Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain

A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain

The primary objective of the study is to investigate the efficacy and safety of KPI-121 1.0% ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery.

This is a Phase III, multicenter, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of KPI-121 1.0% ophthalmic suspension versus placebo in subjects who require treatment of postoperative anterior ocular inflammation.

Inclusion Criteria:

Candidates for routine, uncomplicated cataract surgery

In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.

Exclusion Criteria:

• Known hypersensitivity/contraindication to study product(s) or components.
• History of glaucoma, intraocular pressure (IOP) >21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
• Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
• In the opinion of Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.