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A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Primary Purpose

Fuchs Endothelial Corneal Dystrophy

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ripasudil
Placebo
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 Meets all other inclusion criteria outlined in clinical study protocol Exclusion Criteria: Is a female patient of childbearing potential and any of the following is true: is pregnant or lactating/breastfeeding, or is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) Has a study eye with a history of cataract surgery within 90 days of Visit 1 Meet any other exclusion criteria outlined in clinical study protocol

Sites / Locations

  • Sacramento Eye Consultants
  • Gorovoy MD Eye Specialists
  • Verdier Eye Center
  • Tauber Eye CenterRecruiting
  • NYU Langone Health
  • Cornea Consultants of Albany
  • Devers Eye InstituteRecruiting
  • Ophthalmic Partners
  • Aarhus Universitetshospital
  • Instituto Oftalmologico Fernandez Vega
  • Hospital Universitario Germans Trias i Pujol
  • Althaia Xarxa Assistencial de Manresa
  • Instituto de Microcirugia Ocular
  • Hospital La ArruzafaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

K-321

Placebo

Arm Description

K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase

Outcomes

Primary Outcome Measures

Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

Secondary Outcome Measures

Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Central corneal ECD at Week 12
Central corneal endothelial cell images will be captured by non-contact specular microscopy.

Full Information

First Posted
March 21, 2023
Last Updated
June 19, 2023
Sponsor
Kowa Research Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05795699
Brief Title
A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
Official Title
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

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
A study to assess the safety and efficacy of K-321 in participants with 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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
K-321
Arm Type
Experimental
Arm Description
K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Intervention Type
Drug
Intervention Name(s)
Ripasudil
Other Intervention Name(s)
K-321
Intervention Description
K-321 ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo ophthalmic solution
Primary Outcome Measure Information:
Title
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame
Baseline to Week 12
Title
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Time Frame
Baseline to Week 12
Title
Central corneal ECD at Week 12
Description
Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Time Frame
Week 12

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 Meets all other inclusion criteria outlined in clinical study protocol Exclusion Criteria: Is a female patient of childbearing potential and any of the following is true: is pregnant or lactating/breastfeeding, or is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not practicing an effective method of birth control as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) Has a study eye with a history of cataract surgery within 90 days of Visit 1 Meet any other exclusion criteria outlined in clinical study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director, Clinical Operations
Phone
919-433-1600
Email
Clinical@KowaUS.com
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
Sacramento Eye Consultants
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Gorovoy MD Eye Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Verdier Eye Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Cornea Consultants of Albany
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
Ophthalmic Partners
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Aarhus Universitetshospital
City
Aarhus
State/Province
Central Jutland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Instituto Oftalmologico Fernandez Vega
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33012
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Althaia Xarxa Assistencial de Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
8243
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Microcirugia Ocular
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Hospital La Arruzafa
City
Córdoba
ZIP/Postal Code
14012
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

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