NAC Eye Drops for Fuchs' Dystrophy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests eye drops containing N-acetyl cysteine (NAC) to determine their effectiveness in protecting and improving eye health in individuals with Fuchs' Dystrophy, a condition affecting the cornea that can lead to vision problems. The researchers aim to discover if the eye drops can reduce oxidative stress, potentially aiding corneal healing. Participants will receive either a 10% or 20% NAC solution or a placebo. Suitable candidates have advanced Fuchs' Dystrophy and cataracts affecting their vision and are scheduled for specific eye surgery. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that N-acetyl cysteine (NAC) eye drops, in both 10% and 20% strengths, are generally safe and well-tolerated. Studies have found that NAC is often used in eye treatments for conditions like dry eye and meibomian gland dysfunction, with a good safety record. Although specific safety data for these solutions in Fuchs' Dystrophy is lacking, NAC's broader use in eye care suggests it is safe for most people. No major reports of side effects have emerged in these cases, offering reassurance to potential trial participants.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about NAC eye drops for Fuchs' Dystrophy because they offer a novel approach by using N-acetyl cysteine (NAC), an antioxidant that targets oxidative stress, a key factor in the progression of this condition. Unlike traditional treatments which mainly focus on managing symptoms, NAC eye drops aim to address the underlying oxidative damage to corneal cells. With concentrations of 10% and 20% being tested, this treatment could provide a more effective and direct method to protect and potentially restore corneal health. Additionally, NAC is well-tolerated and has been used in other eye conditions, making it a promising candidate for improving outcomes in Fuchs' Dystrophy.
What evidence suggests that this trial's treatments could be effective for Fuchs' Dystrophy?
Research has shown that N-acetyl cysteine (NAC) eye drops protect eye cells by reducing damage from harmful molecules, known as oxidative stress. Studies have found that NAC improves the survival of corneal endothelial cells, which are crucial for clear vision. This is particularly beneficial for conditions like Fuchs' Dystrophy, where these cells are at risk. In this trial, researchers are testing both 10% and 20% NAC eye drop solutions in separate treatment arms for their protective effects. Early results suggest that these drops are well-tolerated and may improve eye health by managing oxidative stress.12356
Who Is on the Research Team?
Ula Jurkunas, MD
Principal Investigator
Mass Eye and Ear
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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