older
• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
• Willing and able to administer eye drops and record the times the drops were instilled
• Understand and are willing to sign the Informed Consent form
• Willing to complete the entire course of the study.

Exclusion Criteria:

• Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
• Known sensitivity to any of the ingredients in the study medications or similar medications.
• Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
• Corneal edema in either eye.
• Need for regional or general anesthesia during surgery.
• Complicated cataract surgery, including use of iris hooks or iris stretchers.
• Sight better than 20/100 in only one eye.
• A history of previous intraocular surgery in either eye.
• A history of uveitis, iritis, or intraocular inflammation.
• Macular pathology of the retina.
• Presence of glaucoma.
• Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
• History of steroid-related intraocular pressure (IOP) rise in the study eye.
• Lack of an intact corneal epithelium.
• Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.
• Diabetes mellitus.
• Required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period.
• Doctor has determined the presence of a condition (i.e., UNCONTROLLED systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.
• Females, who are pregnant, nursing an infant or planning a pregnancy.
• Currently involved in another investigational study or have participated in one within the 30 days prior to entering this study.
• Unable or unwilling to give signed informed consent prior to participation in any study-related procedures.