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TTHX1114(NM141) in Combination With DWEK/DSO

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04676737
Enrollment
49
Registered
2020-12-21
Start date
2021-02-01
Completion date
2023-01-13
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Fuchs

Brief summary

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

Interventions

TTHX1114

Sponsors

Trefoil Therapeutics, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Best Corrected Visual AcuityDay 28Change from baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026