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

Primary Purpose

Fuchs' Endothelial Corneal Dystrophy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
K-321 Solution
Placebo Solution
Sponsored by
Kowa Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Endothelial Corneal Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jules Stein Eye Institute
  • Byers Eye Institute at Stanford
  • UC Davis Eye Center
  • Sacramento Eye Consultants
  • Gorovoy MD Eye Specialists
  • UF Health Eye Center
  • Chicago Cornea Consultants Ltd
  • Arbor Centers For Eyecare
  • Price Vision Group
  • Massachusetts Eye and Ear Infirmary
  • W Kellogg Eye Center
  • Minnesota Eye Consultants
  • Eye Associates of New Mexico
  • NY Langone Health
  • Cincinnati Eye Institute
  • Devers Eye Institute
  • Casey Eye Institute - OHSU
  • Vantage EyeCare, LLC
  • UPMC Eye Center
  • Sydney Eye Hospital
  • Royal Adelaide Hospital
  • Rigshospitalet - Glostrup
  • Aarhus Universitetshospital
  • Universitätsklinikum Erlangen
  • Universität des Saarlandes
  • Instituto Ophthalmologic Fernandez Vega
  • Hospital Universitario Germans Trias i Pujol
  • Instituto de Microcirugia Ocular
  • Hospital La Arruzafa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

K-321 QID

K-321 BID

Placebo

Arm Description

K-321 Ophthalmic Solution Dose A

K-321 Ophthalmic Solution Dose B

Vehicle Solution Dose

Outcomes

Primary Outcome Measures

Corneal Central ECD Measure at 12 weeks
Change in Central Endothelial Cell Density

Secondary Outcome Measures

Safety Assessment
Number of participants with at least one adverse event

Full Information

First Posted
January 16, 2020
Last Updated
September 20, 2022
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04250207
Brief Title
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
September 22, 2021 (Actual)
Study Completion Date
June 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kowa Research Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Corneal Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
K-321 QID
Arm Type
Experimental
Arm Description
K-321 Ophthalmic Solution Dose A
Arm Title
K-321 BID
Arm Type
Experimental
Arm Description
K-321 Ophthalmic Solution Dose B
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Vehicle Solution Dose
Intervention Type
Drug
Intervention Name(s)
K-321 Solution
Intervention Description
K-321 solution drops
Intervention Type
Drug
Intervention Name(s)
Placebo Solution
Intervention Description
Placebo solution drops for K-321
Primary Outcome Measure Information:
Title
Corneal Central ECD Measure at 12 weeks
Description
Change in Central Endothelial Cell Density
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Safety Assessment
Description
Number of participants with at least one adverse event
Time Frame
52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shona Pendse, MD, MMSc
Organizational Affiliation
Kowa Pharma Development Co.
Official's Role
Study Chair
Facility Information:
Facility Name
Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC Davis Eye Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
98515
Country
United States
Facility Name
Gorovoy MD Eye Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
UF Health Eye Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Chicago Cornea Consultants Ltd
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Arbor Centers For Eyecare
City
Orland Park
State/Province
Illinois
ZIP/Postal Code
60467
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
W Kellogg Eye Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Minnesota Eye Consultants
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
NY Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Casey Eye Institute - OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Vantage EyeCare, LLC
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
UPMC Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Sydney Eye Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Rigshospitalet - Glostrup
City
Glostrup
State/Province
Capital
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
State/Province
Bayern
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universität des Saarlandes
City
Homburg
State/Province
Saarland
ZIP/Postal Code
66421
Country
Germany
Facility Name
Instituto Ophthalmologic Fernandez Vega
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Instituto de Microcirugia Ocular
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital La Arruzafa
City
Córdoba
ZIP/Postal Code
14012
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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