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

NCT04250207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-11-05

Study results available
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Summary

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

Conditions

  • Fuchs' Endothelial Corneal Dystrophy

Interventions

DRUG

K-321 Solution

K-321 solution drops

DRUG

Placebo Solution

Placebo solution drops for K-321

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Shona Pendse, MD, MMSc · Kowa Pharma Development Co.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-23
Primary Completion
2021-09-22
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • Germany
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250207 on ClinicalTrials.gov