Study of N-acetyl cysteine for Fuchs' Endothelial Corneal Dystrophy

This study is looking into whether N-acetyl cysteine (NAC) eye drops can help people with Fuchs' Endothelial Corneal Dystrophy (FECD), a common eye condition that affects the cornea. Currently, the main treatment for FECD is corneal transplant surgery, and there are no medical treatments to slow its progress. Researchers believe that NAC eye drops might reduce stress on the cells in your eye and protect them. You could be eligible if you are at least 21 years old, have advanced FECD and cataracts, and are scheduled for a specific type of corneal transplant surgery (DMEK) along with cataract surgery. The study will measure the level of a substance called H2O2 in your eye fluid during your surgery to see if the NAC eye drops are working.

Study design
This is a single-center, randomized, double-blind, placebo-controlled study involving 45 participants. Participants will receive either N-acetyl cysteine (NAC) 10% solution, N-acetyl cysteine (NAC) 20% solution, or Visine Dry Eye Relief eye drops.
What's involved
The primary measurement for the study will occur during DMEK surgery, which happens 28 to 42 days after you join the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at DMEK surgery, which occurs 28 to 42 days after enrollment.

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NCT04440280

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

Recruiting
PHASE2Ages 21+InterventionalTreatment
Massachusetts Eye and Ear Infirmary
~45 participants
Updated 2025-09-29 on ClinicalTrials.gov
What's tested:N-acetyl cysteine (NAC) 10% solutionN-acetyl cysteine (NAC) 20% solutionVisine Dry Eye Relief eye drops

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Level of H2O2 in the aqueous humor
Measured over DMEK Surgery occurs 28 to 42 days after participant enrollment
Fuchs Endothelial Corneal Dystrophy
1 sites across 1 states
Massachusetts1
  • Ula Jurkunas, MD · PRINCIPAL_INVESTIGATOR · Mass Eye and Ear

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  • Level of H2O2 in the aqueous humorDMEK Surgery occurs 28 to 42 days after participant enrollment

    The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.