Conditions: Cataract
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 194
Healthy volunteers: no

Brief 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.

Detailed description:
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

Arms:
arm 1: dexamethasone depot 517 mcg arm 2: prednisolone drops 1%

Interventions: intervention 1: Dexamethasone intervention 2: Prednisolone
Intervention descriptions: intervention 1: depot intracameral intervention 2: Prednisolone eye drops 1%

Protocol document: