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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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

Eligibility criteria

Qualifiers

Male or female ≥21 years of age at time of surgical evaluation.

Diagnosis of advanced FECD and visually significant cataract

Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery

Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Disqualifiers

Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery

History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections

Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents

Trial design

Treatments tested in this trial

  • N-acetyl cysteine (NAC) 10% solution
  • N-acetyl cysteine (NAC) 20% solution
  • Visine Dry Eye Relief eye drops

Treatment groups

45 Participants
are divided into 3 treatment groups