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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 : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Corneal Dystrophy Drug: K-321 Solution Drug: Placebo Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Corneal Central ECD Measure at 12 weeks [ Time Frame: 12 Weeks ]
    Change in Central Endothelial Cell Density


Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 52 Weeks ]
    Number of participants with at least one adverse event


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250207


Contacts
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Contact: Director, Clinical Operations 919-433-1600 Clinical@KowaUS.com

Locations
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Sponsors and Collaborators
Kowa Research Institute, Inc.
Investigators
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Study Chair: Shona Pendse, MD, MMSc Kowa Pharma Development Co.
More Information
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Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04250207    
Other Study ID Numbers: K-321-201
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Iridocorneal Endothelial Syndrome
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
 Eye Diseases, Hereditary
Genetic Diseases, Inborn
Iris Diseases
Uveal Diseases
Pharmaceutical Solutions