Skip to main content
OpenTrials
Completed

NCT Number: NCT04250207

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fuchs' Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sydney Eye Hospital, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-321 Solution

Drug

K-321 solution drops

Placebo solution

Drug

Placebo solution drops for K-321

Primary outcomes

  1. Central Corneal Endothelial Cell Density (ECD) at Week 12

    Time frame: Baseline to Week 12

    Change in Central ECD at week 12

Secondary outcomes

  1. Central Corneal ECD From Baseline to Each Subsequent Visit

    Time frame: Baseline to Week 52

  2. Change From Baseline in Central Corneal Thickness

    Time frame: Baseline to Week 52

  3. Time to Achievement of no Corneal Oedema of Study Eye

    Time frame: Baseline to Week 52

  4. Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit

    Time frame: Baseline to Week 52

  5. Time to Achieve Central Corneal ECD 700 Cells/mm2 or More

    Time frame: Up to 52 Weeks

  6. Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness

    Time frame: Baseline up to 52 Weeks

  7. Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit

    Time frame: Baseline to Week 52

  8. Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness

    Time frame: Baseline up to Week 52

  9. Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit

    Time frame: Baseline to Week 52

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 31, 2020
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.