What side effects are associated with this type of intervention?

Common treatments for Fuchs' Dystrophy include antioxidants like N-acetyl cysteine (NAC), which aim to reduce oxidative stress and provide cytoprotection. Known side effects of NAC can include gastrointestinal issues such as nausea, vomiting, and diarrhea. Additionally, some patients may experience allergic reactions, including rash, itching, or swelling. In rare cases, NAC can cause more severe reactions like bronchospasm or anaphylaxis. It is important for patients to discuss potential side effects with their healthcare provider to ensure safe and effective treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs that target Fuchs' Endothelial Corneal Dystrophy (FECD) by decreasing oxidative stress or providing cytoprotection similar to N-acetyl cysteine (NAC). The primary treatments for FECD have traditionally focused on managing symptoms and surgical interventions such as corneal transplants. Research is ongoing to explore the potential of antioxidants like NAC in reducing oxidative stress and protecting corneal cells, but these treatments are still in the trial phase and have not yet received FDA approval.

What other types of research exist?

Currently, the provided context does not mention specific novel alternatives to N-acetyl cysteine for Fuchs' Dystrophy. However, patients should discuss with their doctors about ongoing research and emerging treatments targeting oxidative stress and cytoprotection, as advancements in this field are continually evolving.

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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 assessed when subject starts study drug and again, 21 to 28 days later.

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 below

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I need surgery for a cornea transplant and cataract removal at the same time.

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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:

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I have a history of serious eye conditions affecting the cornea.

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I use eye medication, but only for dryness, swelling, or pressure.

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I have had eye surgery for cataract, glaucoma, or retina issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed when subject starts study drug and again, 21 to 28 days later.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed when subject starts study drug and again, 21 to 28 days later.

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed when subject starts study drug and again, 21 to 28 days later. for reporting.

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 more

Awards & 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.)

0 / 5Eligibility criteria met

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.