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

Fuchs' Endothelial Corneal Dystrophy Clinical Trial

Official title:

A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04250207
• Other study ID #: K-321-201
• Status: Completed
• Phase: Phase 2
• Start date: June 23, 2020
• Est. completion date: June 27, 2022

Study information

• Verified date: September 2022
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 27, 2022
• Est. primary completion date: September 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Fuchs' Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• K-321 Solution
K-321 solution drops
• Placebo Solution
Placebo solution drops for K-321

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Sydney Eye Hospital	Sydney	New South Wales
Denmark	Aarhus Universitetshospital	Aarhus
Denmark	Rigshospitalet - Glostrup	Glostrup	Capital
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Universität des Saarlandes	Homburg	Saarland
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Instituto de Microcirugia Ocular	Barcelona
Spain	Hospital La Arruzafa	Córdoba
Spain	Instituto Ophthalmologic Fernandez Vega	Oviedo	Asturias
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	W Kellogg Eye Center	Ann Arbor	Michigan
United States	Vantage EyeCare, LLC	Bala-Cynwyd	Pennsylvania
United States	Minnesota Eye Consultants	Bloomington	Minnesota
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Cincinnati Eye Institute	Cincinnati	Ohio
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	Price Vision Group	Indianapolis	Indiana
United States	Jules Stein Eye Institute	Los Angeles	California
United States	NY Langone Health	New York	New York
United States	Arbor Centers For Eyecare	Orland Park	Illinois
United States	Byers Eye Institute at Stanford	Palo Alto	California
United States	UPMC Eye Center	Pittsburgh	Pennsylvania
United States	Casey Eye Institute - OHSU	Portland	Oregon
United States	Devers Eye Institute	Portland	Oregon
United States	Sacramento Eye Consultants	Sacramento	California
United States	UC Davis Eye Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Central ECD Measure at 12 weeks	Change in Central Endothelial Cell Density	12 Weeks
Secondary	Safety Assessment	Number of participants with at least one adverse event	52 Weeks