NAC Eye Drops for Fuchs' Dystrophy
Trial Summary
Will I have to stop taking my current medications?
You may need to stop using certain eye medications, except for lubricants, hyperosmotic agents, or ocular hypotensive agents. If you're using N-Acetylcysteine in any form, you'll need to stop at least 30 days before joining the trial.
What data supports the effectiveness of the drug N-acetyl cysteine (NAC) eye drops for Fuchs' Dystrophy?
Is N-acetylcysteine (NAC) generally safe for human use?
How is the drug N-acetyl cysteine (NAC) unique for treating Fuchs' Dystrophy?
N-acetyl cysteine (NAC) eye drops are unique for treating Fuchs' Dystrophy because they help protect corneal cells from oxidative stress (damage caused by harmful molecules) and endoplasmic reticulum stress (cellular stress related to protein folding), which are key factors in this condition. This approach is different from other treatments that may not specifically target these stress pathways.12489
What is the purpose of this trial?
This trial tests if NAC eye drops can protect eye cells by reducing harmful oxidative stress in patients with advanced FECD and cataracts. The study involves patients who are already scheduled for eye surgeries. NAC is expected to help by protecting the corneal cells from damage. NAC has been used topically in the treatment of various eye conditions due to its antioxidant, anti-inflammatory, and mucolytic properties.
Research Team
Ula Jurkunas, MD
Principal Investigator
Mass Eye and Ear
Eligibility Criteria
This trial is for adults over 21 with advanced Fuchs' Endothelial Corneal Dystrophy (FECD) and cataracts needing surgery. Participants must be able to follow the medication plan and not be pregnant, breastfeeding, or unwilling to use birth control. They shouldn't have had previous eye surgeries in the study eye or used certain medications recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer NAC or placebo eye drops four times a day for 28 days prior to planned surgery
Surgery
Participants undergo DMEK and cataract surgery, with collection of aqueous fluid and corneal tissue for analysis
Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessment of adverse events and corneal measurements
Treatment Details
Interventions
- N-acetyl cysteine (NAC) 10% solution
- N-acetyl cysteine (NAC) 20% solution
- Visine Dry Eye Relief eye drops
N-acetyl cysteine (NAC) 10% solution is already approved in United States, European Union, Canada for the following indications:
- Mucolytic agent
- Acetaminophen antidote
- Dry eye disease
- Mucolytic agent
- Paracetamol overdose
- Dry eye disease
- Mucolytic agent
- Acetaminophen antidote
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor