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

  • STATUS
    Recruiting
  • End date
    Oct 30, 2021
  • participants needed
    60
  • sponsor
    Kowa Research Institute, Inc.
Updated on 30 November 2020
Investigator
Senior Clinical Research Associate
Primary Contact
Sydney Eye Hospital (7.3 mi away) Contact
+29 other location
corneal 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
Treatment Placebo solution, K-321 Solution
Clinical Study IdentifierNCT04250207
SponsorKowa Research Institute, Inc.
Last Modified on30 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Fuchs' Endothelial Corneal Dystrophy?
Do you have any of these conditions: Do you have Fuchs' Endothelial Corneal Dystrophy??
Do you have any of these conditions: Do you have Fuchs' Endothelial Corneal Dystrophy??
Do you have any of these conditions: Do you have Fuchs' Endothelial Corneal Dystrophy??
Do you have any of these conditions: Do you have Fuchs' Endothelial Corneal Dystrophy??
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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Step 4 Get your study results

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