Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
NCT ID: NCT01244334
Last Updated: 2012-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2009-03-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Difluprednate Ophthalmic Emulsion 0.05%
Difluprednate ophthalmic emulsion 0.05%
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.
Prednisolone acetate suspension 0.1%
Prednisolone acetate 1%
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.
Interventions
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Difluprednate ophthalmic emulsion 0.05%
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.
Prednisolone acetate 1%
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
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Sirion Therapeutics, Inc.
INDUSTRY
Alcon Research
INDUSTRY
Parsons Medical Communications
UNKNOWN
Edward J. Holland
OTHER
Responsible Party
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Edward J. Holland
Sponsor Investigator
Principal Investigators
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Edward J Holland, MD
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Eye Institute
Eric D Donnenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Consultants of Long Island
Kerry S Solomon, MD
Role: PRINCIPAL_INVESTIGATOR
Carolina Eyecare
Locations
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Cincinnati Eye Institute
Edgewood, Kentucky, United States
Ophthalmic Consultants of Long Island
Lynbrook, New York, United States
Carolina Eyecare
Mt. Pleasant, South Carolina, United States
Countries
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References
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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.
Other Identifiers
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SEMC 5/2009-011
Identifier Type: -
Identifier Source: org_study_id