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

NCT04250207 | Completed Phase 2 Results FDA Drug

• 1 other identifier: K-321-201
• Study Type: interventional
• Target: 65
• Locations: 5 countries
• Sites: 29

Brief Summary

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

Conditions

Fuchs' Endothelial Corneal Dystrophy

Outcome Measures

Primary Outcomes (1)

• Central Corneal Endothelial Cell Density (ECD) at Week 12

  Change in Central ECD at week 12

  Baseline to Week 12

Secondary Outcomes (9)

• Central Corneal ECD From Baseline to Each Subsequent Visit

  Baseline to Week 52

• Change From Baseline in Central Corneal Thickness

  Baseline to Week 52

• Time to Achievement of no Corneal Oedema of Study Eye

  Baseline to Week 52

• Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit

  Baseline to Week 52

• Time to Achieve Central Corneal ECD 700 Cells/mm2 or More

  Up to 52 Weeks

Study Arms (3)

K-321 QID

EXPERIMENTAL

K-321 Ophthalmic Solution Dose A

Drug: K-321 Solution

K-321 BID

EXPERIMENTAL

K-321 Ophthalmic Solution Dose B

Drug: K-321 Solution; Drug: Placebo Solution

Placebo

PLACEBO COMPARATOR

Vehicle Solution Dose

Drug: Placebo Solution

Interventions

K-321 Solution DRUG

K-321 solution drops

K-321 BID; K-321 QID

Placebo Solution DRUG

Placebo solution drops for K-321

K-321 BID; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years old at the screening visit (Visit 1).
• Has a diagnosis of FECD at Visit 1.

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.

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (29)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Byers Eye Institute at Stanford

Palo Alto, California, 94304, United States

Location

UC Davis Eye Center

Sacramento, California, 95817, United States

Location

Sacramento Eye Consultants

Sacramento, California, 98515, United States

Location

Gorovoy MD Eye Specialists

Fort Myers, Florida, 33907, United States

Location

UF Health Eye Center

Gainesville, Florida, 32605, United States

Location

Chicago Cornea Consultants Ltd

Hoffman Estates, Illinois, 60169, United States

Location

Arbor Centers For Eyecare

Orland Park, Illinois, 60467, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

W Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

Minnesota Eye Consultants

Bloomington, Minnesota, 55431, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

NY Langone Health

New York, New York, 10017, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Casey Eye Institute - OHSU

Portland, Oregon, 97239, United States

Location

Vantage EyeCare, LLC

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

UPMC Eye Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Rigshospitalet - Glostrup

Glostrup Municipality, Capital, 2600, Denmark

Location

Aarhus Universitetshospital

Aarhus, 8200, Denmark

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Universität des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Instituto Ophthalmologic Fernandez Vega

Oviedo, Principality of Asturias, 33012, Spain

Location

Instituto de Microcirugia Ocular

Barcelona, 8035, Spain

Location

Hospital La Arruzafa

Córdoba, 14012, Spain

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Kowa Research Institute, Inc.

CTGResults@KowaUS.com

919-433-1600

Study Officials

• Shona Pendse, MD, MMSc

  Kowa Pharma Development Co.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 31, 2020
• Study Start: June 23, 2020
• Primary Completion: September 22, 2021
• Study Completion: June 27, 2022
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); DK (2); ES (4); AU (2); DE (2)