Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

Completed · Phase 2 · Has a placebo group

Conditions studied: Fuchs' Endothelial Corneal Dystrophy

In brief

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Key facts

Study ID

NCT04250207

Run by

Kowa Research Institute, Inc.

People needed

65

Starts

2020-06-23

Expected to finish

2022-06-27

Last updated by the study team

2024-11-05

Who can join

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

You may qualify if…

• Is at least 18 years old at the screening visit (Visit 1).
• Has a diagnosis of FECD at Visit 1.
• Meet all other inclusion criteria outlined in clinical study protocol.

You may not qualify if…

• Has a study eye with a history of cataract surgery within 90 days of Visit 1.
• Has a study eye with a history of any previous ocular surgery other than for cataract.
• Meet any other exclusion criteria outlined in clinical study protocol.

Where it is running

• Jules Stein Eye Institute — Los Angeles, California, United States
• Byers Eye Institute at Stanford — Palo Alto, California, United States
• UC Davis Eye Center — Sacramento, California, United States
• Sacramento Eye Consultants — Sacramento, California, United States
• Gorovoy MD Eye Specialists — Fort Myers, Florida, United States
• UF Health Eye Center — Gainesville, Florida, United States
• Chicago Cornea Consultants Ltd — Hoffman Estates, Illinois, United States
• Arbor Centers For Eyecare — Orland Park, Illinois, United States
• Price Vision Group — Indianapolis, Indiana, United States
• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
• W Kellogg Eye Center — Ann Arbor, Michigan, United States
• Minnesota Eye Consultants — Bloomington, Minnesota, United States
• Eye Associates of New Mexico — Albuquerque, New Mexico, United States
• NY Langone Health — New York, New York, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Devers Eye Institute — Portland, Oregon, United States
• Casey Eye Institute - OHSU — Portland, Oregon, United States
• Vantage EyeCare, LLC — Bala-Cynwyd, Pennsylvania, United States
• UPMC Eye Center — Pittsburgh, Pennsylvania, United States
• Sydney Eye Hospital — Sydney, New South Wales, Australia
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Rigshospitalet - Glostrup — Glostrup Municipality, Capital, Denmark
• Aarhus Universitetshospital — Aarhus, Denmark
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany
• Universität des Saarlandes — Homburg, Saarland, Germany

Full record on ClinicalTrials.gov

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