Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
NCT ID: NCT02547623
Last Updated: 2018-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
194 participants
INTERVENTIONAL
2015-11-06
2016-08-16
Brief Summary
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* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
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Detailed Description
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* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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dexamethasone depot
dexamethasone depot 517 mcg
Dexamethasone
depot intracameral
standard of care
prednisolone drops 1%
Prednisolone
Prednisolone eye drops 1%
Interventions
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Dexamethasone
depot intracameral
Prednisolone
Prednisolone eye drops 1%
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
ALL
No
Sponsors
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ICON Bioscience Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Donnenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalmic Consultants of Long Island
Locations
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Kislinger MD inc
Glendora, California, United States
Inland Eye Specialists
Hemet, California, United States
Harvard Eye Associated
Laguna Hills, California, United States
Feinerman Vision Center
Newport Beach, California, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Associated Eye Care
Stillwater, Minnesota, United States
Matossian Eye Associates
Pennington, New Jersey, United States
Ophthalmic Consultants of Long Island
Garden City, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Carolina Eye Care Physicians
Mt. Pleasant, South Carolina, United States
the eye institute of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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C15-01
Identifier Type: -
Identifier Source: org_study_id
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