TTHX1114(NM141) in Combination With DWEK/DSO

Phase 2CompletedNCT04676737

Trefoil Therapeutics, Inc.49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fuchs' Endothelial Dystrophy Fuchs Dystrophy Fuchs

Interventions

TTHX1114(NM141)DRUG

TTHX1114

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Trefoil Investigational Site 124

Long Beach, California, United States

North Bay Eye Associates

Petaluma, California, United States

Trefoil Investigational Site 123

Deerfield Beach, Florida, United States

Outcomes

Primary Outcomes

Best Corrected Visual Acuity

Change from baseline

Time frame: Day 28

Data from ClinicalTrials.gov

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