A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.

Inclusion Criteria:

• Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation.

Exclusion Criteria:

• Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening.
• Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study.
• Patients who are known steroid responders