Safety and Efficacy of KPI-121 in Subjects With DED

Completed · Phase 3

Conditions studied: Kerato Conjunctivitis Sicca

In brief

The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25% ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2 drops instilled in each eye four times daily (QID).

Key facts

Study ID

NCT03616899

Run by

Kala Pharmaceuticals, Inc.

People needed

901

Starts

2018-07-10

Expected to finish

2020-02-05

Last updated by the study team

2021-04-02

Who can join

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

You may qualify if…

• Have a documented clinical diagnosis of dry eye disease in both eyes

You may not qualify if…

• Known hypersensitivity or contraindication to the investigational 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; or have been exposed to an investigational drug within 30 days prior to screening.
• In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Where it is running

• Investigator #278 — Dothan, Alabama, United States
• Investigator #146 — Chandler, Arizona, United States
• Investigator #148 — Phoenix, Arizona, United States
• Investigator #280 — Prescott, Arizona, United States
• Investigator #276 — Sun City, Arizona, United States
• Investigator #185 — Azusa, California, United States
• Investigator #143 — Garden Grove, California, United States
• Investigator #147 — Glendale, California, United States
• Investigator #272 — Hemet, California, United States
• Investigator #155 — Inglewood, California, United States
• Investigator #273 — Long Beach, California, United States
• Investigator #130 — Mission Hills, California, United States
• Investigator #247 — Murrieta, California, United States
• Investigator #215 — Newport Beach, California, United States
• Site #111 — Rancho Cordova, California, United States
• Investigator #271 — Santa Ana, California, United States
• Investigator #107 — Torrance, California, United States
• Investigator #213 — Westminster, California, United States
• Investigator #218 — Littleton, Colorado, United States
• Investigator #184 — Brooksville, Florida, United States
• Investigator #262 — Delray Beach, Florida, United States
• Investigator #279 — Fort Myers, Florida, United States
• Investigator #265 — Jacksonville, Florida, United States
• Investigator #157 — Largo, Florida, United States
• Investigator #133 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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