Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

Completed · Phase 3

Conditions studied: Cataract

In brief

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups * 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.

Key facts

Study ID

NCT02547623

Run by

ICON Bioscience Inc

People needed

194

Starts

2015-11-06

Expected to finish

2016-08-16

Last updated by the study team

2018-08-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• undergoing cataract surgery

You may not qualify if…

• glaucoma patient, pregnancy, allergy to dexamethasone

Where it is running

• 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

Full record on ClinicalTrials.gov

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