Study to Evaluate the Safety for the Treatment of Inflammation Associated

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02547623
Study type	Interventional
Source	ICON Bioscience Inc
Contact
Status	Completed
Phase	Phase 3
Start date	November 6, 2015
Completion date	August 16, 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms