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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250207
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Tracking Information
First Submitted Date  ICMJE January 16, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE June 23, 2020
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
Corneal Central ECD Measure at 12 weeks [ Time Frame: 12 Weeks ]
Change in Central Endothelial Cell Density
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
Safety Assessment [ Time Frame: 52 Weeks ]
Number of participants with at least one adverse event
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fuchs' Endothelial Corneal Dystrophy
Intervention  ICMJE
  • Drug: K-321 Solution
    K-321 solution drops
  • Drug: Placebo Solution
    Placebo solution drops for K-321
Study Arms  ICMJE
  • Experimental: K-321 QID
    K-321 Ophthalmic Solution Dose A
    Intervention: Drug: K-321 Solution
  • Experimental: K-321 BID
    K-321 Ophthalmic Solution Dose B
    Interventions:
    • Drug: K-321 Solution
    • Drug: Placebo Solution
  • Placebo Comparator: Placebo
    Vehicle Solution Dose
    Intervention: Drug: Placebo Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Director, Clinical Operations 919-433-1600 Clinical@KowaUS.com
Listed Location Countries  ICMJE Australia,   Denmark,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250207
Other Study ID Numbers  ICMJE K-321-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kowa Research Institute, Inc.
Study Sponsor  ICMJE Kowa Research Institute, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Shona Pendse, MD, MMSc Kowa Pharma Development Co.
PRS Account Kowa Research Institute, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP