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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Surgical Ocular Inflammation and Pain

In brief

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.

Key facts

Study ID

NCT02793817

Run by

Kala Pharmaceuticals, Inc.

People needed

520

Starts

2016-06-01

Expected to finish

2017-03-01

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Eye Center — Chandler, Arizona, United States
• Cornea and Cataract Consultants of CA — Phoenix, Arizona, United States
• Sall Research Medical Center — Artesia, California, United States
• Orange County Ophthalmology — Garden Grove, California, United States
• Lugene Eye Institute — Glendale, California, United States
• Inland Eye Specialists — Hemet, California, United States
• United Medical Research Institute — Inglewood, California, United States
• LoBue Laser and Eye Medical Center — Murrieta, California, United States
• Pendleton Eye Center — Oceanside, California, United States
• North Bay Eye Associates, Inc. — Petaluma, California, United States
• Arch Health Partners — Poway, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Shasta Eye Medical Group, Inc — Redding, California, United States
• Eye Center of Northern Colorado, PC — Fort Collins, Colorado, United States
• Eye Associates of Fort Myers — Fort Myers, Florida, United States
• Levenson Eye Associates — Jacksonville, Florida, United States
• Shettle Eye Research, Inc — Largo, Florida, United States
• International Research Center — Tampa, Florida, United States
• Chicago Cornea Consultants, Ltd. — Hoffman Estates, Illinois, United States
• Jacksoneye, S. C. — Lake Villa, Illinois, United States
• The Eye Care Institute — Louisville, Kentucky, United States
• Great Lakes Eye Care — Saint Joseph, Michigan, United States
• Minnesota Eye Consultants, PA — Bloomington, Minnesota, United States
• Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC — Washington, Missouri, United States
• Abrams Eye Institute — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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