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

Completed · Phase 3 · Has a placebo group

Conditions studied: Ocular Infections, Irritations and Inflammations

In brief

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.

Key facts

Study ID

NCT02163824

Run by

Kala Pharmaceuticals, Inc.

People needed

380

Starts

2014-05-01

Expected to finish

2014-12-01

Last updated by the study team

2021-01-29

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, 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 19 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

• Sall Research Medical Center — Artesia, California, United States
• North Valley Eye Medical Group — Mission Hills, California, United States
• Martel Eye Medical Group — Rancho Cordova, California, United States
• Wolstan & Goldberg Eye Associates — Torrance, California, United States
• Clayton Eye Center — Morrow, Georgia, United States
• Price Vision Group — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Taustine Eye Center — Louisville, Kentucky, United States
• Tauber Eye Center — Kansas City, Missouri, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Ophthalmology Associates — St Louis, Missouri, United States
• Ophthalmology Consultants — St Louis, Missouri, United States
• Las Vegas Physicians Research Group — Henderson, Nevada, United States
• Raymond Fong, MDPC — New York, New York, United States
• Rochester Ophthalmological Group, PC — Rochester, New York, United States
• Cornerstone Eye Care — High Point, North Carolina, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• The Eye Center of Columbus — Columbus, Ohio, United States
• Westside Research, LLC — Spartanburg, South Carolina, United States
• The Eye Clinic of Texas, Affiliate of Houston Eye Associates — League City, Texas, United States
• R&R Eye Research, LLC — San Antonio, Texas, United States
• Kozlovsky Delay & Winter Eye Consultants, LLC — San Antonio, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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