Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Status:
Completed
Trial end date:
2016-08-16
Target enrollment:
Participant gender:
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.