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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edward J. Holland
• Collaborators: Alcon Research; Parsons Medical Communications; Sirion Therapeutics, Inc.
• Treatments: Difluprednate; Fluprednisolone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.