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

Study Overview
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Brief Summary
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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.

Official Title
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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.

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

Intervention / Treatment
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* Drug: Difluprednate ophthalmic emulsion 0.05%
* Drug: Prednisolone acetate 1%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Difluprednate Ophthalmic Emulsion 0.05%<br> | Drug: Difluprednate ophthalmic emulsion 0.05%<br>* 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.<br>* Other names: Durezol;|
| Active Comparator: Prednisolone acetate suspension 0.1%<br> | Drug: Prednisolone acetate 1%<br>* 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.<br>* Other names: Prednisolone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 |  | change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract surgery, vision, corneal edema, retinal thickness