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



Status:Completed
Conditions:Cardiology, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:21 - Any
Updated:10/14/2017
Start Date:March 2009
End Date:November 2010

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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.

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.
We found this trial at
3
sites
1101 Johnnie Dodds Boulevard
Mt Pleasant, South Carolina 29464
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Mt Pleasant, SC
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Edgewood, Kentucky 41017
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Edgewood, KY
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Lynbrook, New York 11563
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Lynbrook, NY
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