CompletedPhase 2

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

United States65 participantsStarted 2020-06-23

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Central Corneal Endothelial Cell Density (ECD) at Week 12

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT04250207

SponsorKowa Research Institute, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-22

Results submitted2024-09-20

View on ClinicalTrials.gov More Fuchs' Endothelial Corneal Dystrophy trials