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

ICON Bioscience

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Dexamethasone; Drug: Prednisolone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02547623

C15-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 194 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• undergoing cataract surgery

Exclusion criteria

• glaucoma patient, pregnancy, allergy to dexamethasone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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194 participants in 2 patient groups

dexamethasone depot

Active Comparator group

Description:

dexamethasone depot 517 mcg

Treatment:

Drug: Dexamethasone

standard of care

Active Comparator group

Description:

prednisolone drops 1%

Treatment:

Drug: Prednisolone