Skip to main content
OpenTrials
Completed

NCT Number: NCT04676737

TTHX1114(NM141) in Combination With DWEK/DSO

Open label, single-treatment, with a concurrent non-treatment control

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Trefoil Investigational Site 124, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Fuchs Endothelial Cell Dystrophy (FECD) diagnosed more than 6 months
  • Scheduled for DWEK/DSO with a planned central descemetorhexis of approx 4 to 5 mm
  • Subjects in Group 2 must have a stable Fellow Eye with adequate function

Key Exclusion Criteria:

  • Secondary corneal/ocular pathology in the Study Eye
  • Prior refractive surgery in the Study Eye
  • Prior exposure to TTHX1114

Treatment and study plan

TTHX1114(NM141)

Drug

TTHX1114

Primary outcomes

  1. Best Corrected Visual Acuity

    Time frame: Day 28

    Change from baseline

Sponsors and collaborators

Lead sponsor

Trefoil Therapeutics, Inc.

Industry

Registry information

Official study title

Phase 2 Study To Determine the Safety and Efficacy of TTHX1114(NM141) on the Regeneration and Migration of Corneal Endothelial Cells in Patients Undergoing DWEK/DSO

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 21, 2020
Registry last updated
Nov 7, 2023

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.