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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Kowa Research Institute, Inc.
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Updated on 19 February 2024
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corneal dystrophy
fuchs' endothelial dystrophy

Summary

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Details
Condition Fuchs' Endothelial Corneal Dystrophy
Age 18years - 100years
Treatment K-321 Solution, Placebo Solution
Clinical Study IdentifierNCT04250207
SponsorKowa Research Institute, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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