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

Kala Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Post Surgical Ocular Inflammation and Pain

Treatments

Drug: KPI-121 1% Ophthalmic Suspension dosed BID

Drug: Vehicle of KPI-121 Ophthalmic Suspension dosed BID

Study type

Interventional

Funder types

Industry

Identifiers

NCT02793817

KPI-121-C-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment

520 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.