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

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

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

Study Overview

• Status: Completed
• Conditions: Fuchs' Endothelial Corneal Dystrophy
• Intervention / Treatment: Drug: K-321 Solution; Drug: Placebo Solution

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus Universitetshospital
  • Capital
    • Glostrup, Capital, Denmark, 2600
      • Rigshospitalet - Glostrup
• Germany
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitätsklinikum Erlangen
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Universität des Saarlandes
• Spain
  • Barcelona, Spain, 8035
    • Instituto de Microcirugia Ocular
  • Córdoba, Spain, 14012
    • Hospital La Arruzafa
  • Asturias
    • Oviedo, Asturias, Spain, 33012
      • Instituto Ophthalmologic Fernandez Vega
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitario Germans Trias i Pujol
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute
    • Palo Alto, California, United States, 94304
      • Byers Eye Institute at Stanford
    • Sacramento, California, United States, 95817
      • UC Davis Eye Center
    • Sacramento, California, United States, 98515
      • Sacramento Eye Consultants
  • Florida
    • Fort Myers, Florida, United States, 33907
      • Gorovoy MD Eye Specialists
    • Gainesville, Florida, United States, 32605
      • UF Health Eye Center
  • Illinois
    • Hoffman Estates, Illinois, United States, 60169
      • Chicago Cornea Consultants Ltd
    • Orland Park, Illinois, United States, 60467
      • Arbor Centers For Eyecare
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts Eye and Ear Infirmary
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • W Kellogg Eye Center
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Minnesota Eye Consultants
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Eye Associates of New Mexico
  • New York
    • New York, New York, United States, 10017
      • NY Langone Health
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Oregon
    • Portland, Oregon, United States, 97210
      • Devers Eye Institute
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute - OHSU
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Vantage EyeCare, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K-321 QID; K-321 Ophthalmic Solution Dose A	Drug: K-321 Solution; K-321 solution drops
Experimental: K-321 BID; K-321 Ophthalmic Solution Dose B	Drug: K-321 Solution; K-321 solution drops; Drug: Placebo Solution; Placebo solution drops for K-321
Placebo Comparator: Placebo; Vehicle Solution Dose	Drug: Placebo Solution; Placebo solution drops for K-321

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Central Corneal Endothelial Cell Density (ECD) at Week 12	Change in Central ECD at week 12	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness	Baseline up to 52 Weeks
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit	Baseline to Week 52
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness	Baseline up to Week 52
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit	Baseline to Week 52

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.
• Investigators: Study Chair: Shona Pendse, MD, MMSc, Kowa Pharma Development Co.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): June 27, 2022

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Eye Diseases; Corneal Diseases; Eye Diseases, Hereditary; Fuchs' Endothelial Dystrophy; Corneal Dystrophies, Hereditary; Pharmaceutical Solutions
• Other Study ID Numbers: K-321-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No