Back to resultsA Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
Primary Purpose
Fuchs Endothelial Corneal Dystrophy
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ripasudil
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs Endothelial Corneal Dystrophy
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 the Clinical Study Protocol. Exclusion Criteria: Is a female subject 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) Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Sites / Locations
- Gorovoy MD Eye SpecialistsRecruiting
- Cornea Consultants of AlbanyRecruiting
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 Endothelial Cell Density (ECD) (cells/mm2) at Week 12
Central corneal endothelial cell images will be captured by non-contact specular microscopy.
Full Information
NCT ID
NCT05826353
First Posted
April 6, 2023
Last Updated
May 17, 2023
Sponsor
Kowa Research Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05826353
Brief Title
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and 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 Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 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 simultaneous cataract surgery and 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 Endothelial Cell Density (ECD) (cells/mm2) 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
Meet all other inclusion criteria outlined in the Clinical Study Protocol.
Exclusion Criteria:
Is a female subject 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)
Meet any other exclusion criteria outlined in the Clinical Study Protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Director, Clinical Operations
Phone
919-433-1621
Email
StudyRecruitment@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
Gorovoy MD Eye Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Individual Site Status
Recruiting
Facility Name
Cornea Consultants of Albany
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
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