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Antioxidant
NAC Eye Drops for Fuchs' Dystrophy
Phase 2
Recruiting
Led By Ula Jurkunas, MD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
Diagnosis of advanced FECD and visually significant cataract
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug.
Awards & highlights
All Individual Drugs Already Approved
Summary
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.
Who is the study for?
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.
What is being tested?
The study tests if N-acetyl cysteine (NAC) eye drops can reduce oxidative stress and protect cells in patients with FECD. It compares Visine Dry Eye Relief drops, NAC 10% solution, and NAC 20% solution applied topically before corneal surgery.
What are the potential side effects?
Potential side effects may include irritation at the application site, allergic reactions if sensitive to ingredients, temporary visual disturbances due to drop application, or discomfort from the eyedrops.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need surgery for a cornea transplant and cataract removal at the same time.
Select...
I have advanced Fuchs' dystrophy and a significant cataract affecting my vision.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious eye conditions affecting the cornea.
Select...
I use eye medication, but only for dryness, swelling, or pressure.
Select...
I have had eye surgery for cataract, glaucoma, or retina issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tolerability will be assessed after participants have taken study drug for 28 days or earlier, if the participants report difficulties tolerating the drug.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Level of H2O2 in the aqueous humor
Secondary study objectives
Assessment of safety of NAC eye drops in patients with FECD by documenting the number and severity of adverse events.
Assessment of tolerability of N-acetyl cysteine drops in patients with FECD by documenting participants' reports of irritation, burning, itchiness or redness in their eyes while taking the study drug
Change in central corneal thickness after NAC administration
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: NAC 20% groupActive Control1 Intervention
Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
Group II: NAC 10% groupActive Control1 Intervention
Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.
Group III: Placebo groupPlacebo Group1 Intervention
Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Fuchs' Dystrophy, such as N-acetyl cysteine (NAC), work by reducing oxidative stress and providing cytoprotection to corneal endothelial cells. NAC acts as a free radical scavenger, neutralizing reactive oxygen species (ROS) that can damage cells.
By decreasing oxidative stress, NAC helps to maintain the health and function of the corneal endothelium, which is crucial for preserving vision in patients with Fuchs' Dystrophy. This antioxidant approach is significant because it targets the underlying cellular damage that contributes to the progression of the disease, potentially slowing its advancement and improving patient outcomes.
Selenium Deficiency Leads to Reduced Skeletal Muscle Cell Differentiation by Oxidative Stress in Mice.Cisplatin resistance in human cervical, ovarian and lung cancer cells.Coexposure to benzo[a]pyrene plus ultraviolet A induces 8-oxo-7,8-dihydro-2'-deoxyguanosine formation in human skin fibroblasts: preventive effects of anti-oxidant agents.
Selenium Deficiency Leads to Reduced Skeletal Muscle Cell Differentiation by Oxidative Stress in Mice.Cisplatin resistance in human cervical, ovarian and lung cancer cells.Coexposure to benzo[a]pyrene plus ultraviolet A induces 8-oxo-7,8-dihydro-2'-deoxyguanosine formation in human skin fibroblasts: preventive effects of anti-oxidant agents.
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
12,636 Total Patients Enrolled
Ula Jurkunas, MD4.823 ReviewsPrincipal Investigator - Mass Eye and Ear
Massachusetts Eye and Ear Infirmary
1 Previous Clinical Trials
14 Total Patients Enrolled
5Patient Review
She is extremely professional and knowledgeable.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need surgery for a cornea transplant and cataract removal at the same time.I have a history of serious eye conditions affecting the cornea.I use eye medication, but only for dryness, swelling, or pressure.I am 21 years old or older.You have experienced negative reactions to using N-Acetylcysteine on your skin in the past.I have advanced Fuchs' dystrophy and a significant cataract affecting my vision.I am willing and able to follow the medication plan.I am 21 years old or older.I have had eye surgery for cataract, glaucoma, or retina issues.I have not had an eye infection in the last 30 days.I haven't used N-Acetylcysteine in any form in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: NAC 20% group
- Group 3: NAC 10% group
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.