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Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy

NCT04440280 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-09-29

No results posted yet for this study

Summary

This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.

Conditions

  • Fuchs Endothelial Corneal Dystrophy

Interventions

DRUG

N-acetyl cysteine (NAC) 10% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.

DRUG

N-acetyl cysteine (NAC) 20% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.

DRUG

Visine Dry Eye Relief eye drops

Visine Tears Dry Eye Relief artificial tears ophthalmic solution

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Ula Jurkunas, MD · Mass Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2026-04-29
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

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 NCT04440280 on ClinicalTrials.gov